Yes

Antibiotic, Quinolone

Treatment of urinary tract infections

B

Hypersensitivity to nalidixic acid or any component; infants <3 months of age

Use with caution in patients with impaired hepatic or renal function and prepubertal children; has been shown to cause cartilage degeneration in immature animals; may induce hemolysis in patients with G-6-PD deficiency; use caution in patients with seizure disorder.

>10%: Central nervous system: Dizziness, drowsiness, headache

1% to 10%: Gastrointestinal: Nausea, vomiting

<1%: Increased intracranial pressure, malaise, vertigo, confusion, toxic psychosis, convulsions, fever, chills, rash, urticaria, photosensitivity reactions, metabolic acidosis, leukopenia, thrombocytopenia, hepatotoxicity, visual disturbances

Symptoms of overdose include nausea, vomiting, toxic psychosis, convulsions, increased intracranial pressure, metabolic acidosis; severe overdose, intracranial hypertension, increased pressure, and seizures have occurred

After GI decontamination, treatment is symptomatic

Decreased effect with antacids containing magnesium, aluminum, or calcium, sucralfate, metal ions and didanosine. Avoid by 2 hours.

Increased effect of warfarin

Inhibits DNA polymerization in late stages of chromosomal replication

Distribution: Crosses the placenta; appears in breast milk; achieves significant antibacterial concentrations only in the urinary tract

Protein binding: 90%

Metabolism: Partly in the liver

Half-life: 6-7 hours; increases significantly with renal impairment

Time to peak serum concentration: Oral: Within 1-2 hours

Elimination: In urine as unchanged drug and 80% as metabolites; small amounts appear in feces

Oral:

Adults: 1 g 4 times/day for 2 weeks; then suppressive therapy of 500 mg 4 times/day

Dosing comments in renal impairment: Cl_cr <50 mL/minute: Avoid use

Should be administered 1 hour before meals; can administer with food to minimize GI

False-positive urine glucose with Clinitest®, false increase in urinary VMA

Dizziness and drowsiness are common; may rarely cause confusion or psychosis

May rarely cause leukopenia; use caution with clozapine and carbamazepine

No information available to require special precautions

No effects or complications reported

Avoid undue exposure to direct sunlight or use a sunscreen; take 1 hour before meals, but can take with food to decrease GI upset, finish all medication, do not skip doses; if persistent cough occurs, notify physician. Antacids containing calcium, magnesium or aluminum; sucralfate; minerals; multivitamin with zinc; or didanosine should not be taken within 2 hours of nalidixic acid.

Administer around-the-clock rather than 4 times/day, 3 times/day, etc, (ie, 12-6-12-6, not 9-1-5-9) to promote less variation in peak and trough serum levels

Monitor urinalysis, urine culture; CBC, renal and hepatic function tests

Suspension, oral (raspberry flavor): 250 mg/5 mL (473 mL)

Tablet: 250 mg, 500 mg, 1 g

Barbeau G, Belanger PM, "Pharmacokinetics of Nalidixic Acid in Old and Young Volunteers," J Clin Pharmacol, 1982, 22(10):490-6.

Belton EM and Jones RV, "Haemolytic Anaemia Due to Nalidixic Acid," Lancet, 1965, 2(7414):691.

Leslie PJ, Cregeen RJ, and Proudfoot AT, et al, "Lactic Acidosis, Hyperglycaemia and Convulsions Following Nalidixic Acid Overdosage," Hum Toxicol, 1984, 3(3):249-53.

Nuutinen M, Turtinen J, and Uhari M, "Growth and Joint Symptoms in Children Treated With Nalidixic Acid," Pediatr Infect Dis J, 1994, 13(9):798-800.

Stutman HR and Marks MI, "Review of Pediatric Antimicrobial Therapies," Semin Pediatr Infect Dis, 1991, 2:3-17.