EPHEDRINE HYDROCHLORIDE KABI 30 mg/ml INJECTABLE SOLUTION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ephedrine Hydrochloride Kabi 30 mg/mlinjectable solution

Contents of the package leaflet:

1. What is Ephedrine Hydrochloride Kabi 30mg/ml and what is it used for
2. Before using Ephedrine Hydrochloride Kabi 30mg/ml
3. How to use Ephedrine Hydrochloride Kabi 30mg/ml
4. Possible side effects
5. Storage of Ephedrine Hydrochloride Kabi 30mg/ml
6. Further information

1. What is EPHEDRINE HYDROCHLORIDE KABI 30 mg/ml and what is it used for

The active substance of Ephedrine Hydrochloride Kabi 30mg/ml is ephedrine, a cardiac stimulant.

Ephedrine Hydrochloride Kabi 30mg/ml is used to treat hypotension (low blood pressure) during general and epidural anesthesia in surgery and obstetrics.

Ephedrine Hydrochloride Kabi 30mg/ml is a hospital-use injectable solution.

2. Before using EPHEDRINE HYDROCHLORIDE KABI 30mg/ml

Do not use Ephedrine Hydrochloride Kabi 30mg/ml

• If you are allergic (hypersensitive) to ephedrine or any of the other ingredients of Ephedrine Hydrochloride Kabi 30mg/ml.
• Ephedrine should not be used in patients with hypovolemia (reduced circulating blood volume). Hypovolemia should be corrected before administration of ephedrine.
• If you have hyperthyroidism (overactive thyroid gland).
• If you have any cardiovascular disease.
• If you are being treated with cardiac glycosides (digitalis, medications that increase the heart's contractile force).

• If you have closed-angle glaucoma.
• If you suffer from psychoneurosis (mental illness).
• If the anesthesia you are given contains cyclopropane, halogenated hydrocarbons, or lidocaine.
• If you are taking monoamine oxidase inhibitors (MAOIs, used to treat depression).
• Ephedrine should not be administered in conjunction with other sympathomimetic agents, such as amphetamines, due to the possibility of additive effects and increased toxicity.
• If you have hypertension (high blood pressure).
• If you are taking guanethidine (to treat high blood pressure).
• If you are taking tricyclic antidepressants (such as amitriptyline or imipramine), or serotonin-noradrenergic antidepressants (such as duloxetine or venlafaxine).

Be careful when using Ephedrine Hydrochloride Kabi 30mg/ml

• If you have prostate hypertrophy (abnormal enlargement of the prostate).
• If you have vasomotor instability.
• If you have diabetes mellitus.

This medicinal product contains an active substance that can induce a positive response in anti-doping tests.

Use of other medicines

Tell your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

Some medicines should not be used with Ephedrine Hydrochloride Kabi 30mg/ml (see Do not use Ephedrine Hydrochloride Kabi 30mg/ml).

Not recommended combinations:

• Hypotensive agents (such as reserpine or methyldopa), alpha-adrenergic blocking agents (such as doxazosin and tamsulosin), and diuretics (such as furosemide), as they may decrease the pressor response to ephedrine. However, it should be noted that clonidine (an alpha-blocker) is recommended for use in the premedication of ephedrine, as it increases the pressor response in time and intensity.
• Administration of beta-adrenergic blockers (such as propranolol or bisoprolol), as they block the cardiac and bronchodilatory effects of ephedrine.
• Doxapram (a respiratory stimulant) and ergot alkaloids or oxytocics (used to increase uterine contractility), as they may increase the vasoconstrictive and hypertensive effect of ephedrine.
• Concomitant administration of theophylline or its derivatives (such as aminophylline) with ephedrine increases the incidence of adverse effects of both drugs.
• Ephedrine may increase the plasma concentration of some antiepileptics, such as phenytoin.
• Ephedrine may accelerate the metabolism of dexamethasone.

Pregnancy and lactation

Consult your doctor or pharmacist before using any medicine.

The safety of ephedrine during pregnancy and lactation has not been established. Therefore, the administration of Ephedrine Hydrochloride Kabi 30mg/ml should only be done in case of need if you are pregnant, plan to become pregnant, or think you may be pregnant.

During childbirth, it may be necessary to administer Ephedrine Hydrochloride Kabi 30mg/ml for the treatment of hypotension during epidural or spinal anesthesia. However, such administration may accelerate the fetal heart rate.

Keep in mind that ephedrine is excreted in breast milk.

3. How to use EPHEDRINE HYDROCHLORIDE KABI 30mg/ml

Follow the instructions for administration of Ephedrine Hydrochloride Kabi 30mg/ml exactly as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Ephedrine Hydrochloride Kabi 30mg/ml is a hospital-use injectable solution.

Ephedrine Hydrochloride Kabi should be administered by slow intravenous injection or intravenous bolus by an anesthesiologist or under their responsibility.

The normal dose is:

Adults:

The recommended dose is 3 to 7.5 mg. Administration of this dose may be repeated every 5-10 minutes depending on the patient's response, up to a total of 30 mg. After administration of 30 mg, if the treatment is not effective, the administration of ephedrine should be reconsidered. In any case, the total daily dose should not exceed 150 mg.

Children:

Administration of 0.1 to 0.2 mg/kg of ephedrine every 4 to 6 hours.

In the absence of treatment efficacy, the choice of ephedrine should be reconsidered.

If you use more EPHEDRINE HYDROCHLORIDE KABI 30mg/ml than you should

In case of overdose, nausea, vomiting, fever, paranoid psychosis, ventricular and supraventricular arrhythmias, respiratory depression, convulsions, and coma may be observed.

4. Possible side effects

Like all medicines, Ephedrine Hydrochloride Kabi 30mg/ml can cause side effects, although not everybody gets them.

The following side effects have been reported with the use of ephedrine at the recommended doses for the treatment of hypotension during anesthesia.

• Cardiac disorders: palpitations, tachycardia, arrhythmia.
• Blood and lymphatic system disorders: coagulation disorders.
• Nervous system disorders: anxiety, tremors, insomnia, agitation, thirst, confusion, irritability.
• Eye disorders: closed-angle glaucoma crisis.
• Ear and labyrinth disorders: dizziness, vertigo.
• Respiratory, thoracic, and mediastinal disorders: pulmonary edema, chest pain in patients with ischemic heart disease.
• Gastrointestinal disorders: nausea, vomiting, dry mouth.
• Renal and urinary disorders: difficulty urinating, urinary retention in patients with prostate hypertrophy.
• Skin and subcutaneous tissue disorders: sweating, dry mucous membranes.
• Musculoskeletal disorders: muscle weakness.
• Metabolism and nutrition disorders: reduced appetite.
• Vascular disorders: hypotension, cerebral hemorrhage, headaches.
• Immune system disorders: hypersensitivity.
• Psychiatric disorders: psychotic states, depression.

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

5. Storage of EPHEDRINE HYDROCHLORIDE KABI 30mg/ml

Keep out of the reach and sight of children.

Store in the original packaging to protect from light.

Do not use Ephedrine Hydrochloride Kabi 30mg/ml after the expiration date stated on the packaging after EXP. The expiration date is the last day of the month indicated.

Do not use Ephedrine Hydrochloride Kabi 30mg/ml if you notice any changes in color and/or formation of insoluble precipitates or crystals.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. FURTHER INFORMATION

Composition of Ephedrine Hydrochloride Kabi 30mg/ml

The active substance is: ephedrine hydrochloride.

The other ingredients are: water for injection.

Each ml of the injectable solution contains 30 mg of ephedrine hydrochloride, equivalent to 24.6 mg of ephedrine base.

Appearance of the product and packaging contents

Ephedrine Hydrochloride Kabi 30mg/ml is a clear, colorless aqueous solution.

Ephedrine Hydrochloride Kabi 30mg/ml is available in 1 ml (glass) ampoules in packs of 10 and 100 ampoules.

Marketing authorization holder and manufacturer

Marketing authorization holder

Fresenius Kabi España S.A.U.

C/ Marina 16-18

08005 Barcelona

Manufacturer

Laboratoire Renaudin

Z.A. Errobi

F-64 250 Itxassou

France

or

Labesfal - Laboratórios Almiro, S.A.

Zona Industrial do Lagedo

3465-157 Santiago de Besteiros

Portugal

This leaflet was approved in July 2019.