Ovel-500

Generic

Levofloxacin Hemihydrate.

 

Indications

Levofloxacin 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, Haemophiles influenzae, or Moraxella catarrhalis.
• Acute bacterial exacerbation of chronic bronchitis due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophiles influenzae, or Moraxella catarrhalis.
• Community-acquired pneumonia due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophiles 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.

 

Pharmacology

Levofloxacin could be an engineered, broad-spectrum, third-generation fluoroquinolone anti-microbial. Chemically, Levofloxacin could be a chiral fluorinated carboxyquinolone. Levofloxacin applies antibacterial activity by repressing bacterial topoisomerase IV and DNA gyrase, the proteins required for DNA replication, translation repair and recombination. It has in vitro movement against a wide extend of gm-ve and gm+ve microorganisms.

 

Dosage

Levofloxacin 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, Haemophiles influenzae, or Moraxella catarrhalis. Acute bacterial exacerbation of chronic bronchitis due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophiles influenzae, or Moraxella catarrhalis. Community-acquired pneumonia due to Staphylococcus aureus, Streptococcus pneumonia,  aemophiles influenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydia pneumoniae, Legionella pneumophila, or Mycoplasma pneumonia. 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.

Adults:

• 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

In each case, sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.

 

Administration

Instructions for the Use of Levofloxacin Infusion-

• Check the container for minute leaks by squeezing the inner bag firmly. If leaks are found, or if the seal is not intact, discard the solution.
• Do not use if the solution is cloudy or a precipitate is present.
• Do not use flexible containers in series connections.
• Close flow control clamp of administration set.
• Remove cover from port at bottom of container.
• Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated.
• Suspend container from hanger.
• Squeeze and release drip chamber to establish proper fluid level in chamber during infusion of Levoxin Injection.
• Open flow control clamp to expel air from set. Close clamp.
• Regulate rate of administration with flow control clamp.

 

Interaction

Through the same intravenous line, no quinolone should be given with any multivalent cation solution, such as magnesium. Levofloxacin is inhibited by antacids, iron, and adsorbents. NSAIDs may make CNS stimulation more likely. Warfarin may make you bleed more easily.

 

Contraindications

Patients having a history of hypersensitivity to levofloxacin, quinolone antibiotic drugs, or any other component of this medicine should not take it.

 

Side Effect

Levofloxacin is for the most part well endured. In any case, a couple of side-effects can more often than not be seen. There's a chance of retinal separation. Other side-effects incorporate: queasiness, spewing, the runs, abdominal pain, tooting and uncommon event of phototoxicity (0.1%). Side-effects that will be seen exceptionally once in a while incorporate tremors, misery, uneasiness, disarray etc.

 

Pregnancy & Lactation

Because the effects on the unborn child or nursing infant are unknown, levofloxacin is not indicated for use during pregnancy or lactation.

 

Precautions & Warnings

The following measures should be taken during administration of Levofloxacin
Levofloxacin Injection should only be administered by slow intravenous infusion over a period of 60 or 90 minutes depending on the dosage.

• While administrating Levofloxacin, adequate amount of water should be taken to avoid concentrated form of urine.
• Dose adjustment should be exercised during Levofloxacin administration in presence of renal insufficiency.

 

Therapeutic Class

Preparations containing four quinolones.

 

Storage Conditions

Even if the canister appears to be empty, it should not be punctured, broken, or incinerated. Avoid storing in direct sunlight or in a hot environment. Keep it below 30°C. Keep your distance from the eyes. Keep your distance from youngsters.

 

Pharmaceutical Name

Aristopharma Ltd.