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:

WellSpring Pharmaceutical Corporation

INN (International Name):

PHENOXYBENZAMINE HYDROCHLORIDE

Composition:

PHENOXYBENZAMINE HYDROCHLORIDE 10 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

New Drug Application

Summary of Product characteristics

DIBENZYLINE- PHENOXYBENZAMINE HYDROCHLORIDE CAPSULE
WELLSPRING PHARMACEUTICAL CORPORATION
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DIBENZYLINE (PHENOXYBENZAMINE HYDROCHLORIDE, USP) CAPSULES 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, FD&C
Red No. 3, FD&C Yellow No. 6, Gelatin NF, Lactose NF, Sodium Lauryl
Sulfate NF and Silicon
Dioxide 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.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
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
_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 lea