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:

Novitium Pharma LLC

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 are supplied as size #3 capsule with red transparent cap and body, imprinted “365” on cap and “novitium 10 mg” on body with grey ink, filled with white to off white powder in bottles of 100 (NDC 70954-365-10).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PHENOXYBENZAMINE HYDROCHLORIDE - PHENOXYBENZAMINE
HYDROCHLORIDE CAPSULE
NOVITIUM PHARMA LLC
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PHENOXYBENZAMINE HYDROCHLORIDE CAPSULES, USP 10 MG
ADRENERGIC, _ALPHA_-RECEPTOR-BLOCKING AGENT
RX ONLY
DESCRIPTION
Each Phenoxybenzamine Hydrochloride Capsule, USP 10 mg is a size #3
capsule with
red transparent cap and body, imprinted “365” on cap and
“novitium 10 mg” on body
with grey ink, filled with white to off white powder containing 10 mg
of
Phenoxybenzamine Hydrochloride USP and the following inactive
ingredients: lactose
and talc.
Each of the empty hard gelatin capsule contains gelatin, purified
water, sodium lauryl
sulfate, D&C Red 33, FD&C Yellow 6 and FD&C Red 3.
The imprinting ink contains the following: shellac, dehydrated
alcohol, isopropyl alcohol,
butyl alcohol, propylene glycol, strong ammonia solution, potassium
hydroxide, titanium
dioxide, black iron oxide and purified water.
Phenoxybenzamine Hydrochloride is
N-(2-Chloroethyl)-N-(1-methyl-2-phenoxyethyl)
benzylamine hydrochloride:
Phenoxybenzamine hydrochloride is a white to off-white 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.
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 & USAGE
Phenoxyb