Levoseem 500Tablet

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 caused by Streptococcus pneumoniae, Haemophilus influenzae or Moraxella catarrhalis.
• Acute bacterial exacerbation of chronic bronchitis caused by Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae or Moraxella catarrhalis.
• Community-acquired pneumonia caused by Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydia pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae.
• Complex and uncomplicated urinary tract infections caused by Escherichia coli, Klebsiella pneumoniae or Staphylococcus saprophyticus.
• Acute pyelonephritis caused by Escherichia coli.
• Simple and complex skin and soft tissue infections, including abscesses, cellulitis, boils, impetigo, pyoderma, wound infections, caused by Staphylococcus aureus, Streptococcus pyogenes, Proteus mirabilis, or Enterococcus faecalis.
• Intestinal infection caused by Enterobacter, Escherichia coli, Campylobacter, Vibrio cholerae, Shigella, and Salmonella.

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.

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

Side Effects

Levofloxacin is well tolerated by most people. However, there are typically a few adverse effects. Retinal detachment is a possibility. Nausea, vomiting, diarrhea, stomach discomfort, flatulence, and phototoxicity are some of the other adverse effects (0.1 percent ). Tremors, sadness, anxiety, and disorientation are some of the uncommon side effects that may occur.

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 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

Pharmaceutical Name

Seema Pharmaceuticals Ltd.