Consumer medicine information

Targocid

Teicoplanin

BRAND INFORMATION

Brand name

Targocid

Active ingredient

Teicoplanin

Schedule

SUMMARY CMI

Targocid^®

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 being given Targocid?

Targocid contains the active ingredient teicoplanin. Targocid injection is an antibiotic. It is used to kill bacteria responsible for infections which can occur in your blood, bones or joints. For more information, see Section 1. Why am I being given Targocid? in the full CMI.

2. What should I know before I am given Targocid?

Do not use if you have ever had an allergic reaction to Targocid or any of the ingredients listed at the end of the CMI. Talk to your doctor if you have any other medical conditions, take any other medicines, are pregnant or plan to become pregnant, or are breastfeeding or planning to breastfeed. For more information, see Section 2. What should I know before I am given Targocid? in the full CMI. What if I am taking other medicines?

3. What if I am taking other medicines?

Some medicines may interfere with Targocid 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 will I be given Targocid?

Targocid injection should be prepared and administered by a qualified health professional (doctor, pharmacist or nurse). More instructions can be found in Section 4. How will I be given Targocid? in the full CMI.

5. What should I know while being given Targocid?

Things you should do	Call your doctor straight away if you notice any symptoms of serious skin reactions, including blistering of your skin, mouth, eyes or genitals, a red scaly widespread rash and blisters accompanied by a fever, or flu-like symptoms and a rash on your face and body with a fever. Remind any doctor, dentist or pharmacist that you visit that you are being given Targocid.
Things you should not do	Do not stop receiving Targocid because you are feeling better, unless advised by your doctor or pharmacist.
Driving or using machines	Be careful driving or operating machinery until you know how Targocid affects you.
Looking after your medicine	Targocid is stored in the pharmacy or on the ward.

For more information, see Section 5. What should I know while being given Targocid? in the full CMI.

6. Are there any side effects?

There are a number of side effects associated with this medicine. Not all of these side effects are listed here. It is important to be aware of them so that you can identify any symptoms if they occur (see Section 6. Are there any side effects? in the full CMI for more details). Mild side effects include local pain and redness at the injection site, rash, dizziness, nausea, headache and stiffness. Very serious side effects which may indicate an allergic reaction include swelling of the face, lips, mouth or throat, which may cause difficulty in swallowing or breathing, and hives or welts on the skin. Other very serious side effects include blistering of your skin, mouth, eyes or genitals, a red scaly widespread rash with bumps under the skin and blisters accompanied by a fever, flu-like symptoms and a rash on your face followed by an extended rash with a fever, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes, and kidney problems (shown in tests).

FULL CMI

Targocid^®

Active ingredient: teicoplanin

Consumer Medicine Information (CMI)

This leaflet provides important information about using Targocid. 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 Targocid.

Where to find information in this leaflet:

1. Why am I being given Targocid?
2. What should I know before I am given Targocid?
3. What if I am taking other medicines?
4. How will I be given Targocid?
5. What should I know while using Targocid?
6. Are there any side effects?
7. Product details

1. Why am I being given Targocid?

Targocid contains the active ingredient teicoplanin. Targocid is an antibiotic. It is used to kill bacteria responsible for infections which can occur in your blood, bones or joints.

Targocid is generally used when the bacteria causing the infection are not satisfactorily eliminated by other antibiotics (e.g. penicillin), or when patients may be allergic to other antibiotics.

2. What should I know before I am given Targocid?

Warnings

Do not receive Targocid if:

you are allergic to Targocid, or any of the ingredients listed at the end of this leaflet. Always check the ingredients to make sure you can use this medicine.

Check with your doctor if you:

have or have had any other medical conditions, especially kidney problems or liver problems
take any medicines for any other condition
have allergies to any other medicines, including to any other antibiotic (especially an antibiotic called vancomycin, also known as Vancocin^®), or any other substances, such as foods, preservatives or dyes
plan to have surgery

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

Do not receive Targocid if you are pregnant or intend to become pregnant. Targocid is not recommended to be used during pregnancy.

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

3. What if I am 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 interfere with Targocid and affect how it 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

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

4. How will I be given Targocid?

How much you 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 you weigh, depending on what type of infection you have. 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.
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.
Follow the instructions provided and continue to receive Targocid for as long as prescribed by your doctor.

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.

If you receive too much Targocid

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 think you have received too much, or if you experience any unexpected or worrying side effects, you may need urgent medical attention.

You should immediately:

Phone the Poisons Information Centre (In Australia by calling 13 11 26; In New Zealand by calling 0800 POISON (0800 764 766)), 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 using Targocid?

During treatment you may have tests to check your blood, your kidneys, your liver and/or your hearing. This is more likely if your treatment will last for a long time, you need to be treated with high doses, you have a kidney problem, you are taking or may take other medicines that may affect your nervous system, kidneys or hearing.

Things you should do

Remind any doctor, dentist or pharmacist that you visit 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 Targocid.
If you become pregnant while you are being given Targocid, stop receiving it and tell your doctor or pharmacist immediately.

Call your doctor straight away if you notice:

blistering of the skin, mouth, eyes or genitals, which may be symptoms of severe skin reactions called 'Stevens-Johnson Syndrome', or 'Toxic Epidermal Necrolysis', or
a red scaly widespread rash with bumps under the skin and blisters accompanied by a fever, which may be symptoms of a severe skin reaction called 'Acute Generalised Exanthematous Pustulosis', or
flu-like symptoms and a rash on your face, then an extended rash with a high temperature, which may be symptoms of a condition called 'Drug Reaction with Eosinophilia and Systemic Symptoms'.

Things you should not do

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

Driving or using machines

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

Looking after your medicine

Targocid is stored in the pharmacy or on the ward.

6. Are there any side effects?

All medicines have some unwanted 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 effects

What to do

Injection-related:

local pain and redness at the injection site

Other side effects:

rash
dizziness
nausea
headache
stiffness

Speak to your doctor or pharmacist if you notice any of these less serious side effects and they worry you.

Serious side effects

Serious side effects	What to do
fever vomiting diarrhoea balance problems ringing in the ears problems hearing if you suspect you have a second infection low levels of all types of blood cells (pancytopenia) - the symptoms may include shortness of breath, fatigue, fever, chills, and bruising	Speak to your doctor or nurse as soon as possible if you notice any of these side effects.

Very serious side effects

Very serious side effects

What to do

Allergic reaction-related:

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

Skin reactions:

blistering of the skin, mouth, eyes or genitals - these may be symptoms of something called ‘Toxic Epidermal Necrolysis’ or ‘Stevens-Johnson Syndrome’
red scaly widespread rash with bumps under the skin (including your skin folds, chest, abdomen(including stomach), back and arms) and blisters accompanied by fever - these may be symptoms of something called ‘Acute Generalised Exanthematous Pustulosis’
flu-like symptoms and a rash on the face then an extended rash with a high temperature, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes. These may be signs or symptoms of ‘Drug Reaction with Eosinophilia and Systemic Symptoms’

Other very serious side effects:

kidney problems - shown in tests. Frequency or severity of kidney problems may be increased if you receive higher doses

Call your doctor or nurse straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these very serious side effects. 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 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 (Australia) or the Centre for Adverse Reactions Monitoring (CARM) within the New Zealand Pharmacovigilance Centre nzphvc.otago.ac.nz/reporting (New Zealand).

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 Targocid contains

Active ingredient (main ingredient)	Teicoplanin
Other ingredients (inactive ingredients)	Sodium chloride Water for injections
Potential allergens	Targocid does not contain gluten, dyes or preservatives.

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

What Targocid 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.

Who distributes Targocid

Targocid is supplied in Australia by:

Sanofi-Aventis Australia Pty Ltd
12-24 Talavera Road
Macquarie Park NSW 2113
Free call: 1800 818 806
Email: [email protected]

Targocid is supplied in New Zealand by:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
PO Box 62027
Sylvia Park Auckland 1644
Freecall: 0800 283 684
Free call: 0800 283 684
Email: [email protected]

This leaflet was prepared in January 2023.

targocid-ccdsv5-cmiv8-23jan23

Published by MIMS March 2023

BRAND INFORMATION

Brand name

Targocid

Active ingredient

Teicoplanin

Schedule

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).

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