CIPROFLOXACIN

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. After intravenous initiation of treatment, the treatment can be switched to oral treatment with tablet or suspension if clinically indicated at the discretion of the physician.

IV treatment should be followed by oral route as soon as possible. g. patients on enteral nutrition), it is recommended to commence therapy with intravenous ciprofloxacin until a switch to oral administration is possible. g. Pseudomonas aeruginosa, Acinetobacter or Staphylococci) may require higher ciprofloxacin doses and co-administration with other appropriate antibacterial agents.

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.

Adults Indications Daily dose in mg Total duration of treatment (including switch to oral therapy as soon as possible) Infections of the lower respiratory tract 400 mg twice daily to 400 mg three times a day 7 to 14 days Infections of the upper respiratory tract Acute exacerbation of chronic sinusitis 400 mg twice daily to 400 mg three times a day 7 to 14 days Chronic suppurative otitis media 400 mg twice daily to 400 mg three times a day 7 to 14 days Malignant external otitis 400 mg three times a day 28 days up to 3 months Acute and complicated pyelonephritis 400 mg twice daily to 400 mg three times a day 7 to 21 days, it can be continued for longer than 21 days in some specific circumstances (such as abscesses) Urinary tract infections Bacterial prostatitis 400 mg twice daily to 400 mg three times a day 2 to 4 weeks (acute) Genital tract infections Epididymo-orchitis and pelvic inflammatory diseases including cases due to susceptible Neisseria gonorrhoeae 400 mg twice daily to 400 mg three times a day at least 14 days Diarrhoea caused by bacterial pathogens including Shigella spp.

other than Shigella dysenteriae type 1 and empirical treatment of severe travellers’ diarrhoea 400 mg twice daily 1 day Diarrhoea caused by Shigella dysenteriae type 1 400 mg twice daily 5 days Diarrhoea caused by Vibrio cholerae 400 mg twice daily 3 days Infections of the gastro-intestinal tract and intra- abdominal infections Typhoid fever 400 mg twice daily 7 days Indications Daily dose in mg Total duration of treatment (including switch to oral therapy as soon as possible) Intra-abdominal infections due to Gram-negative bacteria 400 mg twice daily to 400 mg three times a day 5 to 14 days Infections of the skin and soft tissue caused by Gram-negative bacteria 400 mg twice daily to 400 mg three times a day 7 to 14 days Infections of the bones and joints 400 mg twice daily to 400 mg three times a day max.

The most commonly reported adverse drug reactions (ADRs) are nausea, diarrhoea, , vomiting, transient increase in transaminases, rash, and injection and infusion site reactions. ADRs derived from clinical studies and post-marketing surveillance with Ciprofloxacin (oral, intravenous and sequential therapy) sorted by categories of frequency are listed below.

The frequency analysis takes into account data from both oral and intravenous administration of ciprofloxacin. 4) Mania, including hypomania Nervous System Disorders* Headache, Dizziness, Sleep disorders, Taste disorders Par- and Dysaesthesia, Hypoaesthesia, Tremor, Seizures (incl.

g. 9). g. 4). A range of psychiatric symptoms may occur as part of these side effects, which may include, but are not necessarily limited to, sleep disorders, anxiety, panic attacks, confusion, or depression. There are no pharmacological treatments established to be effective treatments of the symptoms of long lasting or disabling side effects associated with fluoroquinolones.

The frequency of these prolonged, disabling and potentially irreversible serious drug reactions cannot be estimated with precision using […]

8). 3). Prolonged, disabling and potentially irreversible serious adverse drug reactions Cases of prolonged (continuing for months or years), disabling and potentially irreversible serious adverse drug reactions affecting different, sometimes multiple, body systems (including musculoskeletal, nervous, psychiatric and senses) have been reported in patients receiving quinolones and fluoroquinolones irrespective of their age and pre-existing risk factors.

There are no pharmacological treatments established to be effective treatments of the symptoms of long lasting or disabling side effects associated with fluoroquinolones. Ciprofloxacin should be discontinued immediately at the first signs or symptoms of any serious adverse reaction and patients should be advised to contact their prescriber for advice, so that symptoms can be appropriately investigated and to avoid further exposure which could potentially worsen adverse reactions.

8). Aortic aneurysm and dissection, and heart valve regurgitation/incompetence Epidemiologic studies report an increased risk of aortic aneurysm and dissection, particularly in elderly patients, and of aortic and mitral valve regurgitation after intake of fluoroquinolones.

8). g. g. g. infective endocarditis). The risk of aortic aneurysm and dissection, and their rupture may also be increased in patients treated concurrently with systemic corticosteroids. In case of sudden abdominal, chest or back pain, patients should be advised to immediately consult a physician in an emergency department.

Patients should be advised to seek immediate medical attention in case of acute dyspnoea, new onset of heart palpitations, or development of oedema of the abdomen or lower extremities. Severe infections and mixed infections with Gram-positive and anaerobic pathogens Ciprofloxacin monotherapy is not suited for treatment of severe infections and infections that might be due to Gram-positive or anaerobic pathogens.

1. 5).