COMPOSITION

Quixin™ : Each tablet contains Lavofloxacin Hemihydrate INN equivalent to Lavofloxacin 500 mg.

PHARMACOLOGICAL INFORMATION

Pharmacological Action

Quixin (Lavofloxacin) is a broad-spectrum fluoroquinolone antibiotic with proven activity against bacteria. It acts by inhibiting bacterial DNA gyrase.

Mechanism of Action

Quixin (Levofloxacin) b locks bacterial DNA synthesis by inhibiting bacterial topoisomerase II (DNA gyrase) and topoisomerase IV. Inhibition of DNA gyrase prevents the relaxation of positively supercoiled DNA that is required for normal transcription and replication. Inhibition of topoisomerase IV interferes with the separation of replicated chromosomal DNA into respective daughter cells during cell division.

Pharmacokinetic properties

Levofloxacin is rapidly and completely absorbed after oral administration. Peak plasma concentration is usually attained one to two hours after oral administration. The absolute bioavailability of a 500mg Levofloxacin tablet is approximately 99%, demonstrating complete oral absorption of Levofloxacin. Levofloxacin reaches its peak levels in skin tissues of healthy subjects at approximately 3 hours after dosing. After oral administration, approximately 87% of an administrated dose as recovered as unchanged drug in urine within 48 hours. No Levofloxacin crystals were found in any of the urine samples freshly collected from subjects receiving Levofloxacin.

CLINICAL INFORMATION

Therapeutic Indications

Quixin (Lavofloxacin) is used for the treatment of single or mixed infections caused by two or more susceptible organisms.It is recommended for the following indications

Dosage And Administration

Use in Pregnancy & Lactation

Pregnant women : In animal studies Levofloxacin does not appear to be teratogenic but it may damage developing cartilage. There are insufficient data to recommend the use of Lavofloxacin on pregnancy.

Lactating Mother : Levofloxacin does cross into the breast milk and its use during lactation is not advised.

Use in Children

If possible quinolone antibiotics should be avoided in childhood because of the effects on cartilage.

Use in Elderly

Although higher Levofloxacin serum levels is found in elderly, no dosage adjustment is necessary .

Use in patient with impaired liver function

In studies in patients with stable chronic cirrhosis, no significant changes in Levofloxacin pharmacokinetics have been observed. The kinetics of Levofloxacin in patients with acute hepatic insufficiency, however, has not been fully evaluated.

Use in patient with impaired renal function

Dosage adjustments are usually not required, except in patients with severe renal impairment (creatinine clecrance <20 ml/minute).If adjustment is necessary; this may be achieved by reducing the total daily dose by half .

Side 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 photo-toxicity (0.1%). Side effects that may be seen very rarely include tremors, depression, anxiety, confusion etc . 

Contraindications

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

Drug Interaction

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

Over Dosage & Treatment

In the event of acute, excessive oral overdosage, reversible renal toxicity has been reported in some cases. Therefore, apart from routine emergency measures, it is recommended to monitor renal function and to administer Mg or Ca-containing antacids which reduce the absorption of Levofloxacin.

PHARMACEUTICAL INFORMATION

Storage Conditions

Store in a cool and dry place, away from light. Keep out of reach of children.

Presentation & packaging

Quixin™: Each commercial box contains 30 tablets in Alu-PVDC blister pack