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Levora (Levofloxacin )

Pharmacology:

Levora (Levofloxacin) is a synthetic, broad-spectrum, third generation fluoroquinolone derivative antibacterial agent for oral administration. Chemically, levofloxacin is a chiral fluorinated carboxyquinolone which is the pure (-) enantiomer of the racemic drug, ofloxacin.

Composition:

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

Levora 750 Tablet: Each film coated tablet contains Levofloxacin  Hemihydrate INN equivalent to Levofloxacin 750 mg.

Indication:

Levora (Levofloxacin) is indicated for the treatment of mild to moderate, and severe infections caused by susceptible strains of the designated microorganism in the conditions listed below:

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

·Acute bacterial 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.

·Uncomplicated & complicated skin and skin structure infections (mild to moderate) including abscesses, cellulitis, furuncles, impetigo, pyoderma, wound infections, due to Staphylococcus aureus, or Streptococcus pyogenes, Proteus mirabilis, Enterococcus faecalis.

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

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

·Enteric fever caused by Salmonella typhi & Salmonella paratyphi.

Dosage & Administration:

· Acute Sinusitis, 500 mg once daily for 10-14 days

· Exacerbation of chronic bronchitis 250-500 mg once daily for 7 days

· Community-acquired pneumonia, 500 mg once daily for 7-14 days

· Community-acquired pneumonia, 750 mg once daily for 5 days

· Nosocomial Pneumonia, 750 mg once daily for 7-14 days

· Complicated urinary-tract infections and acute pyelonephritis, 250 mg daily for 7-10 days

· Uncomplicated UTI, 250 mg once daily for 3 days

· Acute pyelonephritis, 250 mg once daily for 10 days

· Chronic bacterial prostatitis, 500 mg once daily for 28 days

· Uncomplicated skin and soft-tissue infections, 500 mg once daily for  7-10 days

· Complicated skin and soft-tissue infections, 750 mg once daily for 7-10 days

Contraindication:

Levofloxacin is contraindicated in patients with a history of hypersensitivity to Levofloxacin, quinolone antimicrobial agents, or any other components of this product.

Precaution & Warning:

While taking levofloxacin, adequate amount of water should be drunk to avoid concentrated form of urine. Dose adjustment should be exercised during Levofloxacin ingestion in presence of renal insufficiency.

Use in Pregnancy & Lactation:

Levofloxacin is not recommended for use during pregnancy or nursing, as the effects on the unborn child or nursing infant are unknown.

Side Effect:

Levofloxacin is generally well tolerated. However, a few side effects can usually be seen. Side effects include: nausea, vomiting, diarrhea, abdominal pain, flatulence and rare occurrence of phototoxicity (0.1%). Side effects that may be seen very rarely include tremors, depression, anxiety, confusion, etc.

Overdosage:

In the events of an acute over dosage, the stomach should be emptied. The patients should be kept under observation and appropriate hydration should be maintained.

Drug Interaction:

Antacids, iron, adsorbents and multivitamin preparations with zinc reduce absorption of Levofloxacin.

Packaging:

Levora 500 Tablet : Each box contains 2×10's tablet in blister pack.

Levora 750 Tablet : Each box contains 1×10's tablet in blister pack.

 

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