- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
No information on PK in children (source SmPC Cystagon)
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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
| Nephropathic cystinosis |
|---|
|
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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
Ehlers-Danlos syndrome-like cases on the elbows have been reported. These skin lesions are in some cases accompanied by vascular proliferation, stretch marks and bone lesions. The results of histopathological examination suggest angio-endotheliomatosis. This side effect has been reported in children chronically treated with high doses (usually above the max dose of 1.95 g/m²/day).
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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 cystinosis is executed in specialized pediatric kidney centers.
In children, treatment with high doses of various cysteamine preparations (cysteamine chlorohydrate or cystamine or cysteamine bitartrate), usually exceeding the maximum daily dose of 1.95 g/m2, was reported to cause a syndrome similar to Ehlers Danlos syndrome and vascular disorders in the elbow area. These skin lesions were associated with vascular proliferation, skin streaks and bone lesions. It is therefore recommended to perform regular skin examinations and to consider bone X-rays if necessary. If any similar skin or bone abnormalities appear, it is recommended to decrease the dose.
[SmPC Cystagon 50 mg hard capsules]
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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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| Amino acids and derivatives | ||
|---|---|---|
| A16AA06 | ||
| A16AA05 | ||
| A16AA01 | ||
| Enzymes | ||
|---|---|---|
| A16AB03 | ||
| A16AB04 | ||
| A16AB07 | ||
| A16AB13 | ||
| A16AB22 | ||
| A16AB17 | ||
| A16AB08 | ||
| A16AB09 | ||
| A16AB02 | ||
| A16AB05 | ||
| A16AB14 | ||
| A16AB10 | ||
| Various alimentary tract and metabolism products | ||
|---|---|---|
| A16AX10 | ||
| A16AX09 | ||
| A16AX | ||
| A16AX18 | ||
| A16AX06 | ||
| A16AX04 | ||
| A16AX07 | ||
| A16AX | ||
| A16AX08 | ||
| A16AX07 | ||
| A16AX05 | ||
| AMINO ACIDS AND DERIVATIVES | ||
|---|---|---|
| A16AA06 | ||
| A16AA05 | ||
| A16AA01 | ||
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References
- Rademaker C.M.A. et al, Geneesmiddelen-Formularium voor Kinderen, 2007
- Blau, Hoffmann, Leonard and Clarke, Physicians guide to the treatment and follow-up of metabolic diseases., Springer, 2006
- Recordati Rare Diseases, SmPC Cystagon (EU/1/97/039/001) Rev 19, 25-07-2024, www.ema.europa.eu
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Changes
Changes
