Pindolol: Difference between revisions
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[[Beta-block]]ade may mask certain clinical signs (e.g., [[tachycardia]]) of [[hyperthyroidism]]. Patients suspected of developing [[thyrotoxicosis]] should be managed carefully to avoid abrupt withdrawal of [[beta-block]]ade which might precipitate a [[thyroid crisis]]. | [[Beta-block]]ade may mask certain clinical signs (e.g., [[tachycardia]]) of [[hyperthyroidism]]. Patients suspected of developing [[thyrotoxicosis]] should be managed carefully to avoid abrupt withdrawal of [[beta-block]]ade which might precipitate a [[thyroid crisis]]. | ||
|clinicalTrials=Most adverse reactions have been mild. The incidences listed in the following table are derived from 12-week comparative double-blind, parallel design trials in hypertensive patients given | |clinicalTrials=Most adverse reactions have been mild. The incidences listed in the following table are derived from 12-week comparative double-blind, parallel design trials in hypertensive patients given pindolol as monotherapy, given various active control drugs as monotherapy, or given placebo. Data for pindolol and the positive controls were pooled from several trials because no striking differences were seen in the individual studies, with one exception. When considering all adverse reactions reported, the frequency of edema was noticeably higher in positive control trials (16% pindolol vs. 9% positive control) than in placebo controlled trials (6% pindolol vs. 3% placebo). The table includes adverse reactions either volunteered or elicited, and at least possibly drug-related, which were reported in greater than 2% of pindolol patients and other selected important reactions. | ||
The following selected (potentially important) adverse reactions were seen in 2% or fewer patients and their relationship to | |||
The following selected (potentially important) adverse reactions were seen in 2% or fewer patients and their relationship to pindolol is uncertain: | |||
* '''Central nervous system:''' [[Anxiety]], [[lethargy]]. | |||
* '''Autonomic nervous system:''' Visual disturbances, [[hyperhidrosis]]. | |||
* '''Cardiovascular:''' [[Bradycardia]], [[claudication]], [[cold extremities]], [[heart block]], [[hypotension]], [[syncope]], [[tachycardia]], weight gain. | |||
* '''Gastrointestinal:''' [[Diarrhea]], [[vomiting]]. | |||
* '''Respiratory:''' [[Wheezing]]. | |||
* '''Urogenital:''' [[Impotence]], [[pollakiuria]]. | |||
* '''Miscellaneous:''' Eye discomfort or burning eyes. | |||
====Potential Adverse Effects==== | ====Potential Adverse Effects==== | ||
In addition, other adverse effects not aforementioned have been reported with other beta- | In addition, other adverse effects not aforementioned have been reported with other [[beta-blockers]] and should be considered potential adverse effects of pindolol: | ||
* '''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]]. | |||
* '''Allergic''': Erythematous [[rash]], [[fever]] combined with aching and [[sore throat]], [[laryngospasm]], [[respiratory distress]]. While taking [[beta-blockers]], patients with a history of severe anaphylactic reaction to a variety of allergens may be more reactive to repeated challenge, either accidental, diagnostic, or therapeutic. Such patients may be unresponsive to the usual doses of epinephrine used to treat [[allergic reactions]]. | |||
* '''Hematologic''': [[Agranulocytosis]], [[thrombocytopenic purpura]] and [[nonthrombocytopenic purpura]]. | |||
* '''Gastrointestinal''': [[Mesenteric arterial thrombosis]], [[ischemic colitis]]. | |||
* '''Miscellaneous''': Reversible [[alopecia]], [[Peyronie’s disease]]. | |||
* The oculomucocutaneous syndrome associated with the [[beta-blocker]] practolol has not been reported with pindolol during investigational use and extensive foreign experience amounting to over 4 million patient-years. | |||
The oculomucocutaneous syndrome associated with the beta-blocker practolol has not been reported with | |||
====Clinical Laboratory==== | ====Clinical Laboratory==== | ||
Minor persistent elevations in serum transaminases (SGOT, SGPT) have been noted in 7% of patients during | Minor persistent elevations in serum [[transaminases]] ([[SGOT]], [[SGPT]]) have been noted in 7% of patients during pindolol administration, but progressive elevations were not observed. These elevations were not associated with any other abnormalities that would suggest [[hepatic impairment]], such as decreased serum [[albumin]] and total proteins. During more than a decade of worldwide marketing, there have been no reports in the medical literature of overt hepatic injury. [[Alkaline phosphatase]], [[lactic acid dehydrogenase]] ([[LDH]]), and uric acid are also elevated on rare occasions. The significance of these findings is unknown. | ||
| | |drugInteractions=* Catecholamine-depleting drugs (e.g., [[reserpine]]) may have an additive effect when given with [[beta-blockers]]. Patients receiving pindolol plus a catecholamine-depleting agent should, therefore, be closely observed for evidence of [[hypotension]] and/or marked [[bradycardia]] which may produce [[vertigo]], [[syncope]], or [[orthostatic hypotension]]. | ||
* Pindolol has been used with a variety of antihypertensive agents, including [[hydrochlorothiazide]], [[hydralazine]], and [[guanethidine]] without unexpected adverse interactions. | |||
* | * Pindolol has been shown to increase serum [[thioridazine]] levels when both drugs are coadministered. Pindolol levels may also be increased with this combination. | ||
|useInPregnancyFDA=(Description) | |useInPregnancyFDA=(Description) | ||
|useInPregnancyAUS=(Description) | |useInPregnancyAUS=(Description) | ||
Revision as of 18:09, 8 July 2014
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alonso Alvarado, M.D. [2]
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Overview
Pindolol is a beta-adrenergic blocker that is FDA approved for the {{{indicationType}}} of hypertension. Common adverse reactions include edema, arthralgia, myalgia, dizziness, feeling nervous, insomnia, fatigue.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Hypertension
- Dosing Information
- The dosage of pindolol tablets should be individualized. The recommended initial dose of pindolol tablets is 5 mg b.i.d. alone or in combination with other antihypertensive agents. An antihypertensive response usually occurs within the first week of treatment. Maximal response, however, may take as long as or occasionally longer than 2 weeks. If a satisfactory reduction in blood pressure does not occur within 3 to 4 weeks, the dose may be adjusted in increments of 10 mg/day at these intervals up to a maximum of 60 mg/day.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Pindolol in adult patients.
Non–Guideline-Supported Use
Angina Pectoris
- Dosing Information
- 10 to 40 mg/day.[1]
Cardiac Disrythmia
- Dosing Information
Hyperthyroidism
- Dosing Information
- 5 to 30 mg daily.[4]
Syncope
- Dosing information
- 2.5 mg daily to 15 mg bid.[5]
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Pindolol 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 Pindolol in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Pindolol in pediatric patients.
Contraindications
- Bronchial asthma
- Overt cardiac failure
- Cardiogenic shock
- Second degree AV heart block
- Third degree AV heart block
- Severe bradycardia
Warnings
Cardiac Failure
Sympathetic stimulation may be a vital component supporting circulatory function in patients with congestive heart failure, and its inhibition by beta-blockade may precipitate more severe failure. Although beta-blockers should be avoided in overt congestive heart failure, if necessary, pindolol can be used with caution in patients with a history of failure who are well-compensated, usually with digitalis and diuretics. Beta-blockes do not abolish the inotropic action of digitalis on heart muscle.
In Patients Without History of Cardiac Failure
In patients with latent cardiac insufficiency, continued depression of the myocardium with beta-blockers over a period of time can in some cases lead to cardiac failure. At the first sign or symptom of impending cardiac failure, patients should be fully digitalized and/or be given a diuretic, and the response observed closely. If cardiac failure continues, despite adequate digitalization and diuretic, pindolol therapy should be withdrawn (gradually if possible).
Exacerbation of Ischemic Heart Disease Following Abrupt Withdrawal
Hypersensitivity to catecholamines has been observed in patients withdrawn from beta-blocker therapy; exacerbation of angina and, in some cases, myocardial infarction have occurred after abrupt discontinuation of such therapy. When discontinuing chronically administered pindolol, particularly in patients with ischemic heart 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, pindolol administration should be reinstituted 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 pindolol therapy abruptly even in patients treated only for hypertension.
Nonallergic Bronchospasm (e.g., chronic bronchitis, emphysema) - Patients with Bronchospastic Diseases Should in General Not Receive Beta-Blockers
Pindolol should be administered with caution since it may block bronchodilation produced by endogenous or exogenous catecholamine stimulation of beta2 receptors.
Major Surgery
Because beta-blockade impairs the ability of the heart to respond to reflex stimuli and may increase the risks of general anesthesia and surgical procedures, resulting in protracted hypotension or low cardiac output, it has generally been suggested that such therapy should be gradually withdrawn several days prior to surgery. Recognition of the increased sensitivity to catecholamines of patients recently withdrawn from beta-blocker therapy, however, has made this recommendation controversial. If possible, beta-blockers should be withdrawn well before surgery takes place. In the event of emergency surgery, the anesthesiologist should be informed that the patient is on beta-blocker therapy.
The effects of pindolol can be reversed by administration of beta-receptor agonists such as isoproterenol, dopamine, dobutamine, or levarterenol. Difficulty in restarting and maintaining the heart beat has also been reported with beta-adrenergic receptor blocking agents.
Diabetes and Hypoglycemia
Beta-blockade may prevent the appearance of premonitory signs and symptoms (e.g., tachycardia and blood pressure changes) of acute hypoglycemia. This is especially important with labile diabetics. Beta-blockade also reduces the release of insulin in response to hyperglycemia; therefore, it may be necessary to adjust the dose of antidiabetic drugs.
Thyrotoxicosis
Beta-blockade may mask certain clinical signs (e.g., tachycardia) of hyperthyroidism. Patients suspected of developing thyrotoxicosis should be managed carefully to avoid abrupt withdrawal of beta-blockade which might precipitate a thyroid crisis.
Adverse Reactions
Clinical Trials Experience
Most adverse reactions have been mild. The incidences listed in the following table are derived from 12-week comparative double-blind, parallel design trials in hypertensive patients given pindolol as monotherapy, given various active control drugs as monotherapy, or given placebo. Data for pindolol and the positive controls were pooled from several trials because no striking differences were seen in the individual studies, with one exception. When considering all adverse reactions reported, the frequency of edema was noticeably higher in positive control trials (16% pindolol vs. 9% positive control) than in placebo controlled trials (6% pindolol vs. 3% placebo). The table includes adverse reactions either volunteered or elicited, and at least possibly drug-related, which were reported in greater than 2% of pindolol patients and other selected important reactions.
The following selected (potentially important) adverse reactions were seen in 2% or fewer patients and their relationship to pindolol is uncertain:
- Central nervous system: Anxiety, lethargy.
- Autonomic nervous system: Visual disturbances, hyperhidrosis.
- Cardiovascular: Bradycardia, claudication, cold extremities, heart block, hypotension, syncope, tachycardia, weight gain.
- Gastrointestinal: Diarrhea, vomiting.
- Respiratory: Wheezing.
- Urogenital: Impotence, pollakiuria.
- Miscellaneous: Eye discomfort or burning eyes.
Potential Adverse Effects
In addition, other adverse effects not aforementioned have been reported with other beta-blockers and should be considered potential adverse effects of pindolol:
- 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.
- Allergic: Erythematous rash, fever combined with aching and sore throat, laryngospasm, respiratory distress. While taking beta-blockers, patients with a history of severe anaphylactic reaction to a variety of allergens may be more reactive to repeated challenge, either accidental, diagnostic, or therapeutic. Such patients may be unresponsive to the usual doses of epinephrine used to treat allergic reactions.
- Hematologic: Agranulocytosis, thrombocytopenic purpura and nonthrombocytopenic purpura.
- Gastrointestinal: Mesenteric arterial thrombosis, ischemic colitis.
- Miscellaneous: Reversible alopecia, Peyronie’s disease.
- The oculomucocutaneous syndrome associated with the beta-blocker practolol has not been reported with pindolol during investigational use and extensive foreign experience amounting to over 4 million patient-years.
Clinical Laboratory
Minor persistent elevations in serum transaminases (SGOT, SGPT) have been noted in 7% of patients during pindolol administration, but progressive elevations were not observed. These elevations were not associated with any other abnormalities that would suggest hepatic impairment, such as decreased serum albumin and total proteins. During more than a decade of worldwide marketing, there have been no reports in the medical literature of overt hepatic injury. Alkaline phosphatase, lactic acid dehydrogenase (LDH), and uric acid are also elevated on rare occasions. The significance of these findings is unknown.
Postmarketing Experience
There is limited information regarding Pindolol Postmarketing Experience in the drug label.
Drug Interactions
- Catecholamine-depleting drugs (e.g., reserpine) may have an additive effect when given with beta-blockers. Patients receiving pindolol plus a catecholamine-depleting agent should, therefore, be closely observed for evidence of hypotension and/or marked bradycardia which may produce vertigo, syncope, or orthostatic hypotension.
- Pindolol has been used with a variety of antihypertensive agents, including hydrochlorothiazide, hydralazine, and guanethidine without unexpected adverse interactions.
- Pindolol has been shown to increase serum thioridazine levels when both drugs are coadministered. Pindolol levels may also be increased with this combination.
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
- Solution 2
- Solution 3
Variable
- Solution 1
- Solution 2
- Solution 3
Incompatible
- Solution 1
- Solution 2
- Solution 3
Y-Site
Compatible
- Solution 1
- Solution 2
- Solution 3
Not Tested
- Solution 1
- Solution 2
- Solution 3
Variable
- Solution 1
- Solution 2
- Solution 3
Incompatible
- Solution 1
- Solution 2
- Solution 3
Admixture
Compatible
- Solution 1
- Solution 2
- Solution 3
Not Tested
- Solution 1
- Solution 2
- Solution 3
Variable
- Solution 1
- Solution 2
- Solution 3
Incompatible
- Solution 1
- Solution 2
- Solution 3
Syringe
Compatible
- Solution 1
- Solution 2
- Solution 3
Not Tested
- Solution 1
- Solution 2
- Solution 3
Variable
- Solution 1
- Solution 2
- Solution 3
Incompatible
- Solution 1
- Solution 2
- Solution 3
TPN/TNA
Compatible
- Solution 1
- Solution 2
- Solution 3
Not Tested
- Solution 1
- Solution 2
- Solution 3
Variable
- Solution 1
- Solution 2
- Solution 3
Incompatible
- Solution 1
- Solution 2
- Solution 3
Overdosage
Acute Overdose
Signs and Symptoms
(Description)
Management
(Description)
Chronic Overdose
Signs and Symptoms
(Description)
Management
(Description)
Pharmacology
| |
Pindolol
| |
| Systematic (IUPAC) name | |
| ? | |
| Identifiers | |
| CAS number | ? |
| ATC code | ? |
| PubChem | ? |
| Chemical data | |
| Formula | ? |
| Mol. mass | ? |
| Pharmacokinetic data | |
| Bioavailability | ? |
| Metabolism | ? |
| Half life | ? |
| Excretion | ? |
| Therapeutic considerations | |
| Pregnancy cat. |
? |
| Legal status | |
| Routes | ? |
Mechanism of Action
(Description)
Structure
(Description with picture)
Pharmacodynamics
(Description)
Pharmacokinetics
(Description)
Nonclinical Toxicology
(Description)
Clinical Studies
Condition 1
(Description)
Condition 2
(Description)
Condition 3
(Description)
How Supplied
(Description)
Storage
There is limited information regarding Pindolol Storage in the drug label.
Images
Drug Images
{{#ask: Page Name::Pindolol |?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::Pindolol |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}
Patient Counseling Information
(Patient Counseling Information)
Precautions with Alcohol
Alcohol-Pindolol 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 Pindolol 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.
- ↑ Frishman W, Kostis J, Strom J, Hossler M, Elkayam U, Goldner S; et al. (1979). "Clinical pharmacology of the new beta-adrenergic blocking drugs. Part 6. A comparison of pindolol and propranolol in treatment of patients with angina pectoris. The role of intrinsic sympathomimetic activity". Am Heart J. 98 (4): 526–35. PMID 39447.
- ↑ Frishman W, Davis R, Strom J, Elkayam U, Stampfer M, Ribner H; et al. (1979). "Clinical pharmacology of the new beta-adrenergic blocking drugs. Part 5. Pindolol (LB-46) therapy for supraventricular arrhythmia: a viable alternative to propranolol in patients with bronchospasm". Am Heart J. 98 (3): 393–98. PMID 38659.
- ↑ James MA, Channer KS, Papouchado M, Rees JR (1989). "Improved control of atrial fibrillation with combined pindolol and digoxin therapy". Eur Heart J. 10 (1): 83–90. PMID 2702970.
- ↑ Schelling JL, Scazziga B, Dufour RJ, Milinkovic N, Weber AA (1973). "Effect of pindolol, a beta receptor antagonist, in hyperthyroidism". Clin Pharmacol Ther. 14 (2): 158–64. PMID 4695378.
- ↑ Iskos D, Dutton J, Scheinman MM, Lurie KG (1998). "Usefulness of pindolol in neurocardiogenic syncope". Am J Cardiol. 82 (9): 1121–4, A9. PMID 9817494.