Pronunciation:

(nal i DIKS ik AS id)

U.S. Brand Names:

Synonyms:

Generic Available:

Canadian Brand Names:

Use:

Pregnancy Risk Factor:

Pregnancy Implications:

Lactation:

Contraindications:

Warnings/Precautions:

Severe hypersensitivity reactions, including anaphylaxis, have occurred with quinolone therapy. If an allergic reaction occurs (itching, urticaria, dyspnea, facial edema, loss of consciousness, tingling, cardiovascular collapse), discontinue drug immediately. Prolonged use may result in superinfection; pseudomembranous colitis may occur and should be considered in all patients who present with diarrhea. Quinolones may exacerbate myasthenia gravis, use with caution (rare, potentially life-threatening weakness of respiratory muscles may occur).

Adverse Reactions:

Central nervous system: Chills, confusion, dizziness, drowsiness, fever, headache, intracranial pressure increased, malaise, seizure, toxic psychosis, vertigo

Dermatologic: Erythema multiforme, photosensitivity reactions, pruritus, rash, Stevens-Johnson syndrome, urticaria

Endocrine & metabolic: Metabolic acidosis

Gastrointestinal: Nausea, vomiting

Hematologic: Eosinophilia, hemolytic anemia, leukopenia, thrombocytopenia

Hepatic: Cholestasis, hepatotoxicity

Neuromuscular and skeletal: Arthralgias, neuropathy, paresthesia, weakness

Ocular: Visual disturbances

Miscellaneous: Anaphylactic shock, anaphylactoid reaction, angioedema, tendon rupture and tendonitis

Overdosage/Toxicology:

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

Drug Interactions:

Corticosteroids: Concurrent use may increase the risk of tendon rupture, particularly in elderly patients (overall incidence rare).

Glyburide: Quinolones may increase the effect of glyburide; monitor.

Melphalan: Concomitant use of I.V. melphalan and nalidixic acid may increase the risk of developing necrotic enterocolitis (reported in pediatric patients).

Metal cations (aluminum, calcium, iron, magnesium, and zinc) bind quinolones in the gastrointestinal tract and inhibit absorption. Concurrent administration of most antacids, oral electrolyte supplements, quinapril, sucralfate, and some didanosine formulations (chewable/buffered tablets and pediatric powder for oral suspension) should be avoided. Nalidixic acid should be administered 2 hours before or 2 hours after these agents.

Probenecid: May decrease renal secretion of nalidixic acid.

Warfarin: The hypoprothrombinemic effect of warfarin may be enhanced by some quinolone antibiotics; monitor INR.

Ethanol/Nutrition/Herb Interactions:

Stability:

Mechanism of Action:

Pharmacodynamics/Kinetics:

Distribution: Achieves significant antibacterial concentrations only in the urinary tract; crosses placenta; enters breast milk

Protein binding: 90%

Metabolism: Partially hepatic; active metabolite, hydroxynalidixic acid

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

Time to peak, serum: 1-2 hours

Excretion: Urine (as unchanged drug, 80% as metabolites); feces (small amounts)

Dosage:

Children 3 months to 12 years: 55 mg/kg/day divided every 6 hours; suppressive therapy is 33 mg/kg/day divided every 6 hours

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

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

Administration:

Monitoring Parameters:

Test Interactions:

Dietary Considerations:

Patient Education:

Dental Health: Effects on Dental Treatment:

Dental Health: Vasoconstrictor/Local Anesthetic Precautions:

Mental Health: Effects on Mental Status:

Mental Health: Effects on Psychiatric Treatment:

Dosage Forms:

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

Tablet: 250 mg [DSC], 500 mg, 1 g [DSC]

International Brand Names: