- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
No information
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dose recommendation of formulary compared to licensed use (on-label versus off-label)
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Available formulations
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Dosages
| Niemann-Pick disease type C |
|---|
|
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Renal impaiment in children > 3 months
Gaucher’s disease, type 1
• at a creatinine clearance of 50-80 ml/min/1.73m²: start with 100% of the normal dose each time and dosage interval 12 hours
• at a creatinine clearance of 30-50 ml/min/1.73m²: start with 100% of the normal dose each time and dosage interval 24 hours
• at a creatinine clearance of < 30 ml/min/1.73m²: contraindicated
Niemann-Pick disease
Children ≥ 12 years
•When the creatinine clearance is 50-80 ml/min/1.73m²: 100% of the normal dose each time, dosage interval 12 hours
• When the creatinine clearance is 30-50 ml/min/1.73m²: 50% of the normal dose each time, dosage interval 12 hours
•When the creatinine clearance is < 30 ml/min/1.73m²: contraindicated
Children aged < 12 years:
Generalized recommendations cannot be given for children aged < 12. The manufacturer states that the dose must be adjusted in reduced renal function, but gives no specific recommendations.
Information
The clearance of miglustat is less when the renal function is reduced. The risk of side effects is elevated as a result.
Clinical consequences:
Dose-related side effects: gastrointestinal side effects, tremor.
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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
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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
Because growth inhibition can occur, check the growth in height regularly in children with Niemann-Pick disease, type C
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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 | ||
| A16AA04 | ||
| Enzymes | ||
|---|---|---|
| A16AB03 | ||
| A16AB04 | ||
| A16AB07 | ||
| A16AB13 | ||
| A16AB22 | ||
| A16AB17 | ||
| A16AB08 | ||
| A16AB09 | ||
| A16AB02 | ||
| A16AB05 | ||
| A16AB14 | ||
| A16AB10 | ||
| Various alimentary tract and metabolism products | ||
|---|---|---|
| A16AX10 | ||
| A16AX09 | ||
| A16AX | ||
| A16AX18 | ||
| A16AX04 | ||
| A16AX07 | ||
| A16AX | ||
| A16AX08 | ||
| A16AX07 | ||
| A16AX05 | ||
| AMINO ACIDS AND DERIVATIVES | ||
|---|---|---|
| A16AA06 | ||
| A16AA05 | ||
| A16AA01 | ||
| A16AA04 | ||
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References
- Blau, Hoffmann, Leonard and Clarke., Physicians guide to the treatment and follow-up of metabolic diseases., Springer, 2006
- SPC Zavesca (Actelion) 20/11/2007, EU/1/02/238/001
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Changes
Changes
