Clindamycin + Benzoyl Peroxide

Clindamycin + Benzoyl Peroxide is a combination of medicines that are used to treat acne. It kills the bacteria which cause acne. It also reduces oil production and replenishes the skin. Clindamycin + Benzoyl Peroxide should be used in the dose and duration as advised by your doctor. It is for external use only. Wash your hands before using this medicine. Apply only on the affected areas of the skin. It is advised to check the label for directions before use. The most common side effects include skin peeling, redness, dry skin and burning and sensation at the application site.

Clindamycin + Benzoyl Peroxide is a combination of two medicines: Benzoyl Peroxide and Clindamycin, which treats pimples (acne) by penetrating into the skin and killing acne-causing bacteria. Benzoyl Peroxide additionally reduces oil production in the skin, replenishes the skin and helps keep your pores open.

• 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.

Clindamycin inhibits bacterial protein synthesis. Benzoyl peroxide generates free radicals that destroy bacterial proteins and increases skin cell turnover to reduce acne.

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.

This gel is for external use only. Apply once daily in the evening to clean, dry skin in a thin film. Wash hands after application. Excessive application will not improve efficacy but may increase the risk of skin irritation.

If you miss a dose of Clindamycin + Benzoyl Peroxide, apply it as soon as you remember. However, if it is almost time for your next application, skip the missed dose. Do not double the dose.

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)

• 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).

• Hypersensitivity to clindamycin, lincomycin, benzoyl peroxide, or any of the excipients.

May enhance the action of neuromuscular blocking agents (e.g., atracurium). May antagonise the effects of parasympathomimetics. May competitively inhibit the effects of macrolides, ketolides, streptogramins, linezolid and chloramphenicol. Increased coagulation tests (prothrombin time/INR) and/or bleeding with vitamin K antagonists (e.g., warfarin). Should not be used in combination with erythromycin-containing products (possible antagonism to clindamycin). Concomitant application with tretinoin, isotretinoin and tazarotene should be avoided (benzoyl peroxide may reduce their efficacy and increase irritation).

No food interactions have been found or established.

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.

Use during lactation has not been studied. Should be used during lactation only if the expected benefit justifies the potential risk to the infant. To avoid accidental ingestion by the infant, should not be applied to the breast area.

Safety and efficacy have not been established in children under 12 years of age; not recommended for use in this population.

No specific recommendations for elderly patients.

For topical use, no dose adjustment is required in renal or hepatic impairment.

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.

Clindamycin + Benzoyl Peroxide