Domela (fluocinolone acetonide/niacinamide)

Topical Corticosteroids Topical Cream (Gram)

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Last reviewed · Source: First Databank (FDB) drug data

Overview

Fluocinolone acetonide and fluocinonide are synthetic fluorinated corticosteroids.

Fluocinolone acetonide and fluocinonide share the actions of the other topical corticosteroids and are used for the relief of the inflammatory manifestations of corticosteroid-responsive dermatoses.

Generic name: fluocinolone acetonide/niacinamide
Drug class: Topical Corticosteroids
Therapeutic class: Dermatological

Reference product & biosimilars

No reference, biosimilar or interchangeable associated with this drug.

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Indications

No indications are available for this drug.

Dosing

Fluocinolone acetonide shampoo should be prepared by a pharmacist at the time of dispensing the shampoo; contents of the 12-mg capsule should be mixed with the shampoo base supplied by the manufacturer. The extemporaneously prepared shampoo is stable for 3 months from the time of compounding. The extemporaneously prepared shampoo must be shaken well prior to administration.

Topical fluocinolone acetonide or fluocinonide cream, gel, ointment, and solution are applied sparingly in thin films and rubbed gently into the skin 2-4 times daily depending on the severity of the condition. Occlusive dressings may be used for severe or resistant dermatoses.

For the treatment of atopic dermatitis in adults, fluocinolone acetonide 0.01% topical oil is applied as a thin film 3 times daily.

For the treatment of moderate to severe atopic dermatitis in children 2 years of age or older, a thin film of fluocinolone acetonide 0.01% topical oil may be applied twice daily to affected areas for no longer than 4 weeks. The topical oil should not be applied to the face or diaper area. Application to intertriginous areas also should be avoided because of an increased risk of developing potentially irreversible adverse local effects (e.g., striae, atrophy, telangiectasia).

For the treatment of seborrheic dermatitis of the scalp in adults, no more than 30 mL of fluocinolone acetonide 0.01% shampoo is applied to the scalp once daily, lathered, and allowed to remain on the scalp for about 5 minutes. The hair and scalp are then rinsed thoroughly with water. Fluocinolone acetonide shampoo should not be used with occlusive dressings and patients should be warned that treated areas of the scalp should not be bandaged or otherwise covered or wrapped as to be occlusive, unless directed by a clinician.

For the treatment of psoriasis of the scalp in adults, a thin film of fluocinolone acetonide 0.01% topical oil should be applied to wet or dampened hair and scalp, massaged well, and covered with the manufacturer-supplied shower cap. The oil should be allowed to remain on the scalp overnight or for a minimum of 4 hours following application before being washed off with regular shampoo and rinsed thoroughly with water.

Drug interactions

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Contraindications

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Adverse reactions

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Precautions

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ICD codes

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Last reviewed · Source: First Databank (FDB) drug data