Topiramate |
Formulary
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Tablets 25mg,50mg, 100mg, 200mg Topiramate oral suspension - Restricted for paediatric use only, when sprinkle capsules are unsuitable. Prescribers should be cautious when selecting the strength of suspension as multiple strengths are available. Category 2 - Doctors should use clinical judgement when deciding whether to switch between different manufacturer's products Topiramate is now contraindicated in pregnancy and in women of childbearing potential unless the conditions of a Pregnancy Prevention Programme are fulfilled. This follows a review by the MHRA which concluded that the use of topiramate during pregnancy is associated with significant harm to the unborn child. Harms included a higher risk of congenital malformation, low birth weight and a potential increased risk of intellectual disability, autistic spectrum disorder and attention deficit hyperactivity disorder in children of mothers taking topiramate during pregnancy. |
MHRA: Topiramate (Topamax): introduction of new safety measures, including a Pregnancy Prevention Programme MHRA: Topiramate (Topamax): start of safety review triggered by a study reporting an increased risk of neurodevelopmental disabilities in children with prenatal exposure |
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