Consumer medicine information

What is in this leaflet

This leaflet answers some common questions about Vancocin CP powder for injection. It does not contain all the available information and 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 this medicine against the benefits they expect it will have for you.

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

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

What Vancocin CP is used for

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

Vancocin CP is an antibiotic used to treat serious infections caused by bacteria (germs). These infections may occur in different parts of the body.

Vancocin CP can also be used orally to treat serious infections involving the bowel.

Vancocin CP works by killing the bacteria causing the infection.

Ask your doctor if you have any questions about why Vancocin CP has been prescribed for you. Your doctor may have prescribed Vancocin CP for another reason.

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

There is no evidence that it is addictive.

Before you are given it

When you must not be given it

You should not be given Vancocin CP if you have ever had an allergic reaction to:

• any medicines containing vancomycin hydrochloride
• the inactive ingredient, disodium edetate.

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.

You should not be given Vancocin CP if the packaging is torn or shows signs of tampering.

You should not be given Vancocin CP if the expiry date on the pack has passed. If you are given this medicine after the expiry date has passed it may not work as well.

Before you are given it

Tell your doctor if you are allergic to any other medicines (such as teicoplanin, a drug used to treat infections) 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
• if you have suffered from hearing loss.

Tell your doctor if you are pregnant or intend to become pregnant.

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

Tell your doctor 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 are given Vancocin CP.

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 affect the way other medicines work. Your doctor or pharmacist has more information on medicines to be careful with or avoid while you are receiving Vancocin CP.

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 it is given

Intravenously

Vancocin CP 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 Vancocin CP to be infused into your vein.

Your doctor or nurse will prepare the infusion of Vancocin CP for you.

Orally

Vancocin CP 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.

How much to be given

Your doctor will decide what dose of Vancocin CP you will be given, depending on your infection and other factors such as your age and weight.

If given orally, the total dose for children should not exceed 2 grams per day.

How often will Vancocin CP be given

For most infections, Vancocin CP is usually given in divided doses throughout the 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.

The oral solution is usually given for 7 to 10 days.

If you are given too much (overdose)

As you will be given Vancocin CP under the supervision of your doctor, it is unlikely that you will receive too much.

However, if you experience any side effects after being given it, immediately tell your doctor or nurse or call the Poisons Information Centre (telephone 13 11 26) for advice.

Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

Side effects

Tell your doctor, nurse or pharmacist as soon as possible if you do not feel well while you are having Vancocin CP.

Like other medicines, Vancocin CP may cause some unwanted side effects. These are likely to vary from patient to patient. It is important that you tell your doctor as soon as possible about any unwanted effects.

Ask your doctor, nurse or pharmacist to answer any questions you may have.

Tell your doctor or nurse if you notice any of the following side effects and they worry you:

• stomach ache
• nausea
• chills
• diarrhoea
• vomiting
• pain, swelling or red skin where you had the injection
• difficulty hearing, dizziness or ringing in the ears.

Tell your doctor or nurse immediately if you notice any of the following:

• irregular or fast heartbeat
• chest tightness, wheezing or breathlessness
• itchy rash
• bleeding or bruising more easily than normal 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 CP. You may need urgent medical attention. Serious side effects are rare.

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

After you have received Vancocin CP

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

• 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 CP.

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

Product Description

What it looks like

Vancocin CP is available in two strengths: 500 mg and 1 g.

It is a white to off-white powder in a glass vial with a rubber stopper.

Available in packs of 1 vial.

Intravenously

The powder is dissolved in a suitable sterile solution before it is given.

Orally

If Vancocin CP is to be taken orally, the powder is dissolved in water.

Storage

Vancocin CP will be stored in the pharmacy or on the hospital ward.

The powder for injection is kept in a cool dry place where the temperature stays below 25°C.

Ingredients

Active ingredient:

Each vial contains either 500 mg or 1 g vancomycin hydrochloride (equivalent to 500,000 I.U. or 1,000,000 I.U. vancomycin activity respectively).

Inactive ingredients:

• disodium edetate
• sodium hydroxide/hydrochloric acid may also be added to adjust the pH.

Vancocin CP does 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:

Vancocin CP 500 mg:
AUST R 14658

Vancocin CP 1 g:
AUST R 41609

This leaflet was revised in
May 2015

Published by MIMS November 2017

Name of the medicine

Vancomycin hydrochloride.

Excipients.

Description

Molecular formula: C₆₆H₇₅Cl₂N₉O₂₄. MW: 1,449. CAS: 1404-93-9. Vancocin CP (sterile vancomycin hydrochloride), intravenous, is a chromatographically purified tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis) which is bactericidal against many Gram positive bacteria. It should be administered intravenously in dilute solution. (See Dosage and Administration.) The structure of vancomycin hydrochloride has been confirmed by X-ray diffraction. It is an off-white lyophilised plug. When reconstituted in water, it is a clear solution with a pH range of 2.8 to 4.5. Sodium hydroxide and/or hydrochloric acid may be used during manufacture for pH adjustment.

Pharmacology

Vancocin CP is poorly absorbed after oral administration; it is given intravenously for therapy of systemic infections. Intramuscular injection is painful.
In subjects with normal kidney function, multiple intravenous dosing of vancomycin 1 g (15 mg/kg) infused over 60 minutes produces mean plasma concentrations of approximately 63 mg/L immediately at the completion of infusion, mean plasma concentrations of approximately 23 mg/L two hours after infusion, and mean plasma concentrations of approximately 8 mg/L eleven hours after the end of the infusion. Multiple dosing of 500 mg infused over 30 minutes produces mean plasma concentrations of about 49 mg/L at the completion of infusion, mean plasma concentrations of about 19 mg/L two hours after infusion, and mean plasma concentrations of about 10 mg/L six hours after infusion. The plasma concentrations during multiple dosing are similar to those after a single dose.
The mean elimination half-life of vancomycin from plasma is four to six hours in subjects with normal renal function. In the first 24 hours, about 75% of an administered dose of vancomycin is excreted in urine by glomerular filtration. Mean plasma clearance is about 0.06 L/kg/hour, and mean renal clearance is about 0.05 L/kg/hour. Renal dysfunction slows excretion of vancomycin. In anephric patients, the average half-life of elimination is 7.5 days. The distribution coefficient is from 0.3 to 0.69 L/kg. There is no apparent metabolism of the drug. About 60% of an intraperitoneal dose of vancomycin administered during peritoneal dialysis is absorbed systemically in six hours. Serum concentrations of about 10 mg/L are achieved by intraperitoneal injection of vancomycin 30 mg/kg.
Although vancomycin is not effectively removed by either haemodialysis or peritoneal dialysis, there have been reports of increased vancomycin clearance with haemoperfusion and haemofiltration.
Total systemic and renal clearance of vancomycin may be reduced in the elderly.
Protein binding is approximately 55% as measured by ultrafiltration at vancomycin serum concentrations of 10 to 100 mg/L. Clinically effective concentrations of this antibiotic in the blood are usually achieved and maintained by its intravenous administration, moreover, inhibitory concentrations can be demonstrated in pleural, pericardial, ascitic and synovial fluids, in urine, in peritoneal dialysis fluid, and in atrial appendage tissue. This antibiotic does not readily diffuse across the meninges into the cerebrospinal fluid.
Measurable serum concentrations of vancomycin may occur in patients treated for active pseudomembranous colitis due to Clostridium difficile.

Microbiology.

Synergy.

Disc susceptibility tests.

Indications

Vancocin CP is indicated in potentially life threatening infections which cannot be treated with another effective, less toxic antimicrobial drug, including the penicillins and cephalosporins.
Vancocin CP is useful in therapy of severe staphylococcal (including methicillin resistant staphylococcal) infections in patients who cannot receive or who have failed to respond to the penicillins and cephalosporins or who have infections with Staphylococci that are resistant to other antibiotics. Once sensitivity data are available, therapy should be adjusted accordingly.
Vancocin CP is effective alone or in combination with an aminoglycoside for endocarditis caused by Strep. viridans or Strep. bovis. For endocarditis caused by Enterococci (e.g. E. faecalis), Vancocin CP is effective only in combination with an aminoglycoside. Vancocin CP is effective for the treatment of diphtheroid endocarditis. Vancocin CP is used in combination with rifampicin, an aminoglycoside, or both in early onset prosthetic valve endocarditis caused by Staph. epidermidis or diphtheroids.
The effectiveness of Vancocin CP has been documented in other infections due to Staphylococci including osteomyelitis, pneumonia, septicaemia, and soft tissue infections. When staphylococcal infections are localised and purulent, antibiotics are used as adjuncts to appropriate surgical measures.
Specimens for bacteriological cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to Vancocin CP.
Vancocin CP should be administered orally for the treatment of staphylococcal enterocolitis and antibiotic associated pseudomembranous colitis (produced by Clostridium difficile). Parenteral administration of Vancocin CP alone is inappropriate for this indication. Vancomycin is not effective by the oral route for other types of infections. For oral administration the parenteral formulation may be used. Some systemic absorption may occur following oral administration in patients with pseudomembranous colitis.

Contraindications

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

Precautions

Bolus administration (e.g. over several minutes) may be associated with exaggerated hypotension including shock and, rarely, cardiac arrest.
Vancocin CP should be administered in a dilute solution over a period of not less than 60 minutes to avoid rapid infusion related reactions. Stopping the infusion usually results in a prompt cessation of these reactions (see Dosage and Administration and Adverse Effects).
Complications of occasional severe hypotension, histamine-like responses and rash can be avoided by slow administration of the recommended dilute solutions over at least one hour for both adults and children.
Vancomycin should be administered with caution in patients allergic to teicoplanin, since allergic cross reactions between vancomycin and teicoplanin have been reported.
Mixtures of solutions of vancomycin and β-lactam antibiotics have been shown to be physically incompatible. The likelihood of precipitation increases with higher concentrations of vancomycin. It is recommended to adequately flush the intravenous lines between the administration of these antibiotics. It is also recommended to dilute solutions of vancomycin to 5 mg/mL or less (see Dosage and Administration, Compatibility with other drugs and intravenous fluids).
Although intravitreal injection is not an approved route of administration for vancomycin, precipitation has also been reported after intravitreal injection of vancomycin and ceftazidime for endophthalmitis using different syringes and needles (see Dosage and Administration, Compatibility with other drugs and intravenous fluids).
Because of its ototoxicity and nephrotoxicity, Vancocin CP should be used with care in patients with renal insufficiency. The risk of toxicity is appreciably increased by high blood concentrations or prolonged therapy. If it is necessary to use Vancocin CP in such patients, blood levels should be monitored and appropriate dosage modifications made.
Vancocin CP should be avoided in patients with previous hearing loss. If it is used in such patients, the dose of Vancocin CP should be regulated, if possible, by periodic determination of the drug level in the blood. Deafness may be preceded by tinnitus. The elderly are more susceptible to auditory damage. Experience with other antibiotics suggests that deafness may be progressive despite cessation of treatment.
Patients with borderline renal function and individuals over the age of 60 years should be given serial tests of auditory function and of vancomycin blood levels.
(Vancomycin serum levels may be determined by use of the modified Rammelkamp serial twofold dilution technique with Streptococcus C203 as the indicator organism.) All patients receiving the drug should have periodic haematological studies, urinalyses, and liver and renal function tests.
Clinically significant serum concentrations have been reported in some patients being treated for active Clostridium difficile induced pseudomembranous colitis after multiple oral doses of vancomycin.
Prolonged use of Vancocin CP may result in the overgrowth of nonsusceptible organisms. Careful observation of the patient is essential. If superinfection occurs during therapy, appropriate measures should be taken. In rare instances, there have been reports of pseudomembranous colitis due to Cl. difficile developing in patients who received intravenous vancomycin.
Vancocin CP is irritating to tissue and causes necrosis when injected intramuscularly; it must be administered intravenously. Pain and thrombophlebitis occur in many patients receiving Vancocin CP 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 sites of injection are rotated.
Reversible neutropenia has been reported in patients receiving Vancocin CP (see Adverse Effects). Patients undergoing prolonged therapy with Vancocin CP or who are receiving concomitant drugs which may cause neutropenia should have periodic monitoring of the leucocyte count.
Neither the safety nor the efficacy of vancomycin administration by the intrathecal or intraventricular routes have been studied. Vancomycin should not be administered by these routes.
Reports have revealed that administration of sterile vancomycin hydrochloride by the intraperitoneal route during continuous ambulatory peritoneal dialysis (CAPD) has resulted in a syndrome of chemical peritonitis. To date, this syndrome has ranged from a cloudy dialysate alone to a cloudy dialysate accompanied by varying degrees of abdominal pain and fever. This syndrome appears to be short-lived after discontinuation of intraperitoneal vancomycin.

Use in pregnancy.

Use in lactation.

Use in paediatrics.

Use in geriatrics.

Interactions

Concurrent and/or sequential systemic or topical use of other potentially neurotoxic and/or nephrotoxic drugs such as amphotericin, aminoglycosides, bacitracin, polymyxin, colistin, viomycin or cisplatin requires careful monitoring.
In animal studies designed to evaluate nephrotoxicity in the rat, renal impairment occurred with high serum concentrations of vancomycin alone and with lower concentrations when vancomycin was administered with an aminoglycoside. Combining vancomycin with a loop diuretic in the rat model did not potentiate the renal impairment that occurred with vancomycin alone. 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 in order to minimise the risk of nephrotoxicity.
There have been reports that the frequency of infusion-related events (including hypotension, flushing, erythema, urticaria and pruritus) increases with the concomitant administration of anaesthetic agents. Infusion related events may be minimised by the administration of Vancocin CP as a 60 minute infusion prior to anaesthetic induction.

Adverse 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 characterized by severe drug eruption accompanied by high fever, erythematous rash and inflammation of internal organs.

Infusion related events.

Gastrointestinal.

Nephrotoxicity.

Ototoxicity.

Haematological.

Liver function.

Phlebitis.

Immunological.

General.

Dosage and Administration

Infusion related events are related to both concentration and rate of administration of vancomycin. Concentrations of no more than 5 mg/mL and rates of no more than 10 mg/minute are recommended in adults (see also age specific recommendations). In selected patients in need of fluid restriction, a concentration up to 10 mg/mL may be used; use of such higher concentrations may increase the risk of infusion related events. Infusion related events may occur, however, at any rate or concentration.

Patients with normal renal function.

Impaired renal function and elderly patients.

Loading dose.

Anephric patients.

For oral administration.

Stability of prepared solution.

Overdosage

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 overdose, interaction among drugs and unusual drug kinetics in the patient.
Contact the Poisons Information Centre on 131 126 for advice on management.

Presentation

Powder for reconstitution (sterile, lyophilised), 500 mg (≡ 500,000 IU, 0.35 mmol): 1's, 10's (10 mL size rubber stoppered vial); 1 g (≡ 1,000,000 IU, 0.70 mmol):1's, 10's (20 mL size rubber stoppered vial).

Storage

Prior to reconstitution store below 25°C.

Poison Schedule

S4.