Clindamycin Phosphate 1.2% + Tretinoin 0.025% Topical

Clindamycin Phosphate 1.2% + Tretinoin 0.025% Topical is a combination of two medicines, used to treat acne, which appears as spots or pimples on your face, chest or back. This medicine works by attacking the germs that cause them and rejuvenates sun damaged skin. Clindamycin Phosphate 1.2% + Tretinoin 0.025% Topical is only meant for external use and should be used as advised by your doctor. You should normally wash and dry the affected area before applying a thin layer of the medicine. It should not be applied to broken or damaged skin. Avoid contact with your eyes, nose or mouth. Rinse it off with water if you accidentally get it in these areas. It may take several weeks for your symptoms to improve, but you should keep using this medicine regularly.

Clindamycin Phosphate 1.2% + Tretinoin 0.025% Topical is a combination of two medicines: Clindamycin and Tretinoin, which treats pimples (acne). Clindamycin is an antibiotic which works by penetrating into the skin and killing acne-causing bacteria. Tretinoin is a form of vitamin A which reduces oil production in the skin, replenishes the skin and helps keep your pores open.

• Acne vulgaris

Clindamycin: Antibacterial agent that binds to the 50S ribosomal subunits of susceptible bacteria and prevents elongation of peptide chains by interfering with peptidyl transfer, thereby suppressing protein synthesis; reduces surface fatty acids on skin; exact mechanism of action in treating acne unknown. Tretinoin: Exact mechanism unknown; appears to increase cohesiveness of follicular epithelial cells with decrease microcomedo formation; also increases turnover of follicular cells to cause extrusion of comedones.

Clindamycin inhibits bacterial protein synthesis and reduces surface fatty acids on skin. Tretinoin increases follicular epithelial cell cohesiveness, decreases microcomedo formation, and increases cell turnover to extrude comedones.

Adult Dose (Acne Vulgaris): Apply a pea-size amount of gel once daily preferably at bedtime. Treatment should be continued for 12 weeks.

Pediatric Dose (12 years): Apply a pea-size amount of gel once daily preferably at bedtime.

This medicine is for external use only. Use it in the dose and duration as advised by your doctor. Check the label for directions before use. Clean and dry the affected area and apply the gel. Wash your hands after applying, unless hands are the affected area. Allow skin to dry for 20-30 minutes before application.

If you miss a dose of Clindamycin Phosphate 1.2% + Tretinoin 0.025% Topical, 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.

Common Side Effects:

• Application site reactions (burning, stinging, itching and redness)
• Dryness
• Skin peeling
• Dermatitis

• Apply as a thin layer onto clean, dry, unbroken skin affected by acne.
• Allow skin to dry for 20-30 minutes before application.
• Avoid contact with your eyes, nose or mouth. Rinse with water if accidental contact occurs.
• Avoid exposure to sunlight as it increases skin sensitivity; use sunscreen or protective clothing.
• Inform your doctor if you are pregnant, planning pregnancy or breastfeeding.
• Use with caution in individuals with a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis.

• Hypersensitivity to clindamycin, tretinoin, or any of the ingredients.

Clindamycin: 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 and/or bleeding with vitamin K antagonists (e.g., warfarin).

Tretinoin: Enhances percutaneous absorption of minoxidil; increased risk of fatal thrombotic complications with antifibrinolytic; increased tretinoin concentrations with azole antifungals; enhances peeling action of sulphur, resorcinol, benzoyl peroxide, salicylic acid; increased photosensitivity with photosensitising medications (thiazides, tetracyclines, fluoroquinolones, phenothiazines and sulfonamides); increased risk of intracranial pressure with tetracyclines.

No food interactions have been found or established.

[CONSULT YOUR DOCTOR] Clindamycin Phosphate 1.2% + Tretinoin 0.025% Topical may be unsafe to use during pregnancy. Although there are limited studies in humans, animal studies have shown harmful effects on the developing baby. Your doctor will weigh the benefits and any potential risks before prescribing it to you. Pregnancy Category C.

[CONSULT YOUR DOCTOR] Clindamycin Phosphate 1.2% + Tretinoin 0.025% Topical is probably unsafe to use during breastfeeding. Limited human data suggests that the drug may pass into the breastmilk and harm the baby.

Pediatric dose (12 years): Apply a pea-size amount once daily at bedtime. Safety and efficacy in children under 12 years have not been established.

Limited information is available regarding dose adjustment 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. In the event of accidental ingestion, gastrointestinal adverse reactions similar to those seen with systemically administered clindamycin may be seen.

Store in a cool and dry place, away from light and out of reach of children.

Clindamycin Phosphate + Tretinoin