OVEL-500

Levofloxacin INN 500mg

Description:

Ovel (Levofloxacin) is a synthetic, broad spectrum, 3rd generation antibacterial agent. Chemically, Levofloxacin is a chiral fluorinated carboxyquinolone.

Composition:

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

Indications:

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:

Acute maxillary sinusitis due to Streptococcus pneumoniae, Haemophilus influenzae,or Moraxella catarrhalis.

Acute exacerbation of chronic bronchitis due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, or Moraxella catarrhalis.

Community-acquired pneumonia due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydia pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae.

Complicated skin and soft tissue infections due to methicillin sensitive Staphylococcus aureus, Streptococcus pyogenes, Enterococcus faecalis, or Proteus mirabilis.

Uncomplicated skin and soft tissue infections (mild to moderate) including abscesses, cellulitis, furuncles, impetigo, pyoderma, wound infections, due to Staphylococcus aureus, or Streptococcus pyogenes.

Complicated urinary tract infections (mild to moderate) due to Enterococcus faecalis, Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, or Pseudomonas aeruginosa.

Uncomplicated urinary tract infections (mild to moderate) due to Escherichia coli, Klebsiella pneumoniae or Staphylococcus saprophyticus.

Acute pyelonephritis (mild to moderate) caused by Escherichia coli.

Dosage and administration:

Indication	Recommended dose	Duration
Acute sinusitis	500 mg daily	10-14 days
Acute exacerbation of chronic bronchitis	250-500 mg daily	7-10 days
Community-acquired pneumonia	500 mg once or twice daily	7-14 days
Uncomplicated skin and soft tissue infections	500 mg daily	7-10 days
Complicated skin and soft tissue infections	750 mg daily	7-14 days
Uncomplicated urinary tract infections	250 mg daily	3 days
Complicated urinary tract infections	250 mg daily	7-10 days
Acute pyelonephritis	250 mg daily	10 days

Enteric Fever: Recent studies show that, Levofloxacin 500 mg given for 14 days as once daily dose is highly effective in enteric fever..

Contraindications:

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

Side-effects:

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

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).

Use in Pregnancy:

Levofloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Use in Nursing Mothers:

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.

Paediatric Use:

Safety and effectiveness of Levofloxacin in children and adolescents below the age of 18 years have not been established.

Drug Interactions:

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.

Nursing mothers:

Levofloxacin has not been measured in human milk. Based upon data from Ofloxacin it can be presumed that Levofloxacin is excreted in human milk. Caution should be exercised when Ovel is administered to a nursing mother.

Overdose:

Levofloxacin exhibits a low potential for acute toxicity. In the event of an acute overdose, the stomach should be emptied. The patient should be observed and appropriate hydration maintained. Levofloxacin is not efficiently removed by hemodialysis or peritoneal dialysis.

Storage:

· Store in a cool and dry place protected from light.

· Keep out of the reach of children.

Packing:

Ovel-500 Tablet: Each box contains 1X10's/2X20's/3x10's tablets in blister pack.