Roflumilast (Cream)

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 inhibitors of PDE4. Roflumilast and roflumilast N-oxide inhibition of PDE4 (a major cyclic 3′,5′-adenosine monophosphate (cyclic AMP) metabolizing enzyme) activity leads to accumulation of intracellular cyclic AMP. The specific mechanism(s) by which roflumilast exerts its therapeutic action is not well defined.

Adult use: Apply Roflumilast cream to affected areas once daily and rub in completely. Wash hands after application, unless Roflumilast is for treatment of the hands. Roflumilast is for topical use only and not for ophthalmic, oral, or intravaginal use.

Pediatric Use: The safety and effectiveness of Roflumilast cream have been established in pediatric patients ages 12 years and older for the treatment of plaque psoriasis.

Drugs that Inhibit Cytochrome P450 (CYP) Enzymes: The coadministration of roflumilast with systemic CYP3A4 inhibitors or dual inhibitors that inhibit both CYP3A4 and CYP1A2 simultaneously (e.g., erythromycin, ketoconazole, fluvoxamine, enoxacin, cimetidine) may increase roflumilast systemic exposure and may result in increased adverse reactions. The risk of such concurrent use should be weighed carefully against benefit

Oral Contraceptives Containing Gestodene and Ethinyl Estradiol: The coadministration of roflumilast with oral contraceptives containing gestodene and ethinyl estradiol may increase roflumilast systemic exposure and may result in increased side effects. The risk of such concurrent use should be weighed carefully against benefit.

The use of Roflumilast cream is contraindicated in the following condition: Moderate to severe liver impairment (Child-Pugh B or C).

There are no randomized clinical trials of oral or topical roflumilast in pregnant women. In animal reproduction studies, roflumilast administered orally to pregnant rats and rabbits during the period of organogenesis produced no fetal structural abnormalities at doses up to 9 and 8 times the maximum recommended human dose (MRHD), respectively.

There is no information regarding the presence of Roflumilast in human milk, the effects on the
breastfed infant, or the effects on milk production. Roflumilast and/or its metabolites are excreted into the milk of lactating rats (see Data). When a drug is present in animal milk, it is likely that the drug will present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Roflumilast and any potential adverse effects on the breastfed infant from Roflumilast or from the underlying maternal condition.

Antihistamines anti-allergies & hypo-sensitisation

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