Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Torbay and South Devon NHS Foundation Trust, Torbay Pharmaceuticals, Wilkins Drive, Paignton, Devon TQ4 7FG, UK Medical enquiries: tsdft.medinfotorbaypharmaceuticals@nhs.net
For the treatment of acute hypotension due to loss of vasoconstrictor tone as may occur during spinal anaesthesia and as an adjunct to accepted remedial procedures.
For intravenous use.
Metaraminol 0.5mg/mL Solution for Injection should not be diluted before use: it is supplied ready to use.
Direct intravenous injection in grave emergencies: 0.5-5 mg (1-10 mL), which may be followed by an infusion of 15–100mg (30–200mL of metaraminol 0.5mg/mL solution for injection) titrated to clinical effect. In the event of escalating vasopressor requirement, the more concentrated metaraminol 10mg/mL solution for injection or infusion can be administered as 15–100mg in 500 mL of infusion liquid. When vasoactive drug support is no longer indicated, the infusion should be gradually decreased. Abrupt withdrawal can result in acute hypotension.
Children: The safety and efficacy of Metaraminol 0.5mg/mL Solution for Injection in children under 12 years of age has not been established. No data are available.
Use in the elderly: The dosage may not require modification for elderly patients; however, geriatric patients may be more sensitive to sympathomimetic agents, therefore particular caution should be taken in this age group.
Metaraminol acts rapidly. The major therapeutic effects are complete within an hour of parenteral administration. Overdosage may result in severe hypertension accompanied by headache, constricting sensation in the chest, nausea, vomiting, euphoria, diaphoresis, pulmonary oedema, tachycardia, bradycardia, sinus arrhythmia, atrial or ventricular arrhythmias, myocardial infarction, cardiac arrest or convulsions.
If the drug has been ingested, induce emesis or perform gastric lavage. If metaraminol has been administered by subcutaneous or intramuscular injection, local ice packs may be applied to delay absorption. Intravenous infusion should be stopped immediately, but reinstated if hypotension occurs.
If needed, alpha-adrenergic blocking agents may also be useful for reducing hypertension and may have a beneficial effect on cardiac arrhythmia, if present. Parenteral diazepam may be given for convulsions.
Shelf life: 2 years.
This medicinal product does not require any special storage condition.
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user and would normally not be longer than 48 hours at 2 to 8°C unless opening has taken place in controlled and validated aseptic conditions.
Glass ampoule containing 5mL or 10mL of solution for injection.
Pack size of 10 ampoules in an outer carton.
Metaraminol 0.5mg/mL Solution for Injection is already diluted and ready to use. It should be used without prior dilution
Any unused product or waste material should be disposed of in accordance with local requirements.
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