CIPROBAY 500 TABLET 500 MG [SIN05085P]

Product Info

CIPROBAY 500 TABLET 500 MG

[SIN05085P]

Indications

Uncomplicated and complicated infections caused by ciprofloxacin sensitive pathogens.

Infections of the respiratory tract:

Ciprofloxacin can be regarded as an advisable treatment for pneumonias caused by Klebsiella spp., Enterobacter spp., Proteus spp., E. coli, Pseudomonas, Haemophilus spp., Moraxella Catarrhalis, Legionella spp. and Staphylococcus.

Infections of the middle ear (otitis media), of the paranasal sinuses (sinusitis), especially if these are caused by Gram-negative organisms including Pseudomonas or by Staphylococcus.

Infections of the eyes

Infections of the kidneys and/or the efferent urinary tract

Infections of the genital organs, including adnexitis, gonorrhoea, prostatitis

Infections of the abdominal cavity (e.g. infections of the gastrointestinal tract or of the biliary tract, peritonitis)

Infections of the skin and soft tissue

Infections of the bones and joints

Sepsis

Infections or imminent risk of infection (prophylaxis) in patients whose immune system has been weakened (e.g. patients on immunosuppressants or have neutropenia)

Selective intestinal decontamination in immunosuppressed patients

Consideration should be given to available official guidance on the appropriate use of antibacterial agents.

Dosage and method of administration

Dosage regimen
Unless otherwise prescribed, the following daily doses are recommended for:

Adults

Table 1: Recommended daily doses of Ciprobay oral and intraveneous in adults

Missed dose

If a dose is missed, it should be taken as anytime but not later than 6 hours prior to the next scheduled dose. If less than 6 hours remain before the next dose, the missed dose should not be taken and treatment should be continued as prescribed with the next scheduled dose.
Double doses should not be taken to compensate for a missed dose.

Additional information on special patient populations

Geriatric patients (> 65 years)

Elderly patients should receive a dose as low as possible depending on the severity of their illness and the creatinine clearance (see also ‘Patients with renal and hepatic impairment’).

Children: contraindicated

Patients with renal and hepatic impairment

Adults

Patients with renal impairment

Table 3: Recommended doses for patients with renal impairment

Patients with renal impairment on hemodialysis

For patients with creatinine clearance between 30 and 60 ml/min/1.73m² (moderate renal impairment) or serum creatinine concentration between 1.4 and 1.9 mg/100 ml, the maximum daily dose of ciprofloxacin should be 1000 mg for oral administration or 800. mg for an intravenous regimen.
For patients with creatinine clearance less than 30 ml/min/1.73m² (severe renal impairment) or serum creatinine concentration equal or higher than 2.0 mg/100 ml, the maximum daily dose of ciprofloxacin should be 500 mg for oral administration or 400 mg for an intravenous regimen on dialysis days after dialysis.

Patients with renal impairment on continuous ambulatory peritoneal dialysis (CAPD)

Addition of Ciprobay solution for infusion to the dialysate (intraperitoneal): 50 mg ciprofloxacin / liter dialysate administered 4 times a day every 6 hours.
The maximum daily oral dose of ciprofloxacin should be 500 mg (1 x 500 mg Ciprobay film-coated tablet or 2 x 250 mg Ciprobay film-coated tablets).

Patients with hepatic impairment

In patients with hepatic impairment, no dose adjustment is required.

Patients with renal and hepatic impairment

For patients with creatinine clearance between 30 and 60 ml/min/1.73m² (moderate renal impairment) or serum creatinine concentration between 1.4 and 1.9 mg/100 ml, the maximum daily oral dose of ciprofloxacin should be 1000 mg or 800 mg for an intravenous regimen.
For patients with creatinine clearance less than 30 ml/min/1.73m² (severe renal impairment) or serum creatinine concentration equal or higher than 2.0 mg/100 ml, the maximum daily oral dose of ciprofloxacin should be 500 mg or 400 mg for an intravenous regimen.

Method of administration

For oral Use

Ciprobay film-coated tablets are to be swallowed whole with a small amount of fluid.
They can be taken independent of mealtimes.
If the tablets are taken on an empty stomach, the active substance is absorbed more rapidly. In this case, the Ciprobay film-coated tablets should not be taken concurrently with dairy products or with mineral- fortified drinks alone (e.g. milk, yoghurt, calcium-fortified orange juice) (see ‘Interaction with other medicinal products and other forms of interaction’ – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

If the patient is unable to take the Ciprobay film-coated tablets because of the severity of the illness or for other reasons (e.g. patients on enteral nutrition), it is recommended to commence the therapy with an intravenous form of ciprofloxacin. After intravenous administration, the treatment can be continued orally.

Intravenous Infusion

Ciprobay solution for infusion should be administered by intravenous infusion. In adult patients, infusion time is 60 minutes for 400 mg Ciprobay infusion solution and 30 minutes for 200 mg Ciprobay infusion solution. Slow infusion into a large vein will minimize patient discomfort and reduce the risk of venous irritation. The solution for infusion can be infused either directly or after mixing with other compatible solutions for infusions.

Incompatibilities

Ciprofloxacin solution for infusion is compatible with physiological saline, Ringer solution and Ringer lactate solution, 5 % and 10 % glucose solutions, 10 % fructose solution, and 5 % glucose solution with 0.225 % NaCl or 0.45 % NaCl. When ciprofloxacin solution for infusion are mixed with compatible infusion solutions, for microbiological reasons and light sensitivity these solutions should be administered shortly after admixture.

Unless compatibility with other solutions for infusion/medicinal products has been confirmed, the infusion solution must always be administered separately. The visual signs of incompatibility are e.g. precipitation, clouding, and discolouration.

Incompatibility appears with all infusion solutions/medicinal products that are physically or chemically unstable at the pH of the solution (e.g. penicillins, heparin solutions), especially in combination with solutions adjusted to an alkaline pH (pH of the ciprofloxacin solution for infusion: 3.9–4.5).

Only clear solutions are to be used.

Duration of treatment

The duration of treatment depends on the severity of the illness and on the clinical and bacteriological course. It is essential to continue therapy for at least 3 days after disappearance of the fever or of the clinical symptoms.

• Mean duration of treatment: 1 day for acute uncomplicated gonorrhoea and cystitis

• up to 7 days for infections of the kidneys, urinary tract and abdominal cavity

• over the entire period of the neutropenic phase in patients with weakened body defences

• a maximum of 2 months in osteomyelitis

• and 7–14 days in all other infections

In streptococcal infections, the treatment must last at least 10 days because of the risk of late complications.

Infections caused by Chlamydia spp. should also be treated for a minimum of 10 days.

Contraindications

Hypersensitivity to ciprofloxacin or other quinolone or any of the excipients (see ’List of excipients’ – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Concurrent administration of ciprofloxacin and tizanidine (see, ’Interaction with other medicinal products and other forms of interaction’ – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Ciprofloxacin must not be prescribed for children, adolescents, since there is no experience on the drug’s safety in these patient groups and since, on the basis of animal studies, it is not entirely improbable that the drug could cause damage to articular cartilage in the immature organism.