Quilev®
Levofloxacin

COMPOSITION:
Quilev® Tablet: Each film coated tablet contains Levofloxacin Hemihydrate INN equivalent to Levofloxacin 500mg.

PHARMACOLOGICAL INFORMATION:
Pharmacological Action
Levofloxacin is a synthetic, broad-spectrum, third generation fluoroquinolone derivative antibacterial agent for oral administration. Chemically Levofloxacin is a chiral fluorinated carboxyquinolone.

Mechanism of Action
Quilev® (Levofloxacin) inhibits to bacterial IV topoisomerase and DNA gyrase, the enzyme that produces a negative super coil in DNA, permitting transcription, replication, repair and recombination.

CLINICAL INFORMATIONS:
Therapeutic Indications
Levofloxacin is indicated for the treatment of adults (18 years of age) with mild, moderate, and severe infections caused by susceptible strains of the designated micro-organisms in the condition listed below:

• 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, or Moraxella catarrhalis.
• Community-acquired pneumonia due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Klebsiella pneumoniae, Moraxella cararrhalis, Chlamydia pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae.
• Complicated urinary tract infections due to Escherichia coli, Klebsiella pneumoniae, or Staphylococcus saprophyticus. Acute pyelonephritis caused by Escherichia coli.
• Uncomplicated & complicated skin and soft tissue infections including abscesses, cellulitis, furuncles, impetigo, pyoderma, wound infections, due to Staphylococcus aureus, Streptococcus pyogenes, Proteus mirabilis or Enterococcus faecalis.

Dosage and Administration

• Acute sinusitis, 500mg once daily for 10-14 days
• Exacerbation of chronic bronchitis, 250-500mg daily for 7 days
• Community-acquired pneumonia, 500mg once or twice daily for 7-14 days
• Complicated urinary-tract infections and acute pyelonephritis, 250mg daily for 7-10 days
• Uncomplicated skin and soft-tissue infections, 500mg once daily for 7-10 days
• Complicated skin and soft-tissue infections, 750mg once daily for 7-14 days.

Use in Children
Not recommended for children.

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

Use in Patients with impaired renal function
The following measures should be taken during administration of Levofloxacin:

• While taking Levofloxacin, adequate amount of water should be taken to avoid concentrated form of urine.
• Dose adjustment should be exercised during Levofloxacin ingestion in presence of renal insufficiency.

Use in Patients with impaired hepatic function
Pharmacokinetic studies in hepatically impaired patients have not been conducted. Due to the limited extent of Levofloxacin metabolism, the pharmacokinetics of Levofloxacin is not expected to be affected by hepatic impairment.

Elderly Patients
Geriatric patients are at increased risk for developing severe tendon disorders including tendon rupture when being treated with a fluoroquinolone such as Quilev®. This risk is further increased in patients receiving concomitant corticosteroid therapy. Tendinitis or tendon rupture can involve the Achilles, hand, shoulder, or other tendon sites and can occur during or after completion of therapy; cases occurring up to several months after fluoroquinolone treatment have been reported. Caution should be used when prescribing Quilev® to elderly patients especially those on corticosteroids.

Drug Interactions
Antacids, Iron and Adsorbents-reduce absorption of Levofloxacin. NSAID- may increase the risk of CNS stimulation.Warfarin- may increase the risk of bleeding.

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

Undesirable Effects
Levofloxacin is generally well tolerated. However, a few side effects can usually be seen. Side effects include: nausea, vomiting, diarrhea, abdominal pain, flatulence and rare occurrence of phototoxicity (0.1%). Side effects that may be seen very rarely include tremors, depression, anxiety, confusion etc.

Over Dosage & Treatment
In the event of an acute overdosage, the stomach should be emptied. The patient should be observed and appropriate hydration maintained. Levofloxacin is not efficiently removed by hemodialysis or peritoneal dialysis.

PHARMACEUTICAL INFORMATION:
Storage Conditions
Store in a cool and dry place, away from light. Keep out of reach of children.

Presentation & Packaging
Quilev® tablet: Each box contains 6x4’s tablets in Alu-Alu blister pack.