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Isotretinoin should only be prescribed by physicians who are experienced in the use of systemic retinoids, preferably dermatologists who understand the risk of teratogenicity if isotretinoin is used during pregnancy.
Liver function should be checked before and one (1) month after the start of treatment, and subsequently at three (3) 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 3-4 months treatment period).
Depression, psychotic symptoms and rarely, suicide and suicide attempts have been reported in patients treated with isotretinoin. Although a causal relationship has not been established, particular care needs to be taken in patients with a history of depression and referred for appropriate treatment if necessary.
Checking with physician anytime vision problems occur; wearing contact lenses may be uncomfortable. Vision impairment can occur including photophobia, blurred vision or dryness of eyes. Vision problems can make driving a car or operating machinery dangerous.
A careful evaluation of the risk/benefit ratio should be carried out in every patient and isotretinoin administration should be restricted to severe cases.
Since acne is an androgen-dependent disease, contraceptives containing an androgen progestational substance, such as one derived form 19-nortestosterone (norsteroid), particularly in the presence of gyne-endocrinological problems should be avoided.
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 in patients on isotretinoin and for a period of 5-6 months after treatment because of the risk of dermatitis.
Special Patient Groups: In high-risk patients (with diabetes, obesity, alcoholism or disorders of lipid metabolism) undergoing treatment with isotretinoin, more frequent checks of the relevant laboratory parameters will be necessary.
In known or suspected diabetics, frequent determination of blood glucose levels is recommended. Although no causal relationship has been established, elevated fasting blood sugars have diagnosed during isotretinoin therapy.
Dental problems can occur resulting from dryness of mouth and may increase dental disease, including tooth decay, gum disease and fungus infections; regular dental appointments are needed and use of sugarless candy or saliva substitute or melting ice in mouth may be necessary to lessen dental problems.
Female patients should have a negative pregnancy test two (2) weeks prior to the start of therapy. She should use contraception without interruption for one (1) month before beginning therapy, during therapy and for one (1) month following discontinuation of therapy.
