Life-threatening and fatal events in infants and young children: Postmarketing cases of seizures, cardiopulmonary arrest, and death in patients under the age of 3 years have been reported with use of lignocaine 2% viscous solution for topical oral use when it was not administered in strict adherence to the dosing and administration recommendations. Kamistad-Gel N should not be used to treat infants and children with teething pain. For other conditions, the use of the product in patients less than 3 years of age should be limited to those situations where safer alternatives are not available or have been tried but failed. Kamistad-Gel N should only be used for the prescribed indication by a doctor.
To decrease the risk of serious adverse events with use of Kamistad-Gel N, instruct caregivers to strictly adhere to the prescribed dose and frequency of administration by a doctor, and store the prescription bottle safely out of reach of children.
The use of the product of treatment of teething pain in infants and children should be abandoned.