Cifloxinal 250 mg

Basic information

Composition

Ciprofloxacinum 250 mg in 1 coated tablet

Pharmacotherapeutic group

Quinolone antibacterial agents, fluoroquinolones (ATC code: J01MA02)

Therapeutic indications

Treatment of infections caused by sensitive strains: Infections of lower respiratory tract, suppurative inflammation of otitis media, exacerbation of chronic sinusitis, urinary tract infections, infections caused by Neisseria gonorrhoeae, gastrointestinal infections, intraabdominal infections, skin and soft tissue infections, bone and joint infections, infections and prophylaxis in patients with neutropenia, inhalation of anthrax and cystic fibrosis in children.

Pharmacological properties

Ciprofloxacin is a bactericidal 3rd generation fluoroquinolone chemotherapeutic agent with a broad antibacterial spectrum. The mechanism of action consists in inhibition of the bacterial enzymes of topoisomerase II (DNA-gyrase), and topoisomerase IV, which are indispensable for the synthesis of bacterial DNA. After oral administration, ciprofloxacin is very rapidly absorbed. Biological availability ranges between 70 % and 80 %; peak plasma concentrations are reached within 1—2 hours after administration depending on the dose size. Ciprofloxacin is excreted through kidneys, mainly in unchanged form, and to a lesser extent through the feces; biological half-life is 4—7 hours. Ciprofloxacin reaches high concentrations in various tissues such as lungs or urogenital tract (urine, prostate, endometrium), where total concentrations exceed plasma concentrations reached.

Pharmaceutical form

Film-coated tablets

More information

Posology and method of administration

Dosage and treatment duration depends on therapeutic indications, infection severity and localisation, sensitivity of the infection cause, function of the patient’s kidneys and in children and adolescents depending on the body weight of the patient. Usual dose is twice daily 500—750 mg with or without meals.

Contraindications

Hypersensitivity to active substance, other quinolones or any excipients, concomitant administration of ciprofloxacin and tizanidine. The medicinal product is not recommended during pregnancy and lactation.

Interactions

Administration of antacides (magnesium and aluminium salts), sucralfate, bivalent iron salts, calcium salts (drugs and milk products), sevelamer and zinc salts results in lower absorption of ciprofloxacin. Ciprofloxacin increases plasma levels and undesirable effects of tizanidine, agomelatine, methotrexate, theophylline and other derivatives of xanthin, ropinirol and clozapine, increases anticoagulant effect of warfarin and may decrease plasma levels of phenytoin as well. Probenecid increases plasma concentration of ciprofloxacin. Ciprofloxacin makes plasma concentration of sildenafil double.

Undesirable effects

Most frequent are nausea and diarrhoea, less frequent are bone and muscle pains, skin rash, urticaria, itching, increased levels of transaminases and bilirubin, vomiting, dyspepsia, abdominal pain and headache, vertigo, sleeping and gustatory sense disorders, psychomotor restlessness, eosinophilia and mycotic superinfections.

Special warnings and precautions for use

It is not recommended to administer the product to patients under 18 years of age (the risk of artropathy and cartilage damage). Administration of ciprofloxacin presents a risk of tendon damage (mainly during sport activities, in elderly patients and corticosteroid administration), risk of photosensitive reactions (it is necessary to avoid the sun) and the risk of QT interval prolongation. Caution is needed in patients with epilepsy as ciprofloxacin decreases convulsive threshold. The product may decrease the ability to drive and operate machines.

For more detailed product information, see the Summary of Product Characteristics.

Availability

The medicinal product is available on prescription only and is partly covered by health insurance.

Contents of container

10, 20 or 200 coated tablets of 250 mg each

Package available in the Czech Republic

10 coated tablets of 250 mg each

SPC and PIL

Manufacturer and marketing authorisation holder

PRO.MED.CS Praha a.s., Telčská 377/1, Michle, 140 00 Prague 4, Czech Republic

Date of revision of the text

1 January 2019

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