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Clindamycin and Tretinoin

Pronunciation

(klin da MYE sin & TRET i noyn)

Index Terms

  • Clindamycin Phosphate and Tretinoin
  • Clindamycin/Tretinoin
  • Tretinoin and Clindamycin
  • Veltin

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Gel, topical:

Veltin™: Clindamycin phosphate 1.2% and tretinoin 0.025% (30 g, 60 g)

Ziana®: Clindamycin phosphate 1.2% and tretinoin 0.025% (30 g, 60 g)

Generic: Clindamycin phosphate 1.2% and tretinoin 0.025% (30 g, 60 g)

Brand Names: U.S.

  • Veltin
  • Ziana

Pharmacologic Category

  • Acne Products
  • Retinoic Acid Derivative
  • Topical Skin Product
  • Topical Skin Product, Acne

Pharmacology

Clindamycin reversibly binds to 50S ribosomal subunits preventing peptide chain elongation thus inhibiting bacterial protein synthesis. Clindamycin exhibits in vitro activity against Propionibacterium acnes, an organism associated with acne vulgaris. Topical tretinoin is believed to decrease follicular epithelial cells cohesiveness and increase follicular epithelial cell turnover resulting in decreased microcomedo formation and increased expulsion of comedones.

Absorption

Topical: Tretinoin: Minimal systemic absorption; Clindamycin: Low, but variable systemic absorption

Use: Labeled Indications

Acne: For the treatment of acne vulgaris in patients ≥12 years.

Contraindications

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

Dosing: Adult

Acne: Topical: Apply once daily in the evening or at bedtime

Dosing: Pediatric

Acne: Topical: Children ≥12 years and Adolescents: Refer to adult dosing.

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment unlikely due to low systemic absorption.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment unlikely due to low systemic absorption.

Administration

For external use only. Not for ophthalmic, oral, or intravaginal use. Prior to application, gently wash face with a mild soap and pat dry. Apply in the evening or at bedtime. Apply a pea-size amount to one fingertip and then dotted on chin, cheeks, nose, and forehead. Avoid contact with sunburned skin. Gently rub over entire face or entire affected area while avoiding eyes, mouth, angles of nose, and mucous membranes.

Storage

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F); do not freeze. Protect from heat and light.

Drug Interactions

Aminolevulinic Acid: Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid. Monitor therapy

Erythromycin (Systemic): May diminish the therapeutic effect of Clindamycin (Topical). Avoid combination

Erythromycin (Topical): May diminish the therapeutic effect of Clindamycin (Topical). Avoid combination

Multivitamins/Fluoride (with ADE): May enhance the adverse/toxic effect of Retinoic Acid Derivatives. Avoid combination

Multivitamins/Minerals (with ADEK, Folate, Iron): May enhance the adverse/toxic effect of Retinoic Acid Derivatives. Avoid combination

Multivitamins/Minerals (with AE, No Iron): May enhance the adverse/toxic effect of Retinoic Acid Derivatives. Avoid combination

Neuromuscular-Blocking Agents: Clindamycin (Topical) may enhance the neuromuscular-blocking effect of Neuromuscular-Blocking Agents. Monitor therapy

Porfimer: Photosensitizing Agents may enhance the photosensitizing effect of Porfimer. Monitor therapy

Verteporfin: Photosensitizing Agents may enhance the photosensitizing effect of Verteporfin. Monitor therapy

Adverse Reactions

Frequency not defined.

>10%: Dermatologic: Burning sensation of skin, desquamation, erythema, xeroderma

1% to 10%:

Dermatologic: Dermatitis, pruritus, skin irritation, stinging of the skin, sunburn

Gastrointestinal: Gastrointestinal symptoms (unspecified)

Respiratory: Nasopharyngitis

Warnings/Precautions

Concerns related to adverse effects:

• Photosensitivity: Tretinoin use is associated with increased susceptibility/sensitivity to ultraviolet (UV) light; avoid sunlamps or excessive sunlight exposure. Daily sunscreen use and other protective measures recommended. Use is not recommended in patients with sunburn.

• Skin irritation: Treatment can increase skin sensitivity to weather extremes of wind or cold. Also, concomitant topical medications (eg, medicated or abrasive soaps, cleansers, or cosmetics with a strong drying effect) should be used with caution due to increased skin irritation.

• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including Clostridium difficile–associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment. Discontinue drug if significant diarrhea, abdominal cramps, or passage of blood and mucus occurs.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Dosage form specific issues:

• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson, 2002; Lucente 2000; Shelley, 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade, 1986; CDC, 1984). See manufacturer’s labeling.

Other warnings/precautions:

• Appropriate use: For external use only; not for ophthalmic, oral, or intravaginal use; avoid mucous membranes, eyes, mouth, and angles of nose.

Pregnancy Risk Factor

C

Pregnancy Considerations

Adverse events were observed in animal reproduction studies using this combination topically. See individual agents.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience skin irritation, itching, burning, peeling, or skin discoloration. Have patient report immediately to prescriber severe injection site irritation; severe diarrhea; black, tarry, or bloody stools; abdominal pain; or abdominal cramps (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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