PROSPECTO: INFORMATION FOR THE USER

Hidrocloruro de Efedrina Kabi 30 mg/ml
injectable solution

1. What is Hidrocloruro de Efedrina Kabi 30mg/ml and for what it is used

2. Before using Hidrocloruro de Efedrina Kabi 30mg/ml

3. How to use Hidrocloruro de Efedrina Kabi 30mg/ml

4. Possible adverse effects

5. Storage of Hidrocloruro de Efedrina Kabi 30mg/ml

6. Additional information

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

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

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

Do not use Hydrochloride of Ephedrine Kabi 30mg/ml

-If you are allergic (hypersensitive) to ephedrine or to any of the other components of Hydrochloride of Ephedrine Kabi 30mg/ml.

-Ephedrine should not be used in patients with hypovolemia (who have reduced circulating blood volume). Hypovolemia should be corrected before administration of ephedrine.

-If you have hyperthyroidism (hyperactivity of the thyroid gland).

-If you have any cardiovascular disease.

-If you are being treated with cardiac glycosides (digitalis, medications that increase the force of heart contraction).

-If you have angle-closure glaucoma.

-If you suffer from psychoneurosis (psychiatric disease).

-If the anesthesia administered to you contains cyclopropane, halogenated hydrocarbons, or lidocaine.

-If you are taking monoamine oxidase inhibitors (MAOIs, used to treat depression).

-Ephedrine should not be administered concurrently with other sympathomimetic agents, such as amphetamines, due to the possibility of additive effect 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-norepinephrine reuptake inhibitors (such as duloxetine or venlafaxine).

Be especially careful with Hydrochloride of Ephedrine Kabi 30mg/ml

-If you have benign prostatic hypertrophy (abnormal enlargement of the prostate).

-If you experience vasomotor instability.

-If you have diabetes mellitus.

This medication contains an active principle that may induce a positive response in antidoping control.

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

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

Non-recommended associations:

-Antihypertensive drugs (such as reserpine or methyldopa), alpha-adrenergic blockers (such as doxazosin and tamsulosin), and diuretics (such as furosemide), as they may decrease the pressor response of ephedrine. Although it should be noted that clonidine (alpha-blocker) is recommended for use in premedication with ephedrine as it increases the pressor response in time and intensity.

-The administration of beta-blockers (such as propranolol or bisoprolol) as they block the cardiac and bronchodilatory effects of ephedrine.

-Doxapram (stimulant of respiratory centers) and ergot alkaloids or oxytocics (used to increase uterine contractility), as they may increase the vasoconstrictor and hypertensive effect of ephedrine.

-The concurrent 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 antiepileptic drugs such as phenytoin.

-Ephedrine may accelerate the metabolism of dexamethasone.

Pregnancy and lactation

Consult your doctor or pharmacist before using any medication.

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

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

Be aware that ephedrine is excreted in breast milk.

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

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

Efedrina Hydrochloride Kabi must be administered by slow intravenous infusion or intravenous bolus by an anesthesiologist or under their responsibility.

The normal dose is:

Adults:

The recommended dose is 3 to 7.5 mg. The 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, in the absence of treatment efficacy, the administration of efedrina 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 efedrina every 4 to 6 hours.

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

If you use more Efedrina Hydrochloride Kabi 30mg/ml than you should

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

Like all medications, Hidrocloruro de Efedrina Kabi 30mg/ml may cause adverse effects, although not everyone will experience them.

The following adverse 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 abnormalities.

-Nervous system disorders: anxiety, tremors, insomnia, agitation, sedation, confusion, irritability.

-Eye disorders: acute angle-closure glaucoma.

-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 benign prostatic hyperplasia.

-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 consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

Keep out of reach and sight of children.

Store in the original packaging to protect it from light.

Do not use Efedrine Hydrochloride Kabi 30mg/ml after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not use Efedrine Hydrochloride Kabi 30mg/ml if you observe eventual changes in color and/or eventual formation of insoluble precipitates or crystals.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medicines that you do not need. In this way, you will help protect the environment.

Composition of Hydrochloride of Ephedrine Kabi 30mg/ml

The active ingredient is: hydrochloride of ephedrine.

The other components are: water for injection.

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

ephedrine base.

Appearance of the product and contents of the package

Hydrochloride of Ephedrine Kabi 30mg/ml is a transparent and colorless aqueous solution.

Hydrochloride of Ephedrine Kabi 30mg/ml is presented in 1 ml glass ampoules in packages of 10 and 100

ampoules.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization

Fresenius Kabi España S.A.U.

C/ Marina 16-18

08005 Barcelona

Responsible for manufacturing

Laboratoire Renaudin

Z.A. Errobi

F-64250 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.