Consumer medicine information

Chlorhexidine and Cetrimide Irrigation Solution

Chlorhexidine gluconate; Cetrimide

BRAND INFORMATION

Brand name

Pfizer (Perth) Chlorhexidine and Cetrimide Irrigation Solution

Active ingredient

Chlorhexidine gluconate; Cetrimide

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Chlorhexidine and Cetrimide Irrigation Solution.

What is in this leaflet

This leaflet answers some common questions about Chlorhexidine and Cetrimide Irrigation Solution. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have benefits and risks. Your doctor has weighed the risks of you using Chlorhexidine and Cetrimide Irrigation Solution against the benefits this product is expected to have for you.

This medicine is likely to be used while you are at the clinic or in hospital. If possible, read this leaflet carefully before this medicine is given to you. In some cases this leaflet may be given to you after the medicine has been used.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet. You may need to read it again.

What Chlorhexidine and Cetrimide Irrigation Solution is used for

Your doctor or nurse will use Chlorhexidine and Cetrimide Irrigation Solution for cleansing and irrigating the skin or dirty wounds. It contains antiseptics which will help prevent infection.

Before you use Chlorhexidine and Cetrimide Irrigation Solution

Do not use it after the expiry date (EXP) printed on the label. It may have no effect at all, or worse, an entirely unexpected effect if you take it after the expiry date.

Do not use Chlorhexidine and Cetrimide Irrigation Solution if the packaging is torn or shows signs of tampering.

Wounds may take longer to heal if cetrimide is used regularly. Therefore it is important to use this product as directed by the doctor.

You must tell your doctor if you have allergies to:

  • chlorhexidine
  • cetrimide
  • any of the ingredients listed at the end of this leaflet
  • any other substances, such as foods, preservatives or dyes

If you have an allergic reaction, you may get a skin rash.

Before any Chlorhexidine and Cetrimide Irrigation Solution is used please tell your doctor about any of these things and anything else which you feel is important.

How Chlorhexidine and Cetrimide Irrigation Solution is used

Your doctor or nurse will normally use this irrigation to wash and clean your skin or wounds. It is for external use only and should not be injected or swallowed. It should not be used in the eyes or ears.

Your doctor or nurse will decide how much of the irrigation to use which will be sufficient for your needs. As each irrigation is sterile, your doctor will use a new solution each time.

If you are given this product to use at home it must be used as directed by your doctor or nurse. Rinse the area to be cleaned with water, then use the smallest amount of irrigation to gently wash the area. Rinse again with water thoroughly. Use a new solution each time.

Your doctor or nurse will be happy to discuss the way the Chlorhexidine and Cetrimide Irrigation Solution will be used.

Overdose:

As your doctor or nurse will administer this irrigation, they will use the correct amount. As it is for external use only, it is unlikely an overdose will occur.

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to your nearest hospital emergency department if you think that someone may have drunk Chlorhexidine and Cetrimide Irrigation Solution or if it has been put into the eyes or ears, even if there are no signs of discomfort or poisoning.

Side effects

Chlorhexidine and Cetrimide Irrigation Solution helps most people when used for washing and cleansing the skin or wounds, but it may have some unwanted side-effects in a few people.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Tell your doctor if you experience a skin rash or reaction. If you get a skin rash it may be because you have had an allergic reaction to the irrigation. If this is the case, you should no longer use this irrigation.

Tell your doctor, nurse or pharmacist as soon as possible if you have any allergic reaction or feel anything unusual during or after Chlorhexidine and Cetrimide Irrigation Solution has been used.

Storage

If you have this product at home, it should be kept in the original container, in a safe place, out of reach of children. A locked cupboard at least one and a half metres above the ground is a good place to store medicines.

Chlorhexidine and Cetrimide Irrigation Solution should be stored below 25 degrees C and protected from light.

Do not leave Chlorhexidine and Cetrimide Irrigation Solution in the car on hot days.

Disposal

Do not exceed the stated expiry date printed on the label

Product Description

What it looks like

Chlorhexidine and Cetrimide Irrigation Solution is a sterile, orange solution and comes in a 30 mL plastic Steritube® ampoule. Pack size: 30 units.

Ingredients

Chlorhexidine 0.015% w/v and Cetrimide 0.15% w/v Irrigation Solution contains chlorhexidine gluconate and cetrimide as the active ingredients and the excipients:

  • sunset yellow FCF
  • purified water.

Chlorhexidine 0.05% w/v and Cetrimide 0.5% w/v Irrigation Solution contains chlorhexidine gluconate and cetrimide as the active ingredients and the excipients:

  • sunset yellow FCF
  • purified water.

Supplier

Chlorhexidine and Cetrimide Irrigation Solution is supplied in Australia by:

Pfizer Australia Pty Ltd
Sydney NSW
Toll Free Number: 1800 675 229
www.pfizer.com.au

Australian Registration Number

Chlorhexidine and Cetrimide Irrigation Solutions can be identified by an Australian Registration Number which is found on the packaging:

AUST R 57021
Chlorhexidine 0.015% and Cetrimide 0.15% Irrigation Solution 30 mL Steritube® ampoule.

AUST R 57011
Chlorhexidine (0.05%) and Cetrimide (0.5%) Irrigation Solution 30 mL Steritube® ampoule.

This leaflet was prepared in March/ 2020

®= Registered Trademark

Published by MIMS May 2020

BRAND INFORMATION

Brand name

Pfizer (Perth) Chlorhexidine and Cetrimide Irrigation Solution

Active ingredient

Chlorhexidine gluconate; Cetrimide

Schedule

Unscheduled

 

1 Name of Medicine

Chlorhexidine gluconate and cetrimide.

6.7 Physicochemical Properties

Chlorhexidine gluconate.

The active ingredient chlorhexidine gluconate solution is an almost colourless or pale yellowish liquid. It is miscible with water, soluble in acetone and in ethanol (96%).

Chemical structure.

The structural formula is represented below:
Molecular Formula: C22H30Cl2N10,2C6H12O7.
Molecular Weight: 898.

CAS number.

18472-51-0.

Cetrimide.

The active ingredient cetrimide is a white or almost white voluminous free-flowing powder, which has a slight and characteristic odour. It is freely soluble in water, chloroform and ethanol (96%) and practically insoluble in ether. The structural formula is represented below:

Chemical structure.


Molecular Formula: C17H38BrN.
Molecular Weight: 336.4.

CAS number.

505-86-2.

2 Qualitative and Quantitative Composition

Chlorhexidine gluconate 4.5 mg/30 mL (0.015% w/v) and cetrimide 45 mg/30 mL (0.15% w/v).
Chlorhexidine gluconate 15 mg/30 mL (0.05% w/v) and cetrimide 150 mg/30 mL (0.5% w/v).

3 Pharmaceutical Form

Sterile, orange coloured irrigation solution containing chlorhexidine gluconate and cetrimide in purified water. The colouring agent is sunset yellow.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Chlorhexidine.

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.

Cetrimide.

Cetrimide is a quaternary ammonium disinfectant with properties typical of cationic surfactants. Solutions of these surfactants have emulsifying and detergent properties and bactericidal activity against both Gram positive and Gram negative organisms, but higher concentrations are necessary to kill the latter. The combined detergent and antibacterial properties of cetrimide make it useful in cleansing dirty or infected wounds. It is however relatively ineffective against bacterial spores, acid fast bacteria, viruses and fungi.

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.

4 Clinical Particulars

4.1 Therapeutic Indications

For cleansing and irrigating the skin and dirty wounds where an added surfactant effect is required.

4.3 Contraindications

Known hypersensitivity to either chlorhexidine or cetrimide.
Do not use to irrigate the brain, meninges, eyes or perforated eardrum.

4.4 Special Warnings and Precautions for Use

For external use only. Not for injection, for irrigation only. Not isotonic and is haemolytic.
Cetrimide may have a prolonging effect on the wound healing process. Use of this antiseptic should be restricted to infection control and cleansing of wounds rather than general wound management.

Use in the elderly.

No data available.

Paediatric use.

Use with care in neonates, particularly in premature infants. Chlorhexidine may cause irritation or chemical burns.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

No data available.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
No data available.
No data available.

4.8 Adverse Effects (Undesirable Effects)

Irritative skin reactions and hypersensitivity reactions to chlorhexidine have been reported. In the event that these reactions occur, discontinue use.
Chlorhexidine may cause anaphylactic reaction.
Cetrimide may have a prolonging effect on the wound healing process.

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.

4.2 Dose and Method of Administration

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.

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.

4.9 Overdose

For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).

7 Medicine Schedule (Poisons Standard)

Unscheduled.

6 Pharmaceutical Particulars

6.1 List of Excipients

Purified water, Sunset yellow FCF.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

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

Store below 25°C. Protect from light. Single use only. Discard unused portion.

6.5 Nature and Contents of Container

Chlorhexidine 0.015% cetrimide 0.15% irrigation solution, 30 mL Steritube ampoule.
Chlorhexidine 0.05% cetrimide 0.5% irrigation solution, 30 mL Steritube ampoule.
Pack size: 30 units.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

Summary Table of Changes