Isotretinoin Gel

Products

Isotretinoin gel has been approved in many countries since 1994 (Roaccutan Gel, Germany: Isotrex Gel).

Structure and properties

Isotretinoin (C20H28O2, Mr = 300.4 g/mol) exists as a yellow to faint orange crystalline powder that is practically insoluble in water. Especially in solution, it is sensitive to air, heat, and light. Isotretinoin is a stereoisomer of the vitamin A acid tretinoin.

Effects

Isotretinoin (ATC D10AD04) has an effect on epithelial growth and differentiation. It causes thinning of the stratum corneum of the skin and promotes elimination of comedones. It additionally has anti-inflammatory properties. The effects appear after about a month.

Indications

For the treatment of acne vulgaris. Off-label: isotretinoin is also given to treat other skin conditions (eg, plane warts) but is not approved for this purpose.

Dosage

According to the SmPC. The gel is applied thinly to the affected areas once daily in the evening after cleansing the skin. Hands should be washed immediately after administration. The duration of treatment is usually three months.

Contraindications

The gel is contraindicated in case of hypersensitivity. It should not be applied during pregnancy because isotretinoin is an early damaging (teratogenic) substance. It is also not indicated for use in fertile women without safe contraception and during lactation. For complete precautions, see the drug label.

Interactions

Drug-drug interactions are possible with irritant medications. Concomitant use of benzoyl peroxide may reduce the effectiveness of isotretinoin.

Adverse effects

Possible adverse effects include local skin irritation such as redness, peeling of the skin, itching, a feeling of tightness, burning, stinging, and dry skin. The irritations usually disappear. If they persist, the treatment should be interrupted or discontinued. The gel may increase sensitivity to UV radiation. Therefore, excessive UV exposure should be avoided or a sunscreen should be applied.