Description

Nalidixic Acid Tablets (500mg)

Manufactured by: Healthy Life Pharma Pvt. Ltd. (WHO-GMP Certified)

Exported by: Healthy Inc (Star Export House)

1. Product Introduction

Healthy Life Pharma Pvt. Ltd. is a specialized Manufacturer of Nalidixic Acid Tablets in India. Nalidixic Acid is a First-Generation Quinolone Antibiotic primarily used for the treatment of uncomplicated Urinary Tract Infections (UTIs) caused by Gram-negative bacteria like E. coli, Proteus, and Klebsiella. While newer antibiotics exist, Nalidixic Acid remains a cost-effective and valuable option in specific formulary segments and for treating Shigellosis in some regions.

We offer Contract Manufacturing (Third Party) services for this legacy anti-infective. Nalidixic Acid is hydrophobic (poorly soluble) and sensitive to light. Our WHO-GMP certified facility in Mumbai utilizes advanced Micronization and Wet Granulation processes to ensure rapid disintegration and dissolution. We apply specialized opaque film coatings to protect the drug from photodegradation. Healthy Inc manages the export logistics, supplying government tenders and pharmacy chains across Africa, Southeast Asia, and Latin America.

2. Product Specifications

3. Manufacturing Technology

Ensuring absorption and stability is critical.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Micronization: The API has low water solubility. We use micronized Nalidixic Acid to increase surface area, ensuring the tablet releases the drug effectively in the GI tract.

  • Photosensitivity Protection: Nalidixic Acid degrades when exposed to UV light. We process the batch under controlled lighting and use Titanium Dioxide-rich Film Coatings to provide a light barrier for the finished tablet.

  • Taste Masking: The drug is bitter. Our coating ensures patient compliance by preventing the bitter taste during swallowing.

• The Exporter: Healthy Inc

  • Tropicalized Packaging: We utilize Alu-PVC or Amber-PVC Blisters to protect the tablets from light and humidity during shipping to tropical climates.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution: We test release profiles to ensure >80% of the drug releases within 30 minutes.

• Assay: We confirm the potency is strictly within 90-110% of the label claim.

• Related Substances: We strictly monitor for degradation products to ensure safety over the 3-year shelf life.

5. Why Use Nalidixic Acid?

It concentrates in the urine to kill bacteria.

• Mechanism: It interferes with the enzyme DNA Polymerase, inhibiting bacterial DNA synthesis and replication. It is bacteriostatic at low concentrations and bactericidal at high concentrations (which it achieves in the urine).

• Key Indications:

  • Uncomplicated UTI: Cystitis caused by susceptible Gram-negative organisms.

  • Recurrent UTI: Prophylaxis (prevention) of recurrent infections.

  • Shigellosis: Bacterial dysentery (used in some protocols).

6. Export and Regulatory Support

We streamline the registration process for our B2B partners:

• Dossier Support: We offer CTD and ACTD Dossiers for quick registration.

• Certificates: Free Sale Certificate (FSC), COPP (WHO-GMP), and COA.

• Logistics: Efficient shipping via Air or Sea (FOB Mumbai / CIF).

7. Frequently Asked Questions

• Q: Who manufactures Nalidixic Acid Tablets?

  A: Healthy Life Pharma Pvt. Ltd. manufactures them in India.

• Q: Does it affect vision?

  A: Yes. A unique side effect of Nalidixic Acid is “visual disturbances,” such as seeing halos around lights, bright colors, or blurred vision. This usually resolves after stopping the drug.

• Q: Can I go out in the sun?

  A: Avoid it. Like other quinolones, it causes Photosensitivity. Patients can get severe sunburns quickly. Wear protective clothing or stay indoors.

• Q: Is it safe for infants?

  A: Caution. It is generally contraindicated in infants under 3 months due to the risk of intracranial hypertension (swelling in the brain).

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Adults: 1g (two 500mg tablets) four times daily for 1-2 weeks.

• Maintenance: 500mg four times daily.

• Administration: Take on an empty stomach (1 hour before meals) for best absorption. Drink plenty of water.

9. Side Effects and Precautions

• Visual: Halos, double vision, color perception changes.

• CNS: Dizziness, headache, drowsiness.

• Photosensitivity: Skin rash upon sun exposure.

• Hemolysis: Risk in patients with G6PD deficiency.

• Tendonitis: Rare risk of tendon damage (though less than newer fluoroquinolones).

10. Storage Instructions

• Store below 25°C in a dry place.

• Protect from light. (Keep in the carton/blister).