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Clindamycin Phosphate / Tretinoin

Pronunciation: KLIN-da-MYE-sin FOS-fate TRET-i-noin
Class: Antibiotic/retinoid combination

Trade Names

Ziana
- Gel, topical Clindamycin phosphate 1.2%, tretinoin 0.025%

Pharmacology

Clindamycin

Suppresses bacterial protein synthesis.

Tretinoin

Decreases cohesiveness and stimulates mitotic activity and turnover of follicular epithelial cells, resulting in decreased formation and increased extrusion of comedones.

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Indications and Usage

Acne vulgaris.

Contraindications

Regional enteritis, ulcerative colitis, history of antibiotic-associated colitis.

Dosage and Administration

Acne
Adults and Children 12 yr of age and older

Topical Apply pea-sized amount to the entire face once daily at bedtime.

Storage/Stability

Store at 59° and 86°F. Protect from light and freezing. Keep away from heat. Keep tube tightly closed.

Drug Interactions

Erythromycin

May cause antagonism with clindamycin; avoid concomitant use.

Medicated or abrasive soaps/cleansers; soaps or cosmetics with strong drying effects; products with a high concentration of alcohol, astringents, spices, or lime

May result in increased skin irritation.

Neuromuscular blockers

May enhance actions of neuromuscular-blocking agents; use with caution.

Adverse Reactions

Dermatologic

Erythema (35%); scaling (17%); itching (10%); burning (4%); stinging (2%); dry skin (1%).

GI

GI symptoms (unspecified) (4%).

Respiratory

Nasopharyngitis (4%); pharyngolaryngeal pain (2%); cough, sinusitis (1%).

Precautions

Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy not established in children younger than 12 yr of age.

Photosensitivity

Photosensitization may occur. Avoid exposure to sunlight, including sunlamps. Instruct patients with sunburn to not use product until fully recovered.

Colitis

Systemic absorption of clindamycin has been demonstrated following topical use of this product. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of topical clindamycin. When significant diarrhea occurs, discontinue product. Stool cultures for Clostridium difficile and stool assay for C. difficile may be helpful diagnostically.

External use only

Keep away from eyes, mouth, angles of nose, or mucous membranes. Not for oral, ophthalmic, or intravaginal use.

Patient Information

  • Advise patient to gently wash the face at bedtime with a mild soap and warm water. After patting the skin dry, apply gel as a thin layer over the entire face (excluding the eyes and lips).
  • Advise patient to not use more than the recommended pea-sized amount and not to apply more often than once daily (at bedtime) because this will not make for faster results and may increase irritation.
  • Instruct patient to notify health care provider if skin becomes very red, swollen, blistered, or crusted, or if severe watery or bloody diarrhea develops.
  • Advise patient to avoid medicated or abrasive soaps/cleansers, soaps, or cosmetics with strong drying effects and products with a high concentration of alcohol, astringents, spices, or lime because they may result in increased skin irritation.
  • Advise patient to apply a sunscreen every morning and reapply over the course of the day as needed.
  • Advise patient to avoid exposure to sunlight, sunlamp, UV light, and other medicines that may increase sensitivity to sunlight.
  • Advise patient to avoid excessive exposures to the sun, cold, and wind because weather extremes can dry and burn the skin.

Copyright © 2009 Wolters Kluwer Health.

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