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 enzyme. Roflumilast and Roflumilast N-oxide inhibition of PDE4 (a major cyclic 3', 5'-adenosine monophosphate or, cyclic AMP metabolizing enzyme) activity leads to accumulation of intracellular cyclic AMP, thus providing anti-inflammatory & immunomodulatory effects. The specific mechanism by which Roflumilast exerts its therapeutic action is not well-defined.

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 that inhibit both CYP3A4 and CYP1A2 simultaneously may increase Roflumilast systemic exposure and may result in increased adverse reactions.

The use of Roflumilast cream is contraindicated in patients with moderate to severe liver impairment.

The reported side effects (41%) are hives, swelling of your face & lips, application site pain, headache, diarrhoea, insomnia, upper respiratory tract infections and urinary tract infections

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.

Use of Roflumilast with oral contraceptives containing gestodene and ethinyl estradiol should be avoided. This may increase the systemic concentration of Roflumilast and increase the side effects

Antihistamines anti-allergies & hypo-sensitisation

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