Phenobarbital (Phenobarbitone) Tablets – Manufacturer & Exporter India

1. Product Introduction

Phenobarbital, also called phenobarbitone, is a long-acting barbiturate anticonvulsant used for the management of certain seizure disorders under medical supervision. Its use is governed by local prescribing guidance, product approvals and controlled-substance requirements. It is not an antihypertensive medicine.

Healthy Life Pharma Pvt. Ltd. is identified as the manufacturer and Healthy Inc as the exporter in the supplied company material. Product-specific manufacturing authorization, controlled-drug permissions and certifications require documentary verification.

2. Product Specifications

Dosage form: Uncoated tablet. CAS: 50-06-6. Therapeutic class: Barbiturate anticonvulsant. SKU: Phenobarbital Tablets. Packaging and shelf life require confirmation against approved records.

3. Manufacturing Technology

Controlled-medicine manufacture requires appropriate licenses, restricted access, secure storage, material reconciliation, traceability, validated processing and documented release controls. Content uniformity and consistent tablet performance are important across the stated strengths.

Claims of automated reconciliation, specific blending systems, dedicated vaults or particular tablet equipment must be substantiated by site-specific records and current authorizations. No particular manufacturing technique is asserted as verified here.

4. Quality Assurance

Product release should follow the approved pharmacopoeial and registered specifications, including identity, assay, dosage-unit uniformity, dissolution or disintegration where applicable, related substances, stability and packaging controls. The stated numerical dissolution and assay limits are not confirmed and should not be published as fixed criteria without approved specifications.

Controlled-drug inventory records, batch reconciliation and distribution documentation should meet applicable law.

5. Therapeutic Information

Phenobarbital enhances inhibitory GABA-A receptor signaling and is used in selected seizure disorders. Choice of treatment depends on seizure type, age, other medicines and local clinical guidance. It may cause sedation, cognitive effects and physical dependence.

Management of status epilepticus is an emergency requiring monitored medical treatment; an oral tablet product must not be advertised as an immediate treatment for ongoing prolonged seizures. The suitability of phenobarbital as first-line therapy varies by clinical setting.

6. Export and Regulatory Support

Phenobarbital is subject to controlled-substance requirements in many jurisdictions. Any manufacturing, stocking, import, export or supply arrangement must be supported by the required licenses, permits, quotas, records and destination-country approvals.

Enquire about registration documentation, approved packaging, batch records, certificates and country-specific authorization requirements. WHO-GMP status, Star Export House status, CTD/ACTD, COPP, COA and controlled-drug licenses must be independently verified before commercial claims are made.

7. Frequently Asked Questions

Are phenobarbital and phenobarbitone different? They are alternative names for the same active substance; the naming convention varies by pharmacopoeia and market.

What strengths are listed? IP 30 mg and 60 mg; BP 30 mg, 60 mg, 90 mg and 100 mg, all as uncoated tablets in the supplied compositions.

Can treatment be stopped suddenly? No. Abrupt withdrawal can provoke serious or life-threatening seizures; any change must be supervised by a clinician.

Is this a controlled medicine? It is regulated as a barbiturate/psychotropic medicine in many jurisdictions; local rules and permits apply.

8. Dosage and Administration

Prescription-only use under a qualified clinician. Dosing is individualized by indication, age, clinical response, co-medications, organ function and, where appropriate, serum drug levels. The draft adult and pediatric dose ranges are not suitable as universal directions for these products.

Do not crush, split or change the prescribed regimen without professional advice. Do not stop abruptly; any discontinuation requires an individualized taper and monitoring.

9. Side Effects and Precautions

Important risks: drowsiness, impaired coordination, cognitive or behavioral changes, respiratory depression, dependence and potentially severe withdrawal. Alcohol, opioids and other sedatives can markedly increase dangerous CNS and breathing suppression. Serious skin reactions, including Stevens–Johnson syndrome, require urgent medical attention.

Phenobarbital has numerous drug interactions through hepatic enzyme induction, including interactions that may reduce the effectiveness of hormonal contraception and other therapies. Pregnancy exposure can harm the fetus, but uncontrolled seizures also pose risks: patients must consult their epilepsy specialist and must not stop medication independently. Avoid driving when impaired.

10. Storage Instructions

Follow the approved product-specific label for temperature, light and moisture protection. Store securely in a locked, access-controlled area as required by applicable controlled-drug law, and keep away from children and unauthorized persons. The proposed below-25°C limit and 36-month shelf life require confirmation from approved stability and labeling records.