Composition: Each tablet contains Nalidixic Acid IP 500 mg
Dosage form: Tablet (coating not specified in supplied composition)
Usage: Selected susceptible bacterial urinary tract infections, subject to local approval and resistance testing
Category: Antibiotic Drugs
Therapeutic category: First-generation quinolone antibacterial
SKU: Nalidixic Acid Tablets
Categories: Pharmaceutical Exporter India, Pharmaceutical Formulations India, WHO GMP Certified Formulations
Nalidixic Acid Tablets is listed in our pharmaceutical product portfolio for business-to-business enquiries. Product-specific formulation details, available strengths, dosage form, pack configuration and supply terms should be confirmed against the current product specification before ordering.
For distributor, wholesaler, hospital procurement and export enquiries, please request the applicable product specifications, batch documentation, shelf-life information, packaging options and regulatory documents. Availability and documentation depend on the product and destination market.
Manufacturer: Healthy Life Pharma Pvt. Ltd. (WHO-GMP status requires verification)
Exporter: Healthy Inc (Star Export House status requires verification)
Nalidixic acid is an older, first-generation quinolone antibacterial agent with activity against some susceptible Gram-negative organisms. It has historically been used for certain urinary tract infections. Because bacterial resistance, availability and regulatory status vary by market, it should not be described as a preferred first-line treatment for all UTIs or other infections.
The supplied product composition confirms Nalidixic Acid IP 500 mg per tablet. The manufacturing process, coating, commercial pack configuration and registered indications should be verified from approved documentation.
| Product name | Nalidixic Acid Tablets |
|---|---|
| Active ingredient | Nalidixic Acid IP 500 mg per tablet |
| Strength | 500 mg |
| Dosage form | Tablet; coating not specified in supplied formula |
| Pharmacopoeial standard | IP (per supplied composition); USP/BP claims require verification |
| CAS number | 389-08-2 |
| Therapeutic class | Quinolone antibacterial |
| SKU | Nalidixic Acid Tablets |
| Shelf life / packaging | Confirm from approved product label and stability data |
Composition note: The submitted formula does not establish that the marketed tablet is film-coated, capsule-shaped or white/yellow.
Manufacture of nalidixic acid tablets requires validated control of raw-material identity, particle-size distribution where relevant, mixing, compression, dissolution and packaging. Light and moisture protection must be selected based on product-specific stability studies. Claims of micronization, wet granulation, opaque film coating and specific blister materials need documentary confirmation.
Release testing should follow the registered IP monograph and approved specifications, including identification, assay, uniformity, dissolution, related substances and stability as applicable. Fixed assay limits, dissolution percentages and a 36-month shelf life cannot be asserted without validated product-specific records.
Nalidixic acid inhibits bacterial DNA gyrase (topoisomerase II), disrupting bacterial DNA replication. Historically it was used for selected uncomplicated lower urinary tract infections caused by susceptible Gram-negative bacteria. Culture and susceptibility results, current local resistance patterns and prescribing guidelines are important; it is not a general treatment for every bacterial infection.
Limitations: Do not advertise routine recurrent-UTI prophylaxis or shigellosis treatment without an approved indication and contemporary susceptibility guidance. Many markets have restricted or discontinued use of older quinolones.
Destination-country approval, manufacturing licenses, current registration status, pharmacovigilance obligations and any restrictions on nalidixic acid must be checked before marketing or export. CTD/ACTD dossiers, COA, COPP, FSC, WHO-GMP certification and exporter recognition should be listed as available only after documentary verification.
Q: What is the tablet strength?
A: The supplied formulation contains Nalidixic Acid IP 500 mg per tablet.
Q: Is it appropriate for every UTI?
A: No. Treatment depends on organism susceptibility, local resistance patterns and approved indications.
Q: Can it affect eyesight or sun sensitivity?
A: Visual disturbances and photosensitivity have been reported. Seek medical advice if these occur.
Q: Can children take it?
A: Pediatric use is subject to strict age-related restrictions and local product labeling; do not administer without specialist guidance.
Use only under a qualified prescriber's direction. Dose, frequency, duration and renal-function adjustments depend on the local approved label, patient factors and infection susceptibility. The historical adult dosing regimen supplied in promotional copy should not be treated as universal current prescribing advice. Follow instructions regarding meals and interactions with mineral-containing antacids or supplements as stated in the approved label.
Potential adverse effects include nausea, abdominal discomfort, headache, dizziness, photosensitivity and visual disturbances. Serious neurological effects, including seizures or raised intracranial pressure, have been reported; use in infants and certain other populations may be contraindicated. Hemolysis can occur in people with G6PD deficiency. Review contraindications, kidney function, pregnancy/breastfeeding status, seizure history and relevant drug interactions before prescribing. Seek urgent care for severe rash, neurological symptoms or visual changes.
Store in the original packaging, protected from light and moisture, according to the temperature stated on the approved label. Keep away from children. Do not assume a universal below-25°C requirement or a 36-month shelf life without registered stability data.