CIPROFLOXACIN is a brand name for Ciprofloxacin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Because of the risk of prolonged, disabling and potentially irreversible serious adverse drug reactions (see section 4.4 and section 4.8) this product must only be prescribed when other antibiotics that are commonly recommended for the infection are inappropriate. This applies to all indications listed below.…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology The dose of ciprofloxacin tablets is determined by the indication, the severity and the site of the infection, the sensitivity 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 disorder and on the clinical and bacteriological course. In principle, treatment should be maintained for at least 3 days after body temperature has returned to normal, or clinical symptoms have resolved.
Treatment may be initiated with tablets or intravenous injection according to the condition of the patient. The following dose recommendations are provided as a guideline and refer to oral dosing only. (Note that different dose recommendations apply to intravenous administration of ciprofloxacin).
Adults: the dosage range for adults is 100-750 mg twice daily. Indication Recommended Dosage Respiratory tract infections 250-500 mg twice daily Usual duration of treatment: 7-14 days Urinary tract infections Acute, uncomplicated cystitis in women: 100-250 mg twice daily for 3 days Complicated infections and pyelonephritis: 250-500 mg twice daily.
Usual duration of treatment: 7-14 days Prostatitis 500 mg twice daily. Usual duration of treatment: up to 28 days Gonorrhoea Acute uncomplicated 250-500 mg as a single dose Severe gastro-enteritis 500 mg twice daily. Usual duration of treatment: 3-7 days Skin and soft tissue infections 500 mg twice daily.
Usual duration of treatment 5-10 days Bone and joint infections 500-750 mg twice daily. Usual duration of treatment 4-6 weeks or longer Severe systemic infections 500-750 mg twice daily. g. osteomyelitis, septicaemia, pneumococcal pneumonia, recurrent bouts of infection in mucoviscidosis patients, bone and joint infections or peritonitis - the recommended dose is 750 mg ciprofloxacin twice daily.
Elective upper gastro-intestinal surgical and endoscopic procedures 750 mg single dose 60-90 minutes prior to the procedure. If gastro-intestinal obstructive lesions are suspected, use with an anti-infective effective against anaerobes.
Other indications 500 - 750 mg twice a day.
Elderly patients:
Elderly patients should receive a dose selected according to the severity of the infection and the patient’s creatinine clearance. e. 20 mg/kg twice daily (maximum 1500 mg daily). Usual duration of treatment: 10-14 days. 0 mg/dL) Maximum dose 500 mg/day* * In patients with severe infections and severe renal impairment, a unit dose of 750 mg can be given.
Adverse reactions are listed by frequency: very common (>1/10); common (>1/100 to <1/10); uncommon (>1/1,000 to <1/100); rare (>1/10,000 to <1/1,000); very rare (<1/10,000). The most commonly reported adverse drug reactions (ADRs) are nausea and diarrhoea.
4) Mania, incl. g. g. 4) Tubulointerstitial nephritis General Disorders and Administration Asthenia Fever Oedema Sweating (hyperhidrosis) Site Conditions* Endocrine disorders Syndrome of inappropriate secretion of antidiuretic hormone (SIADH).
4). 4). Paediatric population The incidence of arthropathy, mentioned above, is referring to data collected in studies with adults. 4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
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.
Tendinitis and tendon rupture Tendinitis and tendon rupture (especially but not limited to Achilles tendon), sometimes bilateral, may occur as early as within 48 hours of starting treatment with quinolones and fluoroquinolones and have been reported to occur even up to several months after discontinuation of treatment.
The risk of tendinitis and tendon rupture is increased in older patients, patients with renal impairment, patients with solid organ transplants, and those treated concurrently with corticosteroids. Therefore, concomitant use of corticosteroids should be avoided.
g. painful swelling, inflammation), the treatment with ciprofloxacin should be discontinued and alternative treatment should be considered. g. immobilisation). Corticosteroids should not be used if signs of tendinopathy occur. Peripheral neuropathy Cases of sensory or sensorimotor polyneuropathy resulting in paraesthesia, hypaesthesia, dysesthesia, or weakness have been reported in patients receiving quinolones and fluoroquinolones.
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Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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However, patients should be carefully monitored. Dosage intervals should remain the same as in patients with normal renal function. Impaired renal function + haemodialysis Recommended dose: 500 mg per day administered as a single dose following haemodialysis.
Impaired renal function + continuous ambulatory peritoneal dialysis (CAPD) Recommended dose: 500 mg per day administered as a single dose following CAPD. Impaired hepatic function Dose adjustment is not necessary in mild or moderate hepatic failure but may be considered necessary in severe hepatic failure.
Children and adolescents (5-17 years):
Dosing in children with impaired renal and/or liver function has not been studied.
Method of administration:
The 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. g. g. 5).
Patients under treatment with ciprofloxacin should be advised to inform their doctor prior to continuing treatment if symptoms of neuropathy such as pain, burning, tingling, numbness, or weakness develop in order to prevent the development of potentially irreversible condition.
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 suitable 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 fluroquinolone-resistant Neisseria gonorrhoeae isolates. Therefore, ciprofloxacin should be administered for the treatment of gonoccocal 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 […]