Direct Healthcare Professional Communication (DHCP) on Tegretal Suspension (carbamazepine): Restriction on use in newborns, as the concentration of the excipient propylene glycol exceeds the recommended limit value.
2026.01.05
Active substance: carbamazepine
Novartis Pharma GmbH, in agreement with the Federal Institute for Drugs and Medical Devices (BfArM), hereby informs that Tegretal (carbamazepine) 100 mg/5 ml suspension must not be used in newborns up to 4 weeks of age (or in premature babies up to 44 weeks of age after the mother's last menstrual period). The reason for this is the high propylene glycol content, which can lead to serious side effects such as metabolic acidosis, renal dysfunction (acute tubular necrosis), acute renal failure and hepatic dysfunction.
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