Cifloxinal®
coated tablets
- Manufacturer:
- PRO.MED.CS Praha a.s.
- Marketing authorisation holder:
- PRO.MED.CS Praha a.s.
- Composition:
- Ciprofloxacin hydrochloride monohydrate 291 mg, equivalent of ciprofloxacin 250 mg in 1 coated tablet. Ciprofloxacin hydrochloride monohydrate 582 mg, equivalent of ciprofloxacin 500 mg in 1 coated tablet.
- Indication group:
- chemotherapeutic
The following information is for health professionals only.
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Characteristics:
Ciprofloxacin is fluoroquinolone chemotherapeutic with a broad spectrum of antimicrobial activity.The mechanism of its action dwells in inhibition of the bacterial enzyme DNA-gyrase, enzyme responsible for creation and management of correct spatial structure of bacterial DNA.
Following oral administration absorption occurs very quickly, the peak plasma concentration(Cmax)is reached in about 1-2 hours. In therapeutic concentrations ciprofloxacin passes into pulmonary tissue, bronchial and nasal secretions, pleural exudates, sputum, tonsilar tissue, muscles, skin, gall, prostatic tissue and secretion and kidneys, and produces high concentration in urine.
Indications:
Treatment of infections caused by aerobic sensitive microbes, especially by strains resistant to other antibiotics (Stahpylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus pyogenes, Haemophilus influenzae, Escherichia coli, Klebsiella sp.,Enterobacter sp.,Proteus sp., Pseudomonas aeruginosa, Legionella pneumophila).The most frequent indications are infections of respiratory tract and urinary tract, gynaecological infections, ORL and intraabdominal infections, eye infections, infection of soft issues, joints, bones and skin, infectious endocarditis, bacterial meningitis, various nosocomial infections, and prophylactic indications, especially surgery.
Contraindications:
Hypersensitivity to ciprofloxacin and other quinolone derivatives. Pregnancy and lactation.
Children below 18 years of age (with exception of urgency of administration).
Undesirable effects:
The adverse effects of ciprofloxacin are known to be frequent but mild and reversible. In the course of treatment the following reaction may occur.
Gastrointestinal troubles - nausea, vomiting, dyspepsia, flatulence, diarrhoea, abdominal pain, occasionally dizziness, headaches, rarely anxiety, nervousness, insomnia, tinnitus,tremor,double vision. Hypersensitivity reaction.
Certain changes in laboratory tests may occur-increased levels of transaminases, increase of creatinine, urea, transitional changes of blood count (e.g. leukopenia,leukocytosis, trombocytopenia, trombocytosis).
Interactions:
Antacides agents containing magnesium and aluminium, sucralfate and iron preparations decrease resorbtion of ciprofloxacin.
There is higher rest of convultion during the concomitant administration of nonsteroidal antiphlogistics. Cifloxinal® increase plasma levels of warfarin, theophylin and ciclosporin.
Caution:
The preparation unfavourably affects activities requiring increased attention and quick-decision making.Caution is needed in elderly people with clinically manifested cerebral arteriosclerosis and in patients suffering from neurological convulsive diseases (epilepsy).
Dosage:
Dosage and duration of treatment depends on the severity of the disease and the clinical and bacteriological findings.
Uncomplicated infections of urinary tract 250 mg 2 times a day (every 12 hours) for 5-10 days.
Uncomplicated acute gonorrhoea: a single of 250 mg.
Other infections: 500-750 mg 2 times a day for 5-10 days.
In renal insufficiency.
Cifloxinal® coated tablets dosing is to be adapted to creatinine clearance.
Tablets are swallowed and washed down with sufficient of liquid.
Package:
10 and 20 coated tablets of 250 mg or 500 mg.
For greater details about the preparation see the product data summary.
Date of latest revision of the text: October 8, 2008.
The preparation is available on medical prescription only.