Version May 2024
Acne vulgaris: Topical: Apply a thin layer to the affected area once daily.
There are no dosage adjustments provided in manufacturer's labeling.
There are no dosage adjustments provided in manufacturer's labeling.
Refer to adult dosing.
(For additional information see "Clindamycin, adapalene, and benzoyl peroxide: Pediatric drug information")
Acne vulgaris, treatment: Children ≥12 years and Adolescents: Topical: Apply a thin layer to the affected area once daily.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in children, adolescents, and adults.
>10%: Local: Application-site pain (14%; including localized burning and stinging)
1% to 10%: Local: Application-site dermatitis (1%), application-site erythema (5%), application-site irritation (2%), local dryness of skin (application site: 4%), local skin exfoliation (application site: 2%)
Frequency not defined:
Dermatologic: Contact dermatitis (including allergic contact dermatitis)
Local: Application-site itching, application-site scaling
Hypersensitivity to clindamycin, adapalene, benzoyl peroxide, lincomycin, or any component of the formulation; history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis.
Concerns related to adverse effects:
• Bleaching effects: Benzoyl peroxide may bleach hair, colored fabric, or carpeting.
• Diarrhea: Systemic absorption may occur after topical use of clindamycin. Clostridioides difficile-associated diarrhea and pseudomembranous colitis have been reported and have been observed >2 months post antibiotic treatment. Use of parenteral and systemic clindamycin has resulted in severe colitis (including fatalities). Discontinue drug if significant diarrhea, abdominal cramps, or passage of blood and mucus occurs.
• Hypersensitivity reactions: Hypersensitivity, including anaphylaxis, angioedema, and urticaria, have been reported with use. Discontinue use immediately and initiate appropriate therapy if severe hypersensitivity occurs.
• Photosensitivity: Use is associated with increased susceptibility/sensitivity to UV light; avoid sunlamps, tanning beds, or excessive sunlight exposure. Daily broad-spectrum sunscreen use and other protective measures (eg, hat) are recommended if sun exposure cannot be avoided.
• Skin irritation: Certain cutaneous signs and symptoms (eg, burning/pain/stinging, dermatitis, dryness, erythema, irritation, scaling) may occur during treatment; these are most likely to occur during the first 4 weeks and usually lessen with continued use. Irritant and allergic contact dermatitis may occur. Use of moisturizer, decreased use, or discontinuation may be recommended.
Concurrent drug therapy issues:
• Sulfone products: Concomitant use of benzoyl peroxide with sulfone products (eg, dapsone, sulfacetamide) may cause temporary discoloration (yellow/orange) of facial hair and skin. Application of products at separate times during the day or washing off benzoyl peroxide prior to application of other products may avoid skin discoloration (Dubina 2009).
Other warnings/precautions:
• Appropriate use: For external use only; avoid contact with eyes, mouth, and mucous membranes. Do not apply to broken, eczematous, or sunburned skin. Avoid use of waxing as a depilatory method on treated skin. Avoid concomitant use of other potentially irritating topical products (peeling, desquamating, or abrasive agents and products with high concentrations of alcohol, astringents, spices, or limes).
Some dosage forms may contain propylene glycol; in neonates, large amounts of propylene glycol delivered orally, intravenously (eg, >3,000 mg/day), or topically have been associated with potentially fatal toxicities which can include metabolic acidosis, seizures, renal failure, and CNS depression; toxicities have also been reported in children and adults including hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Shehab 2009).
Cabtreo: FDA approved October 2023; availability anticipated in 1st quarter of 2024.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Gel, External:
Cabtreo: Clindamycin 1.2%, adapalene 0.15%, and benzoyl peroxide 3.1% (50 g) [contains propylene glycol]
No
Gel (Cabtreo External)
0.15-3.1-1.2% (per gram): $22.80
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.
Topical: Apply a thin layer to affected area. Skin should be clean and dry before applying. For external use only; avoid applying to eyes, mouth, nose, mucous membranes, or intravaginally. Do not apply to broken, eczematous, or sunburned skin. Wash hands after application.
Topical: For external use only; not for oral, ophthalmic, or intravaginal use. Cleanse and dry the affected area, then apply a pea-sized amount in a thin layer. Avoid eyes, mouth, paranasal creases, mucous membranes, and areas of broken, eczematous, or sunburned skin. Wash hands after application. Avoid unnecessary exposure to sunlight, including tanning beds and sun lamps; apply sunscreen and use protective clothing (eg, hat) if going outside. Product may bleach hair or colored fabric.
Acne vulgaris: Treatment of acne vulgaris in adult and pediatric 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
Dapsone (Topical): Benzoyl Peroxide may enhance the adverse/toxic effect of Dapsone (Topical). Specifically, the use of these agents in combination may cause skin and facial hair to temporarily turn a tan or yellow/orange color. 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
Refer to individual monographs.
It is not known if clindamycin, adapalene, or benzoyl peroxide are present in breast milk following topical application.
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother. Because topical agents can be transferred to a breastfeeding infant, avoid direct skin-to-skin contact with treated areas, do not apply directly to the nipple and areola, and apply the smallest amount for the shortest duration possible while breastfeeding. Refer to individual monographs for additional information.
Monitor for hypersensitivity reactions (eg, rash, swelling), stool output or diarrhea, sun sensitivity and skin stinging, burning, pain, or dryness.
Clindamycin: Reversibly binds to 50S ribosomal subunits preventing peptide bond formation, thus inhibiting bacterial protein synthesis; bacteriostatic or bactericidal depending on drug concentration, infection site, and organism.
Adapalene: A retinoid-like compound that is a modulator of cellular differentiation, keratinization, and inflammatory processes, all of which represent important features in the pathology of acne vulgaris.
Benzoyl peroxide: Releases free-radical oxygen, which oxidizes bacterial proteins in the sebaceous follicles, decreasing the number of anaerobic bacteria and decreasing irritating-type free fatty acids.
Also see individual agents.
Absorption: Via the skin.
Excretion: Benzoyl peroxide: Urine.
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