CLINDEX GEL

Each gram of gel contains 10 mg of clindamycin (as clindamycin phosphate), equivalent to 1.0% w/w.
Topical gel

Therapeutic Indications

Topical treatment of inflammatory lesions of acne vulgaris, such as papules and pustules, especially when caused by Propionibacterium acnes (Cutibacterium acnes).

Posology:

• Adults and adolescents aged 12 years and older: Apply a thin layer of gel once or twice daily to the affected skin areas.
• Treatment duration: Usually 8 to 12 weeks; prolonged use should be under medical supervision.

Special Populations:

• Children under 12 years: Safety and efficacy not established; use only under medical advice.

• For external use only.
• Apply gently and avoid contact with eyes, mouth, and other mucous membranes.
• Wash hands before and after application unless hands are being treated.

• Hypersensitivity to clindamycin, lincomycin, or any excipients.
• History of antibiotic-associated colitis.
• Use on broken or inflamed skin (except acne lesions).

• Use with caution in patients with a history of gastrointestinal disease, particularly colitis.
• Discontinue if severe diarrhea or signs of pseudomembranous colitis occur.
• Avoid concomitant systemic antibiotic use with clindamycin unless prescribed by a physician.
• Avoid use near eyes or mucous membranes.
• Prolonged use may cause overgrowth of non-susceptible organisms, including fungi.

• No significant systemic interactions expected with topical use.
• Avoid concomitant topical or systemic antibiotics with overlapping spectra unless directed by a physician.

• Pregnancy: Use only if clearly needed after risk-benefit assessment.
• Lactation: Limited data; use with caution, avoid nipple areas during breastfeeding.

• No effect expected.

Very Common (≥1/10)

Common (≥1/100 to <1/10)

Uncommon (≥1/1,000 to <1/100)

Rare (<1/1,000)

Local Skin Irritation, Dryness, Peeling, Burning Sensation

Erythema, Itching, Rash

Contact Dermatitis

Hypersensitivity Reactions

• Usually mild and transient.

• Topical overdose is unlikely to cause systemic toxicity.
• In case of excessive application, wash the area with water and discontinue use.
• Seek medical advice if symptoms develop.

Pharmacodynamic Properties

• Clindamycin is a lincosamide antibiotic that inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit.
• Active against Cutibacterium acne and other Gram-positive bacteria implicated in acne.

• Minimal systemic absorption after topical application; peak plasma levels generally undetectable.

• Store below 25°C.
• Keep tube tightly closed.