DOBUTAMIN 250 mg Powder

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Dobutamin Sandoz, 250 mg, Powder for Solution for Infusion
   1. Read the Package Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient.
   2. Package Leaflet Contents:
3. What is Dobutamin Sandoz and What is it Used For
4. Important Information Before Using Dobutamin Sandoz
   1. When Not to Use Dobutamin Sandoz
   2. Warnings and Precautions
   3. Dobutamin Sandoz and Other Medications
   4. Pregnancy and Breastfeeding
   5. Driving and Operating Machinery
5. How to Use Dobutamin Sandoz
   1. Overdose of Dobutamin Sandoz
6. Possible Side Effects
   1. Reporting Side Effects
7. How to Store Dobutamin Sandoz
8. Package Contents and Other Information
   1. What Dobutamin Sandoz Contains
   2. What Dobutamin Sandoz Looks Like and What the Package Contains
   3. Marketing Authorization Holder
   4. Manufacturer
   5. For More Information, Contact:
   6. Information Intended for Healthcare Professionals Only
   7. Special Warnings and Precautions for Use
   8. Dosage and Administration
   9. Overdose Procedure
   10. Pharmaceutical Incompatibilities
   11. Instructions for Preparation of the Medication
   12. For puncturing the stopper before dissolving the medication in the vial, needles with a diameter not exceeding 0.8 mm should be used. The rubber stopper should be punctured vertically due to the possibility of its fragments breaking off and entering the prepared solution.

Package Leaflet: Information for the User

Dobutamin Sandoz, 250 mg, Powder for Solution for Infusion

Dobutamine

Read the Package Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medication has been prescribed for you, do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this package leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Package Leaflet Contents:

• 1. What is Dobutamin Sandoz and What is it Used For
• 2. Important Information Before Using Dobutamin Sandoz
• 3. How to Use Dobutamin Sandoz
• 4. Possible Side Effects
• 5. How to Store Dobutamin Sandoz
• 6. Package Contents and Other Information

1. What is Dobutamin Sandoz and What is it Used For

Dobutamin Sandoz contains the active substance dobutamine, which acts on the heart muscle, increasing the force of its contraction.
The medication Dobutamin Sandoz is used:

• in adults, when it is necessary to increase the force of the heart muscle contraction in patients with heart attack, heart disease, after heart surgery, in shock;
• in children (from newborns to 18 years), when it is necessary to increase the force of the heart muscle contraction in patients with uncontrolled heart failure, after heart surgery, with heart muscle disease and in shock.

2. Important Information Before Using Dobutamin Sandoz

When Not to Use Dobutamin Sandoz

if the patient has:

• hypersensitivity to dobutamine or mannitol;
• a pheochromocytoma of the adrenal gland; if the patient is taking monoamine oxidase inhibitors (MAOIs).

Warnings and Precautions

Before starting treatment, discuss it with your doctor.
Caution should be exercised if:
the patient has an acute heart attack,
the patient has undergone a heart transplant,
the patient has asthma,
the patient has heart disease, including unstable angina pectoris,
the patient has high blood pressure,
the patient has severe hypotension in cardiogenic shock,
the patient's condition does not allow for significant physical exertion.
Before administering dobutamine, the doctor will correct hypovolemia (too little blood in the circulatory system) if necessary, by administering whole blood or plasma.
Dobutamine has occasionally been reported to cause a sudden drop in blood pressure.
In case of excessive acceleration of heart rate, increased systolic pressure, or cardiac rhythm disturbances, the doctor will reduce the dose of dobutamine or temporarily discontinue the medication.
In heart failure with acute or chronic myocardial hypoperfusion during dobutamine treatment, the doctor will monitor the patient's heart function and blood pressure.
Children
Acceleration of heart rate and increased blood pressure occur more frequently and are more pronounced in children than in adults. There are reports of lower sensitivity of the cardiovascular system of newborns to dobutamine, and it seems that the hypotensive effect is observed more frequently in adults than in small children. Therefore, the use of dobutamine in children should be carefully monitored, taking into account the above pharmacodynamic characteristics.

Dobutamin Sandoz and Other Medications

Tell your doctor about all medications you are currently taking or have recently taken, as well as any medications you plan to take. This includes medications that are available without a prescription.
Dobutamin Sandoz and other medications used at the same time may affect each other's action and the occurrence of side effects.
It is essential to inform your doctor about the use of the following medications:
beta-adrenergic blockers (medications used to treat high blood pressure, certain heart diseases);
nitroglycerin, sodium nitroprusside (medications that dilate blood vessels);
dopamine;
monoamine oxidase inhibitors (MAOIs).
If the patient is to undergo general anesthesia, it is necessary to inform the anesthesiologist about dobutamine treatment.
In case of doubts about what these medications are or whether the patient is taking them, consult a doctor, pharmacist, or nurse.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before using this medication.
Pregnancy
There is insufficient evidence on the safety of dobutamine use during pregnancy in humans.
It is not known whether dobutamine passes through the placenta. The medication may be used in pregnant women only when the potential benefits to the mother outweigh the risks to the fetus and when no safer alternative treatment is available.
Breastfeeding
It is not known whether dobutamine passes into breast milk, so caution should be exercised. If the use of dobutamine during breastfeeding is necessary, it is recommended to discontinue breastfeeding during treatment.

Driving and Operating Machinery

Patients whose medication impairs their psychophysical abilities should not drive vehicles or operate machinery.

3. How to Use Dobutamin Sandoz

The medication Dobutamin Sandoz is intended for use only in a hospital setting, under the strict supervision of a doctor.
The medication can only be administered by qualified medical personnel.
The medication is administered exclusively by intravenous infusion (drip).
The dosage of dobutamine is determined individually for each patient by the doctor.
A detailed instruction is provided at the end of the package leaflet, in the section intended for medical personnel.
The duration of treatment depends on the patient's clinical condition.

Overdose of Dobutamin Sandoz

The medication is administered by a doctor or nurse, so it is unlikely to receive an overdose.
However, if the patient feels that they have received too much medication and experiences nausea, vomiting, loss of appetite, tremors, anxiety, palpitations, headache, chest pain, or shortness of breath, they should immediately inform their doctor or nurse.
Procedures in case of overdose are described at the end of the package leaflet, in the section intended for medical personnel.
In case of any further doubts related to the use of this medication, consult a doctor, pharmacist, or nurse.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everybody gets them.
The following side effects are possible:
Very common side effects (may occur in more than 1 in 10 people):
accelerated heart rate
Common side effects (may occur in less than 1 in 10 people):
increased number of eosinophils in the blood, inhibition of platelet aggregation, headache, increased or decreased blood pressure, ventricular arrhythmias, additional ventricular contractions, accelerated heart rate in patients with atrial fibrillation, vasoconstriction, angina pectoris, palpitations, bronchospasm, shortness of breath, nausea, rash, chest pain, increased need to urinate, fever, phlebitis at the injection site, local inflammation due to accidental extravascular administration of the medication
Uncommon side effects (may occur in less than 1 in 100 people):
ventricular tachycardia, ventricular fibrillation
Rare side effects (may occur in less than 1 in 10,000 people):
decreased potassium levels in the blood (hypokalemia), slowed heart rate (bradycardia), myocardial ischemia, myocardial infarction, cardiac arrest, petechial bleeding, skin necrosis
Frequency not known (cannot be estimated from the available data):
decreased blood pressure in the pulmonary vessels, restlessness, feeling of heat and anxiety, disturbances of heart function (stress cardiomyopathy, also known as takotsubo syndrome), manifested by chest pain, shortness of breath, dizziness, fainting, irregular heartbeat, occurring during dobutamine stress echocardiography.
Children and Adolescents
Side effects in children include: increased systolic blood pressure, systemic hypertension or hypotension, accelerated heart rate (tachycardia), headache, increased pulmonary artery occlusion pressure leading to pulmonary congestion and edema, as well as related symptoms.

Reporting Side Effects

If you experience any side effects, including any not listed in this package leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medication.

5. How to Store Dobutamin Sandoz

Keep the medication out of the sight and reach of children.
Do not use this medication after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the month.
Store in a temperature below 25°C. Store in the original packaging to protect from light.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Package Contents and Other Information

What Dobutamin Sandoz Contains

The active substance of the medication is dobutamine. One vial contains 250 mg of dobutamine in the form of 280 mg dobutamine hydrochloride and mannitol.

What Dobutamin Sandoz Looks Like and What the Package Contains

The package consists of 1 vial sealed with a rubber stopper and an aluminum cap, placed in a cardboard box.

Marketing Authorization Holder

Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl, Austria

Manufacturer

Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany

For More Information, Contact:

Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00
{Logo Sandoz}
Date of Last Revision of the Package Leaflet:02/2022

Information Intended for Healthcare Professionals Only

Special Warnings and Precautions for Use

In case of excessive acceleration of heart rate, increased systolic pressure, or cardiac rhythm disturbances, the dose of dobutamine should be reduced or its administration temporarily discontinued.
Dobutamine may cause or exacerbate additional ventricular contractions, rarely leading to ventricular tachycardia or fibrillation. Since dobutamine facilitates atrioventricular conduction, in patients with atrial flutter or fibrillation, a rapid ventricular response may develop.
Particular caution is required when using dobutamine in patients with acute myocardial infarction, as any significant acceleration of heart rate or excessive increase in blood pressure may worsen myocardial ischemia and cause angina pectoris and ST-segment elevation.
Products with inotropic effects, including dobutamine, do not improve hemodynamic parameters in most patients with mechanical obstruction impairing ventricular filling, ejection, or both. In patients with significantly reduced ventricular compliance, the inotropic response may be inadequate. This applies to cardiac tamponade, aortic stenosis, and idiopathic hypertrophic subaortic stenosis.
Occasional slight vasoconstriction has been observed, mainly in patients who were previously treated with beta-adrenergic blockers. The inotropic effect of dobutamine results from the stimulation of beta-1 receptors in the heart and is antagonized by beta-adrenergic blockers. It has been shown that dobutamine counteracts the cardiodepressive effect of beta-adrenergic blockers, but beta-adrenergic blockade of beta-1 and beta-2 receptors may lead to tachycardia and vasodilation.
During dobutamine treatment, as with any intravenously administered catecholamine, it is essential to closely monitor heart rate, blood pressure, and infusion rate. At the beginning of treatment, it is recommended to monitor the ECG until a stable response to treatment is achieved.
Occasional cases of sudden drop in blood pressure have been reported during dobutamine treatment. Reducing the dose or discontinuing the infusion usually results in a rapid return of blood pressure to initial values. In rare cases, however, medical intervention may be necessary, and normalization of blood pressure may not occur very quickly.
Dobutamine should be used with caution in patients with severe hypotension in cardiogenic shock (mean arterial blood pressure below 70 mmHg).
Before administering dobutamine, hypovolemia should be corrected if necessary by administering whole blood or plasma.
If during dobutamine treatment, blood pressure remains low or continues to decrease despite adequate filling pressure and cardiac output, the concurrent use of vasoconstrictor agents, such as dopamine or norepinephrine, may be considered.
During dobutamine treatment, local increases or decreases in coronary blood flow may occur, changing the oxygen demand of the heart muscle.
In patients with severe coronary artery disease, the clinical picture may worsen, especially if dobutamine treatment results in accelerated heart rate and/or increased blood pressure. Therefore, for each patient with myocardial ischemia, the indications for dobutamine use should be carefully considered.
In heart failure with concomitant acute or chronic myocardial hypoperfusion during dobutamine treatment, it is essential to avoid significant acceleration of heart rate and/or increased blood pressure. It is impossible to rule out the provocation of myocardial ischemia, especially in cases of relatively preserved ventricular function.
Dopamine is the medication of choice for the treatment of cardiogenic shock characterized by heart failure and decreased blood pressure, as well as septic shock.
In patients with impaired left ventricular function, increased left ventricular filling pressure, and increased peripheral resistance, it is recommended to add dobutamine to dopamine treatment.
Children and Adolescents
Dobutamine has been administered to children with reduced cardiac output in hypoperfusion states due to uncontrolled heart failure after cardiac surgery, in cardiomyopathy, in cardiogenic or septic shock. Some hemodynamic effects of dobutamine hydrochloride in children and adults may differ quantitatively and qualitatively. Accelerated heart rate and increased blood pressure occur more frequently and are more pronounced in children. Pulmonary artery occlusion pressure may not decrease, as it does in adults, but may even increase, especially in infants under 1 year of age. There are reports of lower sensitivity of the cardiovascular system of newborns to dobutamine, and it seems that the hypotensive effect is observed more frequently in adults than in small children. Therefore, the use of dobutamine in children should be carefully monitored, taking into account the above pharmacodynamic characteristics.

Dosage and Administration

The dosage of dobutamine should be determined individually for each patient.
Adults
In most patients, the desired response is achieved with dobutamine doses ranging from 2.5 to 10 micrograms/kg/min. Occasionally, dobutamine has been used in doses up to 40 micrograms/kg/min.
Children and Adolescents
In children of all age groups (from newborns to 18 years), the recommended initial dose is 5 micrograms/kg/min, which should be adjusted according to the clinical response within the range of 2 to 20 micrograms/kg/min. Occasionally, a response is achieved with a small dose of 0.5 to 1.0 microgram/kg/min. It has been proven that the minimum effective doses in children are higher than in adults. When using higher doses of dobutamine, particular caution should be exercised, as the maximum tolerated doses in children are lower than those used in adults. Most side effects (especially tachycardia) have been observed after administration of dobutamine in doses equal to or greater than 7.5 micrograms/kg/min. Rapid resolution of side effects can be achieved by reducing the infusion rate or discontinuing it.
Among pediatric patients, there is significant variability in both the plasma concentration of dobutamine that elicits a hemodynamic response (threshold) and the rate of hemodynamic response to increased plasma concentration, indicating that the required dose for children cannot be predetermined and should be determined based on the likely narrower therapeutic range than in adults.
The following tables show the relationship between infusion rate and dose of the medication.

* When using a twice higher concentration of dobutamine, i.e., 500 mg (2 vials) of dobutamine in 50 ml of solvent, the infusion rate indicated in the table should be reduced by half.
Administration using volumetric (drip) infusion devices
250 mg of dobutamine (1 vial) in 500 ml*

* When using a twice higher concentration of dobutamine, i.e., 500 mg (2 vials) of dobutamine in 500 ml of solvent or 250 mg of dobutamine in 250 ml of solvent, the infusion rate indicated in the table should be reduced by half.
Method of Administration
Due to the short half-life of dobutamine, it should be used in continuous intravenous infusion.
The desired intravenous infusion rate of dobutamine depends on the patient's response and the occurrence of side effects.
During administration of Dobutamin Sandoz, it is essential to closely monitor heart rate, blood pressure, urine output, and infusion rate. Whenever possible, cardiac output, central venous pressure, and pulmonary capillary wedge pressure should be monitored during treatment. The duration of treatment depends on the patient's clinical condition.
Dobutamine should be discontinued by gradually reducing the administered dose.
Method of administration in children
To administer the medication in the form of a continuous infusion using an infusion pump, the solution should be diluted with 5% glucose solution, 0.9% sodium chloride solution, or Ringer's solution with lactate to achieve a dobutamine concentration of 0.5 to 1 mg/ml (maximum 5 mg/ml with restriction of fluid volume). Administration of solutions with higher concentrations is only allowed through a central venous line.
The dobutamine infusion solution is incompatible with solutions containing bicarbonate and other strongly alkaline solutions.
Use in newborns in intensive care settings
Dilute the dose of 30 mg/kg body weight to a final volume of 50 ml of infusion solution.
Infusion administered at a rate of 0.5 ml per hour provides a dose of 5 micrograms/kg/min.

Overdose Procedure

Dobutamine is rapidly metabolized and has a short duration of action (plasma half-life is 2 to 3 minutes).
In case of overdose, the intravenous infusion should be discontinued first. If necessary, supportive measures should be taken under intensive medical supervision. It is essential to monitor blood gas parameters and electrolyte levels.
In case of severe ventricular arrhythmias, lidocaine or beta-adrenergic blockers (e.g., propranolol) can be used.
Angina pectoris should be treated with sublingual nitroglycerin and (or) a short-acting beta-adrenergic blocker administered intravenously (such as esmolol).
In cases of reactions related to increased blood pressure, it is usually sufficient to reduce the dose of the medication or discontinue the infusion.
After accidental oral ingestion, the extent of absorption from the mouth or gastrointestinal tract is difficult to predict. After unintentional oral intake of the medication, absorption can be limited by administering activated charcoal, which is often more effective than emetics or gastric lavage.
In cases of dobutamine overdose, no benefits have been demonstrated from the use of forced diuresis, peritoneal dialysis, hemodialysis, or hemoperfusion through charcoal filters.

Pharmaceutical Incompatibilities

Dobutamin Sandoz should not be mixed with the following substances:
alkaline solutions (e.g., sodium bicarbonate), solutions containing sodium bisulfite and ethanol, acyclovir, aminophylline, bretylium, calcium chloride, calcium gluconate, cefamandole nafate, cefalotin sodium, cefazolin sodium, diazepam, digoxin, sodium ethacrylate, furosemide, heparin sodium, sodium salt of hydrocortisone succinate, insulin, potassium chloride, magnesium sulfate, penicillin, phenytoin, streptokinase, and verapamil.
Dobutamin Sandoz should not be administered using medical equipment (such as needles, syringes, infusion devices) used to administer these substances.

Instructions for Preparation of the Medication

Dobutamin Sandoz is intended for use in the form of intravenous infusions after dissolution and dilution.
The dry substance in the vial should be dissolved in 10 ml of water for injection. If the substance does not dissolve completely, an additional 10 ml of water for injection should be added.
For initial dissolution of the dry substance, salt solutions should not be used due to the possibility of interference with ions contained in the solvent and limited solubility of dobutamine.

For puncturing the stopper before dissolving the medication in the vial, needles with a diameter not exceeding 0.8 mm should be used. The rubber stopper should be punctured vertically due to the possibility of its fragments breaking off and entering the prepared solution.

Immediately before performing the infusion, the solution should be diluted (in 5% glucose solution, 0.9% sodium chloride solution, or Ringer's solution with lactate) to the volume in which the product will be administered. Dilution should be performed immediately before use, and the solution must be used within 24 hours.
After dissolution in 10 ml of water for injection and dilution in one of the following solutions: 5% glucose solution, 0.9% sodium chloride solution, or Ringer's solution with lactate, the product remains stable for 24 hours when stored at a temperature between 15°C and 25°C.
From a microbiological point of view, the solution should be used immediately, unless it was prepared using a method that excludes the possibility of microbial contamination. If the solution is not used immediately after preparation, the user is responsible for the conditions and storage period.