pharmacopeia
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/api/v1/drug/pindolol

Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: Adrenergic beta-Antagonists; Adrenergic beta1-Antagonists; Adrenergic beta2-Antagonists.

Indications

Sourced from openFDA
  • Pindolol tablets are indicated in the management of hypertension. It may be used alone or concomitantly with other antihypertensive agents, particularly with a thiazide-type diuretic.ICD-10: I10

Contraindications

Sourced from openFDA
  • Pindolol tablets are contraindicated in: 1) bronchial asthma; 2) overt cardiac failure; 3) cardiogenic shock; 4) second and third degree heart block; 5) severe bradycardia. (See WARNINGS.contraindicated

Dosage & administration

Sourced from openFDA

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.

Warnings & precautions

Sourced from openFDA

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. Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase risk of bradycardia. Beta-adrenergic blocking agents do not abolish the inotropic action of digitalis on heart muscle. In Patients Without A History of Cardiac Failure In patients with latent cardiac insufficiency, continued depression of the myocardium with beta-blocking agents 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.

Adverse reactions

Sourced from openFDA

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. ADVERSE REACTIONS WHICH WERE VOLUNTEERED OR ELICITED (and at least possibly drug-related) Body System/ Adverse Reactions Pindolol (N = 322) % Central Nervous System Bizarre or Many Dreams 5 Dizziness 9 Fatigue 8 Hallucinations < 1 Insomnia 10 Nervousness 7 Weakness 4 Autonomic Nervous System Paresthesia 3 Cardiovascular Dyspnea 5 Edema 6 Heart Failure < 1 Palpitations < 1 Musculoskeletal Chest Pain 3 Joint Pain 7 Muscle Cramps 3 Muscle Pain 10 Gastrointestinal Abdominal Discomfort 4 Nausea 5 Skin Pruritus 1 Rash < 1 Body System/ Adverse Reactions Active Controls Active Controls: Patients received either propranolol, α-methyldopa or a diuretic (hydrochlorothiazide or chlorthalidone).

Use in specific populations

Sourced from openFDA

Pregnancy Teratogenic Effects. Category B Studies in rats and rabbits exceeding 100 times the maximum recommended human doses, revealed no embryotoxicity or teratogenicity. Since there are no adequate and well controlled studies in pregnant women, and since animal reproduction studies are not always predictive of human response, pindolol, as with any drug, should be employed during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Pharmacokinetics

Sourced from openFDA
Metabolism
AND METABOLISM Pindolol is rapidly and reproducibly absorbed (greater than 95%), achieving peak plasma concentrations within 1 hour of drug administration. Pindolol has no significant first-pass effect.

Overdosage

Sourced from openFDA

No specific information on emergency treatment of overdosage is available. Therefore, on the basis of the pharmacologic actions of pindolol, the following general measures should be employed as appropriate in addition to gastric lavage: Excessive Bradycardia: administer atropine; if there is no response to vagal blockade, administer isoproterenol cautiously. Cardiac Failure: digitalize the patient and/or administer diuretic. It has been reported that glucagon may be useful in this situation. Hypotension: administer vasopressors, e.g., epinephrine or norepinephrine, with serial monitoring of blood pressure. (There is evidence that epinephrine may be the drug of choice.) Bronchospasm: administer a beta 2 stimulating agent such as isoproterenol and/or a theophylline derivative. A case of an acute overdosage has been reported with an intake of 500 mg of pindolol by a hypertensive patient. Blood pressure increased and heart rate was ≥ 80 beats/min. Recovery was uneventful. In another case, 250 mg of pindolol was taken with 150 mg diazepam and 50 mg nitrazepam, producing coma and hypotension. The patient recovered in 24 hours.

Approval history

Sourced from openFDA
  • Mar 29, 1993ANDAANDA073609Ani Pharms
  • Jan 27, 1994ANDAANDA074063Sun Pharm Industries
  • Jan 13, 2016ANDAANDA205415Mpp Pharma
  • Aug 1, 2019ANDAANDA211712Unichem

FDA shortages

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Reference statistics from the openFDA drug-shortage dataset. For a live view, consult the FDA database directly. Not clinical guidance.

  • Pindolol, Tablet, 10 mg (NDC 57664-656-88)To be discontinued
    Sponsor: Sun Pharmaceutical Industries, Inc.
    Updated
  • Pindolol, Tablet, 5 mg (NDC 57664-655-88)To be discontinued
    Sponsor: Sun Pharmaceutical Industries, Inc.
    Updated

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
782 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Ineffective516.5%
  2. 2Fatigue435.5%
  3. 3Nausea435.5%
  4. 4Urinary Tract Infection425.4%
  5. 5Dizziness415.2%
  6. 6Dyspnoea415.2%
  7. 7Drug Interaction405.1%
  8. 8Fall314.0%
  9. 9Diarrhoea303.8%
  10. 10Rhabdomyolysis283.6%
  11. 11Pain263.3%
  12. 12Headache253.2%
  13. 13Muscular Weakness243.1%
  14. 14Myalgia243.1%
  15. 15Sepsis243.1%

Literature

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Recent PubMed references pinned to Pindolol as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 20 ClinicalTrials.gov registrations naming Pindolol as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Pharmacogenomics

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CPIC-curated drug–gene pairs for Pindolol. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

Frequently asked questions

How does Pindolol work?
Mechanism-of-action classes: Adrenergic beta-Antagonists; Adrenergic beta1-Antagonists; Adrenergic beta2-Antagonists.
What is Pindolol used for?
According to FDA labeling, Pindolol carries indications including: Pindolol tablets are indicated in the management of hypertension. It may be used alone or concomitantly with other antihypertensive agents, particularly with a thiazide-type diuretic.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Pindolol?
Pindolol is classified as Beta blocking agents, non-selective, beta-Adrenergic Blocker, Adrenergic beta-Antagonists, Adrenergic beta1-Antagonists, Adrenergic beta2-Antagonists, Decreased Blood Pressure, Negative Chronotropy.
What are the contraindications for Pindolol?
Pindolol labeling lists contraindications including: Pindolol tablets are contraindicated in: 1) bronchial asthma; 2) overt cardiac failure; 3) cardiogenic shock; 4) second and third degree heart block; 5) severe bradycardia. (See WARNINGS.. Always consult the full prescribing information and a clinician.
Note. Data for pindolol is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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