Nordrine Inj: Each ampoule contains 25 mg Ephedrine Hydrochloride BP in 5 ml solution.
Ephedrine is rapidly absorbed after intramuscular or subcutaneous administration. The onset of action after intramuscular administration is 10-20 minutes and the duration of pressor and cardiac responses to Ephedrine is 1 hour after intravenous administration of 10-25 mg or intramuscular or subcutaneous administration of 25-50 mg. Small quantities of Ephedrine are metabolised in the liver, but the majority of Ephedrine is excreted unchanged in the urine. The plasma half life of Ephedrine is 3-6 hours. Elimination of Ephedrine is increased (and hence the half life is decreased) with decreasing pH of the urine. Ephedrine is presumed to cross the placenta, and to be excreted into breast milk.
Adult dose: The usual adult dose is 25-50 mg (range 10-50 mg) administered intramuscularly or subcutaneously. Additional doses should be based on patient response. The intravenous route may be used if an immediate response is required. The dosage for the intravenous route is 10-25 mg which may be repeated every 5-10 minute until the desired response is obtained.
Paediatric dose: The recommended paediatric dose is 3 mg/kg/day or 100 mg/m2/day via the intravenous or subcutaneous route, given in 4-6 divided doses.
During therapy with a pressor agent, blood pressure should be elevated to slightly less than the patient's normal blood pressure. In previously normotensive patients, systolic blood pressure should be maintained at 80-100 mmHg. In previously hypertensive patients, systolic blood pressure should be maintained at 30-40 mmHg below their usual blood pressure. In some patients with very severe hypotension, maintenance of even lower blood pressure may be desirable if blood or fluid volume replacement has not been completed.
Adult dose: The usual adult dose is 12.5-25 mg, given intramuscularly, subcutaneously or intravenously. Further dosage should be determined by patient's response.
Paediatric dose: The usual paediatric dose is 3 mg/kg or 100 mg/m2 intravenously or subcutaneously given in 4-6 divided doses.
Ephedrine Hydrochloride should also be used with caution in geriatric males, especially those with prostatic hypertrophy, since Ephedrine may cause acute urinary retention.
Ephedrine Hydrochloride should also be used with caution in diabetic patients since drug induced hyperglycaemia may result in loss of diabetic control.
Ephedrine Hydrochloride should also be used with caution in patients with cardiovascular disease including angina, cardiac arrhythmia and coronary insufficiency, since the cardiovascular effects of Ephedrine may exacerbate these conditions. Ephedrine may intensify the ischaemia in myocardial infarction by increasing myocardial oxygen demands.
Ephedrine Hydrochloride is contraindicated in patients with pheochromocytoma.
Ephedrine Hydrochloride is contraindicated in patients with asymmetric septal hypertrophy (idiopathic hypertrophic subaortic stenosis).
Ephedrine Hydrochloride is contraindicated in patients undergoing therapy with monoamine oxidase inhibitors (MAO inhibitors), or within 14 days of ceasing such therapy.
Ephedrine Hydrochloride is contraindicated in patients undergoing general anaesthesia with cyclopropane or halothane or other halogenated hydrocarbons.
Ephedrine Hydrochloride is contraindicated in patients with tachyarrhythmias or ventricular fibrillation.
Ephedrine Hydrochloride is also contraindicated in patients with hypersensitivity to Ephedrine and in patients with psychoneurosis.
Lactation: Ephedrine Hydrochloride is distributed into breast milk, and therefore Ephedrine Hydrochloride Injection is not recommended for use during lactation because of the risk of adverse effects in the infant.
Paranoid psychosis, delusions and hallucinations may also follow Ephedrine overdosage.
Treatment of overdose involves the following measures:
reduce dosage or discontinue administration of Ephedrine
general supportive therapy, including monitoring and maintaining vital signs, blood gases, electrolytes and ECG.
The following additional measures may need to be considered:
b-blockers (eg. propranolol) to control tachycardia and arrhythmia
phentolamine or nitropruside to reduce severe hypertension
diazepam to control convulsions. General anaesthesia and neuromuscular blocking agents may need to be considered to
treat refractory seizures
dexamethasone to treat pyrexia