Leflox 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, 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.

 

Pharmacology

Levofloxacin is a third-generation synthetic broad-spectrum fluoroquinolone antibiotic. Chemically, levofloxacin is a chiral fluorinated carboxyquinolone. Levofloxacin exerts antibacterial effects by inhibiting bacterial topoisomerase IV and DNA gyrase (enzymes necessary for DNA replication, transcription repair, and recombination). It has in vitro activity against a variety of gmve and gm + ve microorganisms.

 

Dosage

The usual dose of Levofloxacin Tablets is 250 mg or 500 mg or 750 mg administered orally every 24 hours. Levofloxacin tablets can be administered without regard to food. Levofloxacin oral solution should be taken 1 hour before, or  2 hours after eating.

Levofloxacin injection should only be administered by intravenous infusion. It is not for intramuscular, intrathecal, intraperitoneal, or subcutaneous administration. The usual dose of Levofloxacin injection is 250 mg or 500 mg administered by slow infusion over 60 minutes every 24 hours or 750 mg administered by slow infusion over 90 minutes every 24 hours. Since the Levofloxacin injections are for single-use only, any unused portion should be discarded. Additives or other medications should not be added to Levofloxacin Injection or infused simultaneously through the same intravenous line.

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 solution containing multivalent cations, such as magnesium. Levofloxacin absorption is hampered by antacids, iron, and adsorbents. The use of nonsteroidal anti-inflammatory drugs (NSAIDs) may raise the risk of CNS stimulation. Warfarin can make you bleed more easily.

 

Contraindications

Patients with a history of allergies to levofloxacin, quinolone antibacterial drugs, or any other component of this product should not take levofloxacin.

 

Side Effects

Levofloxacin is well tolerated by most people. However, there are generally a few negative effects. Retinal detachment is a possibility. Nausea, vomiting, diarrhea, abdominal pain, flatulence, and phototoxicity are some of the other side effects (0.1 percent ). Tremors, melancholy, anxiety, and bewilderment are some of the unusual side effects that may occur.

 

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 the administration of levofloxacin:

• Levofloxacin injection should only be administered by slow intravenous drip within 60 or 90 minutes, depending on the dose.
• When taking levofloxacin, drink enough water to avoid concentration of urine.
• In the case of renal insufficiency, the dose should be adjusted during the administration of levofloxacin.

 

Therapeutic Class

4-Quinolone preparations

 

Storage Conditions

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

 

Pharmaceutical Name

ACI Limited