LEVOXAC Levofloxacin 750mg Film-Coated Tablet 1's

Levofloxacin is used to treat infections caused by susceptible organisms including Gram-positive bacteria.

 

It is given by mouth to treat susceptible infections. Levofloxacin is given as hemihydrate but doses are expressed in terms of the base; 750 mg once daily for 7 to 14 days may be used for complicated skin infections and for hospital-acquired pneumonia; shorted course of 750 mg once daily for 5 days may be given for community-acquired pneumonia or for acute bacterial sinusitis. Doses should be reduced in patients with renal impairment. The following dose modifications are recommended: After an initial dose of 750 mg daily, CrCI 20 to 49 ml/minute: subsequent doses are 750 mg every 48 hours; CrCI up to 19 mUminute (including haemodialysis and peritoneal dialysis): subsequent doses are 500 mg every 48 hours.

May be taken with or without food.

Hypersensitivity to fluoroquinolones or the quinolone group of antibacterial agents.

Levofloxacin should be used with caution in patients with epilepsy or a history of CNS disorders. Care is also necessary in those patients with renal impairment, G6PD deficiency, or myasthenia gravis. An adequate fluid intake should be maintained during the treatment with levofloxacin and excessive alkalinity of the urine must be avoided because of the risk of crystalluria.
Since Levofloxacin and related fluoroquinolone have, like nalidixic acid, been shown to cause degenerative changes in weight-bearing joints of young animals, it has been suggested that these drugs should not generally be used in patients aged less than 18 years, pregnant women, or breastfeeding mothers unless the benefits outweigh the risks. Tendon damage may occur rarely with fluoroquinolones and treatment should be stopped if patients experience tendon pain, inflammation, or rupture.
Exposure to strong sunlight or sunlamps should be avoided during treatment with levofloxacin. The ability to drive or operate machinery may be impaired by levofloxacin, especially when alcohol is also taken.
Some fluoroquinolones have the potential to prolong the QT interval and should be avoided or used with caution in patients with QT prolongation or relevant risk factors such as uncorrected electrolyte disturbances, bradycardia, or pre-existing cardiac disease. Certain drugs may also increase the risk.
Levofloxacin and other fluoroquinolones should be avoided in MRSA infections because of the high level of resistance.

Symptomatic hyperglycaemia and/or hypoglycaemia have been reported, usually in diabetics who are also taking hypoglycaemics or insulin. Such patients should have their blood-glucose concentrations closely monitored and if signs or symptoms of glucose disturbances develop, levofloxacin should be stopped.
Levofloxacin is generally well tolerated. The range of adverse effects associated with levofloxacin and the other fluoroquinolones is broadly similar to that of earlier quinolones such as nalidixic acid. They most often involve the gastrointestinal tract, CNS or skin.
Gastrointestinal disturbances include nausea, vomiting, diarrhoea, abdominal pain, and dyspepsia are the most frequent adverse effects. Pseudomembranous colitis, pancreatitis, and dysphagia have been reported rarely.
Headache, dizziness, confusion, insomnia, and restlessness are among the most common effects on the CNS. Others include tremor, drowsiness, nightmares, visual and other sensory disturbances, hallucinations, psychotic reactions, depression, convulsions, and intracranial hypertension. Paraesthesia and peripheral neuropathy have also been reported.
In addition to rash and pruritus, hypersensitivity-type reactions affecting the skin have included, rarely, vasculitis, erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis. Photosensitivity has occurred, although it may be more frequent with some other fluoroquinolones such as lomefloxacin and sparfloxacin. Anaphylaxis has been associated with ciprofloxacin and some other quinolones. As with other quinolones, reversible arthralgia or myalgia has sometimes occurred and joint erosions have been documented in immature animals. Tendon damage has also been reported. Other adverse effects reported with Levofloxacin include cystalluria, transient increases in serum creatinine or blood urea nitrogen and rarely, acute renal failure secondary to interstitial nephritis. Elevated liver enzyme values, jaundice and hepatitis have occurred, as have haematological disturbances including eosinophilia, leucopenia, thrombocytopenia and, very rarely, pancytopenia, haemolytic anemia or agranulocytosis. Cardiovascular adverse effects include tachycardia, hypotension, edema, syncope, hot flushes, and sweating. Some fluroquinolones may rarely cause prolongation of the QT interval and ventricular arrhythmias, including torsade de pointes. Pain and irritation may occur at the site of injection accompanied rarely by phlebitis or thrombophlebitis.
Adverse effects reported after ocular use of levofloxacin include local burning or discomfort, keratopathy, corneal staining, corneal precipitates or infiltrates, and photophobia. Local discomfort, pain, or pruritus have occurred after use of ear drops containing levofloxacin.

 

Fluoroquinolones, including levofloxacin, are known to inhibit the cytochrome P450 isoenzyme CYP1A2 and may increase plasma concentrations of drugs that are metabolised by the isoenzyme such as theophylline and tizanidine. Use of levofloxacin with tizanidine is contraindicated, although theophylline may be used providing its dose is reduced and concentrations monitored.
Levofloxacin is reported to enhance the effect of oral anticoagulants such as warfarin and oral antidiabetic glibenclamide. Severe hypoglycaemia, sometimes fatal, has occurred in patients also taking glibenclamide.
The excretion of levofloxacin or related drugs is reduced and plasma concentrations may be increased by probenecid. Changes in the pharmacokinetics of fluoroquinolones have been reported when given with histamine H2 antagonists, possibly due to changes in gastric pH, but do not seem to be of much clinical significance. Altered serum concentrations of phenytoin have been reported in patients also receiving levofloxacin.
Some fluoroquinolones have the potential to prolong the QT interval and should be avoided in patients also receiving class Ia antiarrhythmic drugs (such as quinidine and procainamide) or class III antiarrhythmics (such as amiodarone and sotalol). In addition, caution should be exercised when they are used with other drugs known to have this effect (such as the antihistamines astemizole and terfenadine, cisapride, erythromycin, pentamidine, phenothiazines, or tricyclic antidepressants).

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Quinolones