Consumer medicine information

Vancomycin Alphapharm 500 mg Powder for infusion

Vancomycin

BRAND INFORMATION

Brand name

Vancomycin Alphapharm

Active ingredient

Vancomycin

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Vancomycin Alphapharm 500 mg Powder for infusion.

1. Why am I being given with 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 with 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 doTell 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 doYou/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 machinesBe 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 medicineStore 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.

BRAND INFORMATION

Brand name

Vancomycin Alphapharm

Active ingredient

Vancomycin

Schedule

S4

 

1 Name of Medicine

Vancomycin hydrochloride.

2 Qualitative and Quantitative Composition

Vancomycin Alphapharm 500 mg. Each vial contains 500 mg (500,000 IU) of vancomycin (as hydrochloride).
Vancomycin Alphapharm 1000 mg. Each vial contains 1000 mg (1,000,000 IU) of vancomycin (as hydrochloride).
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Powder for injection. White to almost white or slightly pink or yellow freeze dried powder.

4 Clinical Particulars

4.9 Overdose

Toxicity due to overdose has been reported. In certain high-risk conditions (e.g. in case of severe renal impairment) high serum levels, ototoxic and nephrotoxic effects can occur.
Supportive care is advised, with maintenance of glomerular filtration. Vancomycin is not effectively removed by either haemodialysis or peritoneal dialysis. Increased vancomycin clearance has been reported with highly permeable membranes (polysulfone resin) used in high-flux haemodialysis. At 4 to 6 hours following the onset of high-flux haemodialysis, steady state concentrations of vancomycin may be reduced by 10 to 15% of the predialysis concentrations. It has also been reported that haemoperfusion with XAD-4 Resin has been shown to be of benefit.
In managing overdosage, consider the possibility of multiple drug overdoses, interaction among medicines, and unusual drug kinetics in your patient.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. There are no studies available demonstrating the mutagenic potential of vancomycin.
Carcinogenicity. No long term carcinogenicity studies have been performed using vancomycin in animals.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSVANHYD.gif Molecular formula: C66H75Cl2N9O24,HCl.
Molecular weight: 1485.7.
CAS number. CAS No: 1404-93-9.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/VANALPST.gif