PHENOXYBENZAMINE HYDROCHLORIDE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PHENOXYBENZAMINE HYDROCHLORIDE (UNII: X1IEG24OHL) (PHENOXYBENZAMINE - UNII:0TTZ664R7Z)

Available from:

Par Pharmaceutical, Inc.

INN (International Name):

PHENOXYBENZAMINE HYDROCHLORIDE

Composition:

PHENOXYBENZAMINE HYDROCHLORIDE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PHENOXYBENZAMINE HYDROCHLORIDE- PHENOXYBENZAMINE HYDROCHLORIDE CAPSULE
PAR PHARMACEUTICAL, INC.
----------
PHENOXYBENZAMINE HYDROCHLORIDE CAPSULES, USP 10 MG ADRENERGIC,
_ALPHA_-RECEPTOR-BLOCKING
AGENT
DESCRIPTION
Each Phenoxybenzamine hydrochloride capsule, USP contains 10 mg of
phenoxybenzamine
hydrochloride, USP. Inactive ingredients consist of lactose anhydrous
and talc.
Phenoxybenzamine hydrochloride is
_N_-(2-Chloroethyl)-_N_-(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.
CLINICAL PHARMACOLOGY
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
INDICATIONS AND USAGE
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
_beta_-blocking agent concomitantly.
CONTRAINDICATIONS
Conditions where a fall in blood pressure may be undesirable;
hypersensitivity to the drug or any of its
components.
WARNINGS
Phenoxybenzamine hydrochloride -induced _alpha_-adrenergic blockade
leaves _beta_-adrenergic
rec