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Hepatic and renal insufficiency; hypervitaminosis A; patients with excessively elevated blood lipid values; hypersensitivity to isotretinoin.
Blood donation by patients during and within one (1) month of isotretinoin treatment to women of childbearing potential should be avoided.
Use in Pregnancy & Lactation: Isotretinoin is highly teratogenic. It is therefore contraindicated in women who are pregnant or who may become pregnant while undergoing treatment. There is an extremely high risk that a deformed infant will result if pregnancy occurs while taking isotretinoin in any amount even for short periods. Potentially all exposed fetuses can be affected. Major human fetal abnormalities related to isotretinoin administration have documented, including hydrocephalus, microcephalus, abnormalities of the external ear (micropinna, small or absent external auditory canals), microphthalmia, cardiovascular abnormalities and cerebellar malformation.
As isotretinoin is highly lipophilic, the passage of the drug in human milk is very likely. Because of the potential for adverse effects, the use of isotretinoin should be avoided by nursing mothers.
It is recommended that the patient use two forms of effective contraception to prevent pregnancy, during treatment and for one (1) month after discontinuation of treatment. Testing serve to remind the patient of the importance of avoiding pregnancy. If pregnancy occurs, patient should be counseled on whether to continue the pregnancy. Isotretinoin therapy starts only on the second or third day of the next normal period.
