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Ovel

Ovel

Levofloxacin

Levofloxacin is a synthetic, broad spectrum, 3rd generation fluoroquinolone antibiotic.

Product Details

Presentation

Ovel Tablet: Each film coated tablet contains Levofloxacin Hemihydrate INN equivalent to Levofloxacin 500 mg.

Pharmacology

Levofloxacin is a synthetic, broad spectrum, 3rd generation fluoroquinolone antibiotic.

Indication

Ovel is indicated for the treatment of adults with mild, moderate and severe infections caused by susceptible strains of the designated microorganisms in the conditions listed below:

Dosage & Administration

IndicationRecommended doseDuration
Acute sinusitis500 mg daily 10-14 days
Acute exacerbation of chronic bronchitis250-500 mg daily7-10 days
Community-acquired pneumonia500 mg once or twice daily7-14 days
Uncomplicated skin and soft tissue infections500 mg daily7-10 days
Complicated skin and soft tissue infections750 mg daily7-14 days
Uncomplicated urinary tract infections250 mg daily3 days
Complicated urinary tract infections250 mg daily7-10 days
Acute pyelonephritis250 mg daily10 days
Enteric fever500 mg daily14 days
Chronic bacterial Prostitis500 mg daily28 days
Travellers's diarrhoea500 mg single dose
Obstetric & gynecological infections250-750 mg once daily3-14 days
Bacterial enteritis250 mg daily3-5 days
Gonococcal urethritis500 mg daily3 days
Uterine cervicitis500 mg once daily7 days
Pharyngitis500 mg once daily14 days
Acute otitis media500 mg once daily5-10 days

Contraindications

Levofloxacin is contraindicated in persons with a history of hypersensitivity of Levofloxacin, quinolone antimicrobial agents, or any other component of this product.

Warning & Precautions

Adequate hydration of patients receiving Levofloxacin should be maintained to prevent the formation of highly concentrated urine.

In patients with impaired renal function (creatinine clearance < 50 ml/min), adjustment of the dosage regimen is necessary to avoid the accumulation of Levofloxacin.

Moderate to severe phototoxicity reactions have been observed in less than 0.1% of patients exposed to direct sunlight while receiving Levofloxacin. Excessive exposure to sunlight should be avoided.

Levofloxacin should be used with caution in any patients with known or suspected CNS disorder that may predispose to seizures or lower the seizure the threshold (e.g., severe cerebral arteiosclerosis, epilepsy).

Side effects

Levofloxacin is generally well tolerated. Side effects include nausea, vomiting, dyspepsia, abdominal pain, diarrhea, headache, dizziness and asthenia; rarely tremor, anxiety, tachycardia, hypotension, hypoglycaemia, pneumonitis, rhabdomyolysis etc.

Drug interaction

Concurrent administration of Levofloxacin with antacids containing magnesium, or aluminum, as well as sucralfate, metal cations (such as iron) and multi-vitamin preparations with zinc may interfere with the gastrointestinal absorption of Levofloxacin resulting in systematic levels considerably lower than desired. These agents should be taken at least two hours before or two hours after Levofloxacin administration.

Use in special groups

Use in pregnancy: Levofloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Use in lactation: Because of the potential for serious adverse reactions from Levofloxacin in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Use in paediatric patients: Safety and effectiveness of Levofloxacin in children and adolescents below the age of 18 years have not been established.

Packing

Ovel-500 Tablet: Each box contains 30's tablets in blister pack.

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