Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK or trading as Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK
Hypersensitivity to teicoplanin or to any of the excipients listed in section 6.
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.
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.
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.
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.
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 has been reported with teicoplanin. Periodic haematological examinations are recommended during treatment, including complete cell blood count.
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).
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.
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 CAPD-related 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.
Interaction studies have only been performed in adults.
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).
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.
Animal reproduction studies have not shown evidence of impairment of fertility.
Targocid 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.
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).
Rare: Abscess
Not known: Superinfection (overgrowth of non-susceptible organisms)
Uncommon: Leucopenia, thrombocytopenia, eosinophilia
Not known: Agranulocytosis, neutropenia
Uncommon: Anaphylactic reaction (anaphylaxis) (see section 4.4)
Not known: Drug reaction with eosinophilia and systemic symptoms (DRESS), anaphylactic shock (see section 4.4)
Uncommon: Dizziness, headache
Not known: Seizures
Not known: Deafness, hearing loss (see section 4.4), tinnitus, vestibular disorder
Uncommon: Phlebitis
Not known: Thrombophlebitis
Uncommon: Bronchospasm
Uncommon: Diarrhoea, vomiting, nausea
Common: Rash, erythema, pruritus
Rare: Red man syndrome (e.g. Flushing of the upper part of the body) (see section 4.4).
Not known: Toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, angioedema, dermatitis exfoliative, urticaria (see section 4.4)
Uncommon: Blood creatinine increased
Not known: Renal failure (including renal failure acute)
Common: Pain, pyrexia
Not known: Injection site abscess, chills (rigors)
Uncommon: Transaminases increased (transient abnormality of transaminases), blood alkaline phosphatase increased (transient abnormality of alkaline phosphatase), blood creatinine increased (transient rise of serum creatinine)
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 at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
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.
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
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