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Active ingredient: Isotretinoin
Indications:
Acne that is resistant to other treatments. Severe acne (nodulocystic acne, acne conglobata, or acne with a risk of scarring).
Contraindications:
Pregnancy, breastfeeding, liver failure, hypervitaminosis A, severe hyperlipidemia, concomitant therapy with tetracyclines.
Hypersensitivity to the drug or its components.
Children under 12 years of age.
Interactions:
Due to the potential for increased symptoms of hypervitaminosis A, the concomitant use of Roaccutane and vitamin A should be avoided.
Since tetracyclines can also cause increased intracranial pressure, their use in combination with Roaccutane is contraindicated.
Isotretinoin may reduce the effectiveness of progesterone-based medications, so contraceptives containing low doses of progesterone should not be used.
Concomitant use with topical keratolytic or exfoliative acne medications is contraindicated due to the potential for increased local irritation.
How to take, course of treatment and dosage:
Standard Dosage
Orally, with meals, once or twice daily.
The therapeutic efficacy of Roaccutane and its side effects are dose-dependent and vary among patients. This necessitates individualized dosage adjustments during treatment.
Roaccutane treatment should be initiated with a dose of 0.5 mg/kg per day. For most patients, the dose ranges from 0.5 to 1.0 mg/kg of body weight per day. Patients with very severe forms of the disease or with corpora acne may require higher daily doses – up to 2.0 mg/kg.
It has been proven that the remission rate and relapse prevention are optimal with a course dose of 120-150 mg/kg (per treatment course). Therefore, the duration of therapy varies depending on the daily dose in individual patients. Complete acne remission is often achieved within 16-24 weeks of treatment. In patients who are very intolerant of the recommended dose, treatment can be continued at a lower dose, but for a longer period.
In most patients, acne completely resolves after a single course of treatment. If a relapse occurs, a second course of Roaccutane is indicated at the same daily and course dose as the first. Since improvement can last up to 8 weeks after discontinuing the drug, a second course should not be prescribed before the end of this period.
Dosing in Special Cases
In patients with severe renal impairment, treatment should be started at a lower dose (e.g., 10 mg/day) and then increased to 1 mg/kg/day or the maximum tolerated dose.
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