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Ciprinol

QUALITATIVE AND QUANTITATIVE COMPOSITION
1 film-coated tablet contains 250 mg ciprofloxacin as ciprofloxacin hydrochloride monohydrate.

1 film-coated tablet contains 500 mg ciprofloxacin as ciprofloxacin hydrochloride monohydrate.

 

PHARMACEUTICAL FORM
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.

 

CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
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.

 

Ciprofloxacin can be regarded as an advisable treatment for pneumonias caused by Klebsiella, Enterobacter, Proteus, E. coli, Pseudomonas, Haemophilus, 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, prostatitis.
Infections of the abdominal cavity (e.g. infections of the gastrointestinal tract or of the biliary tract, peritonitis).

Infections of the skin and soft tissue.
Infections of the bones and joints.

Sepsis.
Infections or imminent risk of infections (prophylaxis) in patients whose Immune system has been weakened (e.g. patients on immunosuppressants or have neutropenia).
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.

 

With a few exceptions anaerobes are moderately sensitive e.g. Peptococcus, Peptostreptococcus to resistant e.g. Bacteroides.

 

Ciprofloxacin is ineffective against Treponema pallidum.


POSOLOGY AND METHOD OF ADMINISTRATION
Unless otherwise prescribed, the following guidelines doses are recommended:

 

Tablets

Respiratory tract infections

(according to severity and organism)

2 x 250 - 500 mg

Urinary tract infections :

- acute uncomplicated

- cystitis in women ( before menopause )

- complicated

2 x 125 mg to 1-2 x 250 mg

single dose 250 mg

2 x 250 - 500 mg

Gonorrhea :

- extragenital

- acute, uncomplicated

2 x 125 mg

single dose 250 mg

Other infections ( see Indications )

2 x 500 mg

Particularly severe, life threatening infections, i.e:

- Streptococcal pneumonia

- Recurrent infections in cystic fibrosis

- Bone and joint infections

 - Septicemia

- Peritonitis

In particular when Pseudomonas,

Staphylococcus or 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 cavity;
- over the entire period of the neutropenic phase in patients with weakened body defenses;

- 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.
Children: Contraindicated.


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 oral administration.

 

1.2. Where creatinine clearance is equal or is less than 30 ml/min/1.73 m2 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.

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