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CIPROFLOXACIN Hydrochloride
XENOFLOX TM
Tablet

FORMULATION :
Each film-coated tablet contains:
Ciprofloxacin 500 mg (as Ciprofloxacin Hydrochloride)

PHARMACOKINETICS :
Ciprofloxacin is rapidly absorbed from the gastrointestinal tract. Oral bioavailability is approximately 70% and a peak plasma concentration of about 2.5 mcg per mL is achieved 1 to 2 hours after a dose of 500 mg by mouth. Absorption may be delayed by the presence of food, but is not substantially affected overall. The plasma half –life is about 3.5 to 4.5 hours. Plasma protein binding ranges from 20 to 40%. Ciprofloxacin is eliminated by urinary excretion. Excretion is virtually complete within 24 hours; about 40 to 50% of an oral dose is excreted unchanged in the urine and about 15% as metabolites.

INDICATIONS :
Used in the treatment of a wide range of infections including anthrax, biliary-tract infections, infected bites and stings, bone and joint infections, brucellosis, cat scratch disease, chancroid, exacerbations of cystic fibrosis, gastro-enteritis, gonorrhea, neutropenia, legionnaires’ disease, otitis externa, otitis media, peritonitis, Q fever, lower respiratory tract infections, septicaemia, skin infections, spotted fevers, surgical infection prophylaxis, typhoid and paratyphoid fever, typhus and urinary tract infection. It is also used for meningococcal meningitis prophylaxis.

DOSAGE AND ADMINISTRATION :
Adult
dosage : 250 mg to 750 mg twice daily depending on the severity and nature of infection.

For the treatment of gonorrhoea: a single oral doses of 250 mg or 500 mg is recommended, depending upon patterns of resistance.

For meningococcal meningitis prophylaxis : a single oral dose of 500 mg is suggested.

For surgical infection prophylaxis : a single dose of 750 mg given 60 to 90 minutes before the procedure.

Or as prescribed by the physician.

PRECAUTIONS :
Ciprofloxacin should be used with caution in patients with epilepsy or a history of CNS disorders. Ciprofloxacin and related fluoroquinolones have been shown to cause degenerative changes in weight-bearing joints of young animals, and should not be used in children, adolescents, pregnant women, or breast-feeding mothers. It should be avoided in meticillin-resistant Stapylococcus aureus infections because of the high level of resistance.

DRUG INTERACTIONS :
Fluoroquinolones are known to inhibit hepatic drug metabolism and may interfere with the clearance of drugs, such as theophylline, that are metabolised by the liver. Cations like aluminum, magnesium, or iron reduce the absorption of ciprofloxacin and related drugs when given concomitantly.

ADVERSE EFFECTS :
Ciprofloxacin is generally well tolerated. The most often involve the gastrointestinal tract, CNS, or skin. Gastrointestinal disturbances include nausea, vomiting, diarrhoea, abdominal pain, and dyspepsia. Headache, dizziness, restlessness are among the commonest effects on the CNS. Other includes tremor, drowsiness, insomnia, nightmares, and visual and other sensory disturbances and, more rarely, hallucinations, psychotic reactions, depression and convulsions.

AVAILABILITY :
Ciprofloxacin HCl 500 mg tablet, blister pack X 10’s (Box of 100’s)

STORAGE CONDITION:
Store at temperatures not exceeding 30°C .

 


 
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