Description

Nitrofurantoin (Modified-Release) Tablets / Capsules

Healthy Inc is a specialized global supplier and exporter of advanced anti-infective, urological, and critical-care therapeutics. We provide ultra-high-purity, kinetically controlled Nitrofurantoin Sustained-Release Tablets & Capsules (100 mg), manufactured in WHO–GMP certified, high-precision oral solid dosage facilities. This “Urinary Tract Specific Bactericidal Agent” is a massive-volume, essential export to urology centers, outpatient clinics, women’s health NGOs, and government health ministries in LATAM, the Middle East, Africa, and Southeast Asia, serving as the globally mandated, first-line intervention for acute, uncomplicated lower Urinary Tract Infections (UTIs).

Product Overview

This formulation contains Nitrofurantoin, a unique nitrofuran antibacterial agent that concentrates exclusively in the urine, providing an overwhelming, localized strike against uropathogens while completely sparing the body’s normal systemic flora.

The “Resistance-Proof UTI Eradicator” Specialist:

• Mechanism (The Multi-Target DNA Strike): Unlike standard antibiotics that target a single bacterial pathway (like the cell wall or a specific enzyme), Nitrofurantoin works like a cluster bomb. Once inside the bacteria, bacterial enzymes (flavoproteins) accidentally activate the drug into highly toxic reactive intermediates. These intermediates simultaneously destroy the bacteria’s DNA, RNA, proteins, and metabolic enzymes. Because it attacks so many targets at once, bacteria find it almost impossible to develop resistance to Nitrofurantoin, even after decades of global use.
• The Modified-Release (Macrocrystal/Monohydrate) Advantage: Older, immediate-release microcrystalline Nitrofurantoin dissolves too fast, causing severe, debilitating nausea and requiring patients to take a pill four times a day. Our advanced Modified-Release formulation perfectly blends Macrocrystals (slower absorption) with Nitrofurantoin Monohydrate (forms a slow-release gel matrix). This completely solves the nausea issue and allows for highly convenient twice-daily (BID) dosing, ensuring massive improvements in patient compliance.
• Strictly Localized Action: Nitrofurantoin is rapidly filtered out of the blood by the kidneys. It never achieves high levels in the systemic tissues, meaning it kills the UTI without destroying the good bacteria in the gut or vagina, drastically reducing the risk of secondary yeast infections or C. difficile diarrhea.

Product Composition & Strength

We supply this product as a Precision-Blended Modified-Release Tablet or Hard Gelatin Capsule, packed in highly secure, moisture-resistant Alu-Alu or Alu-PVC blister strips to ensure the stability of the active pharmaceutical ingredients.

*Pack Sizes: 10×10 or 10×14 Blisters (Optimized specifically for standard 5-to-7 day acute antibiotic regimens).

Technical & Logistics Specifications

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

Manufacturing Authority

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

• Particle Size & Matrix Engineering: The clinical efficacy and tolerability of Nitrofurantoin are entirely dependent on its physical structure. Our manufacturing utilizes advanced crystallization technologies to ensure the exact micrometric particle size for the Macrocrystal component. Simultaneously, the Monohydrate component is blended with advanced Carbomer polymers to create a hydrogel upon ingestion, validating a perfect, steady release of the antibacterial agent into the urinary tract without causing sudden gastric toxicity.

Therapeutic Indications (Human Use)

Indicated for the targeted eradication of susceptible uropathogens:

• Acute Uncomplicated Cystitis: First-line treatment of acute lower urinary tract infections caused by susceptible strains of E. coli, Enterococcus, Staphylococcus saprophyticus, and Klebsiella.
• CRITICAL LIMITATION: It is strictly NOT indicated for the treatment of Pyelonephritis (kidney infections) or systemic/bloodstream infections, as it does not achieve therapeutic concentrations in solid organ tissues or blood.

Dosage & Administration

Recommended Dosage (Strictly as per Physician Guidelines):

• Standard Adult Dosing (100mg MR): One 100 mg tablet/capsule taken every 12 hours (twice daily) for 5 to 7 days.
• Administration (THE FOOD REQUIREMENT): This medication MUST be taken with food or milk. Taking it with meals increases its absorption (bioavailability) by 40% and drastically reduces the incidence of severe nausea and vomiting.
• Swallowing Protocol: The tablet/capsule must be swallowed whole to preserve the modified-release profile.

Safety Warnings (CRITICAL Regulatory & Clinical Data):

• Pulmonary Toxicity (BLACK BOX EQUIVALENT): Acute, subacute, or chronic pulmonary toxicity (interstitial pneumonitis or pulmonary fibrosis) can occur, particularly in elderly patients on prolonged prophylactic therapy. Patients presenting with unexplained cough, shortness of breath, or fever must stop the drug immediately and undergo radiological investigation.
• Renal Impairment Contraindication: Nitrofurantoin is entirely dependent on kidney filtration to reach the bladder. It is strictly contraindicated in patients with significant renal impairment (creatinine clearance < 30 mL/min, and often avoided if < 60 mL/min depending on regional guidelines) because it will fail to reach the bladder (causing treatment failure) and accumulate in the blood (causing systemic toxicity).
• Peripheral Neuropathy: Can cause severe, sometimes irreversible peripheral neuropathy (numbness/tingling in the hands and feet).
• G6PD Deficiency & Late Pregnancy: Contraindicated in patients with G6PD deficiency and in pregnant women at term (38–42 weeks) due to the severe risk of hemolytic anemia in the patient or the newborn.
• Harmless Urine Discoloration: Patients must be counseled that Nitrofurantoin will harmlessly turn their urine dark yellow or brown.

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving the needs of 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 Antibacterial Formulations, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable NGO Tender Supplier for women’s health initiatives in Africa or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely delivery. We actively support Pharmaceutical Drop Shipping models and bulk indenting, ensuring that every Generic Medicine Wholesaler receives WHO-GMP certified products at competitive rates.