Axcel Lignocaine-P Special Precautions

Patients with glucose-6-phosphate dehydrogenase deficiency or congenital or idiopathic methaemoglobinaemia are more susceptible to drug-induced methaemoglobinaemia. Due to insufficient data on absorption, Axcel Lignocaine-P Cream should not be applied to open wounds other than leg ulcers. Studies have been unable to demonstrate the efficacy of Axcel Lignocaine-P Cream for heel lancing in neonates. Care should be taken when applying Axcel Lignocaine-P Cream to patients with atopic dermatitis. A shorter application time, 15-30 minutes, may be sufficient (see Pharmacology: Pharmacodynamics: Mechanism of Action under Actions). Prior to curettage of mollusca in children with atopic dermatitis, an application time of 30 minutes is recommended. Axcel Lignocaine-P Cream should not be applied to the genital mucosa of children owing to insufficient data on absorption. However, when used in neonates for circumcision, a dose of 1.0g Axcel Lignocaine-P Cream on the prepuce has proven to be safe. Care should be taken not to allow Axcel Lignocaine-P Cream to come in contact with the eyes as it may cause eye irritation. Also the loss of protective reflexes may allow corneal irritation and potential abrasion. If eye contact occurs, immediately rinse the eye in water or sodium chloride solution and protect it until sensation returns. Axcel Lignocaine-P Cream should not be applied to an impaired tympanic membrane. Tests on laboratory animals have shown that Axcel Lignocaine-P Cream has an ototoxic effect when instilled into the middle ear. Animals with an intact tympanic membrane, however, show no abnormality when exposed to Axcel Lignocaine-P Cream in the external auditory canal. In children/neonates younger than 3 months a transient, clinically insignificant increase in methaemoglobin level is commonly observed up to 12 hours after an application of Axcel Lignocaine-P Cream. Patients treated with anti-arrhythmic drugs class III (e.g., amiodarone) should be under close surveillance and ECG monitoring considered, since cardiac effects may be additive. Lidocaine and prilocaine have bactericidal and antiviral properties in concentrations above 0.5-2%. For this reason, although one clinical study suggests that the immunization response is not affected when Axcel Lignocaine-P Cream is used prior to BCG vaccination, the results of intracutaneous injections of live vaccines should be monitored.
Until further clinical data are available, Axcel Lignocaine-P Cream should not be used in the following cases: in infants between 0 and 12 months of age receiving treatment with methemoglobin-inducing agents; in preterm infants with a gestational age less than 37 weeks.
Effects on ability to drive and use machines: Not applicable at the recommended dosage.
Use in Pregnancy & Lactation: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development.