Phenoxybenzamine Hydrochloride

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Overview

What is Phenoxybenzamine Hydrochloride?

Each Phenoxybenzamine hydrochloride capsule, USP contains 10 mg of phenoxybenzamine hydrochloride, USP. Inactive ingredients consist of lactose anhydrous and talc.

Phenoxybenzamine hydrochloride is -(2-Chloroethyl)--(1-methyl-2-phenoxyethyl) benzylamine hydrochloride:

Phenoxybenzamine hydrochloride is a white solid crystalline powder with a molecular weight of 340.3, which melts between 136° and 141°C. It is freely soluble in methanol, soluble in acetone, insoluble in ethyl acetate.

USP Organic Impurities Test pending.

What does Phenoxybenzamine Hydrochloride look like?

What are the available doses of Phenoxybenzamine Hydrochloride?

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What should I talk to my health care provider before I take Phenoxybenzamine Hydrochloride?

Sorry No records found

How should I use Phenoxybenzamine Hydrochloride?

Phenoxybenzamine hydrochloride capsules, USP is indicated in the treatment of pheochromocytoma, to control episodes of hypertension and sweating. If tachycardia is excessive, it may be necessary to use a -blocking agent concomitantly.

The dosage should be adjusted to fit the needs of each patient. Small initial doses should be increased until the desired effect is obtained or the side effects from blockade become troublesome. . 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 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 (

What interacts with Phenoxybenzamine Hydrochloride?

Conditions where a fall in blood pressure may be undesirable; hypersensitivity to the drug or any of its components.

What are the warnings of Phenoxybenzamine Hydrochloride?

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of , and surgical evaluation should be instituted as clinically indicated.

What are the precautions of Phenoxybenzamine Hydrochloride?

General

Administer with caution in patients with marked cerebral or coronary arteriosclerosis or renal damage. Adrenergic blocking effect may aggravate symptoms of respiratory infections.

Drug Interactions

Phenoxybenzamine hydrochloride may interact with compounds that stimulate both and adrenergic receptors (i.e., epinephrine) to produce an exaggerated hypotensive response and tachycardia. ( )

Phenoxybenzamine hydrochloride blocks hyperthermia production by levarterenol, and blocks hypothermia production by reserpine.

Carcinogenesis and Mutagenesis

Case reports of carcinoma in humans after long-term treatment with phenoxybenzamine have been reported. Hence long-term use of phenoxybenzamine is not recommended. Carefully weigh the benefits and risks before prescribing this drug.

Phenoxybenzamine hydrochloride showed mutagenic activity in the Ames test and mouse lymphoma assay; it did not show mutagenic activity in the micronucleus test in mice. In rats and mice, repeated intraperitoneal administration of phenoxybenzamine hydrochloride (three times per week for up to 52 weeks) resulted in peritoneal sarcomas. Chronic oral dosing in rats (for up to 2 years) produced malignant tumors of the small intestine and non-glandular stomach, as well as ulcerative and/or erosive gastritis of the glandular stomach. Whereas squamous cell carcinomas of the non-glandular stomach were observed at all tested doses of phenoxybenzamine hydrochloride, there was a no-observed-effect-level of 10 mg/kg for tumors (carcinomas and sarcomas) of the small intestine. This dose is, on a body surface area basis, about twice the maximum recommended human dosage of 20 mg b.i.d.

Pregnancy - Teratogenic Effects - Pregnancy Category C

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.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions from phenoxybenzamine hydrochloride, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

What are the side effects of Phenoxybenzamine Hydrochloride?

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.

What should I look out for while using Phenoxybenzamine Hydrochloride?

Conditions where a fall in blood pressure may be undesirable; hypersensitivity to the drug or any of its components.

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

What might happen if I take too much Phenoxybenzamine Hydrochloride?

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.

How should I store and handle Phenoxybenzamine Hydrochloride?

Store at 25°C (77°F). Excursions permitted to 15°-30°C (59°-86°F) Protect from freezing. Avoid excessive heat.Each bag contains no preservative. Once drug has been withdrawn from ready-to-use bag, the bag should be used within 24 hours, with any unused portion discarded.Do not use plastic containers in series connections. Such use could result in an embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is completed.Do not remove unit from overwrap until ready to use. Do not use if overwrap has been previously opened or damaged. The overwrap is a moisture barrier. The inner bag maintains sterility of the solution. Tear overwrap at notch and remove premixed bag. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually.Check for minute leaks by squeezing the inner bag firmly. If leaks are found, discard solution, as sterility may be impaired. Do not use unless the solution is clear (colorless to light yellow) and the seal is intact.Preparation for intravenous administration:Store at 25°C (77°F). Excursions permitted to 15°-30°C (59°-86°F) Protect from freezing. Avoid excessive heat.Each bag contains no preservative. Once drug has been withdrawn from ready-to-use bag, the bag should be used within 24 hours, with any unused portion discarded.Do not use plastic containers in series connections. Such use could result in an embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is completed.Do not remove unit from overwrap until ready to use. Do not use if overwrap has been previously opened or damaged. The overwrap is a moisture barrier. The inner bag maintains sterility of the solution. Tear overwrap at notch and remove premixed bag. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually.Check for minute leaks by squeezing the inner bag firmly. If leaks are found, discard solution, as sterility may be impaired. Do not use unless the solution is clear (colorless to light yellow) and the seal is intact.Preparation for intravenous administration:Store at 25°C (77°F). Excursions permitted to 15°-30°C (59°-86°F) Protect from freezing. Avoid excessive heat.Each bag contains no preservative. Once drug has been withdrawn from ready-to-use bag, the bag should be used within 24 hours, with any unused portion discarded.Do not use plastic containers in series connections. Such use could result in an embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is completed.Do not remove unit from overwrap until ready to use. Do not use if overwrap has been previously opened or damaged. The overwrap is a moisture barrier. The inner bag maintains sterility of the solution. Tear overwrap at notch and remove premixed bag. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually.Check for minute leaks by squeezing the inner bag firmly. If leaks are found, discard solution, as sterility may be impaired. Do not use unless the solution is clear (colorless to light yellow) and the seal is intact.Preparation for intravenous administration:Store at 25°C (77°F). Excursions permitted to 15°-30°C (59°-86°F) Protect from freezing. Avoid excessive heat.Each bag contains no preservative. Once drug has been withdrawn from ready-to-use bag, the bag should be used within 24 hours, with any unused portion discarded.Do not use plastic containers in series connections. Such use could result in an embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is completed.Do not remove unit from overwrap until ready to use. Do not use if overwrap has been previously opened or damaged. The overwrap is a moisture barrier. The inner bag maintains sterility of the solution. Tear overwrap at notch and remove premixed bag. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually.Check for minute leaks by squeezing the inner bag firmly. If leaks are found, discard solution, as sterility may be impaired. Do not use unless the solution is clear (colorless to light yellow) and the seal is intact.Preparation for intravenous administration:Store at 25°C (77°F). Excursions permitted to 15°-30°C (59°-86°F) Protect from freezing. Avoid excessive heat.Each bag contains no preservative. Once drug has been withdrawn from ready-to-use bag, the bag should be used within 24 hours, with any unused portion discarded.Do not use plastic containers in series connections. Such use could result in an embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is completed.Do not remove unit from overwrap until ready to use. Do not use if overwrap has been previously opened or damaged. The overwrap is a moisture barrier. The inner bag maintains sterility of the solution. Tear overwrap at notch and remove premixed bag. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually.Check for minute leaks by squeezing the inner bag firmly. If leaks are found, discard solution, as sterility may be impaired. Do not use unless the solution is clear (colorless to light yellow) and the seal is intact.Preparation for intravenous administration:Store at 25°C (77°F). Excursions permitted to 15°-30°C (59°-86°F) Protect from freezing. Avoid excessive heat.Each bag contains no preservative. Once drug has been withdrawn from ready-to-use bag, the bag should be used within 24 hours, with any unused portion discarded.Do not use plastic containers in series connections. Such use could result in an embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is completed.Do not remove unit from overwrap until ready to use. Do not use if overwrap has been previously opened or damaged. The overwrap is a moisture barrier. The inner bag maintains sterility of the solution. Tear overwrap at notch and remove premixed bag. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually.Check for minute leaks by squeezing the inner bag firmly. If leaks are found, discard solution, as sterility may be impaired. Do not use unless the solution is clear (colorless to light yellow) and the seal is intact.Preparation for intravenous administration:Each phenoxybenzamine hydrochloride capsule, USP with Scarlet trans colored cap and body imprinted with PAR on cap and 260 in body contains white to off white powder.Phenoxybenzamine hydrochloride capsules USP, 10 mg in bottles of 100 (NDC 49884-038-01).Each phenoxybenzamine hydrochloride capsule, USP with Scarlet trans colored cap and body imprinted with PAR on cap and 260 in body contains white to off white powder.Phenoxybenzamine hydrochloride capsules USP, 10 mg in bottles of 100 (NDC 49884-038-01).

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Phenoxybenzamine hydrochloride is a long-acting, adrenergic, -receptor-blocking agent, which can produce and maintain "chemical sympathectomy" by oral administration. It increases blood flow to the skin, mucosa and abdominal viscera, and lowers both supine and erect blood pressures. It has no effect on the parasympathetic system.

Twenty to 30 percent of orally administered phenoxybenzamine appears to be absorbed in the active form.¹

The half-life of orally administered phenoxybenzamine hydrochloride is not known; however, the half-life of intravenously administered drug is approximately 24 hours. Demonstrable effects with intravenous administration persist for at least 3 to 4 days, and the effects of daily administration are cumulative for nearly a week.¹

Non-Clinical Toxicology

Conditions where a fall in blood pressure may be undesirable; hypersensitivity to the drug or any of its components.

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

Phenoxybenzamine hydrochloride may interact with compounds that stimulate both and adrenergic receptors (i.e., epinephrine) to produce an exaggerated hypotensive response and tachycardia. ( )

Phenoxybenzamine hydrochloride blocks hyperthermia production by levarterenol, and blocks hypothermia production by reserpine.

Administer with caution in patients with marked cerebral or coronary arteriosclerosis or renal damage. Adrenergic blocking effect may aggravate symptoms of respiratory infections.

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.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Review

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).

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