MIMS Revision Date: 01 November 2024

1 Name of Medicine

Chlorhexidine acetate.

2 Qualitative and Quantitative Composition

Baxter Chlorhexidine Acetate (0.05%, 0.1% and 0.5%) Antiseptic solutions are clear, slightly blue sterile solutions. Baxter Chlorhexidine Acetate 0.02% Antiseptic solutions are clear sterile solutions.
They are supplied in 4 strengths. 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 Antiseptic Solution is used as a general antiseptic. It is used for the cleaning and disinfecting of wounds and the antiseptic treatment of 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 individualised 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 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. Allow to dry for 3 minutes.
Discard within 24 hours of opening.
This solution is used as a general antiseptic, and is also recommended for disinfection of respirators.
To open. Hold Steripour bottle and twist lid to open, breaking the tamper proof seal.

4.3 Contraindications

Known hypersensitivity to chlorhexidine or methylene blue.
Baxter Chlorhexidine Acetate 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 Antiseptic Solution should not be used intravenously or taken orally. Do not swallow. If swallowed seek urgent medical attention.
It should not be used if you have a history of allergy to any of the ingredients of Baxter Chlorhexidine Acetate Antiseptic Solution.
The use of chlorhexidine as a mouthwash has been associated with reversible discolouration of the tongue, teeth, and silicate or composite dental restorations.
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 tamper proof 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 using the product. Appropriate therapeutic countermeasures must be instituted as clinically indicated.
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 face or 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 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

Chlorhexidine is poorly absorbed by the gastrointestinal tract. If ingested, advice concerning treatment should be sought immediately from a doctor.
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. Baxter Chlorhexidine Acetate Antiseptic Solution is used as a topical solution. It is used as a general antiseptic.
Clinical trials. No data available.

5.2 Pharmacokinetic Properties

No data available.

5.3 Preclinical Safety Data

Genotoxicity. Studies with chlorhexidine acetate have not been performed to evaluate mutagenic potential.
Carcinogenicity. Studies with chlorhexidine acetate have not been performed to evaluate carcinogenic potential.

6 Pharmaceutical Particulars

6.1 List of Excipients

Baxter Chlorhexidine Acetate 0.02% solution. Glacial acetic acid, water for injections.
Baxter Chlorhexidine Acetate 0.05% solution. Methylene blue, glacial acetic acid, water for injections.
Baxter Chlorhexidine Acetate 0.1% solution. Methylene blue, glacial acetic acid, water for injections.
Baxter Chlorhexidine Acetate 0.5% solution. Cetrimide (0.1% w/v), methylene blue, glacial acetic acid, 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 Antiseptic solution should be stored below 30°C. Protect from light.

6.5 Nature and Contents of Container

Baxter Chlorhexidine Acetate Antiseptic solution is supplied in 4 strengths. Each strength has 3 sizes (see Table 1). It is packaged in plastic pour bottles, sealed with a tamper proof lid. 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

Baxter Chlorhexidine Acetate Antiseptic solutions are hypotonic and are haemolytic.
Chemical structure.

Molecular formula: C₂₂H₃₀Cl₂N₁₀.2C₂H₄O₂.
Molecular Weight: 626.
Appearance: white or almost white, microcrystalline powder.
CAS number. Chlorhexidine acetate. CAS No. 56-95-1.

7 Medicine Schedule (Poisons Standard)

Not scheduled.

Date of First Approval

30 September 1991

Date of Revision

05 September 2024

Summary Table of Changes