CIPROFLOXACIN INFUSION 2MG/ML
Each 100 mL vial contains:
254 mg Ciprofloxacin Lactate equivalent to 200 mg Ciprofloxacin
Ciprofloxacin is a synthetic fluoroquinolone antibiotic. It is
bactericidal and acts by inhibiting the A subunit of DNA-gyrase
which is essential in the reproduction of bacterial DNA.
After oral administration, ciprofloxacin plasma levels are
dose-related and peak at 0,5-2 hours.
Ciprofloxacin2 mg/mL IV is indicated for the treatment of the
following infections, when caused by susceptible organisms:
Lower Respiratory Tract Infections
Urinary tract infections
Skin and soft tissue infections
Ciprofloxacin2 mg/mL IV is contra-indicated in patients with a
history of hypersensitivity to ciprofloxacin, any other quinolones,
or any of the inactive ingredients.
Ciprofloxacin 2 mg/mL IV should be used with caution in patients
with a history of convulsive disorders..
Crystalluria related to the use of ORPIC 2 mg/mL IV has been
observed. Patients receiving ORPIC 2 mg/mL IV should be well
hydrated and excessive alkalinity of the urine should be avoided.
DOSAGE AND DIRECTIONS FOR USE:
In the treatment of infections caused by Pseudomonas aeruginosa, an aminoglycoside must be administered concomitantly.
The dosage of ORPIC 2 mg/mL IV is determined by the severity and
type of infection, the sensitivity of the causative organism(s) and
the age, mass and renal function of the patient.
Adults: The usual dose is 100 mg-200 mg IV every 12 hours.
For severe and/or complicated infections 400 mg may be administered
every 12 hours.
Intravenous therapy should be discontinued as soon as oral ORPIC
therapy can be substituted. The normal duration of intravenous
therapy is up to 7 days.
In cystic fibrosis patients, the normal dose is 200 mg IV every 12
hours. The low body mass of these patients should however, be taken
into consideration when determining dosage (5-10 mg/kg/day).
Ciprofloxaci 2 mg/mL IV should be administered by intravenous
infusion over a period of 60 minutes. Slow infusion into a large
vein will minimize patient discomfort and reduce the risk of venous
irritation. The infusion solution can be infused either directly or
after mixing with the other compatible infusion solutions.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Nausea, diarrhoea, vomiting, dyspepsia, abdominal pain. The
development of severe and persistent diarrhoea may indicate
pseudomembranous colitis, requiring immediate treatment. In such
cases ORPIC 2 mg/mL IV must be discontinued and appropriate therapy
initiated (e.g. vancomycin, orally 4 x 250 mg/day).
Visual disturbances (e.g. diplopia, colour vision).
Hearing and vestibular disorders:
Tinnitus, transient impairment of hearing - especially at high
Eosinophilia, leucocytopenia, granulocytopenia, anaemia,
thrombocytopenia, leucocytosis, thrombocytosis, haemolytic anaemia,
altered prothrombin values.
Central Nervous system:
Store below 25°C, protected from light.
Store in outer carton until required for use.
KEEP OUT OF THE REACH OF CHILDREN.