Registered Malawi · PMRA

NALIGYL 250MG 250MG TABLET

NALIDIXIC ACID

PMPB/PL359/49 TABLET

What it does

Nalidixic acid is an antibiotic used to treat certain infections caused by bacteria.

Commonly used for: urinary tract infections, bacterial infections

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
PMPB/PL359/49
Registration date
13/09/2018
Expiry date
30/06/2019
Status
Registered
Active ingredient
NALIDIXIC ACID
Dosage form
TABLET
Strength
-
Pack size
-
Therapeutic class
-
Manufacturer / MAH
-
Applicant / LTR
-
Country of origin
-

Source: Pharmacy and Medicines Regulatory Authority · fetched 2026-04-21 17:37:41 · updated 2026-09-19 04:30:23

Disclaimer: This information is sourced from Pharmacy and Medicines Regulatory Authority (Malawi). Always consult a qualified healthcare professional before using any medication.

About this medicine

Nalidixic acid is an antibiotic used to treat certain infections caused by bacteria.

What it treats

  • urinary tract infections
  • bacterial infections

How it works

It works by stopping the growth of bacteria, helping the body to fight off the infection.

Who it's for

Nalidixic acid is prescribed for adults and sometimes for children to treat specific bacterial infections.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: nalidixic

BNF-referenced

Nalidixic acid is a synthetic antibacterial agent belonging to the quinolone class, primarily used for the treatment of urinary tract infections. It exhibits potent activity against a range of gram-negative bacteria and is administered orally. The drug is notable for its ability to remain effective across varying urinary pH levels.

Indications

  • Urinary tract infections
  • Cystitis
  • Pyelonephritis

Dosage

Children: Refer to BNF for Children for specific dosing recommendations for paediatric patients.

Adults: Refer to BNF for specific dosing recommendations. Generally, the dosage for adults may vary based on the infection severity and clinical response.

Mechanism of action

Nalidixic acid's active metabolite, hydroxynalidixic acid, binds reversibly to DNA, disrupting RNA synthesis, which in turn inhibits protein synthesis. This mechanism effectively interferes with bacterial DNA synthesis, leading to its bactericidal effects.

Pharmacodynamics

Nalidixic acid demonstrates significant antibacterial activity against gram-negative bacteria, including Enterobacter species, Escherichia coli, Morganella morganii, Proteus mirabilis, Proteus vulgaris, and Providencia rettgeri. It is generally less effective against Pseudomonas species, which are typically resistant. The drug shows a bactericidal action and is effective across the entire urinary pH range. Resistance can develop in a small percentage of patients during treatment, but this resistance is not transferable via R factor.

Pharmacokinetics

Nalidixic acid is rapidly absorbed from the gastrointestinal tract and reaches peak plasma concentrations within 1 to 2 hours post-administration. Its plasma half-life is approximately 1 to 2 hours. The drug is primarily excreted unchanged in the urine, allowing for high concentrations in the urinary tract, which is beneficial for treating urinary infections.

Adverse effects

  • Nausea
  • Vomiting
  • Diarrhea
  • Dizziness
  • Headache
  • Rash
  • Tendon damage

Precautions

  • Use with caution in patients with renal impairment
  • Monitor for signs of tendon damage
  • Caution in patients with a history of seizures

Pregnancy

The safety of nalidixic acid during pregnancy has not been established. It should be used only if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

Nalidixic acid is excreted in breast milk. Caution should be exercised when administered to nursing mothers.

Storage

Store in a cool, dry place away from light. Keep out of reach of children.

Formulations

  • Tablets
  • Oral suspension

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Molecular reference: nalidixic

PubChem CID 4421

Molecular formula: C12H12N2O3

Mechanism of action

Evidence exists for Nalidixic acid that its active metabolite, hydroxynalidixic acid, binds strongly, but reversibly, to DNA, interfering with synthesis of RNA and, consequently, with protein synthesis. IT APPEARS TO ACT BY INHIBITING DNA SYNTH.

Pharmacodynamics

Nalidixic acid is a quinolone antibacterial agent for oral administration. Nalidixic acid has marked antibacterial activity against gram-negative bacteria including <i>Enterobacter</i> species, <i>Escherichia coli</i>, <i>Morganella Morganii</i>; <i>Proteus Mirabilis</i>, <i>Proteus vulgaris</i>, and <i>Providencia rettgeri</i>. <i>Pseudomonas</i> species are generally resistant to the drug. Nalidixic acid is bactericidal and is effective over the entire urinary pH range. Conventional chromosomal resistance to nalidixic acid taken in full dosage has been reported to emerge in approximately 2 to 14 percent of patients during treatment; however, bacterial resistance to nalidixic acid has not been shown to be transferable via R factor.

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.