Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Teicoplanin is an antibiotic. It contains a medicine called 'teicoplanin'. It works by killing the bacteria that cause infections in your body. Teicoplanin is used in adults and children (including newborn babies) to treat bacterial infections of: − the skin and underneath the skin - sometimes called 'soft tissue' − the bones and joints − the lung − the urinary tract − the heart - sometimes called 'endocarditis' − the abdominal wall - peritonitis − the blood, when caused by any of the conditions listed above Teicoplanin can be used to treat some infections caused by 'Clostridium difficile' bacteria in the gut. For this, the solution is taken by mouth.
Tests 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 loading doses (12mg/kg twice a day) • you have a kidney problem • you are taking or may take other medicines that may affect your nervous system, kidneys or hearing. In people who are given teicoplanin for a long time, bacteria that are not affected by the antibiotic may grow more than normal - your doctor will check for this. Other medicines and Teicoplanin Tell your doctor, pharmacist or nurse if you are using, have recently used or might use any other medicines. This is because teicoplanin can affect the way some other medicines work. Also, some medicines can affect the way teicoplanin works. In particular, tell your doctor, pharmacist or nurse if you are taking the following medicines: • Aminoglycosides as they must not be mixed together with teicoplanin in the same injection. They may also cause hearing problems and/or kidney problems. • amphotericin B - a medicine that treats fungal infections which may cause hearing problems and/or kidney problems • ciclosporin - a medicine that affects the immune system which may cause hearing problems and/or kidney problems • cisplatin - a medicine that treats malignant tumors which may cause hearing problems and/or kidney problems • water tablets (such as furosemide) - also called 'diuretics' which may cause hearing problems and/or kidney problems. If any of the above apply to you, (or you are not sure), talk to your doctor, pharmacist or nurse before being given teicoplanin. Pregnancy, breast-feeding and fertility If you are pregnant, think that you might be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before being given this medicine. They will decide whether or not you are given this medicine while you are pregnant. There may be a potential risk of inner ear and kidney problems. Tell your doctor if you are breast-feeding, before being given this medicine. He/she will decide whether or not you can keep breast-feeding, while you are given teicoplanin. Studies in animal reproduction have not shown evidence of fertility problems. Driving and using machines You may have headaches or feel dizzy while being treated with teicoplanin. If this happens, do not drive or use any tools or machines. Teicoplanin contains sodium This medicine contains less than 1 mmol sodium (23 mg) per vial and is essentially 'sodium-free'.
Bone and joint infections, and heart infections • Starting dose (for the first three to five doses): 12 mg for every kilogram of body weight, given every 12 hours, by injection into a vein • Maintenance dose: 12 mg for every kilogram of body weight, given once a day, by injection into a vein or muscle Infection caused by 'Clostridium difficile' bacteria The recommended dose is 100 to 200 mg by mouth, twice a day for 7 to 14 days. Adults and elderly patients with kidney problems If you have kidney problems, your dose will usually need to be lowered after the fourth day of treatment: • For people with mild and moderate kidney problems - the maintenance dose will be given every two days, or half of the maintenance dose will be given once a day. • For people with severe kidney problems or on haemodialysis - the maintenance dose will be given every three days, or one-third of the maintenance dose will be given once a day. Peritonitis for patients on peritoneal dialysis The starting dose is 6 mg for every kilogram of body weight, as a single injection into a vein, followed by: • Week one: 20 mg/L in each dialysis bag • Week two: 20 mg/L in every other dialysis bag • Week three: 20 mg/L in the overnight dialysis bag. Babies (from birth to the age of 2 months) • Starting dose (on the first day): 16 mg for every kilogram of body weight, as an infusion through a drip into a vein. • Maintenance dose: 8 mg for every kilogram of body weight, given once a day, as an infusion through a drip into a vein. Children (from 2 months to 12 years) • Starting dose (for the first three doses): 10 mg for every kilogram of body weight, given every 12 hours, by injection into a vein. • Maintenance dose: 6 to 10 mg for every kilogram of body weight, given once a day, by injection into a vein. How Teicoplanin is given The medicine will normally be given to you by a doctor or nurse. • It will be given by injection into a vein (intravenous use) or muscle (intramuscular use). • It can also be given as a infusion through a drip into a vein. Only the infusion should be given in babies from birth to the age of 2 months. To treat certain infections, the solution may be taken by mouth (oral use). If you have more Teicoplanin than you should It is unlikely that your doctor or nurse will give you too much medicine. However, if you think you have been given too much teicoplanin or if you are agitated, talk to your doctor or nurse straight away. If you forget to have Teicoplanin Your doctor or nurse will have instructions about when to give you teicoplanin. It is unlikely that they will not give you the medicine as prescribed. However, if you are worried, talk to your doctor or nurse. If you stop having Teicoplanin Do not stop having this medicine without first talking to your doctor, pharmacist or nurse. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Like all medicines, this medicine can cause side effects, although not everybody gets them. Serious side effects Stop your treatment and tell your doctor or nurse straight away, if you notice any of the following serious side effects - you may need urgent medical treatment: Uncommon (may affect up to 1 in 100 people) • sudden life-threatening allergic reaction - the signs may include: difficulty in breathing or wheezing, swelling, rash, itching, fever, chills Rare (may affect up to 1 in 1000 people) • flushing of the upper body Not known (frequency cannot be estimated from the available data) • blistering of the skin, mouth, eyes or genitals – these may be signs of something called 'toxic epidermal necrolysis' or 'Stevens-Johnson syndrome' or 'drug reaction with eosinophilia and systemic symptoms (DRESS)'. DRESS appears initially as 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. Tell your doctor or nurse straight away, if you notice any of the side effects above. Tell your doctor or nurse straight away, if you notice any of the following serious side effects - you may need urgent medical treatment: Uncommon (may affect up to 1 in 100 people) • swelling and clotting in a vein • difficulty in breathing or wheezing (bronchospasm) • getting more infections than usual - these could be signs of a decrease in your blood cell count Not known (frequency cannot be estimated from the available data) • lack of white blood cells - the signs may include: fever, severe chills, sore throat or mouth ulcers (agranulocytosis) • low levels of all types of blood cells • kidney problems or changes in the way your kidneys work - shown in tests. Frequency or severity of kidney problems may be increased if you receive higher doses • epileptic fits Tell your doctor or nurse straight away, if you notice any of the side effects above. Other side effects Talk to your doctor, pharmacist or nurse if you get any of these: Common (may affect up to 1 in 10 people) • Rash, erythema, pruritus • Pain • Fever Uncommon (may affect up to 1 in 100 people) • decrease in platelet count. • raised blood levels of liver enzymes • raised in blood levels of creatinine (to monitor your kidney) • hearing loss, ringing in the ears or a feeling that you, or things around you are moving
• feeling or being sick (vomiting), diarrhoea • feeling dizzy or headache Rare (may affect up to 1 in 1,000 people) • infection (abscess). Not known (frequency cannot be estimated from the available data) • problems where the injection was given - such as reddening of the skin, pain or swelling Reporting of side effects If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme website www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
Water for injections is packaged in 3 mL Fiolax clear white OPC DOT ampoule. Pack sizes: 1 powder vial with 1 solvent ampoule. 5x1 powder vials with 5x1 solvent ampoules. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Amarox Limited Congress House, 14 Lyon Road Harrow, HA1 2EN United Kingdom This leaflet was last revised in 11/2025. ………………………………………………………………………………………………………….. The following information is intended for medical or healthcare professionals only: Practical information for healthcare professionals on preparation and handling of Teicoplanin. This medicine is for single use only. Method of administration The reconstituted solution may be injected directly or alternatively further diluted. The injection will be given either as a bolus over 3 to 5 minutes or as a 30-minutes infusion. Only the infusion should be given in babies from birth to the age of 2 months. The reconstituted solution may also be given by mouth. Preparation of reconstituted solution The solution is reconstituted by adding 3.14 mL of water for injection to the 200 mg and 400 mg powder vial. The water is slowly added to the vial which should be rotated until all the powder is dissolved to avoid foaming. If foam is developed, allow the solution to stand for approximately 15 minutes so that the foam disappears. Only clear solutions should be used. The colour of the solution may vary from yellowish to dark yellow. The final solution is isotonic with plasma and has a pH of 7.2-7.8.
Nominal teicoplanin content of vial 200 mg 400 mg Volume of powder vial 10 mL 20 mL Volume containing nominal teicoplanin dose (extracted by 5 mL syringe and 23 G needle)
Preparation of the diluted solution before infusion Teicoplanin can be administered in the following infusion solutions: • sodium chloride 9 mg/mL (0.9%) solution • Ringer solution • Ringer-lactate solution • 5% dextrose injection • 10% dextrose injection • 0.45% sodium chloride and 5% glucose solution • 0.18% sodium chloride and 4% glucose solution • Peritoneal dialysis solution containing 3.86% glucose Solution. Shelf life of reconstituted solution:
3.0 mL 3.0 mL
Chemical and physical in-use stability of the reconstituted solution prepared as recommended has been demonstrated for 24 hours at 2° to 8°C. From a microbiological point of view, the medicinal product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless reconstitution has taken place in controlled and validated aseptic conditions. Shelf life of diluted medicinal product: Chemical and physical in-use stability of the diluted solution prepared as recommended has been demonstrated for 2°-8°C for 24 hours followed by 15°-30°C for 1 hour. From a microbiological point of view, the medicinal product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C followed by 1 hour at 20-25°C, unless dilution has taken place in controlled and validated aseptic conditions. Disposal Any unused medicine or waste material should be disposed of in accordance with local requirements.
Teicoplanin 200 mg powder and solvent for solution for injection/ infusion or oral solution comes as oral solution containing 200mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Teicoplanin 200 mg powder and solvent for solution for injection/ infusion or oral solution is teicoplanin.
Medicines with the same active substance, strength and form include: Teicoplanin 200 mg powder and solvent for solution for injection/infusion or oral solution, Teicoplanin 200mg powder for solution for injection/infusion or oral solution vials, Teicoplanin Altan 200 mg Powder for solution for injection and infusion or oral solution. In total there are 4 equivalent products. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Teicoplanin 200 mg powder and solvent for solution for injection/ infusion or oral solution, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Teicoplanin is indicated in adults and in children from birth for the parenteral treatment of the following infections (see sections 4.2, 4.4 and 5.1):
• complicated skin and soft tissue infections,
• bone and joint infections,
• hospital acquired pneumonia,
• community acquired pneumonia,
• complicated urinary tract infections,
• infective endocarditis,
• peritonitis associated with continuous ambulatory peritoneal dialysis (CAPD),
• bacteraemia that occurs in association with any of the indications listed above.
Teicoplanin is also indicated as an alternative oral treatment for Clostridium difficile infection-associated diarrhoea and colitis.
Where appropriate, teicoplanin should be administered in combination with other antibacterial agents.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Posology
The dose and duration of treatment should be adjusted according to the underlying type and severity of infection and clinical response of the patient, and patient factors such as age and renal function.
Measurement of serum concentrations
Teicoplanin trough serum concentrations should be monitored at steady state after completion of the loading dose regimen in order to ensure that a minimum trough serum concentration has been reached:
• For most Gram-positive infections, teicoplanin trough levels of at least 10 mg/L when measured by High Performance Liquid Chromatography (HPLC), or at least 15 mg/L when measured by Fluorescence Polarization Immunoassay (FPIA) method.
• For endocarditis and other severe infections, teicoplanin trough levels of 15-30 mg/L when measured by HPLC, or 30-40 mg/L when measured by FPIA method.
During maintenance treatment, teicoplanin trough serum concentrations monitoring may be performed at least once a week to ensure that these concentrations are stable.
Adults and elderly patients with normal renal function
Indications
Loading dose
Maintenance dose
Loading dose regimen
Targeted trough concentrations at day 3 to 5
Maintenance dose
Targeted trough concentrations during maintenance
- Complicated skin and soft tissue infections
- Pneumonia
- Complicated urinary tract infections
6 mg/kg body weight every 12 hours for 3 intravenous or intramuscular administrations
>15 mg/L1
6 mg/kg body weight intravenous or intramuscular once a day
>15 mg/L1 once a week
- Bone and joint infections
12 mg/kg body weight every 12 hours for 3 to 5 intravenous administrations
>20 mg/L1
12 mg/kg body weight intravenous or intramuscular once a day
>20 mg/L1
- Infective endocarditis
12 mg/kg body weight every 12 hours for 3 to 5 intravenous administrations
30-40 mg/L1
12 mg/kg body weight intravenous or intramuscular once a day
>30 mg/L1
1 Measured by FPIA
The dose is to be adjusted on bodyweight whatever the weight of the patient.
Duration of treatment
The duration of treatment should be decided based on the clinical response. For infective endocarditis a minimum of 21 days is usually considered appropriate. Treatment should not exceed 4 months.
Combination therapy
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.
Clostridium difficile infection-associated diarrhoea and colitis
The recommended dose is 100-200 mg administered orally twice a day for 7 to 14 days.
Elderly population
No dose adjustment is required, unless there is renal impairment (see below).
Adults and elderly patients with impaired renal function
Dose adjustment is not required until the fourth day of treatment, at which time dosing should be adjusted to maintain a serum trough concentration of at least 10 mg/L when measured by HPLC, or at least 15 mg/L when measured by FPIA method.
After the fourth day of treatment:
• In mild and moderate renal insufficiency (creatinine clearance 30-80 mL/min): maintenance dose should be halved, either by administering the dose every two days or by administering half of this dose once a day.
• In severe renal insufficiency (creatinine clearance less than 30 mL/min) and in haemodialysed patients: dose should be one-third the usual dose, 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 haemodialysis.
Patients in continuous ambulatory peritoneal dialysis (CAPD)
After a single intravenous loading dose of 6 mg/kg bodyweight, 20 mg/L is administered in the bag of the dialysis solution in the first week, 20 mg/L in different bags the second week and then 20 mg/L in the overnight bag in the third week.
Paediatric population
The dose recommendations are the same in adults and children above 12 years of age.
Neonates and infants up to the age of 2 months:
Loading dose
One single dose of 16 mg/kg body weight, administered intravenously by infusion on the first day.
Maintenance dose
One single dose of 8 mg/kg body weight administered intravenously by infusion once a day.
Children (2 months to 12 years):
Loading dose
One single dose of 10 mg/kg body weight administered intravenously every 12 hours, repeated 3 times.
Maintenance dose
One single dose of 6-10 mg/kg body weight administered intravenously once a day.
Method of administration
Teicoplanin should be administered by the intravenous or intramuscular route. The intravenous injection may be administered either as a bolus over 3 to 5 minutes or as a 30-minute infusion.
Only the infusion method should be used in neonates.
For Clostridium difficile infection-associated diarrhoea and colitis, the oral route is to be used.
For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6.
Hypersensitivity to teicoplanin or to any of the excipients listed in section 6.
Teicoplanin should not be administered by intraventricular use.
Hypersensitivity reactions
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.
Teicoplanin must be administered with caution in patients with known hypersensitivity to vancomycin, as crossed hypersensitivity reactions, including fatal anaphylactic shock, may occur.
However, a prior history of "red man syndrome" with vancomycin is not a contraindication to the use of teicoplanin.
Infusion related reactions
In rare cases (even at the first dose), red man syndrome (a complex of symptoms including pruritus, urticaria, erythema, angioneurotic oedema, tachycardia, hypotension, dyspnoea) has been observed.
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 bullous reactions
Life-threatening or even fatal cutaneous reactions Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) have been reported with the use of teicoplanin. If symptoms or signs of SJS or TEN (e.g. progressive skin rash often with blisters or mucosal lesions) are present teicoplanin treatment should be discontinued immediately.
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.
Thrombocytopenia
Thrombocytopenia has been reported with teicoplanin (see section 4.8). Periodic haematological examinations, including complete blood count, are recommended during treatment.
Nephrotoxicity
Nephrotoxicity and renal failure have been reported in patients treated with teicoplanin (see section 4.8). Patients with renal insufficiency, in those receiving the high loading dose regimen of teicoplanin, and those receiving teicoplanin in conjunction with or sequentially with other medicinal products with known nephrotoxic potential (e.g. aminoglycosides, colistin, amphotericin B, ciclosporin, and cisplatin) should be carefully monitored, and should get auditory tests (see “Ototoxicity” below).
Since teicoplanin is mainly excreted by the kidney, the dose of teicoplanin must be adapted in patients with renal impairment (see section 4.2).
Ototoxicity
As with other glycopeptides, ototoxicity (deafness and tinnitus) has been reported in patients treated with teicoplanin (see section 4.8). Patients who develop signs and symptoms of impaired hearing or disorders of the inner ear during treatment with teicoplanin should be carefully evaluated and monitored, especially in case of prolonged treatment and in patients with renal insufficiency. 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) should be carefully monitored and the benefit of teicoplanin evaluated if hearing deteriorates.
Special precautions must be taken when administering teicoplanin in patients who require concomitant treatment with ototoxic and/or nephrotoxic medicinal products for which it is recommended that regular haematology, liver and kidney function tests are carried out.
Superinfection
As with other antibiotics, the use of teicoplanin, especially if prolonged, may result in overgrowth of non-susceptible organisms. If superinfection occurs during therapy, appropriate measures should be taken.
Teicoplanin contains sodium.
This medicinal product contains less than 1 mmol sodium (23 mg) per vial and is essentially 'sodium-free'.
No specific interaction studies have been performed.
Teicoplanin and aminoglycoside solutions are incompatible and must not be mixed for injection; however, they are compatible in dialysis fluid and may be freely used in the treatment of CAPD-related peritonitis. Teicoplanin should be used with care in conjunction with or sequentially with other medicinal products with known nephrotoxic and/or neurotoxic/ototoxic potential. These include e.g. aminoglycosides, colistin, amphotericin B, ciclosporin, cisplatin, furosemide, and ethacrynic acid (see section 4.4 “Nephrotoxicity” and “Ototoxicity”). However, there is no evidence of synergistic toxicity in combinations with teicoplanin.
In clinical studies, teicoplanin has been administered to many patients already receiving various medications including other antibiotics, antihypertensives, anaesthetic agents, cardiac medicinal products and antidiabetic agents without evidence of adverse interaction.
Paediatric population
Interaction studies have only been performed in adults.
Pregnancy
There are a limited amount of data from the use of teicoplanin in pregnant women.
Studies in animals have shown reproductive toxicity at high doses (see section 5.3): in rats there was an increased incidence of stillbirths and neonatal mortality. The potential risk for humans is unknown. Therefore, teicoplanin should not be used during pregnancy unless clearly necessary. A potential risk of inner ear and renal damage to the foetus cannot be excluded (see section 4.4).
Breast-feeding
It is unknown whether teicoplanin is excreted in human milk. There is no information on the excretion of teicoplanin in animal milk. A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with teicoplanin should be made taking into account the benefit of breast-feeding to the child and the benefit of teicoplanin therapy to the mother.
Fertility
Animal reproduction studies have not shown evidence of impairment of fertility.
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.
Tabulated list of adverse reactions
In the table below all the adverse reactions, which occurred at an incidence greater than placebo and more than one patient are listed using the following convention: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
System organ class
Common (≥1/100 to <1/10 )
Uncommon (≥1/1,000 to <1/100)
Rare (≥1/10,000 to <1/1,000)
Very rare (<1/10,000)
Not known (cannot be estimated from available data)
Infections and infestations
Abscess
Superinfection (overgrowth of non-susceptible organisms)
Blood and the lymphatic system disorders
Leucopenia, thrombocytopenia, eosinophilia
Agranulocytosis, neutropenia, pancytopenia
Immune system disorders
Anaphylactic reaction (anaphylaxis) (see section 4.4)
Drug reaction with eosinophilia and systemic symptoms (DRESS), anaphylactic shock (see section 4.4)
Nervous system disorders
Dizziness, headache
Seizures
Ear and Labyrinth disorders
Deafness, hearing loss (see section 4.4), tinnitus, vestibular disorder
Vascular disorders
Phlebitis
Thrombophlebitis
Respiratory, thoracic and mediastinal disorders
Bronchospasm
Gastro-intestinal disorders
Diarrhoea, vomiting, nausea
Skin and subcutaneous tissue disorders
Rash, erythema, pruritus
Red man syndrome (e.g. Flushing of the upper part of the body) (see section 4.4).
Toxic epidermal necrolysis, Stevens-Johnson syndrome, Acute generalized exanthematous pustulosis, erythema multiforme, angioedema, dermatitis exfoliative, urticaria (see section 4.4)
Renal and Urinary disorders
Blood creatinine increased
Renal failure (including renal failure acute) (see below description of selected adverse reactions)*
General disorders and administration site conditions
Pain, pyrexia
Injection site abscess, chills (rigors)
Investigations
Transaminases increased (transient abnormality of transaminases), blood alkaline phosphatase increased (transient abnormality of alkaline phosphatase)
Description of selected adverse reactions
*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%]) (see section 4.4).
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation 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 via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
Symptoms
Cases of accidental administration of excessive doses to paediatric patients have been reported. In one case agitation occurred in a 29-day-old newborn who had been administered 400 mg intravenously (95 mg/kg).
Management
Treatment of teicoplanin overdose should be symptomatic.
Teicoplanin is not removed by haemodialysis and only slowly by peritoneal dialysis.
Ask anything about Teicoplanin 200 mg powder and solvent for solution for injection/ infusion or oral solution. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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