API

Benzoyl Peroxide (2.5% w/w) + Clindamycin (1% w/w)

Drug classification

Topical antibacterial and antiacne agent; benzoyl peroxide (oxidizing), clindamycin (lincosamide antibiotic).

Dosage form

Topical gel containing benzoyl peroxide 2.5% and clindamycin 1%.

API strength per dosage

Dose

Apply a thin layer to affected area(s) once daily, after cleansing. Safety and efficacy in children under 12 years not established. Use with caution in patients with a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis. No specific renal or hepatic dosing adjustments provided. Avoid contact with eyes, mouth, and mucous membranes.

Mechanism of action

Nax B Gel combines benzoyl peroxide, which releases free radicals to oxidize bacterial proteins and reduce Propionibacterium acnes, with clindamycin, which binds the 50S ribosomal subunit to inhibit bacterial protein synthesis. Together, they decrease bacterial load and inflammation in acne lesions.

Indications

Acne

Side effects

Erythema skin redness Skin peeling Dryness Burning sensation Itching Stinging sensation

Pregnancy category

Limited data suggest topical benzoyl peroxide and clindamycin have low systemic absorption; use during pregnancy only if clearly needed and under medical supervision.

Precautions

Avoid contact with eyes, mouth, mucous membranes, and broken skin, monitor for local irritation or allergic reactions, assess for signs of colitis or diarrhea, avoid concurrent use with other topical irritants, monitor for excessive dryness or peeling, use sunscreen due to photosensitivity risk, discontinue if severe reactions occur.

Contraindications

Hypersensitivity to benzoyl peroxide, clindamycin, lincomycin, or any excipients, history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis, including pseudomembranous colitis.