Levofloxin-Natrapharm Special Precautions

Aortic aneurysm and dissection: Epidemiologic studies report an increased risk of aortic aneurysm and dissection after intake of fluoroquinolones, particularly in the older population.
Therefore, fluoroquinolones should only be used after careful benefit-risk assessment and after consideration of other therapeutic options in patients with positive family history of aneurysm disease, or in patients diagnosed with pre-existing aortic aneurysm and/or aortic dissection, or in presence of other risk factors or conditions predisposing for aortic aneurysm and dissection (e.g. Marfan syndrome, vascular Ehlers-Danlos syndrome, Takayasu arteritis, giant cell arteritis, Behcet's disease, hypertension, known atherosclerosis).
In case of sudden abdominal, chest or back pain, patients should be advised to immediately consult a physician in an emergency department.
Hepatotoxicity: Severe hepatotoxicity, including acute hepatitis, has occurred and sometimes resulted in death. Most cases of severe hepatotoxicity occurred within 6-14 days of initiation of levofloxacin therapy and were not associated with hypersensitivity reactions. The majority of fatal cases of hepatotoxicity were in geriatric patients 65 years of age or older.
Levofloxacin should be discontinued in any patient who experiences loss of appetite, nausea, vomiting, fever, weakness, tiredness, right upper quadrant tenderness, itching, yellowing of the skin or eyes, light colored bowel movements or dark colored urine.
CNS Effects: Seizures, toxic psychosis, and increased intracranial pressure and CNS stimulation, which may lead to tremor, restlessness, anxiety, lightheadedness, confusion, hallucinations, paranoia, depression, nightmares, insomnia, and, rarely, suicidal thoughts or acts, have been reported with fluoroquinolones, including levofloxacin. Such nervous system effects may occur following the first dose of the drug.
Use with caution in patients with known or suspected CNS disorders (e.g., severe cerebral arteriosclerosis, epilepsy) or other risk factors that predispose to seizures or lower the seizure threshold (e.g., certain drugs, renal impairment). If nervous system effects occur, discontinue levofloxacin and institute appropriate measures.
Peripheral Neuropathy: Sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias, and weakness reported with fluoroquinolones, including levofloxacin. To prevent development of an irreversible condition, discontinue levofloxacin if symptoms of neuropathy (e.g., pain, burning, tingling, numbness, weakness) or other alterations of sensation (e.g., light touch, pain, temperature, position sense, vibratory sensation) occur.
Superinfection/Clostridium difficile-associated Diarrhea and Colitis (CDAD): Possible emergence and overgrowth of nonsusceptible bacteria or fungi. Institute appropriate therapy if superinfection occurs.
Prolongation of QT Interval: Prolonged QT interval leading to ventricular arrhythmias, including torsades de pointes, reported with some fluoroquinolones, including levofloxacin. Avoid use of levofloxacin in patients with a history of prolonged QT interval, in those with uncorrected electrolyte disorders (e.g., hypokalemia), and in patients receiving class IA (e.g., quinidine, procainamide) or class III (e.g., amiodarone, sotalol) antiarrhythmic agents. Risk may be increased in geriatric patients.
Musculoskeletal Disorders: An increased incidence of musculoskeletal disorders (arthralgia, arthritis, tendinopathy, gait abnormality) has been reported in pediatric patients receiving levofloxacin. Use in pediatric patients only for prevention of inhalational anthrax (post-exposure) in those 6 months of age or older.
Hypoglycemia or Hyperglycemia: Hypoglycemia or hyperglycemia reported with fluoroquinolones, including levofloxacin. Blood glucose disturbances usually have occurred in patients with diabetes receiving insulin or oral hypoglycemic agents. Carefully monitor blood glucose concentrations in diabetic patients. Discontinue levofloxacin and initiate appropriate therapy immediately if hypoglycemic reaction occurs.
Resistance in Neisseria gonorrhoeae: N. gonorrhoeae with decreased susceptibility to fluoroquinolones (quinolone-resistant N. gonorrhoeae; QRNG) has been reported with increasing frequency within the last several years. Recent US data indicate that QRNG has continued to increase among men who have sex with men and among heterosexual males and is now present in all regions of the country. CDC states that fluoroquinolones should not be used to treat proven or suspected gonorrhea including infections acquired within the US or acquired while traveling abroad.
Hepatic Impairment: Pharmacokinetic studies in hepatically impaired patients have not been conducted. Due to the limited extent of levofloxacin metabolism, the pharmacokinetics of levofloxacin are not expected to be affected by hepatic impairment.
Renal Impairment: Clearance of levofloxacin is substantially reduced and plasma elimination half-life is substantially prolonged in patients with impaired renal function (creatinine clearance <50 mL/min), requiring dosage adjustment in such patients to avoid accumulation. Neither hemodialysis nor continuous ambulatory peritoneal dialysis (CAPD) is effective in removal of levofloxacin from the body, indicating that supplemental doses of levofloxacin are not required following hemodialysis or CAPD.
Use in the Elderly: No substantial differences in safety and efficacy relative to younger adults, but increased sensitivity cannot be ruled out. Risk of severe tendon disorders, including tendon rupture, is increased in older adults (usually those older than 60 years of age). This risk is further increased in those receiving concomitant corticosteroids. Use caution in geriatric adults, especially those receiving concomitant corticosteroids.
Risk of fatal hepatotoxicity may be increased in geriatric patients.
Risk of prolonged QT interval leading to ventricular arrhythmias may be increased in geriatric patients, especially those receiving concurrent therapy with other drugs that can prolong QT interval (e.g., class IA or III antiarrhythmic agents) or with risk factors for torsade de pointes (e.g, known QT prolongation, uncorrected hypokalemia).
Consider age-related decreases in renal function when selecting dosage.