Package Insert: Information for the User

Dopamina Grifols 200 mg Injectable Solution

Dopamina

Read this package insert carefully before starting to use this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or nurse.
• If you experience any adverse effects, consult your doctor or nurse, even if they are not listed in this package insert.

1.What is Dopamina Grifols 200 mg and how is it used

2.What you need to know before starting to use Dopamina Grifols 200 mg

3.How to use Dopamina Grifols 200 mg

4.Possible adverse effects

5Storage of Dopamina Grifols 200 mg

6. Contents of the package and additional information

Dopamina Grifols 200 mg belongs to a group of medications called adrenergic and dopaminergic agents. This medication is a cardiac stimulant that acts by increasing the force of contraction of the heart muscle, resulting in an increase in cardiac output (volume of blood expelled by the heart per minute).

Dopamine is indicated for the correction of hemodynamic imbalances (blood flow) that occur when there is a state of shock (acute decrease in blood flow) due to myocardial infarction, trauma, endotoxic septicemia (severe blood infection), open-heart surgery, renal insufficiency, and decompensated congestive heart failure.

No use Dopamina Grifols 200 mg:

• if you are allergic to dopamine or any of the other components of this medication (listed in section 6)

-if you have pheochromocytoma (a tumor that usually develops in the adrenal gland)

• if you experience tachyarrhythmias (rapid or irregular heart rhythm) such as atrial fibrillation, ventricular tachycardia, or ventricular fibrillation.

Warnings and precautions

Consult your doctor or nurse before starting to use Dopamina Grifols 200 mg.

-Before starting treatment with this medication, if necessary, your blood volume should be restored with whole blood or a plasma expander.

-Dopamine must always be diluted before administration.

-The rate of administration should be carefully controlled to avoid accidental bolus administration.

• hypoxia (decreased oxygen in the blood), hypercapnia (excessive carbon dioxide in the blood), or acidosis (decreased blood pH) should be corrected before or during administration of the medication to avoid increased adverse effects or reduced efficacy.

• The use of dopamine should be evaluated based on your clinical situation, and it should be administered with special care if you have shock due to myocardial infarction, open-heart surgery, or acute heart failure, as well as if you have arrhythmias, ischemic heart disease, or hypertension.

• If you have hyperthyroidism (increased activity of the thyroid gland), you may have a higher risk of cardiac effects or be more sensitive to the medication.

• If you have or have had a disease that causes arterial obstruction (vascular occlusive disease) such as atherosclerosis, arterial embolism, Raynaud's disease, cold injury, diabetic endarteritis, or Buerger's disease, you should inform your doctor of any changes in skin color or temperature or if you have pain in your extremities, who should evaluate the benefits of continuing treatment against the risk of possible necrosis. This condition may be reversed by reducing or discontinuing the medication.

• Since this medication must be diluted in a perfusion solution before administration, it may cause fluid overload and/or substance overload, leading to dilution of electrolyte concentrations in the blood, hyperhydration, situations of congestion, or pulmonary edema (accumulation of fluid in the lungs). Additionally, excessive administration of potassium-free intravenous solutions may cause hypokalemia (low potassium levels in the blood). Clinical and laboratory examinations should be performed to control fluid balance, electrolyte concentrations, and acid-base balance if the intravenous treatment is prolonged or your health status requires it.

-During administration of this medication, it is necessary to monitor certain physiological parameters such as heart rate, diuresis, cardiac output, and blood pressure.

If tachyarrhythmia or an increase in ectopic beats (abnormal heart rhythm) is observed, the dopamine dose should be reduced if possible.

If, at low perfusion rates, a decrease in blood pressure is observed, the rate should be increased to achieve an adequate blood pressure. If your blood pressure does not increase, treatment should be discontinued and a more potent vasoconstrictor such as norepinephrine should be administered.

Discontinuation of administration should be done by gradually reducing the dopamine dose while increasing blood volume with intravenous solutions. Sudden discontinuation of treatment may cause a significant decrease in blood pressure.

If an disproportionate increase in diastolic blood pressure (minimum blood pressure value) is detected, the perfusion rate should be reduced. Your doctor should monitor your condition, and in some cases, administration of a short-acting alpha-adrenergic blocker such as fentolamine may be necessary.

-Extravasation of the solution during administration may cause necrosis in the infusion area, so you should be continuously monitored in this area.

• If you have received monoamine oxidase inhibitors (MAOIs) in the weeks preceding the start of treatment with this medication, you should be administered reduced doses of dopamine.

Use of Dopamina Grifols 200 mg with other medications

Inform your doctor if you are using, have used recently, or may need to use any other medication.

It is essential to inform your doctor if you are using any of the following medications:

-diuretics (such as furosemide): concomitant administration with a low dose of dopamine may increase diuretic effects.

-tricyclic antidepressants: they may potentiate the cardiovascular effects of dopamine.

-vasopressors or vasoconstrictors such as ergometrine alkaloids (e.g., ergometrine) or other oxytocic drugs (substances that cause uterine muscle contraction and help induce labor): concomitant administration with dopamine may cause a significant increase in blood pressure.

-beta-adrenergic blockers (such as propranolol or metoprolol): they exert an opposite effect to dopamine at the cardiac level.

-alpha-adrenergic blockers (such as tolazoline): concomitant administration of dopamine and tolazoline may lead to a severe decrease in blood pressure, as they exert an opposite effect to the peripheral vasoconstriction caused by high doses of dopamine.

• butyrophenones (such as haloperidol) and phenothiazines: these substances may suppress mesenteric and renal vasodilation caused by low doses of dopamine.

-phenytoin: concomitant administration with dopamine may cause a decrease in blood pressure and heart rate (pulses per minute).

-monoamine oxidase inhibitors (MAOIs) (such as tranilcipromina and moclobemida): these medications prolong and potentiate the action of dopamine, so if you have used them before dopamine administration, you will require a substantially lower dose. It is estimated that if you have used these medications 2-3 weeks before dopamine administration, you should be administered an initial dopamine dose of no more than one-tenth of the normal dose.

• guanethidine: dopamine reduces the effect of this medication.

• metildopa and entacapona: these medications increase the effect of dopamine.

Dopamine should be used with extreme caution in patients anesthetized by inhalation of cyclopropane or halogenated hydrocarbons, as concomitant administration may cause arrhythmias and increased blood pressure.

It has also been described that concomitant administration of dopamine and the anesthetic propofol causes a decrease in the concentration of the anesthetic.

Pregnancy and lactation

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor before using this medication.

No adequate and well-controlled studies have been conducted in pregnant women, and it is unknown whether dopamine crosses the placenta. Dopamina Grifols 200 mg should not be used during pregnancy except if, in the doctor's judgment, it is clearly necessary.

If it is necessary to administer dopamine to the pregnant woman for advanced life support (ALS) during cardiopulmonary resuscitation, the doctor should take into account that uterine blood flow may decrease. Additionally, if dopamine is used during labor with oxytocic drugs, the simultaneous use of both medications may cause a severe increase in blood pressure.

It is unknown whether dopamine is excreted in breast milk. The doctor will evaluate the possible risk to the infant and inform you if administration of dopamine during breastfeeding is advisable.

Dopamina Grifols 200 mg contains sodium metabisulfite

This medication may cause severe allergic reactions and bronchospasm (sudden sensation of choking) due to the presence of sodium metabisulfite.

This medication contains less than 23 mg (1 mmol) of sodium per 5 ml ampoule, so it is considered essentially "sodium-free".

Dopamina Grifols 200 mg must be diluted before administration.

Once the dilution has been performed, dopamine will be administered intravenously by infusion, preferably through a large-caliber vein, through an appropriate catheter or needle.

This medication will be used in a hospital by the corresponding healthcare personnel.

Your doctor will indicate the duration of your treatment.

Dosing regimen:

Adults

Intravenous infusion of dopamine is usually initiated at a dose between 2 and 5 micrograms/kg/min, increasing it by 1-4 micrograms/kg/min every 10-30 minutes to achieve the desired therapeutic effects. The maintenance dose ranges from 5 to 20 micrograms/kg/min depending on the severity of the condition. When blood pressure, diuresis, and overall circulatory status improve, continue the infusion with the dose that has shown to be effective.

The maximum recommended dose is 20 micrograms/kg/min, although in severe situations, doses of up to 50 micrograms/kg/min or higher have been administered, and in this case, urine excretion should be frequently checked. The effects of dopamine depend on the administered dose.

Seniors

No dose adjustment is required in these patients, although it is recommended to initiate treatment with low doses and closely monitor blood pressure, urine flow, and peripheral perfusion.

Use in children

The safety and efficacy of this medication have not been established, and therefore, its use is not recommended in these patients.

If you are administered more Dopamina Grifols 200 mg than you should

Overdosing with dopamine causes excessive elevation of blood pressure and vasoconstriction (narrowing of a blood vessel) due to the alpha-adrenergic action of dopamine, especially in patients with a history of vascular occlusive disease.In this case, the administration rate of the medication will be reduced or temporarily suspended until your condition stabilizes.

If your condition does not stabilize with these measures, your doctor should consider administering a short-acting alpha-adrenergic blocker such as fentolamine.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone: 915 620 420.

If you have any other questions about the use of this product, ask your doctor or nurse.

Like all medications, Dopamina Grifols 200 mg may produce adverse effects, although not all people may experience them.

The most frequently observed adverse effects are: extrasystoles (heart rhythm disorder), nausea, vomiting, tachycardia, angina pectoris, palpitations, dyspnea (respiratory difficulty), intense headache, hypotension, and vasoconstriction.

At very high doses of dopamine, ventricular arrhythmias may also appear.

The administration of dopamine at high doses for prolonged periods or administration at low doses in patients with a history of vascular occlusive disease may produce gangrene of the extremities.

In case of extravasation of the solution in the injection area during administration, necrosis and scarring (crust) may occur in the nearby tissue.

Less frequent adverse effects are: cardiac conduction disorder, bradycardia (decreased heart rate), piloerection (hair erection), azotemia (excessive presence of nitrogen compounds in the blood), hypertension, prolonged QRS complex on the electrocardiogram, and anxiety. Similarly, dopamine has caused some cases of peripheral cyanosis (blue discoloration of the skin and mucous membranes of the extremities). It may also cause an increase in blood glucose levels, although these do not usually exceed normal values.

A case of choreoathetosis (uncontrolled and involuntary body movements) has been described after administration of dopamine.

Dopamine has been described to inhibit the release of hormones such as prolactin, growth hormone, thyrotropin, and thyroid hormones. There is a possibility that these changes may affect immune function.

Given the short duration of the medication's action, most adverse effects resolve after suspending treatment or reducing the administration rate.

Since this medication contains sodium metabisulfite, severe allergic reactions and bronchospasm may occur.

If you experience adverse effects, consult your doctor or nurse, even if they do not appear in this prospectus.

Store in the original packaging to protect it from light.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging.

Do not use this medication if the solution is not transparent or contains precipitates.

Once the packaging is opened, the solution must be used immediately.

Dopamina Grifols 200 mg Composition

The active ingredient is dopamina hydrochloride. Each 5 ml ampoule of solution contains 200 mg of dopamina hydrochloride (40 mg/ml).

The other components (excipients) are: sodium metabisulphite (E-223) and water for injectable preparations.

Product appearance and packaging content

Dopamina Grifols 200 mg is a transparent and colourless or very pale yellow solution, presented in 5 ml ampoules (box with 6 ampoules).

Marketing authorization holder and manufacturer responsible

LABORATORIOS GRIFOLS, S.A.

Can Guasch, 2

08150 Parets del Vallès, Barcelona (SPAIN)

Last review date of this leaflet: December 2012

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

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This information is intended solely for healthcare professionals:

The effects of dopamine depend on the dose administered, although the patient's actual response will largely depend on their clinical condition:

-At low doses (up to 2 micrograms/kg/min), it causes vasodilation in the renal, mesenteric, coronary, and intracerebral areas (probably due to specific agonist action on dopamine receptors) and diuresis. Hypotension may occur in some cases.

-At moderate doses (2-10 micrograms/kg/min), it stimulatesß1-adrenergic receptors in the myocardium,increasing the force of cardiac contraction and impulse conduction. Peripheral blood flow may decrease while mesenteric blood flow increases due to increased cardiac output. Systolic pressure and pulse pressure usually increase.

-At higher doses (10-20 micrograms/kg/min)producesα-adrenergic stimulation,increasing vasoconstrictive effect and arterial pressure.

-At high doses (>20 micrograms/kg/min) α-adrenergic stimulation predominates,producing strong peripheral vasoconstriction that can cancel out the dopamine effects of the drug.

Dopamina Grifols 200 mgmust be diluted before administration.

-Instructions for correct dilution of the medication:

Use an aseptic technique.

Dilute the contents of one ampoule in 250 or 500 ml of one of the following sterile intravenous solutions:

1. Sodium chloride 0.9% solution (isotonic saline solution)

2. 5% glucose solution

3. 5% glucose and sodium chloride 0.9% solution

4. 5% glucose and sodium chloride 0.45% solution

5. 5% glucose and Ringer lactate solution

6. Sodium lactate 1/6M solution

7. Ringer lactate solution

These dilutions will give the following final concentrations for administration:

- 250 ml of dilution contains 800 micrograms/ml of dopamine.

- 500 ml of dilution contains 400 micrograms/ml of dopamine.

If a higher concentration of dopamine is required, more than one ampoule can be diluted in the above-mentioned sterile intravenous solutions.

Dopamine is stable at room temperature for at least 24 hours after dilution in any of the above-mentioned sterile intravenous solutions. However, like all intravenous mixtures, the dilution should be made extemporaneously.

Do not dilute dopamine injectable with solutions containing sodium bicarbonate or any other alkaline solution, as dopamine is inactivated by alkalines.

Dopamine is degraded by oxygen, so it should be avoided to come into contact with oxidants and iron salts.

Do not administer the dopamine mixtures that present coloration, as this is indicative of alteration of dopamine.

-Incompatibilities:

Dopamine is inactivated in alkaline solution and is incompatible with alkaline substances such as sodium bicarbonate, furosemide, and thiopental sodium. It is also incompatible with oxidizing agents and iron salts.

Furthermore, signs of incompatibility of dopamine with insulin, ampicillin, amphotericin B, gentamicin sulfate, cephalothin sodium, oxacillin sodium, acyclovir sodium, alteplase, penicillin G potassium, aldesleucin, cefepime hydrochloride, indomethacin sodium trihydrate, and some parenteral nutrition mixtures have been described.

In the absence of compatibility studies, this medication should not be mixed with other medications.

Dopamine should be infused, whenever possible, in a large-calibre vein to avoid the possibility of infiltration into the surrounding tissue, as extravasation can cause necrosis and scarring of the adjacent tissue. The antecubital fossa veins are preferred to the dorsal hand or foot veins. Less suitable sites should only be used if the patient's condition requires immediate attention or if larger-calibre veins cannot be used, and as soon as possible, the infusion should be switched to a more appropriate site. The free circulation in the infusion area should be continuously monitored.

In the event of extravasation, a rapid infiltration of the affected area with a?-adrenergic blocker such as phentolamine (e.g., 5-10 mg in 10-15 ml of saline solution) should be administered.