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. After intravenous initiation of treatment, the treatment can be switched to oral treatment with tablet or suspension if clinically indicated at the discretion of the physician.

IV treatment should be followed by oral route as soon as possible. g. patients on enteral nutrition), it is recommended to commence therapy with intravenous ciprofloxacin until a switch to oral administration is possible. 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) Bacterial prostatitis 400 mg twice daily to 400 mg three times a day 2 to 4 weeks (acute) Genital tract infections Epididymo-orchitis and pelvic inflammatory diseases Gonococcal uretritis and cervicitis due to susceptible Neisseria gonorrhoeae 400 mg twice daily to 400 mg three times a day at least 14 days Infections of the gastro-intestinal tract and intra- abdominal infections Diarrhoea caused by bacterial pathogens including Shigella spp.

other than Shigella dysenteriae type 1 and empirical treatment of 400 mg twice daily 1 day severe travellers’ diarrhoea Diarrhoea caused by Shigella dysenteriae type 1 400 mg twice daily 5 days Diarrhoea caused by Vibrio cholerae 400 mg twice daily 3 days Typhoid fever 400 mg twice daily 7 days Intra-abdominal infections due to Gram- negative bacteria 400 mg twice daily to 400 mg three times a day 5 to 14 days Complicated skin and structure infections/complicated skin and soft tissue infections 400 mg twice daily to 400 mg three times a day 7 to 14 days Infections of the bones and joints 400 mg twice daily to 400 mg three times a day max.

of 3 months Management of neutropenic patients with feverCiprofloxacin should be co-administered with appropriate antibacterial agent(s) in accordance to official guidance. 400 mg twice daily to 400 mg three times a day Therapy should be continued over the entire period of neutropenia Inhalation anthrax post-exposure prophylaxis and curative treatment for persons requiring parenteral treatment Drug administration should begin as soon as possible after suspected or confirmed exposure.

400 mg twice daily 60 days from the confirmation of Bacillus anthracis exposure Paediatric population Indications Daily dose in mg Total duration of treatment (including switch to oral therapy as soon as possible) Broncho-pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis 10 mg/kg body weight three times a day with a maximum of 400 mg per dose.

10 to 14 days Complicated urinary tract infections and acute pyelonephritis 6 mg/kg body weight three times a day to 10 mg/kg body weight three times a day with a maximum of 400 mg per dose. 10 to 21 days Inhalation anthrax post- exposure curative treatment for persons requiring parenteral treatment 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 400 mg per dose. 60 days from the confirmation of Bacillus anthracis exposure Other severe infections 10 mg/kg body weight three times a day with a maximum of 400 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] Intravenous Dose [mg] > 60 < 124 See usual dosage.

30 – 60 124 to 168 200 – 400 mg every 12 h < 30 > 169 200 – 400 mg every 24 h Patients on haemodialysis > 169 200 – 400 mg every 24 h (after dialysis) Patients on peritoneal dialysis > 169 200 – 400 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 Ciprofloxacin should be checked visually prior to use. It must not be used if cloudy. Ciprofloxacin should be administered by intravenous infusion.

For children, the infusion duration is 60 minutes. In adult patients, infusion time is 60 minutes for 400 mg Ciprofloxacin and 30 minutes for 200 mg Ciprofloxacin. Slow infusion into a large vein will minimize patient discomfort and reduce the risk of venous irritation.

The infusion solution can be infused either directly or […]

The most commonly reported adverse drug reactions (ADRs) are nausea and diarrhea, vomiting, transient increase in transaminases, rash, and injection and infusion site reactions. 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) System Organ Class Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Very rare (<1/10,000) Frequency not known (cannot be estimated from the available data) Taste disorders Tremor Seizures (incl.

g. g. 4). 4). The following undesirable effects have a higher frequency category in the subgroups of patients receiving intravenous or sequential (intravenous to oral) treatment: Common Vomiting Transient increase in transaminases Rash Uncommon Thrombocytopenia Thrombocytaemia Confusion and disorientation Hallucinations Par- and dysaesthesia Seizures Vertigo Visual disturbances Hearing loss Tachycardia Vasodilatation Hypotension Transient hepatic impairment Cholestatic icterus Renal failure Oedema Rare Pancytopenia Bone marrow depression Anaphylactic shock Psychotic reactions Migraine […]

8). 3). 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 Epididymo-orchitis and pelvic inflammatory diseases may be caused by fluoroquinolone- resistant Neisseria gonorrhoeae. 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 fluoroquinolones. 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). Prolonged, disabling and potentially irreversible serious adverse drug reactions Very rare cases of prolonged (continuing months or years), disabling and potentially irreversible serious adverse drug reactions affecting different, sometimes multiple, body systems (musculoskeletal, nervous, psychiatric and senses) have been reported in patients receiving quinolones and fluoroquinolones irrespective of their age and pre-existing risk factors.

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. 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 acute 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, caution is advised when treating patients with these infections.

8) and may be life-threatening. If such reaction occurs, ciprofloxacin should be discontinued, and an adequate medical treatment is required. Tendinitis and tendon rupture Tendinitis and tendon rupture (especially but not limited to Achilles tendon), sometimes bilateral, may occur as early as within 48 hours of starting treatment with quinolones and fluoroquinolones and have been reported to occur even up to several months after discontinuation of treatment.

The risk of tendinitis and tendon rupture is increased in older patients, patients with renal impairment, patients with solid organ […]

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