3-F Tablet

750 mg
Edruc Ltd.

Pack Size & Price:

Price not available.

Indications

Levofloxacin Hemihydrate is indicated in 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, Chronic bacterial prostatitis

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 & Administration

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
Community acquired pneumonia: 500 mg once daily for 7-14 days or 750 mg once daily for 5 days
Nosocomial pneumonia: 750 mg once daily for 7-14 days
Uncomplicated urinary tract infections: 250 mg once daily for 3 days
Complicated urinary tract infections and acute pyelonephritis: 250 mg once daily for 10 days
Complicated urinary tract infections and acute pyelonephritis: 750 mg once daily for 5 days
Uncomplicated skin and skin structure infections: 500 mg once daily for 7-10 days
Complicated skin and skin structure infections: 750 mg once daily for 7-14 days
Chronic bacterial prostatitis: 500 mg once daily for 28 days

Interaction

Antacids, Iron and Absorbents: reduce absorption of Levofloxacin
NSAIDs: may increase risk of CNS stimulation
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, dyspepsia, abdominal pain, diarrhea, headache, dizziness and asthenia; rarely tremor, anxiety, tachycardia, hypotension, hypoglycaemia, pneumonitis, rhabdomyolysis 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

The following measures should be taken during administration of Levofloxacin: 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.

Overdose Effects

Levofloxacin exhibits a low potential for acute toxicity. However, in the events of an acute overdosage, the stomach should be emptied. The patients should be kept under observation and appropriate hydration should be maintained.

Use in Special Population

Use in Children: From clinical studies, it is evident that Levofloxacin can be used in children aged as low as 6 months.

The usual dose for children in community acquired pneumonia (CAP) 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 (AOM) 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.

Storage Conditions

Store in a cool & dry place, protected from light. Keep out of the reach of children.