Generic

Levofloxacin Hemihydrate

Indications

Levofloxacin is used to treat mild, moderate, and severe infections caused by susceptible strains of the following microorganisms in the following conditions:

• Acute maxillary sinusitis due to Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis.
• Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis cause an acute bacterial aggravation of chronic bronchitis.
• Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydia pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae are common causes of community-acquired pneumonia.
• Urinary tract infections caused by Escherichia coli, Klebsiella pneumoniae, or Staphylococcus saprophyticus, both simple and complex.
• Escherichia coli-induced acute pyelonephritis.
• Skin and soft tissue infections caused by Staphylococcus aureus, Streptococcus pyogenes, Proteus mirabilis, or Enterococcus faecalis, include abscesses, cellulitis, furuncles, impetigo, pyoderma, and wound infections.
• Enterobacter sp., E. coli, Campylobacter sp., Vibrio cholerae, Shigella sp., and Salmonella sp. cause enteric illnesses.

Pharmacology

Levofloxacin is a third-generation fluoroquinolone antibiotic that is synthetic and broad-spectrum. Levofloxacin is a chiral fluorinated carboxyquinolone chemically. The enzymes necessary for DNA replication, transcription repair, and recombination, bacterial topoisomerase IV and DNA gyrase, are inhibited by levofloxacin. It exhibits efficacy against a variety of gm-ve and gm+ve bacteria in vitro.

Dosage & Administration

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.

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

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

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

• Levofloxacin Depending on the dosage, injection should only be given as a gradual intravenous infusion over a period of 60 or 90 minutes.
• A sufficient amount of water should be consumed when taking Levofloxacin to avoid a concentrated type of urine.
• In the presence of renal impairment, dose adjustments should be made during Levofloxacin administration.

Therapeutic Class

4-Quinolone preparations.

Storage Conditions

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

Pharmaceutical Name

ACME Laboratories Ltd.