Available EU DMF/CEP
API Status
Therapeutic Category
Alimentary tract & metabolism
Anti-infectives for systemic use
Antipyretic, analgesic and anti-inflammatory
Antineoplastic & immunomodulating agents
Blood & blood forming organs
Cardiovascular system
Genito-urinary system & sex hormones
Injectable forms
Musculo-skeletal system
Nervous system
Opthalmological preparations
Respiratory system
Available US DMF
Additional DMF
Japanese DMF
Chinese DMF
Korean DMF
Injectable Forms




Reference product


Polymorphic form

Orthorhombic structure

Therapeutic Area

Nervous system



EU DMF readiness

US DMF readiness


Other documentation

Korean DMF

Drug description:

Topiramate is a dioxolopyrans derivative acts as an anticonvulsant agent.
Topiramate is indicated for monotherapy in adults, adolescents and children over 6 years of age with partial seizures with or without secondary generalized seizures, and primary generalized tonic-clonic seizures. Topiramate is indicated for adjunctive therapy in children aged 2 years and above, adolescents and adults with partial onset seizures with or without secondary generalization or primary generalized tonic-clonic seizures and for the treatment of seizures associated with Lennox-Gastaut syndrome. Topiramate is indicated in adults for the prophylaxis of migraine headache after careful evaluation of possible alternative treatment options.
It is formulated as tablets for oral route of administration.

Mechanism of action:

Topiramate blocks the action potentials elicited repetitively by a sustained depolarization of the neurons in a time-dependent manner, suggesting a state-dependent sodium channel (voltage dependent sodium channel) blocking action. Topiramate increased the frequency at which GABA-activated chloride channels (GABAA receptors) and enhances the ability of GABA to induce a flux of chloride ions into neurons, suggesting that topiramate potentiates the activity of this inhibitory neurotransmitter.
Topiramate antagonizes the ability of kainate to activate the kainate/AMPA subtype of excitatory amino acid (glutamate) receptor, but had no apparent effect on the activity of N-methyl-D-aspartate (NMDA) at the NMDA receptor subtype and it also inhibits the carbonic anhydrase enzyme, particularly isozymes II and IV.

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