NOVADAC

What it is

NOVADAC is a topical gel containing clindamycin 1% w/w (as phosphate) and benzoyl peroxide 5% w/w. The gel is white to slightly yellow and is for topical use.

Approved indications

— Topical treatment of comedo, papular and pustular acne vulgaris.

Dosing overview

NOVADAC should be applied as a thin film once daily in the evening to affected areas after the skin has been thoroughly washed, rinsed with warm water and gently patted dry. It is recommended for adults and adolescents aged 12 years and above. The maximum duration of treatment is 11 weeks.

Key safety warnings

If the patient experiences a reaction that indicates contact hypersensitivity or severe irritation, treatment with NOVADAC should be discontinued immediately. Contact with the mouth, eyes, lips, other mucous membranes or areas of irritated or broken skin should be avoided. Since benzoyl peroxide may cause increased sensitivity to sunlight, sunlamps should not be used and deliberate or prolonged exposure to sunlight should be avoided or minimised. When exposure to strong sunlight cannot be avoided, patients should be advised to use a sunscreen product and wear protective clothing. The product may bleach hair and coloured or dyed fabrics, and contact with these should be avoided. Although severe diarrhoea and pseudomembranous colitis associated with oral and parenteral clindamycin are unlikely to occur with topically applied clindamycin/benzoyl peroxide, if prolonged or significant diarrhoea occurs or the patient experiences abdominal cramps, treatment should be discontinued immediately and the patient investigated further. Prolonged use of clindamycin may lead to selection of resistant micro-organisms and their overgrowth. NOVADAC is recommended for a maximum duration of 11 weeks.

Contraindications

NOVADAC is contraindicated in patients who have demonstrated hypersensitivity to lincomycin, clindamycin, benzoyl peroxide or any components of the formulation. It is also contraindicated in patients with, or with a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis (including pseudomembranous colitis).

PBS listing

Information regarding PBS listing for NOVADAC is not available in the provided source documents.

Regulatory history

NOVADAC ONCE DAILY GEL was first listed on the Australian Register of Therapeutic Goods on 29 May 2024 under ARTG registration 406130.