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.

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 (potentially including initial parenteral treatment with ciprofloxacin)
Infections of the lower respiratory tract
500 mg twice daily to        7 to 14 days
750 mg twice daily
Infections of the Acute exacerbation of 500 mg twice daily to 7 to 14 days upper respiratory chronic sinusitis     750 mg twice daily tract             Chronic suppurative 500 mg twice daily to 7 to 14 days otitis media          750 mg twice daily
Malignant external    750 mg twice daily    28 days up to 3 months otitis
Urinary tract     Uncomplicated acute 250 mg twice daily to 3 days infections (see   cystitis              500 mg twice daily section 4.4)                            In pre-menopausal women, 500 mg single dose may be used
Complicated cystitis, 500 mg twice daily    7 days
Acute pyelonephritis
Complicated           500 mg twice daily to at least 10 days, it can be pyelonephritis        750 mg twice daily    continued for longer than 21 days in some specific circumstances (such as abscesses)
Indications                                Daily dose in mg        Total duration of treatment (potentially including initial parenteral treatment with ciprofloxacin)
Bacterial prostatitis  500 mg twice daily to    2 to 4 weeks (acute) to 4 to 750 mg twice daily       6 weeks (chronic)
Genital tract       Gonococcal urethritis 500 mg as a single       1 day (single dose) infections          and cervicitis due to dose susceptible Neisseria gonorrhoeae
Epididymo-orchitis    500 mg twice daily to    at least 14 days and pelvic            750 mg twice daily inflammatory diseases including cases due to susceptible Neisseria gonorrhoeae
Infections of the Diarrhoea caused by 500 mg twice daily           1 day gastro-intestinal bacterial pathogens tract and intra-    including Shigella abdominal           spp. other than infections          Shigella dysenteriae type 1 and empirical treatment of severe travellers' diarrhoea
Diarrhoea caused by 500 mg twice daily         5 days
Shigella dysenteriae type 1
Diarrhoea caused by 500 mg twice daily         3 days
Vibrio cholerae
Typhoid fever         500 mg twice daily       7 days
Intra-abdominal       500 mg twice daily to    5 to 14 days infections due to     750 mg twice daily
Gram-negative bacteria
Infections of the skin and soft tissue    500 mg twice daily to    7 to 14 days caused by Gram-negative bacteria          750 mg twice daily
Bone and joint infections                  500 mg twice daily to   max. of 3 months 750 mg twice daily
Neutropenic patients with fever            500 mg twice daily to   Therapy should be suspected to be due to a bacterial         750 mg twice daily      continued over the entire infection.                                                         period of neutropenia Ciprofloxacin should be co-administered with appropriate antibacterial agent(s) in accordance to official guidance.
Inhalation anthrax post-exposure           500 mg twice daily      60 days from the prophylaxis and curative treatment for                             confirmation of Bacillus persons able to receive treatment by                               anthracis exposure oral route when clinically appropriate.
Drug administration should begin as soon as possible after suspected or confirmed 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       10 to 14 days daily with a maximum of 750 mg per dose.
Complicated urinary tract infections    10 mg/kg body weight twice       10 to 21 days and acute pyelonephritis                daily to 20 mg/kg body weight twice daily with a maximum of
750 mg per dose.
Inhalation anthrax post-exposure        10 mg/kg body weight twice       60 days from the prophylaxis and curative treatment for daily to 15 mg/kg body weight     confirmation of persons able to receive treatment by twice daily with a maximum of       Bacillus anthracis oral route when clinically appropriate. 500 mg per dose.                 exposure Drug administration should begin as soon as possible after suspected or confirmed exposure.
Other severe infections                 20 mg/kg body weight twice       According to the type daily with a maximum of 750      of infections 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           Oral Dose
[mL/min/1.73 m2]                       Creatinine      [mg]
[µmol/L]
> 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
Ciprodex caplets 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.
Ciprodex caplets should not be taken with dairy products (e.g. milk, yoghurt) or mineral-fortified fruit-juice (e.g. calcium-fortified orange juice) alone, but may be taken with a meal that contains these products (see section 4.5).
In severe cases or if the patient is unable to take caplets (e.g. patients on enteral nutrition), it is recommended to commence therapy with intravenous ciprofloxacin until a switch to oral administration is possible.

If a dose is missed, it should be taken anytime but not later than 6 hours prior to the next scheduled dose. If less than 6 hours remain before the next dose, the missed dose should not be taken and treatment should be continued as prescribed with the next scheduled dose. Double doses should not be taken to compensate for a missed dose.