Pregabalin & Nortriptyline Tablets (50 mg / 10 mg & 75 mg / 10 mg)

Healthy Inc is a specialized global supplier and exporter of advanced neurology, diabetology, and central nervous system (CNS) therapeutics. We provide ultra-high-purity, kinetically synchronized Pregabalin & Nortriptyline Hydrochloride Film-Coated Tablets (50mg/10mg & 75mg/10mg), manufactured in WHO–GMP certified, high-precision oral solid dosage facilities under strict controlled-substance compliance. This “Dual-Pathway Neuromodulator” is a massive-volume, highly lucrative export to neurology centers, diabetic care clinics, chronic pain networks, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated intervention for refractory Neuropathic Pain, Post-Herpetic Neuralgia, and severe Sciatica.

Product Overview

This highly advanced Fixed-Dose Combination masterfully synchronizes two distinct classes of nerve-calming agents, delivering unparalleled 24-hour pain control by blocking excitatory pain signals at the spinal level while simultaneously boosting the brain’s natural pain-inhibiting pathways.

The “Dual-Pathway & Dose-Sparing” Specialist:

• Mechanism 1 (The Excitatory Blockade – Pregabalin): In severe neuropathy, damaged nerves misfire continuously, sending “shock-like” pain signals to the brain. Pregabalin directly binds to the alpha-2-delta subunit of voltage-gated calcium channels in the CNS, physically blocking the influx of calcium. This violently shuts down the release of excitatory pain neurotransmitters (like glutamate and substance P) right at the source.
• Mechanism 2 (The Descending Pain Inhibitor – Nortriptyline): While Pregabalin works from the bottom up, Nortriptyline works from the top down. As a secondary-amine Tricyclic Antidepressant (TCA), it aggressively inhibits the reuptake of Serotonin and Norepinephrine in the brain. This massive boost in neurotransmitters activates the “descending inhibitory pathways,” essentially telling the spinal cord to ignore incoming pain signals. Crucially, Nortriptyline is vastly superior to older TCAs like Amitriptyline because it causes significantly less sedation, dry mouth, and severe cardiovascular toxicity.
• The “Dose-Sparing” Advantage (CRITICAL CLINICAL BENEFIT): Using a massive dose of Pregabalin alone causes extreme dizziness and weight gain. Using a massive dose of a TCA alone causes severe cardiac issues and dry mouth. By combining them, physicians achieve superior pain relief using much smaller, highly tolerable doses of both drugs, drastically improving long-term patient compliance.

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.

• Precision Micro-Dose Geometric Blending: Manufacturing an FDC that incorporates a low 10 mg dose of a highly potent TCA (Nortriptyline) requires elite pharmaceutical engineering. Our facilities utilize advanced high-shear wet granulation and strict geometric dilution protocols. This is rigorously verified by high-frequency HPLC content uniformity testing to guarantee that the tiny Nortriptyline API is flawlessly and evenly distributed throughout every single tablet, preventing catastrophic localized over-dosing or severe cardiovascular toxicity.

Therapeutic Indications (Human Use)

Indicated for the comprehensive, multi-pathway management of severe nerve damage:

• Diabetic Peripheral Neuropathy (DPN): Treatment of refractory nerve pain and hyperalgesia in patients with long-standing diabetes who have failed monotherapy.
• Post-Herpetic Neuralgia (PHN): Management of severe, lingering nerve pain following a shingles (Herpes Zoster) outbreak.
• Chronic Sciatica & Lumbar Radiculopathy: Adjunctive management of severe nerve root compression pain.

Dosage & Administration

Recommended Dosage (Strictly as per Neurologist Guidelines):

• Standard Adult Dosing: One tablet taken orally once or twice daily, depending on symptom severity and patient tolerance.
• Administration (THE BEDTIME RULE): Because both Pregabalin and Nortriptyline cause significant CNS depression, sedation, and somnolence, the primary or total daily dose MUST be taken at bedtime. This leverages the sedating side effect to help patients sleep through the pain. Tablets must be swallowed whole with water.
• Discontinuation: This medication must never be stopped abruptly. Sudden withdrawal can cause severe insomnia, nausea, “electric shock” sensations, and rebound anxiety. It must be tapered over a minimum of two weeks.

Safety Warnings (CRITICAL Regulatory & Clinical Data):

• BLACK BOX WARNING (Suicidality – Nortriptyline): As an antidepressant, Nortriptyline increases the risk of suicidal thinking and behavior in children, adolescents, and young adults. Patients of all ages must be aggressively monitored for clinical worsening, suicidality, or unusual changes in behavior.
• Severe Cardiac Arrhythmias (TCA Toxicity): Nortriptyline can cause QT prolongation, heart block, and severe arrhythmias, particularly in patients with pre-existing cardiovascular disease or if overdosed. A baseline ECG is highly recommended for elderly patients before initiating therapy.
• Serotonin Syndrome: Concomitant use with other serotonergic drugs (SSRIs, SNRIs, MAOIs, Tramadol) can trigger fatal Serotonin Syndrome (hyperthermia, seizures, coma). A strict 14-day washout period is required if the patient was previously taking an MAO Inhibitor.
• Anticholinergic Toxidrome: Nortriptyline causes systemic drying. Extreme caution is required in patients with narrow-angle glaucoma or urinary retention (BPH).

Global Export & Contract Manufacturing Services

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