Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Amdipharm UK Limited, Capital House, 85 King William Street, London EC4N 7BL, UK
Maxolon is indicated in adults for:
Diagnostic procedures:
Maxolon 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 0.5mg/kg body weight.
The maximum recommended treatment duration is 5 days.
The safety and efficacy of Maxolon in children below 1 year has not yet been established (see section 4.3).
Prevention of delayed chemotherapy induced nausea and vomiting (CINV) (paediatric patients aged 1-18 years).
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 0.5mg/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 61 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).
Other pharmaceutical forms/strengths may be more appropriate for administration to these populations.
A single dose of ‘Maxolon’ may be given 5-10 minutes before the examination, subject to body weight consideration, (see above).
For oral use only.
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.
Sixty months.
Do not store above 30°C.
Standard aluminium containers of 3, 6, 9, 12, 100 or 500 tablets.
Plastic reclosable containers packed into carton of 42, 84, 100 or 500 tablets.
Amber glass bottles of 100 or 500 tablets.
PVC blister (300 microns) of 20, 21, 42 or 84 tablets backed with aluminium foil (20 microns). The underside of the foils is coated with vinyl based laquer.
PVC (200 microns)/PVDC (60gsm) blister of 20, 21, 42 or 84 tablets.
Standard aluminium canister for 12 tablets packed with one ampoule of Maxolon injection as a home visit pack.
Not all pack sizes may be marketed.
No special requirements for disposal.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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