Metoprolol tartrate (tablet): Difference between revisions

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Lopressor may mask certain clinical signs (e.g., [[tachycardia]]) of [[hyperthyroidism]]. Avoid abrupt withdrawal of beta blockade, which might precipitate a [[thyroid storm]].
Lopressor may mask certain clinical signs (e.g., [[tachycardia]]) of [[hyperthyroidism]]. Avoid abrupt withdrawal of beta blockade, which might precipitate a [[thyroid storm]].
|clinicalTrials=======Central Nervous System======
|clinicalTrials======Hypertension and Angina=====


: (list/description of adverse reactions)
* Most adverse effects have been mild and transient.
* [[Central Nervous System]]: Tiredness and [[dizziness]] have occurred in about 10 of 100 patients. [[Depression]] has been reported in about 5 of 100 patients. Mental confusion and short-term memory loss have been reported. [[Headache]], [[nightmares]], and [[insomnia]] have also been reported.
* [[Cardiovascular]]: [[Shortness of breath]] and [[bradycardia]] have occurred in approximately 3 of 100 patients. [[Cold extremities]]; [[arterial insufficiency]], usually of the  Raynaud type; [[palpitations]]; [[congestive heart failure]]; [[peripheral edema]]; and [[hypotension]] have been reported in about 1 of 100 patients. [[Gangrene]] in patients with pre-existing severe [[peripheral circulatory]] disorders has also been reported very rarely.
* [[Respiratory]]: [[Wheezing]] ([[bronchospasm]]) and [[dyspnea]] have been reported in about 1 of 100 patients. [[Rhinitis]] has also been reported.
* [[Gastrointestinal]]: [[Diarrhea]] has occurred in about 5 of 100 patients. [[Nausea]], dry mouth, [[gastric pain]], [[constipation]], [[flatulence]], and [[heartburn]] have been reported in about 1 of 100 patients. [[Vomiting]] was a common occurrence.
* [[Hypersensitive]] Reactions: [[Pruritus]] or rash have occurred in about 5 of 100 patients. Very rarely, photosensitivity and worsening of [[psoriasis]] has been reported.
* Miscellaneous: Peyronie's disease has been reported in fewer than 1 of 100,000 patients. Musculoskeletal pain, [[blurred vision]], and [[tinnitus]] have also been reported. There have been rare reports of reversible [[alopecia]], [[agranulocytosis]], and dry eyes. Discontinuation of the drug should be considered if any such reaction is not otherwise explicable. There have been very rare reports of weight gain, [[arthritis]], and retroperitoneal fibrosis (relationship to Lopressor has not been definitely established). The oculomucocutaneous syndrome associated with the [[beta blocker]] practolol has not been reported with Lopressor.


======Cardiovascular======
=====Myocardial Infarction=====


: (list/description of adverse reactions)
* [[Central Nervous System]]: Tiredness has been reported in about 1 of 100 patients. [[Vertigo]], [[sleep disturbances]], [[hallucinations]], [[headache]], [[dizziness]], visual disturbances, [[confusion]], and reduced [[libido]] have also been reported, but a drug relationship is not clear.
* [[Cardiovascular]]: In the randomized comparison of Lopressor and placebo, the following adverse reactions were reported:


======Respiratory======
[[File:MetoprololTTable1.png|800px|thumbnail|left|This image is provided by the National Library of Medicine.]]
{{clr}}


: (list/description of adverse reactions)
* [[Respiratory]]: [[Dyspnea]] of pulmonary origin has been reported in fewer than 1 of 100 patients.
* [[Gastrointestinal]]: [[Nausea]] and [[abdominal pain]] have been reported in fewer than 1 of 100 patients.
* [[Dermatologic]]: [[Rash]] and worsened [[psoriasis]] have been reported, but a drug relationship is not clear.
* Miscellaneous: Unstable [[diabetes]] and claudication have been reported, but a drug relationship is not clear.


======Gastrointestinal======
=====Potential Adverse Reactions=====


: (list/description of adverse reactions)
* A variety of adverse reactions not listed above have been reported with other [[beta blockers]] and should be considered potential adverse reactions to Lopressor.
* [[Central Nervous System]]: Reversible mental [[depression]] progressing to [[catatonia]]; an acute reversible syndrome characterized by [[disorientation]] for time and place, [[short-term memory loss]], [[emotional lability]], slightly clouded sensorium, and decreased performance on neuropsychometrics.
* [[Cardiovascular]]: Intensification of [[AV block]].
* [[Hematologic]]: [[Agranulocytosis]], [[nonthrombocytopenic purpura]] and [[thrombocytopenic purpura]].
* [[Hypersensitive Reactions]]: [[Fever]] combined with aching and [[sore throat]], [[laryngospasm]] and [[respiratory distress]].


======Hypersensitive Reactions======
|postmarketing=The following adverse reactions have been reported during postapproval use of Lopressor:  
 
* [[Confusional state]].
: (list/description of adverse reactions)
* An increase in [[blood triglycerides]] and a decrease in [[High Density Lipoprotein]] (HDL).
 
* [[Hepatitis]], [[jaundice]] and non-specific [[hepatic dysfunction]].
======Miscellaneous======
* Isolated cases of [[transaminase]], [[alkaline phosphatase]], and [[lactic dehydrogenase]] elevations have also been reported.
 
* Because these reports are from a population of uncertain size and are subject to confounding factors, it is not possible to reliably estimate their frequency
: (list/description of adverse reactions)
 
=====Condition 2=====
 
======Central Nervous System======
 
: (list/description of adverse reactions)
 
======Cardiovascular======
 
: (list/description of adverse reactions)
 
======Respiratory======
 
: (list/description of adverse reactions)
 
======Gastrointestinal======
 
: (list/description of adverse reactions)
 
======Hypersensitive Reactions======
 
: (list/description of adverse reactions)
 
======Miscellaneous======
 
: (list/description of adverse reactions)
|postmarketing=(Description)
|drugInteractions=* Drug 1
|drugInteractions=* Drug 1
* Drug 2
* Drug 2

Revision as of 14:11, 7 July 2014

Metoprolol tartrate (tablet)
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

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Overview

Metoprolol tartrate (tablet) is a anti-anginal, antiarrhythmic, beta-adrenergic blocker that is FDA approved for the {{{indicationType}}} of acute myocardial infarction (AMI). Common adverse reactions include bradyarrhythmia, constipation, depression, diarrhea, dizziness, dyspnea, fatigue, headache, heart block, heart failure, hypotension, indigestion, nausea, pruritus, rash, and wheezing.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Hypertension
  • Dosing Information
  • Individualize the dosage of Lopressor tablets. Lopressor tablets should be taken with or immediately following meals.
  • The usual initial dosage of Lopressor tablets is 100 mg daily in single or divided doses, whether used alone or added to a diuretic. Increase the dosage at weekly (or longer) intervals until optimum blood pressure reduction is achieved. In general, the maximum effect of any given dosage level will be apparent after 1 week of therapy. The effective dosage range of Lopressor tablets is 100-450 mg per day. Dosages above 450 mg per day have not been studied. While once-daily dosing is effective and can maintain a reduction in blood pressure throughout the day, lower doses (especially 100 mg) may not maintain a full effect at the end of the 24-hour period, and larger or more frequent daily doses may be required. This can be evaluated by measuring blood pressure near the end of the dosing interval to determine whether satisfactory control is being maintained throughout the day. Beta1 selectivity diminishes as the dose of Lopressor is increased.
Angina Pectoris
  • Dosing Information
  • The dosage of Lopressor tablets should be individualized. Lopressor tablets should be taken with or immediately following meals.
  • The usual initial dosage of Lopressor tablets is 100 mg daily, given in two divided doses. gradually increase the dosage at weekly intervals until optimum clinical response has been obtained or there is pronounced slowing of the heart rate. The effective dosage range of Lopressor tablets is 100-400 mg per day. Dosages above 400 mg per day have not been studied. If treatment is to be discontinued, gradually decrease the dosage over a period of 1-2 weeks
Myocardial Infarction
  • Dosing information
  • Early treatment:
  • During the early phase of definite or suspected acute myocardial infarction, initiate treatment with Lopressor as soon as possible after the patient's arrival in the hospital. Such treatment should be initiated in a coronary care or similar unit immediately after the patient's hemodynamic condition has stabilized.
  • Begin treatment in this early phase with the intravenous administration of three bolus injections of 5 mg of Lopressor each; give the injections at approximately 2-minute intervals. During the intravenous administration of Lopressor, monitor blood pressure, heart rate, and electrocardiogram.
  • In patients who tolerate the full intravenous dose (15 mg), initiate Lopressor tablets, 50 mg every 6 hours, 15 minutes after the last intravenous dose and continue for 48 hours. Thereafter, the maintenance dosage is 100 mg twice daily.
  • Start patients who appear not to tolerate the full intravenous dose on Lopressor tablets either 25 mg or 50 mg every 6 hours (depending on the degree of intolerance) 15 minutes after the last intravenous dose or as soon as their clinical condition allows. In patients with severe intolerance, discontinue Lopressor.
  • Late treatment: Start patients with contraindications to treatment during the early phase of suspected or definite myocardial infarction, patients who appear not to tolerate the full early treatment, and patients in whom the physician wishes to delay therapy for any other reason on Lopressor tablets, 100 mg twice daily, as soon as their clinical condition allows. Continue therapy for at least 3 months. Although the efficacy of Lopressor beyond 3 months has not been conclusively established, data from studies with other beta blockers suggest that treatment should be continued for 1-3 years.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Atrial Fibrillation, Rate Control
  • Dosing Information
Acute Setting: Lopressor injection 2.5—5 mg IV bolus over 2 min; up to 3 doses[1]

In the absence of preexcitation, intravenous administration of beta blockers (esmolol, metoprolol, or propranolol) or nondihydropyridine calcium channel antagonists (verapamil, diltiazem) is recommended to slow the ventricular response to atrial fibrillation in the acute setting, exercising caution in patients with hypotension or heart failure.[2]

Non–Guideline-Supported Use

Atrial flutter
  • Dosing Information
Lopressor injection dose range: 2—15 mg[3]
Multifocal atrial tachycardia
  • Dosing Information
Lopressor injection dose range: 2—15 mg[3]
Supraventricular Tachycardia
  • Dosing Information
Lopressor injection dose range: 2—15 mg[3]
Aggressive Behavior
Injection Site Pain Associated with Propofol Use
  • Dosing Information
Pretreatment with Lopressor injection 2 mg.[4]

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Metoprolol tartrate (tablet) FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Metoprolol tartrate in pediatric patients.

Contraindications

Warnings

Heart Failure

Beta blockers, like Lopressor, can cause depression of myocardial contractility and may precipitate heart failure and cardiogenic shock. If signs or symptoms of heart failure develop, treat the patient according to recommended guidelines. It may be necessary to lower the dose of Lopressor or to discontinue it.

Ischemic Heart Disease

Do not abruptly discontinue Lopressor therapy in patients with coronary artery disease. Severe exacerbation of angina, myocardial infarction and ventricular arrhythmias have been reported in patients with coronary artery disease following the abrupt discontinuation of therapy with beta-blockers. When discontinuing chronically administered Lopressor, particularly in patients with coronary artery disease, the dosage should be gradually reduced over a period of 1-2 weeks and the patient should be carefully monitored. If angina markedly worsens or acute coronary insufficiency develops, Lopressor administration should be reinstated promptly, at least temporarily, and other measures appropriate for the management of unstable angina should be taken. Patients should be warned against interruption or discontinuation of therapy without the physician's advice. Because coronary artery disease is common and may be unrecognized, it may be prudent not to discontinue Lopressor therapy abruptly even in patients treated only for hypertension.

Use During Major Surgery

Chronically administered beta-blocking therapy should not be routinely withdrawn prior to major surgery; however, the impaired ability of the heart to respond to reflex adrenergic stimuli may augment the risks of general anesthesia and surgical procedures.

Bradycardia

Bradycardia, including sinus pause, heart block, and cardiac arrest have occurred with the use of Lopressor. Patients with first-degree atrioventricular block, sinus node dysfunction, or conduction disorders may be at increased risk. Monitor heart rate and heart rhythm in patients receiving Lopressor. If severe bradycardia develops, reduce or stop Lopressor.

Exacerbation of Bronchospastic Disease

Patients with bronchospastic disease,should, in general, not receive beta blockers, including Lopressor. Because of its relative beta1 selectivity, however, Lopressor may be used in patients with bronchospastic disease who do not respond to, or cannot tolerate, other antihypertensive treatment. Because beta1 selectivity is not absolute use the lowest possible dose of Lopressor and consider administering Lopressor in smaller doses three times daily, instead of larger doses two times daily, to avoid the higher plasma levels associated with the longer dosing interval. Bronchodilators, including beta2 agonists, should be readily available or administered concomitantly.

Diabetes and Hypoglycemia

Beta blockers may mask tachycardia occurring with hypoglycemia, but other manifestations such as dizziness and sweating may not be significantly affected.

Pheochromocytoma

If Lopressor is used in the setting of pheochromocytoma, it should be given in combination with an alpha blocker, and only after the alpha blocker has been initiated. Administration of beta blockers alone in the setting of pheochromocytoma has been associated with a paradoxical increase in blood pressure due to the attenuation of beta-mediated vasodilatation in skeletal muscle.

Thyrotoxicosis

Lopressor may mask certain clinical signs (e.g., tachycardia) of hyperthyroidism. Avoid abrupt withdrawal of beta blockade, which might precipitate a thyroid storm.

Adverse Reactions

Clinical Trials Experience

Hypertension and Angina
Myocardial Infarction
This image is provided by the National Library of Medicine.
Potential Adverse Reactions

Postmarketing Experience

The following adverse reactions have been reported during postapproval use of Lopressor:

Drug Interactions

  • Drug 1
  • Drug 2
  • Drug 3
  • Drug 4
  • Drug 5
Drug 1

(Description)

Drug 2

(Description)

Drug 3

(Description)

Drug 4

(Description)

Drug 5

(Description)

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): (Description)
Pregnancy Category (AUS): (Description)

Labor and Delivery

(Description)

Nursing Mothers

(Description)

Pediatric Use

(Description)

Geriatic Use

(Description)

Gender

(Description)

Race

(Description)

Renal Impairment

(Description)

Hepatic Impairment

(Description)

Females of Reproductive Potential and Males

(Description)

Immunocompromised Patients

(Description)

Others

(Description)

Administration and Monitoring

Administration

(Oral/Intravenous/etc)

Monitoring

Condition 1

(Description regarding monitoring, from Warnings section)

Condition 2

(Description regarding monitoring, from Warnings section)

Condition 3

(Description regarding monitoring, from Warnings section)

IV Compatibility

Solution

Compatible

  • Solution 1
  • Solution 2
  • Solution 3

Not Tested

  • Solution 1
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Variable

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Incompatible

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Y-Site

Compatible

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Not Tested

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Variable

  • Solution 1
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Incompatible

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Admixture

Compatible

  • Solution 1
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  • Solution 3

Not Tested

  • Solution 1
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  • Solution 3

Variable

  • Solution 1
  • Solution 2
  • Solution 3

Incompatible

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Syringe

Compatible

  • Solution 1
  • Solution 2
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Not Tested

  • Solution 1
  • Solution 2
  • Solution 3

Variable

  • Solution 1
  • Solution 2
  • Solution 3

Incompatible

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  • Solution 2
  • Solution 3

TPN/TNA

Compatible

  • Solution 1
  • Solution 2
  • Solution 3

Not Tested

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  • Solution 2
  • Solution 3

Variable

  • Solution 1
  • Solution 2
  • Solution 3

Incompatible

  • Solution 1
  • Solution 2
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Overdosage

Acute Overdose

Signs and Symptoms

(Description)

Management

(Description)

Chronic Overdose

Signs and Symptoms

(Description)

Management

(Description)

Pharmacology

Metoprolol tartrate (tablet)
Systematic (IUPAC) name
?
Identifiers
CAS number ?
ATC code ?
PubChem ?
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Formula ?
Mol. mass ?
Pharmacokinetic data
Bioavailability ?
Metabolism ?
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Therapeutic considerations
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Mechanism of Action

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Structure

(Description with picture)

Pharmacodynamics

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Pharmacokinetics

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Nonclinical Toxicology

(Description)

Clinical Studies

Condition 1

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Condition 2

(Description)

Condition 3

(Description)

How Supplied

(Description)

Storage

There is limited information regarding Metoprolol tartrate (tablet) Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Metoprolol tartrate (tablet) |?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::Metoprolol tartrate (tablet) |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

(Patient Counseling Information)

Precautions with Alcohol

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

Brand Names

There is limited information regarding Metoprolol tartrate (tablet) Brand Names in the drug label.

Look-Alike Drug Names

  • (Paired Confused Name 1a) — (Paired Confused Name 1b)
  • (Paired Confused Name 2a) — (Paired Confused Name 2b)
  • (Paired Confused Name 3a) — (Paired Confused Name 3b)

Drug Shortage Status

Drug Shortage

Price

References

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

  1. ↑ Fuster, V.; Rydén, LE.; Cannom, DS.; Crijns, HJ.; Curtis, AB.; Ellenbogen, KA.; Halperin, JL.; Le Heuzey, JY.; Kay, GN. (2006). "ACC/AHA/ESC 2006 guidelines for the management of patients with atrial fibrillation-executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Revise the 2001 Guidelines for the Management of Patients with Atrial Fibrillation)". Eur Heart J. 27 (16): 1979–2030. doi:10.1093/eurheartj/ehl176. PMID 16885201. Unknown parameter |month= ignored (help)
  2. ↑ Wann, LS.; Curtis, AB.; Ellenbogen, KA.; Estes, NA.; Ezekowitz, MD.; Jackman, WM.; January, CT.; Lowe, JE.; Page, RL. (2013). "Management of patients with atrial fibrillation (compilation of 2006 ACCF/AHA/ESC and 2011 ACCF/AHA/HRS recommendations): a report of the American College of Cardiology/American Heart Association Task Force on practice guidelines". Circulation. 127 (18): 1916–26. doi:10.1161/CIR.0b013e318290826d. PMID 23545139. Unknown parameter |month= ignored (help)
  3. ↑ 3.0 3.1 3.2 Amsterdam, EA.; Kulcyski, J.; Ridgeway, MG. (1991). "Efficacy of cardioselective beta-adrenergic blockade with intravenously administered metoprolol in the treatment of supraventricular tachyarrhythmias". J Clin Pharmacol. 31 (8): 714–8. PMID 1880230. Unknown parameter |month= ignored (help)
  4. ↑ Aşik, I.; Yörükoğlu, D.; Gülay, I.; Tulunay, M. (2003). "Pain on injection of propofol: comparison of metoprolol with lidocaine". Eur J Anaesthesiol. 20 (6): 487–9. PMID 12803269. Unknown parameter |month= ignored (help)
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