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

Indications                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 times a day with a           10 to 14 days maximum of 400 mg per dose.
Complicated urinary        6 mg/kg body weight three times a day to 10 mg/kg       10 to 21 days tract infections and       body weight three times a day with a maximum of acute pyelonephritis       400 mg per dose.
Inhalation anthrax post- 10 mg/kg body weight twice daily to 15 mg/kg body         60 days from the exposure curative        weight twice daily with a maximum of 400 mg per           confirmation of Bacillus treatment for persons    dose.                                                     anthracis exposure requiring parenteral treatment.
Drug administration should begin as soon as possible after suspected or confirmed exposure.
Other severe infections 10 mg/kg body weight three times a day with a              According to the type of maximum of 400 mg per dose.                                infections 
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 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 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).