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{{DrugProjectFormSinglePage
{{DrugProjectFormSinglePage
|authorTag={{Alonso}}
|authorTag={{Alonso}}
|genericName=Digoxin
|genericName=generic name
|aOrAn=a
|aOrAn=a
|drugClass=[[cardiac glycoside]]
|drugClass=Adrenergic receptor agonist
|indicationType=treatment
|indication=[[ventricular arrhythmias]] such as those occurring in relation to acute [[myocardial infarction]], or during cardiac manipulation, such as [[cardiac surgery]]
|indication=[[atrial fibrillation]], [[atrial flutter]], and [[heart failure]]
|adverseReactions=[[bradyarrhythmia]], [[hypotension]], [[backache]] [[dizziness]], [[headache]], [[lightheadedness]], [[numbness]], [[paresthesia]], [[shivering]], [[somnolence]], blurred vision, burning sensation in eye, [[conjunctival hyperemia]], corneal epithelial defect, [[diplopia]], [[apprehension]], [[confusion]], [[euphoria]], feeling nervous.
|adverseReactions=[[dizziness]], [[headache]], [[mental disorder]], [[nausea]], and [[vomiting]]
|blackBoxWarningTitle=Warning Title
|blackBoxWarningTitle=Warning Title
|blackBoxWarningBody=<i><span style="color:#FF0000;">Condition Name:</span></i> (Content)
|blackBoxWarningBody=<i><span style="color:#FF0000;">Condition Name:</span></i> (Content)
|fdaLIADAdult======Heart failure=====
|fdaLIADAdult======Single Direct Intravenous Injection (bolus)=====
* Only the 50 and 100 mg dosage sizes should be used for direct intravenous injection. The usual dose is 50 to 100 mg of lidocaine hydrochloride (0.70 to 1.4 mg/kg; 0.32 to 0.63 mg/lb) administered intravenously under [[ECG monitoring]]. This dose may be administered at the rate of approximately 25 to 50 mg/min (0.35 to 0.70 mg/kg/min; 0.16 to 0.32 mg/lb/min).
* Sufficient time should be allowed to enable a slow circulation to carry the drug to the site of action. If the initial injection of 50 to 100 mg does not produce a desired response, a second dose may be injected after 5 minutes. No more than 200 to 300 mg of lidocaine hydocloride should be administered during a one hour period.
 
=====Continuous Intravenous Infusion=====
* Following bolus administration, intravenous infusions of lidocaine hydrochloride may be initiated at the rate of 1 to 4 mg/min of lidocaine hydrochloride (0.014 to 0.057 mg/kg/min; 0.006 to 0.026 mg/lb/min). The rate of intravenous infusions should be reassessed as soon as the patient’s basic [[cardiac rhythm]] appears to be stable or at the earliest signs of toxicity. It should rarely be necessary to continue intravenous infusions of lidocaine for prolonged periods.
* Solutions for intravenous infusion may be prepared by the addition of one gram (or two grams) of lidocaine hydrochloride to one liter of 5% dextrose in water using aseptic technique. Approximately a 0.1% (or 0.2%) solution will result from this procedure; that is, each milliliter will contain approximately 1 (or 2) mg of lidocaine hydrochloride. In those cases in which fluid restriction is medically appropriate, a more concentrated solution may be prepared.
* Lidocaine hydrochloride injection has been found to be chemically stable for 24 hours after dilution in 5% dextrose in water. However, as with all intravenous admixtures, dilution of the solution should be made just prior to its administration.
* It is very important that after adding lidocaine hydrochloride, or any other medication, to an I.V. container, the contents be thoroughly mixed before beginning the infusion.
* When administering by continuous I.V. infusion, it is advisable to use a precision volume control I.V. set.
|offLabelAdultNoGuideSupport======Aortocoronary Bypass Grafting=====


* Dosing Information
* Dosing Information


:* Loading dose:  '''10-15 mcg/kg PO'''  administer half the total loading dose initially, then ¼ the loading dose every 6 to 8 hours twice.
:* 1 mg/min IV infusion<ref name="pmid6981016">{{cite journal| author=Sunamori M, Okamura T, Amano J, Suma H, Suzuki A| title=Myocardial protection by lidocaine hydrochloride in aorto-coronary bypass surgery. | journal=Jpn J Surg | year= 1982 | volume= 12 | issue= 2 | pages= 93-7 | pmid=6981016 | doi= | pmc= | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=6981016 }} </ref>
:: '''8-12 mcg/kg IV''' administer half the total loading dose initially, then ¼ the loading dose every 6 to 8 hours twice.
:* 100 mg bolus 2 minutes before releasing the aortic clamp administered through a bypass pump.<ref name="pmid11052433">{{cite journal| author=Baraka A, Kawkabani N, Dabbous A, Nawfal M| title=Lidocaine for prevention of reperfusion ventricular fibrillation after release of aortic cross-clamping. | journal=J Cardiothorac Vasc Anesth | year= 2000 | volume= 14 | issue= 5 | pages= 531-3 | pmid=11052433 | doi=10.1053/jcan.2000.9484 | pmc= | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=11052433 }} </ref>


:* Maintenance dose:  '''3.4-5.1 mcg/kg/day PO ''' once daily.
=====Regional Pain Syndrome=====


:: '''2.4-3.6 mcg/kh/day IV''' once daily.
* Dosing Information
=====Atrial fibrillation=====


* Dosing Information
:* Lidocaine continuous infusion administered as a initial dose of 200 mg through the first hour, followed by  100 to 190 mg/h according to tolerance. Infusion should be continue until maximum pain control is reached.<ref name="pmid10206569">{{cite journal| author=Linchitz RM, Raheb JC| title=Subcutaneous infusion of lidocaine provides effective pain relief for CRPS patients. | journal=Clin J Pain | year= 1999 | volume= 15 | issue= 1 | pages= 67-72 | pmid=10206569 | doi= | pmc= | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=10206569  }} </ref>


:* Loading dose:  '''10-15 mcg/kg PO'''  administer half the total loading dose initially, then ¼ the loading dose every 6 to 8 hours twice.
=====Infusion Pain=====
:: '''8-12 mcg/kg IV'''  administer half the total loading dose initially, then ¼ the loading dose every 6 to 8 hours twice.
:*Maintenance dose:  '''3.4-5.1 mcg/kg/day PO''' once daily.
:: '''2.4-3.6 mcg/kh/day IV''' once daily.
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of SandboxAlonso in adult patients.
|offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of SandboxAlonso in adult patients.
|fdaLIADPed======Heart failure=====


* Dosing Information
* Dosing Information
:*Loading dose


::* 5-10 years old:  '''20-45 mcg/kg PO''' administer half the total loading dose initially, then ¼ the loading dose every 6 to 8 hours twice.  
:* Addition to methohexital and propofol, concentrations: lidocaine 0.1% to 1%.<ref name="pmid10470630">{{cite journal| author=Ho CM, Tsou MY, Sun MS, Chu CC, Lee TY| title=The optimal effective concentration of lidocaine to reduce pain on injection of propofol. | journal=J Clin Anesth | year= 1999 | volume= 11 | issue= 4 | pages= 296-300 | pmid=10470630 | doi= | pmc= | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=10470630 }} </ref><ref name="pmid9175962">{{cite journal| author=Eriksson M, Englesson S, Niklasson F, Hartvig P| title=Effect of lignocaine and pH on propofol-induced pain. | journal=Br J Anaesth | year= 1997 | volume= 78 | issue= 5 | pages= 502-6 | pmid=9175962 | doi= | pmc= | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=9175962  }} </ref>


::* >10 year old:  '''10-15 mcg/kg PO''' administer half the total loading dose initially, then ¼ the loading dose every 6 to 8 hours twice.
=====Cough=====


:*Maintenence dose:
* Dosing Information


::*5-10 years:   '''6.4 – 12.9 mcg/kg/day PO''' or '''3.2 – 6.4 mcg/kg/day Twice daily'''.
:* 1 to 2 mg/kg.<ref name="pmid6837243">{{cite journal| author=Gefke K, Andersen LW, Friesel E| title=Lidocaine given intravenously as a suppressant of cough and laryngospasm in connection with extubation after tonsillectomy. | journal=Acta Anaesthesiol Scand | year= 1983 | volume= 27 | issue= 2 | pages= 111-2 | pmid=6837243 | doi= | pmc= | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=6837243  }} </ref><ref name="pmid3347458">{{cite journal| author=Stewart RH, Kimbrough RL, Engstrom PF, Cameron B| title=Lidocaine: an anti-tussive for ophthalmic surgery. | journal=Ophthalmic Surg | year= 1988 | volume= 19 | issue= 2 | pages= 130-1 | pmid=3347458 | doi= | pmc= | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=3347458 }} </ref>


::*More than 10 years:  '''3.4 – 5.1 mcg/kg/day PO'''.
=====Elective Abortion=====
|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of SandboxAlonso in pediatric patients.
|offLabelPedNoGuideSupport======Supraventricular tachycardia, Recurrent; Prophylaxis=====
*Dosage information
:*0.01 mg/kg orally 3 times daily for the first 2 doses, then 0.0035 mg/kg 3 times daily<ref name="Pfammatter-1998">{{Cite journal  | last1 = Pfammatter | first1 = JP. | last2 = Stocker | first2 = FP. | title = Re-entrant supraventricular tachycardia in infancy: current role of prophylactic digoxin treatment. | journal = Eur J Pediatr | volume = 157 | issue = 2 | pages = 101-6 | month = Feb | year = 1998 | doi =  | PMID = 9504781 }}</ref><ref name="Sanatani-2012">{{Cite journal  | last1 = Sanatani | first1 = S. | last2 = Potts | first2 = JE. | last3 = Reed | first3 = JH. | last4 = Saul | first4 = JP. | last5 = Stephenson | first5 = EA. | last6 = Gibbs | first6 = KA. | last7 = Anderson | first7 = CC. | last8 = Mackie | first8 = AS. | last9 = Ro | first9 = PS. | title = The study of antiarrhythmic medications in infancy (SAMIS): a multicenter, randomized controlled trial comparing the efficacy and safety of digoxin versus propranolol for prophylaxis of supraventricular tachycardia in infants. | journal = Circ Arrhythm Electrophysiol | volume = 5 | issue = 5 | pages = 984-91 | month = Oct | year = 2012 | doi = 10.1161/CIRCEP.112.972620 | PMID = 22962431 }}</ref>
=====Fetal tachycardia - Supraventricular tachycardia=====
*Dosage information
:*Maternal 0.25 to 0.375 mg PO daily alone or with [[verapamil]].<ref name="Lilja-1984">{{Cite journal  | last1 = Lilja | first1 = H. | last2 = Karlsson | first2 = K. | last3 = Lindecrantz | first3 = K. | last4 = Sabel | first4 = KG. | title = Treatment of intrauterine supraventricular tachycardia with digoxin and verapamil. | journal = J Perinat Med | volume = 12 | issue = 3 | pages = 151-4 | month =  | year = 1984 | doi =  | PMID = 6502442 }}</ref>
|contraindications=* [[Ventricular fibrillation]]
* Known hypersensitivity to digoxin (reactions seen include unexplained rash, swelling of the mouth, lips or throat or a difficulty in breathing). A hypersensitivity reaction to other digitalis preparations usually constitutes a contraindication to digoxin.
|warnings====== Ventricular Fibrillation in Patients With Accessory AV Pathway ([[Wolff-Parkinson-White Syndrome]])=====
Patients with [[Wolff-Parkinson-White syndrome]] who develop [[atrial fibrillation]] are at high risk of ventricular fibrillation. Treatment of these patients with digoxin leads to greater slowing of conduction in the atrioventricular node than in accessory pathways, and the risks of rapid ventricular response leading to[[ ventricular fibrillation]] are thereby increased.


=====[[Sinus Bradycardia]] and Sino-atrial Block=====
* Dosing Information
Digoxin may cause severe [[sinus bradycardia]] or sino-atrial block particularly in patients with pre-existing sinus node disease and may cause advanced or complete heart block in patients with pre-existing incomplete AV block. Consider insertion of a pacemaker before treatment with digoxin.


=====Digoxin Toxicity=====
:* 7 to 30 mL of 1% lidocaine administered through the umbilical vein, associated to 5 mcg of sufentanil, both administered 48 hours following mifepristone treatment (600 mg).<ref name="pmid12628271">{{cite journal| author=Senat MV, Fischer C, Bernard JP, Ville Y| title=The use of lidocaine for fetocide in late termination of pregnancy. | journal=BJOG | year= 2003 | volume= 110 | issue= 3 | pages= 296-300 | pmid=12628271 | doi= | pmc= | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=12628271  }} </ref>
Signs and symptoms of digoxin toxicity include anorexia, nausea, vomiting, visual changes and cardiac arrhythmias [first-degree, second-degree (Wenckebach), or [[third-degree heart block ]](including [[asystole]]); [[atrial tachycardia]] with block; [[AV dissociation]]; accelerated junctional (nodal) rhythm; unifocal or multiform ventricular premature contractions (especially bigeminy or trigeminy); [[ventricular tachycardia]]; and ventricular fibrillation]. Toxicity is usually associated with digoxin levels greater than 2 ng/mL although symptoms may also occur at lower levels. Low body weight, advanced age or impaired renal function, [[hypokalemia]], [[hypercalcemia]], or [[hypomagnesemia]] may predispose to digoxin toxicity. Obtain serum digoxin levels in patients with signs or symptoms of digoxin therapy and interrupt or adjust dose if necessary. Assess serum electrolytes and renal function periodically.
The earliest and most frequent manifestation of digoxin toxicity in infants and children is the appearance of cardiac arrhythmias, including [[sinus bradycardia]]. In children, the use of digoxin may produce any arrhythmia. The most common are conduction disturbances or supraventricular tachyarrhythmias, such as atrial tachycardia (with or without block) and junctional (nodal) tachycardia. Ventricular arrhythmias are less common. Sinus bradycardia may be a sign of impending digoxin intoxication, especially in infants, even in the absence of first-degree heart block. Any arrhythmias or alteration in cardiac conduction that develops in a child taking digoxin should initially be assumed to be a consequence of digoxin intoxication.


=====Misidentification of Digoxin Toxicity=====
=====Fibromyalgia=====
Given that adult patients with heart failure have some symptoms in common with digoxin toxicity, it may be difficult to distinguish digoxin toxicity from [[heart failure]]. Misidentification of their etiology might lead the clinician to continue or increase digoxin dosing, when dosing should actually be suspended. When the etiology of these signs and symptoms is not clear, measure serum digoxin levels.


=====Risk of Ventricular Arrhythmias During Electrical [[Cardioversion]]=====
* Dosing Information
It may be desirable to reduce the dose of or discontinue digoxin for 1-2 days prior to electrical [[cardioversion]] of atrial fibrillation to avoid the induction of ventricular arrhythmias, but physicians must consider the consequences of increasing the ventricular response if digoxin is decreased or withdrawn. If digitalis toxicity is suspected, elective cardioversion should be delayed. If it is not prudent to delay cardioversion, the lowest possible energy level should be selected to avoid provoking ventricular arrhythmias.


=====Risk of Ischemia in Patients With Acute Myocardial Infarction=====
:* Administer an initial dose of 5 mg/kg minus 100 mg, followed by 50 mg/day increases up to 5 mg/kg plus 150 mg. Do not excede 550 mg infused. Infusion should be administered over 6 hours, diluted in 500 mL of Hartman's solution.<ref name="pmid12217079">{{cite journal| author=Raphael JH, Southall JL, Treharne GJ, Kitas GD| title=Efficacy and adverse effects of intravenous lignocaine therapy in fibromyalgia syndrome. | journal=BMC Musculoskelet Disord | year= 2002 | volume= 3 | issue= | pages= 21 | pmid=12217079 | doi= | pmc=PMC126218 | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=12217079  }} </ref>
Digoxin is not recommended in patients with [[acute myocardial infarction]] because digoxin may increase myocardial oxygen demand and lead to [[ischemia]].


=====Vasoconstriction in Patients With Myocarditis=====
=====Indigestion=====
Digoxin can precipitate vasoconstriction and may promote production of pro-inflammatory cytokines; therefore, avoid use in patients with [[myocarditis]].


=====Decreased Cardiac Output in Patients With Preserved Left Ventricular Systolic Function=====
* Dosing Information
Patients with heart failure associated with preserved left ventricular ejection fraction may experience decreased cardiac output with use of digoxin.  Such disorders include [[restrictive cardiomyopathy]], [[constrictive pericarditis]], [[amyloid]] heart disease, and acute[[ cor pulmonale]]. Patients with [[idiopathic hypertrophic subaortic stenosis]] may have worsening of the outflow obstruction due to the inotropic effects of digoxin. Patients with amyloid heart disease may be more susceptible to digoxin toxicity at therapeutic levels because of an increased binding of digoxin to extracellular amyloid fibrils.
Digoxin should generally be avoided in these patients, although it has been used for ventricular rate control in the subgroup of patients with atrial fibrillation.


=====Reduced Efficacy in Patients With [[Hypocalcemia]]=====
:* 30 mL of antacid associated with 15 mL of 2% viscous lidocaine, both administered simultaneously PO.<ref name="pmid2202240">{{cite journal| author=Welling LR, Watson WA| title=The emergency department treatment of dyspepsia with antacids and oral lidocaine. | journal=Ann Emerg Med | year= 1990 | volume= 19 | issue= 7 | pages= 785-8 | pmid=2202240 | doi= | pmc= | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=2202240  }} </ref>
[[Hypocalcemia]] can nullify the effects of digoxin in humans; thus, digoxin may be ineffective until serum calcium is restored to normal. These interactions are related to the fact that digoxin affects contractility and excitability of the heart in a manner similar to that of calcium.
=====Altered Response in Thyroid Disorders and Hypermetabolic States=====
[[Hypothyroidism]] may reduce the requirements for digoxin.
Heart failure and/or atrial arrhythmias resulting from hypermetabolic or hyperdynamic states (e.g., [[hyperthyroidism]], [[hypoxia]], or arteriovenous shunt) are best treated by addressing the underlying condition. Atrial arrhythmias associated with hypermetabolic states are particularly resistant to digoxin treatment. Patients with beri beri heart disease may fail to respond adequately to digoxin if the underlying thiamine deficiency is not treated concomitantly.
|clinicalTrials======= Nervous System======


: Visual disturbances (blurred or yellow vision), [[headache]], [[weakness]], [[dizziness]], [[apathy]], confusion, and mental disturbances (such as anxiety, depression, delirium, and hallucination).
=====Peritubular Block=====
======Cardiovascular======


: '''Arrhythmia'''( first-degree, second-degree (Wenckebach), or [[third-degree heart block]] (including [[asystole]]); atrial tachycardia with block; AV dissociation; accelerated junctional (nodal) rhythm; unifocal or multiform ventricular premature contractions (especially bigeminy or trigeminy);[[ ventricular tachycardia]]; and [[ventricular fibrillation]]).
* Dosing Information


======Gastrointestinal======
:*  5 mL of lidocaine (2%) plus 5 mL bupivacaine 0.75% with 150 IU of hyaluronidase.<ref name="pmid9038442">{{cite journal| author=Gao F, Budd AJ| title=Venous levels of lignocaine and bupivacaine after peribulbar block. | journal=Anaesthesia | year= 1996 | volume= 51 | issue= 12 | pages= 1109-12 | pmid=9038442 | doi= | pmc= | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=9038442  }} </ref>


: [[Anorexia]], [[nausea]], [[vomiting]], and [[diarrhea]]
=====Tumescent Anesthesia-Liposuction Procedure=====
======Miscellaneous======


: [[Gynecomastia]], [[thrombocytopenia ]]and maculopapular rash.
* Dosing Information


====Infant and Children====
:* Administer a solution of: lidocaine 500 to 1000 mg + epinephrine 0.5 mg + sodium bicarbonate 10 mEq + triamcinolone 10 mg + 1 liter saline solution 0.09%. Solution should be administered directly into the subcutaneous tissue undergoing the procedure at a rate of 150 mL/hour. Administer over an average time of 90 to 120 minutes.<ref name="pmid9063507">{{cite journal| author=Ostad A, Kageyama N, Moy RL| title=Tumescent anesthesia with a lidocaine dose of 55 mg/kg is safe for liposuction. | journal=Dermatol Surg | year= 1996 | volume= 22 | issue= 11 | pages= 921-7 | pmid=9063507 | doi= | pmc= | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=9063507  }} </ref>
The side effects of digoxin in infants and children differ from those seen in adults in several respects. Although digoxin may produce anorexia, nausea, vomiting, diarrhea, and CNS disturbances in young patients, these are rarely the initial symptoms of overdosage. Rather, the earliest and most frequent manifestation of excessive dosing with digoxin in infants and children is the appearance of cardiac arrhythmias, including [[sinus bradycardia]]. In children, the use of digoxin may produce any arrhythmia. The most common are conduction disturbances or supraventricular tachyarrhythmias, such as [[atrial tachycardia]] (with or without block) and junctional (nodal) tachycardia. [[Ventricular arrhythmias]] are less common. [[Sinus bradycardia]] may be a sign of impending digoxin intoxication, especially in infants, even in the absence of [[first-degree heart block]]. Any arrhythmia or alteration in cardiac conduction that develops in a child taking digoxin should be assumed to be caused by digoxin, until further evaluation proves otherwise.
|drugInteractions======Drugs that Affect Renal Function=====
Caution should be exercised when combining digoxin with any drug that may cause significant deterioration in renal function (e.g., [[ACE inhibitors]], [[angiotensin receptor blockers]],[[ nonsteroidal anti-inflammatory drugs]] [NSAIDs], COX-2 inhibitors) since a decline in [[glomerular filtration]] or tubular secretion may impair the excretion of digoxin.


=====Antiarrthymics=====
=====Postoperative Pain=====
*Dofetilid : Concomitant administration with digoxin was associated with a higher rate of [[torsades de pointes]]
*[[Sotalol]]: Proarrhythmic events were more common in patients receiving sotalol and digoxin than on either alone; it is not clear whether this represents an interaction or is related to the presence of [[CHF]], a known risk factor for proarrhythmia, in patients receiving digoxin.
*[[Dronedarone]]: Sudden death was more common in patients receiving digoxin with dronedarone than on either alone; it is not clear whether this represents an interaction or is related to the presence of advanced heart disease, a known risk factor for sudden death in patients receiving digoxin.


=====Parathyroid Hormone Analog=====
* Dosing Information
*[[Teriparatide]]: Sporadic case reports have suggested that hypercalcemia may predispose patients to digitalis toxicity. Teriparatide transiently increases serum calcium.


=====Potassium-depleting diuretics=====
:* Administer 1.5 mg/kg 30 minutes before surgery, followed by a 1.5 mg/kg/hour continuous infusion through the first hour following surgery.<ref name="pmid15041597">{{cite journal| author=Koppert W, Weigand M, Neumann F, Sittl R, Schuettler J, Schmelz M et al.| title=Perioperative intravenous lidocaine has preventive effects on postoperative pain and morphine consumption after major abdominal surgery. | journal=Anesth Analg | year= 2004 | volume= 98 | issue= 4 | pages= 1050-5, table of contents | pmid=15041597 | doi= | pmc= | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=15041597  }} </ref>
Potassium-depleting diuretics are a major contributing factor to digitalis toxicity.


=====Calcium=====
=====Seizure=====
[[Calcium]], particularly if administered rapidly by the intravenous route, may produce serious arrhythmias in digitalized patients.


=====Quinidine, verapamil, amiodarone, propafenone, indomethacin, itraconazole, alprazolam, and spironolactone=====
* Dosing Information
[[Quinidine]], [[verapamil]], [[amiodarone]], [[propafenone]], [[indomethacin]], [[itraconazole]], [[alprazolam]], and [[spironolactone]] raise the serum digoxin concentration due to a reduction in clearance and/or in volume of distribution of the drug, with the implication that digitalis intoxication may result.


=====Erythromycin, clarithromycin, and tetracycline=====
:* Administer 1.5 to 2 mg/kg IV infucion over 2 minutes. If seizure recurrence is observed dosage can be repeated.<ref name="pmid3409844">{{cite journal| author=Pascual J, Sedano MJ, Polo JM, Berciano J| title=Intravenous lidocaine for status epilepticus. | journal=Epilepsia | year= 1988 | volume= 29 | issue= 5 | pages= 584-9 | pmid=3409844 | doi= | pmc= | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=3409844  }} </ref>
[[Erythromycin]] and [[clarithromycin]] (and possibly othermacrolide antibiotics) and [[tetracycline]] may increase digoxin absorption in patients who inactivate digoxin by bacterial metabolism in the lower intestine, so that digitalis intoxication may result (see ''[[{{PAGENAME}}#Pharmacology|Pharmacology]]'').


=====[[Propantheline]] and [[diphenoxylate]]=====
=====Tinnitus=====
Decrease gut motility, which may increase digoxin absorption.


=====Antacids, kaolin-pectin, [[sulfasalazine]], [[neomycin]], [[cholestyramine]], certain anticancer drugs,  and [[metoclopramide]]=====
* Dosing Information
May interfere with intestinal digoxin absorption, resulting in unexpectedly low serum concentrations.


===== [[Rifampin]]=====
:* 1.5 mg/kg IV.<ref name="pmid7049137">{{cite journal| author=Israel JM, Connelly JS, McTigue ST, Brummett RE, Brown J| title=Lidocaine in the treatment of tinnitus aurium. A double-blind study. | journal=Arch Otolaryngol | year= 1982 | volume= 108 | issue= 8 | pages= 471-3 | pmid=7049137 | doi= | pmc= | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=7049137  }} </ref>
May decrease serum digoxin concentration, especially in patients with renal dysfunction, by increasing the non-renal clearance of digoxin.
|fdaLIADPed=Controlled clinical studies in the pediatric population to establish dosing schedules have not been conducted. The American Heart Association’s Standards and Guidelines recommends a bolus dose of 1 mg/kg, and an infusion rate of between 20 to 50 mcg/kg/min for prolonged therapy. When drug clearance is reduced, as in patients with shock, [[congestive heart failure]] or [[cardiac arrest]], the infusion rate should not exceed 20 mcg/kg/min.


=====[[Thyroxine]]=====
'''Note Regarding Prolonged Infusion:''' There are data that indicate the half-life may be 3 hours or longer following infusions of greater than 24 hours in duration.
Thyroid administration to a digitalized, [[hypothyroid ]]patient may increase the dose requirement of digoxin.
'''Note:''' Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever the solution and container permit.
|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Lidocaine in pediatric patients.
|offLabelPedNoGuideSupport======Seizure=====


=====Sympathomimetics=====
* Dosing Information
Concomitant use of digoxin and [[sympathomimetics ]]increases the risk of cardiac arrhythmias.


=====Succinylcholine=====
:* Initial dose of 4 to 6 mg/kg/hr, followed by infusions of 4 to 8 mg/kg/hr administered over 11 to 60 hours until successful response was achieved.<ref name="pmid23738612">{{cite journal| author=Lundqvist M, Ågren J, Hellström-Westas L, Flink R, Wickström R| title=Efficacy and safety of lidocaine for treatment of neonatal seizures. | journal=Acta Paediatr | year= 2013 | volume= 102 | issue= 9 | pages= 863-7 | pmid=23738612 | doi=10.1111/apa.12311 | pmc= | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=23738612  }} </ref>
[[Succinylcholine ]]may cause a sudden extrusion of potassium from muscle cells, and may thereby cause [[arrhythmias ]]in digitalized patients.
|contraindications=* [[Hypersensitivity]] to local anesthetics of the amide type.
* [[Stokes-Adams syndrome]].
* [[Wolff-Parkinson-White syndrome]].
* Patients with severe degrees of sinoatrial, atrioventricular, or intraventricular block in the absence of an artificial pacemaker.
|warnings=* Systemic toxicity may result in manifestations of [[central nervous system depression]] ([[sedation]]) or [[irritability]] (twitching), which may progress to frank [[convulsions]] accompanied by [[respiratory depression]] and/or [[Respiratory depression|arrest]]. Early recognition of premonitory signs, assurance of adequate oxygenation and, where necessary, establishment of artificial airway with [[ventilatory support]] are essential to management of this problem. Should [[convulsions]] persist despite [[ventilatory therapy]] with oxygen, small increments of [[anticonvulsant drugs]] may be used intravenously. Examples of such agents include [[benzodiazepines]] (e.g., [[diazepam]]), ultra short-acting [[barbiturates]] (e.g., [[thiopental]] or [[thiamylal]]), or a short-acting [[barbiturate]] (e.g., [[pentobarbital]] or [[secobarbital]]). If the patient is under anesthesia, a short-acting muscle relaxant (e.g., [[succinylcholine]]) may be used. Longer acting drugs should be used only when recurrent convulsions are evidenced.
* Should circulatory depression occur, [[vasopressors]] may be used.
* Constant [[electrocardiographic]] monitoring is essential to the proper administration of lidocaine hydrochloride. Signs of excessive depression of cardiac electrical activity such as sinus node dysfunction, prolongation of the P-R interval and QRS complex or the appearance or aggravation of [[arrhythmias]], should be followed by flow adjustment and, if necessary, prompt cessation of the intravenous infusion of this agent. Occasionally, acceleration of ventricular rate may occur when lidocaine hydrochloride is administered to patients with [[atrial flutter]] or [[atrial fibrillation]].


=====Calcium Channel Blockers=====
====Precautions====
Use with digoxin may be useful in combination to control atrial fibrillation, their additive effects on [[AV node]] conduction can result in advanced or [[complete heart block]].
=====General=====
* Caution should be employed in the use of lidocaine hydrochloride in patients with severe [[liver disease]] or [[kidney disease]] because accumulation of the drug or metabolites may occur.
* Lidocaine hydrochloride should be used with caution in the treatment of patients with [[hypovolemia]], severe [[congestive heart failure]], shock, and all forms of [[heart block]]. In patients with sinus [[bradycardia]] or incomplete [[heart block]], the administration of lidocaine hydrochloride intravenously for the elimination of ventricular ectopic beats, without prior acceleration in [[heart rate]] (e.g., by [[atropine]], [[isoproterenol]] or electric pacing), may promote more frequent and serious [[ventricular arrhythmias]] or complete [[heart block]].
* Dosage should be reduced for children and for debilitated and/or elderly patients, commensurate with their age and physical status.
* The safety of amide local anesthetic agents in patients with genetic predisposition to malignant [[hyperthermia]] has not been fully assessed; therefore, lidocaine should be used with caution in such patients.
* In hospital environments where drugs known to be triggering agents for malignant [[hyperthermia]] (fulminant hypermetabolism) are administered, it is suggested that a standard protocol for management should be available.
* It is not known whether lidocaine may trigger this reaction; however, large doses resulting in significant plasma concentrations, as may be achieved by intravenous infusion, pose potential risk to these individuals. Recognition of early unexplained signs of [[tachycardia]], [[tachypnea]], labile [[blood pressure]] and [[metabolic acidosis]] may precede temperature elevation. Successful outcome is dependent on early diagnosis, prompt discontinuance of the triggering agent and institution of treatment including oxygen therapy, supportive measures and dantrolene.
|clinicalTrials=Adverse experiences following the administration of lidocaine are similar in nature to those observed with other amide local anesthetic agents. Adverse experiences may result from high plasma levels caused by excessive dosage or may result from a [[hypersensitivity]], idiosyncrasy or diminished tolerance on the part of the patient. Serious adverse experiences are generally systemic in nature. The following types are those most commonly reported. The adverse experiences under [[Central Nervous System]] and [[Cardiovascular System]] are listed, in general, in a progression from mild to severe.


=====Beta blockers=====
=====Central Nervous System=====
Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of [[bradycardia]]. Digoxin concentrations are increased by about 15% when digoxin and carvedilol are administered concomitantly. Therefore, increased monitoring of digoxin is recommended when initiating, adjusting, or discontinuing [[carvedilol]].
CNS reactions are excitatory and/or depressant, and may be characterized by [[lightheadedness]], [[nervousness]], apprehension, [[euphoria]], [[confusion]], [[dizziness]], [[drowsiness]], [[tinnitus]], blurred or double vision, [[vomiting]], sensations of heat, cold or numbness, twitching, [[tremors]], [[convulsions]], [[unconsciousness]], [[respiratory depression]] and [[respiratory arrest]]. The excitatory reactions may be very brief or may not occur at all, in which case, the first manifestation of toxicity may be [[drowsiness]], merging into [[unconsciousness]] and [[respiratory arrest]].


====Drug/Laboratory Test Interactions====
=====Cardiovascular System=====
*Endogenous substances of unknown composition (digoxin-like immunoreactive substances [DLIS]) can interfere with standard radioimmunoassays for digoxin. The interference most often causes results to be falsely positive or falsely elevated, but sometimes it causes results to be falsely reduced. Some assays are more subject to these failings than others. Several LC/MS/MS methods are available that may provide less susceptibility to DLIS interference.
Cardiovascular reactions are usually depressant in nature and are characterized by [[bradycardia]], [[hypotension]], and cardiovascular collapse, which may lead to [[cardiac arrest]].
*DLIS are present in up to half of all neonates and in varying percentages of pregnant women, patients with hypertrophic cardiomyopathy, patients with renal or hepatic dysfunction, and other patients who are volume-expanded for any reason. The measured levels of DLIS (as digoxin equivalents) are usually low (0.2-0.4 ng/mL), but sometimes they reach levels that would be considered therapeutic or even toxic.
*In some assays, [[spironolactone]], [[canrenone]], and potassium canrenoate may be falsely detected as digoxin, at levels up to 0.5 ng/mL. Some traditional Chinese and Ayurvedic medicine substances like Chan Su, Siberian Ginseng, Asian Ginseng, Ashwagandha, or Dashen can cause similar interference.
[[Spironolactone]] and DLIS are much more extensively protein-bound than digoxin. As a result, assays of free digoxin levels in protein-free ultrafiltrate (which tend to be about 25% less than total levels, consistent with the usual extent of protein binding) are less affected by spironolactone or DLIS.
*It should be noted that ultrafiltration does not solve all interference problems with alternative medicines. The use of an LC/MS/MS method may be the better option according to the good results it provides, especially in terms of specificity and limit of quantization.
|FDAPregCat=C
|useInPregnancyFDA=Animal reproduction studies have not been conducted with digoxin. It is also not known whether digoxin can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Digoxin should be given to a pregnant woman only if clearly needed.
|AUSPregCat=A
|useInNursing=Studies have shown that digoxin concentrations in the mother’s serum and milk are similar. However, the estimated exposure of a nursing infant to digoxin via breastfeeding will be far below the usual infant maintenance dose. Therefore, this amount should have no pharmacologic effect upon the infant. Nevertheless, caution should be exercised when digoxin is administered to a nursing woman.
|useInPed=Newborn infants display considerable variability in their tolerance to digoxin. Premature and immature infants are particularly sensitive to the effects of digoxin, and the dosage of the drug must not only be reduced but must be individualized according to their degree of maturity. Digitalis glycosides can cause poisoning in children due to accidental ingestion.
|useInGeri=The majority of clinical experience gained with digoxin has been in the elderly population. This experience has not identified differences in response or adverse effects between the elderly and younger patients. However, this drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, which should be based on renal function, and it may be useful to monitor renal function
|useInGender=In a study of 184 patients, the clearance of digoxin was 12% lower in female than in male patients. This difference is not likely to be clinically important.
|useInRace=The impact of race differences on digoxin pharmacokinetics have not been formally studied. Because digoxin is primarily eliminated as unchanged drug via the kidney and because there are no important differences in [[creatinine clearance]] among races, pharmacokinetic differences due to race are not expected.)
|useInRenalImpair=Since the clearance of digoxin correlates with[[ creatinine clearance]], patients with renal impairment generally demonstrate prolonged digoxin elimination half-lives and greater exposures to digoxin. Therefore, titrate carefully in these patients based on clinical response and based on monitoring of serum digoxin concentrations, as appropriate.
|useInHepaticImpair=Because only a small percentage (approximately 13%) of a dose of digoxin undergoes metabolism, hepatic impairment would not be expected to significantly alter the pharmacokinetics of digoxin. In a small study, plasma digoxin concentration profiles in patients with acute hepatitis generally fell within the range of profiles in a group of healthy subjects. No dosage adjustments are recommended for patients with hepatic impairment; however, serum digoxin concentrations should be used, as appropriate, to help guide dosing in these patients.
|administration=*Oral
:*In selecting a LANOXIN dosing regimen, it is important to consider factors that affect digoxin blood levels (e.g., body weight, age, renal function, concomitant drugs) since toxic levels of digoxin are only slightly higher than therapeutic levels. Dosing can be either initiated with a loading dose followed by maintenance dosing if rapid titration is desired or initiated with maintenance dosing without a loading dose.
:*Consider interruption or reduction in digoxin dose prior to electrical [[cardioversion]].
Use digoxin solution to obtain the appropriate dose in infants, young pediatric patients, or patients with very low body weight.
*Intravenous:
:*In selecting a digoxin dosing regimen, it is important to consider factors that affect digoxin blood levels (e.g., body weight, age, renal function, concomitant drugs) since toxic levels of digoxin are only slightly higher than therapeutic levels.  Dosing can be either initiated with a loading dose followed by maintenance dosing if rapid titration is desired or initiated with maintenance dosing without a loading dose.
:*Parenteral administration of digoxin should be used only when the need for rapid digitalization is urgent or when the drug cannot be taken orally. Intramuscular injection can lead to severe pain at the injection site, thus intravenous administration is preferred. If the drug must be administered by the intramuscular route, it should be injected deep into the muscle followed by massage. For adults, no more than 500 mcg of Digoxin Injection should be injected into a single site.  For pediatric patients, see the full prescribing information for pediatric digoxin injection (not available from West-Ward) for specific recommendations.
:*Administer the dose over a period of 5 minutes or longer and avoid bolus administration to prevent systemic and coronary vasoconstriction. Mixing of Digoxin Injection with other drugs in the same container or simultaneous administration in the same intravenous line is not recommended.
:*Digoxin Injection can be administered undiluted or diluted with a 4-fold or greater volume of Sterile Water for Injection, 0.9% Sodium Chloride Injection, or 5% Dextrose Injection. The use of less than a 4-fold volume of diluent could lead to precipitation of the digoxin. Immediate use of the diluted product is recommended.
:*If tuberculin syringes are used to measure very small doses do not flush with the parenteral solution after its contents are expelled into an indwelling vascular catheter to avoid over administration of digoxin.
:*Consider interruption or reduction in digoxin dose prior to electrical [[cardioversion]]


====Switching from Intravenous Digoxin to Oral Digoxin====
=====Allergic Reactions=====
[[Allergic reactions]] as a result of sensitivity to lidocaine are extremely rare and, if they occur, should be managed by conventional means.


When switching from intravenous to oral digoxin formulations, make allowances for differences in bioavailability when calculating maintenance dosages
=====Drug Abuse or Dependance=====
 
Although specific studies have not been conducted, lidocaine hydrochloride has been used clinically without evidence of abuse of this drug or of physiological or physical dependence as a result of its use.
[[File:Diginj6.png|800px|thumbnail|left|This image is provided by the National Library of Medicine.]]
|drugInteractions=* Lidocaine hydrochloride should be used with caution in patients with [[digitalis]] toxicity accompanied by [[atrioventricular block]].  
{{clr}}
* Concomitant use of [[beta blockers]] may reduce hepatic blood flow and thereby reduce lidocaine clearance.
|monitoring=Monitor for signs and symptoms of digoxin toxicity and clinical response.  Adjust dose based on toxicity, efficacy, and blood levels.
* Lidocaine and [[tocainide]] are pharmacologically similar.
Serum digoxin levels less than 0.5 ng/mL have been associated with diminished efficacy, while levels above 2 ng/mL have been associated with increased toxicity without increased benefit.
* The concomitant use of these two agents may cause an increased incidence of adverse reactions, including [[central nervous system]] adverse reactions such as [[seizure]].
Interpret the serum digoxin concentration in the overall clinical context, and do not use an isolated measurement of serum digoxin concentration as the basis for increasing or decreasing the digoxin dose. Serum digoxin concentrations may be falsely elevated by endogenous digoxin-like substances [see Drug Interactions (7.4)]. If the assay is sensitive to these substances, consider obtaining a baseline digoxin level before starting digoxin and correct post-treatment values by the reported baseline level.
|FDAPregCat=B
Obtain serum digoxin concentrations just before the next scheduled digoxin dose or at least 6 hours after the last dose. The digoxin concentration is likely to be 10-25% lower when sampled right before the next dose (24 hours after dosing) compared to sampling 8 hours after dosing (using once-daily dosing). However, there will be only minor differences in digoxin concentrations using twice daily dosing whether sampling is done at 8 or 12 hours after a dose.
|useInPregnancyFDA=Reproduction studies have been performed in rats at doses up to 6.6 times the maximum human doses and have revealed no significant findings. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predicted of human response, this drug should be used during pregnancy only if clearly needed.
|IVCompat====Solution===
|useInLaborDelivery=The effects of lidocaine hydrochloride on the mother and the fetus, when used in the management of cardiac arrhythmias during labor and delivery, are not known. Lidocaine readily crosses the placental barrier.
 
|useInNursing=It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when lidocaine is administered to a nursing woman.
====Compatible====
|useInPed=Safety and effectiveness in children have not been established by controlled clinical studies.
 
|administration=* Intravenous
*  0.9% Sodium Chloride
|monitoring=Lidocaine hydrochloride is administered intravenously under [[ECG monitoring]].
*  5% Dextrose
|IVCompat=There is no information regarding IV compatibility provided by the label.
|overdose====Acute Overdose===
|overdose=* Overdosage of lidocaine hydrochloride usually results in signs of [[central nervous system]] or [[cardiovascular system]] toxicity.
 
* Should convulsions or signs of [[respiratory depression]] and [[respiratory arrest]] develop, the patency of the airway and adequacy of ventilation must be assured immediately. Should [[convulsions]] persist despite ventilatory therapy with oxygen, small increments of [[anticonvulsive agents]] may be given intravenously. Examples of such agents include a [[benzodiazepine]] (e.g., [[diazepam]]), an ultrashort-acting [[barbiturate]] (e.g., [[thiopental]] or [[thiamylal]]), or a short-acting barbiturate (e.g., [[pentobarbital]] or [[secobarbital]]). If the patient is under general anesthesia, a short-acting muscle relaxant (e.g., [[succinylcholine]]) may be administered.
====Signs and Symptoms====
* Should circulatory depression occur, [[vasopressors]] may be used. Should cardiac arrest occur, standard [[CPR]] procedures should be instituted.
 
* [[Dialysis]] is of negligible value in the treatment of acute overdosage from lidocaine hydrochloride.
*'''Adults''': The most common signs and symptoms of digoxin toxicity are nausea, vomiting, anorexia, and fatigue that occur in 30 to 70% of patients who are overdosed. Extremely high serum concentrations produce [[hyperkalemia ]]especially in patients with impaired renal function. Almost every type of cardiac arrhythmia has been associated with digoxin overdose and multiple rhythm disturbances in the same patient are common. Peak cardiac effects occur 3 to 6 hours following ingestion and may persist for 24 hours or longer. Arrhythmias that are considered more characteristic of digoxin toxicity are new-onset [[Mobitz ]]type 1 A-V block, accelerated junctional rhythms, non-paroxysmal atrial tachycardia with[[ AV block|A-V block]], and bi-directional [[ventricular tachycardia]]. [[Cardiac arrest]] from [[asystole ]]or [[ventricular fibrillation]] is usually fatal.
|drugBox=| verifiedrevid = 464370713
 
| IUPAC_name = 2-(diethylamino)-<br>''N''-(2,6-dimethylphenyl)acetamide
:*Digoxin toxicity is related to serum concentration. As digoxin serum levels increase above 1.2 ng/mL, there is a potential for increase in adverse reactions. Furthermore, lower potassium levels increases the risk for adverse reactions. In adults with heart disease, clinical observations suggest that an overdose of digoxin of 10 to 15 mg results in death of half of patients. A dose above 25 mg ingested by an adult without heart disease appeared to be uniformly fatal if no Digoxin Immune Fab (DIGIBIND®, [[Digifab|DIGIFAB]]®) was administered.
| image = LidocaineStructure.png
 
| width = 200px
:*Among the extra-cardiac manifestations, gastrointestinal symptoms (e.g., [[nausea]], [[vomiting]], [[anorexia]]) are very common (up to 80% incidence) and precede cardiac manifestations in approximately half of the patients in most literature reports. Neurologic manifestations (e.g., [[dizziness]], various CNS disturbances), [[fatigue]], and malaise are very common. Visual manifestations may also occur with aberration in color vision (predominance of yellow green) the most frequent. Neurological and visual symptoms may persist after other signs of toxicity have resolved. In chronic toxicity, nonspecific extra-cardiac symptoms, such as malaise and weakness, may predominate.
 
*'''Children''': In pediatric patients, signs and symptoms of toxicity can occur during or shortly after the dose of digoxin. Frequent non-cardiac effects are similar to those observed in adults although nausea and vomiting are not seen frequently in infants and small pediatric patients. Other reported manifestations of overdose are weight loss in older age groups, failure to thrive in infants, abdominal pain caused by [[mesenteric artery ischemia]], drowsiness, and behavioral disturbances including psychotic episodes. Arrhythmias and combinations of arrhythmias that occur in adult patients can also occur in pediatric patients although sinus tachycardia, supraventricular tachycardia, and rapid atrial fibrillation are seen less frequently in pediatric patients. Pediatric patients are more likely to develop A-V conduction disturbances, or [[sinus bradycardia]]. Any arrhythmia in a child treated with digoxin should be considered related to digoxin until otherwise ruled out. In pediatric patients aged 1 to 3 years without heart disease, clinical observations suggest that an overdose of digoxin of 6 to 10 mg would result in death of half of the patients. In the same population, a dose above 10 mg resulted in death if no [[Digoxin Immune Fab]] were administered.
 
====Management====
*Patients who have intentionally or accidently ingested massive doses of digoxin should receive [[activated charcoal]] orally or by nasogastric tube regardless of the time since ingestion since digoxin recirculates to the intestine by enterohepatic circulation. In addition to cardiac monitoring, temporarily discontinue digoxin until the adverse reaction resolves. Correct factors that may be contributing to the adverse reactions [see [[DIGOXIN tablet warnings and precautions|Warnings and Precautions]]].
*In particular, correct [[hypokalemia]] and [[hypomagnesemia]].  
*Digoxin is not effectively removed from the body by [[dialysis]]because of its large extravascular volume of distribution. Life threatening arrhythmias ([[ventricular tachycardia]], [[ventricular fibrillation]], high degree A-V block, bradyarrhythma, [[sinus arrest]]) or [[hyperkalemia ]]requires administration of Digoxin Immune Fab.
*Digoxin Immune Fab has been shown to be 80 to 90% effective in reversing signs and symptoms of digoxin toxicity. [[Bradycardia ]]and heart block caused by digoxin are parasympathetically mediated and respond to [[atropine]].  
*A temporary cardiac pacemaker may also be used. [[Ventricular arrhythmias]] may respond to [[lidocaine ]]or [[phenytoin]]. When a large amount of digoxin has been ingested, especially in patients with impaired renal function, [[hyperkalemia]]may be present due to release of potassium from skeletal muscle. In this case, treatment with Digoxin Immune Fab is indicated; an initial treatment with glucose and insulin may be needed if the [[hyperkalemia ]]is life-threatening.
*Once the adverse reaction has resolved, therapy with digoxin may be reinstituted following a careful reassessment of dose.
 
===Chronic Overdose===
 
====Signs and Symptoms====
 
The most common signs and symptoms of digoxin toxicity are nausea, vomiting, anorexia, and fatigue that occur in 30 to 70% of patients who are overdosed.
 
====Management====
 
*If there is suspicion of toxicity, discontinue digoxin and place the patient on a cardiac monitor. Correct factors such as electrolyte abnormalities, thyroid dysfunction, and concomitant medications [see [[DIGOXIN injection dosage and administration| Dosage and Administration]]].  
*Correct [[hypokalemia ]]by administering potassium so that serum potassium is maintained between 4.0 and 5.5 mmol/L. Potassium is usually administered orally, but when correction of the arrhythmia is urgent and serum potassium concentration is low, potassium may be administered by the intravenous route.
*Monitor electrocardiogram for any evidence of potassium toxicity (e.g., peaking of T waves) and to observe the effect on the arrhythmia. Avoid potassium salts in patients with [[bradycardia ]]or [[heart block]]. Symptomatic arrhythmias may be treated with [[Digoxin Immune Fab]].
|drugBox={{drugbox2 | Watchedfields = changed
| verifiedrevid = 459476549
| IUPAC_name = <small>4-[(3''S'',5''R'',8''R'',9''S'',10''S'',12''R'',13''S'',14''S'')-3-[(2''S'',4''S'',5''R'',6''R'')-5-[(2''S'',4''S'',5''R'',6''R'')-5-[(2''S'',4''S'',5''R'',6''R'')-4,5-dihydroxy-6-methyl-oxan-2-yl]oxy-4-hydroxy-6-methyl-oxan-2-yl]oxy-4-hydroxy-6-methyl-oxan-2-yl]oxy-12,14-dihydroxy-10,13-dimethyl-1,2,3,4,5,6,7,8,9,11,12,15,16,17-tetradecahydrocyclopenta[''a'']phenanthren-17-yl]-5''H''-furan-2-one</small>
| image = diginj9.png
| width = 300px
| image2 = Digon ball-and-stick.png


<!--Clinical data-->
<!--Clinical data-->
| tradename = Lanoxin
| tradename = Xylocaine
| Drugs.com = {{drugs.com|monograph|digoxin}}
| Drugs.com = {{drugs.com|CONS|lidocaine}}
| MedlinePlus = a682301
| pregnancy_AU = A
| pregnancy_category = A <small>([[Australia|Au]])</small>, C <small>([[United States|U.S.]])</small>
| pregnancy_US = B
| legal_status = S4 <small>(Au)</small>, POM <small>([[United Kingdom|UK]])</small>, ℞-only <small>(U.S.)</small>
| legal_AU = S4
| routes_of_administration = [[Route of administration#Enteral|Oral]], [[Intravenous therapy|Intravenous]]
| legal_US = Rx Only (U.S.) (excluding 1%)
| routes_of_administration = [[Intravenous therapy|intravenous]], [[subcutaneous]], [[topical]], [[oral]]


<!--Pharmacokinetic data-->
<!--Pharmacokinetic data-->
| bioavailability = 60 to 80% (Oral)
| bioavailability = 35% (oral) <br> 3% (topical)
| protein_bound = 25%
| metabolism = [[Liver|Hepatic]], 90% [[CYP1A2]]-mediated
| metabolism = [[Liver|Hepatic]] (16%)
| elimination_half-life = 1.5–2 hours
| elimination_half-life = 36 to 48 [[hour]]s <br /><small>(patients with normal [[renal function]])</small><br />3.5 to 5 [[day]]s <br><small>(patients with impaired renal function)</small>
| excretion = [[renal]]
| excretion = [[Renal]]


<!--Identifiers-->
<!--Identifiers-->
| CASNo_Ref = {{cascite|correct|CAS}}
| CASNo_Ref = {{cascite|correct|CAS}}
| CAS_number_Ref = {{cascite|correct|??}}
| CAS_number_Ref = {{cascite|correct|??}}
| CAS_number = 20830-75-5
| CAS_number = 137-58-6
| CAS_supplemental = <br>{{CAS|73-78-9}} (hydrochloride)
| ATC_prefix = C01
| ATC_prefix = C01
| ATC_suffix = AA05
| ATC_suffix = BB01
| ATC_supplemental =  
| ATC_supplemental = {{ATC|C05|AD01}} {{ATC|D04|AB01}} {{ATC|N01|BB02}} {{ATC|R02|AD02}} {{ATC|S01|HA07}} {{ATC|S02|DA01}}
| StdInChI = 1S/C41H64O14/c1-19-36(47)28(42)15-34(50-19)54-38-21(3)52-35(17-30(38)44)55-37-20(2)51-33(16-29(37)43)53-24-8-10-39(4)23(13-24)6-7-26-27(39)14-31(45)40(5)25(9-11-41(26,40)48)22-12-32(46)49-18-22/h12,19-21,23-31,33-38,42-45,47-48H,6-11,13-18H2,1-5H3/t19-,20-,21-,23-,24+,25-,26-,27+,28+,29+,30+,31-,33+,34+,35+,36-,37-,38-,39+,40+,41+/m1/s1
| PubChem = 367
| PubChem = 2724385
| IUPHAR_ligand = 2623
| DrugBank_Ref = {{drugbankcite|correct|drugbank}}
| DrugBank_Ref = {{drugbankcite|correct|drugbank}}
| DrugBank = DB00390
| DrugBank = DB00281
| ChemSpiderID_Ref = {{chemspidercite|correct|chemspider}}
| ChemSpiderID_Ref = {{chemspidercite|correct|chemspider}}
| ChemSpiderID = 2006532
| ChemSpiderID = 3548
| UNII_Ref = {{fdacite|correct|FDA}}
| UNII_Ref = {{fdacite|correct|FDA}}
| UNII = 73K4184T59
| UNII = 98PI200987
| KEGG_Ref = {{keggcite|correct|kegg}}
| KEGG_Ref = {{keggcite|correct|kegg}}
| KEGG = D00298
| KEGG = D00358
| ChEBI_Ref = {{ebicite|correct|EBI}}
| ChEBI_Ref = {{ebicite|correct|EBI}}
| ChEBI = 4551
| ChEBI = 6456
| ChEMBL_Ref = {{ebicite|correct|EBI}}
| ChEMBL_Ref = {{ebicite|correct|EBI}}
| ChEMBL = 1751
| ChEMBL = 79


<!--Chemical data-->
<!--Chemical data-->
| C=41 | H=64 | O=14
| C=14 | H=22 | N=2 | O=1
| molecular_weight = 780.938 [[Gram|g]]/[[Mole (unit)|mol]]
| molecular_weight = 234.34 g/mol
| smiles = O=C\1OC/C(=C/1)[C@H]2CC[C@@]8(O)[C@]2(C)[C@H](O)C[C@H]7[C@H]8CC[C@H]6[C@]7(C)CC[C@H](O[C@@H]5O[C@H](C)[C@@H](O[C@@H]4O[C@@H]([C@@H](O[C@@H]3O[C@@H]([C@@H](O)[C@@H](O)C3)C)[C@@H](O)C4)C)[C@@H](O)C5)C6
| smiles = O=C(Nc1c(cccc1C)C)CN(CC)CC
| InChI = 1/C41H64O14/c1-19-36(47)28(42)15-34(50-19)54-38-21(3)52-35(17-30(38)44)55-37-20(2)51-33(16-29(37)43)53-24-8-10-39(4)23(13-24)6-7-26-27(39)14-31(45)40(5)25(9-11-41(26,40)48)22-12-32(46)49-18-22/h12,19-21,23-31,33-38,42-45,47-48H,6-11,13-18H2,1-5H3/t19-,20-,21-,23-,24+,25-,26-,27+,28+,29+,30+,31-,33+,34+,35+,36-,37-,38-,39+,40+,41+/m1/s1
| InChI = 1/C14H22N2O/c1-5-16(6-2)10-13(17)15-14-11(3)8-7-9-12(14)4/h7-9H,5-6,10H2,1-4H3,(H,15,17)
| StdInChI_Ref = {{stdinchicite|correct|chemspider}} 
| StdInChI_Ref = {{stdinchicite|correct|chemspider}}
| StdInChI = 1S/C14H22N2O/c1-5-16(6-2)10-13(17)15-14-11(3)8-7-9-12(14)4/h7-9H,5-6,10H2,1-4H3,(H,15,17)
| StdInChIKey_Ref = {{stdinchicite|correct|chemspider}}
| StdInChIKey_Ref = {{stdinchicite|correct|chemspider}}
| StdInChIKey = LTMHDMANZUZIPE-PUGKRICDSA-N
| StdInChIKey = NNJVILVZKWQKPM-UHFFFAOYSA-N
| melting_point = 249.3
| synonyms = ''N''-(2,6-dimethylphenyl)-''N''<sup>2</sup>,''N''<sup>2</sup>-diethylglycinamide
| solubility = 0.0648
| melting_point = 68
}}
}}
|mechAction=All of digoxin’s actions are mediated through its effects on Na-K ATPase. This enzyme, the “sodium pump,” is responsible for maintaining the intracellular milieu throughout the body by moving sodium ions out of and potassium ions into cells. By inhibiting Na-K ATPase, digoxin
|mechAction=Studies of the effects of therapeutic concentrations of lidocaine on the electrophysiological properties of mammalian [[Purkinje fibers]] have shown that lidocaine attenuates phase 4 diastolic depolarization, decreases automaticity and causes a decrease or no change in excitability and membrane responsiveness.
 
|structure=Lidocaine Hydrochloride Injection USP, is a sterile, aqueous solution of lidocaine, an antiarrhythmic agent, prepared with the aid of hydrochloric acid. It is intended for intravenous administration by either direct injection or continuous infusion.  
*causes increased availability of intracellular calcium in the myocardium and conduction system, with consequent increased inotropy, increased automaticity, and reduced conduction velocity
 
*indirectly causes parasympathetic stimulation of the autonomic nervous system, with consequent effects on the [[sinoatrial node|sino-atrial]] (SA) and [[atrioventricular nodes|atrioventricular (AV) nodes]]
 
*reduces [[catecholamine ]]reuptake at nerve terminals, rendering blood vessels more sensitive to endogenous or exogenous catecholamines
 
*increases [[baroreceptor ]]sensitization, with consequent increased carotid sinus nerve activity and enhanced sympathetic withdrawal for any given increment in mean arterial pressure
 
*increases (at higher concentrations) [[sympathetic ]]outflow from the central nervous system (CNS) to both cardiac and peripheral sympathetic nerves
allows (at higher concentrations) progressive efflux of intracellular [[potassium]], with consequent increase in serum potassium levels.
 
The cardiologic consequences of these direct and indirect effects are an increase in the force and velocity of myocardial systolic contraction (positive inotropic action), a slowing of the heart rate (negative chronotropic effect), decreased conduction velocity through the AV node, and a decrease in the degree of activation of the sympathetic nervous system and renin-angiotensin system (neurohormonal deactivating effect).
|structure=Digoxin is one of the cardiac (or [[digitalis]]) [[glycosides]], a closely related group of drugs having in common specific effects on the myocardium. These drugs are found in a number of plants. Digoxin is extracted from the leaves of Digitalis lanata. The term “digitalis” is used to designate the whole group of glycosides. The glycosides are composed of 2 portions: a sugar and a cardenolide (hence “glycosides”).
 
Digoxin is described chemically as (3β,5β,12β)-3-[(O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-O-2,6-dideoxy-β-D-ribo-hexopyranosyl-(1→4)-2,6-dideoxy-β-D-ribo-hexopyranosyl)oxy]-12,14-dihydroxy-card-20(22)-enolide. Its molecular formula is C41H64O14, its molecular weight is 780.95.


[[File:Diginj9.png|600px|thumbnail|left|This image is provided by the National Library of Medicine.]]
Lidocaine hydrochloride is designated 2-(Diethylamino)-2’, 6’-acetoxylidide monohydrochloride and isrepresented by the following structural formula:
{{clr}}
Digoxin exists as clear to white odorless crystals or white, odorless crystalline powder that melts with decomposition above 230°C. The drug is practically insoluble in water and in ether; slightly soluble in diluted (50%) alcohol and in chloroform; and freely soluble in pyridine.


Digoxin injection USP is a sterile solution of digoxin for intravenous or intramuscular injection. Each mL contains: digoxin 0.25 mg, propylene glycol 40% (v/v), anhydrous ethanol 10% (v/v), dibasic sodium phosphate 0.3% (w/v) and anhydrous citric acid 0.08% (w/v) to adjust pH between 6.8 and 7.2, and water for injection. Dilution is not required.
|PD=The times to onset of pharmacologic effect and to peak effect of preparations of digoxin are shown in the table below.


[[File:Diginj10.png|800px|thumbnail|left|This image is provided by the National Library of Medicine.]]
[[File:LidocaineStructure.png|600px|thumbnail|left|This image is provided by the National Library of Medicine.]]
{{clr}}
{{clr}}


'''Hemodynamic Effects:''' Short- and long-term therapy with the drug increases cardiac output and lowers pulmonary artery pressure, [[pulmonary capillary wedge pressure]], and systemic vascular resistance in patients with heart failure. These hemodynamic effects are accompanied by an increase in the left ventricular [[ejection fraction ]]and a decrease in end-systolic and end-diastolic dimensions.
*pH of the above solution adjusted with sodium hydroxide and/or hydrochloric acid to finished product pH limits between 5 and 7.
The medication and fluid pathway of these disposable syringes are sterile and nonpyrogenic in the original, unopened package with component caps in place. These dosage forms do not contain preservatives; once the unit is assembled and used, any remaining portion of the solution must be discarded with the entire unit.
|PD=Action potential duration and effective refractory period of [[Purkinje fibers]] are decreased, while the ratio of effective refractory period to action potential duration is increased. Action potential duration and effective refractory period of ventricular muscle are also decreased. Effective refractory period of the [[AV node]] may increase, decrease or remain unchanged, and atrial effective refractory period is unchanged. Lidocaine raises the [[ventricular fibrillation]] threshold. No significant interactions between lidocaine and the autonomic nervous system have been described and consequently lidocaine has little or no effect on autonomic tone.  


'''ECG Changes:''' The use of therapeutic doses of digoxin may cause prolongation of the[[ PR interval]] and depression of the[[ ST segmen]]t on the electrocardiogram. Digoxin may produce false positive ST-T changes on the electrocardiogram during exercise testing. These electrophysiologic effects are not indicative of toxicity. Digoxin does not significantly reduce heart rate during exercise.
Clinical electrophysiological studies with lidocaine have demonstrated no change in [[sinus node]] recovery time or sinoatrial conduction time. [[AV nodal conduction]] time is unchanged or shortened, and [[His-Purkinje conduction]] time is unchanged.
|PK='''Distribution:''' Following drug administration, a 6 to 8 hour tissue distribution phase is observed. This is followed by a much more gradual decline in the serum concentration of the drug, which is dependent on the elimination of digoxin from the body. The peak height and slope of the early portion (absorption/distribution phases) of the serum concentration-time curve are dependent upon the route of administration and the absorption characteristics of the formulation. Clinical evidence indicates that the early high serum concentrations do not reflect the concentration of digoxin at its site of action, but that with chronic use, the steady-state post-distribution serum concentrations are in equilibrium with tissue concentrations and correlate with pharmacologic effects. In individual patients, these post-distribution serum concentrations may be useful in evaluating therapeutic and toxic effects.


Digoxin is concentrated in tissues and therefore has a large apparent volume of distribution (approximately 475 to 500 L). Digoxin crosses both the blood-brain barrier and the placenta. At delivery, the serum digoxin concentration in the newborn is similar to the serum concentration in the mother. Approximately 25% of digoxin in the plasma is bound to protein. Serum digoxin concentrations are not significantly altered by large changes in fat tissue weight, so that its distribution space correlates best with lean (i.e., ideal) body weight, not total body weight.
=====Hemodynamics=====
At therapeutic doses, lidocaine has minimal hemodynamic effects in normal subjects and in patients with heart disease. Lidocaine has been shown to cause no, or minimal, decrease in ventricular contractility, cardiac output, arterial pressure or heart rate.
|PK=Lidocaine is rapidly metabolized by the liver, and less than 10% of a dose is excreted unchanged in the urine. Oxidative N dealkylation, a major pathway of metabolism, results in the metabolites monoethylglycinexylidide and glycinexylidide. The pharmacological/toxicological activities of these metabolites are similar to, but less potent than, lidocaine. The primary metabolite in urine is a conjugate of 4-hydroxy-2,6,-dimethylaniline.  


'''Metabolism''': Only a small percentage (13%) of a dose of digoxin is metabolized in healthy volunteers. The urinary metabolites, which include dihydrodigoxin, digoxigenin bisdigitoxoside, and their glucuronide and sulfate conjugates are polar in nature and are postulated to be formed via hydrolysis, oxidation, and conjugation. The metabolism of digoxin is not dependent upon the cytochrome P-450 system, and digoxin is not known to induce or inhibit the[[ cytochrome P-450]] system.
The elimination half-life of lidocaine following an intravenous bolus injection is typically 1.5 to 2 hours. There are data that indicate that the half-life may be 3 hours or longer following infusions of greater than 24 hours.
 
Because of the rapid rate at which lidocaine is metabolized, any condition that alters liver function, including changes in liver blood flow, which could result from severe congestive heart failure in shock, may alter lidocaine kinetics. The half-life may be two-fold or more, greater in patients with liver dysfunction. [[Renal dysfunction]] does not affect lidocaine kinetics, but may increase the accumulation of metabolites. Therapeutic effects of lidocaine are generally associated with plasma levels at 6 to 25 μmole/L (1.5 to 6 mcg free base per mL). The blood to plasma distribution ratio is approximately 0.84. Objective adverse manifestations become increasingly apparent with increasing plasma levels above 6 mcg free base per mL.  
   
The plasma protein binding of lidocaine is dependent on drug concentration, and the fraction bound decreases with increasing concentration. At concentrations of 1 to 4 mcg free base per mL, 60 to 80 percent of lidocaine is protein bound. In addition to lidocaine concentration, the binding is dependent on the plasma concentration of the α-1-acid glycoprotein.
   
Lidocaine readily crosses the placental and blood-brain barriers. [[Dialysis]] has negligible effects on the kinetics of lidocaine.
|nonClinToxic=Long term studies in animals to evaluate the carcinogenic and mutagenic potential or the effect on fertility of lidocaine hydrochloride have not been conducted.
|clinicalStudies======Condition 1=====


'''Excretion:''' Elimination of digoxin follows first-order kinetics (that is, the quantity of digoxin eliminated at any time is proportional to the total body content). Following intravenous administration to healthy volunteers, 50 to 70% of a digoxin dose is excreted unchanged in the urine. Renal excretion of digoxin is proportional to creatinine clearance and is largely independent of urine flow. In healthy volunteers with normal renal function, digoxin has a half-life of 1.5 to 2 days. The half-life in anuric patients is prolonged to 3.5 to 5 days. Digoxin is not effectively removed from the body by dialysis, exchange transfusion, or during cardiopulmonary bypass because most of the drug is bound to extravascular tissues.
(Description)
|nonClinToxic=Digoxin showed no genotoxic potential in in vitro studies (Ames test and mouse lymphoma). No data are available on the carcinogenic potential of digoxin, nor have studies been conducted to assess its potential to affect fertility.
|clinicalStudies======Chronic Heart Failure=====
Two 12-week, double-blind, placebo-controlled studies enrolled 178 (RADIANCE trial) and 88 (PROVED trial) patients with NYHA class II or III heart failure previously treated with digoxin, a diuretic, and an ACE inhibitor (RADIANCE only) and randomized them to placebo or treatment with LANOXIN. Both trials demonstrated better preservation of exercise capacity in patients randomized to LANOXIN. Continued treatment with LANOXIN reduced the risk of developing worsening heart failure, as evidenced by heart failure-related hospitalizations and emergency care and the need for concomitant heart failure therapy.


======Dig Trial of LANOXIN in Patients with Heart Failure======
=====Condition 2=====


The Digitalis Investigation Group (DIG) main trial was a 37-week, multicenter, randomized, double-blind mortality study comparing digoxin to placebo in 6800 adult patients with heart failure and left ventricular ejection fraction ≤0.45. At randomization, 67% were NYHA class I or II, 71% had heart failure of ischemic etiology, 44% had been receiving digoxin, and most were receiving a concomitant ACE inhibitor (94%) and diuretics (82%). As in the smaller trials described above, patients who had been receiving open-label digoxin were withdrawn from this treatment before randomization. Randomization to digoxin was again associated with a significant reduction in the incidence of hospitalization, whether scored as number of hospitalizations for heart failure (relative risk 75%), risk of having at least one such hospitalization during the trial (RR 72%), or number of hospitalizations for any cause (RR 94%). On the other hand, randomization to digoxin had no apparent effect on mortality (RR 99%, with confidence limits of 91 to 107%).
(Description)


=====Chronic Atrial Fibrillation=====
=====Condition 3=====


Digoxin has also been studied as a means of controlling the ventricular response to chronic atrial fibrillation in adults. Digoxin reduced the resting heart rate, but not the heart rate during exercise.
(Description)
 
|howSupplied=In unit-use packages containing a Luer-JetTM Luer-Lock Prefilled Syringe, ten cartons per package:
In 3 different randomized, double-blind trials that included a total of 315 adult patients, digoxin was compared to placebo for the conversion of recent-onset atrial fibrillation to sinus rhythm. Conversion was equally likely, and equally rapid, in the digoxin and placebo groups. In a randomized 120-patient trial comparing digoxin, sotalol, and amiodarone, patients randomized to digoxin had the lowest incidence of conversion to sinus rhythm, and the least satisfactory rate control when conversion did not occur.
* Concentration: 2%               
 
* Stock No.: 3390               
In at least one study, digoxin was studied as a means of delaying reversion to atrial fibrillation in adult patients with frequent recurrence of this arrhythmia. This was a randomized, double-blind, 43-patient crossover study. Digoxin increased the mean time between symptomatic recurrent episodes by 54%, but had no effect on the frequency of fibrillatory episodes seen during continuous electrocardiographic monitoring.
* NDC No.: 76329-3390-1               
|howSupplied======DIgoxin Tablets=====
* Size: 5 mL (100 mg)
LANOXIN (digoxin) Tablets, Scored 125 mcg (0.125 mg): Bottles of 100 with child-resistant cap (NDC 24987-242-55), (NDC 24987-242-57) and 1,000 (NDC 24987-242-75), (NDC 24987-242-76); unit dose pack of 100 (NDC 24987-242-56). Imprinted with LANOXIN and Y3B (yellow).
|storage=* Store at 20 to 25°C (68 to 77°F).
 
|fdaPatientInfo=The patients should be advised of the possible occurrence of the experiences listed under adverse reactions.
LANOXIN (digoxin) Tablets, Scored 250 mcg (0.25 mg): Bottles of 100 with child-resistant cap (NDC 24987-249-55), (NDC 24987-249-57), 1,000 (NDC -24987-249-75), (NDC-24987-249-76), and 5,000 (NDC 24987-249-80); unit dose pack of 100 (NDC 24987-249-56). Imprinted with LANOXIN and X3A (white).
|alcohol=Alcohol-Lidocaine interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
* National Drug Code (NDC): see above
|lookAlike=* (Paired Confused Name 1a) — (Paired Confused Name 1b)
* Manufactured by: Manufactured by DSM Pharmaceuticals, Inc. Greenville, NC 27834
* (Paired Confused Name 2a) — (Paired Confused Name 2b)
* Distributed by:Covis Pharmaceuticals, Inc. Cary, NC 27511
* (Paired Confused Name 3a) — (Paired Confused Name 3b)
 
 
=====Digoxin Injection=====
Digoxin Injection, USP is available as:
500 mcg/2 mL (250 mcg/mL) ampuls packaged in 25s
 
* National Drug Code (NDC):(NDC 0641-1410-35)
* Manufactured by: HIKMA FARMACÊUTICA (PORTUGAL), S.A. Estrada do Rio da Mό, 8, 8A e 8B – Fervença – 2705-906 Terrugem SNT, PORTUGAL 
* Distributed by:WEST-WARD PHARMACEUTICALS Eatontown, NJ 07724 USA
 
=====Digoxin Solution=====
Digoxin Solution:Each 1 mL of clear, colorless Digoxin Oral Solution contains 0.05 mg (50 mcg).
The Digoxin Oral Solution bottles are to be used with the graduated droppers provided in the carton. Starting at 0.2 mL, this 1 mL dropper is marked in divisions of 0.1 mL, corresponding to 5 mcg or 0.005 mg of digoxin.
The calibrated dropper supplied with the 60 mL bottle of Digoxin Oral Solution is not appropriate to measure doses below 0.2 mL. Doses less than 0.2 mL require appropriate methods or measuring devices designed to administer an accurate amount to the patient, such as a graduated syringe
 
* National Drug Code (NDC):NDC:17856-0057
* Manufactured by:Roxane Laboratories, Inc. Columbus, Ohio 43216
* Distributed by:Atlantic Biologicals Corps
|storage======DIgoxin Tablets=====
* Storage: Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) in a dry place.
* Keep out of reach of children.
 
=====Digoxin Injection=====
* Storage: Store at 20˚-25˚C (68˚-77˚F), excursions permitted to 15˚-30˚C (59˚-86˚F).
 
=====Digoxin Solution=====
* Storage:Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). * Protect from light.
|fdaPatientInfo=* Advise patients that digoxin is a cardiac glycoside used to treat heart failure and heart arrhythmias.
* Instruct patients to take this medication as directed by their physician.
* Advise patients that many drugs can interact with digoxin. Instruct patients to inform their doctor and pharmacist if they are taking any over the counter medications, including herbal *medication, or are started on a new prescription.
* Advise patient that blood tests will be necessary to ensure that their digoxin dose is appropriate for them.
* Advise patients to contact their doctor or a health care professional if they experience nausea, vomiting, persistent diarrhea, confusion, weakness, or visual disturbances (including *blurred vision, green-yellow color disturbances, halo effect) as these could be signs that the dose of digoxin may be too high.
* Advise parents or caregivers that the symptoms of having too high digoxin doses may be difficult to recognize in infants and pediatric patients. Symptoms such as weight loss, failure to thrive in infants, abdominal pain, and behavioral disturbances may be indications of digoxin toxicity.
* Suggest to the patient to monitor and record their heart rate and blood pressure daily.
* Instruct women of childbearing potential who become or are planning to become pregnant to consult a physician prior to initiation or continuing therapy with digoxin.
|alcohol=Alcohol-SandboxAlonso interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
|brandNames=* Digoxin
* Digox
* Lanoxin
|lookAlike=* Digoxin — [[Dioxin]]
* Digoxin — [[Digitoxin]]
|nlmPatientInfo=(Link to patient information page)
|nlmPatientInfo=(Link to patient information page)
|drugShortage=Drug Shortage
|drugShortage=Drug Shortage
}}
}}
{{LabelImage
{{LabelImage
|fileName=Lanoxintablet1.jpg
|fileName=LidocaineHydrochloridePackage1.png
}}
{{LabelImage
|fileName=Lanoxintablet2.jpg
}}
{{LabelImage
|fileName=Lanoxintablet3.png
}}
{{LabelImage
|fileName=Digoxininjection.jpg
}}
{{LabelImage
|fileName=Digoxininjection1.png
}}
{{LabelImage
|fileName=Digoxinsolution.jpg
}}
{{LabelImage
|fileName=Digoxinsolution1.png
}}
}}
[[Category:Cardiac glycosides]]
[[Category:Antiarrhythmic agents]]
[[Category:Cardiovascular Drugs]]
[[Category:Cardiovascular Drugs]]
[[Category:Drugs]]
[[Category:Drug]]

Revision as of 16:26, 24 July 2014

SandboxAlonso
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alonso Alvarado, M.D. [2]

Disclaimer

WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.

Overview

SandboxAlonso is a Adrenergic receptor agonist that is FDA approved for the {{{indicationType}}} of ventricular arrhythmias such as those occurring in relation to acute myocardial infarction, or during cardiac manipulation, such as cardiac surgery. Common adverse reactions include bradyarrhythmia, hypotension, backache dizziness, headache, lightheadedness, numbness, paresthesia, shivering, somnolence, blurred vision, burning sensation in eye, conjunctival hyperemia, corneal epithelial defect, diplopia, apprehension, confusion, euphoria, feeling nervous..

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Single Direct Intravenous Injection (bolus)
  • Only the 50 and 100 mg dosage sizes should be used for direct intravenous injection. The usual dose is 50 to 100 mg of lidocaine hydrochloride (0.70 to 1.4 mg/kg; 0.32 to 0.63 mg/lb) administered intravenously under ECG monitoring. This dose may be administered at the rate of approximately 25 to 50 mg/min (0.35 to 0.70 mg/kg/min; 0.16 to 0.32 mg/lb/min).
  • Sufficient time should be allowed to enable a slow circulation to carry the drug to the site of action. If the initial injection of 50 to 100 mg does not produce a desired response, a second dose may be injected after 5 minutes. No more than 200 to 300 mg of lidocaine hydocloride should be administered during a one hour period.
Continuous Intravenous Infusion
  • Following bolus administration, intravenous infusions of lidocaine hydrochloride may be initiated at the rate of 1 to 4 mg/min of lidocaine hydrochloride (0.014 to 0.057 mg/kg/min; 0.006 to 0.026 mg/lb/min). The rate of intravenous infusions should be reassessed as soon as the patient’s basic cardiac rhythm appears to be stable or at the earliest signs of toxicity. It should rarely be necessary to continue intravenous infusions of lidocaine for prolonged periods.
  • Solutions for intravenous infusion may be prepared by the addition of one gram (or two grams) of lidocaine hydrochloride to one liter of 5% dextrose in water using aseptic technique. Approximately a 0.1% (or 0.2%) solution will result from this procedure; that is, each milliliter will contain approximately 1 (or 2) mg of lidocaine hydrochloride. In those cases in which fluid restriction is medically appropriate, a more concentrated solution may be prepared.
  • Lidocaine hydrochloride injection has been found to be chemically stable for 24 hours after dilution in 5% dextrose in water. However, as with all intravenous admixtures, dilution of the solution should be made just prior to its administration.
  • It is very important that after adding lidocaine hydrochloride, or any other medication, to an I.V. container, the contents be thoroughly mixed before beginning the infusion.
  • When administering by continuous I.V. infusion, it is advisable to use a precision volume control I.V. set.

Off-Label Use and Dosage (Adult)

Non–Guideline-Supported Use

Aortocoronary Bypass Grafting
  • Dosing Information
  • 1 mg/min IV infusion[1]
  • 100 mg bolus 2 minutes before releasing the aortic clamp administered through a bypass pump.[2]
Regional Pain Syndrome
  • Dosing Information
  • Lidocaine continuous infusion administered as a initial dose of 200 mg through the first hour, followed by 100 to 190 mg/h according to tolerance. Infusion should be continue until maximum pain control is reached.[3]
Infusion Pain
  • Dosing Information
  • Addition to methohexital and propofol, concentrations: lidocaine 0.1% to 1%.[4][5]
Cough
  • Dosing Information
Elective Abortion
  • Dosing Information
  • 7 to 30 mL of 1% lidocaine administered through the umbilical vein, associated to 5 mcg of sufentanil, both administered 48 hours following mifepristone treatment (600 mg).[8]
Fibromyalgia
  • Dosing Information
  • Administer an initial dose of 5 mg/kg minus 100 mg, followed by 50 mg/day increases up to 5 mg/kg plus 150 mg. Do not excede 550 mg infused. Infusion should be administered over 6 hours, diluted in 500 mL of Hartman's solution.[9]
Indigestion
  • Dosing Information
  • 30 mL of antacid associated with 15 mL of 2% viscous lidocaine, both administered simultaneously PO.[10]
Peritubular Block
  • Dosing Information
  • 5 mL of lidocaine (2%) plus 5 mL bupivacaine 0.75% with 150 IU of hyaluronidase.[11]
Tumescent Anesthesia-Liposuction Procedure
  • Dosing Information
  • Administer a solution of: lidocaine 500 to 1000 mg + epinephrine 0.5 mg + sodium bicarbonate 10 mEq + triamcinolone 10 mg + 1 liter saline solution 0.09%. Solution should be administered directly into the subcutaneous tissue undergoing the procedure at a rate of 150 mL/hour. Administer over an average time of 90 to 120 minutes.[12]
Postoperative Pain
  • Dosing Information
  • Administer 1.5 mg/kg 30 minutes before surgery, followed by a 1.5 mg/kg/hour continuous infusion through the first hour following surgery.[13]
Seizure
  • Dosing Information
  • Administer 1.5 to 2 mg/kg IV infucion over 2 minutes. If seizure recurrence is observed dosage can be repeated.[14]
Tinnitus
  • Dosing Information

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Controlled clinical studies in the pediatric population to establish dosing schedules have not been conducted. The American Heart Association’s Standards and Guidelines recommends a bolus dose of 1 mg/kg, and an infusion rate of between 20 to 50 mcg/kg/min for prolonged therapy. When drug clearance is reduced, as in patients with shock, congestive heart failure or cardiac arrest, the infusion rate should not exceed 20 mcg/kg/min.

Note Regarding Prolonged Infusion: There are data that indicate the half-life may be 3 hours or longer following infusions of greater than 24 hours in duration. Note: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever the solution and container permit.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Lidocaine in pediatric patients.

Non–Guideline-Supported Use

Seizure
  • Dosing Information
  • Initial dose of 4 to 6 mg/kg/hr, followed by infusions of 4 to 8 mg/kg/hr administered over 11 to 60 hours until successful response was achieved.[16]

Contraindications

Warnings

Precautions

General
  • Caution should be employed in the use of lidocaine hydrochloride in patients with severe liver disease or kidney disease because accumulation of the drug or metabolites may occur.
  • Lidocaine hydrochloride should be used with caution in the treatment of patients with hypovolemia, severe congestive heart failure, shock, and all forms of heart block. In patients with sinus bradycardia or incomplete heart block, the administration of lidocaine hydrochloride intravenously for the elimination of ventricular ectopic beats, without prior acceleration in heart rate (e.g., by atropine, isoproterenol or electric pacing), may promote more frequent and serious ventricular arrhythmias or complete heart block.
  • Dosage should be reduced for children and for debilitated and/or elderly patients, commensurate with their age and physical status.
  • The safety of amide local anesthetic agents in patients with genetic predisposition to malignant hyperthermia has not been fully assessed; therefore, lidocaine should be used with caution in such patients.
  • In hospital environments where drugs known to be triggering agents for malignant hyperthermia (fulminant hypermetabolism) are administered, it is suggested that a standard protocol for management should be available.
  • It is not known whether lidocaine may trigger this reaction; however, large doses resulting in significant plasma concentrations, as may be achieved by intravenous infusion, pose potential risk to these individuals. Recognition of early unexplained signs of tachycardia, tachypnea, labile blood pressure and metabolic acidosis may precede temperature elevation. Successful outcome is dependent on early diagnosis, prompt discontinuance of the triggering agent and institution of treatment including oxygen therapy, supportive measures and dantrolene.

Adverse Reactions

Clinical Trials Experience

Adverse experiences following the administration of lidocaine are similar in nature to those observed with other amide local anesthetic agents. Adverse experiences may result from high plasma levels caused by excessive dosage or may result from a hypersensitivity, idiosyncrasy or diminished tolerance on the part of the patient. Serious adverse experiences are generally systemic in nature. The following types are those most commonly reported. The adverse experiences under Central Nervous System and Cardiovascular System are listed, in general, in a progression from mild to severe.

Central Nervous System

CNS reactions are excitatory and/or depressant, and may be characterized by lightheadedness, nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus, blurred or double vision, vomiting, sensations of heat, cold or numbness, twitching, tremors, convulsions, unconsciousness, respiratory depression and respiratory arrest. The excitatory reactions may be very brief or may not occur at all, in which case, the first manifestation of toxicity may be drowsiness, merging into unconsciousness and respiratory arrest.

Cardiovascular System

Cardiovascular reactions are usually depressant in nature and are characterized by bradycardia, hypotension, and cardiovascular collapse, which may lead to cardiac arrest.

Allergic Reactions

Allergic reactions as a result of sensitivity to lidocaine are extremely rare and, if they occur, should be managed by conventional means.

Drug Abuse or Dependance

Although specific studies have not been conducted, lidocaine hydrochloride has been used clinically without evidence of abuse of this drug or of physiological or physical dependence as a result of its use.

Postmarketing Experience

There is limited information regarding SandboxAlonso Postmarketing Experience in the drug label.

Drug Interactions

  • Lidocaine hydrochloride should be used with caution in patients with digitalis toxicity accompanied by atrioventricular block.
  • Concomitant use of beta blockers may reduce hepatic blood flow and thereby reduce lidocaine clearance.
  • Lidocaine and tocainide are pharmacologically similar.
  • The concomitant use of these two agents may cause an increased incidence of adverse reactions, including central nervous system adverse reactions such as seizure.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): B Reproduction studies have been performed in rats at doses up to 6.6 times the maximum human doses and have revealed no significant findings. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predicted of human response, this drug should be used during pregnancy only if clearly needed.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of SandboxAlonso in women who are pregnant.

Labor and Delivery

The effects of lidocaine hydrochloride on the mother and the fetus, when used in the management of cardiac arrhythmias during labor and delivery, are not known. Lidocaine readily crosses the placental barrier.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when lidocaine is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in children have not been established by controlled clinical studies.

Geriatic Use

There is no FDA guidance on the use of SandboxAlonso in geriatric settings.

Gender

There is no FDA guidance on the use of SandboxAlonso with respect to specific gender populations.

Race

There is no FDA guidance on the use of SandboxAlonso with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of SandboxAlonso in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of SandboxAlonso in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of SandboxAlonso in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of SandboxAlonso in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Intravenous

Monitoring

Lidocaine hydrochloride is administered intravenously under ECG monitoring.

IV Compatibility

There is no information regarding IV compatibility provided by the label.

Overdosage

Pharmacology

There is limited information regarding SandboxAlonso Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding SandboxAlonso Mechanism of Action in the drug label.

Structure

There is limited information regarding SandboxAlonso Structure in the drug label.

Pharmacodynamics

There is limited information regarding SandboxAlonso Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding SandboxAlonso Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding SandboxAlonso Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding SandboxAlonso Clinical Studies in the drug label.

How Supplied

There is limited information regarding SandboxAlonso How Supplied in the drug label.

Storage

There is limited information regarding SandboxAlonso Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::SandboxAlonso |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::SandboxAlonso |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding SandboxAlonso Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-SandboxAlonso interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding SandboxAlonso Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding SandboxAlonso Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

  1. ↑ Sunamori M, Okamura T, Amano J, Suma H, Suzuki A (1982). "Myocardial protection by lidocaine hydrochloride in aorto-coronary bypass surgery". Jpn J Surg. 12 (2): 93–7. PMID 6981016.
  2. ↑ Baraka A, Kawkabani N, Dabbous A, Nawfal M (2000). "Lidocaine for prevention of reperfusion ventricular fibrillation after release of aortic cross-clamping". J Cardiothorac Vasc Anesth. 14 (5): 531–3. doi:10.1053/jcan.2000.9484. PMID 11052433.
  3. ↑ Linchitz RM, Raheb JC (1999). "Subcutaneous infusion of lidocaine provides effective pain relief for CRPS patients". Clin J Pain. 15 (1): 67–72. PMID 10206569.
  4. ↑ Ho CM, Tsou MY, Sun MS, Chu CC, Lee TY (1999). "The optimal effective concentration of lidocaine to reduce pain on injection of propofol". J Clin Anesth. 11 (4): 296–300. PMID 10470630.
  5. ↑ Eriksson M, Englesson S, Niklasson F, Hartvig P (1997). "Effect of lignocaine and pH on propofol-induced pain". Br J Anaesth. 78 (5): 502–6. PMID 9175962.
  6. ↑ Gefke K, Andersen LW, Friesel E (1983). "Lidocaine given intravenously as a suppressant of cough and laryngospasm in connection with extubation after tonsillectomy". Acta Anaesthesiol Scand. 27 (2): 111–2. PMID 6837243.
  7. ↑ Stewart RH, Kimbrough RL, Engstrom PF, Cameron B (1988). "Lidocaine: an anti-tussive for ophthalmic surgery". Ophthalmic Surg. 19 (2): 130–1. PMID 3347458.
  8. ↑ Senat MV, Fischer C, Bernard JP, Ville Y (2003). "The use of lidocaine for fetocide in late termination of pregnancy". BJOG. 110 (3): 296–300. PMID 12628271.
  9. ↑ Raphael JH, Southall JL, Treharne GJ, Kitas GD (2002). "Efficacy and adverse effects of intravenous lignocaine therapy in fibromyalgia syndrome". BMC Musculoskelet Disord. 3: 21. PMC 126218. PMID 12217079.
  10. ↑ Welling LR, Watson WA (1990). "The emergency department treatment of dyspepsia with antacids and oral lidocaine". Ann Emerg Med. 19 (7): 785–8. PMID 2202240.
  11. ↑ Gao F, Budd AJ (1996). "Venous levels of lignocaine and bupivacaine after peribulbar block". Anaesthesia. 51 (12): 1109–12. PMID 9038442.
  12. ↑ Ostad A, Kageyama N, Moy RL (1996). "Tumescent anesthesia with a lidocaine dose of 55 mg/kg is safe for liposuction". Dermatol Surg. 22 (11): 921–7. PMID 9063507.
  13. ↑ Koppert W, Weigand M, Neumann F, Sittl R, Schuettler J, Schmelz M; et al. (2004). "Perioperative intravenous lidocaine has preventive effects on postoperative pain and morphine consumption after major abdominal surgery". Anesth Analg. 98 (4): 1050–5, table of contents. PMID 15041597.
  14. ↑ Pascual J, Sedano MJ, Polo JM, Berciano J (1988). "Intravenous lidocaine for status epilepticus". Epilepsia. 29 (5): 584–9. PMID 3409844.
  15. ↑ Israel JM, Connelly JS, McTigue ST, Brummett RE, Brown J (1982). "Lidocaine in the treatment of tinnitus aurium. A double-blind study". Arch Otolaryngol. 108 (8): 471–3. PMID 7049137.
  16. ↑ Lundqvist M, Ågren J, Hellström-Westas L, Flink R, Wickström R (2013). "Efficacy and safety of lidocaine for treatment of neonatal seizures". Acta Paediatr. 102 (9): 863–7. doi:10.1111/apa.12311. PMID 23738612.

|mechAction=Studies of the effects of therapeutic concentrations of lidocaine on the electrophysiological properties of mammalian Purkinje fibers have shown that lidocaine attenuates phase 4 diastolic depolarization, decreases automaticity and causes a decrease or no change in excitability and membrane responsiveness. |structure=Lidocaine Hydrochloride Injection USP, is a sterile, aqueous solution of lidocaine, an antiarrhythmic agent, prepared with the aid of hydrochloric acid. It is intended for intravenous administration by either direct injection or continuous infusion.

Lidocaine hydrochloride is designated 2-(Diethylamino)-2’, 6’-acetoxylidide monohydrochloride and isrepresented by the following structural formula:


This image is provided by the National Library of Medicine.
  • pH of the above solution adjusted with sodium hydroxide and/or hydrochloric acid to finished product pH limits between 5 and 7.

The medication and fluid pathway of these disposable syringes are sterile and nonpyrogenic in the original, unopened package with component caps in place. These dosage forms do not contain preservatives; once the unit is assembled and used, any remaining portion of the solution must be discarded with the entire unit. |PD=Action potential duration and effective refractory period of Purkinje fibers are decreased, while the ratio of effective refractory period to action potential duration is increased. Action potential duration and effective refractory period of ventricular muscle are also decreased. Effective refractory period of the AV node may increase, decrease or remain unchanged, and atrial effective refractory period is unchanged. Lidocaine raises the ventricular fibrillation threshold. No significant interactions between lidocaine and the autonomic nervous system have been described and consequently lidocaine has little or no effect on autonomic tone.

Clinical electrophysiological studies with lidocaine have demonstrated no change in sinus node recovery time or sinoatrial conduction time. AV nodal conduction time is unchanged or shortened, and His-Purkinje conduction time is unchanged.

Hemodynamics

At therapeutic doses, lidocaine has minimal hemodynamic effects in normal subjects and in patients with heart disease. Lidocaine has been shown to cause no, or minimal, decrease in ventricular contractility, cardiac output, arterial pressure or heart rate. |PK=Lidocaine is rapidly metabolized by the liver, and less than 10% of a dose is excreted unchanged in the urine. Oxidative N dealkylation, a major pathway of metabolism, results in the metabolites monoethylglycinexylidide and glycinexylidide. The pharmacological/toxicological activities of these metabolites are similar to, but less potent than, lidocaine. The primary metabolite in urine is a conjugate of 4-hydroxy-2,6,-dimethylaniline.

The elimination half-life of lidocaine following an intravenous bolus injection is typically 1.5 to 2 hours. There are data that indicate that the half-life may be 3 hours or longer following infusions of greater than 24 hours.

Because of the rapid rate at which lidocaine is metabolized, any condition that alters liver function, including changes in liver blood flow, which could result from severe congestive heart failure in shock, may alter lidocaine kinetics. The half-life may be two-fold or more, greater in patients with liver dysfunction. Renal dysfunction does not affect lidocaine kinetics, but may increase the accumulation of metabolites. Therapeutic effects of lidocaine are generally associated with plasma levels at 6 to 25 μmole/L (1.5 to 6 mcg free base per mL). The blood to plasma distribution ratio is approximately 0.84. Objective adverse manifestations become increasingly apparent with increasing plasma levels above 6 mcg free base per mL.

The plasma protein binding of lidocaine is dependent on drug concentration, and the fraction bound decreases with increasing concentration. At concentrations of 1 to 4 mcg free base per mL, 60 to 80 percent of lidocaine is protein bound. In addition to lidocaine concentration, the binding is dependent on the plasma concentration of the α-1-acid glycoprotein.

Lidocaine readily crosses the placental and blood-brain barriers. Dialysis has negligible effects on the kinetics of lidocaine. |nonClinToxic=Long term studies in animals to evaluate the carcinogenic and mutagenic potential or the effect on fertility of lidocaine hydrochloride have not been conducted. |clinicalStudies======Condition 1=====

(Description)

Condition 2

(Description)

Condition 3

(Description) |howSupplied=In unit-use packages containing a Luer-JetTM Luer-Lock Prefilled Syringe, ten cartons per package:

  • Concentration: 2%
  • Stock No.: 3390
  • NDC No.: 76329-3390-1
  • Size: 5 mL (100 mg)

|storage=* Store at 20 to 25°C (68 to 77°F). |fdaPatientInfo=The patients should be advised of the possible occurrence of the experiences listed under adverse reactions. |alcohol=Alcohol-Lidocaine interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication. |lookAlike=* (Paired Confused Name 1a) — (Paired Confused Name 1b)

  • (Paired Confused Name 2a) — (Paired Confused Name 2b)
  • (Paired Confused Name 3a) — (Paired Confused Name 3b)

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