Doxiderm Cream 5%

Generic

Doxepin

Indications

Doxepin cream is used to treat mild pruritus in adult patients with atopic dermatitis or lichen simplex chronicus for a short period of time (up to 8 days).

Pharmacology

Doxepin hydrochloride belongs to the dibenzoxepin tricyclic antidepressant compound family. Despite the fact that doxepin HCl inhibits H1 and H2 histamine receptors, the exact mechanism by which doxepin works as an antipruritic is uncertain. In a large proportion of individuals, it can cause drowsiness, and this sedation can diminish awareness, including awareness of pruritic symptoms.

Dosage & Administration

Adult and child over 12 years: apply thinly 3–4 times daily; usual max. 3 g per application; usual total max. 12 g daily; coverage should be less than 10% of body surface area.

Interaction

Concomitant use of tricyclic antidepressants with drugs that can inhibit cytochrome P450 2D6 like MAO inhibitors, cimetidine, alcohol may require lower doses than usually prescribed for either the tricyclic antidepressant or the other drug. MAO inhibitors should be discontinued at least two weeks prior to the cautious initiation of therapy with Doxepin cream.

Contraindications

Patients with untreated narrow angle glaucoma or a tendency to urinary retention because doxepin has an anticholinergic effect.

Side Effects

Systemic side-effects such as antimuscarinic effects, headache, fever, dizziness, and gastro-intestinal problems have been observed, as well as drowsiness, local burning, stinging, irritation, tingling, and rash.

Pregnancy & Lactation

Pregnancy: Category B: No sufficient and well-controlled trials on pregnant women have been conducted. This medication should only be used during pregnancy if absolutely necessary.

Doxepin is excreted in human milk following oral dosing in nursing mothers. Following topical administration of Doxepin cream, it's likely that doxepin will be excreted in human milk.

Precautions & Warnings

If you have a history of angle-closure glaucoma, urinary retention, severe liver impairment, mania, or are pregnant or breastfeeding, you should use caution. Because drowsiness might impair performance of skilled tasks (such as driving), the patient should use caution.

Therapeutic Class

Local Antipruritic

Storage Conditions

Keep out of children's reach. Store away from heat and direct light in a cool, dry location.

Pharmaceutical Name

Incepta Pharmaceuticals Ltd.