Description

Nicotinic Acid (Niacin) Extended-Release Tablets (500 mg / 1000 mg)

Healthy Inc is a specialized global supplier and exporter of advanced cardiovascular, lipid-modifying, and metabolic therapeutics. We provide ultra-high-purity, kinetically stabilized Nicotinic Acid Extended-Release Film-Coated Tablets (500 mg / 1000 mg), manufactured in WHO–GMP certified, high-precision modified-release oral solid dosage facilities. This “Broad-Spectrum Lipid Modulator” is a massive-volume, highly lucrative export to cardiology centers, specialized metabolic clinics, retail pharmacy networks, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally trusted intervention for severe mixed dyslipidemia, hypertriglyceridemia, and clinical Pellagra.

Product Overview

This highly advanced formulation contains Nicotinic Acid (Vitamin B3), administered at pharmacological mega-doses to fundamentally alter the liver’s lipid-producing machinery, forcefully driving down toxic fats while boosting the body’s natural cardiovascular defense systems.

The “HDL-Raising & Triglyceride Crashing” Specialist:

• Mechanism 1 (The VLDL/LDL Blockade): Nicotinic Acid aggressively targets the liver, severely inhibiting the release of free fatty acids from adipose (fat) tissue and directly blocking the liver’s synthesis of Very-Low-Density Lipoprotein (VLDL). Because VLDL is the precursor to LDL (“bad” cholesterol), crashing VLDL levels forces a massive, downstream reduction in circulating LDL and total triglycerides.
• Mechanism 2 (The Unmatched HDL Surge): While statins barely move the needle on HDL (“good” cholesterol), Nicotinic Acid decreases the clearance of ApoA-1 (the primary protein in HDL). This forces HDL levels to surge by up to 35%, actively pulling cholesterol out of the arterial walls and returning it to the liver for destruction, physically reversing early-stage atherosclerosis.
• The Extended-Release “Anti-Flush” Advantage (CRITICAL): Standard, immediate-release Niacin causes a massive spike in prostaglandins, triggering severe, burning cutaneous vasodilation (the “Flush”). Our advanced Extended-Release (ER) formulation paces the absorption perfectly over 8 to 12 hours. This drastically blunts the prostaglandin spike, providing a highly tolerable therapy that ensures long-term patient compliance while completely avoiding the severe liver toxicity associated with older, 24-hour “sustained-release” generics.

Product Composition & Strength

We supply this product as a Precision-Blended, Hydrophilic Matrix Tablet, packed exclusively in highly secure, moisture-resistant Alu-PVC or Alu-Alu blister strips to ensure the absolute physical stability of the extended-release polymer.

*Pack Sizes: 10×10 Blisters or Bottles of 100 (Optimized specifically for strict chronic cardiology dispensing regimens).

Technical & Logistics Specifications

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

Manufacturing Authority

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

• Hydrophilic Polymer Matrix Engineering (CRITICAL COMPLIANCE): The clinical safety of Niacin is entirely dependent on its release rate. If it releases too fast (IR), it causes severe flushing; if it releases too slowly (over 24 hours), the liver cannot clear it, leading to fatal hepatotoxicity. Our facilities utilize advanced high-shear granulation to embed the Nicotinic Acid into a precise Hypromellose (HPMC) polymer matrix. This guarantees the exact 8-to-12 hour pharmacokinetic “sweet spot,” delivering maximum lipid-modifying efficacy while ensuring absolute hepatic safety.

Therapeutic Indications (Human Use)

Indicated for the comprehensive management of severe lipid disorders and nutritional deficiencies:

• Mixed Dyslipidemia: To reduce elevated TC, LDL-C, Apo B, and TG levels, and to massively increase HDL-C in patients with primary hyperlipidemia.
• Severe Hypertriglyceridemia: To drastically lower toxic triglyceride levels in adult patients at high risk of acute pancreatitis.
• Secondary Prevention of Cardiovascular Events: Used in combination with a statin to slow the progression or promote the regression of atherosclerotic disease.
• Pellagra: Treatment of severe Vitamin B3 deficiency (characterized by dermatitis, diarrhea, and dementia).

Dosage & Administration

Recommended Dosage (Strictly as per Cardiologist Guidelines):

• Maintenance Dosing: Typically 1000 mg to 2000 mg once daily.
• Administration (THE BEDTIME RULE): Extended-Release tablets MUST be taken at bedtime, after a low-fat snack. Taking it while sleeping helps the patient sleep through any mild residual flushing.
• The Intact Rule: Tablets must be swallowed completely whole. Breaking, crushing, or chewing the tablet destroys the polymer matrix, dumping the entire mega-dose into the bloodstream instantly and causing violent flushing and potential liver injury.
• Aspirin Premedication: Physicians frequently recommend taking a 325 mg Aspirin 30 minutes before the Niacin dose to block the prostaglandins that cause the flush.

Safety Warnings (CRITICAL Regulatory & Clinical Data):

• BLACK BOX WARNING / CRITICAL ALERT (Fatal Hepatotoxicity): Cases of severe hepatic toxicity, including fulminant liver necrosis, have occurred. Patients must never substitute Immediate-Release Niacin for Extended-Release Niacin at the same dose. Liver transaminases (AST/ALT) must be strictly monitored during therapy.
• Diabetic Glycemic Worsening: Mega-dose Niacin causes insulin resistance. Diabetic patients will frequently see a severe spike in their fasting blood glucose and HbA1c levels, requiring immediate adjustment of their diabetic medications.
• Active Peptic Ulcer Disease: Strictly contraindicated in patients with active peptic ulcers, as Niacin stimulates massive histamine release, aggravating severe gastric bleeding.
• Hyperuricemia & Acute Gout: Niacin competes with uric acid for excretion in the kidneys. It can cause massive spikes in blood uric acid levels, triggering agonizing, acute gout attacks in susceptible patients.

Global Export & Contract Manufacturing Services

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