Source: Υπουργείο Υγείας (CY) Revision Year: 2019 Publisher: Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus
Cloperan is indicated in adults for:
Cloperan is indicated in children (aged 1-18 years) for:
The recommended single dose is 10 mg, repeated up to three times daily.
The maximum recommended daily dose is 30 mg or 0.5 mg/kg body weight.
The maximum recommended treatment duration is 5 days.
The recommended dose is 0.1 to 0.15 mg/kg body weight, repeated up to three times daily by oral route. The maximum dose in 24 hours is 0.5 mg/kg body weight.
Dosing table:
| Age | Body Weight | Dose | Frequency |
|---|---|---|---|
| 1-3 years | 10-14 kg | 1 mg | Up to 3 times daily |
| 3-5 years | 15-19 kg | 2 mg | Up to 3 times daily |
| 5-9 years | 20-29 kg | 2.5 mg | Up to 3 times daily |
| 9-18 years | 30-60 kg | 5 mg | Up to 3 times daily |
| 15-18 years | Over 60kg | 10 mg | Up to 3 times daily |
The maximum treatment duration is 5 days for prevention of delayed chemotherapy induced nausea and vomiting (CINV).
Tablets are not suitable for use in children weighing less than 30 kg.
Other pharmaceutical forms/strengths may be more appropriate for administration to this population.
A minimal interval of 6 hours between two administrations is to be respected, even in case of vomiting or rejection of the dose (see section 4.4).
In elderly patients a dose reduction should be considered, based on renal and hepatic function and overall frailty.
In patients with end stage renal disease (Creatinine clearance ≤15 ml/min), the daily dose should be reduced by 75%.
In patients with moderate to severe renal impairment (Creatinine clearance 15-60 ml/min), the dose should be reduced by 50% (see section 5.2).
In patients with severe hepatic impairment, the dose should be reduced by 50% (see section 5.2).
Metoclopramide is contraindicated in children aged less than 1 year (see section 4.3).
Extrapyramidal disorders, drowsiness, decreased level of consciousness, confusion, hallucination, and cardio-respiratory arrest may occur.
In case of extrapyramidal symptoms related or not to overdose, the treatment is only symptomatic (benzodiazepines in children and/or anticholinergic anti-parkinsonian medicinal products in adults).
A symptomatic treatment and a continuous monitoring of the cardiovascular and respiratory functions should be carried out according to clinical status.
5 years.
Store below 25°C.
Protect from light and moisture.
PVC/Aluminium blisters. Pack sizes of 30, 100 and 1000 tablets.
PP containers with PE closure. Pack sizes of 500 and 1000 tablets.
Not all pack sizes may be marketed.
No special requirements.
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