- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
Body weight adjusted CL (l / h / kg) and volume of distribution at steady state (l / kg) were similar in all age groups. (SmPC Ecalta)
| Age | Vd (L/kg) | Cl (L/kg/hour) | T1/2 (hour) |
| Neonates (Cohen) | 1,7 | 0.02 | - |
| 1 month-2 years (Cohen) | 0,9 | 0,015 | - |
| > 2 years | 0,434-0,537 (SmPC) | 0,0159 - 0,0175 (Benjamin) | 40-50 (SmPC) |
SmPC: Immunocomrpomised patients
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dose recommendation of formulary compared to licensed use (on-label versus off-label)
No information is present at this moment.
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Available formulations
No information is present at this moment.
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Dosages
| Invasive candidiasis |
|---|
|
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Renal impaiment in children > 3 months
GFR ≥10 ml/min/1.73m2: Dose adjustment not required.
GFR <10 ml/min/1.73m2: A general recommendation on dose adjustment cannot be provided.
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The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here
Side effects in children
Hepatic and bile side effects appear to be more common in children than in adults.
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The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here
Contra-indications
No information available on specific contra indications in children.
The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here
Warnings & precautions in children
Treatment of neonates (<1 month) is not recommended. When treating neonates, attention should be paid to the range of disseminated candidiasis, including the central nervous system (CNS); non-clinical infection models indicate that higher doses of anidulafungin are required to obtain adequate CNS permeation
leading to higher doses of polysorbate 80, an excipient of the formulation. High
doses of polysorbates have been associated with potentially life-threatening toxicities in neonates. (SmPC Ecalta)
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Interactions
The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here
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| Antibiotics | ||
|---|---|---|
| J02AA01 | ||
| Triazole and tetrazole derivatives | ||
|---|---|---|
| J02AC01 | ||
| J02AC02 | ||
| J02AC03 | ||
| Other antimycotics for systemic use | ||
|---|---|---|
| J02AX04 | ||
| J02AX01 | ||
| J02AX05 | ||
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References
- Benjamin DK Jr, et al, Safety and pharmacokinetics of intravenous anidulafungin in children with neutropenia at high risk for invasive fungal infections, Antimicrob Agents Chemother, 2006, 50(2), 632-8
- Cohen-Wolkowiez M, et al, Safety and pharmacokinetics of multiple-dose anidulafungin in infants and neonates., Clin Pharmacol Ther, 2011, 89(5), 702-7
- Pfizer Europe MA EEIG, SmPc Ecalta (EU/1/07/416) 27-05-2020, www.geneesmiddeleninformatiebank.nl
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Changes
Changes
