Consumer medicine information

Vancomycin BNM

Vancomycin

BRAND INFORMATION

Brand name

Vancomycin BNM

Active ingredient

Vancomycin

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Vancomycin BNM.

SUMMARY CMI

Vancomycin BNM

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 doctor or pharmacist.

1. Why am I taking VANCOMYCIN BNM?

Vancomycin BNM contains the active ingredient vancomycin hydrochloride. Vancomycin BNM is used to treat infections involving the bowel.

For more information, see Section 1. Why am I taking Vancomycin BNM? in the full CMI.

2. What should I know before I take VANCOMYCIN BNM?

Do not take if you have ever had an allergic reaction to Vancomycin or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions such as pre-existing hearing loss or a special sensory impairment (e.g. blindness), kidney or liver disease, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I take Vancomycin BNM? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Vancomycin BNM 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 do I take VANCOMYCIN BNM?

  • Follow the instructions provided when Vancomycin BNM was prescribed, including the number of days it should be taken.

More instructions can be found in Section 4. How do I take Vancomycin BNM? in the full CMI.

5. What should I know while taking VANCOMYCIN BNM?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are taking Vancomycin BNM.
  • Tell your doctor if the symptoms of your infection do not improve within a few days or if they become worse.
  • Tell your doctor if you become pregnant while taking Vancomycin BNM capsules.
Things you should not do
  • Do not stop taking this medicine suddenly.
  • Do not take Vancomycin BNM capsules to treat any other complaints unless your doctor tells you to.
  • Do not give your medicine to anyone else, even if they have the same condition as you.
Driving or using machines
  • You should take care when driving or operating machinery until you know how Vancomycin BNM capsules affects you.
Drinking alcohol
  • Tell your doctor if you drink alcohol.
Looking after your medicine
  • Keep your medicine in a place where the temperature stays below 25°C.
  • Store it in a cool dry place away from moisture, heat or sunlight

For more information, see Section 5. What should I know while taking Vancomycin BNM? in the full CMI.

6. Are there any side effects?

The more common side effects are indigestion, stomach-ache, nausea, chills, diarrhoea and vomiting.

Some more serious side effects are frequent infections such as fever, severe chills, sore throat or mouth ulcers, bleeding or bruising more easily than normal, vertigo, dizziness or tinnitus (ringing in the ears), itchy rash, loss of appetite, fatigue, irregular or fast heartbeat, chest tightness, wheezing, breathlessness, redness of the upper body or pain and muscle spasm of the chest and back, skin blister and bleeding in the lips, eyes, mouth, nose and genitals, high fever and rash.

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.



FULL CMI

Vancomycin BNM

Active ingredient(s): vancomycin hydrochloride

Consumer Medicine Information (CMI)

This leaflet provides important information about using Vancomycin BNM. 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 BNM.

Where to find information in this leaflet:

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

1. Why am I taking VANCOMYCIN BNM?

Vancomycin BNM contains the active ingredient vancomycin hydrochloride. Vancomycin BNM is an antibiotic.

Vancomycin BNM is used to treat serious infections involving the bowel. It works by killing or stopping the growth of the bacteria causing your infection.

2. What should I know before I take VANCOMYCIN BNM?

Warnings

Do not take Vancomycin BNM if:

  • You are allergic to Vancomycin and similar antibiotics e.g. teicoplanin., or any of the ingredients listed at the end of this leaflet. Always check the ingredients to make sure you can use this medicine.
    Signs of an allergic reaction may include shortness of breath, wheezing or difficulty in breathing; swelling of the face, lips, tongue or any other parts of the body; rash, itching or hives on the skin.

Check with your doctor if you:

  • have any of the following medical conditions:
    - kidney or liver disease
    - a special sensory impairment (e.g. blindness)
    - pre-existing hearing loss
    - inflammatory bowel disorders.
  • take any medicines for any other condition
  • are allergic to any other medicines or any foods, dyes or preservatives.

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.

It is not recommended for use while breastfeeding as it is found in breast milk.

Use in elderly 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.

Some medicines may interfere with Vancomycin BNM. These include:

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

These medicines may be affected by Vancomycin BNM or may affect how well it works. You may need different amounts of your medicines or may need to take different medicines. Your doctor or pharmacist has more information on medicines to be careful with or to avoid while taking Vancomycin BNM capsules.

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

4. How do I take VANCOMYCIN BNM?

How much to take

  • Follow the instructions provided when Vancomycin BNM was prescribed, including the number of days it should be taken.
  • If you are elderly or have a pre-existing kidney condition, you may need to take fewer capsules.
  • The total dose for children should not exceed 2 grams per day.

When to take Vancomycin BNM

  • Vancomycin BNM should be used as advised by your doctor. This will depend on the type of infection. The dose varies from patient to patient.
  • Swallow the capsules whole with a full glass of water.
  • Vancomycin BNM capsules can be taken with or without food.
  • It is important to complete the full course prescribed by your doctor, even if you begin to feel better after a few days. If you do not, the bacteria causing your infection may not clear completely or your symptoms may return.

If you forget to take Vancomycin BNM

Vancomycin BNM should be taken regularly at the same time each day. If you miss your dose at the usual time, and there is still a long time to go before your next dose, take it as soon as you remember, and then go back to taking your capsules as you would normally.

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

If you are not sure whether to skip the dose, talk to your doctor or pharmacist.

Do not take a double dose to make up for the dose you missed.

If you have trouble remembering to take your tablets, ask your pharmacist for some hints.

If you take too much Vancomycin BNM

If you think that you have taken too much Vancomycin BNM, you may need urgent medical attention.

You should immediately:

  • phone the Poisons Information Centre
    (by calling 13 11 26), 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 taking VANCOMYCIN BNM?

Things you should do

  • Tell your doctor if the symptoms of your infection do not improve within a few days or if they become worse.
  • Tell your doctor if you become pregnant while taking Vancomycin BNM capsules.

Remind any doctor, dentist or pharmacist you visit that you are taking Vancomycin BNM.

Things you should not do

  • Do not stop taking this medicine or change the dosage without first checking with your doctor. If you stop taking it, your condition may worsen.
  • Do not take Vancomycin BNM capsules to treat any other complaints unless your doctor tells you to.
  • Do not give your medicine to anyone else, even if they have the same condition as you.
  • Do not take Vancomycin BNM capsules if the expiry date on the pack has passed.
  • Do not take Vancomycin BNM capsules if the packaging is torn or shows signs of tampering.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Vancomycin BNM affects you.

Vancomycin BNM may cause dizziness in some people.

Drinking alcohol

Tell your doctor if you drink alcohol.

Looking after your medicine

Keep your capsules in the blister pack until it is time to take them.

  • If you take your capsules out of the blister pack they may not keep as well.
  • Keep your medicine in a place where the temperature stays below 25°C.

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

  • in the bathroom or near a sink, or
  • in the car or on window sills.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

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 or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effectsWhat to do
Digestive system-related:
  • indigestion
  • stomach-ache
  • nausea
  • diarrhoea
  • vomiting
General disorders
  • chills
Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effectsWhat to do
Skin related:
  • itchy rash
Bleeding related:
  • bleeding
  • bruising more easily than normal
Infections related:
  • frequent infections or symptoms of infections such as fever, severe chills, sore throat or mouth ulcers
Head and neurology related:
  • vertigo
  • dizziness
  • tinnitus (ringing in the ears)
  • loss of appetite
  • fatigue
Cardiac related:
  • irregular or fast heartbeat
Allergy related:
  • skin blister
  • bleeding in the lips, eyes, mouth, nose and genitals
  • high fever and rash
  • redness of the upper body or pain and muscle spasm of the chest and back
  • chest tightness, wheezing or breathlessness
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.

These are serious side effects of Vancomycin BNM capsules. You may need urgent medical attention.

Serious side effects are rare.

Hearing loss has occurred in some patients taking Vancomycin BNM capsules. Most of these have occurred in patients who have pre-existing conditions such as kidney disease or partial hearing loss.

Tell your doctor immediately if you notice any of the following side effects, particularly if they occur several weeks after stopping treatment with Vancomycin BNM capsules:

  • severe stomach cramps or pain
  • severe, watery or bloody diarrhoea
  • fever, in combination with one of the above.

These are rare but serious side effects. You may have a serious condition affecting your bowel and may need urgent medical attention.

Do not take any diarrhoea medicine without first checking with your doctor.

Tell your doctor 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 BNM contains

Active ingredient
(main ingredient)		Vancomycin HCl
Other ingredients
(inactive ingredients)		macrogol 6000, gelatin, titanium dioxide, sodium lauryl sulfate, brilliant blue FCF, iron oxide yellow (250 mg capsules only), tartrazine (125 mg capsules only), carnauba wax, white shellac and glyceryl monooleate.

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

What Vancomycin BNM looks like

Vancomycin BNM Capsule 125 mg:
Size 2 capsules with a blue cap and yellow body, imprinted with “OP64” on the cap and the body in white ink.
(Aust R 375011).

Vancomycin BNM Capsules 250 mg:
Size 0 capsules with a blue cap and dark-yellow body, imprinted with “OP65” on the cap and the body in white ink.
(Aust R 375010).

Who distributes Vancomycin BNM

Boucher & Muir Pty Ltd
t/a ADVANZ PHARMA (Australia)
Level 9, 76 Berry Street
North Sydney NSW 2060

Ph: 1800 627 680

This leaflet was prepared in June 2022.

Published by MIMS March 2023

BRAND INFORMATION

Brand name

Vancomycin BNM

Active ingredient

Vancomycin

Schedule

S4

 

1 Name of Medicine

Vancomycin hydrochloride.

2 Qualitative and Quantitative Composition

Vancomycin BNM capsules contain either 125 mg or 250 mg of vancomycin (as hydrochloride) as the active ingredient.

Excipient(s) with known effect.

Tartrazine (125 mg capsules only). It may contain sulfites.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Vancomycin BNM 125 mg capsules are size 2, hard gelatin capsules, with blue cap and yellow body, imprinted with "OP64" on the cap and the body in white ink.
Vancomycin BNM 250 mg capsules are size 0, hard gelatin capsules, with blue cap and dark-yellow body, imprinted with "OP65" on the cap and the body in white ink.

4 Clinical Particulars

4.1 Therapeutic Indications

Vancomycin BNM capsules may be administered orally for the treatment of staphylococcal enterocolitis and antibiotic-associated pseudomembranous colitis produced by C. difficile. Parenteral administration of vancomycin is not effective for the above indications; therefore, Vancomycin BNM must be given orally. Vancomycin BNM is not effective by the oral route for other types of infection.

4.2 Dose and Method of Administration

Adults.

The usual daily dosage for staphylococcal enterocolitis and for antibiotic induced pseudomembranous colitis produced by C. difficile is 250 mg 6 hourly for 5-10 days. However, doses of 500 mg to 2 g orally administered in 3 or 4 divided doses for 7-10 days have been used for the treatment of antibiotic associated pseudomembranous colitis produced by C. difficile. Vancomycin is not effective by the oral route for other types of infections.

Children.

The usual daily dose is 20 mg/kg orally in 4 divided doses but doses of up to 40 mg/kg/day may be used. The total daily dose should not exceed 2 g.

4.3 Contraindications

Vancomycin BNM is contraindicated in patients with known hypersensitivity to vancomycin or any of the excipients or other glycopeptides.

4.4 Special Warnings and Precautions for Use

General.

Patients with a creatinine clearance < 60 mL/minute and all elderly individuals should be given serial tests of auditory function and of vancomycin blood levels. All patients receiving the drug should have periodic haematological studies, urine analysis, and renal function tests.

Potential for systemic absorption.

Clinically significant serum concentrations have been reported in some patients who have taken multiple oral doses of vancomycin for active C. difficile-induced pseudomembranous colitis; therefore, monitoring of serum concentrations may be appropriate in these patients.
Significant systemic absorption of orally administered vancomycin has been reported in some patients with inflammatory disorders of the intestinal mucosa. Therefore, patients treated with Vancomycin BNM capsules may be at risk for the development of adverse reactions associated with the parenteral administration of vancomycin (see package insert accompanying the intravenous products). The risk is greater if renal impairment is present. It should be noted that the total systemic and renal clearances of vancomycin are reduced in the elderly. The need for estimation of serum levels and dosage adjustment should be considered in such cases.

Hypersensitivity reactions.

Serious and occasionally fatal hypersensitivity reactions are possible (see Section 4.3 Contraindications; Section 4.8 Adverse Effects (Undesirable Effects)). In case of hypersensitivity reactions, treatment with vancomycin must be discontinued immediately and the adequate emergency measures must be initiated.

Severe cutaneous adverse reactions.

Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalised exanthematous pustulosis (AGEP) have been reported in association with vancomycin treatment (see Section 4.8 Adverse Effects (Undesirable Effects)). Patients should be advised to inform their doctor at the first appearance of rash or any other sign of hypersensitivity.
If a SCAR is suspected, the drug should be discontinued and specialist dermatological assessment should be carried out.

Ototoxicity.

Ototoxicity has occurred in patients receiving vancomycin. It may be transient or permanent. It has been reported mostly in patients who have been given excessive intravenous doses, who have an underlying hearing loss, or who are receiving concomitant therapy with another ototoxic agent such as an aminoglycoside or have impaired renal clearance of vancomycin (e.g. in the elderly). Serial tests of auditory function may be helpful in order to minimise the risk of ototoxicity and are recommended, particularly in patients at risk and those with other special sensory impairment (e.g. blindness). Vancomycin BNM capsules should be avoided in patients with previous hearing loss unless no other appropriate therapy is available. If it is used in such patients, the dose of vancomycin should be regulated by periodic determination of drug levels in the blood. Patients with renal insufficiency and individuals over the age of 60 should be given serial tests of auditory function and of vancomycin blood levels. All patients receiving the drug should have periodic hematologic studies, urinalyses, and liver and renal function tests.

Infusion reactions.

Rapid bolus administration of vancomycin (e.g. over several minutes) may be associated with exaggerated hypotension, including shock, and, rarely, cardiac arrest, histamine like responses and maculopapular or erythematous rash ("red neck").
For intravenous infusion, vancomycin should be administered in a dilute solution at a rate not exceeding 500 milligram/hour to avoid rapid infusion related reactions, e.g. hypotension, flushing, erythema, urticaria and pruritus. Stopping the infusion usually results in a prompt cessation of these reactions (see Section 4.2 Dose and Method of Administration; Section 4.8 Adverse Effects (Undesirable Effects)).
When given intravenously, toxic serum levels can occur. Vancomycin is excreted fairly rapidly by the kidney and blood levels increase markedly with decreased renal clearance. During parenteral therapy, the risk of toxicity and nephrotoxicity appears appreciably increased by high blood concentrations or prolonged treatment.
Since vancomycin is irritating to tissue and causes drug fever, pain and possibly necrosis, it should never be injected intramuscularly; it must be administered intravenously.
Pain and thrombophlebitis occur in many patients receiving vancomycin and are occasionally severe. The frequency and severity of thrombophlebitis can be minimised if the drug is administered in a volume of at least 200 mL of glucose or saline solution and if the injection sites are rotated.

Drug interactions with anti-motility agents and proton pump inhibitors.

Anti-motility agents should be avoided and proton pump inhibitor use should be reconsidered.

Cross-sensitivity reactions.

Vancomycin should be used with caution in patients with allergic reactions to teicoplanin, since cross hypersensitivity, including fatal anaphylactic shock, may occur.

Blood disorders.

Reversible neutropenia has been reported in patients receiving vancomycin hydrochloride (see Section 4.8 Adverse Effects (Undesirable Effects)). Patients who will undergo prolonged therapy with vancomycin or those who are receiving concomitant medicines which may cause neutropenia should have periodic monitoring of the leukocyte count.

Use during anaesthesia.

In surgical patients, the administration of vancomycin should be carefully timed in relation to the induction of anaesthesia (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).

Clostridioides difficile-associated disease.

In rare instances there have been reports of pseudomembranous colitis due to Clostridioides difficile developing in patients who received intravenous vancomycin. C. difficile associated diarrhoea (CDAD) has been reported with use of nearly all antibacterial agents, including vancomycin hydrochloride, and may range in severity from mild diarrhoea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhoea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over 2 months after the administration of antibacterial agents.

Overgrowth of non-susceptible organisms.

Prolonged use of vancomycin may result in the overgrowth of non-susceptible organisms. Careful observation of the patient is essential. If superinfection occurs during therapy, appropriate measures should be taken.

Use in renal impairment.

Because of its ototoxicity and nephrotoxicity, vancomycin should be used with care in patients with renal insufficiency. When treating patients with underlying renal dysfunction or those patients receiving concomitant therapy with an aminoglycoside or other nephrotoxic drugs, serial monitoring of renal function should be performed.

Haemorrhagic occlusive retinal vasculitis.

Haemorrhagic occlusive retinal vasculitis, including permanent loss of vision, can occur in patients receiving intracameral or intravitreal administration of vancomycin during or after cataract surgery. The safety and efficacy of vancomycin administered by the intracameral or the intravitreal route have not been established by adequate and well-controlled trials and these are not approved routes of administration for vancomycin. Vancomycin is not indicated for prophylaxis of endophthalmitis.

Other.

Concurrent and sequential use of other neurotoxic and/or nephrotoxic antibiotics, particularly etacrynic acid, neuromuscular blocking agents, aminoglycoside antibiotics, polymyxin B, colistin, viomycin and cisplatin requires careful monitoring.

Use in the elderly.

It should be noted that the total systemic and renal clearances of vancomycin are reduced in the elderly. The natural decrement of glomerular filtration with increasing age may lead to elevated vancomycin serum concentrations if dosage is not adjusted. Vancomycin dosage schedules should be adjusted in elderly patients (see Section 4.2 Dose and Method of Administration).

Paediatric use.

In premature neonates, infants and children, it is appropriate to confirm vancomycin serum concentrations. Concomitant administration of vancomycin and anaesthetic agents has been associated with erythema and histamine like flushing in children (see Section 4.8 Adverse Effects (Undesirable Effects)).

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Concurrent administration with other neurotoxic (e.g. ototoxic) or nephrotoxic drugs, e.g. streptomycin, neomycin, gentamicin, kanamycin, amikacin, amphotericin B, bacitracin, tobramycin, polymyxin B, colistin, cisplatin or piperacillin/tazobactam, requires careful monitoring (see Section 4.4 Special Warnings and Precautions for Use).
In order to minimise the risk of nephrotoxicity when treating patients with underlying renal dysfunction or those patients receiving concomitant therapy with an aminoglycoside, serial monitoring of renal function should be performed and particular care should be taken in following appropriate dosing schedules (see Section 4.2 Dose and Method of Administration).
Diuretics such as etacrynic acid and furosemide (frusemide) may aggravate ototoxicity.
Colestyramine has been shown to bind vancomycin in vitro. Therefore, if oral vancomycin is used with colestyramine, the two medicines should be administered several hours apart.
Reversible neutropenia has been reported in patients receiving vancomycin hydrochloride (see Section 4.8 Adverse Effects (Undesirable Effects)). Patients who are receiving concomitant medicines which may cause neutropenia should have periodic monitoring of the leukocyte count.
Vancomycin may enhance neuromuscular blockade produced by medicines such as suxamethonium or vecuronium.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category B2)
Animal reproduction studies have not been conducted with vancomycin. It is also not known whether vancomycin can affect reproduction capacity. In a controlled clinical study vancomycin was administered intravenously to pregnant women for serious staphylococcal infections complicating intravenous drug abuse to evaluate potential ototoxic and nephrotoxic effects on the infant. Vancomycin was found in cord blood. No sensorineural hearing loss or nephrotoxicity attributable to vancomycin was noted. One infant whose mother received vancomycin in the third trimester experienced conductive hearing loss that was not attributed to the administration of vancomycin. As only 10 patients were treated with vancomycin in this study, and administration was only in the second and third trimesters, it is not known whether vancomycin causes foetal harm. Vancomycin BNM capsules should be given to a pregnant woman only if clearly needed and blood levels should be monitored carefully to minimise fetal toxicity.
 Vancomycin hydrochloride is excreted in human milk after intravenous administration. Caution should be exercised when vancomycin hydrochloride is administered to a lactating woman. Because of the potential for adverse events, a decision should be made whether to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

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)

Drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome is a serious, potentially life-threatening adverse drug reaction with distinct feature. Prompt recognition along with drug withdrawal is essential for improved prognosis. DRESS is characterised by severe drug eruption accompanied by high fever, erythematous rash and inflammation of internal organs.
Vancomycin capsules may cause indigestion, stomach ache, nausea, chills, diarrhoea, pseudomembranous enterocolitis, and occasionally vomiting. Because oral vancomycin may be absorbed in some patients, the possibility of other adverse effects normally associated with parenteral administration (see below) should be borne in mind.

Nephrotoxicity.

Cases of increased serum creatinine or BUN concentrations and rare cases of interstitial nephritis in patients given intravenously administered vancomycin have been reported. Most of these have occurred in patients who were given aminoglycosides concomitantly or who had pre-existing kidney dysfunction. When vancomycin was discontinued, azotemia resolved in most patients. Transient elevations of urea and granular casts in the urine occasionally occur.

Vascular disorders.

Phlebitis and vasculitis have been reported in patients given vancomycin intravenous therapy.

Ototoxicity.

Cases of hearing loss associated with intravenously administered vancomycin have been reported. Most of these patients had kidney dysfunction, pre-existing hearing loss, or concomitant treatment with an ototoxic drug. Vertigo, dizziness and tinnitus have been reported rarely.

Haematological.

Patients have been reported to have developed reversible neutropenia, usually starting one week or more after onset of intravenous therapy with vancomycin or after a total dose of more than 25 g. Neutropenia appears to be promptly reversible when vancomycin is discontinued. Thrombocytopenia has rarely been reported. Eosinophilia has also been reported.
Although a causal relationship has not been established, reversible agranulocytosis (granulocyte count less than 500/mm3) has been reported rarely.

Liver function.

Elevation of liver transaminases.

Sensitivity reactions.

Infrequently, patients have been reported to have anaphylaxis, urticaria, pruritus, drug fever, hypotension, wheezing, dyspnoea, flushing of the upper body ("red neck"), pain and muscle spasm of the chest and back, and rashes including exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis and rare cases of vasculitis in association with vancomycin.

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

Supportive care is advised, with maintenance of glomerular filtration. Vancomycin is poorly removed by dialysis. Haemoperfusion with Amberlite resin XAD-4 has been reported to be of limited benefit. Haemofiltration and haemoperfusion with polysulfone resin have been reported to result in increased vancomycin clearance.
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

5.1 Pharmacodynamic Properties

Mechanism of action.

The bactericidal action of vancomycin results primarily from inhibition of cell-wall biosynthesis. In addition, vancomycin alters bacterial-cell-membrane permeability and RNA synthesis. There is no cross-resistance between vancomycin and other antibiotics.
Vancomycin is active against C. difficile (e.g. toxigenic strains implicated in pseudomembranous enterocolitis). It is also active against staphylococci, including Staphylococcus aureus and Staphylococcus epidermidis (including heterogeneous methicillin-resistant strains).
Many strains of streptococci and C. difficile, are susceptible in vitro to concentrations of less than 5 mg/L. A small proportion of S. aureus strains require 10 to 20 mg/L for inhibition.
Vancomycin is not active in vitro against Gram-negative bacilli, mycobacteria or fungi.

Disc susceptibility tests.

Quantitative methods that require measurement of zone diameters give the most precise estimates of antibiotic susceptibility. One such procedure has been recommended for use with discs for testing susceptibility to vancomycin. Interpretations correlate zone diameters of the disc test with minimum inhibitory concentrations (MIC) values for vancomycin. With the procedure, a report from the laboratory of "resistant" indicates that the infecting organism is not likely to respond to therapy. A report of "intermediate susceptibility" suggests that the organism would be susceptible if the infection is confined to the urine, in which high antibiotic levels can be obtained, or if high dosage is used in other types of infection.
If the Bauer-Kirby method* of disc susceptibility testing is used, a 30 microgram disc of vancomycin should produce a zone of more than 11 mm when tested against a vancomycin-susceptible bacterial strain.
*Bauer AW, Kirby WM, Sherris JC, Turck M. Antibiotic susceptibility testing by a standardized single disk method. Am J Clin Pathol. 1966 Apr;45(4):493-6.; Standardized disk susceptibility test. Federal Register 1974;39:19182-19184.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption and Excretion.

Vancomycin is poorly absorbed after oral administration. In a comparative bioavailability study of the capsule dosage form and the oral solution dosage form, there were no significant differences in serum or faecal concentrations. During multiple dosing of 250 mg every 8 hours for seven doses, faecal concentrations of vancomycin in volunteers exceeded 100 mg/kg in the majority of samples. No blood levels were detected and urinary recovery did not exceed 0.76%.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Vancomycin BNM contains macrogol 6000, gelatin, titanium dioxide, sodium lauryl sulfate, brilliant blue FCF, iron oxide yellow (250 mg capsules only), tartrazine (125 mg capsules only), carnauba wax, white shellac and glyceryl monooleate.

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 moisture.

6.5 Nature and Contents of Container

Vancomycin BNM capsules 125 mg and 250 mg are supplied in PVC/PVDC/Alu blisters of 20 capsules.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Vancomycin hydrochloride is a mixture of related glycopeptides, consisting principally of vancomycin B, a substance produced by certain strains of Amycolatopsis orientalis or obtained by any other means. It is a white or almost white, hygroscopic powder; freely soluble in water; slightly soluble in alcohol. A 5% solution in water has a pH of 2.5 to 4.5.

Chemical structure.

The following structure of vancomycin hydrochloride has been confirmed by X-ray diffraction:
Molecular formula: C66H75Cl2N9O24.HCl.
Molecular weight: 1486; 500 mg of the base is equivalent to 0.34 mmol.

CAS number.

1404-93-9.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.