CIPROFLOXACIN

Posology 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. g. Pseudomonas aeruginosa, Acinetobacter or Staphylococci) may require higher ciprofloxacin doses and co-administration with other appropriate antibacterial agents.

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.

4) Prostatitis 500 mg twice daily to 750 mg twice daily 2 to 4 weeks (acute) to 4 to 6 weeks (chronic) Gonococcal uretritis and cervicitis 500 mg as a single dose 1 day (single dose)Genital tract infections Epididymo-orchitis and pelvic inflammatory diseases 500 mg twice daily to 750 mg twice daily at least 14 days Diarrhoea caused by bacterial pathogens including Shigella spp.

other than Shigella dysenteriae type 1 and empirical treatment of severe travellers’ diarrhoea 500 mg twice daily 1 day Diarrhoea caused by Shigella dysenteriae type 1 500 mg twice daily 5 days Diarrhoea caused by Vibrio cholerae 500 mg twice daily 3 days Typhoid fever 500 mg twice daily 7 days Infections of the gastro-intestinal tract and intra- abdominal infections Intra-abdominal infections due to Gram-negative 500 mg twice daily to 750 mg 5 to 14 days bacteria twice daily Infections of the skin and soft tissue 500 mg twice daily to 750 mg twice daily 7 to 14 days Bone and joint infections 500 mg twice daily to 750 mg twice daily max.

of 3 months Neutropenic patients with fever that is suspected to be due to a bacterial infection. Ciprofloxacin should be co- administered with appropriate antibacterial agent(s) in accordance to official guidance. 500 mg twice daily to 750 mg twice daily Therapy should be continued over the entire period of neutropenia Prophylaxis of invasive infections due to Neisseria meningitides 500 mg as a single dose 1 day (single dose) 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. 500 mg twice daily 60 days from the confirmation of Bacillus anthracis exposure Paediatric population 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 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 when clinically appropriate. Drug administration should begin as soon as possible after suspected or confirmed 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 Elderly patients should receive a dose selected according to the severity of the infection and the patient’s creatinine clearance. 73 m²] Serum Creatinine [μmol/L] Oral Dose [mg] > 60 < 124 See Usual Dosage.

30-60 124 to 168 250-500 mg every 12 h <30 > 169 250-500 mg every 24 h Patients on haemodialysis > 169 250-500 mg every 24 h (after dialysis) Patients on peritoneal dialysis > 169 250-500 mg every 24 h 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. Method of administration 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.

g. g. 5). g. patients on enteral nutrition), it is recommended to commence therapy with intravenous ciprofloxacin until a switch to oral administration is possible.

The most commonly reported adverse drug reactions (ADRs) are nausea and diarrhoea. ADRs derived from clinical studies and post-marketing surveillance with Ciprofloxacin (oral, intravenous, and sequential therapy) sorted by categories of frequency are listed below.

The frequency analysis takes into account data from both oral and intravenous administration of ciprofloxacin. 4) Mania, incl. g. g. 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).

4). Paediatric population The incidence of arthropathy (arthralgia, arthritis), mentioned above, is referring to data collected in studies with adults. 4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

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8). 3). 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 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 Severe infections and mixed infections with Gram-positive and anaerobic pathogens Ciprofloxacin monotherapy is not suited for treatment of severe infections and infections that might be due to Gram-positive or anaerobic pathogens.

In such infections ciprofloxacin must be co-administered with other appropriate antibacterial agents. Streptococcal Infections (including Streptococcus pneumoniae) Ciprofloxacin is not recommended for the treatment of streptococcal infections due to inadequate efficacy.

Genital tract infections Gonococcal uretritis, cervicitis, epididymo-orchitis and pelvic inflammatory diseases may be caused by fluoroquinolone-resistant Neisseria gonorrhoeae isolates. Therefore, ciprofloxacin should be administered for the treatment of gonococcal uretritis or cervicitis only if ciprofloxacin-resistant Neisseria gonorrhoeae can be excluded.

g. a cephalosporin) unless ciprofloxacin resistant Neisseria gonorrhoeae can be excluded. If clinical improvement is not achieved after 3 days of treatment, the therapy should be reconsidered. Urinary tract infections Resistance to fluoroquinolones of Escherichia coli – the most common pathogen involved in urinary tract infections – varies across the European Union.

Prescribers are advised to take into account the local prevalence of resistance in Escherichia coli to quinolones. The single dose of ciprofloxacin that may be used in uncomplicated cystitis in pre-menopausal women is expected to be associated with lower efficacy than the longer treatment duration.

This is all the more to be taken into account as regards the increasing resistance level of Escherichia coli to quinolones. Intra-abdominal infections There are limited data on the efficacy of ciprofloxacin in the treatment of post- surgical intra-abdominal infections.

Travellers’ diarrhoea The choice of ciprofloxacin should take into account information on resistance to ciprofloxacin in relevant pathogens in the countries visited. Infections of the bones and joints Ciprofloxacin should be used in combination with other antimicrobial agents depending on the results of the microbiological documentation.

Inhalational anthrax Use in humans is based on in-vitro susceptibility data and on animal experimental data together with limited human data. Treating physicians should refer to national and/or international consensus documents regarding the treatment of anthrax.

Paediatric population The use of ciprofloxacin in children and adolescents should follow available official guidance. Ciprofloxacin treatment should be initiated only by physicians who are experienced in the treatment of cystic fibrosis and/or severe infections in children and adolescents.

Ciprofloxacin has been shown to cause arthropathy in weight-bearing joints of immature animals. 6%. 7%. The increase of suspected drug-related arthropathy cases over time was not statistically significant between groups. 8).. Broncho-pulmonary infections in cystic fibrosis Clinical trials have included children and adolescents aged 5-17 years.

More limited experience is available in treating children between 1 and 5 years of age. Complicated urinary tract infections and pyelonephritis Ciprofloxacin treatment of urinary tract infections should be considered when other treatments cannot be used, and should be based on the results of the microbiological documentation.

Clinical trials have included children and adolescents aged 1-17 years. Other specific severe infections Other severe infections in accordance with official guidance, or after careful benefit-risk evaluation when other treatments cannot be used, or after failure to conventional therapy and when the microbiological documentation can justify a ciprofloxacin use.

The use of ciprofloxacin for specific severe infections other than those mentioned above has not been evaluated in clinical trials and the clinical experience is limited. Consequently, […]

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