DRUGS & SUPPLEMENTS

Dibenzyline

Name: Dibenzyline drug & pharmaceuticals. Available Forms, Doses, Prices
Creator: sdrugs.com
Published: 2021-11-11T10:10:10+00:00

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Dibenzyline uses

Description
Clinical pharmacology
Indication and usage
Contraindications
Warning
Precautions
Adverse reactions
Overdosage
Treatment
Dosage and administration
Storage
How supplied
References
Dibenzyline reviews

DESCRIPTION

Each Dibenzyline capsule, with red cap and body, is imprinted WPC 001 and 10 mg, and contains 10 mg of Dibenzyline USP. Inactive ingredients consist of D&C Red No. 33, FD&C Red No. 3, FD&C Yellow No. 6, Gelatin NF, Lactose NF, Sodium Lauryl Sulfate NF and Silicon Dioxide NF.

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

Dibenzyline is a colorless, crystalline powder with a molecular weight of 340.3, which melts between 136°and 141°C. It is soluble in water, alcohol and chloroform; insoluble in ether.

structure

CLINICAL PHARMACOLOGY

Dibenzyline (phenoxybenzamine hydrochloride) is a long-acting, adrenergic, alpha-receptor-blockingagent, which can produce and maintain "chemical sympathectomy" by oral administration. It increases blood flow to the skin, mucosa and abdominalviscera, and lowers both supine and erect blood pressures. It has no effecton the parasympathetic system.

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

The half-life of orally administeredphenoxybenzamine hydrochloride is not known; however, the half-life of intravenouslyadministered drug is approximately 24 hours. Demonstrable effects with intravenousadministration persist for at least 3 to 4 days, and the effects of dailyadministration are cumulative for nearly a week.¹

INDICATION AND USAGE

Dibenzyline 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 beta-blockingagent concomitantly.

CONTRAINDICATIONS

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

WARNING

Dibenzyline-induced alpha-adrenergicblockade leaves beta-adrenergic receptors unopposed. Compounds that stimulate both types of receptors may, therefore, produce an exaggerated hypotensiveresponse and tachycardia.

PRECAUTIONS

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 ²

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

Dibenzyline 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.³^,⁴ Carefully weigh the benefits and risks before prescribing this drug.

Dibenzyline showed invitro mutagenic activity in the Ames test and mouse lymphoma assay;it did not show mutagenic activity in vivo inthe micronucleus test in mice. In rats and mice, repeated intraperitonealadministration of Dibenzyline (three times per week forup 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-glandularstomach, as well as ulcerative and/or erosive gastritis of the glandular stomach. Whereas squamous cell carcinomas of the non-glandular stomach were observedat all tested doses of Dibenzyline, there was a no-observed-effect-levelof 10 mg/kg for tumors (carcinomas and sarcomas) of the smallintestine. This dose is, on a body surface area basis, about twice the maximumrecommended human dosage of 20 mg b.i.d.

Pregnancy

Teratogenic Effects - Pregnancy Category C

Adequate reproductive studies in animals have not been performed with Dibenzyline. It is also not known whether Dibenzyline can cause fetal harm when administered to a pregnant woman. Dibenzyline 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 potentialfor serious adverse reactions from Dibenzyline, a decisionshould 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.

ADVERSE REACTIONS

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 WellSpring Pharmaceutical Corporation at 1-866-337-4500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

OVERDOSAGE

SYMPTOMS-These are largely the result of blocking of the sympatheticnervous system and of the circulating epinephrine. They may include posturalhypotension, resulting in dizziness or fainting; tachycardia, particularlypostural; vomiting; lethargy; shock.

TREATMENT

When symptoms and signs of overdosage exist, discontinuethe drug. Treatment of circulatory failure, if present, is a prime consideration. In cases of mild overdosage, recumbent position with legs elevated usuallyrestores cerebral circulation. In the more severe cases, the usual measuresto 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 effectof epinephrine administration is vasodilation and a further drop in bloodpressure (epinephrine reversal).

The patient may have to be kept flat for 24 hours or more in the case of overdose, as the effectof the drug is prolonged. Leg bandages and an abdominal binder may shorten the period of disability.

I.V. Infusion of levarterenol bitartrate** may be used to combat severe hypotensive reactions, because it stimulates alpha-receptors primarily. Although Dibenzyline (phenoxybenzamine hydrochloride) is an alpha -adrenergic blocking agent, a sufficient dose of levarterenol bitartrate will overcome this effect.

The oral LD₅₀ for Dibenzyline is approximately 2000 mg/kg in rats and approximately500 mg/kg in guinea pigs.

DOSAGE AND ADMINISTRATION

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 Dibenzyline (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

STORAGE

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°- 86°F).

HOW SUPPLIED

Dibenzyline (phenoxybenzamine hydrochloride) capsules, 10 mg, in bottles of 100 (NDC 65197-001-01).

REFERENCES

1. Weiner, N.: Drugs That Inhibit Adrenergic Nerves and Block Adrenergic Receptors, in Goodman, L., and Gilman, A., The Pharmacological Basis of Therapeutics, ed. 6, New York, Macmillan Publishing Co., 1980, p. 179; p. 182.

2. Martin, E.W.: Drug Interactions Index 1978/1979, Philadelphia, J.B. Lippincott Co., 1978, pp. 209-210.

3. Nettesheim O, Hoffken G, Gahr M, Breidert M: Haematemesis and dysphagia in a 20-year-old woman with congenital spine malformation and situs inversus partialis [German]. Zeitschrift fur Gastroenterologie. 2003; 41(4):319-24.

4. Vaidyanathan S, Mansour P, Soni BM, Hughes PL, Singh G: Chronic lymphocytic leukaemia, synchronous small cell carcinoma and squamous neoplasia of the urinary bladder in a paraplegic man following long-term phenoxybenzamine therapy. Spinal Cord. 2006;44(3):188-91.

** Available as Levophed^® Bitartrate (brand of norepinephrine bitartrate) from Abbott Laboratories.

DATE OF ISSUANCE MARCH 2009

©WellSpring, 2009

Manufactured for

WellSpring Pharmaceutical Corporation

Sarasota, FL 34243 USA

By WellSpring Pharmaceutical

Canada Corp.

Oakville, Ontario L6H 1M5 Canada

Rev. 03/09

Dibenzyline pharmaceutical active ingredients containing related brand and generic drugs:

Phenoxybenzamine Hydrochloride

Dibenzyline available forms, composition, doses:

Capsules; Oral; Phenoxybenzamine Hydrochloride 10 mg

Dibenzyline destination | category:

Human:
Antihypertensives
Drugs acting on the genito-urinary system

Dibenzyline Anatomical Therapeutic Chemical codes:

C04AX02 - Phenoxybenzamine

Dibenzyline pharmaceutical companies:

WellSpring Pharmaceuticals

References

Dailymed."DIBENZYLINE (PHENOXYBENZAMINE HYDROCHLORIDE) CAPSULE [WELLSPRING PHARMACEUTICAL CORPORATION]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
"phenoxybenzamine". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).
"phenoxybenzamine". http://www.drugbank.ca/drugs/DB0092... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Dibenzyline?

Depending on the reaction of the Dibenzyline after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Dibenzyline not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Dibenzyline addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

Review

sdrugs.com conducted a study on Dibenzyline, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Dibenzyline consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.