TICOPEX 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),
• Bacteremia that occurs in association with any of the indications listed above.
Ticopex is also indicated as an alternative oral treatment for Clostridium difficile infection-associated
diarrhea 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.
Summary of product characteristics
Ticopex® (200mg/vial)
Powder for solution for injection
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

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 hemodialysis.
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.

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
Loading dose regimen
Since data on safety are limited, patients should be carefully monitored for adverse reactions when
teicoplanin doses of 12mg/kg body weight twice a day are administered. Under this regimen blood
creatinine values should be monitored in addition to the recommended periodic haematological
examination.
Teicoplanin should not be administered by intraventricular use.

Thrombocytopenia
Thrombocytopenia has been reported with teicoplanin. Periodic haematological examinations are
recommended during treatment, including complete cell blood count.
Nephrotoxicity
Renal failure has been reported in patients treated with teicoplanin (see section 4.8). Patients with
renal insufficiency, and/or in those receiving teicoplanin in conjunction with or sequentially with
other medicinal products with known nephrotoxic potential (aminoglycosides, colistin, amphotericin
B, ciclosporin, and cisplatin) should be carefully monitored, and should include auditory tests.
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
neurotoxic/ototoxic potential (aminoglycosides, 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.
 

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 CAPDrelated
peritonitis. Teicoplanin should be used with care in conjunction with or sequentially with
other medicinal products with known nephrotoxic or ototoxic potential. These include
aminoglycosides, colistin, amphotericin B, ciclosporin, cisplatin, furosemide, and ethacrynic
acid (see section 4.4). 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

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.

TICOPEX 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.

Like all medicines, TICOPEX can cause side effects, although not all patients have them.
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.
Adverse reactions should be monitored when teicoplanin doses of 12 mg/kg body weight twice a day
are administered(see section 4.4).

Symptoms
Cases of accidental administration of excessive doses to pediatric 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 hemodialysis and only slowly by peritoneal dialysis

Pharmacotherapeutic group: Glycopeptide Antibacterials,
ATC code: J01XA 02
Mechanism of action
Teicoplanin inhibits the growth of susceptible organisms by interfering with cell-wall biosynthesis at a site
different from that affected by beta-lactams. Peptidoglycan synthesis is blocked by specific binding to Dalanyl-
D-alanine residues.
Mechanism of resistance
Resistance to teicoplanin can be based on the following mechanisms:
• Modified target structure: this form of resistance has occurred particularly in Enterococcus faecium. The
modification is based on exchange of the terminal D-alanine-D-alanine function of the amino-acid chain in
a murein precursor with D-Ala-D-lactate, thus reducing the affinity to vancomycin. The responsible
enzymes are a newly synthesised D-lactate dehydrogenase or ligase.
• The reduced sensitivity or resistance of staphylococci to teicoplanin is based on the overproduction of
murein precursors to which teicoplanin is bound.
Summary of product characteristics
Ticopex® (200mg/vial)
Powder for solution for injection
Cross-resistance between teicoplanin and the glycoprotein vancomycin may occur. A number of
vancomycin-resistant enterococci are sensitive to teicoplanin (Van-B phenotype).

 

 

Absorption
Teicoplanin is administered by parenteral route (intravenously or intramuscularly). After intramuscular
administration, the bioavailability of teicoplanin (as compared to intravenous administration) is almost
complete (90%). After six daily intramuscular administrations of 200 mg the mean (SD) maximum
teicoplanin concentration (Cmax) amounts to 12.1 (0.9) mg/L and occurs at 2 hours after administration.
After a loading dose of 6 mg/kg administered intravenously every 12 hours for 3 to 5 administrations,
Cmax values range from 60 to 70 mg/L and Ctrough are usually above 10 mg/L. After an intravenous loading
dose of 12 mg/kg administered every 12 hours for 3 administrations, mean values of Cmax and Ctrough are
estimated to be around 100 mg/L and 20 mg/L, respectively.
After a maintenance dose of 6 mg/kg administered once daily Cmax and Ctrough values are approximately 70
mg/L and 15 mg/L, respectively. After a maintenance dose of 12 mg/kg once daily Ctrough values range
from 18 to 30 mg/L.

When administered by oral route teicoplanin is not absorbed from the gastrointestinal tract. When
administered by oral route at 250 or 500 mg single dose to healthy subjects, teicoplanin is not detected in
serum or urine but only recovered in feces (about 45% of the administered dose) as unchanged medicinal
product.
Distribution
The binding to human serum proteins ranges from 87.6 to 90.8% without any variation in function of the
teicoplanin concentrations. Teicoplanin is mainly bound to human serum albumin. Teicoplanin is not
distributed in red cells.
The volume of distribution at steady-state (Vss) varies from 0.7 to 1.4 L/kg. The highest values of Vss are
observed in the recent studies where the sampling period was superior to 8 days.
Teicoplanin distributed mainly in lung, myocardium and bone tissues with tissue/serum ratios superior to
1. In blister fluids, synovial fluid and peritoneal fluid the tissue/serum ratios ranged from 0.5 to 1.
Elimination of teicoplanin from peritoneal fluid occurs at the same rate as from serum. In pleural fluid and
subcutaneous fat tissue the tissue/serum ratios are comprised between 0.2 and 0.5. Teicoplanin does not
readily penetrate into the cerebrospinal fluid (CSF).
Biotransformation
Unchanged form of teicoplanin is the main compound identified in plasma and urine, indicating minimal
metabolism. Two metabolites are formed probably by hydroxylation and represents 2 to 3% of the
administered dose.
Elimination
Unchanged teicoplanin is mainly excreted by urinary route (80% within 16 days) while 2.7% of the
administered dose is recovered in feces (via bile excretion) within 8 days following administration.
Elimination half-life of teicoplanin varies from 100 to 170 hours in the most recent studies where blood
sampling duration is about 8 to 35 days.
Teicoplanin has a low total clearance in the range of 10 to 14 mL/h/kg and a renal clearance in the range
of 8 to 12 mL/h/kg indicating that teicoplanin is mainly excreted by renal mechanisms.
Linearity
Teicoplanin exhibited linear pharmacokinetics at dose range of 2 to 25 mg/kg.
Special populations
• Renal impairment:
As teicoplanin is eliminated by renal route, teicoplanin elimination decreases according to the degree of
renal impairment. The total and renal clearances of teicoplanin depends on the creatinine clearance.
• Elderly patients:
In the elderly population the teicoplanin pharmacokinetics is not modified unless in case of renal
impairment.
• Paediatric population
A higher total clearance (15.8 mL/h/kg for neonates, 14.8 mL/h/kg for a mean age 8 years) and a shorter
elimination half-life (40 hours neonates; 58 hours for 8 years) are observed compared to adult patients.

NA

Sodium Chloride
Sodium hydroxide

Teicoplanin and aminoglycoside are incompatible when mixed directly and must not be mixed before
injection.
If teicoplanin is administered in combination therapy with other antibiotics, the preparation must be
administered separately

Two years. Shelf life of reconstituted solution: 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, inuse storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 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 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, inuse storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.

Do not store above 30°C

Clear Tubular Glass Vials (10R)
RUBBER STOPPER Chlorobutyl LYO 20 mm1319 4432/50/ grey
Flip off 20 mm

This medicinal product is for single use only.
Preparation of reconstituted solution:

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 and yellowish solutions should be used
Nominal teicoplanin content of vial 200mg 400mg
Volume of powder vial 10ml 22ml
Volume containing nominal teicoplanin dose
(extracted by 5 mL syringe and 23 G needle)
3.0 ml 3.0 ml
The reconstituted solution may be injected directly or alternatively further diluted, or orally
administered.
Preparation of the diluted solution before infusion:
Ticopex 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
- 0.18% sodium chloride and 4% glucose solution
- 0.45% sodium chloride and 5% glucose solution
- Peritoneal dialysis solution containing 1.36% or 3.86% glucose solution.
Any unused product or waste material should be disposed of in accordance with local
requirements.