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      7 to 14 days 400 mg three times a day
Infections of the        Acute                400 mg twice daily to      7 to 14 days upper respiratory        exacerbation of      400 mg three times a day tract                    chronic sinusitis
Chronic              400 mg twice daily to      7 to 14 days suppurative otitis   400 mg three times a day media
Malignant            400 mg three times a day   28 days up to 3 external otitis                                 months
Urinary tract            Acute and            400 mg twice daily to      7 to 21 days, it can infections               complicated          400 mg three times a       be continued for (see section 4.4)        pyelonephritis       day                        longer than 21 days in some specific circumstances
(such as abscesses)
Bacterial            400 mg twice daily to      2 to 4 weeks prostatitis          400 mg three times a       (acute) day
Genital tract           Epididymo-orchitis    400 mg twice daily to      At least 14 days infections              and pelvic            400 mg three times a day inflammatory diseases including cases due to susceptible
Neiserria gonorrhoeae

Infections of the       Diarrhoea caused      400 mg twice daily         1 day gastro-intestinal       by bacterial tract and intra-        pathogens abdominal               including Shigella infections              spp. other than
Shigella dysenteriae type 1 and empirical treatment of severe travellers' diarrhoea


Indications                                  Daily dose in mg           Total duration of treatment
(including switch to oral therapy as soon as possible)
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 due to     400 mg three times a day
Gram-negative bacteria
Infections of the skin and soft tissue       400 mg twice daily to      7 to 14 days caused by Gram-negative bacteria             400 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 that is      400 mg twice daily to      Therapy should be suspected to be due to a bacterial           400 mg three times a       continued over the infection                                    day                        entire period of Ciprofloxacin should be co-administered                                 neutropenia with appropriate antibacterial agent(s) in accordance to official guidance
Inhalation anthrax post-exposure             400 mg twice daily         60 days from the prophylaxis and curative treatment for                                  confirmation of persons requiring parenteral treatment                                  Bacillus anthracis Drug administration should begin as soon                                exposure 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       10 to 14 days three times a day with a maximum of 400 mg per dose
Complicated urinary tract infections     6 mg/kg body weight        10 to 21 days and acute pyelonephritis                 three times a day to 10 mg/kg body weight three times a day with a maximum of 400 mg per dose


Indication                                Daily dose in mg           Total duration of treatment (including switch to oral therapy as soon as possible)
Inhalation anthrax post-exposure          10 mg/kg body weight       60 days from the curative treatment for persons            twice daily to 15 mg/kg    confirmation of Bacillus requiring parenteral treatment            body weight twice daily    anthracis exposure Drug administration should begin as       with a maximum of 400 soon as possible after suspected or       mg per dose confirmed exposure.
Other severe infections                   10 mg/kg body weight       According to the type of three times a day with a   infections maximum 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 200-400 mg every 24 h
Patients on haemodialysis               > 169
(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
Cipro-Teva 2 mg/mL solution for infusion should be checked visually prior to use. It must not be used if cloudy.

Cipro-Teva 2 mg/mL 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 Cipro-Teva 2 mg/mL solution for infusion and 30 minutes for 200 mg Cipro-Teva 2 mg/mL 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).