This gel is intended for external use only. It is indicated for the topical treatment of mild to moderate acne vulgaris, particularly inflammatory lesions, in adults and adolescents aged 12 years and above.

Clindamycin works by inhibiting bacterial protein synthesis through binding to the 23S RNA of the 50S ribosomal subunit. This action interferes with ribosomal assembly and the protein translation process. Its mechanism is related to its structural similarity to the 3’-ends of L-Pro-Met-tRNA and deacylated tRNA during peptide chain elongation, thereby disrupting peptide chain initiation and promoting the dissociation of peptidyl-tRNA from bacterial ribosomes.

Benzoyl peroxide undergoes cleavage of its peroxide bond to release active benzoyloxy radicals. These radicals act on bacterial proteins in a non-specific manner, disrupting their function and reducing bacterial survival. Additionally, these free radicals help decrease keratin and sebum accumulation around hair follicles. Benzoyl peroxide also enhances epithelial cell turnover, promoting skin exfoliation and reducing comedone formation.

Adults and Adolescents (aged 12 years and above): This gel should be applied once daily in the evening, to the entire affected area. Patients should be advised that excessive application will not improve efficacy, but may increase the risk of skin irritation. If excessive dryness or peeling occurs, frequency of application should be reduced or application temporarily interrupted. An effect on inflammatory and non-inflammatory lesions may be seen as early as week 2–5 of treatment. The safety and efficacy of this gel has not been studied beyond 12 weeks in acne vulgaris clinical trials. Treatment with this gel should not exceed more than 12 weeks of continuous use.

Paediatric population: The safety and efficacy of this gel has not been established in children under 12 years of age, therefore this gel is not recommended for use in this population.

Elderly patients: No specific recommendations. This gel should be applied in a thin film 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.

May enhance the effects of neuromuscular blocking agents (e.g., atracurium). May reduce the effects of parasympathomimetic drugs. It may also competitively inhibit the activity of macrolides, ketolides, streptogramins, linezolid, and chloramphenicol. Increased coagulation test values (prothrombin time/INR) and/or bleeding may occur when used with vitamin K antagonists (e.g., warfarin, acenocoumarol, fluindione). PABA-containing sunscreens may temporarily discolor fabrics.

Benzoyl Peroxide 5% & Clindamycin 1% gel should not be used in patients with known hypersensitivity to clindamycin, lincomycin, benzoyl peroxide, or any of the excipients.

Adverse drug reactions (ADRs) for Benzoyl Peroxide 5% & Clindamycin 1% gel include those reported for the combination as well as for each individual component. The frequency of adverse effects is categorized according to MedDRA classification: very common (≥1/10); common (≥1/100 and <1/10); uncommon (≥1/1,000 and <1/100); rare (≥1/10,000 and <1/1,000); and not known.

Immune system disorders: Hypersensitivity reactions including allergic reactions and anaphylaxis; Not known.
Nervous system disorders: Paraesthesia; Uncommon.
Gastrointestinal disorders: Colitis (including pseudomembranous colitis), hemorrhagic diarrhea, diarrhea, abdominal pain; Not known.
Skin and subcutaneous tissue disorders: Erythema, peeling, dryness (generally mild); Very common. Burning sensation; Common. Dermatitis, pruritus, erythematous rash, worsening of acne; Uncommon. Urticaria; Not known.
General disorders and administration site conditions: Application site reactions including skin discoloration; Not known.

Pregnancy: There is insufficient data regarding the use of Benzoyl Peroxide 5% & Clindamycin 1% gel in pregnant women. Animal studies on reproductive and developmental toxicity have not been conducted for this combination. Limited data from exposure to clindamycin in early pregnancy have not shown adverse effects on the fetus or newborn. However, the safety of this combination during pregnancy has not been established. Therefore, it should only be used if the expected benefit outweighs the potential risk, as determined by a physician.

Breastfeeding: The use of this combination during breastfeeding has not been adequately studied. Although systemic absorption is low, it is unknown whether clindamycin or benzoyl peroxide is excreted in breast milk after topical application. Oral or injectable clindamycin is known to pass into breast milk. Therefore, it should be used cautiously during lactation and avoided on the breast area to prevent accidental ingestion by the infant.

Fertility: There is no available data regarding the effects of this combination on human fertility.

Avoid contact with the mouth, eyes, lips, other mucous membranes, and irritated or broken skin. Apply cautiously on sensitive skin areas. In case of accidental contact, rinse thoroughly with water. Benzoyl Peroxide 5% & Clindamycin 1% gel should be used with caution in patients with a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis.

Use cautiously in atopic patients, as further skin dryness may occur. During the initial weeks of treatment, peeling and redness are common. Depending on severity, patients may use a non-comedogenic moisturizer, temporarily reduce frequency, or discontinue use; however, efficacy for less than once-daily use is not established.

Concurrent topical acne therapies should be used carefully due to possible cumulative irritation, which may sometimes be severe. If excessive dryness, peeling, or irritation occurs, discontinue use. Benzoyl peroxide increases sensitivity to sunlight; therefore, minimize sun exposure, use sunscreen, and wear protective clothing.

If a patient experiences sunburn, treatment should be paused. In cases of prolonged or severe diarrhea or abdominal cramps, discontinue use immediately, as this may indicate antibiotic-associated colitis. Appropriate diagnostic evaluation (e.g., Clostridium difficile toxin testing) should be considered.

The product may bleach hair or colored fabrics. Avoid contact with hair, fabrics, furniture, or carpets.

Resistance to clindamycin: Patients with recent use of clindamycin or erythromycin may be more likely to have resistant bacteria.

Cross-resistance: May occur with antibiotics such as lincomycin and erythromycin.

Interaction with other products: Avoid using with erythromycin-containing products due to antagonism. Use cautiously with medicated or abrasive soaps, alcohol-containing products, or strong drying agents. Benzoyl peroxide may reduce the effectiveness of tretinoin, isotretinoin, and tazarotene; if combined, apply at different times (e.g., morning and evening).

Use with sulfonamide-containing topical products may cause temporary yellow/orange discoloration of skin and facial hair.

Excessive application may lead to severe skin irritation. In such cases, discontinue use until recovery. Benzoyl peroxide is minimally absorbed systemically, but excessive clindamycin absorption may lead to systemic effects. Accidental ingestion may cause gastrointestinal adverse effects similar to those seen with systemic clindamycin.

Benzoyl peroxide, Azelaic acid & other preparations

Store in a refrigerator at 2°–8°C. Do not freeze. After dispensing, do not store above 25°C.