Consumer medicine information

Teicoplanin Sandoz

Teicoplanin

BRAND INFORMATION

Brand name

Teicoplanin Sandoz

Active ingredient

Teicoplanin

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Teicoplanin Sandoz.

SUMMARY CMI

Teicoplanin Sandoz®

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 Teicoplanin Sandoz?

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

2. What should I know before I am given Teicoplanin Sandoz?

Do not use if you have ever had an allergic reaction to Teicoplanin Sandoz 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, or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section 2. What should I know before I am given Teicoplanin Sandoz? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Teicoplanin Sandoz 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 Teicoplanin Sandoz?

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

More instructions can be found in Section 4. How do I use Teicoplanin Sandoz? in the full CMI.

5. What should I know while being given Teicoplanin Sandoz?

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 you visit that you are being given Teicoplanin Sandoz.
Things you should not do
  • Do not receive more than the recommended dose unless your doctor or pharmacist tells you to.
  • Do not stop receiving Teicoplanin Sandoz 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 Teicoplanin Sandoz affects you.
Looking after your medicine
  • Teicoplanin Sandoz is stored in the pharmacy or on the ward.

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

6. Are there any side effects?

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 a serious 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 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).

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.



FULL CMI

Teicoplanin Sandoz®

Active ingredient: teicoplanin

Consumer Medicine Information (CMI)

This leaflet provides important information about using Teicoplanin Sandoz. 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 Teicoplanin Sandoz.

Where to find information in this leaflet:

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

1. Why am I being given Teicoplanin Sandoz?

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

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

2. What should I know before I use Teicoplanin Sandoz?

Warnings

Do not use Teicoplanin Sandoz if:

  • you are allergic to Teicoplanin Sandoz, 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 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 of other antibiotic (especially an antibiotic called vancomycin) 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 Teicoplanin Sandoz if you are pregnant or intend to become pregnant. Teicoplanin Sandoz is not recommended to be used during pregnancy.

Do not receive Teicoplanin Sandoz if you are breastfeeding or planning to breastfeed. It is not known whether Teicoplanin Sandoz 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 medicines, vitamins, or supplements that you buy without a prescription from your pharmacy, supermarket, or health food shop.

Some medicines may interfere with Teicoplanin Sandoz and affect how it works. These include:

  • aminoglycoside antibiotics, medicine used to treat bacterial infections
  • amphotericin B, 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
  • ethacrynic acid, a medicine used to help the kidneys get rid of salt and water.

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

4. How will I be given Teicoplanin Sandoz?

How much you will be given

  • On the first day of treatment most patients generally receive two doses of Teicoplanin Sandoz, 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 Teicoplanin Sandoz 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 Teicoplanin Sandoz for 2 to 4 weeks. If you have an infection in any bones or joints, you may require a daily injection of Teicoplanin Sandoz for 3 to 6 weeks
  • Follow the instructions provided and continue to receive Teicoplanin Sandoz for as long as prescribed by your doctor.

How is Teicoplanin Sandoz given

  • Teicoplanin Sandoz should be prepared and administered by a qualified health professional (doctor, pharmacist or nurse).
  • The vial of Teicoplanin Sandoz 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.
  • Teicoplanin Sandoz may also be injected directly into a muscle.

If you receive too much Teicoplanin Sandoz

As Teicoplanin Sandoz 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, of if you experience any unexpected or worrying side effects, you may need urgent medical attention.

You should immediately:

  • phone the Poisons Information Centre
    (by calling 13 11 26), or
  • contact your doctor, or
  • go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while being given Teicoplanin Sandoz?

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 Teicoplanin Sandoz.
  • If you plan to have surgery that needs a general anaesthetic, tell your doctor or dentist that you are being given Teicoplanin Sandoz.
  • If you become pregnant while you are being given Teicoplanin Sandoz, 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 maybe 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 maybe 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 the medicine to treat any other complaints unless your doctor or pharmacist tells you to.
  • Do not stop receiving Teicoplanin Sandoz because you are feeling better, unless advised by your doctor or pharmacist.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Teicoplanin Sandoz affects you.

Looking after your medicine

  • Teicoplanin Sandoz is stored in the pharmacy or on the ward.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention. See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effectsWhat to do
Injection related
  • local pain and redness at the injection site
Other
  • 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 effectsWhat 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 pharmacist as soon as possible if you notice any of these side effects.
Very Serious side effectsWhat 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 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. 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 Teicoplanin Sandoz contains

Active ingredient
(main ingredient)		Teicoplanin
Other ingredients
(inactive ingredients)		Sodium Chloride
Water for injections
Potential allergensSoy

Teicoplanin Sandoz does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.

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

What Teicoplanin Sandoz looks like

Teicoplanin Sandoz 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.

Available in packs containing one vial of powder for injection and one ampoule of diluent (AUSTR 157812).

Who distributes Teicoplanin Sandoz

Sandoz Pty Ltd
ABN 60 075 449 553
54 Waterloo Road
Macquarie Park, NSW 2113
Tel: 1800 726 369

This leaflet was revised in March 2023.

Published by MIMS May 2023

BRAND INFORMATION

Brand name

Teicoplanin Sandoz

Active ingredient

Teicoplanin

Schedule

S4

 

1 Name of Medicine

Teicoplanin.

2 Qualitative and Quantitative Composition

Teicoplanin Sandoz 400 mg injection containing a white to pale yellow, sterile lyophilised powder, equivalent to 400 mg teicoplanin. It is freely soluble in water and on reconstitution gives a clear solution.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Teicoplanin Sandoz 400 mg injection is presented as a sterile, lyophilised white to light yellow powder for reconstitution with water for injections.

4 Clinical Particulars

4.1 Therapeutic Indications

Teicoplanin Sandoz 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 beta-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 Teicoplanin Sandoz injection should be administered intravenously or intramuscularly. Intravenous dosing may be by slow injection over 5 minutes or by infusion over 30 minutes.

Dosage.

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 Teicoplanin Sandoz should not exceed 3 mL (400 mg) at a single site.
Teicoplanin Sandoz 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 to 12 mg/kg by the intravenous 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.

Duration of treatment.

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: two to four weeks; septic arthritis or osteomyelitis: three to six weeks.

Method of administration.

Preparation of Teicoplanin Sandoz injection.

The powder should be reconstituted strictly in accordance with the instructions that follow. Errors in reconstitution may result in the formation of a stable foam and delivery of smaller doses.
Withdraw 3.0 mL from the accompanying water for injections ampoule and add it slowly down the side wall of the vial of Teicoplanin Sandoz. 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. The reconstituted solution contains teicoplanin 400 mg/3 mL.

Dilution of reconstituted solution.

The reconstituted solution may be injected directly, or alternatively diluted with any of the following diluents.
Sodium chloride solution 0.9% and Hartmann's solution: if necessary, diluted solutions may be stored between 2°C and 8°C for up to 24 hours. Solutions left for longer than 24 hours should be discarded.
Glucose 5% solution, sodium chloride 0.18% and glucose 4% solution: solutions containing these diluents can be stored between 2°C and 8°C and should be used within 24 hours; solutions kept longer than 24 hours should be discarded.
Ringer's solution: the diluted solution can be stored between 2°C and 8°C for up to 24 hours only.

Dosage adjustment.

Renal impairment. Reduction of dosage in patients with impaired renal function is not required until the fourth day of teicoplanin 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, dose adjustments should be made as follows.

Mild renal insufficiency.

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

Severe renal insufficiency.

If the creatinine clearance is less than 40 mL/minute and in haemodialysed patients, the dose should be one-third of the normal dose. This is achieved 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.
Elderly. 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.

4.3 Contraindications

Teicoplanin Sandoz is contraindicated in patients with known hypersensitivity to teicoplanin or any excipients associated with this product.

4.4 Special Warnings and Precautions for Use

Hypersensitivity reactions and anaphylaxis.

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

Hypersensitivity to vancomycin.

Teicoplanin 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 teicoplanin.

Infusion related reactions.

"Red man syndrome" (a complex of symptoms including pruritus, urticaria, 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 teicoplanin. 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, teicoplanin treatment should be discontinued immediately.

Nephrotoxicity.

Nephrotoxicity and renal failure have been reported in patients treated with teicoplanin (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 teicoplanin 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.

Thrombocytopenia.

Thrombocytopenia has been reported with teicoplanin. Periodic haematological examinations are recommended during treatment, including complete cell blood count.

Ototoxicity.

Hearing impairment has been reported with use of teicoplanin (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 teicoplanin (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 teicoplanin (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 teicoplanin 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.

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

Superinfection.

The use of teicoplanin 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.

Spectrum of antibacterial activity.

Teicoplanin has a limited spectrum of antibacterial activity (Gram positive). It is not suitable for use as a single agent for the treatment of some types of infections unless the pathogen is already documented and known to be susceptible or there is a high suspicion that the most likely pathogen(s) would be suitable for treatment with teicoplanin.
The rational use of teicoplanin should take into account the bacterial spectrum of activity, the safety profile and the suitability of standard antibacterial therapy to treat the individual patient. On this basis it is expected that in most instances teicoplanin will be used to treat severe infections in patients for whom standard antibacterial activity is considered to be unsuitable.

Intrathecal use.

The safety and efficacy of teicoplanin 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, 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.

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, teicoplanin should be administered with caution in patients receiving concurrent nephrotoxic or ototoxic drugs, such as aminoglycosides, colistin, amphotericin B (amphotericin), ciclosporin, cisplatin, furosemide (frusemide) and ethacrynic acid.
Teicoplanin and aminoglycosides solutions are incompatible when mixed directly and therefore should not be mixed before injection.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

Animal reproduction studies have not shown evidence of impairment of fertility.
(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 (subcutaneous doses ≥ 10 mg/kg/day).
Teicoplanin should not be used during confirmed or presumed pregnancy unless the potential benefits outweigh possible risks.
 It is not known if teicoplanin is excreted in breast milk during lactation. Teicoplanin should not be used during lactation unless the potential benefits outweigh possible risks.

4.7 Effects on Ability to Drive and Use Machines

Teicoplanin has minor influence on the ability to drive and use machines.
Teicoplanin can cause dizziness and headache. The ability to drive or use machines may be affected. Patients experiencing these undesirable effects should not drive or use machines.

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, pyrexia, 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)). Anaphylactic shock has also been reported.

Hepatic.

Increased transaminases and/or alkaline phosphatase.

Haematological.

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

Renal and urinary disorders.

Rise in serum creatinine, blood urea, acute 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 non-susceptible organisms).

Infusion related events.

Infusion related events, such as erythema or flushing of the upper body or red man syndrome (a complex of symptoms including pruritus, urticaria, erythema, angioneurotic oedema, tachycardia, hypotension, dyspnoea), have been rarely reported. These events occurred without a history of previous teicoplanin 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 http://www.tga.gov.au/reporting-problems.

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.

In case of overdose, treatment should be supportive and symptomatic. Teicoplanin is not removed by haemodialysis or peritoneal dialysis.
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Teicoplanin is a factorial mixture of glycopeptides, comprised of at least 80% of the teicoplanin A2 group, not more than 20% of the teicoplanin A3 group, and not more than 5% of other components.
Teicoplanin is a glycopeptide antibiotic produced by Actinoplanes teichomyceticus.

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 beta-lactams. Teicoplanin is therefore effective against Staphylococci (including those resistant to methicillin and other beta-lactam antibiotics) and Streptococci.
Some cross resistance is observed between teicoplanin and the glycopeptide vancomycin. Teicoplanin has shown no cross resistance to beta-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 to 4 hours following a dose of 3 mg/kg.

Distribution.

In humans, 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 a 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 to 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 to 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

Each vial of Teicoplanin Sandoz powder for injection also contains 24 mg sodium chloride.

6.2 Incompatibilities

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

6.3 Shelf Life

To reduce microbiological hazard, use as soon as practicable after reconstitution/dilution. If storage is necessary, hold at 2°C - 8°C for not more than 24 hours.
As a matter of good pharmaceutical practice, solutions for intravenous infusion should be used immediately after admixing.

6.4 Special Precautions for Storage

When storing the reconstituted solution, do not store it in a syringe.
Store below 25°C.

6.5 Nature and Contents of Container

25 mL clear glass vial with rubber stopper and flip-off aluminium crimp. Each pack also contains an accompanying diluent containing 3.2 mL sterile water for injections in a glass ampoule. Available in a single pack containing one vial of teicoplanin powder for injection and one ampoule of water for injections diluent.

6.6 Special Precautions for Disposal

Teicoplanin Sandoz injection is for single use in one patient only. Discard any residue.
In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Chemical structure.

The chemical structure of teicoplanin is:

CAS number.

61036-62-2.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes