Classes
DEA Class; Rx
Common Brand Names; Twyneo
- Acne Agents, Topical Combos
Description
Naturally occurring retinoid analog; also known as all-trans-retinoic acid (aTRA)
Oral form used in acute promyelocytic leukemia; topical form used for cutaneous disorders like acne and photoaging
Treatment with oral form may cause acute promyelocytic leukemia differentiation syndrome
Indications
Indicated for topical treatment of acne vulgaris
Contraindications
Hypersensitivity to benzoyl peroxide or any components of the product
Adverse Effects
- Erythema, mild (33%)
- Pigmentation, mild (27.3%)
- Dryness, mild (22.3%)
- Scaling, mild (16.4%)
- Itching, mild (11.1%)
- Application site pain (10.6%)
- Erythema, moderate (6.9%)
- Pigmentation, moderate (6.3%)
- Burning, mild (5.9%)
- Stinging, mild (5.3%)
- Dryness, moderate (5.3%)
- Application site dryness (4.9%)
- Application site exfoliation (4.1%)
- Application site erythema (4%)
- Scaling, moderate (2.6%)
- Burning, moderate (2.2%)
- Itching, moderate (1.8%)
- Application site dermatitis (1.3%)
- Application site pruritus (1.3%)
- Application site irritation (1.1%)
Warnings
Severe hypersensitivity reactions (eg, anaphylaxis, angioedema) reported with use of benzoyl peroxide products; if a serious hypersensitivity reaction occurs, discontinue therapy immediately and initiate appropriate therapy
Pain, dryness, exfoliation, erythema, and irritation may occur
Avoid application to cuts, abrasions, eczematous, or sunburned skin
Minimize unprotected exposure to sunlight and sunlamps; use sunscreen and protective clothing when sun exposure cannot be avoided; discontinue therapy at first evidence of sunburn
Pregnancy and Lactation
No data are available on use in pregnant females
Topical tretinoin: Available data from published observational studies in pregnant females have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes
Topical benzyl peroxide: Studies conducted with topical benzoyl peroxide have not demonstrated systemic absorption and maternal use is not expected to result in fetal exposure to benzoyl peroxide
No data available on presence of benzoyl peroxide and tretinoin or its metabolites in human milk, effects on breastfed infants, or effects on milk production
Maximum Dosage
Apply a thin layer to affected areas qDay
How supplied
Tretinoin/benzoyl peroxide
topical cream
- 0.1%/3%
