Consumer medicine information

Targocid

Teicoplanin

BRAND INFORMATION

Brand name

Targocid

Active ingredient

Teicoplanin

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Targocid.

What is in this leaflet

This leaflet answers some common questions about Targocid.

It does not contain all the available information. It does not take the place of talking to your doctor, or pharmacist.

All medicines have risks and benefits. Your doctor or pharmacist has weighed the risks of you being given this medicine against the benefits they expect it will have.

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

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

What Targocid is used for

Targocid injection is an antibiotic. It is used to kill bacteria responsible for infections which can occur in your blood, bones or joints. This antibiotic is generally used when the bacteria causing the infection are not satisfactorily eliminated by other antibiotics (eg penicillin) or when patients may be allergic to other antibiotics.

Your doctor, however, may prescribe Targocid for another purpose.

Ask your doctor if you have any questions about why it has been prescribed for you. This medicine is only available with a doctor's prescription.

There is no evidence that this medicine is addictive.

Before you are given it

When you must not be given it

Do not receive Targocid if you are allergic to it or any of the ingredients listed at the end of this leaflet. Some symptoms of an allergic reaction include skin rash, itching, shortness of breath or swelling of the face, lips or tongue, which may cause difficulty in swallowing or breathing.

Do not receive it if you are pregnant or intend to become pregnant. It may affect your developing baby if you are given it during pregnancy.

Do not receive it if you are breastfeeding or planning to breastfeed. It is not known whether Targocid passes into breast milk.

Do not receive it after the expiry date (EXP) printed on the pack or vial. If you receive it after the expiry date has passed, it may not work as well.

Do not receive it if the package is damaged or shows signs of tampering.

Before you are given it

Tell your doctor or pharmacist if you have allergies to:

  • any of the ingredients listed at the end of this leaflet
  • any other medicines, including to any other antibiotic (especially an antibiotic called vancomycin, also known as Vancocin®)
  • any other substances, such as foods, preservatives or dyes.

Tell your doctor or pharmacist if you are pregnant or intend to become pregnant. Like most medicines of this kind, Targocid is not recommended to be used during pregnancy. Your doctor or pharmacist will discuss the risks and benefits of being given it if you are pregnant.

Tell your doctor or pharmacist if you are breastfeeding or planning to breastfeed. It is not known whether Targocid passes into breast milk. Your doctor or pharmacist will discuss the risks and benefits of being given it if you are breastfeeding or planning to breastfeed.

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

  • kidney problems
  • liver problems

Tell your doctor or pharmacist if you plan to have surgery.

If you have not told your doctor or pharmacist about any of the above, tell them before you are given Targocid.

Taking other medicines

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

Some medicines may affect with how Targocid works. These include:

  • aminoglycoside antibiotics, medicine used to treat bacterial infections
  • amphotericin B (amphotericin), medicine used to treat fungal infections
  • ciclosporin, medicine used to help control your body's immune system
  • cisplatin, a medicine used in the treatment of some cancers
  • furosemide (frusemide), a medicine used to remove excess fluid in the body
  • etacrynic acid, a medicine used to help the kidneys get rid of salt and water

These medicines may be affected by Targocid. You may need to use different amounts of your medicine, or take different medicines. Your doctor or pharmacist will advise you.

Your doctor or pharmacist has more information on medicines to be careful with or to avoid while being given Targocid.

How it is given

How much will be given

On the first day of treatment most patients generally receive TWO doses of Targocid, 12 hours apart. During the following days, most patients receive ONE dose each day.

After the first day, the daily dose varies between 6 mg and 12 mg for each kilogram of body weight, depending on the type of infection. An adult of normal weight (around 70 kg) would therefore receive a single daily dose of between 400 mg and 800 mg.

Patients with kidney problems may need lower doses (or doses less often) than other patients. Your doctor can calculate how much Targocid you require if you have kidney problems.

How it is given

Targocid injection should be prepared and administered by a qualified health professional (doctor, pharmacist or nurse).

The vial of Targocid powder should be mixed carefully with the sterile water, which is included in the pack, to form a clear solution.

The solution may be injected into a vein directly over about 5 minutes, or it may be mixed with other sterile solutions and delivered into a vein from a 'drip' bottle or bag over about 30 minutes.

Targocid solution may also be injected directly into a muscle.

How long it will be given

If you have an infection in your blood, you will probably need to receive a daily injection of Targocid for 2 to 4 weeks. If you have an infection in any bones or joints, you may require a daily injection of Targocid for 3 to 6 weeks.

If you receive too much (overdose)

As Targocid is given to you under the supervision of your doctor, it is very unlikely that you will receive too much. However, if you experience any unexpected or worrying side effects after being given Targocid, tell your doctor immediately or go to Accident and Emergency at your nearest hospital.

While you are being given it

Things you must do

Tell all the doctors, dentists and pharmacists who are treating you that you are being given Targocid.

If you are about to be started on any new medicine, tell your doctor and pharmacist that you are being given Targocid.

If you plan to have surgery that needs a general anaesthetic, tell your doctor or dentist that you are being given this medicine.

If you become pregnant while you are being given this medicine, stop using it and tell your doctor or pharmacist immediately.

Things you must not do

Do not receive more than the recommended dose unless your doctor or pharmacist tells you to.

Do not give this medicine to anyone else, even if they have the same condition as you.

Do not use this medicine to treat any other complaints unless your doctor or pharmacist tells you to.

Do not stop receiving Targocid because you are feeling better, unless advised by your doctor or pharmacist.

If you do not complete the full course prescribed by your doctor, all of the bacteria causing your infection may not be killed. These bacteria may continue to grow and multiply so that your infection may not completely clear or it may return.

Things to be careful of

Be careful driving or operating machinery until you know how Targocid affects you.

Make sure you know how you react to it before you drive a car, operate machinery, or do anything else that could be dangerous if you feel dizzy.

Side Effects

All medicines have some unwanted side effects. Sometimes they are serious, but most of the time they are not. Your doctor or pharmacist has weighed the risks of using this medicine against the benefits they expect it will have for you.

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are being given Targocid.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

  • local pain and redness at the injection site
  • rash
  • dizziness
  • nausea
  • headache
  • stiffness

These are mild side effects of this medicine and usually short-lived.

Tell your doctor pharmacist as soon as possible if you notice any of the following:

  • fever
  • vomiting
  • diarrhoea
  • balance problems
  • ringing in the ears
  • problems hearing
  • if you suspect a second infection

Tell your doctor immediately, or go to Accident and Emergency at your nearest hospital if you notice any of the following:

  • swelling of the face, lips, mouth or throat, which may cause difficulty in swallowing or breathing
  • hives or welts on your skin

These are very serious side effects. If you have them, you may have had a serious allergic reaction to Targocid. You may need urgent medical attention or hospitalisation.

These side effects are very rare.

Tell your doctor or pharmacist if you notice anything else that is making you feel unwell. Other side effects not listed above may occur in some people.

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

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

There is no evidence that this medicine is addictive.

After receiving it

If you have any queries about any aspect of your medicine, or any questions regarding the information in this leaflet, discuss them with your doctor or pharmacist.

Storage

Targocid is stored in the pharmacy or on the ward.

Product description

What it looks like

Targocid injection is presented in a glass vial as a white powder which your doctor, pharmacist or nurse will mix with the ampoule of sterile water, included in the pack. A clear solution is formed when the powder is mixed with the water.

Ingredients

Active Ingredients:

The active ingredient in Targocid injection is teicoplanin. Each vial of Targocid injection contains 400 mg teicoplanin.

Inactive Ingredients:

The glass vial also contains an inactive ingredient, sodium chloride which is included to minimise stinging and pain when the injection is administered.

The ampoule contains water for injections.

Targocid does not contain gluten, dyes or preservatives.

Sponsor

Targocid is supplied in Australia by:

sanofi-aventis australia pty ltd
12-24 Talavera Road
Macquarie Park NSW 2113
Freecall No: 1800 818 806

Targocid is supplied in New Zealand by:

sanofi-aventis new zealand limited
Level 8, 56 Cawley Street
Ellerslie, Auckland 1051
Freecall No: 0800 283 684

This leaflet was prepared in April 2020.

targocid-ccdsv2-cmiv6-30apr20

Australian Register Number:

AUST R 47886

Published by MIMS June 2020

BRAND INFORMATION

Brand name

Targocid

Active ingredient

Teicoplanin

Schedule

S4

 

1 Name of Medicine

Teicoplanin.

2 Qualitative and Quantitative Composition

Each vial contains lyophilised teicoplanin 460 mg* and sodium chloride 24.8 mg with an accompanying ampoule containing Water for injections 3.14 mL*.
* An overage is included to allow withdrawal of the correct dose.
The reconstituted solution contains:
For a 400 mg vial: 400 mg/3.0 mL of teicoplanin.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Powder for injection.
Sterile, pyrogen-free ivory white powder for reconstitution with water for injections. It is freely soluble in water and on reconstitution gives a clear solution.

4 Clinical Particulars

4.1 Therapeutic Indications

Targocid is indicated for the treatment of the following serious infections due to staphylococci or streptococci, which cannot be treated satisfactorily with less toxic agents, including β-lactam antibiotics: bone - osteomyelitis; joints - septic arthritis; blood - non-cardiac bacteraemia, septicaemia.

4.2 Dose and Method of Administration

Note.

Special instructions apply for reconstitution. See below.
The reconstituted Targocid injection should be administered intravenously or intramuscularly. Intravenous dosing may be by slow injection over 5 minutes or by infusion over 30 minutes. Maintenance dosage is once daily; however, initially a loading dose regimen of three doses at 12-hourly intervals is recommended, for rapid attainment of steady-state plasma levels.
The dose is to be adjusted on bodyweight whatever the weight of the patient.
An intramuscular injection of Targocid should not exceed 3 mL (400 mg) at a single site.
Targocid should not be administered by intraventricular route, due to risk of seizure.

Adults.

Septicaemia/ bacteraemia, acute or chronic osteomyelitis.

Treatment should be started with 6-12 mg/kg by the I.V. route every 12 hours for 3 doses, then the daily maintenance dose should be 6 mg/kg.

Septic arthritis.

Patients with septic arthritis should receive 12 mg/kg, intravenously, every 12 hours for 3 doses then a daily maintenance dose of 12 mg/kg.

Elderly patients.

As for adults. If renal function is impaired, the instructions for impaired renal function should be followed.
While the total duration of therapy is determined by the type and severity of infection and by the clinical response of the patient, the following periods are often appropriate.

Uncomplicated bacteraemia.

2-4 weeks.

Septic arthritis or osteomyelitis.

3-6 weeks.

Patients with renal impairment.

For patients with impaired renal function, reduction of dosage is not required until the fourth day of Targocid treatment. Trough plasma teicoplanin concentrations should be monitored periodically after the first week of therapy and the dosage adjusted to prevent trough concentrations exceeding 30 microgram/mL in patients with septic arthritis or 15 microgram/mL in other cases.
From the fourth day of treatment.

In mild renal insufficiency.

Creatinine clearance between 40 and 60 mL/min, Targocid dose should be halved, either by administering the initial unit dose every two days, or by administering half of this dose once a day.

In severe renal insufficiency.

Creatinine clearance less than 40 mL/min and in haemodialysed patients, Targocid dose should be one third of the normal either by administering the initial unit dose every third day, or by administering one third of this dose once a day. Teicoplanin is not removed by dialysis.

Method of administration.

Preparation of injection.

Note.

The powder should be reconstituted strictly in accordance with the instructions below. Errors in reconstitution may result in the formation of a stable foam and delivery of smaller doses.
The entire contents of the accompanying diluent water ampoule should be added slowly down the side wall of the vial of Targocid. The vial should be rolled gently between the palms until the powder is completely dissolved, taking care to avoid foam formation. Do not shake. If the solution does become foamy, allow to stand for 15 minutes for the foam to subside. Withdraw the entire contents from the vial slowly into a syringe, trying to recover most of the solution by placing the needle in the central part of the stopper.
Satisfactory potency of the reconstituted injection is retained for 48 hours at 25°C and for 7 days at 4°C. As a matter of good pharmaceutical practice, it is recommended that reconstituted solutions be stored under refrigeration (4°C) and solutions stored longer than 24 hours be discarded. When storing reconstituted solution do not store in a syringe.
The reconstituted solution contains for a 400 mg vial: 400 mg/3.0 mL of teicoplanin.
Dilution of reconstituted solution. The reconstituted solution may be injected directly, or alternatively diluted with any of the following diluents.
0.9% Sodium chloride solution.
Compound sodium lactate solution.
If necessary, solutions with the above diluents may be stored at 4°C for up to 7 days. Solutions left at room temperature for longer than 24 hours should be discarded.
5% Glucose solution.
0.18% Sodium chloride and 4% glucose solution.
Solutions containing the above diluents (which contain glucose) should be stored at 4°C and should be used within 24 hours; solutions kept longer than 24 hours should be discarded.
As a matter of good pharmaceutical practice, solutions for intravenous infusion should be used immediately after admixing.

4.3 Contraindications

Targocid is contraindicated in patients with known hypersensitivity to the drug.

4.4 Special Warnings and Precautions for Use

Hypersensitivity reactions and anaphylaxis.

Serious, life-threatening hypersensitivity reactions, sometimes fatal, have been reported with Targocid (e.g. anaphylactic shock). If an allergic reaction to Targocid occurs, treatment should be discontinued immediately and appropriate emergency measures should be initiated.

Hypersensitivity to vancomycin.

Targocid should be administered with caution in patients known to be hypersensitive to vancomycin since cross-hypersensitivity reactions, including fatal anaphylactic shock, may occur. However, a history of the 'Red Man Syndrome' that can occur with vancomycin, is not a contraindication to Targocid.

Infusion related reactions.

'Red man syndrome' (a complex of symptoms including pruritus, urticarial, erythema, angioneurotic oedema, tachycardia, hypotension, dyspnoea), has been rarely observed (even at the first dose). Stopping or slowing the infusion may result in cessation of these reactions. Infusion related reactions can be limited if the daily dose is not given via bolus injection but infused over a 30-minute period.

Severe cutaneous adverse reactions (SCARS).

Life-threatening and fatal cutaneous reactions, including Stevens-Johnson syndrome (SJS), Toxic Epidermal Necrolysis (TEN) and Drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported with the use of Targocid. Acute generalised exanthematous pustulosis (AGEP) has also been reported. Patients should be informed about the signs and symptoms of serious skin manifestations and monitored closely. If symptoms or signs of SJS, or TEN, DRESS or AGEP (e.g. progressive skin rash often with blisters or mucosal lesion or pustular rash, or any other sign of skin hypersensitivity) are present, Targocid treatment should be discontinued immediately.

Nephrotoxicity.

Nephrotoxicity and renal failure have been reported in patients treated with Targocid (see Section 4.8 Adverse Effects (Undesirable Effects)). Patients with renal insufficiency, or with risk factors for development of nephrotoxicity, patients receiving the high loading dose regimen of teicoplanin, and/or patients receiving Targocid in conjunction with or sequentially with other medicinal products with known nephrotoxic potential (e.g. aminoglycosides, colistin, amphotericin B, ciclosporin, cisplatin, furosemide and ethacrynic acid) should be carefully monitored.

Ototoxicity.

Hearing impairment has been reported with use of Targocid (see Section 4.8 Adverse Effects (Undesirable Effects)). Periodic auditory function tests are advised especially in cases of prolonged treatment, patients with renal insufficiency and/or patients receiving teicoplanin in conjunction with or sequentially with other medicinal products with known nephrotoxic and/or neurotoxic/ototoxic potential (e.g. aminoglycosides, colistin, amphotericin B, ciclosporin, cisplatin, furosemide and ethacrynic acid). These patients should be carefully monitored and the benefit of teicoplanin evaluated if hearing deteriorates.

Hepatic toxicity.

Hepatic toxicities have been reported with use of Targocid (see Section 4.8 Adverse Effects (Undesirable Effects)). Periodic liver function tests are recommended for prolonged treatment.

Haematologic toxicity.

Haematologic toxicities have been reported with the use of Targocid (see Section 4.8 Adverse Effects (Undesirable Effects)). Periodic haematological studies are advised during prolonged treatment.

Loading dose regimen.

Safety data show increased rates of nephrotoxicity when high Targocid loading doses such as 12 mg/kg body weight twice a day are administered (see Section 4.8 Adverse Effects (Undesirable Effects)). For patients given high loading dose regimens, blood creatinine values should be closely monitored for nephrotoxicity in addition to haematological examinations.

Intraventricular use.

Targocid should not be administered by intraventricular route, due to the risk of seizure.

Superinfection.

The use of Targocid may result in overgrowth of non-susceptible organisms. Repeated evaluation of the patient's condition is essential. If new infections due to bacteria or fungi appear during treatment, appropriate measures should be taken.
The safety and efficacy of Targocid by the intrathecal route has not been studied.

Use in hepatic impairment.

No data available.

Use in renal impairment.

See Section 4.2 Dose and Method of Administration, Patients with renal impairment; Section 4.4 Special Warnings and Precautions for Use, Loading dose regimen, Ototoxicity and Nephrotoxicity.

Use in the elderly.

See Section 4.2 Dose and Method of Administration, Elderly patients.

Paediatric use.

No data available.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Due to the potential for increased adverse effects, Targocid should be administered with caution in patients receiving concurrent nephrotoxic or ototoxic drugs, such as aminoglycosides, amphotericin B (amphotericin), ciclosporin and furosemide (frusemide).

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category B3)
Reproductive studies in rats and rabbits with subcutaneous doses up to 200 mg/kg/day and 15 mg/kg/day respectively did not reveal teratogenic effects. Teicoplanin was associated with an increase in the number of stillborn pups when rats were treated with subcutaneous doses ≥ 100 mg/kg/day. Pup weight was reduced at all doses tested (SC doses ≥ 10 mg/kg/day). It is not known if teicoplanin is excreted in breast milk during lactation.
Targocid should not be used during confirmed or presumed pregnancy unless the potential benefits outweigh possible risks.
 Targocid should not be used during lactation unless the potential benefits outweigh possible risks.

4.7 Effects on Ability to Drive and Use Machines

Targocid can cause dizziness and headache. The ability to drive or operate machinery may be affected. Patients experiencing these undesirable effects should not drive or operate machinery.

4.8 Adverse Effects (Undesirable Effects)

In an open clinical trial involving patients with bone or joint infections, teicoplanin was associated with adverse reactions in 32% of the patients. However, treatment was discontinued because of adverse reactions in 17% of patients only. A clear cause-effect relationship was not established in these patients. The most frequent adverse reactions were fever, rashes, nausea, vomiting, rigors, pruritus and diarrhoea.
The following adverse effects have been reported.

Local reactions.

Pain, phlebitis, redness, abscess, thrombophlebitis.

Hypersensitivity.

Skin rash, erythema, pruritus, rigor, fever, bronchospasm, anaphylaxis, urticaria, angioedema, DRESS syndrome (drug reaction with eosinophilia and systemic symptoms), toxic epidermal necrolysis, erythema multiforme including Stevens-Johnson syndrome and rare reports of exfoliative dermatitis, acute generalised exanthematous pustulosis (see Section 4.4 Special Warnings and Precautions for Use, Severe cutaneous adverse reactions (SCARS)).

Hepatic.

Increased transaminases and/or alkaline phosphatase.

Haematologic.

Eosinophilia, thrombocytopenia, leucopenia, neutropenia, rare cases of reversible agranulocytosis, and pancytopenia.

Renal and urinary disorders.

Including rise in serum creatinine, blood urea, renal failure. Based on literature reports, the estimated rate of nephrotoxicity in patients receiving low loading dose regimen of average 6 mg/kg twice a day, followed by a maintenance dose of average 6 mg/kg once daily, is around 2%. In an observational post-authorisation safety study which enrolled 300 patients with a mean age of 63 years (treated for bone and joint infection, endocarditis or other severe infections) who received the high loading dose regimen of 12 mg/kg twice a day (receiving 5 loading doses as a median) followed by a maintenance dose of 12 mg/kg once daily, the observed rate of confirmed nephrotoxicity was 11.0% (95% CI = [7.4%; 15.5%]) over the first 10 days. The cumulative rate of nephrotoxicity from the start of treatment up to 60 days after the last dose was 20.6% (95% CI = [16.0%; 25.8%]). In patients receiving more than 5 high loading doses of 12 mg/kg twice a day, followed by a maintenance dose of 12 mg/kg once daily, the observed cumulative rate of nephrotoxicity from the start of treatment up to 60 days after the last administration was 27% (95% CI = [20.7%; 35.3%]).

Gastrointestinal.

Nausea or vomiting, diarrhoea.

Nervous system.

Dizziness, headache, seizures with intraventricular use.

Auditory.

Hearing loss, tinnitus, vertigo, other vestibular disorders.

Infections and infestations.

Superinfection (overgrowth of nonsusceptible organisms).
In addition, infusion-related events, such as erythema or flushing of the upper body, have been rarely reported. These events occurred without a history of previous Targocid exposure and did not recur on re-exposure when the infusion rate was slowed and/or the concentration was decreased. These events were not specific to any concentration or rate of infusion.

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 (Australia).

4.9 Overdose

In an observational post-authorisation safety study, patients receiving more than 5 high loading doses of 12 mg/kg twice a day, followed by a maintenance dose of 12 mg/kg once daily, had an observed cumulative rate of nephrotoxicity from the start of treatment up to 60 days after the last administration of 27% (95% CI = [20.7%; 35.3%]).
Cases of excessive doses administered in error to paediatric patients have been reported. In one report, agitation occurred in a 29 day-old newborn given 400 mg I.V. (95 mg/kg). In the other cases, there were no symptoms or laboratory abnormalities associated with teicoplanin.
Treatment of overdosage should be symptomatic. Teicoplanin is not removed by haemodialysis or peritoneal dialysis.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Anti-infectives for systemic use, Glycopeptide antibacterials, ATC code: J01XA02.

Mechanism of action.

Microbiology.

Teicoplanin is bactericidal or bacteriostatic on growing populations of susceptible Gram-positive organisms; depending on the sensitivity of the organism and antibiotic concentration.
Teicoplanin inhibits the growth of susceptible organisms by interfering with cell-wall biosynthesis at a different site from that affected by β-lactams. Teicoplanin is therefore effective against staphylococci (including those resistant to methicillin and other β-lactam antibiotics) and streptococci.
Some cross-resistance is observed between teicoplanin and the glycopeptide vancomycin.
Teicoplanin has shown no cross-resistance to β-lactam antibiotics, macrolides, aminoglycosides, tetracycline, rifampicin or chloramphenicol.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Following intramuscular injection bioavailability is 100%; average peak plasma levels of 7.1 microgram/mL are achieved in 3-4 hours following a dose of 3 mg/kg.

Distribution.

In man, the plasma level profile after intravenous administration indicates a biphasic distribution (with a rapid distribution phase having a half-life of about 0.3 hours, followed by a more prolonged distribution phase having a half-life of 3 hours). At the end of the distribution phase, plasma levels and the subsequent time-concentration curves, are identical following intramuscular or intravenous administration of 3 mg/kg dose.
The apparent volume of distribution at steady state is similar to total body water, i.e. 0.6 L/kg.
Approximately 90-95% of teicoplanin is bound to plasma proteins. Teicoplanin penetrates into blister exudates and bone where it achieves peak concentrations comparable to those in serum after intramuscular injection. Peak levels in joint fluid are approximately 60% of peak serum concentrations. Teicoplanin penetrates very poorly into cerebrospinal fluid (CSF) and red blood cells.

Metabolism.

Metabolic transformation is minor, about 3%.

Excretion.

The elimination half-life is 70-100 hours. About 80% of administered drug is excreted in the urine over a 16 day collection period.

5.3 Preclinical Safety Data

Genotoxicity.

Teicoplanin was negative in assays evaluating the potential to cause gene mutations, but assays to evaluate the potential to cause chromosome damage have not been performed.

Carcinogenicity.

Long-term studies in animals to evaluate the carcinogenic potential of teicoplanin have not been performed.

6 Pharmaceutical Particulars

6.1 List of Excipients

Vial.

Sodium chloride.

Ampoule.

Water for injections.

6.2 Incompatibilities

Solutions of Targocid and aminoglycosides are incompatible when mixed directly and therefore should not be mixed before injection.

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.
See Section 4.2 Dose and Method of Administration, for the shelf life of the reconstituted and diluted solutions.

6.4 Special Precautions for Storage

Store below 25°C.
See Section 4.2 Dose and Method of Administration, for the shelf life of the reconstituted and diluted solutions.

6.5 Nature and Contents of Container

One 25 mL glass vial containing teicoplanin powder for injection.
One ampoule containing diluent.

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

Teicoplanin is a glycopeptide-antibiotic produced by Actinoplanes teichomyceticus.

Chemical structure.

No data available.

CAS number.

61036-62-2.

7 Medicine Schedule (Poisons Standard)

Prescription Only Medicine (Schedule 4).

Summary Table of Changes