Qualitative and quantitative composition
1 ml solution for infusion contains: 2 mg ciprofloxacin (as ciprofloxacin lactate).
Excipients: 1 ml solution contains: 50 mg glucose monohydrate: equivalent to 45 mg glucose.
For a full list of excipients, see section 6.1.
Pharmaceutical form
Solution for infusion
Clear, colourless or slightly yellow solution.
The pH-value of the solution for infusion ranges from 3.9 to 4.5
Clinical particulars
Therapeutic indications
Ciprofloxacin solution for infusion is indicated for the treatment of the following infections (see sections 4.4 and 5.1). Special attention should be paid to available information on resistance to ciprofloxacin before commencing therapy.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Adults
• Lower respiratory tract infections due to Gram-negative bacteria
- exacerbations of chronic obstructive pulmonary disease
- broncho-pulmonary infections in cystic fibrosis or in bronchiectasis
- pneumonia
• Chronic suppurative otitis media
• Acute exacerbation of chronic sinusitis especially if these are caused by Gram-negative bacteria
• Urinary tract infections
• Genital tract infections
- epididymo-orchitis including cases due to susceptible Neisseria gonorrhoeae
- pelvic inflammatory disease including cases due to susceptible Neisseria gonorrhoeae
• Infections of the gastro-intestinal tract (e.g. travellers` diarrhoea)
• Intra-abdominal infections
• Infections of the skin and soft tissue caused by Gram-negative bacteria
• Malignant external otitis
• Infections of the bones and joints
• Inhalation anthrax (post-exposure prophylaxis and curative treatment)
Ciprofloxacin may be used in the management of neutropenic patients with fever that is suspected to be due to a bacterial infection.
Children and adolescents
• Broncho-pulmonary infections in cystic fibrosis caused by Pseudomonas aeruginosa
• Complicated urinary tract infections and pyelonephritis
• Inhalation anthrax (post-exposure prophylaxis and curative treatment)
Ciprofloxacin may also be used to treat severe infections in children and adolescents when this is considered to be necessary.
Treatment should be initiated only by physicians who are experienced in the treatment of cystic fibrosis and/or severe infections in children and adolescents (see sections 4.4 and 5.1).
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 respiratory tract |
400 mg twice daily to 400 mg three times a day |
7 to 14 days |
|
Infections of the upper respiratory tract |
Acute exacerbation of chronic sinusitis |
400 mg twice daily to 400 mg three times a day |
7 to 14 days |
|
Chronic suppurative otitis media |
400 mg twice daily to 400 mg three times a day |
7 to 14 days |
|
|
Malignant external otitis |
400 mg three times a day |
28 days up to 3 months |
|
|
Urinary tract infections
(see section 4.4) |
Complicated and uncomplicated pyelonephritis |
400 mg twice daily to 400 mg three times a day |
7 to 21 days, it can be continued for longer than 21 days in some specific circumstances (such as abscesses) |
|
|
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 |
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 severe travellers' diarrhoea |
400 mg twice daily |
1 day |
|
|
Diarrhoea caused byShigella dysenteriae type 1 |
400 mg twice daily |
5 days |
|
Diarrhoea caused byVibrio 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 |
|
Infections of the skin and soft tissue |
400 mg twice daily to 400 mg three times a day |
7 to 14 days |
|
|
Bone and joint infections |
400 mg twice daily to 400 mg three times a day |
max. of 3 months |
|
|
Neutropenic patients with fever that is suspected to be due to a bacterial infection.
Ciprofloxacin 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 ofBacillus anthracis 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 times a day with a maximum of 400 mg per dose. |
10 to 14 days |
|
Complicated urinary tract infections and 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.
Patients with renal and hepatic impairment
Recommended starting and maintenance doses for patients with impaired renal function:
|
Creatinine Clearance
[mL/min/1.73 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.
|
