Consumer medicine information

Vancocin Capsules

Vancomycin

BRAND INFORMATION

Brand name

Vancocin Capsules

Active ingredient

Vancomycin

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Vancocin Capsules.

What is in this leaflet

This leaflet answers some common questions about Vancocin capsules. It does not contain all the available information that is known about Vancocin capsules.

It does not take the place of talking to your doctor.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking Vancocin capsules against the benefits they expect it will have for you.

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

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

What Vancocin capsules are used for

Vancocin capsules contains the active vancomycin (as vancomycin hydrochloride).

Vancocin capsules are an antibiotic used to treat serious infections involving the bowel. It works by killing or stopping the growth of the bacteria causing your infection.

Ask your doctor if you have any questions about why Vancocin capsules have been prescribed for you. Your doctor may have prescribed it for another purpose.

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

There is no evidence that it is addictive.

Before you take it

When you must not take it

Do not take Vancocin capsules if you have ever had an allergic reaction to:

  • any medicines containing vancomycin
  • any of the ingredients listed at the end of this leaflet.

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.

Do not take Vancocin capsules if the expiry date on the pack has passed.

Do not take Vancocin capsules if the packaging is torn or shows signs of tampering.

Before you start to take it

Tell your doctor if you are allergic to any other medicines or any foods, dyes or preservatives.

Tell your doctor if you have or have had any of the following medical conditions:

  • kidney or liver disease
  • a special sensory impairment (e.g. blindness)
  • pre-existing hearing loss.

Do not take Vancocin capsules if you are pregnant or plan to become pregnant unless you and your doctor have discussed the benefits and risks involved.

Do not take Vancocin capsules if you are breast feeding or plan to breast feed. It is not recommended for use while breastfeeding as it is found in breast milk.

If you have not told your doctor about any of these things, tell them before you take Vancocin capsules.

Taking other medicines

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

Some medicines may interfere with Vancocin capsules. These include:

  • antibiotics called aminoglycosides. Aminoglycosides taken at the same time as this medicine may cause abnormal kidney function or hearing problems.

These medicines may be affected by Vancocin capsules 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 Vancocin capsules.

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.

How to take it

How much to take

Your doctor will tell you how many Vancocin capsules you need to take each day. This will depend on the type of infection. The dose varies from patient to patient.

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.

How to take it

Swallow the capsules whole with a full glass of water.

When to take it

Vancocin capsules can be taken with or without food.

How long to take it

Continue taking Vancocin capsules for as long as your doctor tells you.

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 it

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise, take it as soon as you remember, and then go back to taking your capsules as you would normally.

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 that you missed.

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

If you take too much

Immediately telephone your doctor or Poisons Information Centre (13 11 26) for advice, or go to Accident and Emergency at your nearest hospital if you think that you or anyone else may have taken too much Vancocin capsules. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

While you are taking it

Things you must do

Tell your doctor if the symptoms of your infection do not improve within a few days or if they become worse.

Tell any other doctors, dentists and pharmacists who are treating you that you are taking Vancocin capsules, especially if you are being started on any new medicines.

Tell your doctor if you become pregnant while taking Vancocin capsules.

Things you must not do

Do not take Vancocin 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 stop taking your medicine or change the dosage without first checking with your doctor. If you stop taking it, your condition may worsen.

Things to be careful of

As with any new medicine, you should take care when driving or operating machinery until you know how Vancocin capsules affects you.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Vancocin capsules.

This medicine helps most people with bacterial infections of the bowel, but it may have 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 notice any of the following side effects and they worry you:

  • indigestion
  • stomach ache
  • nausea
  • chills
  • diarrhoea
  • vomiting.

Tell your doctor as soon as possible if you notice any of the following and they worry you:

  • 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.

Tell your doctor immediately or go to casualty at your nearest hospital if you notice any of the following:

  • 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.

These are serious side effects of Vancocin capsules. You may need urgent medical attention. Serious side effects are rare.

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

After finishing it

Tell your doctor immediately if you notice any of the following side effects, particularly if they occur several weeks after stopping treatment with Vancocin 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 if you notice anything else that is making you feel unwell. Some people may get other side effects while using Vancocin capsules.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

After taking it

Storage

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 cool, dry place where the temperature stays below 25°C. Protect from moisture.

Keep it where young children cannot reach it. A locked cupboard at least one-and-a-half metres above ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking Vancocin capsules or you find that the expiry date has passed, ask your pharmacist what to do with any capsules that are left over.

Product Description

What it looks like

Vancocin 125 mg capsules are opaque peach and opaque blue. They are available in packs of 20.

Vancocin 250 mg capsules are opaque mushroom grey and opaque blue. They are available in packs of 20.

Ingredients

Active ingredient:

125 mg capsules
Each capsule contains 125 mg vancomycin hydrochloride (equivalent to 125,000 IU of vancomycin activity).

250 mg capsules
Each capsule contains 250 mg vancomycin hydrochloride (equivalent to 250,000 IU of vancomycin activity).

Inactive ingredients:

  • macrogol 6000.

Capsule shell:

  • gelatin
  • indigo carmine
  • iron oxide red
  • titanium dioxide
  • iron oxide yellow (125 mg only)
  • iron oxide black (250 mg only).

Vancocin capsules do not contain lactose, sucrose, tartrazine or any other azo dyes.

Sponsor

Aspen Pharmacare Australia Pty Ltd
34-36 Chandos St
St Leonards NSW 2065

Australian Registration Numbers:

125 mg: AUST R 14674
250 mg: AUST R 14657

This leaflet was revised in March 2020.

Published by MIMS June 2020

BRAND INFORMATION

Brand name

Vancocin Capsules

Active ingredient

Vancomycin

Schedule

S4

 

1 Name of Medicine

Vancomycin hydrochloride.

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.
The chemical formula is C66H75Cl2N9O24.HCl.
The molecular weight is 1,486; 500 mg of the base is equivalent to 0.34 mmol.

Chemical structure.

The following structure of vancomycin hydrochloride has been confirmed by X-ray diffraction.

CAS number.

1404-93-9.

2 Qualitative and Quantitative Composition

Vancocin capsules contain either 125 mg or 250 mg of vancomycin hydrochloride as the active ingredient.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Vancocin 125 mg capsules are size 2, hard gelatin capsules, with opaque blue cap and an opaque peach body.
Vancocin 250 mg capsules are size 0, hard gelatin capsules, with opaque blue cap and opaque mushroom grey body.

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 Vancocin. 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 Vancocin should produce a zone of more than 11 mm when tested against a vancomycin susceptible bacterial strain.
* Bauer, AW, Kirby, WMM., Sherris, JC and Turck, M; Antibiotic Susceptibility Testing by a Standardized Single Disk Method, Am. J. Clin. Pathol.,45:493, 1966; Standardized Disc Susceptibility Test, Federal Resgister, 39:19182-19184, 1974.

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.

4 Clinical Particulars

4.1 Therapeutic Indications

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

4.3 Contraindications

Vancocin is contraindicated in patients with known hypersensitivity to this antibiotic.

4.4 Special Warnings and Precautions for Use

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 Vancocin Capsules may be at risk for the development of adverse reactions associated with the parenteral administration of vancomycin. See package insert accompanying the intravenous preparation. 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.

Ototoxicity.

Ototoxicity has occurred in patients receiving Vancocin. 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). Vancocin Capsules should be avoided in patients with previous hearing loss unless no other appropriate therapy is available.

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.

When treating patients with underlying renal dysfunction or those patients receiving concomitant therapy with a potentially nephrotoxic drug, including aminoglycosides, serial monitoring of renal function should be performed.

Use in the elderly.

No data available.

Paediatric use.

No data available.

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.
(Category B2)
Animal reproduction studies have not been conducted with Vancocin. It is also not known whether Vancocin 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. Vancocin Capsules should be given to a pregnant woman only if clearly needed.
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.

4.8 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.
Vancocin Capsules may cause indigestion, stomach ache, nausea, chills, diarrhoea 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 Vancocin have been reported. Most of these have occurred in patients who were given aminoglycosides concomitantly or who had pre-existing kidney dysfunction. When Vancocin was discontinued, azotaemia resolved in most patients.

Ototoxicity.

Cases of hearing loss associated with intravenously administered Vancocin 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 Vancocin or after a total dose of more than 25 g. Neutropenia appears to be promptly reversible when Vancocin 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 Vancocin.

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

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.

4.7 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

Supportive care is advised, with maintenance of glomerular filtration. Vancomycin is poorly removed by dialysis. Haemofiltration and haemoperfusion with polysulfone resin have been reported to result in increased vancomycin clearance.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

7 Medicine Schedule (Poisons Standard)

S4.

6 Pharmaceutical Particulars

6.1 List of Excipients

Macrogol 6000, gelatin, indigo carmine, iron oxide red, iron oxide yellow (125 mg), iron oxide black (250 mg) and titanium dioxide.

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

Vancocin Capsules are available in PVC/Al blisters in two strengths in packs of 20.

6.6 Special Precautions for Disposal

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

Summary Table of Changes