Posology : מינונים

4.2        Posology and method of administration

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.
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.
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.
Adults
Indications                         Daily dose in mg            Total duration of treatment (including switch to oral therapy as soon as possible)
Infections of the lower             400 mg twice daily to       7 to 14 days respiratory tract                   400 mg three times a day
Infections of Acute                 400 mg twice daily to       7 to 14 days the upper       exacerbation of     400 respiratory     chronic sinusitis   mg three times a day tract           Chronic             400 mg twice daily to       7 to 14 days suppurative otitis 400 media               mg three times a day
Malignant           400 mg three times a        28 days up to 3 months external otitis     day
Urinary tract Acute and             400 mg twice daily to       7 to 21 days, it can be infections      complicated         400                         continued for (see section pyelonephritis         mg three times a day        longer than 21 days in some 4.4)                                                            specific circumstances (such as abscesses)
Bacterial           400 mg twice daily to       2 to 4 weeks (acute) prostatitis         400 mg three times a day
Genital tract Epididymo-            400 mg twice daily to       at least 14 days infections      orchitis and        400 pelvic              mg three times a day inflammatory diseases including cases due to susceptible
Neiserria gonorrhoeae
Infections of Diarrhoea caused 400 mg twice daily               1 day the             by gastro-         bacterial intestinal      pathogens tract           including Shigella and intra-      spp.
abdominal       other than infections      Shigella dysenteriae type
1 and empirical treatment of severe travellers' diarrhoea
Diarrhoea caused 400 mg twice daily             5 days by
Shigella
dysenteriae type
1
Diarrhoea caused   400 mg twice daily      3 days by Vibrio cholerae
Typhoid fever      400 mg twice daily      7 days
Intra-abdominal    400 mg twice daily to   5 to 14 days infections         400 due to Gram-       mg three times a day negative bacteria
Infections of the skin and soft    400 mg twice daily to   7 to 14 days tissue caused by                   400
Gram-negative bacteria             mg three times a day
Bone and joint infections          400 mg twice daily to   max. of 3 months 400 mg three times a day
Neutropenic patients with fever    400 mg twice daily to   Therapy should be continued that is suspected to               400                     over the be due to a bacterial infection.   mg three times a day    entire period of neutropenia Ciprofloxacin should be co- administered with appropriate antibacterial agent(s) in accordance to official guidance.
Inhalation anthrax post-exposure   400 mg twice daily      60 days from the prophylaxis and                                            confirmation of curative treatment for persons                             Bacillus anthracis exposure requiring parenteral treatment
Drug administration should begin as soon as possible after suspected or confirmed exposure.

Paediatric population

Indication                    Daily dose in mg             Total duration of treatment (including switch to oral therapy as soon as possible)
Cystic fibrosis               10 mg/kg body weight three   10 to 14 days times a day with a maximum of 400 mg per dose.
Complicated urinary tract     6 mg/kg body weight three    10 to 21 days infections and acute          times a day to 10 mg/kg pyelonephritis                body weight three times a day with a maximum of 400 mg per dose.
Inhalation anthrax            10 mg/kg body weight twice   60 days from the postexposure                  daily to 15 mg/kg body       confirmation of Bacillus curative treatment            weight                       anthracis exposure for persons requiring         twice daily with a maximum parenteral treatment          of 400 mg per dose.
Drug administration should
begin as soon as possible after suspected or confirmed exposure
Other severe infections           10 mg/kg body weight three      According to the type of times a day with a maximum      infections of 400 mg per dose

Elderly patients
Elderly patients should receive a dose selected according to the severity of the infection and the patient`s creatinine clearance.
Patients with renal and hepatic impairment
Recommended starting and maintenance doses for patients with impaired renal function: Creatinine Clearance             Serum Creatinine               Intravenous Dose [mL/min/1.73 m²]                 [μmol/L]                       [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           > 169                          200-400 mg every 24 h dialysis

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 solution for infusion 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 solution for infusion and 30 minutes for 200 mg
Ciprofloxacin solution for infusion. Slow infusion into a large vein will minimise patient discomfort and reduce the risk of venous irritation.
The infusion solution can be infused either directly or after mixing with other compatible infusion solutions (see section 6.6).