Clindax-B 10gm

• Mild to moderate acne vulgaris (inflammatory lesions) - patients 12 years and older

Clindamycin inhibits bacterial protein synthesis by binding to 23S RNA of the 50S subunit of the bacterial ribosome. It impedes both the assembly of the ribosome and the translation process. The peroxide bond of benzoyl peroxide is cleaved to form 2 benzoyloxy radicals. These radicals interact nonspecifically with bacterial proteins, interfering with their function, and survival of the bacteria. Over time, free radical interactions with bacterial proteins lead to decreased keratin and sebum around follicles. Benzoyl peroxide can also increase the turnover rate of epithelial cells, leading to skin peeling, and breaking down comedones.

Adults and Adolescents (aged 12 years and older): Apply once daily in the evening to the entire affected area. Wash gently with a mild cleanser and fully dry before application. Apply a thin film and wash hands after application.

Children (under 12 years): Safety and efficacy have not been established; not recommended.

Very Common (≥1/10): Erythema, peeling, dryness (generally reported as 'mild' in severity)

Common (≥1/100 and <1/10): Burning sensation

Uncommon (≥1/1,000 and <1/100): Dermatitis, pruritus, erythematous rash, worsening of acne, paraesthesia

Not Known: Allergic reactions including hypersensitivity and anaphylaxis, colitis (including pseudomembranous colitis), haemorrhagic diarrhoea, diarrhoea, abdominal pain, urticaria, application site reactions (including skin discoloration)

There are no adequate data from the use of this gel in pregnant women. Should only be prescribed to pregnant women after careful risk/benefit assessment by the physician.

• Avoid contact with mouth, eyes, lips, other mucous membranes or areas of irritated or broken skin. In case of accidental contact, rinse well with water.
• Use with caution in patients with a history of regional enteritis or ulcerative colitis, or a history of antibiotic-associated colitis.
• Use with caution in atopic patients, in whom further skin drying may occur.
• During the first weeks of treatment, an increase in peeling and reddening will occur in most patients; use a non-comedogenic moisturiser or temporarily reduce frequency if needed.
• Benzoyl peroxide may cause increased sensitivity to sunlight; sunlamps should not be used and deliberate or prolonged exposure to sun should be avoided or minimised.
• If prolonged or significant diarrhoea occurs or the patient suffers from abdominal cramps, treatment should be discontinued immediately (may indicate antibiotic-associated colitis).

Excessive application may result in severe irritation. Discontinue use and wait until the skin has recovered. Topically applied benzoyl peroxide is not generally absorbed in sufficient amounts to produce systemic effects. Excessive application of topically applied clindamycin may result in absorption of sufficient amounts to produce systemic effects.

Store in a refrigerator (2°-8°C), do not freeze. Do not store above 25°C after dispensing. Keep out of reach of children.