Phenoxybenzamine Hydrochloride Capsules, USP

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Hikma Pharmaceuticals USA Inc.

INN (International Name):

PHENOXYBENZAMINE HYDROCHLORIDE

Composition:

PHENOXYBENZAMINE HYDROCHLORIDE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

Phenoxybenzamine Hydrochloride Capsules, USP 10 mg capsule is supplied as a red opaque/red opaque capsule with “54 036” printed in black on the cap and “54 036” printed in black ink on the capsule body, containing a white to off-white powder. NDC 0054-0349-25: Bottle of 100 Capsules Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PHENOXYBENZAMINE HYDROCHLORIDE- PHENOXYBENZAMINE HYDROCHLORIDE CAPSULE
HIKMA PHARMACEUTICALS USA INC.
----------
PHENOXYBENZAMINE HYDROCHLORIDE CAPSULES, USP
Rx only
DESCRIPTION
Each Phenoxybenzamine Hydrochloride Capsule, USP contains 10 mg of
phenoxybenzamine
hydrochloride, USP. Inactive ingredients consist of anhydrous lactose,
black monogramming ink,
colloidal silicon dioxide and sodium lauryl sulfate. The black
monogramming ink contains ammonium
hydroxide, iron oxide black, isopropyl alcohol, N-butyl alcohol,
propylene glycol, and shellac. The
capsule shells also contain FD&C Red No. 40, gelatin, purified water
and titanium dioxide.
Phenoxybenzamine is
_N_-(2-Chloroethyl)-_N_-(1-methyl-2-phenoxyethyl)benzylamine
hydrochloride:
Phenoxybenzamine hydrochloride is a white to almost white powder with
a molecular weight of 340.3,
which melts between 136° and 141°C. It is soluble in alcohol and
chloroform; insoluble in ether and
water.
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.
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.
INDICATIONS 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.
CONTRAINDICATIONS
Conditions where a fall