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Tretinoin and benzoyl peroxide: Pediatric drug information

Tretinoin and benzoyl peroxide: Pediatric drug information
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For additional information see "Tretinoin and benzoyl peroxide: Drug information" and "Tretinoin and benzoyl peroxide: Patient drug information"

For abbreviations, symbols, and age group definitions show table
Brand Names: US
  • Twyneo
Therapeutic Category
  • Acne Products;
  • Topical Skin Product, Acne
Dosing: Pediatric
Acne vulgaris

Acne vulgaris: Children ≥9 years and Adolescents: Topical: Apply a thin layer to affected area once daily.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Liver Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Adult

(For additional information see "Tretinoin and benzoyl peroxide: Drug information")

Acne vulgaris

Acne vulgaris: Topical: Apply a thin layer to affected skin once daily. Consider starting with the lowest possible concentration to minimize skin irritation and increase potency as tolerated. For moderate to severe acne, may be used as part of an appropriate combination regimen (Ref).

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Liver Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Adverse Reactions

Also see individual agents.

>10%: Local: Application site pain (11%)

1% to 10%:

Dermatologic: Application-site scaling (4%), local dryness of skin (5%; application site)

Local: Application-site dermatitis (1%), application site erythema (4%), application site irritation (1%), application-site pruritus (1%)

Contraindications

Hypersensitivity to benzoyl peroxide, tretinoin, or any component of the formulation.

Warnings/Precautions

Concerns related to adverse effects:

• Bleaching effects: May bleach hair and colored fabric.

• Hypersensitivity reaction: Hypersensitivity reactions, including anaphylaxis, angioedema, and urticaria, have been reported with use of benzoyl peroxide-containing products. Discontinue use and initiate appropriate therapy if a serious hypersensitivity reaction occurs.

• Photosensitivity: Use is associated with increased susceptibility/sensitivity to UV light; avoid or minimize excessive exposure to sunlamps or sunlight. Daily sunscreen (SPF ≥15) use and other protective measures (eg, clothing over treated areas) are recommended. Discontinue use with first sunburn.

• Skin irritation: Skin irritation (eg, dryness, pain, exfoliation, erythema, dermatitis, pruritus) may occur. Depending on the severity of irritation, use a moisturizer, reduce the amount or frequency of application, or discontinue use until irritation disappears.

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, lips, angles of nose, mucous membranes, cuts, or abraded, eczematous, or sunburned skin.

Dosage Forms: US

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

Cream, External:

Twyneo: Tretinoin 0.1% and benzoyl peroxide 3% (30 g) [contains alcohol, usp, cetyl alcohol]

Generic Equivalent Available: US

No

Pricing: US

Cream (Twyneo External)

0.1-3% (per gram): $19.68

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.

Administration: Pediatric

For external use only; not for oral, ophthalmic, or intravaginal use.

Topical: Skin should be clean and dry before applying. Apply thin layer to affected areas avoiding contact with eyes, lips, inside of nose, mouth, all mucous membranes, and areas of broken, eczematous, or sunburned skin. Wash hands immediately after applying.

Administration: Adult

Topical: For topical external use only; not for oral, ophthalmic, or intravaginal use. Apply thin layer to clean, dry skin avoiding contact with eyes, lips, angles of nose, mucous membranes, cuts, or abraded, eczematous, or sunburned skin. Wash hands before and after use. May bleach hair or colored fabrics.

Hazardous Drugs Handling Considerations

Tretinoin is a hazardous agent (NIOSH 2024 [table 2]).

Use appropriate precautions for receiving, handling, storage, preparation, dispensing, transporting, administration, and disposal. Follow NIOSH and USP 800 recommendations and institution-specific policies/procedures for appropriate containment strategy (NIOSH 2023; NIOSH 2024; USP-NF 2020).

Note: Facilities may perform risk assessment of some hazardous drugs to determine if appropriate for alternative handling and containment strategies (USP-NF 2020). Refer to institution-specific handling policies/procedures.

Storage/Stability

Prior to dispensing, store in refrigerator between 2°C to 8°C (36°F to 46°F); do not freeze. Once dispensed, store at 20°C to 25°C (68°F to 77°F), protect from freezing, and use within 12 weeks after dispensing or 60 days after first opening, whichever is sooner.

Use

Topical treatment of acne vulgaris (FDA approved in ages ≥9 years and adults).

Metabolism/Transport Effects

Refer to individual components.

Drug Interactions

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 drug interactions program by clicking on the “Launch drug interactions program” link above.

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 drug interactions program

Aminolevulinic Acid (Systemic): Photosensitizing Agents may increase photosensitizing effects of Aminolevulinic Acid (Systemic). Risk X: Avoid

Aminolevulinic Acid (Topical): Photosensitizing Agents may increase photosensitizing effects of Aminolevulinic Acid (Topical). Risk C: Monitor

Dapsone (Topical): Benzoyl Peroxide may increase adverse/toxic effects 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

Methoxsalen (Systemic): Photosensitizing Agents may increase photosensitizing effects of Methoxsalen (Systemic). Risk C: Monitor

Porfimer: Photosensitizing Agents may increase photosensitizing effects of Porfimer. Risk X: Avoid

Verteporfin: Photosensitizing Agents may increase photosensitizing effects of Verteporfin. Risk C: Monitor

Pregnancy Considerations

Animal reproduction studies have not been conducted with this combination.

Refer to individual monographs for additional information.

Mechanism of Action

See individual agents.

Pharmacokinetics (Adult Data Unless Noted)

See individual agents.

  1. Dubina MI, Fleischer AB Jr. Interaction of topical sulfacetamide and topical dapsone with benzoyl peroxide. Arch Dermatol. 2009;145(9):1027-1029. doi:10.1001/archdermatol.2009.186 [PubMed 19770443]
  2. Hodson L, Ovesen J, Couch J, et al; US Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health. Managing hazardous drug exposures: information for healthcare settings, 2023. https://doi.org/10.26616/NIOSHPUB2023130. Updated April 2023. Accessed December 27, 2024.
  3. Ovesen JL, Sammons D, Connor TH, et al; US Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health. NIOSH list of hazardous drugs in healthcare settings, 2024. https://doi.org/10.26616/NIOSHPUB2025103. Updated December 18, 2024. Accessed December 20, 2024.
  4. Twyneo (tretinoin and benzoyl peroxide) [prescribing information]. Dallas, TX: Galderma Laboratories; August 2022.
  5. United States Pharmacopeia. <800> Hazardous Drugs—Handling in Healthcare Settings. In: USP-NF. United States Pharmacopeia; July 1, 2020. Accessed January 16, 2025. doi:10.31003/USPNF_M7808_07_01
  6. Zaenglein AL, Pathy AL, Schlosser BJ, et al. Guidelines of care for the management of acne vulgaris. J Am Acad Dermatol. 2016;74(5):945-973.e33. doi:10.1016/j.jaad.2015.12.037 [PubMed 26897386]
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