Description

Gabapentin Film-Coated Tablets (600 mg / 800 mg)

Healthy Inc is a specialized global supplier and exporter of advanced neurology, pain management, and high-dose CNS therapeutics. We provide ultra-high-purity, kinetically precise Gabapentin Film-Coated Tablets (600 mg / 800 mg), manufactured in WHO–GMP certified, high-compression oral solid dosage facilities. This “Alpha-2-Delta Ligand & Neuropathic Pain Anchor” is a massive-volume, highly critical export to neurology centers, diabetic care networks, pain management clinics, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated, opioid-sparing intervention for severe diabetic neuropathy, postherpetic neuralgia, and partial-onset seizures.

Product Overview

This highly advanced formulation operates as a highly specific electrical dampener for the central nervous system. Instead of numbing the entire brain like an opioid, it specifically targets hyperactive, “misfiring” damaged nerves, chemically blocking them from sending agonizing pain signals to the brain.

The “Voltage-Gated Channel Blocker & Opioid-Sparing” Specialist:

• Mechanism 1 (The Alpha-2-Delta Blockade): When nerves are damaged by high blood sugar (diabetes) or viruses (shingles), they begin to fire uncontrollably, causing severe burning and shooting pain. Gabapentin aggressively binds to the alpha-2-delta ($\alpha_2\delta$) subunit of voltage-gated calcium channels in the central nervous system. By blocking these channels, it instantly shuts down the influx of calcium into the nerve terminal.
• Mechanism 2 (The Excitatory Neurotransmitter Halt): Without calcium entering the nerve, the neuron physically cannot release excitatory neurotransmitters like glutamate, substance P, and norepinephrine. By choking off this chemical supply line, Gabapentin silences the hyperactive nerve, providing profound relief from chronic neuropathic pain without causing respiratory depression.
• The “Non-GABA” Paradox (CLINICAL CLARIFICATION): Despite its name being derived from gamma-aminobutyric acid (GABA), and despite its structural similarity, Gabapentin does not bind to GABA receptors, nor does it inhibit GABA uptake or degradation. Its entire clinical efficacy relies purely on the calcium channel blockade.

Product Composition & Strength

We supply this product as a Precision-Blended, High-Density Macrodose Tablet, packed exclusively in highly secure, moisture-resistant Alu-PVC or Alu-Alu blister strips to ensure the absolute physical stability of the heavily compressed active pharmaceutical ingredient.

*Pack Sizes: 10×10 Blisters or Bottles of 100 (Optimized specifically for chronic, high-volume daily dispensing regimens).

Technical & Logistics Specifications

Critical data for Pharmaceutical Importers, Neurology Distributors, and Hospital Procurement Boards.

Manufacturing Authority

Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.

• Macrodose Compression Engineering (CRITICAL COMPLIANCE): Gabapentin requires enormous dosing. A typical patient takes 1800 mg to 3600 mg a day. Manufacturing a single 800 mg tablet is a severe mechanical challenge; standard presses will produce a brittle tablet that chips in the blister or expands from humidity. Our neurology suites utilize elite Copovidone binders and high-tonnage rotary presses to create a deeply consolidated, rock-solid core. Finished with a heavy, slick film-coating, we guarantee a pharmaceutical-grade caplet that geriatric patients can swallow safely and easily.

Therapeutic Indications (Human Use)

Indicated for the targeted, highly specialized management of severe neurological dysfunction:

• Neuropathic Pain: Management of postherpetic neuralgia (pain following shingles) and peripheral diabetic neuropathy in adults.
• Epilepsy: Adjunctive therapy in the treatment of partial-onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older.
• Restless Legs Syndrome (Off-Label / Specialized Formulation): Management of moderate-to-severe primary Restless Legs Syndrome.

Dosage & Administration

Recommended Dosage (Strictly as per Neurologist Guidelines):

• The Titration Protocol: Gabapentin must be titrated slowly to avoid severe dizziness and sedation. A typical starting dose is 300 mg once daily, escalating over days to 600 mg or 800 mg three times daily (Maximum 3600 mg/day).
• Renal Clearance Rule (CRITICAL): Gabapentin is not metabolized by the liver; it is excreted 100% unchanged by the kidneys. If a patient has renal impairment, the dose must be drastically reduced to prevent toxic drug accumulation and severe neurological depression.
• Administration: Can be taken with or without food. Tablets should be swallowed whole with plenty of water.

Safety Warnings (CRITICAL Regulatory & Clinical Data):

• Fatal Respiratory Depression (FDA Warning): When Gabapentin is co-administered with CNS depressants (specifically Opioids like Tramadol or Oxycodone), or used in patients with severe respiratory conditions (like COPD), it can trigger profound, fatal respiratory depression.
• Withdrawal Seizures (The Tapering Mandate): Abruptly stopping Gabapentin can trigger status epilepticus (continuous, life-threatening seizures) and severe withdrawal symptoms (anxiety, sweating, tachycardia). The drug must be tapered off slowly over a minimum of one week.
• Suicidal Behavior and Ideation: Like all antiepileptic drugs (AEDs), Gabapentin increases the risk of suicidal thoughts or behavior. Psychiatric monitoring is required.
• Severe Somnolence & Dizziness: Patients must be explicitly warned not to drive or operate heavy machinery until they know how the drug affects them, as extreme drowsiness is the most common side effect.

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and Neurology Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Anticonvulsants, Neuropathic Pain Modulators, and Macrodose Compression Formulations. Whether you are looking for a reliable Government Tender Supplier for diabetic clinics in the CIS or a B2B Pharma Marketplace partner for Latin America, our highly regulated logistics network ensures timely, secure delivery of WHO-GMP certified products.