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Uritracin_8.jpg

Norfloxacin

Uritracin

Therapeutic Category
Anti-infectives (Systemic)
Class
Quinolone
Generic Name
Norfloxacin
Brand Name, Dosage Format and Strength
Uritracin 400 mg tablet

STATEMENT ON USAGE FOR HIGH RISK GROUPS

Pregnancy: Pregnancy Category C. Norfloxacin has been embryocidal and caused slight maternotoxicity (vomiting and anorexia) in monkeys at doses of 150 mg/kg/day or more. Embryonic loss occurred in monkeys when norfloxacin was given in doses 10 times the maximum human dose and when peak plasma concentrations of the drug were 2 to 3 times higher than those obtained in humans. No evidence of teratogenicity has been observed in rats, rabbits, mice, or monkeys receiving norfloxacin doses 6 to 50 times the usual human dose.

To date, there are no adequate and well-controlled studies using norfloxacin in pregnant women. Since the drug, like most other fluoroquinolones, causes arthropathy in immature animals, norfloxacin should not be used in pregnant women [see Warnings and Precautions].
 
Lactation:  It is not known whether norfloxacin is distributed into human milk. When a single 200 mg dose of oral norfloxacin was administered to lactating women, the drug was not detected in human milk, but the possibility of distribution into milk after higher or multiple doses remains to be determined. Since other quinolones are distributed in human milk, and norfloxacin may cause serious adverse effects of norfloxacin to the infant, a decision should be made whether to discontinue breastfeeding or to discontinue the drug, taking into account the importance of the drug to the mother [see Warnings and Precautions].
 
Children: The safety and efficacy of oral norfloxacin in children and adolescents below 18 yrs old have not been established. Norfloxacin causes arthropathy in juvenile animas of several animal species [see Warnings and Precautions].
 
Elderly: No dosage adjustment is necessary for elderly patients with normal renal function. However, since norfloxacin is substantially excreted by the kidneys and some elderly patients experience age-related reduction in renal function, care should be taken in dose selection and renal function monitoring is recommended.
 
Elderly patients are at increased risk of developing severe tendon disorders including tendon rupture or to drug-associated effects on QT interval when being treated with a quinolone including norfloxacin [see Warnings and Precautions].
 
Renal impairment: Norfloxacin dose and/or frequency of administration should be decreased in patients with renal impairment since the drug’s serum concentrations are higher and prolonged in these patients compared with those with normal renal function.
 
Effects on Ability to Drive and Use Machines: Since norfloxacin can cause dizziness and lightheadedness,patients should be advised to avoid performing tasks which require complete mental alertness such as driving and operating machinery.

Last Update: Aug 6, 2011


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