Drug Detail:Clascoterone topical (Clascoterone topical [ klas-koe-ter-one ])
Drug Class: Topical acne agents
Usual Adult Dose for Acne
Apply a thin uniform layer, approximately 1 gram twice per day, in the morning and the evening.
Comment: For topical use only. Not for ophthalmic, oral, or vaginal use.
Use: For the topical treatment of acne vulgaris in patients 12 years of age and older
Usual Pediatric Dose for Acne
12 years or older: Apply a thin uniform layer, approximately 1 gram twice per day, in the morning and the evening.
Comments:
- Pediatric patients may be more susceptible to systemic toxicity.
- For topical use only. Not for ophthalmic, oral, or vaginal use.
Use: For the topical treatment of acne vulgaris in patients 12 years of age and older
Renal Dose Adjustments
Data not available
Liver Dose Adjustments
Data not available
Precautions
CONTRAINDICATIONS: None
Safety and efficacy have not been established in patients younger than 12 years.
Consult WARNINGS section for additional precautions.
Dialysis
Data not available
Other Comments
Administration advice:
- For topical use only. Not for ophthalmic, oral, or vaginal use.
- Gently clean the affected area and apply after the skin is dry.
- Avoid contact with eyes, mouth, or other mucous membranes.
- Rinse thoroughly with water if contact with mucous membranes.
Storage requirements:
- Refrigerate at 2C to 8C (36F to 46F) prior to dispensing. Do not freeze.
- Store at 20C to 25C (68F to 77F).
- Discard unused product 180 days after dispensing date or one month after opening, whichever is sooner.
Patient advice:
- Read the US FDA-approved patient labeling (Patient Information).
- Avoid applying to damaged skin (such as cuts, abrasions), eczematous areas, and sunburned skin.
- Avoid concomitant use of other potentially irritating topical products.
Frequently asked questions
- How long does Winlevi take to work for acne?
- Does Winlevi need to be refrigerated?
