Ephedrin Sintetica 50 mg/ml

/ Biomed - JR

Adults and adolescents:
Ephedrine must be administered at the lowest effective dose over the shortest possible period of time.
Adjust the dosage on case-by-case basis depending on the cardiovascular and hemodynamic parameters. The following dosage is provided for guidance purposes only.
Adults:
5-25 mg i.v., administered slowly. It is recommended that ephedrin be administered in divided doses of 5-10 mg until the blood pressure normalizes.
Maximum daily dose (150 mg/24h). Ephedrin can also be administered s.c or i.m. The dose is 25-50 mg (range 10-50 mg). If necessary, a second of 50 mg may be administered i.m, or 10-25 mg administered i.v.
Children:
The recommended pediatric dose is 3 mg/kg per day (750 micrograms/kg per dose) or 100 mg/m per day (25 mg/m2 per dose) in 4-6 doses per day, administered s.c. or i.v.
The bolus i.v. dose for hypotension is 0.1-0.3 mg/kg.
When administered intravenously, the injection should be given slowly.
Elderly patients:
As for adults, starting from 5 mg boluses.

Prevention and treatment of hypotension from spinal or epidural anaesthesia and during general anaesthesia, with or without a reduction in the heart rate, administered for a surgical or obstetric procedure.

• Hypersensitivity to the active substance or to any of the excipients.
• Hyperexcitability, phaeochromocytoma.
• Combination with phenylpropanolamine, phenylephrine, pseudoephedrine, methylphenidate (other indirect sympathomimetics)
The administration of ephedrine to patients who are undergoing or have undergone treatment with MAO inhibitors within the last 2 weeks is contraindicated as the combination may cause severe, possibly fatal, hypertension.

Ephedrine should be used with caution in case of:
* Diabetes mellitus
* Hypertension
* Prostatic hypertrophy
* Uncontrolled hyperthyroidism
* Angle-closure glaucoma,
* Chronic anxiety/psychiatric disorders.
Patients with cardiovascular disease such as ischaemic heart disease, arrhythmia or tachycardia, occlusive vascular disorders including arteriosclerosis, or aneurysms. Angina pain may be precipitated in patients with angina pectoris.
Patients with renal impairment may be at risk for toxicity and should be treated with caution at the minimum effective dose.
Dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Precautions for use:
Ephedrine should be used with caution in patients with cardiac history.
Interference with serological testing:
Athletes: warning, this medicinal product contains an active substance that may cause a positive reaction in anti-doping tests.
See prescribing information for full details.

Very common: Episodes of angle-closure glaucoma in patients who are anatomically predisposed.
Common: Changes in primary haemostasis, hypersensitivity reactions, insomnia, nervousness.

Contraindicated combinations
* Indirect sympathomimetic agents: (phenylpropanolamine, pseudoephedrine, phenylephrine, methylphenidate): risk of vasoconstriction and/or of acute episodes of hypertension.
* Non-selective MAO inhibitors: The administration of ephedrine to patients who are undergoing or have undergone treatment with MAO inhibitors within the last 2 weeks is contraindicated as the combination may cause severe, possibly fatal, hypertension.
Combinations not recommended
* Volatile halogen anaesthetics: Serious ventricular arrhythmias (increase in cardiac excitability). Nonetheless, the new volatile drugs, such as sevoflurane and desflurane, show less cardiac side effect allowing a possible co-administration of ephedrine.
* Tricyclic antidepressants (e.g. imipramine): Paroxysmal hypertension with possibility of arrhythmias (inhibition of adrenaline or noradrenaline entry in sympathetic fibers).
* Noradrenergic-serotoninergic antidepressants (milnacipran, venlafaxine): Paroxysmal hypertension with possibility of arrhythmias (inhibition of adrenaline or noradrenaline entry in sympathetic fibers).
* Guanethidine and related products: Substantial increase in blood pressure (hyperreactivity linked to the reduction in sympathetic tone and/or to the inhibition of adrenaline or noradrenaline entry in sympathetic fibers). If the combination cannot be avoided, use with caution lower doses of sympathomimetic agents.
* Sibutramine: Paroxysmal hypertension with possibility of arrhythmias (inhibition of adrenaline or noradrenaline entry in sympathetic fibers).
* Selective MAO-A inhibitors (moclobemide, toloxatone): Risk of vasoconstriction and/or episodes of hypertension.
* Linezolid: Risk of vasoconstriction and/or episodes of hypertension.
* Ergot alkaloids: Risk of vasoconstriction and/or episodes of hypertension.
Combinations requiring precautions for use
* Alpha- and beta-adrenergic blocking agents: Alpha blockers (e.g. phentolamine) reduce the vasopressor effect of ephedrine. Beta blockers may inhibit the cardiac and bronchodilator effects of ephedrine.
* Reserpine and methyldopa reduce the vasopressor action of ephedrine.
* Theophylline and derivatives (aminophylline). Concomitant administration of ephedrine and theophylline may result in insomnia, nervousness and gastrointestinal complaints.
* Agents that alter urine pH: alkalization, e.g. from Acetazolamide or Sodium Bicarbonate, inhibits renal excretion of ephedrine.
* Corticosteroid: Ephedrine has been shown to increase the clearance of dexamethasone.
* Antiepileptics: increased plasma concentration of phenytoin and possibly of phenobarbitone and primidone.
* Clonidine, atropine: augment the pressor effect of ephedrine.
* Oxytocin and oxytocic drugs: serious postpartum hypertension has been described in patients who received both a vasopressor (i.e., methoxamine, phenylephrine, ephedrine) and an oxytocic (i.e., methylergonovine, ergonovine). Some of these patients experienced a stroke.
* Cardiac glycosides: ephedrine with a cardiac glycoside, such as digitalis, may increase the possibility of arrhythmias.
* Aminophylline or other xanthines, diuretic therapy: concomitant administration may result in hypokalaemia
See prescribing information for full details.

Pregnancy: There are no or limited amount of data from the use of ephedrine in pregnant women. The use of ephedrine in pregnancy should be avoided as ephedrine crossed the placenta and this has been associated with an increase in fetal heart rate and beat-to-beat variability.
Lactation: Although specific data are lacking in this regard, it is assumed that ephedrine crosses the placenta and passes into breast milk. Breastfeeding should be suspended for two days after the administration. Irritability and disturbed sleep patterns have been reported in breast-fed infants.

Symptoms:
In the event of an overdose, the following are seen to occur: migraines, nausea, vomiting, hypertension, tachycardia, fever, paranoid psychosis, hallucinations, ventricular and supraventricular heart rhythm disorders, respiratory depression, convulsions and coma.
The lethal dose in humans is about 2 g, equivalent to blood concentrations of about 3.5 to 20 mg/l.
Management:
To treat the overdose and control stimulation of the central nervous system and convulsions, diazepam can be administered at doses ranging from 0.1 to 0.2 mg/kg per injection. The dose of 10 to 20 mg can be administered at once via slow intravenous route.
To treat excitation, hallucinations and hypertension, chlorpromazine should be administered.
To treat severe hypertension, phentolamine or another alpha-adrenergic receptor blocker can be administered.
To treat hypertension or severe tachyarrhythmia, a beta-blocker such as propranolol may prove beneficial.

Do not store above 25°C. Store in the original package in order to protect from light. Do not refrigerate or freeze. The ampoule is for single use only. The solution should be used immediately after the opening of the container.
After dilution the product is chemically stable for 24 hours.
See prescribing information for full details.