GMP Ciprofloxacin HCl tablet 500mg use
Product Description
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 750 mg twice daily |
7 to 14 days |
|
Infections of the upper respiratory tract |
Acute exacerbation of chronic sinusitis |
500 mg twice daily to 750 mg twice daily |
7 to 14 days |
Chronic suppurative otitis media |
500 mg twice daily to 750 mg twice daily |
7 to 14 days |
|
Malignant external otitis |
750 mg twice daily |
28 days up to 3 months |
|
Urinary tract infections (see section 4.4) |
Uncomplicated cystitis |
250 mg twice daily to 500 mg twice daily |
3 days |
In pre-menopausal women, 500 mg single dose may be used |
|||
Complicated cystitis, Uncomplicated pyelonephritis |
500 mg twice daily |
7 days |
|
Complicated pyelonephritis |
500 mg twice daily to 750 mg twice daily |
at least 10 days, it can be continued for longer than 21 days in some specific circumstances (such as abscesses) |
|
Prostatitis |
500 mg twice daily to 750 mg twice daily |
2 to 4 weeks (acute) to 4 to 6 weeks (chronic) |
|
Genital tract infections |
Gonococcal uretritis and cervicitis |
500 mg as a single dose |
1 day (single dose) |
Epididymo-orchitis and pelvic inflammatory diseases |
500 mg twice daily to 750 mg twice daily |
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 dysenteriaetype 1 and empirical treatment of severe travellers' diarrhoea |
500 mg twice daily |
1 day |
Diarrhoea caused by Shigella dysenteriae type 1 |
500 mg twice daily |
5 days |
|
Diarrhoea caused by Vibrio cholerae |
500 mg twice daily |
3 days |
|
Typhoid fever |
500 mg twice daily |
7 days |
|
Intra-abdominal infections due to Gram-negative bacteria |
500 mg twice daily to 750 mg twice daily |
5 to 14 days |
|
Infections of the skin and soft tissue |
500 mg twice daily to 750 mg twice daily |
7 to 14 days |
|
Bone and joint infections |
500 mg twice daily to 750 mg twice daily |
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. |
500 mg twice daily to 750 mg twice daily |
Therapy should be continued over the entire period of neutropenia |
|
Prophylaxis of invasive infections due to Neisseria meningitidis |
500 mg as a single dose |
1 day (single dose) |
|
Inhalation anthrax post-exposure prophylaxis and curative treatment for persons able to receive treatment by oral route when clinically appropriate. Drug administration should begin as soon as possible after suspected or confirmed exposure. |
500 mg twice daily |
60 days from the confirmation of Bacillus anthracis 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 daily with a maximum of 750 mg per dose. |
10 to 14 days |
Complicated urinary tract infections and pyelonephritis |
10 mg/kg body weight twice daily to 20 mg/kg body weight twice daily with a maximum of 750 mg per dose. |
10 to 21 days |
Inhalation anthrax post-exposure prophylaxis and curative treatment for persons able to receive treatment by oral route when clinically appropriate. 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 500 mg per dose. |
60 days from the confirmation of Bacillus anthracis exposure |
Other severe infections |
20 mg/kg body weight twice daily with a maximum of 750 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] |
Oral Dose [mg] |
> 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
Tablets 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. Ciprofloxacin tablets should not be taken with dairy products (e.g. milk, yoghurt) or mineral-fortified fruit -juice (e.g. calcium-fortified orange juice) (see section 4.5).
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.
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