CIPROM
Ciprofloxacin Tablet/ Injection

DESCRIPTION
Ciprom Tablet: Single scored coated tablet, each contains 250mg of Ciprofloxacin USP.
Ciprom Tablet: Single scored coated tablet, each contains 500mg of Ciprofloxacin USP.
Ciprom Tablet: Single scored coated tablet, each contains 750mg of Ciprofloxacin USP.

INDICATIONS
Ciprofloxacin is indicated for the treatment of single or mixed infections caused by two or more susceptible organisms. It can also be used for infections caused by organisms resistant to other antibiotics including Aminoglycosides, Penicillins and Cephalosporins. As antibacterial concentrations of Cliprofloxacin are obtained in serum and body tissues as well as in the urine following administration by mouth, Ciprofloxacin has been sugested for use in the treatment of a wide range of infections caused by susceptible and gastrointestinal tracts, gonorrhea and septicemia.

The extensive tissue penetration of Ciprofloxacin combined with its enhanced antibacterial activity (including antipseudomonal activity), enables Ciprofloxacin to be used alone (pending sensitivity results), or in combination with an Aminoglycoside or with beta-lactam antibiotics for instance when severe neutropenia is presence of Bacteroides fragillis is suspected.

Ciprom is indicated for the treatment of following infections caused by sensitive bacteria:

--> Severe systemic infections: Septicemia, bacteremia, peritonitis, infections in immunosuppressed patients with hematological or solid tumors and in patients in intensive care unit with specific problems such as infected burns.

--> Respiratory tract infections: Lobar and bronchopneumonia, acute and chronic bronchitits acute exacerbation of cysticfibrosis, bronchiectasis, empyema.

--> Urinary tract infections: Uncomplicated and complicated are urethritis, cystitis, pyelonephritis, prostatitis, epididymitis.

--> Skin and soft tissue infections: Infected ulcers, wound infections, abscesses, cellulitis, otitis externa, erysipelas, infected burns.

--> Gastronitestinal infections: Enteric fever, infective diarrhea.

--> Infection of the billary tract : Cholangitis, cholecystics, empyema of the gall bladder.

--> Intra abdominal infections: Peritonitis, intra abdominal abscesses.

--> Bone and joint infections: Osteomylitis, spetic arithritis.

--> Pelvic infections: Salpingitis, Pelvic inflammatory diseases.

--> Eye, ear, nose and throat infections: Otitis media, sinusitis, mastoiditis, tonsillitis.

--> Gonorrhea: Including urethral, rectal and pharyngeal gonorrhea caused by beta-lactamase producing organisms or organisms moderately sensitive to penicillin.

CLINICAL PHARMACOLOGY
Ciprofloxacin is a fluoroquinolone antibacterial agent with a wide spectrum of activity including Enterobacteriaceae, Pseudomonas aeruginasa, Haemophilus, and Neisseria spp. and also against staphylococci and some other Gram-positive bacteria.

Ciprofloxacin is bactericidal and acts by inhibitating the A subunit of DNA gyrase (topoisomerse 11) which is essential in the formation of supercoils of DNA. The process is necessary for compacting the bacterial chromosome within the cell. The events following lethal effect of ciprofloxacin on exposed bacterial cells are not completely understood.

Ciprofloxacin is well absorbed from the gastrointestinal tract. Oral bioavailability is approximately 70% and a peak plasma concentration of about 2.5 mg per ml is achieved 1 to 2 hours after a dose of 500 mg by mouth. The plasma half-life is about 3.5 to there is limited information on the effect of liver dysfunction. Plasma protein binding ranges from 20 to 40 %. Ciprofloxacin is widely distributed in the body and tissue penetration is generally good. It crosses the placenta and is excreted in breast milk. High concentrations are achieved in bile.

Ciprofloxacin is eliminated mainly by urinary excretion (about 40 to 50% in unchanged form and 15% as metabolites). Fecal excretion over 5 days has accounted for 20 to 35% of an oral dose.

DOSAGE AND ADMINISTRATION
--> Tablet: The dosage range for adults is 250-750 mg twice daily.

Dosage Guidelines (Tablet)
--> Adolescents and children: Its use in children, growing children and growing adolescents is not recommended.

However, where the benefit of using Ciprofloxacin is considered to outweigh this potential risk, the dosage should be 7.5-15 mg/kg/day depending upon the severity of infection, administered in two divided doses.

--> Duration of treatment: For acute infections the usual treatment period is 5 to 10 days with Ciprom tablets. Generally treatment should be continued for 3 days after the signs and symptoms of the infection have disappeared.

CONTRAINDICATION
Ciprofloxacin is contraindicated in patients who have shown hypersensitivity to Ciprofloxacin or other quinolones.

WARNING AND PRECAUTIONS
Ciprofloxacin should be used with caution in patients with a history of convulsive disorders. Crystalluria related to the use of Ciprofloxacin has been observed only rarely. Patients receiving Ciprofloxacin Should be well hydrated and excessive alkalinity of the urine should be avoided.

DRUG INTERACTIONS
Concurrent administration of Ciprofloxacin with Theophylline may lead to elevated plasma concentrations of Theophylline and prolongation of its elimination half-life.

Antacids containing Magnesium hydroxide or Aluminium hydroxide may interfere with the absorption of Ciprofloxacin. Probenecid interferes with renal tubular secretion of Ciprofloxacin and produces an increase in the level of Ciprofloxacin in the serum.

INFORMATION FOR PATIENTS
Patients should be advised that Ciprofloxacin may be taken with or without meals. The preferred time of dosing is 2 hours after a meal.

USE IN PREGNANCY AND LACTATION
As with other quinolones, Ciprofloxacin has been shown to cause arthropathy in immature animals and therefore its use during pregnancy is not recommended. Studies in rats have indicated that Ciprofloxacin is secreted in milk, administration to nursing mother is thus not recommended.

SIDE EFFECTS
--> Gastrointestinal disturbances e.g. nausea, diarrhea, vomiting, dyspepsia, abdominal pain

--> Disturbance of the central nervous system e.g. dizziness, headache, tiredness, confusion, convulsions.

--> Hypersensitivity reactions e.g. skin rashes, pruritus and possible systemic reactions

The following other reactions have also been reported, joint pan, mild photosensitivity and transient increase in liver enzymes (particularly in patients with previous liver damage), serum bilirubin, urea or creatinine levels.

PACKAGING
Ciprom Tablet 250mg: Box contains 30 tablets in 3X10's blister strips.
Ciprom Tablet 500mg: Box contains 30 tablets in 5x6's blister strips.
Ciprom Tablet 750mg: Box contains 12 tablets in 2X6's blister strips.