warnings
WARNINGS Excessive dosage, or short interval between doses, can result in high plasma levels and serious adverse effects. Patients should be instructed to strictly adhere to the recommended dosage and administration guidelines set forth in this literature and on your prescription label. The management of serious adverse reactions may require the use of resuscitative equipment, oxygen or other resuscitative drugs. PRECAUTIONS : Because of the possibility of sedation, patients should be cautioned regarding the operation of serious machinery or automobiles, and activities made hazardous by decreased alertness. DRUG INTERACTIONS: No Drug interactions have been assessed with MaL Patch 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 product on fertility has not been evaluated in animals. PREGNANCY: The safety of MaL Patch has not been established during pregnancy. There are no well-controlled studies in pregnant women. PEDIATRIC / GERIATRIC USE: Safety and effectiveness in pediatric and geriatric patients have not been established. NURSING MOTHERS: The effect of MaL Patch on nursing infants has not been evaluated. ADVERSE REACTIONS: The most common adverse reactions are application site reactions, including dermatitis, itching or scaling. These tend to be dose-limiting and diminish with time. Serious adverse experiences following the administration of MaL Patch are similar in nature to those observed in other amide anestheticcontaining agents. These adverse experiences are, in general, dose-related and may result from high plasma levels caused by excessive dosage, rapid absorption, or may result from hypersensitivity, idiosyncrasy, or a diminished tolerance on the part of the patient. Serious adverse experiences are generally systemic in nature. OVERDOSAGE: There have been no reports of over-dosage with MaL Patch. Signs of overdosage would 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.