Roflumilast cream is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in patients 12 years of age and older.

Roflumilast and its active metabolite, roflumilast N-oxide, are selective inhibitors of the phosphodiesterase-4 (PDE4) enzyme. PDE4 is responsible for the breakdown of cyclic adenosine monophosphate (cAMP). Inhibition of PDE4 leads to increased intracellular cAMP levels, which results in anti-inflammatory and immunomodulatory effects. The exact mechanism by which roflumilast produces its clinical therapeutic effect in psoriasis is not fully understood.

Roflumilast cream should be applied on affected areas once daily and rubbed in completely. Hands should be washed after application, unless the cream is for treatment of the hands. Roflumilast cream is for topical use only and not for ophthalmic, oral, or intravaginal use or as directed by the physician.

Use in Children and Adolescents: The safety and effectiveness of Roflumilast cream have not been established in patients aged less than 12 years.

Coadministration of Roflumilast cream with systemic CYP3A4 inhibitors or dual inhibitors of CYP3A4 and CYP1A2 may increase systemic exposure of roflumilast, which can lead to an increased risk of adverse reactions.

Roflumilast cream is contraindicated in patients with moderate to severe hepatic impairment.

Reported side effects (approximately 41%) include hives, swelling of the face and lips, application site pain, headache, diarrhea, insomnia, upper respiratory tract infections, and urinary tract infections.

There are no adequate randomized clinical trials of topical or oral roflumilast in pregnant women. Animal studies have shown no fetal structural abnormalities at doses up to 9 times (rats) and 8 times (rabbits) the maximum recommended human dose.

There is no available information on the presence of roflumilast in human breast milk or its effects on breastfed infants or milk production. However, it is excreted in the milk of lactating animals, suggesting possible excretion in human milk. The benefits of breastfeeding should be weighed against the mother’s need for treatment and potential risks to the infant.

Concomitant use with oral contraceptives containing gestodene and ethinyl estradiol should be avoided, as this may increase systemic exposure to roflumilast and enhance adverse effects.

Antihistamines, anti-allergy & desensitizing agents

Store below 30°C. Protect from light and moisture. Keep out of reach of children.