Vancomycin Alphapharm

vancomycin hydrochloride

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VANCOMYCIN ALPHAPHARM

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your healthcare professional.

1. Why am I being given VANCOMYCIN ALPHAPHARM?

VANCOMYCIN ALPHAPHARM contains the active ingredient vancomycin hydrochloride. Vancomycin is used to treat severe bacterial infections. For more information, see Section 1. Why am I being given VANCOMYCIN ALPHAPHARM? in the full CMI.

2. What should I know before being treated with VANCOMYCIN ALPHAPHARM?

Do not start treatment if you/your child have ever had an allergic reaction to vancomycin, other antibiotics that are the same type, or any of the ingredients listed at the end of the CMI. Your doctor will know which antibiotics are the same type. Talk to your doctor if you/your child have had any allergic reaction to any antibiotic; have kidney or hearing problems, have inflammatory bowel disorders; take any other medicines; or are pregnant, plan to become pregnant or are breastfeeding. Do not use if you have ever had an allergic reaction to vancomycin or any of the ingredients listed at the end of the CMI. For more information, see Section 2. What should I know before being treated with VANCOMYCIN ALPHAPHARM? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with vancomycin and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How is VANCOMYCIN ALPHAPHARM given?

The doctor will decide how much vancomycin is needed. It will depend on factors such as the type of infection, age and bodyweight and if you/your child have kidney problems. More instructions can be found in Section 4. How is VANCOMYCIN ALPHAPHARM given? in the full CMI.

5. What should I know while I am treated with VANCOMYCIN ALPHAPHARM?

Things you should do

Tell your healthcare professional immediately if you develop a rash or any other sign of allergic reaction (shortness of breath, wheezing or difficulty breathing, swelling of the lips, face, throat, tongue or other parts of the body, rash, itching or hives on the skin)

Things you should not do

You/your child should not be treated with vancomycin if you/your child have had an allergic reaction to vancomycin, the same type of antibiotics as vancomycin, or any of the other ingredients listed in Section 7. Product details. Your doctor will know which antibiotics are the same type as vancomycin.

Driving or using machines

Be careful before you drive a car or operate machinery until you know how vancomycin affects you. Vancomycin may cause dizziness in some people.

Looking after your medicine

Store in original carton at below 25°C until ready for use.

For more information, see Section 5. What should I know while I am treated with VANCOMYCIN ALPHAPHARM? in the full CMI.

6. Are there any side effects?

Side effects of this medicine may include allergic reactions (chest pain, shortness of breath, wheezing or difficulty breathing, swelling of the lips, face, throat, tongue or other parts of the body, rash, itching or hives on the skin); rash or severe skin reaction that may be accompanied with a fever; severe stomach or abdominal cramps; nausea or vomiting, appetite loss, weight loss; fatigue, general aches and pains, pale skin; severe blisters and bleeding in the lips, eyes, mouth, nose or genitals; vertigo, dizziness, ringing in the ears or hearing loss; pain and irritation at the injection site; extremely tender, swelling and redness along a vein; fast, slow or irregular heartbeat, heart attack, drowsiness, loss of consciousness, sweating, restlessness; upper body flushing, chest and backpain and muscle spasm; watery and severe diarrhoea which may also be bloody; fever, chills, other infections; bruising more than usual; kidney problems, little or no urine.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

VANCOMYCIN ALPHAPHARM

Active ingredient: Vancomycin hydrochloride

Consumer Medicine Information (CMI)

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

Where to find information in this leaflet:

6. Are there any side effects?
7. Product details

1. Why am I being given with VANCOMYCIN ALPHAPHARM?

VANCOMYCIN ALPHAPHARM contains the active ingredient vancomycin hydrochloride. VANCOMYCIN ALPHAPHARM is a glycopeptide antibiotic use to treat severe bacterial infections.

2. What should I know before being treated with VANCOMYCIN ALPHAPHARM?

Warnings

You/your child should not be given VANCOMYCIN ALPHAPHARM if you/your child are:

  • allergic to vancomycin, or any of the ingredients listed at the end of this leaflet. Always check the ingredients to make sure you can use this medicine.
  • allergic to or have previously had a severe allergic reaction to similar antibiotics as VANCOMYCIN ALPHAPHARM. Your doctor will know which antibiotics are the same type as VANCOMYCIN ALPHAPHARM.

Check with your doctor if you/your child:

  • have kidney problems
  • have hearing problems
  • have inflammatory bowel disorders
  • are taking 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.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

Your doctor can discuss with you the risks and benefits involved.

3. What if I am taking other medicines?

Tell your healthcare professional 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.

Some medicines may interfere with VANCOMYCIN ALPHAPHARM and affect how it works.

These include:

  • some other antibiotic medicines used to treat infections, such as aminoglycoside antibiotics (e.g. amikacin, gentamicin, neomycin and tobramycin), cephalosporin antibiotics (e.g. cefalexin, cefalotin, cefazolin, cefoxitin, cefuroxime, cefamandole, cefaclor, cefotaxime, ceftazidime, ceftriaxone, cefepime, ceftaroline, fosamil, ceftolozane), colistin, colistimethate sodium, capreomycin, piperacillin/tazobactam, clindamycin, ethambutol hydrochloride, and sulfadiazine
  • amphotericin B, a medicine used to treat fungal infections
  • medicine used to control and treat viral injections e.g. elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide, tenofovir alafenamide, adefovir dipivoxil, emtricitabine with tenofovir alafenamide, and cidofovir
  • ciclosporin or tacrolimus, medicine used to suppress the immune system after organ transplants, severe rheumatoid arthritis, severe psoriasis, atopic dermatitis (skin allergies), and dry eye disease
  • sulfasalazine, medicine used to treat inflammatory bowel diseases such as ulcerative colitis and Crohn's disease, and rheumatoid arthritis.
  • some medicines used to treat pain and inflammation such as naproxen, ketorolac trometamol, flurbiprofen, and methoxyflurane
  • etoricoxib, a medicine used to treat osteoarthritis, gout attacks, and relieve short-term pain
  • medicines used to treat certain cancers, including cisplatin, carmustine, cyclophosphamide mitomycin, Mycobacterium bovis (Bacillus Calmette and Guerin (BCG) strain, and teicoplanin
  • antithyroid medicines (e.g. propylthiouracil and carbimazole)
  • clozapine, medicine used mainly in the treatment of schizophrenia
  • fluid tablets (diuretics), such as furosemide (frusemide) and bumetanide
  • anaesthetic agents, e.g. halothane, isoflurane, desflurane, sevoflurane, thiopental, fentanyl, alfentanil, ketamine, propofol, nitrous oxide, and esketamine
  • colestyramine, a powder taken to lower cholesterol levels
  • medicines used to relax muscles, such as suxamethonium, vecuronium, pancuronium, atracurium, cisatracurium, rocuronium bromide, mivacurium chloride, and botulinum toxin.

Check with your healthcare professional if you are not sure about what medicines, vitamins or supplements you are taking and if these affect VANCOMYCIN ALPHAPHARM.

4. How is VANCOMYCIN ALPHAPHARM given?

How much will be given?

The doctor will decide what dose of VANCOMYCIN ALPHAPHARM is needed depending on certain factors such as the type of infection, age, bodyweight, and if you/your child have kidney problems.

How long will VANCOMYCIN ALPHAPHARM need to be given?

A course of treatment depends on the type, severity of the infection and how you/your child responds. The doctor will decide how many days you will need treatment with VANCOMYCIN ALPHAPHARM.

How is VANCOMYCIN ALPHAPHARM given?

VANCOMYCIN ALPHAPHARM is given as either an injection into a vein or by mouth, depending on the infection. Vancomycin has an offensive taste.

If too much VANCOMYCIN ALPHAPHARM is given

As VANCOMYCIN ALPHAPHARM is generally given to you in hospital under the supervision of your healthcare professional, it is very unlikely that you will receive an overdose. Symptoms of a vancomycin overdose include the effects listed below in Section 6. Are there any side effects?

You should immediately:

  • phone the Poisons Information Centre
    (Australia telephone 13 11 26) for advice, or
  • contact your doctor, or
  • go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while I am treated with VANCOMYCIN ALPHAPHARM?

Things you should do

  • Remind any doctors, nurses, dentists and pharmacists you see that you/your child are being given VANCOMYCIN ALPHAPHARM.
  • 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.
  • If you become pregnant soon after being given
  • vancomycin, tell your doctor.

Tell your healthcare professional straight away if you/your child:

  • get severe diarrhoea, severe abdominal or stomach cramps
  • get a fever, in combination with one of all of the above.

Do this even if it occurs several weeks after VANCOMYCIN ALPHAPHARM has been stopped.

Diarrhoea may be caused by a serious condition affecting the bowel. You or your child may need urgent medical care. Do not take any medication to stop the diarrhoea before speaking with your doctor.

When given orally, VANCOMYCIN VIATRIS may increase your chances of developing drug-resistant bacteria in the gastrointestinal tract.

Driving or using machines

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

VANCOMYCIN ALPHAPHARM may cause dizziness in some people.

Looking after your medicine

VANCOMYCIN ALPHAPHARM will be stored in the pharmacy or on the ward. The injection is kept in a cool, dry place away from moisture, heat or sunlight, where the temperature stays below 25°C. The expiry date will be checked that it has not passed.

6. Are there any side effects?

All medicines can have side effects. If you/your child 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 healthcare professional if you have any further questions about side effects.

Less serious side effects

What to do
  • irritation at the injection site
  • nausea, vomiting or mild diarrhoea
  • dizziness
  • redness and flushing in children

Speak to your doctor if you have any of these less serious side effects and they worry you.

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

Tell your healthcare professional 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 healthcare professional 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 ALPHAPHARM contains

Active ingredient

(main ingredient)

Vancomycin hydrochloride

Other ingredients

(inactive ingredients)
  • hydrochloric acid
  • sodium hydroxide

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

What VANCOMYCIN ALPHAPHARM looks like

VANCOMYCIN ALPHAPHARM is a white to off-white powder, which will be dissolved to a clear solution before it is given to you.

VANCOMYCIN ALPHAPHARM is available in the following strengths:

  • VANCOMYCIN ALPHAPHARM 500 mg (as hydrochloride) powder for Injection Vial (AUST R 153438)
  • VANCOMYCIN ALPHAPHARM 1 g (as hydrochloride) powder for Injection Vial (AUST R 153439)

Sponsor

Alphapharm Pty Ltd trading as Viatris

Level 1, 30 The Bond

30-34 Hickson Road

Millers Point NSW 2000

www.viatris.com.au

Phone: 1800 274 276

This leaflet was prepared in September 2024.

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