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Concise Prescribing Info
Severe forms of acne (nodulo-cystic) & acne which has failed to respond to other therapies.
Dosage/Direction for Use
Individualized dosage. Initially 0.5 mg/kg/day. Dose range: 0.5-1 mg/kg/day. Patient w/ very severe disease or w/ truncal acne Up to 2 mg/kg/day.
Should be taken with food.
Hypersensitivity. Hepatic & renal insufficiency. Hypervitaminosis A. Patients w/ excessively elevated blood lipid values. Pregnancy (highly teratogenic).
Special Precautions
Check liver function before & 1 mth after the start of treatment & subsequently at 3-mthly intervals. Check serum lipids before & 1 mth after the start of treatment & also at the end of the 3-4 mth treatment period. Frequently check high risk patients (w/ diabetes, obesity, alcoholism or lipid metabolism disturbances). Not to be used w/ any medicine known to enhance liver metabolism or interfere w/ enterohepatic circulation. Discontinue use if uncontrolled hypertriglyceridaemia or symptoms of pancreatitis occur. Monitor for development of keratitis particularly in patients w/ dry eyes. Supplementary treatment w/ tetracyclines is contraindicated due to rare cases of benign intracranial HTN. Myalgia & arthralgia may occur & may be associated w/ reduced tolerance to vigorous exercise. Hyperostosis (w/ higher doses & long-term administration). Avoid aggressive dermabrasion for a period of 5-6 mth after treatment; wax epilation during therapy & at least for a period of 6 mth thereafter. Inflammatory bowel disease (including regional ileitis) in patients w/o a prior history of intestinal disorders. Immediately discontinue use if patients experience severe (haemorrhagic) diarrhoea. Psychiatric disorders (eg, depression, depression aggravated, anxiety, aggressive tendencies, mood alterations, psychotic symptoms, & very rarely, suicidal ideation, suicide attempts & suicide). Patients w/ a history of depression; monitor for signs of depression. Concurrent administration of other keratolytic or exfoliative anti-acne prep; radiation therapy w/ UV light. Avoid sun exposure. Decreased night vision during therapy & rarely persisted after discontinuation; patients driving or operating any vehicle at night. Carefully monitor visual problems. Male patients must not share their medication w/ anyone, particularly females. Blood donation to women of childbearing age by patients being or recently treated (1-2 wks) w/ isotretinoin is contraindicated. Not to be given to nursing mothers. Childn <12 yr.
Adverse Reactions
Hypervitaminosis A symptoms (ie, dry mucosa); dry eyes; exanthema, pruritus, dermatitis facialis, sweating, pyogenic granuloma, paronychia, nail dystrophy, increased formation of granulation tissue; bone changes, hyperostosis; allergic vasculitis, decreased WBC & RBC, increased & decreased platelets, elevated sedimentation rate; behavioural disorders, depression, headache, increased intracranial pressure, seizures; increased serum triglycerides & cholesterol levels, decreased HDL.
Drug Interactions
Avoid concurrent therapy w/ vit A. Combination w/ tetracyclines is contraindicated due to increase in intracranial pressure. Concurrent administration of other keratolytic or exfoliative anti-acne prep; radiation therapy w/ UV light.
ATC Classification
D10AD01 - tretinoin ; Belongs to the class of topical retinoid preparations used in the treatment of acne.
Oratane cap 10 mg
Oratane cap 20 mg
Oratane cap 5 mg
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