Clindamycin Phosphate / Tretinoin

What it is and how it works

Mechanism of Action Clindamycin : Tretinoin : Although the exact mode of action of tretinoin is unknown, current evidence suggests that topical tretinoin decreases cohesiveness of follicular epithelial cells with decreased microcomedone formation. Additionally, tretinoin stimulates mitotic activity and increased turnover of follicular epithelial cells causing extrusion of the comedones.

Indications

Clindamycin phosphate and tretinoin gel is indicated for the topical treatment of acne vulgaris in patients 12 years or older. Clindamycin phosphate and tretinoin gel is a lincosamide antibiotic and retinoid combination product indicated for the topical treatment of acne vulgaris in patients 12 years or older.

Dosage and administration (summary)

Clindamycin phosphate and tretinoin gel should be applied once daily in the evening, gently rubbing the medication to lightly cover the entire affected area. Approximately a pea-sized amount will be needed for each application. Avoid the eyes, lips, and mucous membranes. Clindamycin phosphate and tretinoin gel is not for oral, ophthalmic, or intravaginal use. Apply a pea-size amount once daily in the evening lightly covering the entire affected area. Avoid the eyes, lips, and mucous membranes. Not for oral, ophthalmic, or intravaginal use.

Contraindications

Clindamycin phosphate and tretinoin gel is contraindicated in patients with regional enteritis, ulcerative colitis, or history of antibiotic-associated colitis. Clindamycin phosphate and tretinoin gel is contraindicated in patients with regional enteritis, ulcerative colitis, or history of antibiotic- associated colitis.

Warnings and precautions

Colitis: Clindamycin can cause severe colitis, which may result in death. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of clindamycin. Clindamycin phosphate and tretinoin gel should be discontinued if significant diarrhea occurs. Ultraviolet Light and Environmental Exposure: Avoid exposure to sunlight, sunlamps, and weather extremes. Wear sunscreen daily. Colitis Systemic absorption of clindamycin has been demonstrated following topical use.

Pregnancy

Pregnancy Pregnancy Category C. There are no well-controlled studies in pregnant women treated with clindamycin phosphate and tretinoin gel. Clindamycin phosphate and tretinoin gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Storage and supply

How Supplied Clindamycin phosphate and tretinoin gel, 1.2%/0.025% supplied as off white to yellow, opaque topical gel is as follows: 30 g aluminum tubes NDC 21922-050-05 60 g aluminum tubes NDC 21922-050-07 Storage and Handling Store at 25°C (77°F); excursions permitted from 15°C to 30°C (59°F to 86°F). Protect from heat. Protect from light.

Source: Clindamycin Phosphate And Tretinoin Gel 1.2%/0.025% (Clindamycin Phosphate And Tretinoin Gel 1.2%/0.025%) — US FDA prescribing information, 2025-09-05, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.