Aknil Gel 10gm

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 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 Isotretinoin. The optimal interval before re-treatment has not been defined for patients who have not completed skeletal growth

Pharmacology

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

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.

Interaction

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

Contraindications

Hypervitaminosis A, hyperlipidemia. Hepatic impairment. Pregnancy and lactation. Concomitant admin of tetracyclines.

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.

Pregnancy & Lactation

Category X: Studies in animals or human beings have demonstrated fetal abnormalities or there is evidence of fetal 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 hypertriglyceridemia (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. Protects from light.