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warnings and cautions
WARNINGS AND PRECAUTIONS Patients should be instructed to strictly adhere to the recommended dosage and administration guidelines set forth in this literature and on your prescription label. Accidental Exposure in Children: the potential exists for a small child or a pet to suffer adverse effects from chewing or ingesting a new or used Antiscar patch. It is important for patients to store and dispose of Antiscar patchs out of the reach of children and pets. For external use only. The Antiscar patch should not be used if there are mental or physical conditions that may preclude compliance with physician instructions CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY: Nonclinical toxicity studies to determine the potential of this topical preparation to cause carcinogenicity or mutagenicity have not been performed. The effect of the topical product on fertility has not been evaluated in animals or humans. PREGNANCY: The safety of Antiscar patch has not been established during pregnancy. Teratogenesis is a serious concern with oral retinoic acid as vitamin A analogs are well-known teratogens. Teratogenic and embryotoxic effects have been demonstrated in animals receiving oral retinoic acid. It is expected that retinoic acid will cause fetal harm when administered to a pregnant woman and that there is a high risk of producing a severely deformed infant. Adequate and well-controlled trials have not been performed in humans, but increased spontaneous fetal abortion and major human fetal abnormalities have occurred when pregnant women received other retinoids. OVERDOSAGE: There have been no reports of over-dosage with Antiscar patch. Signs of overdosage could include vomiting, drowsiness, coma, respiratory depression, and seizures. In the case of an overdosage, discontinue the product immediately, treat the patient symptomatically, and institute supportive measures.
ADVERSE REACTIONS The most common adverse reactions are application site reactions, including dermatitis, irritation, itching or scaling. These tend to be dose-limiting and diminish with time. About 4% of patients had to discontinue use of topical retinoic acid because of adverse reactions. If severe erythema, edema, vesicle formation (e.g., vesicular rash), or crusting develops, Antiscar should be discontinued until skin integrity is restored. Therapy may be reinitiated with less frequent application.