Cravit IV Special Precautions

Cravit i.v. should be administered with caution in the following patients: Patients with severe renal impairment: Levofloxacin is excreted mainly by the kidneys and persistence of high serum level in patients with renal impairment has been reported.
Patients with known or suspected CNS disorder such as epilepsy or with a history of convulsive diseases that may predispose to seizures or lower the seizure threshold, convulsion may occur.
Diabetic patients receiving concomitant treatment with an oral hypoglycemic agent (especially, sulfonylureas) or with insulin preparations.
Patients with history of hypersensitivity to quinolone antibiotics.
Patients with serious heart diseases (e.g. arrhythmia and ischemic heart disease), patients with uncorrected electrolyte imbalance (e.g. hypokalemia, hypomagnesemia) and patients receiving Class IA and III antiarrythmic agents. QT prolongation may occur. (See SERIOUS ADVERSE REACTIONS under ADVERSE REACTIONS and INTERACTIONS).
Patient with myasthenia gravis: Levofloxacin may cause exacerbation of myasthenia gravis symptom.
Rapid or bolus intravenous injection may result in hypotension. Cravit i.v. should only be administered by slow intravenous infusion over a period of 60 minutes or 90 minutes.
Levofloxacin is more soluble than other quinolones; adequate hydration of patients receiving levofloxacin should be maintained to prevent the formation of highly concentrated urine.
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 concentration and react, and therefore may constitute a risk in situation where these abilities are of special importance (e.g. driving a car or operating machinery).
Excessive exposure to sunlight should be avoided. However, phototoxicity has been observed very rare: incidence < 0.01%. Therapy should be discontinued if phototoxicity (e.g. a skin eruption) occurs.
Patients complicated with aortic aneurysm or aortic dissection, or patients who have a previous history, positive family history, or risk factors (Marfan syndrome, etc.) of aortic aneurysm or aortic dissection [The increased risk of aortic aneurysm and dissection after intake of fluoroquinolones have been reported in overseas epidemiologic studies (see SERIOUS ADVERSE REACTIONS under ADVERSE REACTIONS)].
Aortic aneurysm or aortic dissection may occur; there-fore, patients should be carefully observed and instructed to seek medical attention immediately if they experience symptoms, e.g. in case of pain in the abdomen, chest, or back. Imaging assessment should be considered if necessary, for patients complicated with aortic aneurysm or aortic dissection, or patients who have a previous history, positive family history, or risk factors of aortic aneurysm or aortic dissection (see Serious Adverse Reactions under Adverse Reactions).
Use in Elderly: Since renal function is generally depressed in geriatric patients and levofloxacin is excreted mainly by the kidneys, levofloxacin should be used with caution in this population. (See Geriatric patients under Dosage & Administration).
Effect on ability to drive and use machine: Neurologic adverse effects such as dizziness/vertigo and somnolence may occur. Therefore, patients should be instructed that such neurologic adverse effects 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 (e.g. activities at high place, driving a car or operating machinery).