Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Ranbaxy (UK) Limited, 5th floor, Hyde Park, Hayes 3, 11 Millington Road, Hayes, UB3 4AZ, United Kingdom
Ciprofloxacin 250 mg film-coated tablets are indicated for the treatment of the following infections (see sections 4.4 and 5.1). Special attention should be paid to available information on resistance to ciprofloxacin before commencing therapy.
Ciprofloxacin may be used in the management of neutropenic patients with fever that is suspected to be due to bacterial infection.
Ciprofloxacin may also be used to treat severe infections in children and adolescents when this is considered to be necessary.
Treatment should be initiated only by physicians who are experienced in the treatment of cystic fibrosis and/or severe infections in children and adolescents (see sections 4.4 and 5.1).
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
The dosage is determined by the indication, the severity and the site of the infection, the susceptibility to ciprofloxacin of the causative organism(s), the renal function of the patient and, in children and adolescents the body weight.
The duration of treatment depends on the severity of the illness and on the clinical and bacteriological course.
Treatment of infections due to certain bacteria (e.g. Pseudomonas aeruginosa, Acinetobacter or Staphylococci) may require higher ciprofloxacin doses and co-administration with other appropriate antibacterial agents.
Treatment of some infections (e.g. pelvic inflammatory disease, intra-abdominal infections, infections in neutropenic patients and infections of bones and joints) may require co-administration with other appropriate antibacterial agents depending on the pathogens involved.
| Indications | Daily dose in mg | Total duration of treatment (potentially including initial parenteral treatment with ciprofloxacin) |
|---|---|---|
| Cystic fibrosis | 20 mg/kg body weight twice daily with a maximum of 750 mg per dose. | 10 to 14 days |
| Complicated urinary tract infections and pyelonephritis | 10 mg/kg body weight twice daily to 20 mg/kg body weight twice daily with a maximum of 750 mg per dose. | 10 to 21 days |
| Inhalation anthrax post-exposure prophylaxis and curative treatment for persons able to receive treatment by oral route when clinically appropriate. Drug administration should begin as soon as possible after suspected or confirmed exposure. | 10 mg/kg body weight twice daily to 15 mg/kg body weight twice daily with a maximum of 500 mg per dose. | 60 days from the confirmation of Bacillus anthracis exposure |
| Other severe infections | 20 mg/kg body weight twice daily with a maximum of 750 mg per dose. | According to the type of infections |
Elderly patients should receive a dose selected according to the severity of the infection and the patient’s creatinine clearance.
Recommended starting and maintenance doses for patients with impaired renal function:
| Creatinine Clearance [ml/min/1.73m2] | Serum Creatinine [µmol/L] | Oral Dose [mg] |
|---|---|---|
| >60 | <124 | See Usual Dosage. |
| 30–60 | 124–168 | 250-500 mg every 12h |
| ≤30 | ≥169 | 250-500 mg every 24h |
| Patients on haemodialysis | >169 | 250-500 mg every 24h (after dialysis) |
| Patients on peritoneal dialysis | >169 | 250-500 mg every 24h |
In patients with impaired liver function no dose adjustment is required.
Dosing in children with impaired renal and/or hepatic function has not been studied.
Tablets are to be swallowed unchewed with fluid. They can be taken independent of mealtimes. If taken on an empty stomach, the active substance is absorbed more rapidly. Ciprofloxacin tablets should not be taken with dairy products (e.g. milk, yoghurt) or mineral-fortified fruit-juice (e.g. calcium-fortified orange juice) (see section 4.5).
In severe cases or if the patient is unable to take tablets (e.g. patients on enteral nutrition), it is recommended to commence therapy with intravenous ciprofloxacin until a switch to oral administration is possible.
An overdose of 12 g has been reported to lead to mild symptoms of toxicity. An acute overdose of 16 g has been reported to cause acute renal failure.
Symptoms in overdose consist of dizziness, tremor, headache, tiredness, seizures, hallucinations, confusion, abdominal discomfort, renal and hepatic impairment as well as crystalluria and haematuria.
Reversible renal toxicity has been reported.
Apart from routine emergency measures, e.g. ventricular emptying followed by medical carbon, it is recommended to monitor renal function, including urinary pH and acidify, if required, to prevent crystalluria. Patient should be kept well hydrated. Calcium or magnesium containing antacids may theoretically reduce the absorption of ciprofloxacin in overdoses.
Only a small quantity of ciprofloxacin (<10%) is eliminated by haemodialysis or peritoneal dialysis.
In the event of overdose, symptomatic treatment should be implemented. ECG monitoring should be undertaken, because of the possibility of QT interval prolongation.
3 years.
This medicinal product does not require any special storage conditions.
The tablets are available in blisters comprising of:
Packs of 1, 8, 10, 14, 16, 20, 28, 32 and 100 tablets per carton are available.
Not all pack sizes may be marketed.
No special requirements.
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