Evo 500

Generic

Levofloxacin Hemihydrate

 

Indications

• 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, Klebsiella pneumoniae or Moraxella catarrhalis.
• Nosocomial pneumonia due to methicillin-susceptible Staphylococcus aureus, Pseudomonas aeruginosa, Serratia marcescens, Escherichia coli, Klebsiella pneumoniae, Haemophilus influenzae, or Streptococcus pneumoniae.
• 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 urinary tract infections due to E. coli, Klebsiella pneumoniae or Staphylococcus saprophyticus.
• Complicated urinary tract infections due to Enterococcus faecalis, Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, or Pseudomonas aeruginosa.
• Acute pyelonephritis caused by E. coli.
• Uncomplicated & complicated skin and skin structure infections including abscesses, cellulitis, furuncles, impetigo, and pyoderma, wound infections, due to Staphylococcus aureus, Streptococcus pyogenes, Proteus mirabilis or Enterococcus faecalis.
• Chronic bacterial prostatitis due to Escherichia coli, Enterococcus faecalis, or Staphylococcus epidermidis.

 

Pharmacology

Levofloxacin is a third generation fluoroquinolone antibiotic that is synthetic and broad-spectrum. Chemically, Levofloxacin is a chiral fluorinated carboxyquinolone. Levofloxacin works as an antibiotic by blocking the enzymes necessary for DNA replication, transcription repair, and recombination, bacterial topoisomerase IV and DNA gyrase. It is active in vitro against a wide variety of gm-ve and gm+ve bacteria.

 

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 sever 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

No quinolone should be delivered concurrently with any solution containing multivalent cations, such as magnesium, via the same intravenous line. Antacids, iron, and adsorbents all inhibit levofloxacin absorption. NSAIDs have been linked to an increased risk of CNS stimulation. Warfarin has been linked to an increase in the risk of bleeding.

 

Contraindications

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

 

Side Effects

In general, levofloxacin is well tolerated. However, a few adverse effects are common. There is a possibility of retinal detachment. Other adverse effects include nausea, vomiting, diarrhea, stomach discomfort, flatulence, and, in rare cases, phototoxicity (0.1 percent ). Tremors, sadness, anxiety, disorientation, and other side effects are extremely infrequent.

 

Pregnancy & Lactation

Because the effects on the unborn child or nursing infant are unclear, levofloxacin is not advised for use during pregnancy or breastfeeding.

 

Precautions & Warnings

During the administration of Levofloxacin, the following precautions should be taken:

• Levofloxacin Injections should only be given through gradual intravenous infusion over 60 or 90 minutes, depending on the dose.
• A sufficient amount of water should be consumed when administering Levofloxacin to avoid concentrated urine.
• In the case of renal impairment, dose modification should be used while administering Levofloxacin.

 

Therapeutic Class

Preparations containing 4-quinolone

 

Storage Conditions

Keep below 30°C and away from light and moisture. Keep out of children's reach.

 

Pharmaceutical Name

Beximco Pharma Ltd