Naldix

📌 COMPOSITION

  • Each 5 ml contains: Nalidixic Acid B.P. 125 mg or 300 mg.
  • Each tablet contains: Nalidixic Acid B.P. 500 mg.

📌 DESCRIPTION

Naldix (Nalidixic Acid) is a bactericidal agent that appears to interfere with DNA polymerisation. It is active against Gram‑negative bacteria including Escherichia coli, Klebsiella spp., Proteus spp., Enterobacter spp., Salmonella spp., and Shigella spp. Gram‑positive bacteria, anaerobes and Pseudomonas aeruginosa are not generally susceptible. Nalidixic Acid is well absorbed, and peak serum levels of 20-40 mcg/ml are attained 1-2 hours after an oral dose of 1 g. The drug concentrates in renal tissue and seminal fluid. Nalidixic Acid is metabolised in the liver to hydroxynalidixic acid (similar activity to Nalidixic Acid) and inactive conjugates, which are rapidly excreted by the kidneys. Protein binding is approximately 93-97% and 63% for Nalidixic Acid and hydroxynalidixic acid, respectively. Plasma half‑life in normal renal function is 1.5 hours. Half‑life in urine is approximately 6 hours.

📌 INDICATIONS

  • Urinary tract infections caused by susceptible organisms.
  • Shigellosis (bacillary dysentery).
  • Decontamination of the digestive tract in intensive care patients.

📌 DOSAGE & ADMINISTRATION

Naldix is administered orally with food as follows:

  • Adults: For acute infections: 1 g 4 times daily for at least 1 week. For chronic infections: 0.5 g 4 times daily.
  • Children (3 months to under 12 years): 50-55 mg/kg/day in 4 equally divided doses.
  • Do not administer to infants under 3 months.

📌 RESTRICTIONS ON USE

Contraindications
  • Hypersensitivity to Nalidixic Acid.
  • History of convulsive disorders.
Precautions
  • Use with caution in patients with liver disease, epilepsy or severe cerebral arteriosclerosis.
  • Perform periodic blood counts and renal and liver function tests if treatment is continued for more than 2 weeks.
Effects on the capacity to drive vehicles or use machines

May produce drowsiness; observe caution while driving or performing tasks requiring alertness.

Use in Pregnancy and Lactation

Administer under medical supervision.

📌 DRUG INTERACTIONS

Nalidixic Acid may enhance the effects of anticoagulants.

📌 ADVERSE EFFECTS

Rarely, headache, intracranial hypertension and hypersensitivity may occur. Visual disturbances and gastrointestinal upset may occur.

📌 STORAGE INSTRUCTIONS

  • Suspension: Store below 30°C, protect from light.
  • Tablets: Store below 30°C in a dry place, protect from light.

📌 PHARMACEUTICAL FORMS

  • Naldix Suspension: Bottle of 100 ml and 200 ml.
  • Naldix Tablets: Pack of 20 tablets and hospital packs of 500 tablets.
  • * Other presentations may also be available.