Acnetane 10 mg & 20 mg capsules
Clinical Summary
Quick overview from the medicine insert
Indication
Severe acne vulgaris unresponsive to conventional therapy.
Dosage (summary)
Initial dose is typically 0.5 mg/kg/day, which may be adjusted based on response and tolerance. The total cumulative dose should be at least 120-150 mg/kg.
Onset of Action / Duration
Improvement may be seen within 4-6 weeks, with maximum effects typically observed after 16-24 weeks of treatment.
Special Populations
- Patients with hepatic impairment
- Patients with renal impairment
- Pediatric patients
- Elderly patients
Pregnancy & Breastfeeding
Isotretinoin is contraindicated in pregnancy due to high risk of teratogenic effects. Women of childbearing potential must use effective contraception during treatment and for at least one month after discontinuation. It is not recommended during lactation.
Key Drug Interactions
- Tetracyclines may increase the risk of intracranial hypertension.
- Vitamin A supplements may increase the risk of hypervitaminosis A.
- St. John's Wort may reduce the effectiveness of isotretinoin.
Contraindications
- Pregnancy
- Hypersensitivity to isotretinoin or any component of the formulation
- Severe hepatic impairment
- Hypervitaminosis A
Common side effects
- Dry skin and mucous membranes
- Chapped lips
- Nosebleeds
- Photosensitivity
- Muscle and joint pain
- Elevated liver enzymes
Counselling Points
- Advise patients to avoid sun exposure and use sunscreen.
- Instruct on the importance of adhering to contraception measures if of childbearing potential.
- Inform about potential side effects and the need for regular follow-up appointments.
- Encourage hydration and use of moisturizers to alleviate dryness.
Serious warnings
- Monitor for signs of depression or mood changes.
- Regular blood tests may be required to monitor liver function and lipid levels.
- Avoid donating blood during treatment and for at least one month after discontinuation.
Important Disclaimer
The Acnetane 10 mg & 20 mg capsules professional information leaflet below is the property of Adcock Ingram 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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