PHENOXYBENZAMINE HYDROCHLORIDE

Each phenoxybenzamine hydrochloride capsule, USP with red cap and body, is imprinted with “Amneal” on cap and “1502” on body, and contains 10 mg of phenoxybenzamine hydrochloride, USP. Inactive ingredients consist of colloidal silicon dioxide, D&C red 33, FD & C red 3, gelatin, iron oxide yellow, lactose monohydrate and sodium lauryl sulfate. The capsule is imprinted with white pharmaceutical ink which contains butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac, strong ammonia solution and titanium dioxide. Phenoxybenzamine hydrochloride is chemically known as N-(2-Chloroethyl)-N-(1-methyl-2-phenoxyethyl) benzylamine hydrochloride. Its molecular formula is C 18 H 22 ClNO·HCl. The chemical structure is: Phenoxybenzamine hydrochloride, USP is a white to almost white crystalline powder with a molecular weight of 340.29 g/mol, which melts between 136° and 141°C. It is freely soluble in ethanol (96%) and insoluble in diethyl ether. FDA approved organic impurity specification differs from the USP. 1

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.

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 ).

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

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.

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