Meclopstad

Rx

Indications

Adults

• Prevention of delayed chemotherapy induced nausea and vomiting.
• Prevention of radiotherapy induced nausea and vomiting.
• Symptomatic treatment of nausea and vomiting, including acute migraine induced nausea and vomiting.

Paediatric patients aged 1 – 18 years

• Prevention of delayed chemotherapy induced nausea and vomiting as a second line option.

Dosage

Adults

• Single dose is 10 mg, repeated up to three times daily. The maximum dose in 24 hours is 30 mg or 0.5 mg/kg body weight, maximum 5 days.

Paediatric patients aged 1 – 18 years

Prevention of delayed chemotherapy induced nausea and vomiting:

• The recommended dose is 0.1 to 0.15 mg/kg body weight, repeated up to three times daily. The maximum dose in 24 hours is 0.5 mg/kg body weight, maximum 5 days.

Dosing for children:

• 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)

* Meclopstad is not suitable for use in children weighing less than 60 kg. Other pharmaceutical forms/strengths may be more appropriate for administration to this population.

Elderly

A dose reduction should be considered, based on hepatic, renal function and overall frailty.

Renal impairment

Moderate to severe (CrCl 15 – 60 ml/min): The daily dose should be reduced by 50%.

End stage (CrCl ≤ 15 ml/min): The daily dose should be reduced by 75%.

Hepatic impairment

Severe hepatic impairment: The daily dose should be reduced by 50%.

Usage

Meclopstad is administered orally.

• Hypersensitivity to the active substance or to any of the excipients.
• Gastrointestinal haemorrhage, mechanical obstruction or gastrointestinal.
• Confirmed or suspected phaeochromocytoma.
• A history of neuroleptic or metoclopramide-induced tardive dyskinesia.
• Epilepsy (increased crises frequency and intensity).
• Parkinson’s disease.
• Combination with levodopa or dopaminergic agonists.
• Known history of methaemoglobinaemia with metoclopramide or of NADH cytochrome b5 reductase deficiency.
• Use in children less than 1 year of age.

Very common:

• Somnolence.

Common:

• Diarrhoea,
• Extrapyramidal disorders,
• Parkinsonism, akathisia,
• Depression,
• Hypotension.

Neurological disorders

• Extrapyramidal disorders may occur.
• The time interval of at least 6 hours specified should be respected between each metoclopramide administration, even in case of vomiting and rejection of the dose, in order to avoid overdose.
• Treatment should not be prolonged (exceed 3 months) with metoclopramide.
• Metoclopramide should be discontinued immediately in the event of symptoms of neuroleptic malignant syndrome and appropriate treatment should be initiated.
• Special care should be exercised in patients with underlying neurological conditions and in patients being treated with other centrally-acting drugs.
• Symptoms of Parkinson’s disease may also be exacerbated by metoclopramide.

Methaemoglobinemia

• In methaemoglobinemia cases, metoclopramide should be immediately and permanently discontinued and appropriate measures initiated.

Cardiac disorders

• Serious cardiovascular undesirable effects have been reported.
• Special care should be taken when administering metoclopramide, particularly via the intravenous route to the elderly population, to patients with cardiac conduction disturbances (including QT prolongation), patients with uncorrected electrolyte imbalance, bradycardia and those taking other drugs known to prolong QT interval.

Renal and hepatic impairment

• In patients with renal impairment or with severe hepatic impairment, a dose reduction is recommended.
• Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
• Report any involuntary movements (e.g. muscle spasms and jerky movements of the head and face) that may occur, especially in children and the elderly.
• Metoclopramide should be avoided at the end of pregnancy. Metoclopramide is not recommended during breastfeeding.
• Metoclopramide may cause drowsiness, dizziness, dyskinesia and dystonias which could affect the vision and also interfere with the ability to drive and operate machinery.