其 他 安 全 警 示
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| Singapore: Tegretol Oral Suspension 2%: Update to the posology, method of administration, and limitation of use in neonates (English only) |
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Health Sciences Authority (HSA) announces that a Dear Healthcare Professional Letter has been issued by Novartis (Singapore) Pte Ltd to inform healthcare professionals of updates to the posology, method of administration, and limitation of use in neonates with Tegretol Oral Suspension 2% (OS) (carbamazepine). The product is indicated for epilepsy including complex or simple partial seizures (with or without loss of consciousness) with or without secondary generalization, generalized tonic-clonic seizures and mixed forms of seizures.
The revised maximum daily dose for Tegretol OS is recommended to be limited to 1200 mg/day. This recommendation is initiated to limit the amount of sorbitol intake given current constraints in sourcing sorbitol batches compliant with appropriate specifications. In addition, Tegretol OS is no longer recommended for neonates (below 4 weeks of age for term babies or 44 weeks post-menstrual age for pre-term babies) due to the amount of propylene glycol in this formulation.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/announcements/dear-healthcare-professional-letter/tegretol-oral-suspension---update-to-the-posology--method-of-administration--and-limitation-of-use-in-neonates
In Hong Kong, Tegretol Syrup 2% (HK-35117) is a pharmaceutical product registered by Novartis Pharmaceuticals (HK) Limited (Novartis), and is a prescription-only medicine. So far, the Department of Health (DH) has received 10 cases of adverse events with regard to carbamazepine, but these cases were not related to neonates. In light of the above HSA’s announcement, letters to inform local healthcare professionals will be issued. Novartis was contacted and confirmed that they will apply for change of package insert of their product. The DH will remain vigilant on safety update of the drug issued by other overseas drug regulatory authorities.
Ends/Wednesday, Nov 13, 2024
Issued at HKT 18:00
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