Civox™
Ciprofloxacin 0.2% w/v
Intravenous Infusion
Presentation
Civox™ 100 ml IV Infusion: Each 100 ml contains Ciprofloxacin Lactate INN equivalent to 200 mg Ciprofloxacin.
Description
Ciprofloxacin is a synthetic, 4-quinolone derivative with bactericidal activity against a wide range of gram-negative and gram-positive organisms including strains resistant to penicillins, cephalosporins and/or aminoglycosides. The antibacterial action of Ciprofloxacin results from the inhibition of bacterial DNA gyrase.
Indications
Civox™ is indicated for the treatment of a wide variety of infections caused by susceptible gram-positive and gram-negative organisms including mixed infections caused by two or more organisms. The extensive tissue penetration of Civox™ combined with its enhanced antibacterial activity (including anti-pseudomonal activity) enables Civox™ to be used alone pending sensitivity results or in combination with an aminoglycoside or with beta-lactam antibiotics or with an antibiotic active against anaerobes (metronidazole) where the presence of anaerobes is suspected. Civox™ is indicated for the treatment of the following infections caused by sensitive bacteria: 1. Respiratory Tract Infections 2. Ear, Nose and Throat Infections 3. Gastrointestinal Tract Infections 4. Intra-abdominal Infections 5. Skin and Soft Tissue Infections 6. Bone and Joint Infections - acute and chronic osteomyelitis, septic arthritis. 7. Urinary Tract Infections 8. Gonorrhoea including urethral, rectal and pharyngeal gonococcal infections 9. Gynaecological Infections 10. Eye infections 11. Severe Systemic Infections. Civox™ is also indicated for prophylaxis against infection in elective upper-gastrointestinal surgery and endoscopic procedures where there is an increased risk of infection.
Dosage and Administration
The dosage of Civox™ is determined by the severity and type of infection, the sensitivity of the causative organism(s) and the age, weight, and renal function of the patient. The usual intravenous dose is 100 to 400 mg twice daily.
|
Indication |
Dosage |
Infusion rate |
Duration |
|
Upper & lower UTI |
100 mg (50 ml) every 12 hourly |
Should be administered by slow intravenous infusion over period of 30-60 minutes. |
Duration of the treatment depend upon the severity of the infection, clinical response and bacteriological findings. The usual duration of therapy for acute infection is 5 to 7 days. Generally therapy should be continued for at least 3 days after the sign and symptoms of the infection have disappeared. |
|
Lower RTI |
200 mg(100 ml) every 12 hourly |
||
|
Other infection |
200 mg (100 ml) every 12 hourly |
||
|
Gonorrhoea |
100 mg (50 ml) as a single dose |
Side Effects
Ciprofloxacin is generally well tolerated. Common side effects include
nausea, vomiting, abdominal pain, diarrhoea, headache, dizziness, sleep
disorders, rash, pruritus, anaphylaxis, photosensitivity, increase in blood
urea and creatinine, transient disturbances in liver enzymes and bilirubin,
arthralgia and myalgia, blood disorders (including eosinophilia, leucopenia,
thrombocytopenia and altered prothrombin concentration). Less frequent side
effects include anorexia, restlessness, hallucinations, confusion and
disturbances in vision, taste and smell.
Contraindications
Ciprofloxacin is contraindicated in individuals with a history of
hypersensitivity to this drug. It is also contraindicated in children and
growing adolescents except where the benefits of treatment exceed the risks.
Drug Interactions
Concurrent administration of Ciprofloxacin and theophylline can cause an
increase in the serum theophylline concentration. This can result in
theophylline induced side effects which in rare cases may be life
threatening or fatal. If concurrent use of the two products is unavoidable,
the serum theophylline concentration should be monitored and the
theophylline dose reduced as appropriate. The combinations of very high
doses of quinolones and some NSAIDs can cause convulsions. A transient rise
in serum creatinine concentration was observed when Ciprofloxacin and
cyclosporin were administered simultaneously. The simultaneous
administration of Ciprofloxacin and warfarin may intensify the action of
warfarin. Concurrent administration of Ciprofloxacin and glibenclamide may
cause hypoglycaemia. Co-administration of probenicid and Ciprofloxacin
increases Ciprofloxacin serum concentrations. Patients receiving
methotrexate therapy should be carefully monitored when concomitant
Ciprofloxacin therapy is indicated. Tizanidine must not be administered
together with Ciprofloxacin.
Precautions and Warnings
Ciprofloxacin should be used with caution in epileptics and patients with a
history of CNS disorders. Infusion of fluid should be immediately
discontinued if rigor arises for any reason during the process. Do not use
if the solution is cloudy, contains particles or after expiry date. Use in
Pregnancy: Reproduction study with Ciprofloxacin did not reveal any evidence
of teratogenicity, impairment of fertility or impairment of peri/post-natal
development. Use in Lactation: Ciprofloxacin has been shown to cause
arthropathy in immature animals. It is secreted in breast milk. So
Ciprofloxacin should not be used in pregnant and nursing women.
Pharmaceutical Precautions
Civox™ should be stored at controlled room temperature. This Infusion is not
intended for multi-dose use.
Overdosage
In addition to normal emergency measures, it is recommended that renal
function be monitored. Less than 10% of Ciprofloxacin is removed from the
body after haemodialysis or peritoneal dialysis.
Commercial Pack
Civox™ 100 ml IV Infusion: Available in 100 ml Polypropylene bag.
Administration Procedure
1. Check infusion set and infusion solution prior to use
2. Pull moderately to tear off the protective cover of the Eurohead
(Picture-1)
3. Hold lightly the Eurohead but not the bag (Picture-2)
4. Open the flow regulator fully and hold the giving set on the top white
area, but not the membrane venting region (Picture-2)
5. Insert the spike of the administration set to the Eurohead and fit the
connector of the administration set firmly to the needle
(Picture-2)
6. Gradually allow the fluid to flow down to the needle tip and close
7. Remove the protective cover of the needle
8. Locate the venipuncture site and clean the site with an antiseptic
solution, and then insert the needle (Picture-3)
9. Securely tape the puncture site
10. Securely tape the wings and tubing
11. Start infusion while adjusting drip speed
