COMPOSITION :

Each 5 ml contains : Nalidixic Acid B.P. 125 mg and 300 mg.

Each tablet contains : Nalidixic Acid B.P. 500 mg.

DESCRIPTION :

Naldix (Nalidixic Acid) is a bactericidal agent which appears to interfere with DNA polymerization.It is

active against Gram-negative bacteria including Eschrichia 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 to 40 mcg/ml are attained 1 to 2 hours after an oral dose of 1 gm. The drug concentrates in

renal tissue and seminal fluid. Nalidixic Acid is metabolized in the liver to hydroxynalidixic acid

(similar activity to Nalidixic acid) and inactive conjugates which are rapidly excreted by the kidneys.Protein binding is ≈ 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 ≈ 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 1g four times daily for at least 1 week.

For chronic infections 0.5 g four times daily.

Children (3 months - ≤ 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 liver disease, epilepsy or severe cerebral arteriosclerosis patients.

- 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

gastro-intestinal upset may occur.

STORAGE INSTRUCTIONS :

Suspension : Store below 30°C, protect from light.

Tablets : Store below 25°C in a dry place, protect from light.

PRESENTATIONS* :

Naldix Suspension : Bottle of 100 ml and 200 ml.

Naldix Tablets : Pack of 20 tablets and hospital packs of 500 tablets.

* Other presentations also may be available.

Naldix