Oratane Special Precautions

General: Prescribers should inform the individual patient of the risks associated with the use of isotretinoin.
Isotretinoin should only be prescribed by doctors who are experienced in the use of systemic retinoids and understand the risk of teratogenicity associated with isotretinoin therapy Hypersensitivity reactions may occur in susceptible individuals.
Liver function should be checked before and one month after the start of treatment and subsequently at three-monthly intervals.
Serum lipids (fasting value) should also be checked (before and one month after the start of therapy, and also at the end of the three-to-four-month treatment period). In high risk patients (with diabetes, obesity, alcoholism or disturbances of the lipid metabolism) undergoing treatment with isotretinoin, more frequent checks may be necessary. Isotretinoin should not be used together with any medicine known to enhance liver metabolism or interfere with enterohepatic circulation.
The serum lipid values usually return to normal on reduction of the dose or discontinuation of treatment. The changes in serum lipids may also resolve in response to dietary measures.
In known or suspected diabetic patients, frequent determination of blood glucose levels is recommended. Although no causal relationship has been established, elevated fasting blood sugars have been reported and new cases of diabetes have been diagnosed during isotretinoin therapy.
It is recommended that clinically significant serum triglyceride elevations be controlled, since levels in excess of 800 mg/dL are sometimes associated with acute pancreatitis, which is known to be potentially fatal. Hence, isotretinoin should be discontinued if uncontrolled hypertriglyceridaemia or symptoms of pancreatitis occur.
Patients, particularly those with dry eyes, should be monitored for the development of keratitis. Decreased night vision has occurred during isotretinoin therapy and in rare instances has persisted after discontinuation of therapy (see Adverse Reactions). Because the onset in some patients was sudden, patients should be advised of this potential problem and warned to be cautious when driving or operating any vehicle at night. Visual problems should be carefully monitored.
Rare cases of benign intracranial hypertension have been reported after isotretinoin and after tetracyclines. Supplementary treatment with tetracyclines is, therefore, contraindicated.
Myalgia and arthralgia may occur and may be associated with reduced tolerance to vigorous exercise (see Adverse Reactions). Isolated instances of raised serum CPK values have been reported in patients receiving isotretinoin, particularly those undertaking vigorous physical activity.
Hyperostosis has been seen in some patients suffering from keratinising dermatoses on treatment with higher doses (> 2 mg/kg) and long-term administration (> 1 year). Blood donation to women of childbearing age by patients being treated or recently treated (one to two weeks) with isotretinoin is contraindicated.
Aggressive dermabrasion should be avoided in patients on isotretinoin and for a period of 5-6 months after treatment because of the risk of hypertrophic scarring in atypical areas. Wax epilation should be avoided during therapy and at least for a period of 6 months thereafter due to the possibility of scarring or dermatitis.
Isotretinoin has been associated with inflammatory bowel disease (including regional ileitis) in patients without a prior history of intestinal disorders. Patients experiencing severe (haemorrhagic) diarrhoea should discontinue isotretinoin immediately.
Psychiatric disorders: Depression, depression aggravated, anxiety, aggressive tendencies, mood alterations, psychotic symptoms, and very rarely, suicidal ideation, suicide attempts and suicide have been reported in patients treated with isotretinoin. Particular care needs to be taken in patients with a history of depression and all patients should be monitored for signs of depression and referred for appropriate treatment if necessary. However, discontinuation of isotretinoin may be insufficient to alleviate symptoms and therefore further psychiatric or psychological evaluation may be necessary. Awareness by family or friends may be useful to detect mental health deterioration.
Male Patients: The available data suggest that the level of maternal exposure from the semen of patients receiving isotretinoin, is not of sufficient magnitude to be associated with the teratogenic effect of isotretinoin.
Male patients should be reminded that they must not share their medication with anyone, particularly not females.
Use in Pregnancy: (Category X): Isotretinoin is highly teratogenic and must not be given to women who are pregnant. Isotretinoin crosses the placental barrier in amounts that lead to congenital deformities. There is an extremely high risk that a deformed infant will result if pregnancy occurs while taking ORATANE in any amount even for short periods. Potentially all exposed foetuses can be affected.
Use in Lactation: Owing to its lipophilicity, there is a high probability that isotretinoin is secreted into the breast milk. Isotretinoin must not be given to nursing mothers.
Use in Children: The use of Oratane in pediatric patients less than 12 years of age has not been studied. The use of Oratane for the treatment of severe recalcitrant nodular acne in pediatric patients age 12 to 17 years should be given careful consideration, especially for those patients where a known metabolic or structural bone disease exists. Clinical study has shown that isotretinoin, at a dose of 1mg/kg/day given in two divided doses, was effective in treating recalcitrant nodular acne in patients age 13 to 17 years.