pharmacopeia

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Adrenergic alpha-Antagonists.

Indications

Sourced from openFDA
  • INDICATION AND USAGE Phenoxybenzamine hydrochloride capsules are indicated in the treatment of pheochromocytoma, to control episodes of hypertension and sweating. If tachycardia is excessive, it may be necessary to use a beta -blocking agent concomitantly.ICD-10: I10

Contraindications

Sourced from openFDA
  • Conditions where a fall in blood pressure may be undesirable; hypersensitivity to the phenoxybenzamine hydrochloride capsules, or any of its components.contraindicated

Dosage & administration

Sourced from openFDA

The dosage should be adjusted to fit the needs of each patient. Small initial doses should be slowly increased until the desired effect is obtained or the side effects from blockade become troublesome. After each increase, the patient should be observed on that level before instituting another increase . The dosage should be carried to a point where symptomatic relief and/or objective improvement are obtained, but not so high that the side effects from blockade become troublesome. Initially, 10 mg of phenoxybenzamine hydrochloride twice a day. Dosage should be increased every other day, usually to 20 mg to 40 mg 2 or 3 times a day, until an optimal dosage is obtained, as judged by blood pressure control. Long-term use of phenoxybenzamine is not recommended (see PRECAUTIONS - Carcinogenesis and Mutagenesis ).

Warnings & precautions

Sourced from openFDA

Phenoxybenzamine hydrochloride-induced alpha -adrenergic blockade leaves beta -adrenergic receptors unopposed. Compounds that stimulate both types of receptors may, therefore, produce an exaggerated hypotensive response and tachycardia.

Adverse reactions

Sourced from openFDA

The following adverse reactions have been observed, but there are insufficient data to support an estimate of their frequency. Autonomic Nervous System*: Postural hypotension, tachycardia, inhibition of ejaculation, nasal congestion, miosis. *These so-called “side effects” are actually evidence of adrenergic blockade and vary according to the degree of blockade. Miscellaneous: Gastrointestinal irritation, drowsiness, fatigue. To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Use in specific populations

Sourced from openFDA

Pregnancy - Teratogenic Effects Adequate reproductive studies in animals have not been performed with phenoxybenzamine hydrochloride. It is also not known whether phenoxybenzamine hydrochloride can cause fetal harm when administered to a pregnant woman. Phenoxybenzamine hydrochloride should be given to a pregnant woman only if clearly needed.

Overdosage

Sourced from openFDA

SYMPTOMS - These are largely the result of blocking of the sympathetic nervous system and of the circulating epinephrine. They may include postural hypotension, resulting in dizziness or fainting; tachycardia, particularly postural; vomiting; lethargy; shock. Treatment When symptoms and signs of overdosage exist, discontinue phenoxybenzamine hydrochloride capsules. Treatment of circulatory failure, if present, is a prime consideration. In cases of mild overdosage, recumbent position with legs elevated usually restores cerebral circulation. In the more severe cases, the usual measures to combat shock should be instituted. Usual pressor agents are not effective. Epinephrine is contraindicated because it stimulates both alpha - and beta - receptors; since alpha- receptors are blocked, the net effect of epinephrine administration is vasodilation and a further drop in blood pressure (epinephrine reversal). The patient may have to be kept flat for 24 hours or more in the case of overdose, as the effect of the drug is prolonged. Leg bandages and an abdominal binder may shorten the period of disability.

Approval history

Sourced from openFDA
  • Oct 27, 2020ANDAANDA212568Amneal
  • Jul 19, 2022ANDAANDA215042Novitium Pharma
  • May 8, 2023ANDAANDA215600Aurobindo Pharma

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.
26 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. 1Urinary Tract Infection623%
  2. 2Covid-19415%
  3. 3Blood Pressure Decreased312%
  4. 4Diarrhoea312%
  5. 5Dizziness312%
  6. 6Headache312%
  7. 7Influenza312%
  8. 8Catastrophic Reaction27.7%
  9. 9Constipation27.7%
  10. 10Cystitis27.7%
  11. 11Dehydration27.7%
  12. 12Delirium27.7%
  13. 13Device Use Issue27.7%
  14. 14Fatigue27.7%
  15. 15Feeding Disorder27.7%

Literature

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

Clinical trials

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The 9 most recently updated of 9 ClinicalTrials.gov registrations naming Phenoxybenzamine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Phenoxybenzamine work?
Mechanism-of-action class: Adrenergic alpha-Antagonists.
What is Phenoxybenzamine used for?
According to FDA labeling, Phenoxybenzamine carries indications including: INDICATION AND USAGE Phenoxybenzamine hydrochloride capsules are indicated in the treatment of pheochromocytoma, to control episodes of hypertension and sweating. If tachycardia is excessive, it may be necessary to use a beta -blocking agent concomitantly.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Phenoxybenzamine?
Phenoxybenzamine is classified as Other peripheral vasodilators, alpha-Adrenergic Blocker, Adrenergic alpha-Antagonists, Decreased Bladder Sphincter Tone, Decreased Blood Pressure, Decreased Urethra Smooth Muscle Tone.
What are the brand names for Phenoxybenzamine?
Phenoxybenzamine is marketed under brand names including Dibenzyline.
What are the contraindications for Phenoxybenzamine?
Phenoxybenzamine labeling lists contraindications including: Conditions where a fall in blood pressure may be undesirable; hypersensitivity to the phenoxybenzamine hydrochloride capsules, or any of its components.. Always consult the full prescribing information and a clinician.
Note. Data for phenoxybenzamine 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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