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Brand Name, Dosage Format and Strength
Uritracin 400 mg ablet
WARNINGS AND PRECAUTIONS
- The safety and efficacy of oral norfloxacin in pediatric patients, adolescents (under 18 yrs old), pregnant women, and breastfeeding women have not been established. Administration of single oral doses of norfloxacin 6 times the usual recommended human dose (on a mg/kg basis), caused lameness in immature dogs. Histologic examination of the weight-bearing joints of these dogs revealed permanent lesions of the cartilage. Other quinolones also produced erosions of the cartilage in weight-bearing joints and other signs of arthropathy in immature animals of various species.
- Tendinopathy / Tendon Rupture: Quinolones, including norfloxacin, are associated with an increased risk of tendinitis and tendon rupture in all ages. This adverse reaction most frequently involves the Achilles tendon, and rupture of the Achilles tendon may require surgical repair. Tendinitis and tendon rupture in the rotator cuff (the shoulder), the hand, the biceps, the thumb, and other tendon sites have also been reported. This risk is further increased in those > 60 yrs old, in kidney, heart, or lung transplant recipients, and with concomitant steroid therapy. Strenuous physical activity, renal failure, and previous tendon disorders such as rheumatoid arthritis may also increase the risk of tendon rupture. Tendinitis and tendon rupture have been reported in patients taking quinolones who do not have the above risk factors. Tendon rupture can occur during or after completion of therapy; cases occurring up to several mos after completion of therapy have been reported. Physicians should advise patients at the first sign of tendon pain, swelling or inflammation, to stop taking the quinolone, to avoid exercise and use of the affected area, and to promptly contact their doctor about changing to a non-quinolone antimicrobial drug.
- Seizures: As with other quinolones, norfloxacin should be used with caution in patients with known or suspected CNS disorders, such as severe cerebral arteriosclerosis, epilepsy, or other factors that predispose to seizures. The effects of norfloxacin on brain function or on electrical activity of the brain have not been fully established. Patients should be advised that quinolones may also cause CNS stimulation which may lead to tremors, restlessness, lightheadedness, confusion, and hallucinations. If these reactions occur during treatment with norfloxacin, the drug should be discontinued and appropriate therapeutic measures instituted.
- Peripheral neuropathy: Patients receiving quinolones, including norfloxacin may experience rare cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias and weakness. If symptoms of neuropathy including pain, burning, tingling, numbness, and/or weakness occur or if the patient is found to have deficits in light touch, pain, temperature, position sense, vibratory sensation, and/or motor strength, norfloxacin should be discontinued to prevent the development of an irreversible condition.
- Hypersensitivity/anaphylaxis: Serious and occasionally fatal hypersensivity (anaphylactoid or anaphylactic) reactions, some after the initial dose, have been reported in patients receiving quinolone therapy, including norfloxacin.Some reactions were accompanied by CV collapse, loss of consciousness, tingling, pharyngeal or facial edema, dyspnea, urticaria and itching. Only a few patients had a history of hypersensitivity reactions. In case of an allergic reaction to norfloxacin, the drug should be discontinued and appropriate therapy instituted. Serious acute hypersensitivity reactions may require treatment with epinephrine and other resuscitative measures, including oxygen, IV fluids, antihistamines, corticosteroids, pressor amines, and airway management, including intubation, as clinically indicated.
- Other Serious and Sometimes Fatal Reactions: Other serious and sometimes fatal events, some due to hypersensitivity, and some due to uncertain etiology, have been reported rarely in patients receiving treatment with quinolones, including norfloxacin. Clinical manifestations which may be severe and generally occur after multiple doses may include one or more of the following: fever, rash or severe dermatologic reactions (e.g., toxic epidermal necrolysis, Stevens-Johnson Syndrome); vasculitis; arthralgia; myalgia; serum sickness; allergic pneumonitis; interstitial nephritis; acute renal insufficiency or failure; hepatitis; jaundice; acute hepatic necrosis or failure; anemia, including hemolytic and aplastic; thrombocytopenia, including thrombotic thrombocytopenic purpura; leukopenia; agranulocytosis; pancytopenia; and/or other hematologic abnormalities. Norfloxacin should be discontinued immediately at the first appearance of skin rash, jaundice, or any other sign of hypersensitivity, and supportive measures should be instituted.
- CDAD and Colitis: Thesehave been observed with the use of nearly all antibacterial agents, including norfloxacin, and may range in severity from mild to life threatening. It is important to consider this diagnosis in patients who present with diarrhea following administration of antibacterial agents.
- Cardiac Disorders:Prolongations of the QT interval on the ECG and arrhythmia (including torsades de pointes) have been reported very rarely with quinolones. Norfloxacin should be avoided in patients with known prolongation of the QT interval, in patients with proarrhythmic conditions such as recent hypokalemia, bradycardia, or myocardial ischemia, and those receiving class IA (quinidine, procainamide) or class III (amiodarone, sotalol) antiarrhythmic agents, or drugs that prolong the QT interval (e.g., cisapride, erythromycin, antipsychotic agents, tricyclic antidepressants).
- Myasthenia gravis: Symptoms may be aggravated by norfloxacin which may lead to life threatening weakness of the respiratory muscles. Use with caution in patients with myasthenia gravis.
- Photosensitivity/Phototoxicity: Moderate to severe photosensitivity/phototoxicity reactions manifesting as exaggerated sunburn reaction have been observed in patients exposed to direct sunlight or ultraviolet (UV) light while receiving quinolones; hence, direct exposure to excessive sunlight or UV radiation should be avoided during treatment. Therapy should be discontinued if photosensitization occurs.
- Hemolytic reactions: These reactions have been shown in patients with glucose-6-phosphate dehydrogenase dysfunction receiving quinolones, including norfloxacin.
- Syphilis treatment: Norfloxacin has not been shown to be effective in the treatment of syphilis. High doses of anti-infective agents given for short periods of time to treat gonorrhea may mask or delay the symptoms of incubating syphilis. Therefore, a serologic test for syphilis should be done in all patients with gonorrhea at the time of diagnosis. Patients treated with norfloxacin should have a follow-up serologic test for syphilis after three months.
- Crystalluria: Patients receiving norfloxacin should be well hydrated to prevent formation of highly concentrated urine.
- Alteration in dosage regimen is necessary for patients with renal impairment [see Statement on Usage for High Risk Groups]. Norfloxacin is not recommended in anuric patients.
- As with any potent drug, periodic assessment of organ system functions, including renal, hepatic, hematopoietic, is recommended during prolonged therapy.
- Prescribing norfloxacin in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to be beneficial to the patient and increases the risk of the development of drug-resistant microorganisms.
- As with other antibacterial drugs, long term or repeated use may result in overgrowth of non-susceptible organisms, including fungi
Last Update: Aug 6, 2011