Version May 2024
Acne vulgaris: Topical: Apply to the affected area once daily in the evening or at bedtime.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment unlikely due to low systemic absorption.
There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment unlikely due to low systemic absorption.
(For additional information see "Clindamycin and tretinoin: Pediatric drug information")
Acne vulgaris: Topical: Children ≥12 years and Adolescents: Topical: Apply pea-size amount to entire face once daily in the evening or at bedtime; Note: Higher dosages (larger amount or more frequent use) have not been shown to improve efficacy and are associated with increased adverse effects (eg, skin irritation).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment unlikely due to low systemic absorption.
There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment unlikely due to low systemic absorption.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adolescents and adults.
1% to 10%:
Dermatologic: Xeroderma (1%)
Local: Application-site dermatitis (1%), application-site erythema (4%), application-site irritation (5%), application-site pruritus (2%), application-site scaling (5%), local dryness of skin (6%)
Respiratory: Nasopharyngitis (4%)
Frequency not defined:
Dermatologic: Stinging of the skin (application site)
Local: Application-site burning
Regional enteritis, ulcerative colitis, history of antibiotic-associated colitis
Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to clindamycin, tretinoin, or any component of the formulation; hypersensitivity to lincomycin
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 Clostridioides 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.
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.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Gel, External:
Veltin: Clindamycin phosphate 1.2% and tretinoin 0.025% (30 g, 60 g) [contains edetate (edta) disodium, methylparaben, propylene glycol]
Ziana: Clindamycin phosphate 1.2% and tretinoin 0.025% (30 g, 60 g) [contains methylparaben, propylparaben]
Generic: Clindamycin phosphate 1.2% and tretinoin 0.025% (30 g, 60 g)
Yes
Gel (Clindamycin-Tretinoin External)
1.2-0.025% (per gram): $13.20 - $17.63
Gel (Veltin External)
1.2-0.025% (per gram): $20.60
Gel (Ziana External)
1.2-0.025% (per gram): $14.68
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Gel, External:
Biacna: Clindamycin phosphate 1.2% and tretinoin 0.025% (2 g, 30 g, 60 g) [contains edetate (edta) disodium, methylparaben, polysorbate 80, propylparaben]
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.
For topical administration only; not for oral, ophthalmic, or intravaginal use. At bedtime, wash face with mild soap, rinse with water, and pat skin dry. Place pea-size amount on one fingertip and then dot on affected areas including chin, cheeks, nose, and forehead. Gently rub over entire face or entire affected area while avoiding eyes, lips, mouth, angles of nose, and mucous membranes. Wash hands after use. Apply sunscreen every morning and reapply throughout the day as needed. Avoid exposure to sunlight (including sunlamps) and wear protective clothing.
Hazardous agent (NIOSH 2016 [group 3]).
Tretinoin is a hazardous agent. Use appropriate precautions for receiving, handling, administration, and disposal (NIOSH 2016). Gloves (single) should be worn during receiving, unpacking, and placing in storage.
NIOSH recommends double gloving, a protective gown, and (if liquid that could splash) eye/face protection for administration of a topical product; if there is potential for inhalation, respiratory protection is recommended (NIOSH 2016). Facilities may perform assessment of some (non-antineoplastic) hazardous drugs to determine if appropriate for alternative containment strategies and handling requirements; assess risk to determine appropriate containment strategy (USP-NF 2017).
Acne vulgaris: For the treatment of acne vulgaris in patients ≥12 years of age.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Aminolevulinic Acid (Systemic): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Systemic). Risk X: Avoid combination
Aminolevulinic Acid (Topical): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Topical). Risk C: Monitor therapy
Erythromycin (Systemic): May diminish the therapeutic effect of Clindamycin (Topical). Management: Consider avoiding the concomitant use of systemic erythromycin and topical clindamycin when treating acne vulgaris. This recommendation does not appear to apply to intravaginal use of clindamycin for the treatment of bacterial vaginosis. Risk D: Consider therapy modification
Erythromycin (Topical): May diminish the therapeutic effect of Clindamycin (Topical). Management: Consider avoiding use of topical erythromycin and topical clindamycin at the same application site when treating acne vulgaris. This recommendation does not appear to apply to intravaginal use of clindamycin for the treatment of bacterial vaginosis. Risk D: Consider therapy modification
Methoxsalen (Systemic): Photosensitizing Agents may enhance the photosensitizing effect of Methoxsalen (Systemic). Risk C: Monitor therapy
Multivitamins/Fluoride (with ADE): May enhance the adverse/toxic effect of Retinoic Acid Derivatives. Risk X: Avoid combination
Multivitamins/Minerals (with ADEK, Folate, Iron): May enhance the adverse/toxic effect of Retinoic Acid Derivatives. Risk X: Avoid combination
Multivitamins/Minerals (with AE, No Iron): May enhance the adverse/toxic effect of Retinoic Acid Derivatives. Risk X: Avoid combination
Neuromuscular-Blocking Agents: Clindamycin (Topical) may enhance the neuromuscular-blocking effect of Neuromuscular-Blocking Agents. Risk C: Monitor therapy
Porfimer: Photosensitizing Agents may enhance the photosensitizing effect of Porfimer. Risk C: Monitor therapy
Verteporfin: Photosensitizing Agents may enhance the photosensitizing effect of Verteporfin. Risk C: Monitor therapy
Adverse events were observed in animal reproduction studies using this combination topically. See individual agents.
It is not known if clindamycin or tretinoin is excreted into breast milk following topical administration. Due to the potential for serious adverse reactions in nursing infants, the manufacturer recommends a decision be made whether to discontinue nursing or the drug, taking into account the importance of treatment to the mother. See individual agents.
Clindamycin reversibly binds to 50S ribosomal subunits preventing peptide chain elongation thus inhibiting bacterial protein synthesis. Clindamycin exhibits in vitro activity against Cutibacterium 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 microcomedone formation and increased expulsion of comedones.
Absorption: Topical: Tretinoin: Minimal systemic absorption; Clindamycin: Low, but variable systemic absorption
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