Source: Health Products Regulatory Authority (IE) Revision Year: 2020 Publisher: Clonmel Healthcare Ltd, Waterford Road, Clonmel, Co. Tipperary, Ireland
Profloxin 250 mg film-coated tablets are indicated for the treatment of the following infections (see sections 4.4 and 5.1). 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.
Ciprofloxacin may also be used to treat severe infections in children and adolescents when this is considered to be necessary.
Treatment should be initiated only by physicians who are experienced in the treatment of cystic fibrosis and/or severe infections in children and adolescents (see sections 4.4 and 5.1).
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.
| Indications | Daily dose in mg | Total duration of treatment (potentially including initial parenteral treatment with ciprofloxacin) | |
|---|---|---|---|
| Infections of the lower respiratory tract | 500mg twice daily to 750mg twice daily | 7 to 14 days | |
| Infections of the upper respiratory tract | Acute exacerbation of chronic sinusitis | 500mg twice daily to 750mg twice daily | 7 to 14 days |
| Chronic suppurative otitis media | 500mg twice daily to 750 mg twice daily | 7 to 14 days | |
| Malignant external otitis | 750mg twice daily | 28 days up to 3 months | |
| Urinary tract infections | Uncomplicated acute cystitis | 250mg twice daily to 500mg twice daily | 3 days |
| In pre-menopa usal women, 500mg single dose may be used | |||
| Complicated cystitis, Uncomplicated acute pyelonephritis | 500mg twice daily | 7 days | |
| Complicated pyelonephritis | 500 mg twice daily to 750 mg twice daily | at least 10 days, it can be continued for longer than 21 days in some specific circumstances (such as abscesses) | |
| Bacterial prostatitis | 500mg twice daily to 750mg twice daily | 2 to 4 weeks (acute) to 4 to 6 weeks (chronic) | |
| Genital tract infections | Gonococcal uretritis and cervicitis due to susceptible Neisseria gonorrhoeae | 500mg as a single dose | 1 day (single dose) |
| Epididymo-orc hitis and pelvic inflammatory diseases | 500mg twice daily to 750mg twice daily | at least 14 days | |
| Infections of the gastro-intestin al tract and intra-abdomin al infections | Diarrhoea caused by bacterial pathogens including Shigella spp. other than Shigella dysenteriae type 1 and empirical treatment of severe travellers' diarrhoea | 500mg twice daily | 1 day |
| Diarrhoea caused by Shigella dysenteriae type 1 | 500mg twice daily | 5 days | |
| Diarrhoea caused by Vibrio cholera | 500mg twice daily | 3 days | |
| Typhoid fever | 500mg twice daily | 7 days | |
| Intra-abdominal infections due to Gram-negative bacteria | 500mg twice daily to 750mg twice daily | 5 to 14 days | |
| Infections of the skin and soft tissue | 500mg twice daily to 750mg twice daily | 7 to 14 days | |
| Infections of the bones and joints | 500mg twice daily to 750mg twice daily | max. of 3 months | |
| Neutropenic patients with fever that is suspected to be due to a bacterial infection. Ciprofloxacin should be co-administered with appropriate antibacterial agent(s) in accordance to official guidance | 500mg twice daily to 750mg twice daily | Therapy should be continued over the entire period of neutropenia | |
| Prophylaxis of invasive infections due to Neisseria meningitidis | 500mg as a single dose | 1 day (single dose) | |
| Inhalation anthrax post-exposure prophylaxis and curative treatment for persons able to receive treatment by oral route when clinically appropriate. Drug administration should begin as soon as possible after suspected or confirmed exposure. | 500mg twice daily | 60 days from the confirmation of Bacillus anthracis exposure |
| Indications | Daily dose in mg | Total duration of treatment (potentially including initial parenteral treatment with ciprofloxacin) |
|---|---|---|
| Broncho-pulm onary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis | 20mg/kg body weight twice daily with a maximum of 750mg per dose | 10 to 14 days |
| Complicated urinary tract infections and acute pyelonephritis | 10mg/kg body weight twice daily to 20mg/kg body weight twice daily with a maximum of 750mg per dose | 10 to 21 days |
| Inhalation anthrax post-exposure prophylaxis and curative treatment for persons able to receive treatment by oral route when clinically appropriate. Drug administration should begin as soon as possible after suspected or confirmed exposure. | 10mg/kg body weight twice daily to 15mg/kg body weight twice daily with a maximum of 500mg per dose | 60 days from the confirmation of Bacillus anthracis exposure |
| Other severe infections | 20mg/kg body weight twice daily with a maximum of 750mg per dose | According to the type of infections |
Geriatric patients should receive a dose selected according to the severity of the infection and the patient’s creatinine clearance.
Recommended starting and maintenance dose for patients with impaired renal function:
| Creatinine Clearance [mL/min/1.73m²] | Serum Creatinine [micromole/L] | Oral Dose [mg] |
|---|---|---|
| >60 | <124 | See Usual Dosage |
| 30-60 | 124 to 168 | 250-500mg every 12 h |
| <30 | >169 | 250-500mg every 24 h |
| Patients on haemodialysis | >169 | 250-500mg every 24 h (after dialysis) |
| Patients on peritoneal dialysis | >169 | 250-500mg every 24 h |
In patients with impaired liver function no dose adjustment is required.
Dosing in children with impaired renal and/or hepatic function has not been studied.
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) (see section 4.5).
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.
An overdose of 12 g has been reported to lead to mild symptoms of toxicity. An acute overdose of 16g has been reported to cause acute renal failure.
Symptoms in overdose consist of dizziness, tremor, headache, tiredness, seizures, hallucinations, confusion, abdominal discomfort, renal and hepatic impairment as well as crystalluria and haematuria. Reversible renal toxicity has been reported.
Apart from routine emergency measures, it is recommended to monitor renal function, including urinary pH and acidify, if required, to prevent crystalluria. Patients should be kept well hydrated. Only a small quantity of ciprofloxacin (<10%) is eliminated by haemodialysis or peritoneal dialysis.
In the event of overdose, symptomatic treatment should be implemented. ECG monitoring should be undertaken, because of the possibility of QT interval prolongation.
5 years.
No special precautions for storage.
Blister strips consisting of 250 microM clear PVC and 20 microM hard temper aluminium foil contained in a carton.
Pack sizes: 5, 10, 12, 20, 30, 50, 60, 90 and 100 film-coated tablets.
Not all pack sizes may be marketed.
No special requirement.
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