Indications

Difamilast ointment is used topically to treat atopic dermatitis, commonly known as eczema.

Composition

• 0.3% Ointment : Each gram of ointment contains Difamilast INN 3 mg.
• 1% Ointment : Each gram of ointment contains Difamilast INN 10 mg.

Pharmacology

Difamilast is a phosphodiesterase 4 (PDE4) inhibitor. It increases cyclic adenosine 3',5'-monophosphate (cAMP) concentration and consequently suppresses the production of inflammatory cytokines, exerting effects in treatment of atopic dermatitis.

Dosage & Administration

The usual adult dosage is an appropriate amount of the Difamilast 1% ointment applied to the affected area twice daily. The usual pediatric dosage is an appropriate amount of the Difamilast 0.3% ointment applied to the affected area twice daily.

Contraindications

Difamilast is contraindicated in individuals with a known hypersensitivity to the drug.

Side Effects

Well tolerated in recommended dosage. At higher dosage it may cause mild skin reactions at the site of application, such as redness, burning, or stinging.

Pregnancy & Lactation

Difamilast is not recommended for pregnant women or women who may possibly be pregnant. For breastfeeding, safety profile has not been fully established.

Precautions & Warnings

External use only. Difamilast ointment is not for oral, ophthalmic, or intravaginal use. If there is any hypersensitivity issue with the use of Difamilast, treatment should be discontinued.

Therapeutic Class

Storage Conditions

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