Shanghai Sine Yanan


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Full Prescribing Info
Each soft capsule contains Isotretinoin 10 mg.
Retinoid for systemic treatment of acne.
Severe forms of nodulo-cystic acne which are resistant to previous therapy.
Dosage/Direction for Use
Take with meals, low doses once daily, higher amounts as a single dose or in several doses spread over a day.
Start therapy with 0.5 mg/kg daily. Acne will be aggravated for a short period at the beginning of treatment. Efficacy and side effect vary according to the individual patient. After 4 weeks, the maintenance treatment should be adjusted within 0.1-1.0 mg/kg daily. The maximum dosage is 1 mg/kg daily given for only a limited period of time. Treatment usually lasts 16 weeks. There should be an interval of at least 8 weeks before restarting treatment.
Pregnant & nursing women; Hepatic and renal insufficiency; Hypervitaminosis; Hypersensitivity; Patients with excessively elevated blood lipid values; Concurrent therapy with vitamin A.
Special Precautions
ISOTANE should be prescribed by physicians and dermatologists who are experienced in the use of systemic retinoids and also understand the risk of teratogenicity.
Should check liver function before and one month after the start of treatment, and subsequently at three month intervals.
Serum lipids (fasting value) should be checked before and one month after the start of treatment as well as at the end of therapy.
Side Effects
Most of the side effects are dose-related.
Unwanted effects with ISOTANE: Dryness of skin, lips, nasal mucosa (epistaxis), pharynx (hoarseness), eye (conjunctivitis).
Pruritus, facial erythema, dermatitis, sweating, pyogenic granuloma, nail dystrophy, persistent hair thinning, reversible alopecia, hyperpigmentation, photosensitivity.
Muscle pain, joint pain, hyperostosis and other bone changes.
Depression, headache, increased intracranial pressure, seizures.
Visual disturbances, decreased night vision, photophobia.
Nausea, inflammatory bowel disease.
Bronchospasm (rarely).
Corneal opacities.
Drug Interactions
Concurrent therapy with isotretinoin and vitamin A must be avoided as symptoms of hypervitaminosis A may be intensified.
Supplementary treatment with tetracyclines should therefore be avoided for rare case of benign intracranial hypertension; "pseudotumor cerebri" has been reported after tetracycline and isotretinoin administration.
Avoid administration with other keratolytic or exfoliative antiacne agents because it will cause more dry skin and peeling action.
Store below 25°C protected from light and air.
MIMS Class
Acne Treatment Preparations
ATC Classification
D10BA01 - isotretinoin ; Belongs to the class of systemic retinoid preparations used in the treatment of acne.
Isotane softcap 10 mg
10 × 5's
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