VANCOMYCIN JUNO

VANCOMYCIN JUNO

Active ingredient(s): vancomycin hydrochloride

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Consumer Medicine Information (CMI)

This leaflet provides important information about using VANCOMYCIN JUNO. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using VANCOMYCIN JUNO.

Where to find information in this leaflet:

1. Why am I using VANCOMYCIN JUNO?
2. What should I know before I use VANCOMYCIN JUNO?
3. What if I am taking other medicines?
4. How do I use VANCOMYCIN JUNO?
5. What should I know while using VANCOMYCIN JUNO?
6. Are there any side effects?
7. Product details

1. Why am I using VANCOMYCIN JUNO?

VANCOMYCIN JUNO contains the active ingredient vancomycin hydrochloride. Vancomycin is an antibiotic. It works by killing the bacteria causing the infection.

VANCOMYCIN JUNO is used:

• to treat serious infections caused by bacteria (germs).
  These infections may occur in different parts of the body.
• orally, to treat serious infections involving the bowel.

2. What should I know before I use VANCOMYCIN JUNO?

Warnings

Do not use VANCOMYCIN JUNO if:

• you are allergic to vancomycin or similar antibiotics e.g. teicoplanin
• you are allergic to any of the ingredients listed at the end of this leaflet.

Check with your doctor if you:

• you are allergic to any other medicines, foods, dyes or preservatives
• have any other medical conditions, in particular kidney or liver disease or inflammatory bowel disorders, or if you have suffered from hearing problems
• take any medicines for any other condition.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant. Your doctor can discuss with you the benefits and risks involved.

Talk to your doctor if you are breastfeeding or intend to breastfeed. Vancomycin is not recommended for use while breastfeeding as it is found in breast milk.

Elderly patients or patients with pre-existing kidney disease

Elderly patients or those with a pre-existing kidney condition may be more sensitive to the effects or side effects of this medicine.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

These include:

• some other medicines used to treat infections, such as amikacin, amphotericin, bacitracin, colistin, piperacillin/tazobactam, gentamicin, neomycin and tobramycin
• cisplatin, an anticancer medicine
• some fluid tablets (diuretics), such as etacrynic acid and furosemide (frusemide)
• anaesthetic agents
• cholestyramine, a powder taken to lower cholesterol levels
• suxamethonium or vecuronium, medicines used to relax muscles.

Some medicines may affect the way other medicines work.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these could affect vancomycin.

4. How do I use VANCOMYCIN JUNO?

How much to take / use

• Your doctor will decide what dose of VANCOMYCIN JUNO you will be given, depending on your infection and other factors such as your age and weight.
• If given orally, the dose for adults is 500 mg to 2 g given in 3 or 4 divided doses for 7 to 10 days. The total daily dosage in children is 40 mg/kg of body weight in 3 or 4 divided doses. The total dose for children should not exceed 2 grams per day.
• Your doctor will decide for how long you will be given this medicine. This will depend on the severity of the infection being treated.

When to take / use VANCOMYCIN JUNO

For most infections, VANCOMYCIN JUNO is usually given in divided doses throughout the day.

How to use VANCOMYCIN JUNO

Intravenously

VANCOMYCIN JUNO is a sterile powder which is dissolved and diluted with suitable sterile fluids. It is given as a slow injection into a vein, known as a continuous infusion or a ‘drip’.

It will take at least 60 minutes for the solution containing your dose of VANCOMYCIN JUNO to be infused into your vein.

Your doctor or nurse will prepare the infusion of VANCOMYCIN JUNO for you.

Orally

VANCOMYCIN JUNO may also be given as an oral solution to treat serious infections involving the bowel.

Your doctor or pharmacist may use flavouring to improve the taste of the solution.

If you use too much VANCOMYCIN JUNO

As VANCOMYCIN JUNO is given to you in hospital under the supervision of your doctor, it is very unlikely that you will receive an overdose. Symptoms of a dopamine overdose include the effects listed below in the ‘Side Effects’ section but are usually of a more severe nature.

5. What should I know while using VANCOMYCIN JUNO?

Things you should do

• Remind any doctor, dentist or pharmacist you visit that you are using vancomycin.
• If you are going to have surgery, tell the surgeon or anaesthetist that you are being given this medicine. It may affect other medicines used during surgery.

Things you should not do

Do not take any anti-diarrhoeal medicine without first checking with your doctor.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how VANCOMYCIN JUNO affects you.

Vancomycin may cause dizziness in some people. If this occurs, do not drive, operate machinery or do anything else that could be dangerous. If you drink alcohol, dizziness may be worse.

Drinking alcohol

Tell your doctor if you drink alcohol.

Alcohol may increase the side effects of some medicines.

Looking after your medicine

VANCOMYCIN JUNO will be stored in the pharmacy or on the ward. The injection is kept in a cool dry place, protected from light, where the temperature stays below 25°C.

Getting rid of any unwanted medicine

Any unwanted medicine will be disposed of in a safe manner by your doctor, nurse or pharmacist.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor, nurse or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effects	What to do
stomach ache nausea, vomiting or mild diarrhoea dizziness chills irritation at the injection site	Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effects

What to do

severe pain, warmth, itching, redness of the skin at the injection site severe blisters and bleeding in the lips, eyes, mouth, nose and genitals severe flaking or peeling of the skin fluid-filled blisters that are located along creases in the skin which may be itchy severe skin reaction starting with painful red areas, then large blisters and end with peeling layers of skin, accompanied by fever and chills, aching muscles and generally feeling unwell rash with small puss-filled blisters that may be accompanied by a fever pain, swelling and redness along a vein which is extremely tender when touched itchy spots accompanied by fever and feeling unwell signs of an allergic reaction, such as chest pain, shortness of breath, wheezing, coughing or difficulty breathing, swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin bleeding or bruising more easily than normal flushing/redness of the upper body or pain and muscle spasm of the chest and back chills or fever, which may be accompanied by shivering fever, loss of appetite, weight loss, fatigue, general aches and pains severe and constant abdominal pain, fever, inability to break wind or pass stools, nausea and vomiting, shock fast, slow or irregular heart beat, heart palpitations dizziness and lightheadedness, fast pulse rate, white skin, sweating, restlessness, loss of consciousness; heart attack ringing in the ears (tinnitus) or hearing loss, deafness, dizziness or problems with your balance diarrhoea, usually with blood and mucus, stomach pain, fever frequent infections such as fever, severe chills, sore throat or mouth ulcers; tiredness, being short of breath and looking pale little or no urine, drowsiness, nausea, vomiting, breathlessness, kidney disease other infections.

Call your doctor or nurse straight away or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Side effects after treatment

Side effects after treatment	What to do
severe stomach cramps or pain severe, watery or bloody diarrhoea fever, in combination with one of the above.	Tell your doctor immediately, particularly if these occur several weeks after stopping treatment.

Tell your doctor, nurse or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor’s prescription.

What VANCOMYCIN JUNO contains

Active ingredient (main ingredient)	Vancomycin hydrochloride
Other ingredients (inactive ingredients)	None
Potential allergens	VANCOMYCIN JUNO does not contain lactose, sucrose, tartrazine or any other azo dyes.

Do not take this medicine if you are allergic to any of these ingredients.

What VANCOMYCIN JUNO looks like

Vancomycin JUNO is available in two strengths:

• 500 mg (Aust R 407963)
• 1 g (Aust R 407964)

It is an off white to light beige powder in a glass vial with a rubber stopper.

Who distributes VANCOMYCIN JUNO

Juno Pharmaceuticals Pty Ltd
15-17 Chapel Street
Cremorne VIC 3121

This leaflet was prepared in December 2023.