QUALITATIVE AND QUANTITATIVE COMPOSITION
1 film-coated tablet contains 250 mg ciprofloxacin as ciprofloxacin
1 film-coated tablet contains 500 mg
ciprofloxacin as ciprofloxacin hydrochloride monohydrate.
Ciprinol film-coated tablets 250 mg: round, white film-coated tablets,
scored on one side.
Ciprinol film-coated tablets 500 mg: oval, white
film-coated tablets, scored on one side.
UNCOMPLICATED AND COMPLICATED INFECTIONS CAUSED BY CIPROFLOXACIN SENSITIVE
PATHOGENS: Infections of the respiratory tract.
In the treatment of outpatients with pneumonia due to Pneumococcus
ciprofloxacin should not be used as a first choice of drug.
can be regarded as an advisable treatment for pneumonias caused by Klebsiella, Enterobacter, Proteus, E. coli,
Branhamella, Legionella and Staphylococcus.
Infections of the middle ear (otitis media) of the paranasal sinuses
(sinusitis), especially it these are caused by gram-negative organisms
including Pseudomonas or by Staphylococcus.
Infections of the eyes.
Infections of the kidneys and/ or the efferent urinary tract.
Infections of the genital organs, including adnexitis, gonorrhoea,
Infections of the abdominal cavity (e.g. infections of the gastrointestinal
tract or of the biliary tract, peritonitis).
Infections of the skin and soft
Infections of the bones and joints.
Infections or imminent risk of infections (prophylaxis) in patients whose
Immune system has been weakened (e.g. patients on immunosuppressants or have
Selective intestinal decontamination in immunosuppressed patients.
According to in-vitro investigations, the following pathogens can be
regarded as sensitive:
E. cold, Shigella, Salmonella, Citrobacter, Klebsiella, Enterobacter,
Serratia, Hafnia, Edwardsiella, Proteus (indole-positive and indole-negative),
Providencia, Morganella, Yersinia, Vibrio, Aeromonas, Plesiomonas,
Pasteurella, Haemophilus, Campylobacter, Pseudomonas, Legionella, Neisseria,
Moraxella, Acinetobacter, Brucella, Staphylococcus, Listeria,
Corynebacterium, Chlamydia and Bacillus anthracis.
The following show varying degrees of sensitivity:
Gardnerella, Flavobacterium, Alcaligenes, Streptococcus agalactlae,
Enterococcus faecalis, Streptococcus pyogenes, Streptococcus pneumoniae,
Viridans group streptococci, Mycoplasma hominis, Mycobacterium tuberculosis
and Mycobacterium fortuitum.
The following are usually resistant:
Enterococcus faecium, Ureaplasma urealyticum, Nocardia asteroides.
few exceptions anaerobes are moderately sensitive e.g. Peptococcus,
Peptostreptococcus to resistant e.g. Bacteroides.
ineffective against Treponema pallidum.
POSOLOGY AND METHOD OF ADMINISTRATION
Unless otherwise prescribed, the following guidelines doses are recommended:
(according to severity
2 x 250 - 500 mg
Urinary tract infections
- acute uncomplicated
- cystitis in women (
before menopause )
2 x 125 mg to 1-2 x 250
single dose 250 mg
2 x 250 - 500 mg
- acute, uncomplicated
2 x 125 mg
single dose 250 mg
Other infections ( see
2 x 500 mg
Particularly severe, life
threatening infections, i.e:
- Streptococcal pneumonia
- Recurrent infections in
- Bone and joint
In particular when
Streptococcus is present
2 x 750 mg
Method of administration
The tablets are swallowed whole with a small amount of fluid.
They can be taken independent of mealtimes (if the tablets are taken on an
empty stomach, the active substance is absorbed more rapidly).
If the patient is unable to take tablets, because of the severity of the
illness or for other reasons, it is recommended to commence the therapy with
an intravenous form of ciprofloxacin. After intravenous administration the
treatment can be continued orally.
Duration of treatment
The duration of treatment depends on the severity of the illness and on the
clinical and bacteriological course. It is essential to continue therapy for
at least 3 days after disappearance of the fever or of the clinical
symptoms. Mean duration of treatment:
- 1 day for acute uncomplicated gonorrhoea and cystitis;
up to 7 days for infections of the kidneys, urinary tract, and abdominal
over the entire period of the neutropenic phase in patients with weakened
- a maximum of 2 months in osteomyelitis;
and 7-14 days in all other infections.
In streptococcal infections the treatment must last at least 10 days because
of the risk of late complications.
Infections caused by Chlamydia should
also be treated for a minimum of 10 days.
Elderly: Elderly patients should receive a dose as low as possible depending
on the severity of their illness and the creatinine clearance.
Renal and hepatic impairment
1. Impaired renal function
1.1. Where creatinine clearance is between 31 and 60 ml/min/1.73 m2 or where
the serum creatinine concentration is between
1.4 and 1.9 mg/100 ml the maximum daily dose should be 1000 mg per day for
1.2. Where creatinine clearance is equal or is less than 30 ml/min/1.73
or where the serum creatinine concentration is equal or
higher than 2.0 mg/100 ml the maximum daily dose should be 500 mg per day
for oral administration.
2. Impaired renal function + haemodialysis
Dose as in 1.2; on dialysis days after dialysis.
3. Impaired renal function + CAPD
Administration of ciprofloxacin film coated tablets as 1 x 500 mg film
coated tablet (or 2 x 250 mg).
4. Impaired liver function
No dose adjustment is required.
5. Impaired renal and liver function
Dose adjustment as in 1.1 and 1.2.