CLINDOXYL ONCE DAILY GEL [SIN13332P]

Product Info

CLINDOXYL ONCE DAILY GEL

[SIN13332P]

Indications

Clindoxyl® Once Daily Gel is indicated for the topical treatment of mild to moderate acne vulgaris.

Clindoxyl® Once Daily Gel has not been demonstrated to have any additional benefit when compared to benzoyl peroxide alone in the same vehicle when used for the treatment of non-inflammatory acne.

Dosage and Administration

Adults and Adolescents

Clindoxyl® Once Daily Gel is for topical use only.

Clindoxyl® Once Daily Gel should be applied in a thin film over entire affected area once daily after washing gently with a mild cleanser and fully drying.

If the gel does not rub into the skin easily, too much is being applied.

Hands should be washed after application. Patients may also use a moisturiser as needed.

Two to five weeks of treatment may be required before a therapeutic effect is observed (see Clinical Studies – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

The safety and efficacy of clindamycin/benzoyl peroxide have not been studied beyond 12 weeks in acne vulgaris clinical trials. The prescriber should evaluate the benefit of continuing treatment beyond 12 weeks of uninterrupted use.

Children

The safety and efficacy of Clindoxyl® Once Daily Gel have not been established in children less than 12 years of age, therefore clindamycin/benzoyl peroxide is not recommended for use in this population.

Elderly

There are no specific recommendations for use in the elderly.

Contraindications

Clindoxyl® Once Daily Gel is contraindicated in:

• patients who have demonstrated hypersensitivity to lincomycin, clindamycin, benzoyl peroxide or any components of the formulation.

• patients with, or with a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis (including pseudomembranous colitis).