Name of the medicinal product
Ciprofloxacin 500 mg film-coated tablets.
Qualitative and quantitative composition
Ciprofloxacin 500.00 mg (as ciprofloxacin hydrochloride).
Pharmaceutical form
Film-coated tablets.
White, oval shaped film-coated tablets debossed 'C500' on one side and breakline on other side.
Therapeutic indications
Ciprofloxacin film-coated tablets are indicated for the treatment of the following infections. Special attention should be paid to available information on resistance to ciprofloxacin before commencing therapy.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
• Lower respiratory tract infections due to Gram-negative bacteria
- acute exacerbations of chronic obstructive pulmonary disease
- broncho-pulmonary infections in cystic fibrosis or in bronchiectasis
- pneumonia
• Chronic suppurative otitis media
• Acute exacerbation of chronic sinusitis especially if these are caused by Gram-negative bacteria
• Uncomplicated acute cystitis
In uncomplicated acute cystitis Ciprofloxacin film-coated tablets should be used only when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the treatment of these infections.
• Acute pyelonephritis
• Complicated urinary tract infections
• Bacterial prostatitis
• Genital tract infections
- gonococcal uretritis and cervicitis due to susceptible Neisseria gonorrhoeae
- epididymo-orchitis including cases due to Neisseria gonorrhoeae
- pelvic inflammatory disease including infections due to Neisseria gonorrhoeae
• Infections of the gastro-intestinal tract (e.g. travellers' diarrhoea)
• Intra-abdominal infections
• Infections of the skin and soft tissue caused by Gram-negative bacteria
• Infections of the bones and joints
• Inhalation anthrax (post-exposure prophylaxis and curative treatment)
Ciprofloxacin may be used in the management of neutropenic patients with fever that is suspected to be due to a bacterial infection.
Posology and method of administration
Posology
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.
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).
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.
Contraindications:
• Hypersensitivity to the active substance, to other quinolones or to any of the excipients;
• Concomitant administration of ciprofloxacin and tizanidine.
