Dibenzyline (Phenoxybenzamine)
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Dibenzyline (Phenoxybenzamine)

DIBENZYLINE®
(phenoxybenzamine hydrochloride) Capsules, USP
10 mg Adrenergic, Alpha-Receptor- blocking agent

DRUG DESCRIPTION

Each Dibenzyline (phenoxybenzamine) capsule, with red cap and body, is imprinted WPC 001 and 10 mg, and contains 10 mg of Phenoxybenzamine Hydrochloride 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 (phenoxybenzamine) is N-(2-Chloroethyl)-N-(1-methyl-2-phenoxyethyl)benzylamine hydrochloride:

Dibenzyline (phenoxybenzamine hydrochloride) structural formula illustration

Phenoxybenzamine hydrochloride 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.

What are the possible side effects of phenoxybenzamine (Dibenzyline)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using phenoxybenzamine and call your doctor at once if you severe dizziness or if you feel like you might pass out.

Less serious side effects may include:

  • stuffy nose;
  • mild dizziness or drowsiness;
  • blurred vision;
  • trouble having an orgasm;
  • upset stomach; or
  • tired feeling.

This is not a complete list of side effects and others may occur....

Read All Potential Side Effects and See Pictures of Dibenzyline »

What are the precautions when taking phenoxybenzamine (Dibenzyline)?

Before taking phenoxybenzamine, tell your doctor or pharmacist if you are allergic to it; or to other alpha blockers (e.g., phentolamine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood vessel disease (e.g., cerebral arteriosclerosis, coronary artery disease), heart disease (e.g., congestive heart failure), kidney disease, lung infections.

Before having surgery, tell your doctor or dentist that you are taking this medication.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires...

Read All Potential Precautions of Dibenzyline »

Last reviewed on RxList: 5/14/2008
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Dibenzyline (phenoxybenzamine) 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-blocking agent concomitantly.

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 (see PRECAUTIONS Carcinogenesis and Mutagenesis).

Storage

Store at 25°C (77°F); excursions permitted to 15°- 30°C (59°- 86°F) [See USP Controlled Room Temperature].

HOW SUPPLIED

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

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

DATE OF ISSUANCE: MARCH 2008. Manufactured for WellSpring Pharmaceutical Corporation, Bradenton, FL 34202-4101, USA. By WellSpring Pharmaceutical Canada Corp. Oakville, Ontario L6H 1M5 Canada. Rev. 03/08. FDA rev date: 4/3/2008

Last reviewed on RxList: 5/14/2008
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

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.

Read the Dibenzyline (phenoxybenzamine) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

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

Dibenzyline (phenoxybenzamine) blocks hyperthermia production by levarterenol, and blocks hypothermia production by reserpine.

REFERENCES

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

Last reviewed on RxList: 5/14/2008
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

Dibenzyline (phenoxybenzamine) -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.

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.

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.

Phenoxybenzamine hydrochloride showed in vitro mutagenic activity in the Ames test and mouse lymphoma assay; it did not show mutagenic activity in vivo 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 Dibenzyline (phenoxybenzamine hydrochloride). It is also not known whether Dibenzyline (phenoxybenzamine) can cause fetal harm when administered to a pregnant woman. Dibenzyline (phenoxybenzamine) 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.

REFERENCES

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.

Last reviewed on RxList: 5/14/2008
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

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 the drug. 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.

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 phenoxybenzamine hydrochloride is approximately 2000 mg/kg in rats and approximately 500 mg/kg in guinea pigs.

CONTRAINDICATIONS

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

Last reviewed on RxList: 5/14/2008
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Dibenzyline (phenoxybenzamine hydrochloride) is a long-acting, adrenergic, alpha-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

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.

Last reviewed on RxList: 5/14/2008
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Last reviewed on RxList: 5/14/2008
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Last reviewed on RxList: 5/14/2008
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Dibenzyline Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

PHENOXYBENZAMINE - ORAL

(fen-OX-ee-BEN-za-meen)

COMMON BRAND NAME(S): Dibenzyline

USES: This medication is used to treat high blood pressure and heavy sweating due to a certain tumor of the adrenal glands (pheochromocytoma). Phenoxybenzamine belongs to a class of drugs known as alpha blockers. It works by relaxing and widening blood vessels so that blood can flow more easily.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This drug may also be used with other medications to treat certain blood circulation problems (e.g., Raynaud's syndrome).

It is also used to treat certain conditions which involve difficulty urinating (e.g., neurogenic bladder, partial prostatic obstruction).

HOW TO USE: Take this medication by mouth with or without food, usually 2 to 3 times daily or as directed by your doctor.

Dosage is based on your medical condition and response to therapy.

Use this medication regularly in order to get the most benefit from it. To help you remember, take it at the same times each day. It is important to continue taking this medication even if you feel well. Most people with high blood pressure do not feel sick.

Do not suddenly stop taking this medication without consulting your doctor. Your condition may become worse when the drug is suddenly stopped. Your dose may need to be gradually decreased.

Inform your doctor if your condition worsens (e.g., your routine blood pressure readings increase).

Disclaimer

Dibenzyline Consumer (continued)

SIDE EFFECTS: Stomach upset, nausea, stuffy nose, drowsiness, dizziness or decrease in pupil size may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

To lower your risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: fast heartbeat, fainting, sexual problems in males (e.g., trouble ejaculating), weakness.

For males, in the very unlikely event that you have a painful or prolonged erection lasting 4 or more hours, stop using this drug and seek immediate medical attention, or permanent problems could occur.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Dibenzyline (phenoxybenzamine) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before taking phenoxybenzamine, tell your doctor or pharmacist if you are allergic to it; or to other alpha blockers (e.g., phentolamine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood vessel disease (e.g., cerebral arteriosclerosis, coronary artery disease), heart disease (e.g., congestive heart failure), kidney disease, lung infections.

Before having surgery, tell your doctor or dentist that you are taking this medication.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Caution is advised when using this drug in the elderly because they may be more sensitive to its effects, especially dizziness.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Disclaimer

Dibenzyline Consumer (continued)

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: drugs for male sexual problems (e.g., sildenafil, tadalafil, vardenafil), epinephrine, other alpha blockers (e.g., prazosin), other drugs for high blood pressure (e.g., diuretics, ACE inhibitors, beta blockers).

Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine), anti-seizure drugs (e.g., carbamazepine), medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., chlorpromazine, risperidone, amitriptyline, trazodone).

Check the labels on all your medicines (e.g., cough-and-cold products, diet aids, nonsteroidal anti-inflammatory drugs-NSAIDs such as ibuprofen for pain/fever reduction) because they may contain ingredients that could increase your blood pressure or contain drowsiness-causing ingredients. Ask your pharmacist about using those products safely.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents should call the US National Poison Hotline at 1-800-222-1222. Canada residents should call a provincial poison control center. Symptoms of overdose may include: fainting, severe weakness, fast heartbeat.

NOTES: Do not share this medication with others.

Have your blood pressure checked regularly while taking this medication. Learn how to monitor your own blood pressure at home, and share the results with your doctor.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).

Information last revised October 2010. Copyright(c) 2010 First Databank, Inc.

Dibenzyline Patient Information Including Side Effects

Brand Names: Dibenzyline

Generic Name: phenoxybenzamine (Pronunciation: fen OX ee BENZ a meen)

What is phenoxybenzamine (Dibenzyline)?

Phenoxybenzamine lowers blood pressure.

Phenoxybenzamine is used control blood pressure and reduce sweating in people with pheochromocytoma.

Phenoxybenzamine may also be used for other purposes not listed in this medication guide.

Dibenzyline 10 mg

red, imprinted with SKF E33

What are the possible side effects of phenoxybenzamine (Dibenzyline)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using phenoxybenzamine and call your doctor at once if you severe dizziness or if you feel like you might pass out.

Less serious side effects may include:

  • stuffy nose;
  • mild dizziness or drowsiness;
  • blurred vision;
  • trouble having an orgasm;
  • upset stomach; or
  • tired feeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Dibenzyline (phenoxybenzamine) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about phenoxybenzamine (Dibenzyline)?

You should not use this medication if you are allergic to phenoxybenzamine.

Before taking phenoxybenzamine, tell your doctor if you have coronary artery disease, a lung infection, or kidney disease.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Avoid drinking alcohol. It can increase drowsiness caused by phenoxybenzamine.

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Side Effects Centers

Dibenzyline Patient Information including How Should I Take

What should I discuss with my healthcare provider before taking phenoxybenzamine (Dibenzyline)?

You should not use this medication if you are allergic to phenoxybenzamine.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:

  • coronary artery disease (hardened arteries);
  • a lung infection; or
  • kidney disease.

FDA pregnancy category C. It is not known whether phenoxybenzamine is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether phenoxybenzamine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take phenoxybenzamine (Dibenzyline)?

Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results from this medication.

Take this medicine with a full glass of water.

Store phenoxybenzamine at room temperature away from moisture and heat.

Side Effects Centers

Dibenzyline Patient Information including If I Miss a Dose

What happens if I miss a dose (Dibenzyline)?

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose (Dibenzyline)?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include fast heart rate, vomiting, dizziness, or fainting.

What should I avoid while taking phenoxybenzamine (Dibenzyline)?

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Avoid drinking alcohol. It can increase drowsiness caused by phenoxybenzamine.

What other drugs will affect phenoxybenzamine (Dibenzyline)?

Tell your doctor about all other medications you use, especially:

  • reserpine;
  • tizanidine (Zanaflex);
  • epinephrine (Epi-Pen), norepinephrine; or
  • blood pressure medications.

This list is not complete and there may be other drugs that can interact with phenoxybenzamine. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about phenoxybenzamine.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 3.02. Revision date: 12/15/2010.

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