CIPROFLOXACIN

, glibenclamide) or with insulin. Cases of hypoglycaemic coma have been reported. In diabetic patients, careful monitoring of blood glucose is recommended. 8). In such cases, ciprofloxacin should immediately be discontinued, and an appropriate therapy initiated.

Anti- peristaltic drugs are contraindicated in this situation. 8). Patients receiving ciprofloxacin should be well hydrated and excessive alkalinity of the urine should be avoided. 2 to avoid an increase in adverse drug reactions due to accumulation of ciprofloxacin.

8). In the event of any signs and symptoms of hepatic disease (such as anorexia, jaundice, dark urine, pruritus, or tender abdomen), treatment should be discontinued. Glucose-6-phosphate dehydrogenase deficiency Haemolytic reactions have been reported with ciprofloxacin in patients with glucose- 6-phosphate dehydrogenase deficiency.

Ciprofloxacin should be avoided in these patients unless the potential benefit is considered to outweigh the possible risk. In this case, potential occurrence of haemolysis should be monitored. Resistance During or following a course of treatment with ciprofloxacin bacteria that demonstrate resistance to ciprofloxacin may be isolated, with or without a clinically apparent superinfection.

There may be a particular risk of selecting for ciprofloxacin- resistant bacteria during extended durations of treatment and when treating nosocomial infections and/or infections caused by Staphylococcus and Pseudomonas species. g. theophylline, clozapine, olanzapine, ropinirole, tizanidine, duloxetine, agomelatine).

g. 5). Co- administration of ciprofloxacin and tizanidine is contra-indicated. 5). Interaction with tests The in-vitro activity of ciprofloxacin against Mycobacterium tuberculosis might give false negative bacteriological test results in specimens from patients currently taking ciprofloxacin.

Important Information about excipients This medicine contains less than 1mmol sodium (23mg) per 500mg tablet, that is to say essentially ‘sodium-free’. This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

g. 4). g. g. g. didanosine tablets) containing magnesium, aluminium, or calcium reduces the absorption of ciprofloxacin. Consequently, ciprofloxacin should be administered either 1-2 hours before or at least 4 hours after these preparations.

The restriction does not apply to antacids belonging to the class of H2 receptor blockers. Food and Dairy Products Dietary calcium as part of a meal does not significantly affect absorption. g. milk, yoghurt, calcium-fortified orange juice) with ciprofloxacin should be avoided because absorption of ciprofloxacin may be reduced.

Probenecid Probenecid interferes with renal secretion of ciprofloxacin. Co-administration of probenecid and ciprofloxacin increases ciprofloxacin serum concentrations.

Metoclopramide:

Metoclopramide accelerates the absorption of ciprofloxacin (oral) resulting in a shorter time to reach maximum plasma concentrations.

No effect was seen on the bioavailability of ciprofloxacin Omeprazole:

Concomitant administration of ciprofloxacin and omeprazole containing medicinal products results in a slight reduction of Cmax and AUC of ciprofloxacin. 3). In a clinical study with healthy subjects, there was an increase in serum tizanidine concentration (Cmax increase: 7-fold, range: 4 to 21-fold; AUC increase: 10-fold, range: 6 to […]

1). 5). 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.

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. In such infections ciprofloxacin must be co-administered with other appropriate antibacterial agents.

Streptococcal Infections (including Streptococcus pneumoniae) Ciprofloxacin is not recommended for the treatment of streptococcal infections due to inadequate efficacy. Genital tract infections Gonococcal urethritis, cervicitis, epididymo-orchitis and pelvic inflammatory diseases may be caused by fluoroquinolone-resistant Neisseria gonorrhoeae isolates.

Therefore, Ciprofloxacin should be administered for the treatment of gonococcal urethritis or cervicitis only if ciprofloxacin resistant Neisseria gonorrhoeae can be excluded. g. a cephalosporin) unless ciprofloxacin-resistant Neisseria gonorrhoeae can be excluded.

If clinical improvement is not achieved after 3 days of treatment, the therapy should be reconsidered. Urinary tract infections Resistance to fluoroquinolones of Escherichia coli - the most common pathogen involved in urinary tract infections - varies across the European Union.

Prescribers are advised to take into account the local prevalence of resistance in Escherichia coli to fluoroquinolones. The single dose of ciprofloxacin that may be used in uncomplicated cystitis in pre- menopausal women is expected to be associated with lower efficacy than the longer treatment duration.

This is all the more to be taken into account as regards the increasing resistance level of Escherichia coli to quinolones Intra-abdominal infections There are limited data on the efficacy of ciprofloxacin in the treatment of postsurgical intra-abdominal infections.

Travellers' diarrhoea The choice of ciprofloxacin should take into account information on resistance to ciprofloxacin in relevant pathogens in the countries visited. Infections of the bones and joints Ciprofloxacin should be used in combination with other antimicrobial agents depending on the results of the microbiological documentation.

Inhalational anthrax Use in humans is based on in-vitro susceptibility data and on animal experimental data together with limited human data. Treating physicians should refer to national and/or international consensus documents regarding the treatment of anthrax.

Paediatric population The use of ciprofloxacin in children and adolescents should follow available official guidance. Ciprofloxacin treatment should be initiated only by physicians who are experienced in the treatment of cystic fibrosis and/or severe infections in children and adolescents.

Ciprofloxacin has been shown to cause arthropathy in weight- bearing joints of immature animals. 6%. 7%. The increase of suspected drug-related arthropathy cases over time was not statistically significant between groups. 8). Broncho-pulmonary infections in cystic fibrosis Clinical trials have included children and adolescents aged 5-17 years.

More limited experience is available in treating children between 1 and 5 years of age. Complicated urinary tract infections and pyelonephritis Ciprofloxacin treatment of urinary tract infections should be considered when other treatments cannot be used, and should be based on the results of the microbiological documentation.

Clinical trials have included children and adolescents aged 1-17 years. Other specific severe infections Other severe infections in accordance with official guidance, or after careful benefit- risk evaluation when other treatments cannot be used, or after failure to conventional therapy and when the […]