Doxepin cream is indicated for the short-term (up to 8 days) management of moderate pruritus in adult patients with atopic dermatitis or lichen simplex chronicus.

Doxepin hydrochloride is one of a class of agents known as dibenzoxepin tricyclic antidepressant compounds. Although doxepin HCl does have H₁ and H₂ histamine receptor blocking actions, the exact mechanism by which doxepin exerts its antipruritic effect is unknown. It can produce drowsiness in a significant number of patients, and this sedation may reduce awareness, including awareness of pruritic symptoms.

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

Use in Children: The use of Doxepin cream in pediatric patients is not recommended. Safe conditions for use of the cream in children have not been established.

Use in Elderly Patients: Dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

Concomitant use of tricyclic antidepressants with drugs that can inhibit cytochrome P450 2D6, such as MAO inhibitors, cimetidine, and 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.

Patients with untreated narrow-angle glaucoma or a tendency to urinary retention, because doxepin has an anticholinergic effect. Individuals who have shown progressive activity to any of its components.

Drowsiness, local burning, stinging, irritation, tingling, rash; systemic side-effects such as antimuscarinic effects, headache, fever, dizziness, and gastrointestinal disturbances have been reported.

Pregnancy Category B. There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed. Doxepin is excreted in human milk after oral administration. It is possible that doxepin may also be excreted in human milk following topical application of Doxepin cream.

Caution should be exercised in cases of susceptibility to angle-closure glaucoma, urinary retention, severe liver impairment, mania, and also in pregnancy and breastfeeding. Drowsiness may affect performance of skilled tasks (e.g., driving), so the patient should be careful.

If overdosage with topical application of Doxepin cream occurs, the signs and symptoms may include cardiac dysrhythmias, severe hypotension, convulsions, and CNS depression, including coma. Changes in the electrocardiogram, particularly in QRS axis or width, are clinically significant indicators of tricyclic antidepressant toxicity. Other signs of overdose may include confusion, disturbed concentration, transient visual hallucinations, dilated pupils, agitation, hyperactive reflexes, stupor, drowsiness, muscle rigidity, vomiting, hypothermia, and hyperpyrexia.

Local Antipruritic

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.