COMPOSITION

XbacTM: Each tablet contains Ciprofloxacin Hydrochloride USP equivalent to Ciprofloxacin 500 mg.

PHARMACOLOGICAL INFORMATION

Pharmacological Action

XbacTM (Ciprofloxacin) is one of the compounds of fluoroquinolone class of antibiotics. It is rapidly absorbed after oral administration and shows excellent penetration into extra-vascular tissues and other body compartments. It is a synthetic bactericidal antibiotic that inhibits bacterial nuclear DNA synthesis, so that bacteria rapidly die.

Mechanism of Action

XbacTM (Ciprofloxacin) inhibits the replication of bacterial DNA by interfering with the action of DNA gyrase during bacterial growth and reproduction. DNA gyrase (topoisomerase II) is responsible for the supercoiling and uncoiling of the DNA. Supercoiling of the DNA allows the long DNA molecule to fit into the cell. Uncoiling of the structure is the initiative step for replication, transcription and repair of the DNA. Thus, prolonged inhibition will eventually lead to the death of the cell.

Pharmacokinetics

XbacTM (Ciprofloxacin) is rapidly and well absorbed from the gastrointestinal tract after oral administrations. The absolute bioavailability of Ciprofloxacin tablet is approximately 70-80% with no substantial loss by first pass metabolism. Following oral administration Ciprofloxacin is absorbed rapidly and extensively mainly from the small intestine, reaching maximum serum concentrations 1-2 hours later with maximum concentrations ranging from 1.2 to 4.3 µg/ml. The protein binding of Ciprofloxacin is low (20-30%). Ciprofloxacin undergoes predominantly renal and some extra-renal excretion. The serum elimination half-life in subjects with normal renal function is approximately 4 hours.

CLINICAL INFORMATIONS

Therapeutic Indications

Urinary tract infections

Typhoid and paratyphoid fever

Infectious diarrhoea

Lower respiratory-tract infections

Skin and soft-tissue infections

Bone & joint infections

Gastro-enteritis (including travellers diarrhoea and campylobacter enteritis, cholera, salmonella enteritis and shigellosis)

Gonorrhoea

Dosage and Administration

XbacTM (Ciprofloxacin) may be given orally without regard to meals. Patients receiving Ciprofloxacin should be well hydrated and should be instructed to drink fluids liberally. The usual adult oral dose of Ciprofloxacin ranges from 250 to 750 mg twice daily depending on the severity and nature of the infection.

Use in Pregnancy and Lactation

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

Lactating mother: Ciprofloxacin 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

Higher ciprofloxacin levels may be seen in the elderly, but dose modification is only required in association with impaired renal function.

Use in patient with Impaired Hepatic Function

In studies, patients with stable chronic cirrhosis, no significant changes in ciprofloxacin pharmacokinetics have been observed. The kinetics of ciprofloxacin 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 clearance <20 ml/minute).

Side Effects

Adverse effects include nausea and other gastrointestinal disturbances, headache, dizziness and skin rashes.

Contraindications

Ciprofloxacin is contraindicated in persons with a history of hypersensitivity to ciprofloxacin or any member of the quinolone class of antimicrobial agents.

Precautions

Ciprofloxacin should be used with caution in patients with epilepsy or a history of CNS disorders. Since Ciprofloxacin and related fluoroquinolones have been shown to cause degenerative changes in weight-bearing joints of young animals, these drugs should not be used in children, adolescents, pregnant women, or breast-feeding mothers. Patients should be well hydrated to prevent the formation of highly concentrated urine.

Drug Interactions

Concurrent administration of Ciprofloxacin with theophylline may lead to elevated plasma concentrations of theophylline and prolongation of its elimination half-life. This may result in increased risk of theophylline related adverse reactions. Antacid containing magnesium or aluminum may interfere with the absorption of Ciprofloxacin resulting in serum and urine levels lower then desired and concurrent administration of these agents with Ciprofloxacin should be avoided.

Overdosage & Treatment

In the event of acute overdosage, reversible renal toxicity has been reported in some cases. The stomach should be emptied by inducing vomiting or by gastric lavage. The patient should be carefully observed and given supportive treatment.

PHARMACEUTICAL INFORMATION

Storage Conditions

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

Presentation & Packaging

XbacTM : Each commercial box contains 30 tablets in Alu-PVDC blister pack.