Ephedrine Hydrochloride Injection 3mg Per Ml
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ephedrine Hydrochloride Injection 3mg per ml
2. Qualitative and Quantitative Composition
Ephedrine Hydrochloride Ph Eur 0.3% w/v
3. Pharmaceutical Form
An isotonic, sterile Solution for Injection
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Therapeutic Indications Reversal of hypotension from spinal or epidural anaesthesia.
4.2. Posology and Method of Administration
Adults and children over 12 years
Slow intravenous injection of a solution containing ephedrine hydrochloride 3mg/ml, 3-6mg (maximum of 9mg) repeated every 3-4 minutes to a maximum of 30mg.
Children under 12 years Not recommended.
Elderly As for adults.
4.3. Contra-indications
Hypersensitivity Known sensitivity.
Ischeamic heart disease
Ephedrine has positive inotropic and chronotropic effects on the heart, it should be avoided in patients with ischaemic heart disease.
Hypertension
Ephedrine increases blood pressure and should be avoided in hypertensive patients.
Thyrotoxicosis
Patients with hyperthyroidism may be hypersensitive or have an increased susceptibility to the effects of ephedrine.
Prostatic hypertrophy
Acute urinary retention may be precipitated in patients with prostatic hypertrophy.
4.4. Special Warnings and Precautions for Use
Ephedrine should be used with caution in patients who may be particularly susceptible to their effects, particularly those with hyperthyroidism. Great care is also needed in patients with cardiovascular disease such as ischaemic heart disease, arrhythmia or tachycardia, occlusive vascular disorders including arteriosclerosis, hypertension, or aneurysms. Anginal pain may be precipitated in patients with angina pectoris.
Care is also required when Ephedrine is given to patients with diabetes mellitus or closed-angle glaucoma.
Ephedrine should be avoided or used with caution in patients undergoing anaesthesia with cyclopropane, halothane, or other halogenated anaesthetics, as they may induce ventricular fibrillation. An increased risk of arrhythmias may also occur if Ephedrine is given to patients receiving cardiac glycosides, quinidine, or tricyclic antidepressants.
Many sympathomimetics interact with monoamine oxidase inhibitors, and should not be given to patients receiving such treatment or within 14 days of its termination. It is advisable to avoid sympathomimetics when taking reversible MAOIs.
Ephedrine increases blood pressure and therefore special care is advisable in patients receiving antihypertensive therapy. Interactions of Ephedrine with alpha- and beta-blocking drugs may be complex. Propranolol and other beta-adrenoceptor blocking agents antagonise the effects of beta2 adrenoceptor stimulants (beta2 agonists) such as salbutamol.
Adverse metabolic effects of high doses of beta2 agonists may be exacerbated by concomitant administration of high doses of corticosteroids; patients should therefore be monitored carefully when the 2 forms of therapy are used together although this precaution is not so applicable to inhalation therapy. Hypokalaemia associated with high doses of beta2 agonists may result in
increased susceptibility to digitalis-induced cardiac arrhythmias.
Hypokalaemia may be enhanced by concomitant administration of aminophylline or other xanthines, corticosteroids, or by diuretic therapy
4.5. Interactions with other Medicaments and other forms of Interaction
Antidepressants: with tricyclics administration of adrenaline and noradrenaline may cause hypertension and arrhythmias (but local anaesthetics with adrenaline appear to be safe): with MAOIs administration of inotropics such as dopamine and dopexamine may cause hypertensive crisis; also with MAOIs administration of dexamphetamine and other amphetamines, dexfenfluramine, diethylpropion, ephedrine, fenfluramine, isometheptene, methylphenidate, pemoline, phentermine, phenylephrine, phenylpropanolamine, and pseudoepedrine may cause hypertensive crisis (these drugs are contained in anorectics or cold and cough remedies).
Antiepileptics: increased plasma concentration of phenytoin and possibly of phenobarbitone and primidone.
Antihypertensives: sympathomimetics in anorectics and cold and cough remedies antagonise hypotensive effects of adrenergic neurone blockers; possible risk of hypertension with apraclonidine and adrenaline or noradrenaline; hypotensive effect of some other antihypertensives may be enhanced by dexfenfluramine and fenfluramine.
Doxapram: risk of hypertension.
Oxytocin: hypertension with vasoconstrictor sympathomimetics.
4.6. Pregnancy and Lactation
The licenced indications for this product mean that a pregnant woman may be given the product to reverse hypotension associated with spinal anaesthesia, the doctor administering the drug should be aware of the following actions of the drug.
The use of ephedrine in lactation has been associated with irritability and disturbed sleep in the infant. Breast-feeding should be regarded as a contraindication for ephedrine administration.
Ephedrine readily crosses the placenta and this is associated with an increase in foetal heart rate and beat-to-beat variability.
4.7. Effects on Ability to Drive and Use Machines
Not applicable.
4.8. Undesirable Effects
Ephedrine may produce a wide range of adverse effects, most of which mimic the results of excessive stimulation of the sympathetic nervous system. These effects are mediated via the various types of adrenergic receptor, and the adverse effects of an individual drug depend to some extent upon its relative agonist activity on these different types of receptor at a given dose.
Central effects of Ephedrine include fear, anxiety, restlessness, tremor, insomnia, confusion, irritability and psychotic states. Appetite may be reduced, and nausea and vomiting may occur.
Effects on the cardiovascular system are complex. Stimulation of alpha-adrenergic receptors produces vasoconstriction with resultant hypertension. This vasoconstriction is sometimes sufficiently severe to produce gangrene when sympathomimetics are infiltrated into the digits. The rise in blood pressure may produce cerebral haemorrhage and pulmonary oedema. There may also be a reflex bradycardia, but stimulation of P1 adrenergic receptors of the heart may produce tachycardia and cardiac arrhythmias, anginal pain, palpitations, and cardiac arrest; hypotension with dizziness and fainting, and flushing, may occur due to stimulation of the ^-adrenergic receptors and the resulting vasodilatation. Hypokalaemia may occur with beta2 agonist sympathomimetics.
Other effects that may occur with Ephedrine include difficulty in micturition and urinary retention, dyspnoea, weakness, altered metabolism including changes in blood sugar concentrations, sweating, and hypersalivation. Headache is also common.
4.9. Overdose
Symptoms
The effects of Ephedrine in overdose include nausea, vomiting, fever, palpitations, tachycardia, hypertension, paranoid psychosis, respiratory depression, convulsions and coma.
Treatment
The treatment of ephedrine overdose with this product may require intensive supportive treatment. Slow intravenous injection of labetalol 50-200mg may be given with electrocardiograph monitoring for the treatment of
supraventricular tachycardia. Marked hypokalaemia (<2.8mmol.l-1) due to compartmental shift of potassium predisposes to cardiac arrhythmias and may be corrected by infusing potassium chloride in addition to propranolol and correcting respiratory alkalosis, when present.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Ephedrine is a sympathomimetic agent with direct and indirect effects on adrenergic receptors. It acts indirectly by releasing neurotransmitter from storage sites in the sympathetic nerves to the effector organ. Ephedrine exhibits substantial effects in reserpine-treated animals and man. Like adrenaline, it possesses weak a as well as P1 and P2 adrenergic activity. Tachyphylaxis occurs due to depletion of neurotransmitter from storage sites.
5.2. Pharmacokinetic Properties
Ephedrine is readily and completely absorbed from the gastro-intestinal tract. It is resistant to metabolism by monoamine oxidase and is largely excreted unchanged in the urine, together with small amounts of metabolites produced by hepatic metabolism. Ephedrine has been variously reported to have a plasma half-life ranging from 3 to 6 hours depending on urinary pH; elimination is enhanced and half-life accordingly shorter in acid urine.
5.3. Preclinical Safety Data
There is no pre-clinical data of relevance to the prescriber which is additional to that already included in other sections of the SPC.
PHARMACEUTICAL PARTICULARS
6.
6.1. List of Excipients
Sodium Chloride Dilute Hydrochloric Acid Water for Injections Nitrogen
6.2. Incompatibilities
Not known
6.3. Shelf Life
3 years
6.4. Special Precautions for Storage
Do not store above 25°C. Keep in the outer carton.
6.5. Nature and Contents of Container
Sterile solution for injection in Glass (Type I) 10ml ampoule
6.6. Instruction for Use/Handling
Use once and discard any remaining solution Not for dilution
7
MARKETING AUTHORISATION HOLDER
Aurum Pharmaceuticals Ltd
Bampton Road
Harold Hill
Romford
Essex
RM3 8UG
United Kingdom
8. MARKETING AUTHORISATION NUMBER(S)
PL 12064/0032
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
04/02/2009
10 DATE OF REVISION OF THE TEXT
04/02/2009