100ml infusion solution contains Ciprofloxacin USP 200mg in the form of Ciprofloxacin Lactate 254.4mg.
Ciprofloxacin is a synthetic 4-quinolone derivative, with bactericidal activity. It acts via inhibition of bacterial DNA gyrase, ultimately resulting in interference with DNA function. Ciprofloxacin is highly active against a wide range of Gram-positive and Gram-negative organisms and has shown activity against some anaerobes; Chlamydia spp. and Mycoplasma spp. It is often found that minimum bactericidal concentrations are in the range of minimum inhibitory concentrations.
Ciprofloxacin is indicated for the treatment of the following infections caused by sensitive bacteria:-
- Severe systemic infections e.g. Septicaemia, Bacteraemia, Peritonitis, Infection in immunosuppressed patient with haematological or solid tumours and in patients in intensive care units with specific problems such as infected burns.
- Respiratory tract infection: e.g. lobar and bronchopneumonia, acute and chronic bronchitis, acute exacerbation of cystic fibrosis, bronchiectasis, emphysema.
- Ear, Nose and Throat infection: e.g. mastoiditis, otitis media and sinusitis, especially if due to Gram-negative bacteria (including pseudomonas spp.).
- Eye infections e.g. bacterial conjunctivitis.
- Urinary tract infections: e.g. uncomplicated and complicated urethritis, cystitis, pyelonephritis, prostatitis, epididymitis.
- Skin and soft tissue infections: infected ulcers, wound infections, abscesses, cellulites, otitis externa, erysipelas, infected burns.
- Bone and joint infections e.g. osteomyelitis, septic arthritis.
- Intra-abdominal infections e.g. peritonitis, intra-abdominal abscesses.
- Infections of the biliary tract: e.g. cholangitis, cholecystitis, empyema of the gall bladder.
- Gastro-intestinal infections: e.g. enteric fever, infective diarrhea.
- Pelvic infections: e.g. salpingitis, endometritis, pelvic inflammatory disease.
- Gonorrhoea: including urethral, rectal and pharyngeal gonorrhoea caused by B-lactamase producing organisms or organisms moderately sensitive to penicillin.
For the treatment of acute pulmonary exacerbation of cystic fibrosis associated with P. aeruginosa infection in paediatric patients aged 15 – 17years.
Ciprofloxacin in Ciflaxin® Infusion is contraindicated in patients who have shown hypersensitivity to Ciprofloxacin or other quinolone anti-infectives. Except in cases of exacerbation of cystic fibrosis associated with P. aeruginosa (in patients aged 5 -17year), Ciprofloxacin is contra-indicated in children and growing adolescents unless the benefits of treatment are considered to out weigh the risks.
- Increase plasma levels of theophylline have been observed following concurrent administration with Ciprofloxacin. It is recommended that the dose of theophylline should be reduced and plasma levels of theophylline monitored.
- The simultaneous administration of quinolones and glibenclamide can on occasion potentiate the effect of glibenclamide resulting in hypolycaemia.
- Concomitant use with probenecid reduces the renal clearance of Ciprofloxacin, resulting in increased quinolones plasma levels.
- Use with cyclosporine may cause an increase in serum creatinine and nephrotoxic effects.
- Serum level may be increased with cimetidine.
- Severe hypoglycemia has been reported with concomitant use of glyburide, monitor serum glucose levels.
- Ciprofloxacin should be used with caution in epileptics and patients with a history of CNS disorders and only if the benefits of treatment are considered to outweigh the risk of possible CNS side-effects.
- Patients with a family history of or actual defects in glucose-6-phosphate dehydrogenase activity are prone to haemolytic reactions with quinolones and so Ciprofloxacin should be used with caution in these patients.
- Tendon inflammation and rupture may occur with quinolone antibiotics. Such reactions have been observed particularly in older patients and in those treated concurrently with corticosteroids. At the first sign of pain or inflammation, patients should discontinue Ciprofloxacin and rest the affected limbs.
- As with other quinolones, patients should avoid prolonged exposure to strong sunlight or UV radiation during treatment.
Ciprofloxacin is generally well tolerated. The most frequently reported adverse reactions are: nausea, diarrhoea and rash.
- Cardiovascular, e.g. tachycardia, oedema, fainting, hot flushes and sweating.
- Effects on haematological parameters e.g. anaemia, eosinophilia, increases or decreases in white cell and /or platelet count and altered prothrombin levels.
- Local irritation including pain at the site of injection accompanied in a small number of patients by phlebitis or thrombophlebitis.
SYMPTOMS OF OVERDOSE AND ANTIDOTE:
- Discontinue Ciprofloxacin at the first appearance of a skin rash or any other sign of hypersensitivity at the onset of any CNS symptom, or the onset of pseudomembranous colitis. Treat allergic reaction with epinephrine (Adrenaline).
- Many will require symptomatic treatment; monitor closely. Maintain hydration in overdose. No specific antidote; up to 10% may be excreted by hemodialysis or peritoneal dialysis. Maintain patient until drug is excreted.
DOSAGE AND ADMINISTRATION.
The dosage of intravenous ciprofloxacin is determined by the severity and type of infection, the sensitivity of causative organism(s), the age, weight and renal function of the patient. The dosage range for adults is 100-400mg twice daily. The product may be infused directly and administered by short-term infusion over periods of 30-50 minutes. The 400mg dose should be administered over a period of 60 minutes. Initial intravenous administration may be followed by oral treatment.
Impaired renal function:
Dosage adjustments are not usually required, except in patients with severe renal impairment (serum creatinine>265 micromole/ L or creatinine clearance<20ml/ minute). If adjustment is necessary this may be achieved by reducing the total daily dose by half, although monitoring of drug serum levels provides the most reliable basis for dose adjustment.
Adolescents and children:
Ciprofloxacin has been shown to cause arthropathy in weight-bearing joints of immature animals. Although analysis of available safety data from Ciprofloxacin use in patients less than 18years of age, the majority of whom had cystic fibrosis, did not disclose any evidence of drug related cartilage or articular damage, its use in the paediatric patient population is generally not recommended.
Complicated UTIs or pyelonephritis in patients from 1 to 17years of age: 6 to 10mg/ kg every 8hours for 10 to 21days.
Pulmonary exacerbations of cystic fibrosis: 10 to 15mg/ kg every 8hours.
Other infection: infants and children 5 to 10mg/ kg of body weight every 12hours.
Neonates: 3.5 to 20mg/ kg every 12hours.
Ciflaxin® infusion is presented in bottle with a total content of 100ml.
Store in a cool dry place
DRUGFIELD PHARMACEUTICAL LTD,
Lynson Chemical Avenue,
Km 38 Lagos-Abeokuta Expressway,