DIBENZYLINE- 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:

Concordia Pharmaceuticals Inc.

INN (International Name):

PHENOXYBENZAMINE HYDROCHLORIDE

Composition:

PHENOXYBENZAMINE HYDROCHLORIDE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Dibenzyline (phenoxybenzamine hydrochloride) capsules, 10 mg, in bottles of 100 (NDC 59212-001-01) and (NDC 59212-001-02)

Authorization status:

New Drug Application

Summary of Product characteristics

DIBENZYLINE - PHENOXYBENZAMINE HYDROCHLORIDE CAPSULE
CONCORDIA PHARMACEUTICALS INC.
----------
RX ONLY
PRESCRIBING INFORMATION
DIBENZYLINE (PHENOXYBENZAMINE HYDROCHLORIDE CAPSULES, USP) 10 MG
ADRENERGIC, _ALPHA_-RECEPTOR-BLOCKING AGENT
DESCRIPTION
Each Dibenzyline capsule, with red cap and body, is imprinted WPC 001
and 10 mg, and
contains 10 mg of Phenoxybenzamine Hydrochloride USP. Inactive
ingredients consist
of D&C Red No. 33, and FD&C Red No. 3, FD&C Yellow No. 6, Gelatin NF,
and Lactose
NF.
Dibenzyline is
_N_-(2-Chloroethyl)-_N_-(1-methyl-2-phenoxyethyl)benzylamine
hydrochloride:
Phenoxybenzamine hydrochloride is a colorless, crystalline 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
Dibenzyline (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.
INDICATION AND USAGE
Dibenzyline 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
®
1
1
_beta_-blocking agent concomitantly.
CONTRAINDICATIONS
Conditions where a fall in blood pressure may be undesirable;
hypersensitivity to the
drug or any of its components.
WARNING
Dibenzyline-induced _alpha_-adrenergic blockade leaves
_beta_-