Phenoxybenzamine Hydrochloride

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.

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

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.

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.

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 Northstar Rx LLC at 1-800-206-7821 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.