CIPROFLOXACIN

General dosage recommendations:

The dosage of Ciprofloxacin film coated tablets is determined by the severity and type of infection, the sensitivity of the causative organism(s) and the age, weight and renal function of the patient. Ciprofloxacin film coated tablets should be swallowed whole with an adequate amount of liquid.

Adults The dosage range for adults is 250-750mg twice daily. d. d. d. d. d. d. Prophylaxis Elective upper gastro-intestinal surgical and endoscopic procedures 750mg single dose 60-90 minutes prior to the procedure**. If gastro-oesophageal obstructive lesions are suspected use with an anti-infective effective against anaerobes * Although the pharmacokinetics of ciprofloxacin remains unchanged in patients with cystic fibrosis, the low bodyweight of these patients should be taken into consideration when determining dosage.

5 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.

Elderly Although higher ciprofloxacin serum levels are found in the elderly, no adjustment of dosage is necessary. Adolescents and children As with other drugs in its class, 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 18 years 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 population is generally not recommended.

Clinical and pharmacokinetic data support the use of ciprofloxacin in paediatric cystic fibrosis patients (aged 5 - 17 years) with acute pulmonary exacerbations associated with P. aeruginosa infection, at a dose of 20mg/kg orally twice daily (maximum daily dose 1500mg).

For indications other than treatment of pulmonary exacerbations in cystic fibrosis, ciprofloxacin may be used in children and adolescents where the benefit is considered to outweigh the potential risks. In these cases a dosage of 5-15mg/kg orally twice daily should be administered depending upon the severity of infection.

4). A range of psychiatric symptoms may occur as part of these side effects, which may include, but are not necessarily limited to, sleep disorders, anxiety, panic attacks, confusion, or depression. There are no pharmacological treatments established to be effective treatments of the symptoms of long lasting or disabling side effects associated with fluoroquinolones.

The frequency of these prolonged, disabling and potentially irreversible serious drug reactions cannot be estimated with precision using available data, but the reporting incidence from adverse drug reaction reports indicates the frequency is at minimum between 1/1,000 and 1/10,000 (corresponding to the Rare frequency category).

Ciprofloxacin is generally well tolerated. The most frequently reported adverse reactions are nausea, diarrhoea and rash. Blood and the lymphatic system disorders Anaemia, eosinophilia, increases or decreases in white cell and/or platelet count, altered prothrombin levels.

Very rarely: haemolytic anaemia, agranulocytosis or pancytopenia. Metabolism and nutrition disorders Hyperglycaemia. Nervous system disorders Headache, restlessness, depression, dizziness, tremor, convulsions, confusion, hallucinations, somnolence, sleep disorders.

Very rarely: migraine and anxiety states. Isolated cases of ciprofloxacin-induced psychoses have been reported, which may progress to self-endangering behaviour. Paresthesia has been reported. Eye disorders Very rarely: visual disturbances including diplopia and colour disturbances.

Ear and labyrinth disorders Very rarely: tinnitus, transient impairment of hearing particularly at high frequencies. Cardiac disorders Tachycardia Vascular disorders Oedema, fainting, hot flushes and sweating. Very rarely: vasculitis.

There are isolated reports of intracranial hypertension associated with quinolone therapy. Gastrointestinal disorders Nausea, diarrhoea, vomiting, dyspepsia, abdominal pain, anorexia, flatulence, dusphagia. Rarely: pseudomembranous colitis.

Prolonged, disabling and potentially irreversible serious adverse drug reactions:

Cases of prolonged (continuing for months or years), disabling and potentially irreversible serious adverse drug reactions affecting different, sometimes multiple, body systems (including musculoskeletal, nervous, psychiatric and senses) have been reported in patients receiving quinolones and fluoroquinolones irrespective of their age and pre-existing risk factors.

There are no pharmacological treatments established to be effective treatments of the symptoms of long lasting or disabling side effects associated with fluoroquinolones. Ciprofloxacin 250 mg, film coated tablets should be discontinued immediately at the first signs or symptoms of any serious adverse reaction and patients should be advised to contact their prescriber for advice, so that symptoms can be appropriately investigated and to avoid further exposure which could potentially worsen adverse reactions.

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. CNS side-effects have been reported after first administration of ciprofloxacin in some patients.

8). Crystalluria related to the use of ciprofloxacin has been reported. Patients receiving ciprofloxacin should be well hydrated and excessive alkalinity of the urine should be avoided. 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.

Ciprofloxacin is contra-indicated in patients who have shown hypersensitivity to ciprofloxacin or other quinolone anti-infectives. Except in cases of exacerbations of cystic fibrosis associated with P. aeruginosa (in patients aged 5-17 years), ciprofloxacin is contra-indicated in children and growing adolescents unless the benefits of treatment are considered to outweigh the risks.