Roaccutane 10 mg Capsule
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Indications
- Isotretinoin is indicated for the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. Because of significant adverse effects associated with its use, Isotretinoin should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. In addition, Isotretinoin is indicated only for those female patients who are not pregnant, because Isotretinoin can cause severe birth defects
- A single course of therapy for 15 to 20 weeks has been shown to result in complete and prolonged remission of disease in many patients. If the second course of therapy is needed, it should not be initiated until at least 8 weeks after completion of the first course, because experience has shown that patients may continue to improve while off Isotretinoin. The optimal interval before re-treatment has not been defined for patients who have not completed skeletal growth
Dosage & Administration
- Oral-
- Adult: Initially, 0.5 mg/kg daily in single or 2 divided doses, increased to 1 mg/kg daily if necessary. The usual duration of treatment: 16-24 wk. May repeat treatment course after at least 8 wk if relapse after the first course.
- Child: ≥12 yr Same as adult dose.
- Topical: Apply Isotretinoin 0.05% gel cautiously over the affected area once or twice daily. Patients should be advised that 6-8 weeks of treatment may be required before a therapeutic effect is observed. The safety and efficacy of Isotretinoin have not been established in children since acne vulgaris rarely present in this age group. There are no specific recommendations for use in the elderly. Acne vulgaris does not present in the elderly.
Side Effects
- Erythema, skin exfoliation, stinging sensation, pruritus, irritation, tenderness, dry skin, hirsutism, photosensitivity, skin pigmentation, paronychia, nail dystrophy, pyogenic granuloma, increased sweating, corneal opacities, visual disturbances, headache, nausea and vomiting, arthralgia, myalgia, back pain, intracranial HTN, hyperostosis and calcinosis. Elevation of serum triglycerides, LFTs, ESR and blood glucose. Mood changes, psychotic symptoms, depression and suicidal behavior.
Therapeutic Class
Oral retinoids for Acne
Storage Conditions
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
| Size/Weight | 10 mg |
|---|---|
| Generic Name | Isotretinoin |
| Formation | Capsule |
| Manufactured By | Radiant Pharmaceuticals Ltd. |
| Country of Manufacture | Bangladesh |
| Prescription Required | No |
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