DOXEPIN HYDROCHLORIDE- doxepin hydrochloride cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DOXEPIN HYDROCHLORIDE (UNII: 3U9A0FE9N5) (DOXEPIN - UNII:5ASJ6HUZ7D)

Available from:

Renaissance Pharma, Inc.

INN (International Name):

DOXEPIN HYDROCHLORIDE

Composition:

DOXEPIN 50 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Doxepin Hydrochloride Cream, 5% is indicated for the short-term (up to 8 days) management of moderate pruritus in adult patients with atopic dermatitis or lichen simplex chronicus. (See DOSAGE AND ADMINISTRATION.) Because doxepin HCl has an anticholinergic effect and because significant plasma levels of doxepin are detectable after topical Doxepin Hydrochloride Cream, 5% application, the use of Doxepin Hydrochloride Cream, 5% is contraindicated in patients with untreated narrow angle glaucoma or a tendency to urinary retention. Doxepin Hydrochloride Cream, 5% is contraindicated in individuals who have shown previous sensitivity to any of its components.

Product summary:

Doxepin Hydrochloride Cream, 5 % is available in 30 g (NDC 40085-716-30) and 45 g (NDC 40085-716-45) tubes. Store at or below 27°C (80°F). Manufactured for: Renaissance Pharma, Inc., Newtown, PA 18940 Manufactured by: DPT Laboratories, Ltd. San Antonio, Texas 78215 Rev. 7/ 2015 140607

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

DOXEPIN HYDROCHLORIDE- DOXEPIN HYDROCHLORIDE CREAM
RENAISSANCE PHARMA, INC.
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DOXEPIN HYDROCHLORIDE CREAM
DOXEPIN HYDROCHLORIDE CREAM, 5%
FOR TOPICAL DERMATOLOGIC USE ONLY — NOT FOR OPHTHALMIC, ORAL, OR
INTRAVAGINAL USE.
RX ONLY
DESCRIPTION
Doxepin Hydrochloride Cream, 5% is a topical cream. Each gram
contains: 50 mg of doxepin
hydrochloride (equivalent to 44.3 mg of doxepin).
Doxepin hydrochloride is one of a class of agents known as
dibenzoxepin tricyclic antidepressant
compounds. It is an isomeric mixture of
N,N-dimethyldibenz[_b,e_]oxepin-Δ11(6H),γ-propylamine
hydrochloride. Doxepin hydrochloride has an empirical formula of C
H NO•HCl and a molecular
weight of 316.
Doxepin Hydrochloride Cream, 5% also contains sorbitol, cetyl alcohol,
isopropyl myristate, glyceryl
stearate, PEG-100 stearate, petrolatum, benzyl alcohol, titanium
dioxide and purified water.
CLINICAL PHARMACOLOGY
Although doxepin HCl does have H and H histamine receptor blocking
actions, the exact mechanism
by which doxepin exerts its antipruritic effect is unknown. Doxepin
Hydrochloride Cream, 5% can
produce drowsiness which may reduce awareness, including awareness of
pruritic symptoms. In 19
pruritic eczema patients treated with Doxepin Hydrochloride Cream, 5%,
plasma doxepin concentrations
ranged from nondetectable to 47 ng/mL from percutaneous absorption.
Plasma levels from topical
application of Doxepin Hydrochloride Cream, 5% can result in CNS and
other systemic side effects.
Once absorbed into the systemic circulation, doxepin undergoes hepatic
metabolism that results in
conversion to pharmacologically-active desmethyldoxepin. Further
glucuronidation results in urinary
excretion of the parent drug and its metabolites. Desmethyldoxepin has
a half-life that ranges from 28 to
52 hours and is not affected by multiple dosing. Plasma levels of both
doxepin and desmethyldoxepin
are highly variable and are poorly correlated with dosage. Wide
distribution occurs in body tissues
including lungs, heart, brain, and liver. Renal diseas