Cravit Warnings





Zuellig Pharma
Full Prescribing Info
Levofloxacin is more soluble than other quinolones, adequate hydration of patients receiving levofloxacin should be maintained to prevent the formation of highly concentrated urine.
Acute renal failure or interstitial nephritis.
Excessive exposure to sunlight should be avoided. However, phototoxicity has been observed very rare incidence <0.01%. Therapy should be discontinued if phototoxicity (eg, a skin eruption) occurs.
Dysglycemia: During post-marketing surveillance, hypoglycemia and hyperglycemia have been reported in patients taking levofloxacin. Serious symptoms eg, hypoglycemic coma have been reported in patients receiving levofloxacin. Hypoglycemia may be prone to develop in patients with diabetes mellitus (especially those receiving sulfonylureas or insulin preparations), patients with impaired renal function and elderly patients. Serious colitis with bloody stool eg, pseudomembranous colitis. If such symptoms as abdominal pain and frequent diarrhea are noted, treatment with levofloxacin should be discontinued immediately and appropriate therapeutic measures taken.
Rhabdomyolysis characterized by myalgia, weakness, elevated CK (CPK) and increased myoglobin in plasma and urine, and accompanied with acute exacerbation of renal function.
Tendon disorder eg, Achilles tendonitis or tendon rupture. If symptoms eg, pain and edema in the peritendinous region are observed, treatment with levofloxacin should be discontinued immediately and appropriate therapeutic measures taken. The risk of tendonitis and tendon rupture is increased in patients >60 yrs, in those on concomitant corticosteroid therapy, and transplant recipients.
Levofloxacin may inhibit the growth of Mycobacterium tuberculosis, and therefore may give false-negative results in the bacteriological diagnosis of tuberculosis.
Some undesirable effects (see Adverse Reactions) may impair the patient's ability to concentrate and react, and therefore may constitute a risk in situation where these abilities are of special importance (eg, driving a car or operating machinery).
Shock or anaphylactoid reaction (initial symptoms erythema, rigor, dyspnea); toxic epidermal necrolysis or oculomucocutaneous syndrome (Stevens-Johnson syndrome); convulsion.
Prolonged QT and Ventricular Tachycardia (Including Torsades De Pointes): During post-marketing surveillance, prolonged QT which may sometimes lead to the occurrence of ventricular tachycardia including Torsades de pointes have been reported spontaneously in patients taking levofloxacin. The risk of the events may be increased in patients with serious heart diseases (eg, arrhythmia and ischemic heart disease), patients with uncorrected hypokalemia, patients receiving class 1A (quinidine sulfate, procainamide hydrochloride) and class III (amiodarone hydrochloride, sotalol hydrochloride) antiarrhythmic agents and in elderly patients.
Fulminant hepatitis, hepatic function disorder or jaundice (Initial Symptoms: Nausea, vomiting, anorexia, malaise, pruritus).
Pancytopenia, agranulocytosis (Initial Symptoms: Pyrexia, pharynx pain, malaise), hemolytic anemia with hemoglobinuria or thrombocytopenia.
Interstitial pneumonia or eosinophilic pneumonia accompanied with pyrexia, cough, dyspnea, abnormal chest X-ray or eosinophilia.
Psychiatric symptoms eg, confusion, delirium and depression.
Hypersensitivity Vasculitis: If symptoms eg, pyrexia, abdominal pain, arthralgia, purpura or maculopapules and skin biopsy evidence of leukocytoclastic vasculitis are observed, treatment with levofloxacin should be discontinued immediately and appropriate therapeutic measures taken.
Exacerbation of myasthenia gravis.
Patients receiving levofloxacin 750 mg may develop some adverse reactions eg, dizziness, headache, nausea or vomiting more than levofloxacin 500 mg.
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