Chlorhexidine Acetate with Cetrimide Antiseptic Solution

MIMS Revision Date: 01 November 2024

1 Name of Medicine

Chlorhexidine acetate and cetrimide.

2 Qualitative and Quantitative Composition

Baxter Chlorhexidine Acetate with Cetrimide antiseptic solutions are yellow sterile solutions.
Baxter Chlorhexidine Acetate with Cetrimide antiseptic solutions are hypotonic and haemolytic. They are supplied in the following strengths:
Chlorhexidine Acetate 0.015% with Cetrimide 0.15%.
Chlorhexidine Acetate 0.05% with Cetrimide 0.5%.
Chlorhexidine Acetate 0.10% with Cetrimide 1.0%.
Each strength is supplied in 3 pack sizes (see Section 6.5 Nature and Contents of Container, Table 1).
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Antiseptic solution.

4 Clinical Particulars

4.1 Therapeutic Indications

Baxter Chlorhexidine Acetate with Cetrimide Antiseptic Solution is used as a general antiseptic.
It is used for the cleaning and disinfecting of wounds as an antiseptic treatment for burns.

4.2 Dose and Method of Administration

Dosage. As required to disinfect wound area. See Directions for use. Dosage and duration of administration are to be individualized and depend upon the indication for use, the patient's ages, weight, clinical condition, concomitant treatment and on patient's clinical response to treatment.
Not for intravenous or oral route of administration.
Product should be inspected visually for particulate matter and discolouration prior to administration whenever solution and container permit. Do not use unless the solution is clear and the seal is intact.
Directions for use. The area where Baxter Chlorhexidine Acetate with Cetrimide Antiseptic Solution is to be used should be rinsed thoroughly with water. Apply the minimum amount necessary to cover the wound area and wash gently. Leave the area to dry by air for 3 minutes.
Use undiluted. Do not mix with detergents or other chemicals. Discard within 24 hours of opening.
The solution is used for cleaning and disinfecting wounds and as an antiseptic treatment for burns.
To open. Hold Steripour bottle and twist lid to open, breaking the tamper proof seal.

4.3 Contraindications

Known hypersensitivity to chlorhexidine or cetrimide.
Baxter Chlorhexidine Acetate with Cetrimide Antiseptic Solution should not be used in the eye, intravenously, orally, in the auditory canal (especially perforated eardrums) or near meninges, brain or spinal cord.

4.4 Special Warnings and Precautions for Use

General. Baxter Chlorhexidine Acetate with Cetrimide Antiseptic Solution is used as a topical solution; it must not be administered intravenously or taken orally.
This product should not be used in body cavities or as an enema. It should not be used for the disinfection of soft contact lenses.
Seek urgent medical attention if Baxter Chlorhexidine Acetate with Cetrimide Antiseptic Solution is swallowed. If ingested, cetrimide may cause nausea and vomiting. Swallowing this solution may cause oesophageal damage or necrosis. Demulcents may be given, but emesis and lavage should be avoided.
Accidental intrauterine or intravenous administration may cause haemolysis.
It should not be used if you have a history of allergy to any of the ingredients of Baxter Chlorhexidine Acetate with Cetrimide Antiseptic Solution.
It should not be used if the expiry date printed on the label is overdue. Do not use unless the solution is clear, free of particles and the tamperproof seal is intact.
Hypersensitivity reactions. Hypersensitivity reactions including anaphylactic/ anaphylactoid reactions have been reported with chlorhexidine. Fatal anaphylactic reactions have been reported with other products containing chlorhexidine.
If any signs or symptoms of a suspected hypersensitivity reaction develop, immediately stop use the product. Appropriate therapeutic countermeasures must be instituted as clinically indicated.
Some patients become hypersensitive to cetrimide after repeated applications. The use of chlorhexidine as a mouthwash has been associated with reversible discolouration of the tongue, teeth and silicate or composite dental restorations.
Chemical burns in neonates. The use of chlorhexidine solutions, both alcohol based and aqueous, for skin antisepsis prior to invasive procedures has been associated with skin reactions such as chemical burns in neonates. Based on available case reports in the published literature, this risk appears to be higher in preterm infants, especially those born before 32 weeks of gestation and within the first 2 weeks of life.
Remove any soaked materials, drapes or gowns before proceeding with the intervention. Do not use excessive quantities and do not allow the solution to pool in skin folds or under the patient or drip on sheets or other material in direct contact with the patient. Where occlusive dressings are to be applied to areas previously exposed to chlorhexidine, care must be taken to ensure no excess product is present prior to application of the dressing.
Preoperative skin preparation. Chlorhexidine should not be used in preoperative skin preparations for the face and head.
Chlorhexidine must not come into contact with the eye. Serious cases of persistent corneal injury, potentially requiring corneal transplant, were reported following accidental ocular exposure to chlorhexidine containing medicinal products despite taking eye protective measures due to migration of solution beyond the intended surgical preparation area. Extreme care must be taken during application to ensure that chlorhexidine does not migrate beyond its intended application site into the eyes. Particular care should be taken in anesthetized patients, who are unable to immediately report ocular exposure. If chlorhexidine comes into contact with the eyes, wash out promptly and thoroughly with water. An ophthalmologist's advice should be sought.
Use in the elderly. No data available.
Paediatric use. This product is safe for use on children.
The use of chlorhexidine solutions has been associated with skin reactions such as chemical burns in neonates.
Effects on laboratory tests. The effect of this medicine on laboratory tests has not been established.

4.5 Interactions with Other Medicines and Other Forms of Interactions

The action of chlorhexidine is reduced by an alkaline pH, the presence of organic matter, anionic detergents and tannins.
See Section 6.2 Incompatibilities.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility. No data available.
Use in pregnancy. (Category A)
The "Prescribing Medicines in Pregnancy" booklet categorises chlorhexidine as a Category A medicine.
Use in lactation. This product is safe for use in lactation.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Anaphylactic/ anaphylactoid reactions to chlorhexidine have been reported. Manifestations of such reactions have included cardiac arrest, circulatory collapse, hypotension, bronchospasm, rash, erythema, tachycardia, urticaria and shock. Fatal anaphylactic reaction has been reported.
Some patients may experience skin irritation or an allergic reaction/ hypersensitivity reactions on contact with this product. If this occurs, the use of this product should be stopped immediately.
Skin sensitivity to chlorhexidine has occasionally been reported.
Very occasionally the following reactions have been noted when chlorhexidine containing irrigating solutions have been used intravesically, intravaginally or topically on traumatised skin: hypotension, paraesthesia, dyspnoea, tachycardia cold sweat, generalized erythema, urticaria and loss of consciousness.
Strong solutions may cause irritation of the conjunctiva and other sensitive tissues. Transient taste disturbances and a burning sensation of the tongue may occur on initial use.
Oral desquamation and occasional parotid gland swelling have been reported with the mouthwash. If desquamation occurs, a 50% dilution of the mouthwash with water and less vigorous rinsing may allow continued use.
The adverse events reported and/or observed with other chlorhexidine products include:
Fatal anaphylactic reactions;
Chemical burns in neonates (see Section 4.4 Special Warnings and Precautions for Use);
Eye disorder. Frequency not known: corneal erosion, corneal epithelium defect/ injury corneal, visual impairment*.
*Cases of severe corneal erosion and permanent significant visual impairment due to inadvertent ocular exposure have been reported post-marketing, leading to some patients requiring corneal transplant (see Section 4.4 Special Warnings and Precautions for Use).
Reporting suspected adverse effects. Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

If taken by mouth, cetrimide and other quaternary ammonium compounds cause nausea and vomiting. If ingested, advice concerning treatment should be sought immediately from a doctor or contact the Poison Information Centre on 13 11 26 (Australia).
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action. Cetrimide is a quaternary ammonium antiseptic with actions and uses typical of cationic surfactants. These surfactants dissociate in aqueous solution into a relatively large and complex cation, which is responsible for the surface activity, and a smaller inactive anion. In addition to emulsifying and detergent properties, quaternary ammonium compounds have bactericidal activity against Gram-positive and, at the higher concentrations, against some Gram-negative bacteria. Some Pseudomonas spp. are particularly resistant as are strains of Mycobacterium tuberculosis. They are ineffective against bacterial spores, have variable antifungal activity, and are effective against some viruses.
Quaternary ammonium compounds are most effective in neutral or slightly alkaline solutions and their bactericidal activity is appreciably reduced in acid media; alcohols enhance their activity.
Clinical trials. No data available.

5.2 Pharmacokinetic Properties

No data available.

5.3 Preclinical Safety Data

Genotoxicity. No data available.
Carcinogenicity. No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Tartrazine, glacial acetic acid and water for injections.

6.2 Incompatibilities

Prolonged immersion of rubber appliances in these solutions should be avoided. Chlorhexidine is incompatible with soaps, other anionic materials and with potassium iodide.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Baxter Chlorhexidine Acetate with Cetrimide Antiseptic Solution should be stored below 30°C.
Protect from light.

6.5 Nature and Contents of Container

Baxter Chlorhexidine Acetate with Cetrimide antiseptic solutions are supplied in 3 strengths. Each strength has 3 pack sizes (see Table 1). Do not heat bottle in excess of 80°C.

Package size. 100 mL, 500 mL and 1000 mL.

6.6 Special Precautions for Disposal

Any unused product or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Chemical structure. Chlorhexidine acetate.

Molecular formula: C₂₆H₃₈Cl₂N₁₀O₄.
Molecular weight: 626.
Appearance: white or almost white, microcrystalline powder.
Solubility: sparingly soluble in water, soluble in ethanol (96 per cent), slightly soluble in glycerol and in propylene glycol.
Cetrimide.
Molecular formula: C₁₇H₃₈BrN.
Molecular weight: 336.4.
Appearance: white or almost white, voluminous, free-flowing powder.
Solubility: freely soluble in water and in alcohol.
CAS number. Chlorhexidine acetate. CAS No.: 56-95-1.
Cetrimide. CAS No.: 505-86-2.

7 Medicine Schedule (Poisons Standard)

Not scheduled.

Date of First Approval

30 September 1991

Date of Revision

05 September 2024

Summary Table of Changes