Roaccutane 10 mg & 20 mg Capsules
PDF Leaflet Revision Date: 12 August 2022
Clinical Summary
Quick overview from the medicine insert
Indication
Severe recalcitrant nodular acne.
Dosage (summary)
Start at 0.5 mg/kg daily; adjust between 0.5 - 2.0 mg/kg based on response.
Onset of Action / Duration
Onset: 7-10 days, Duration: 16-24 weeks
Special Populations
- Renal impairment
- Hepatic impairment
Pregnancy & Breastfeeding
Contraindicated in pregnancy; teratogenic effects.
Key Drug Interactions
- Vitamin A
- Tetracyclines
Contraindications
- Pregnancy
- Lactation
- Hypersensitivity to soya
- Hypervitaminosis A
- Hepatic insufficiency
Common side effects
- Dry skin
- Cheilitis
- Headache
- Increased triglycerides
Counselling Points
- Use effective contraception
- Avoid sun exposure
- Monitor for mood changes
- Do not donate blood during treatment
Serious warnings
- Teratogenicity
- Hepatotoxicity
- Psychiatric disorders
- Pseudotumor cerebri
Important Disclaimer
The Roaccutane 10 mg & 20 mg Capsules professional information leaflet below is the property of Equity Pharmaceuticals and is provided on Medinsert exactly as issued, with no.. alterations or editorial changes. We make every effort to keep content current by updating documents as soon as new versions become available. Medinsert serves as a trusted access point for healthcare professionals, but does not replace official sources or clinical judgement. For more details, please read our full disclaimer. read more>>
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