Uses of Isotrin 20 Licap: - Acne Acne Pregnancy, lactation.

Oral retinoids for Acne

Isotretinoin 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.

How to use Isotretinoin: Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Isotretinoin is to be taken with food. Administration: Should be taken with food. Adult Dose: Oral Severe, Recalcitrant Nodular Acne Severe nodular acne unresponsive to conventional therapy, including systemic antibiotics Adult: 0.5-1 mg/kg/day PO divided BID for 15-20 weeks Dose up to 2 mg/kg/day (as tolerated) if disease is very severe with scarring or is primarily manifested on the trunk Hepatic impairment: Contraindicated. Child Dose: Severe, Recalcitrant Nodular Acne Severe nodular acne unresponsive to conventional therapy, including systemic antibiotics <12 years: Safety and efficacy not established >12 years: 0.5-1 mg/kg/day PO divided BID for 15-20 weeks Dose up to 2 mg/kg/day (as tolerated) if disease is very severe with scarring or is primarily manifested on the trunk Renal Dose: Renal impairment: Severe: Reduce initial dose (e.g. 10 mg daily), then gradually increase to 1 mg/kg as necessary.

Additive toxicity with vitamin A or its derivatives. Decreased efficacy of microdosed progesterone (use 2 forms of contraception). May increase risk of bone loss with phenytoin. May increase risk of osteoporosis with systemic corticosteroids. Reduces plasma levels of carbamazepine. Potentially Fatal: Increased risk of pseudotumor cerebri with tetracyclines.

Pregnancy, lactation.

Common - Dry skin >10% Cheilitis (90%),Xerosis,Xerostomia,Dry nose,Epistaxis,Pruritus,Conjunctivitis (including blepharoconjunctivitis) (40%),Irritation (40%),Increased erythrocyte sedimentation rates (40%),Thinning of hair (which has persisted in rare instances),Palmoplantar desquamation,Skin fragility,Skin infections (eg, paronychial infections),Rash (including erythema, seborrhea, eczema), photosensitivity,Hypertriglyceridemia (25%),Bone or joint pain,Generalized muscle aches,Arthralgia,Decreased HDLs (15%),Increased LFTs (15%),Increased CPK (12-24%),Decreased hemoglobin concentration and hematocrit,Decreased erythrocyte and leukocyte counts,Increased platelet count 1-10% Decreased bone mineral density (8.8%),Premature epiphyseal closure (3%) Frequency Not Defined Lethargy,Fatigue,Headache,Anorexia,Nausea,Vomiting,Increased appetite,Thirst Potentially Fatal: Anaphylaxis. Haemorrhagic pancreatitis.

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.

Precaution: Preexisting or predisposition to hypertriglyceridaemia (e.g. DM, obesity or increased alcohol intake). Monitor triglyceride levels. Monitor blood lipids and LFTs at wkly or bi-wkly intervals. Monitor blood glucose in known or suspected DM patients. Genetic predisposition for age-related osteoporosis, history of childhood osteoporosis, osteomalacia or other bone metabolism disorders. Anorexia nervosa. History of psychiatric disorder. May impair night vision. Avoid wax epilation and skin resurfacing procedures for at least 6 mth. Avoid prolonged exposure to UV light or sunlight. Discontinue if hearing impairment, abdominal pain, rectal bleeding, severe diarrhoea or adverse ocular effects occur. Patient should not donate blood during therapy and for at least 1 mth following drug discontinuation. Lactation: Unknown whether distributed into breast milk; because of potential for serious adverse reactions in nursing infants, do not administer to women who are breastfeeding

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

Isotretinoin is a synthetic retinoid which reduces sebaceous gland size and sebum production. It also regulates cell proliferation and differentiation.