Description

Nitrofurantoin (Macrocrystals / Monohydrate) Capsules & Tablets (50 mg / 100 mg)

Healthy Inc is a specialized global supplier and exporter of advanced urological, anti-infective, and antimicrobial-resistance (AMR) compliant therapeutics. We provide ultra-high-purity, kinetically optimized Nitrofurantoin Macrocrystalline / Monohydrate Hard Gelatin Capsules & Tablets (50 mg / 100 mg), manufactured in WHO–GMP certified, high-precision modified-release oral solid dosage facilities. This “Bladder-Specific Antibacterial” is a massive-volume, highly lucrative export to urology centers, gynecology networks, urgent care clinics, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated, first-line intervention for Acute Uncomplicated Cystitis (UTIs) and long-term urinary tract infection prophylaxis.

Product Overview

This highly advanced formulation utilizes a highly targeted nitrofuran derivative that bypasses systemic circulation and drops an overwhelming, multi-pathway antimicrobial “bomb” directly into the infected urine, eradicating resistant pathogens without destroying the patient’s gut microbiome.

The “Multi-Targeted UTI Eradicator” Specialist:

• Mechanism 1 (The Four-Pronged Bacterial Attack): Once Nitrofurantoin concentrates in the urine, bacterial enzymes (flavoproteins) mistakenly ingest and reduce the drug. This converts the Nitrofurantoin into highly reactive, toxic intermediates. These intermediates violently and simultaneously attack the bacteria’s ribosomal proteins, DNA, RNA, and vital metabolic enzymes. Because it destroys multiple targets at once, it is virtually impossible for E. coli or Staphylococcus saprophyticus to mutate fast enough to develop resistance.
• Mechanism 2 (The Bladder-Specific Sanctuary): Broad-spectrum antibiotics (like Levofloxacin) flood the entire body, killing healthy gut bacteria and causing severe diarrhea or yeast infections. Nitrofurantoin is rapidly filtered out of the blood by the kidneys. It achieves lethal, incredibly high concentrations specifically in the urine and bladder wall, making it a highly localized “sniper” therapy that protects the rest of the body from collateral damage.
• Mechanism 3 (Macrocrystalline & Monohydrate Synergy – CRITICAL): Older, microcrystalline versions of this drug dissolve immediately in the stomach, causing severe nausea and requiring dosing four times a day. Our advanced formulation utilizes large, slowly dissolving Macrocrystals combined with a sustained-release Monohydrate gel matrix. This completely shields the stomach lining and extends the absorption window, allowing for a highly tolerable, convenient twice-daily (BID) dosing regimen.

Product Composition & Strength

We supply this product as a Precision-Engineered Dual-Release Capsule or Tablet, packed exclusively in highly secure, moisture-resistant Alu-PVC or Alu-Alu blister strips to ensure the absolute chemical stability of the nitrofuran compounds.

*Pack Sizes: 10×10 Blisters or Bottles of 100 (Optimized specifically for strict 5-to-7 day acute urology dispensing 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 Control & Polymeric Matrix Engineering: The efficacy and tolerability of Nitrofurantoin are entirely dependent on API particle size. If the crystals are too small, toxicity spikes; if too large, the drug isn’t absorbed. Our facilities utilize advanced laser-diffraction particle size analyzers to guarantee the exact micronization profile of the Macrocrystals. This is perfectly blended with Carbomer polymers to create the Monohydrate sustained-release fraction, ensuring a flawless pharmacokinetic curve that peaks exactly where it needs to—in the bladder.

Therapeutic Indications (Human Use)

Indicated for the targeted, bladder-specific eradication of severe urinary tract pathogens:

• Acute Uncomplicated Cystitis: First-line treatment of acute lower urinary tract infections caused by susceptible strains of E. coli, Staphylococcus saprophyticus, and Enterococcus faecalis.
• UTI Prophylaxis: Long-term, low-dose suppression therapy to prevent highly recurrent urinary tract infections.
• Note: Not indicated for the treatment of pyelonephritis (kidney infections) or deep tissue abscesses, as the drug does not achieve effective concentrations in systemic tissues.

Dosage & Administration

Recommended Dosage (Strictly as per Urologist Guidelines):

• Acute Uncomplicated Cystitis: 100 mg (Dual-Release) taken orally twice daily (every 12 hours) for 5 to 7 days.
• Prophylaxis: 50 mg to 100 mg taken once daily at bedtime.
• Administration (THE FOOD RULE – CRITICAL): Tablets/Capsules MUST be taken with food or milk. Taking the drug with food massively increases its absorption (bioavailability) and almost entirely eliminates the risk of severe gastric irritation and nausea.
• The Discoloration Warning: Patients must be explicitly warned that this medication will turn their urine a dark yellow, rust, or brown color. This is completely harmless and simply the color of the metabolized dye.

Safety Warnings (CRITICAL Regulatory & Clinical Data):

• Renal Impairment (Absolute Contraindication): Nitrofurantoin must be filtered by the kidneys to reach the bladder. In patients with significant renal impairment (Creatinine Clearance < 60 mL/min or < 30 mL/min depending on specific regional guidelines), the drug cannot reach the urine and instead builds up to toxic levels in the blood. It is strictly contraindicated in these patients.
• Severe Pulmonary Toxicity: Rare but potentially fatal acute, subacute, or chronic pulmonary reactions (pulmonary fibrosis/pneumonitis) have been observed, especially in patients on long-term prophylactic therapy for over 6 months. Patients must report sudden cough, chest pain, or severe shortness of breath immediately.
• Peripheral Neuropathy: Can cause severe, irreversible damage to the peripheral nerves (numbness/tingling in hands and feet), particularly in diabetic or renally impaired patients.
• Late Pregnancy / Neonatal Risk: Contraindicated in pregnant patients at term (38-42 weeks) and in infants under 1 month of age due to the risk of triggering hemolytic anemia in the newborn.

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and Urology Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Anti-Infective and Modified-Release Formulations. Whether you are looking for a reliable Government Tender Supplier for primary care 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.