In the pharmaceutical industry, Clobazam 10 mg is a unique 1,5-benzodiazepine that stands out from more common 1,4-benzodiazepines (like Diazepam) due to its specialized profile. As a pharmacist, I characterize Clobazam as an essential adjunctive anticonvulsant that offers a favorable balance between seizure control and sedation.
Primary Clinical Uses
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Lennox-Gastaut Syndrome (LGS): Used as a secondary or adjunctive treatment for seizures associated with this severe form of childhood-onset epilepsy.
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Refractory Epilepsy: Indicated for patients whose seizures are not adequately controlled by primary anti-epileptic drugs (AEDs).
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Anxiety Disorders: While its primary use is neurological, it is prescribed for the short-term management of severe anxiety, particularly when a less sedating benzodiazepine is preferred.
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Catamenial Epilepsy: Sometimes used for the short-term prevention of seizures that occur in a predictable pattern related to the menstrual cycle.
Mechanism of Action
Clobazam acts as a selective agonist at the receptor. It enhances the inhibitory effect of gamma-aminobutyric acid (GABA), the brain’s primary inhibitory neurotransmitter.
By binding to the benzodiazepine site on the GABA receptor, Clobazam increases the frequency of chloride channel opening. This leads to hyperpolarization of the neuron, making it less likely to fire and thereby raising the seizure threshold. Because of its 1,5-substitution, it typically causes fewer psychomotor side effects and less daytime sleepiness than traditional benzodiazepines.
The Manufacturer’s Perspective: Formulation & Export
From a manufacturing and global trade standpoint, Clobazam is a high-precision CNS (Central Nervous System) molecule:
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Controlled Substance Management: As a WHO-GMP manufacturer, we maintain strict adherence to international narcotics and psychotropic conventions. Exporting Clobazam requires specific import/export permits and rigorous chain-of-custody documentation.
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Dose Uniformity: Because it is a potent 10 mg tablet, we utilize validated wet granulation and blending protocols to ensure absolute content uniformity, preventing the risk of “seizure breakthrough” or “over-sedation” due to batch variation.
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Stability for Global Trade: Clobazam is stable, but we prioritize Alu-Alu or high-grade PVC/PVDC blister packaging to ensure a 36-month shelf life for export to Zone IVb regions (Africa, Middle East, and Southeast Asia).
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Regulatory Dossiers: Our Mumbai hub provides comprehensive CTD/eCTD Dossiers and bioequivalence data to support our international B2B partners in registering this specialized AED.