LEVOSAFE ® – Levofloxacin Hemihydrate INN

Chemical Name:
Sodium;(2S,5R,6R)-6-[[3-(2-chloro-6-fluorophenyl)-5-methyl-1,2-oxazole-4-carbonyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate

Levofloxacin Hemihydrate is an antibiotic from the quinolones class. It is used to treat a wide range of bacterial infections. It is particularly effective in the case of respiratory infections and is also popularly collective known as “respiratory quinolones” along with other effective quinolones.

— 500 mg 2×10 tablets

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LEVOSAFE ® – Levofloxacin Hemihydrate INN

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

PHARMACOLOGY
Levofloxacin is a synthetic, broad-spectrum, third generation fluoroquinolone antibiotic. Chemically, Levofloxacin is a chiral fluorinated carboxyquinolone. Levofloxacin exerts antibacterial action by inhibiting bacterial topoisomerase IV and DNA gyrase, the enzymes required for DNA replication, transcription repair and recombination. It has in vitro activity against a wide range of Gram negative and Gram positive microorganisms.

INDICATION
Levosafe is indicated for the treatment of mild, moderate and severe infections caused by susceptible strains of the designated micro-organisms in the condition 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, or Moraxella catarrhalis.
Community-acquired pneumonia due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydia pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae.
Uncomplicated & complicated urinary tract infections due to Escherichia coli, Klebsiella pneumoniae, or Staphylococcus saprophyticus.
Acute pyelonephritis caused by Escherichia coli.
Uncomplicated & complicated skin and soft tissue infections including abscesses, cellulitis, furuncles, impetigo, pyoderma, wound infections, due to Staphylococcus aureus, Streptococcus pyogenes, Proteus mirabilis or Enterococcus faecalis.
Enteric infections caused by Enterobacter sp., Escherichia coli, Campylobacter sp., Vibrio cholerae, Shigella sp., Salmonella sp.

DOSAGE AND ADMINISTRATION
Tablet:
The usual dose of Levosafe Tablets is 250 mg or 500 mg or 750 mg administered orally every 24 hours. Levosafe tablets can be administered without regard to food.
Adult:
Acute sinusitis: 500 mg once daily for 10-14 days, or 750 mg once daily for 5 days
Exacerbation of chronic bronchitis: 500 mg once daily for 7 days, or 750 mg once daily for 3 days (Uncomplicated), 750 mg once daily for 5 days (Complicated)
Community-acquired pneumonia: 500 mg once daily for 7-14 days, or 750 mg once daily for 5 days
Uncomplicated urinary-tract infections: 250 mg once daily for 3 days
Complicated urinary-tract infections and acute pyelonephritis: 250 mg once daily for 7-10 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 7-14 days
Enteric fever: 500 mg once daily for 7-14 days
Diarrhea, cholera, shigellosis & enteritis:
Mild to moderate case: 500 mg (single dose)
Moderate to severe case: 500 mg once daily for 3 days
Children:
Children 6 months to <5 years: 10 mg/kg every 12 hours Children > 5 years:10 mg/kg every 24 hours

SIDE EFFECT
Levofloxacin is generally well tolerated. However, a few side-effects can usually be seen. There is a risk of retinal detachment. Other 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.

PRECAUTION
The following measures should be taken during administration of Levofloxacin:
While taking Levofloxacin adequate amount of water should be drunk to avoid risk of crystalluria.
Dose adjustment should be exercised during Levofloxacin ingestion in presence of renal insufficiency & hepatic insufficiency.

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

DRUG INTERCATION
Antacids, Iron and Adsorbents reduce absorption of Levofloxacin. NSAID may increases the risk of CNS stimulation. Warfarin may increase the risk of bleeding.
Overdose:
Levofloxacin exhibits a low potential for acute toxicity. However, in the events of an acute overdosage, the stomach should be emptied. The patients should be kept under observation and appropriate hydration should be maintained.

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

STORAGE
Store below 30° C in a cool & dry place, protected from light. Keep out of the reach of children.

PAKAGING
LEVOSAFE®: 500mg Tablet: Box containing 2 Strips of 10 Tablets in blister pack.

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