AGILEVO 250

AGILEVO 500

AGILEVO 750



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Composition

Agilevo 250
Each film-coated tablet contains:
Levofloxacin Hemihydrate
equivalent to Levofloxacin 250 mg
Colour : Titanium Dioxide I.P. & Iron oxide of Red

Agilevo 500
Each film-coated tablet contains:
Levofloxacin Hemihydrate
equivalent to Levofloxacin 500 mg
Colour : Titanium Dioxide I.P. & Iron oxide of Red

Agilevo 750
Each film-coated tablet contains:
Levofloxacin Hemihydrate
equivalent to Levofloxacin 750 mg
Colour : Titanium Dioxide I.P. & Iron oxide of Red

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Indications

Treatment of acute maxillary sinusitis, lower respiratory tract infections, skin and skin structure infections, urinary tract infections, acute pyelonephritis and prostatitis.

Dosage and Administration

For the treatment of Acute maxillary sinusitis, acute bacterial exacerbations of chronic bronchitis, or community-acquired pneumonia in adults : 500 mg every 24 hours. Uncomplicated skin and skin structure infections: 500 mg every 24 hours Complicated skin and skin structure infections : 750 mg every 24 hours. Uncomplicated urinary tract infection, complicated urinary tract infections, or acute pyelonephritis : 250 mg every 24 hours. The duration of levofloxacin therapy depends on the type and severity of infection and should be determined by the clinical and bacteriologic response of the patient. Acute maxillary sinusitis usually requires 10-14 days of therapy. Acute bacterial exacerbations of chronic bronchitis require 7 days; community-acquired pneumonia or complicated skin and skin structure infections require 7-14 days of therapy. For uncomplicated skin and skin structure infections, the usual duration of levofloxacin therapy is 7-10 days. Uncomplicated urinary tract infections require 3 days of therapy; complicated urinary tract infections and acute pyelonephritis usually require 10 days of therapy. Or As directed by the physician.

CONTRAINDICATIONS:

Hypersensitivity to Levofloxacin , other quinolones or any of the ingredients in this product , in patients with epilepsy; in patients with history of tendon disorders related to fluoroquinolone administration; in children or growing adolescents

WARNINGS & PRECAUTIONS:

As with other quinolones, levofloxacin should be used with caution in any patient with a known or suspected CNS disorder that may predispose to seizures or lower the seizure threshold (e.g., severe cerebral arterioserosis, epilepsy) or in the presence of other risk factors that may predispose to seizures or lower the seizure threshold. As with other quinolones, disturbances of blood glucose, including symptomatic hyper- and hypoglycemia, have been reported usually in diabetic patients receiving concomitant treatment with an oral hypoglycemic agent (e.g., glyburide/glibenamide) or with insulin. In these patients, careful monitoring of blood glucose is recommended.

DRUG-INTERACTIONS:

Concurrent administration of antacids containing aluminium or iron , magnesium salts can reduce the rate of absorption of Levofloxacin.

PREGNANCY AND LACTATION:

Levofloxacin tablets are contraindicated in pregnancy and lactation.

UNDESIRABLE EFFECTS:

Doses of 200-600 mg levofloxacin per day appear to be well tolerated with side-effects largely consisting of those noted with all fluoroquinolones, such as abdominal discomfort, anorexia, occasionally diarrhea and central nervous system effects, including headache. The phototoxic potential of levofloxacin is similar to that of ofloxacin and ciprofloxacin in studies in mice. Transient elevations of liver function tests, eosinophilia and leukopenia have been described occasionally. Overall, levofloxacin appears to have fewer side-effects than ofloxacin.

OVERDOSE AND TREATMENT:

In the event of acute overdosages, the stomach should be emptied. The patient should be observed and appropriate hydration maintained. Levofloxacin is not efficiently removed by hemodialysis or peritoneal dialysis. – PDR

PHARMACOLOGICAL ACTION:

Levofloxacin is a synthetic antibacterial agent of the fluoroquinolone class and is the S (-) enantiomer of the racemic drug substance ofloxacin. As a fluoroquinolone antibacterial agent, levofloxacin acts on the DNA-DNA-gyrase complex and topoisomerase IV.

PHARMACOKINETICS:

Absorption:

Levofloxacin is rapidly and almost completely absorbed following oral administration with peak plasma concentrations achieved within an hour of a dose. It is distributed into body tissues including the bronchial mucosa and lungs , but penetration into CSF is relatively poor.Levofloxacin is approximately 30 - 40 % bound to plasma proteins. It is only metabolised to a small degree to inactive metabolites . The elimination half-life of Levofloxacin is 6 - 8 hours, although this may be prolonged in patients with renal impairement. Levofloxacin is excreted largely unchanged, primarily in the urine.

STORAGE INSTRUCTIONS:

Store below 25°C , in a dry place. Protect from light.

NATURE AND CONTENTS OF CONTAINER:

1 Blister of 10 Tablets each is packed in a Carton along with the Pack Insert.

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