Beximco Pharma


Pharmatech Resources
Full Prescribing Info
Each film-coated tablet contains 250 mg of Ciprofloxacin USP.
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 Ciprofloxacin are obtained in serum and body tissues as well as in the urine following administration by mouth, Ciprofloxacin has been suggested for use in the treatment of a wide range of infections caused by susceptible organisms including infections of the urinary, respiratory and gastrointestinal tracts, gonorrhoea and septicaemia.
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 present or with an antibiotic active against anaerobes where the presence of Bacteroides fragillis is suspected.
Neofloxin is indicated for the treatment of following infections caused by sensitive bacteria: Severe systemic infections: e.g. septicaemia, bacteraemia, peritonitis, infections in immunosuppressed patients with haematological 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 bronchitis, acute exacerbation of cystic fibrosis, bronchiectasis, empyema.
Urinary tract infections: Uncomplicated and complicated urethritis, cystitis, pyelonephritis, prostatitis, epididymitis.
Skin and soft tissue infections: e.g. infected ulcers, wound infections, abscesses, cellulitis, otitis externa, erysipelas, infected burns.
Gastrointestinal infections: e.g. enteric fever, infective diarrhoea.
Infection of the biliary tract: e.g. cholangitis, cholecystitis, empyema of the gall bladder.
Intra-abdominal infections: e.g. peritonitis, intra-abdominal abscesses.
Bone and joint infections: e.g. osteomyelitis, septic arthritis.
Pelvic infections: e.g. salpingitis, endometritis, pelvic inflammatory diseases.
Eye, ear, nose and throat infections: e.g. otitis media, sinusitis, mastoiditis, tonsilitis.
Gonorrhoea: Including urethral, rectal and pharyngeal gonorrhoea caused by beta-lactamase producing organisms or organisms moderately sensitive to penicillin.
Dosage/Direction for Use
Adults: The dosage range for adults is 250-750 mg twice daily.
Dosage Guidelines: 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 Neofloxin tablets. Generally treatment should be continued for 3 days after the signs and symptoms of the infection have disappeared.
In the event of overdose, symptomatic treatment should be implemented. ECG monitoring should be undertaken, because of the possibility of QT interval prolongation.
Ciprofloxacin is contraindicated in patients who have shown hypersensitivity to Ciprofloxacin or other quinolones.
Special 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.
Caution should be taken when using fluoroquinolones, including ciprofloxacin, in patients with known risk factors for prolongation of the QT interval such as, for example: congenital long QT syndrome, concomitant use of drugs that are known to prolong the QT interval (e.g. Class IA and III antiarrhythmics, tricyclic antidepressants, macrolides, antipsychotics), uncorrected electrolyte imbalance (e.g. hypokalaemia, hypomagnesaemia), elderly, cardiac disease (e.g. heart failure, myocardial infarction, bradycardia).
Peripheral Neuropathy: Cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias and weakness have been reported in patients receiving fluoroquinolones, including Ciprofloxacin. Symptoms may occur soon after initiation of Ciprofloxacin and may be irreversible. Ciprofloxacin should be discontinued immediately if the patient experiences symptoms of peripheral neuropathy including pain, burning, tingling, numbness, and/or weakness or other alterations of sensation including light touch, pain, temperature, position sense, and vibratory sensation.
Vision disorders: If vision becomes impaired or any effects on the eyes are experienced, an eye specialist should be consulted immediately.
Use In Pregnancy & 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 mothers is thus not recommended.
Adverse Reactions
Gastrointestinal disturbances e.g. nausea, diarrhoea, 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.
Cardiac disorders not known: ventricular arrhythmia and torsades de pointes (reported predominantly in patients with risk factors for QT prolongation), ECG QT prolonged.
The following other reactions have also been reported, joint pain, mild photosensitivity and transient increase in liver enzymes (particularly in patients with previous liver damage) serum bilirubin, urea or creatinine levels.
Isolated cases of tendon damage (especially in the elderly and those taking corticosteroids) have been reported.
Nervous system disorders (frequency not known): Peripheral neuropathy (that may be irreversible) and polyneuropathy.
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. Ciprofloxacin, like other fluoroquinolones, should be used with caution in patients receiving drugs known to prolong the QT interval (e.g. Class IA and III anti-arrhythmics, tricyclic antidepressants, macrolides, antipsychotics).
Caution For Usage
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.
Incompatibility: The combination of Ciprofloxacin and Chloramphenicol may be antagonistic.
Store at room temperature in dry place and protect from light.
MIMS Class
ATC Classification
J01MA02 - ciprofloxacin ; Belongs to the class of fluoroquinolones. Used in the systemic treatment of infections.
FC tab 250 mg (single scored) x 5 x 10's.
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