In the pharmaceutical industry, Phenobarbital 30 mg is a long-acting Barbiturate classified as an anticonvulsant and sedative-hypnotic. As a pharmacist and manufacturer, I view this 30 mg strength as a versatile “titration dose.” While it is an older generation medication, it remains a frontline, cost-effective essential medicine in global health, particularly for long-term seizure management.
Primary Clinical Uses
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Epilepsy Management: Used primarily for the control of generalized tonic-clonic (grand mal) and partial seizures. It is often the drug of choice in neonatal seizures.
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Status Epilepticus: Used as a secondary treatment to stop prolonged, acute seizures when first-line benzodiazepines fail.
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Sedation: Short-term treatment for anxiety or as a pre-operative sedative to calm patients before surgery.
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Insomnia: Occasionally used for the short-term treatment of sleep disorders, though this has largely been replaced by newer agents.
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Detoxification: Sometimes utilized in the management of withdrawal symptoms from other barbiturates or alcohol.
Mechanism of Action: GABA Potentiation
Phenobarbital works by depressing the central nervous system through a specific interaction with the inhibitory neurotransmitter system.
GABA-A Receptor Binding: It binds to a specific site on the GABA-A receptor complex in the brain.
Chloride Channel Modulation: Unlike benzodiazepines (which increase the frequency of channel opening), Phenobarbital increases the duration that the chloride channel remains open.
Hyperpolarization: The influx of chloride ions into the neuron makes the cell “hyperpolarized” (more negatively charged).
Inhibition: This raises the seizure threshold and reduces the excitability of the neurons, effectively “quieting” the electrical storm in the brain.
The Manufacturer’s Perspective: Technical & Export
From a production and B2B standpoint at your WHO-GMP facility in Mumbai, Phenobarbital 30 mg involves high-level regulatory and technical requirements:
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Controlled Substance Status: As a firm owner, you know that Phenobarbital is a Schedule IV Controlled Substance (under the 1971 Convention). For your export business, this requires specific Export/Import Permits (NDPS) and rigorous “Track and Trace” documentation.
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The “Titration” USP: The 30 mg strength is a critical selling point for your digital platform. It allows doctors to fine-tune dosages for pediatric patients or elderly patients with compromised hepatic function, where the standard 60 mg or 100 mg might be too potent.
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Enzyme Induction (The Interaction Challenge): Phenobarbital is a potent CYP450 enzyme inducer. It speeds up the metabolism of many other drugs (like warfarin or oral contraceptives). Including a Drug Interaction Matrix in your technical dossiers is a major value-add for your B2B clients.
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Stability & Packaging: Phenobarbital is stable but should be protected from light. We utilize Alu-Alu or Amber-colored PVC/PVDC blisters to ensure a 36-month shelf life for international tenders.