Healthy Inc > Blog > Nalidixic Acid BP/USP/IP
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What is the brand name of nalidixic acid?

In the pharmaceutical industry, Nalidixic Acid is recognized as the first synthetic quinolone antibiotic. As a pharmacist and manufacturer, I view this as a legacy anti-infective primarily used for Gram-negative urinary tract infections (UTIs) and, in certain markets, for diarrhea and dysentery.

At your WHO-GMP facility in Mumbai, where you focus on both domestic and export markets, understanding the diverse global branding of this molecule is essential for your B2B marketplace and digital promotion.

Major Brand Names

While the innovator brand is NegGram, Nalidixic Acid is sold under many names worldwide and across India:

MarketBrand Name(s)
Global / InnovatorNegGram (USA/Canada), Nevigramon, Wintomylon
India (Leading Brands)Gramoneg, Negadix, Dix, Nadix Acutab, Ulix-250, Nal-P
India (Combinations)Gramoneg M, Negadix M, Maxogyl, Abdogyl N (often with Metronidazole)

Clinical Indications

  • Urinary Tract Infections (UTIs): Specifically those caused by susceptible Gram-negative bacteria such as E. coli, Enterobacter, Klebsiella, and Proteus.

  • Diarrhea and Dysentery: Often formulated as an FDC with Metronidazole for more complete coverage of intestinal pathogens.

Mechanism: DNA Gyrase Inhibition

Targeting Enzymes: It acts as a selective inhibitor of the A subunit of bacterial DNA gyrase (topoisomerase II) and topoisomerase IV.

Replication Block: By inhibiting these enzymes, it prevents the uncoiling of supercoiled DNA, effectively stopping bacterial cell division and repair.

Bactericidal Action: This interference leads to rapid cell death in sensitive Gram-negative microorganisms.

The Pharmacist’s “Technical Warning”

  • Photosensitivity: Patients must be warned about increased sensitivity to sunlight; it can cause severe skin blistering.

  • CNS Side Effects: It can occasionally cause dizziness, drowsiness, or visual disturbances.

  • Empty Stomach: For optimal absorption, it is best taken 1 hour before or 2 hours after a meal.

  • G6PD Deficiency: It should be used with extreme caution in patients with G6PD deficiency due to the risk of hemolytic anemia.

The Manufacturer’s Perspective: Technical & Export

From a production and B2B standpoint at your facility in Mumbai:

  • The “FDC” Strategy: On your multivendor marketplace, position the Nalidixic Acid + Metronidazole combination as a high-volume essential for treating mixed infections in emerging markets.

  • Stability for Export: Nalidixic Acid is a stable, white to beige crystalline powder with a melting point around 227–229°C. For Zone IVb tropical regions, utilizing Alu-Alu blister packaging is critical for maintaining a 36-month shelf life.

  • Regulatory Compliance: As an older quinolone, ensure your dossiers highlight its specific efficacy against Gram-negative species while noting its resistance profile (e.g., Pseudomonas is generally resistant).

  • Dossier Support: We provide full CTD/eCTD Dossiers to support your firm’s registration in international tenders.

Nalidixic Acid Tablets

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What is Nalidixic Acid 500mg used for?

In the pharmaceutical industry, Nalidixic Acid 500 mg is recognized as the first of the quinolone class of antibiotics. As a pharmacist and manufacturer, I view Nalidixic Acid as a “urinary antiseptic.” While it has largely been superseded by newer fluoroquinolones (like Ciprofloxacin) in urban centers, it remains a vital, cost-effective treatment in international markets for specific bacterial infections.

Primary Clinical Uses

  • Urinary Tract Infections (UTIs): It is primarily indicated for the treatment of uncomplicated UTIs caused by Gram-negative bacteria, such as E. coli, Proteus, Klebsiella, and Enterobacter species.

  • Shigellosis (Bacillary Dysentery): Used in certain regions to treat intestinal infections caused by Shigella species, particularly where resistance to other antibiotics is a factor.

  • Gram-Negative Infections: Because it achieves high concentrations in the urine rather than the blood, its use is almost exclusively confined to the urinary tract.

Mechanism of Action: Inhibiting DNA Gyrase

Nalidixic Acid is a bactericidal agent that interferes with the bacterial reproductive cycle.

Targeting DNA Gyrase: It inhibits the A-subunit of the bacterial enzyme DNA gyrase (Topoisomerase II).

Supercoiling Interference: DNA gyrase is responsible for the negative supercoiling of DNA, which is essential for bacterial DNA replication and transcription.

DNA Fragmentation: By blocking this enzyme, Nalidixic Acid causes the DNA strands to break, leading to the rapid death of the bacterial cell.

The Manufacturer’s Perspective: Formulation & Export

From a manufacturing and global trade standpoint, Nalidixic Acid 500 mg requires specific technical attention:

  • Photosensitivity (Critical Warning): Nalidixic Acid is highly photosensitive. As a firm owner, you must ensure your Product Information Leaflet (PIL) warns patients to avoid excessive sunlight, as it can cause severe phototoxic reactions.

  • Packaging Requirements: At our WHO-GMP facility in Mumbai, we utilize Amber-colored PVC or Alu-Alu blister packaging to protect the 500 mg tablets from light degradation, ensuring a 36-month shelf life for export to Zone IVb regions.

  • Pediatric Considerations: While the 500 mg is for adults, the molecule is generally avoided in young children due to its potential effect on cartilage and the risk of increased intracranial pressure.

  • B2B & Dossier Support: This product is often requested for government tenders in emerging markets. We provide full CTD/eCTD Dossiers to support your firm in international registration and supply.

Nalidixic Acid Tablets

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