Ephedrine HCl Sterop 50mg/1ml

/ Raz Pharmaceutics

Adults and adolescents:
Ephedrine must be administered at the lowest effective dose over the shortest possible period of time. This medicinal product must be used solely by or under the supervision of the anesthetist.
Adjust the dosage of the 50mg/1ml product on case-by-case basis depending on the cardiovascular and hemodynamic parameters. The following dosage is provided for guidance purposes only.
Adults:
5-25mg I.V., administered slowly.
It is recommended that this medicinal product be administered in divided doses of 5-10mg until the blood pressure normalizes.
Maximum daily dose – 150 mg/24h.
This medicinal product can also be administered S.C. or I.M. The dose is 25-50mg (range 10-50mg). If necessary, a second of 50mg may be administered I.M., or 10-25mg administered I.V.
Children:
The recommended pediatric dose is 3mg/kg per day (750 microgram/kg per dose) or 100mg/m² per day (25mg/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 5mg boluses.

Prevention and treatment of hypotension from spinal or epidural anesthesia and during general anesthesia, 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, pheochromocytoma, arteriosclerosis and aneurism.
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.

Should be used with caution in case of:
* Diabetes mellitus
* Hypertension
* Prostatic hypertrophy
* Uncontrolled hyperthyroidism
* Coronary heart disease and chronic heart diseases
* Angle-closure glaucoma
* Chronic anxiety/psychiatric disorders.
Patients with renal impairment may be at risk for toxicity and should be treated with caution at the minimum effective dose.
Patients with impaired circulation of the cerebrum and autonomic dysfunction should be treated with special caution.
Precautions for use:
Ephedrine should be used with caution in patients with cardiac history. Interference with serological testing
Interference with serological testing:
Athletes: warning, this medicinal product contains an active substance that may cause a positive reaction in anti-doping tests.

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

Contraindicated combinations:
– Indirect sympathomimetic agents (phenylpropanolamine, pseudoephedrine, phenylephrine, methylphenidate): risk of vasoconstriction and/or of acute episodes of hypertension.
– Alpha- and beta-adrenergic blocking agents (phentolamine): reduce the vasopressor effect of ephedrine.
– 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 anesthetics: 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 (minalcipran, 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).
Combinations requiring precautions for use:
– 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).
– Corticosteroids.
– Alcohol.

Pregnancy:
There are no or limited amount of data from the use of Ephedrine in pregnant women.
Teratogenicity studies in animals demonstrated that ephedrine could cause cardiovascular defects, reduction in fertility, foetal loss and midline wall defects.
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.
Breast-feeding:
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.
Fertility:
Animal studies are insufficient with respect to effects on fertility.

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. Protect from light.