Source: Υπουργείο Υγείας (CY) Revision Year: 2022 Publisher: Sanofi-Aventis groupe, 54, rue La Boetie, F-75008 Paris, France
Primperan 10mg tablets are indicated in adults for:
Primperan 10mg tablets are indicated in children (aged 9-18 years) for:
Primperan 10mg scored tablets, are not suitable for use in children weighing less than 31 kg.
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 60 kg | 10 mg | Up to 3 times daily |
The maximum treatment duration is 5 days for prevention of delayed chemotherapy induced nausea and vomiting (CINV).
Primperan 10 mg scored 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).
Oral route.
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).
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.
3 years.
Store at a temperature below 25°C.
40 Tablets in heat-sealable blister strips (PVC and Aluminium).
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