Chlorhexidine Gluconate Solution BP.
Chlorhexidine Irrigation Solutions are sterile blue coloured solutions for irrigation containing Chlorhexidine Gluconate Solution BP in Water for Injections BP. The colouring agent is methylene blue. Chlorhexidine Irrigation Solution 0.1%w/v contains octoxinol 8 as a wetting agent. Chlorhexidine gluconate solution is an almost colourless or pale yellowish liquid. It is miscible with water, soluble in acetone and in alcohol. The structural formula of chlorhexidine gluconate is represented below:
H H
N N
CO2H
H H H HO C H
N C N C N Cl
,
H C OH
HO C H
N C N C N Cl
H H H HO C H N N
H H CH2OH 2
Molecular Formula: C22H30Cl2N10,2C6H12O7 Molecular Weight: 898 CAS Number: 18472-51-0
Chlorhexidine is an antiseptic and disinfectant which is effective against a wide range of vegetative Gram-positive and Gram-negative organisms, some viruses and some fungi. It is ineffective against bacterial spores at room temperature, and acid-fast bacteria are inhibited but not killed. It is more active against Gram-positive than Gram- negative bacteria and some species of Pseudomonas and Proteus are relatively less susceptible. Chlorhexidine is most active at a neutral or slightly acid pH and its activity may be reduced by blood and other organic matter.
Chlorhexidine Irrigation Solution 0.1%w/v for skin and wound irrigation or dressing to prevent and control infection Chlorhexidine Irrigation Solution 0.2%w/v for antisepsis of external genitalia prior to catheterisation of the bladder
known hypersensitivity to chlorhexidine do not use to irrigate the brain, meninges, eyes or perforated eardrums do no use in body cavities or as enema
for external use only
not for injection, for irrigation only
not isotonic and is haemolytic
not to be used as a preoperative skin preparation for face or head
Use in pregnancy:
Category A. Chlorhexidine has been used by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed.
Based on negligible topical absorption and a complete lack of any unusual reported effects when used during pregnancy, chlorhexidine would not appear to present a risk to pregnant women. No special precautions or changes in methods of application or use of chlorhexidine seem needed in pregnant health care workers or patients.
Carcinogenicity/mutagenicity:
Chlorhexidine is not teratogenic in rats.
Irritative skin reactions and hypersensitivity reactions to chlorhexidine have been reported. In the event that these reactions occur, discontinue use. Chlorhexidine may cause anaphylaxis. Hematuria has been reported following bladder irrigation. There have been at least four cases of irreversible corneal damage due to contact with chlorhexidine. Chlorhexidine has been reported to cause deafness when instilled into the middle ear through a perforated eardrum.
Chlorhexidine Irrigation Solution 0.1%w/v rinse the area to be cleaned with water, apply the minimum amount of irrigation necessary to cover the wound area and wash gently. Rinse again thoroughly. Apply to wound as necessary. Discard remaining solution after use. Chlorhexidine Irrigation Solution 0.2%w/v irrigate the area of the external genitalia thoroughly prior to catheterisation.
If poisoning occurs, contact a doctor or Poisons Information Centre.
Symptoms and treatment
In case of accidental or deliberate oral poisoning or ingestion:
Chlorhexidine taken orally is poorly absorbed. Immediate dilution with (120 - 240mL) water or milk (not to exceed 15mL/kg in children) is recommended. The administration of charcoal is not likely to be beneficial and may obscure visualisation during endoscopy. It is not recommended unless other substances known to be absorbed to charcoal are co-ingested. Employ supportive measures as appropriate.
In case of accidental intravenous administration:
Haemolysis due to hypotonicity has been reported. Blood transfusion may be necessary to counteract haemolysis.
AUST R 11175 Chlorhexidine Irrigation Solution 0.1%w/v 30mL (sterile) Steritube AUST R 11324 Chlorhexidine Irrigation Solution 0.2%w/v 30mL (sterile) Steritube (Not available in New Zealand)
Note: All above irrigation solutions are tinted blue.
Store below 25C. Protect from light. Single use only. Discard unused portion. The expiry date (month/year) is stated on the package after the word EXP.
Australia - Nil.
Pfizer (Perth) Pty Limited ABN 32 051 824 956 15 Brodie Hall Drive Bentley WA 6102 Australia
Pfizer Australia Pty Ltd ABN 50 008 422 348 38-42 Wharf Road West Ryde NSW 2114 Australia
Pfizer Australia Pty. Ltd. ABN 50 008 422 348
38-42 Wharf Road West Ryde NSW 2114 Australia
Registered Trademark
This information was approved by the TGA on 9 October 2001. Date of most recent amendment: 2 February 2010