Roaccutane

Roaccutane20 mg

Capsule

Isotretinoin

Radiant Pharmaceuticals Ltd.

Product Code : 15006
MRP 1132.00
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Medicine overview

Indications of Roaccutane 20 mg

Roaccutane 20 mg 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, Roaccutane 20 mg should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. In addition, Roaccutane 20 mg is indicated only for those female patients who are not pregnant, because Roaccutane 20 mg can cause severe birth defectsA 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 a 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 Roaccutane 20 mg . The optimal interval before re-treatment has not been defined for patients who have not completed skeletal growth

Theropeutic Class

Oral retinoids for Acne

Pharmacology

Roaccutane 20 mg is a synthetic retinoid which reduces sebaceous gland size and inhibits sebum production. It also regulates cell proliferation and differentiation and has dermal anti-inflammatory effect.

Dosage & Administration of Roaccutane 20 mg

Oral- Adult: Initially, 0.5 mg/kg daily in single or 2 divided doses, increased to 1 mg/kg daily if necessary. Usual duration of treatment: 16-24 wk. May repeat treatment course after at least 8 wk if relapse after first course. Child: ≥12 yr Same as adult dose. Topical: Apply Roaccutane 20 mg 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 therapeuticeffect is observed. The safety and efficacy of Roaccutane 20 mg 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.

Interaction of Roaccutane 20 mg

Additive adverse effects with vit A or its derivatives. Decreased efficacy of microdosed progesterone (use 2 forms of contraception).Increased risk of local irritation with topical keratolytic or exfoliative anti-acne agents. Oxidising agents (e.g. benzoyl peroxide) may reduce the efficacy of topical Roaccutane 20 mg.

Contraindications

Hypervitaminosis A, hyperlipidaemia. Hepatic impairment. Pregnancy and lactation. Concomitant admin of tetracycylines.

Side Effects of Roaccutane 20 mg

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 behaviour.

Pregnancy & Lactation

Category X: Studies in animals or human beings have demonstrated foetal abnormalities or there is evidence of foetal risk based on human experience or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.

Precautions & Warnings

Women of childbearing potential; anorexia nervosa. History of photoallergy, psychiatric disorder (e.g. depression); pre-existing or predisposition to hypertriglyceridaemia (e.g. DM, obesity or increased alcohol intake). Genetic predisposition for age-related osteoporosis, history of childhood osteoporosis, osteomalacia or other bone metabolism disorders. Not intended for the treatment of prepubertal acne. Severe renal impairment.

Storage Conditions

Store between 20-25° C. Protect from light.

Use In Special Populations

Renal Impairment: Oral: Severe: Reduce initial dose (e.g. 10 mg daily), then gradually increase to 1 mg/kg as necessary.Hepatic Impairment: Oral: Contraindicated.
Disclaimer

The information provided is accurate to our best practices, but it does not replace professional medical advice. We cannot guarantee its completeness or accuracy. The absence of specific information about a drug should not be seen as an endorsement. We are not responsible for any consequences resulting from this information, so consult a healthcare professional for any concerns or questions.