Lumilast 0.30%

Description

Indications
Lumilast cream is indicated for the topical treatment of plaque psoriasis, including intertriginous areas, in patients aged 12 years and older.
Use only as directed by a registered healthcare professional.

Pharmacology
Roflumilast and its active metabolite, roflumilast N-oxide, are inhibitors of phosphodiesterase-4 (PDE4). By inhibiting PDE4, a key enzyme responsible for metabolizing cyclic 3′,5′-adenosine monophosphate (cyclic AMP), Lumilast leads to the accumulation of intracellular cyclic AMP. While the exact mechanism of action is not fully defined, this inhibition is believed to contribute to its therapeutic effects.

Dosage & Administration

• Adult use: Apply Lumilast cream to affected areas once daily, ensuring it is rubbed in completely. Wash hands after application unless the treatment is for the hands. Lumilast is for topical use only and should not be applied to the eyes, ingested, or used intravaginally.
• Pediatric use: The safety and effectiveness of Lumilast cream have been established for pediatric patients aged 12 years and older in the treatment of plaque psoriasis.
  Use only as directed by a registered healthcare professional.

Interaction

• Drugs that inhibit Cytochrome P450 (CYP) enzymes: Coadministration of Lumilast with systemic CYP3A4 inhibitors or dual CYP3A4 and CYP1A2 inhibitors (e.g., erythromycin, ketoconazole, fluvoxamine, enoxacin, cimetidine) may increase Lumilast systemic exposure and potentially cause more adverse reactions. The risk of concurrent use should be carefully weighed against the benefits.
• Oral contraceptives containing gestodene and ethinyl estradiol: The concurrent use of Lumilast with oral contraceptives containing gestodene and ethinyl estradiol may increase Lumilast’s systemic exposure, potentially leading to increased side effects. Again, the risks should be carefully considered.

Contraindications
Roflumilast cream is contraindicated in patients with moderate to severe liver impairment (Child-Pugh B or C).

Pregnancy & Lactation

• Pregnancy: There are no randomized clinical trials involving oral or topical roflumilast in pregnant women. Animal studies showed no fetal structural abnormalities when roflumilast was administered orally to pregnant rats and rabbits at doses up to 9 and 8 times the maximum recommended human dose (MRHD), respectively.
• Lactation: Roflumilast and/or its metabolites are excreted into the milk of lactating rats. There is no data on whether roflumilast is present in human milk or its effects on a breastfed infant. The developmental and health benefits of breastfeeding should be considered alongside the mother’s clinical need for Roflumilast and any potential adverse effects on the infant.

Therapeutic Class
Antihistamines, Anti-allergies, & Hypo-sensitisation

Storage Conditions
Store below 30°C, away from light and moisture. Keep out of the reach of children.

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