Levofloxacin (Injection)

Indications
Acute maxillary sinusitis, acute bacterial exacerbation of chronic bronchitis, nosocomial pneumonia, community acquired pneumonia, uncomplicated urinary tract infections, complicated urinary tract infections, acute pyelonephritis, uncomplicated & complicated skin and skin structure infections including abscesses, cellulitis, furuncles, impetigo, pyoderma, wound infections, chronic bacterial prostatitis and typhoid fever.
Levofloxacin Injection has
Proven clinical success in hospital infections
Reaches high concentrations in lung, urine, skin and prostate
Ensures excellent gram-positive and gram-negative bacterial coverage, Offers better option for switch therapy

Therapeutic Class
4-Quinolone preparations

Pharmacology
Levofloxacin exerts antibacterial action by inhibiting bacterial topoisomerase IV and DNA gyrase, the enzymes required for DNA replication, transcription repair and recombination. It has in vitro activity against a wide range of gm-ve and gm+ve microorganisms.

Dosage
Levofloxacin solution for infusion is administered by slow intravenous infusion once or twice daily. The dosage depends on the type and severity of the infection and the sensitivity of the causative pathogen. The duration of treatment varies according to the severity of the disease.
Adult:
Community-acquired pneumonia: 500 mg once or twice daily,
Complicated urinary tract infections (including pyelonephritis): 250 mg once daily,
Chronic bacterial prostatitis: 500 mg once daily,
Skin and soft tissue infections: 500 mg twice daily
Enteric fever: 500 mg once daily.
Children:
Levofloxacin can be used in children aged as low as 6 months. The usual dose for children in community acquired pneumonia is:
Children aged 6 months to less than 5 years: 10 mg/kg b.i.d. (up to 500 mg per day) for 10 days,
Children aged 5 years to 16 years: 10 mg/kg q.d. (up to 500 mg per day) for 10 days.
The usual dose for children in recurrent or persistent Acute Otitis Media is:
Children aged 6 months to less than 5 years: 10 mg/kg per day (maximum dose: 500 mg/day) given twice daily for 10 days.

Administration
Administration of Levofloxacin (solution for infusion) should be continued for a minimum of 48 to 72 hours after the patient has become febrile or evidence of bacterial eradication has been obtained. Levofloxacin solution for infusion is only intended for slow intravenous infusion; it is administered once or twice daily. The infusion time must be at least 30 minutes for 250 mg or 60 minutes for 500 mg Levofloxacin solution for infusion. It is possible to switch from an initial intravenous application to the oral route at the same dosage after a few days.

Interaction
Antacids, Iron and Absorbents–reduce absorption of Levofloxacin. NSAIDs may increase risk of CNS stimulation and Warfarin may increase the risk of bleeding.

Contraindications
Levofloxacin is contraindicated in patients with a history of hypersensitivity to Levofloxacin, quinolone antimicrobial agents, or any other components of this product.

Side Effects
Levofloxacin is generally well tolerated. Side effects include: nausea, vomiting, diarrhoea, abdominal pain, flatulence and rare occurrence of phototoxicity. Side effects that may be seen very rarely include tremors, depression, anxiety, confusion etc.

Pregnancy & Lactation
Levofloxacin is not recommended for use during pregnancy or nursing, as the effects on the unborn child or nursing infant are unknown.

Precautions & Warnings
While taking Levofloxacin adequate amount of water should be drunk to avoid risk of crystalluria. Dose adjustment should be exercised during Levofloxacin ingestion in presence of renal insufficiency & hepatic insufficiency.
Infusion of fluid should be immediately discontinued if rigor arises for any reason during the process. Do not use if the solution is cloudy, contains particles or after expiry date.

Use in Special Populations
Paediatric Use: Levofloxacin is not recommended for children less than 6 (six) months of age.

Storage Conditions
Store at controlled room temperature. Protect from light. This IV Infusion is not intended for multi-dose use.