What Dobutamine is used for and how to use it
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Dobutamine - Consumer Medicine Information

Manufacture: hameln pharmaceuticals
Country: Germany
Condition: Heart Failure (Congestive Heart Failure), Shock
Class: Cardiac stressing agents, Catecholamines, Inotropic agents, Vasopressors
Form: Liquid solution, Intravenous (IV)
Ingredients: dobutamine hydrochloride, sodium metabisulfite (E 223), sodium chloride, hydrochloric acid and water for injections

Dobutamine

What Dobutamine is and what it is used for

Dobutamine belongs to a group of medicines called catecholamines. It helps your heart to work more effectively. It works by strengthening the pumping action of the heart, increasing the amount of blood flow in the body and by expanding your veins and arteries.

Dobutamine is used

  • to treat heart failure (cardiac decompensation) if the heart is not beating strongly enough (depressed contractility),
  • in heart failure where there is severe low blood pressure (hypotension),
  • to detect poor blood supply to the heart (cardiac stress testing).

Paediatric population

Dobutamine is indicated in all paediatric age groups (from neonates to 18 years of age) as inotropic support in low cardiac output hypoperfusion states resulting from decompensated heart failure, following cardiac surgery, cardiomyopathies and in cardiogenic or septic shock.

What you need to know before you use dobutamine

Do not use Dobutamine if

  • you are allergic (hypersensitive) to Dobutamine or any of the other ingredients (see list of ingredients in section 6). An allergic reaction may include rash, itching, difficulty in breathing or swelling of the face, lips, throat or tongue. You may know this from earlier experience.
  • there is a narrowing in your heart or blood vessels that prevents the heart from filling or ejecting blood properly (your doctor will know this).
  • there is a lack of adequate circulatory filling (hypovolaemia).

If you have certain heart or blood vessel disorders, Dobutamine should not be used to detect poor blood supply to your heart.

Warnings and precautions

Tell your doctor if you have any of the following conditions:

  • asthma and you have been told that you are allergic to sulfites,
  • severe coronary heart disease,
  • acute (sudden) heart failure.

Children

Increments in heart rate and blood pressure appear to be more frequent and intense in children than in adults. The new-born baby cardiovascular system has been reported to be less sensitive to dobutamine and hypotensive effect (low blood pressure) seems to be more often observed in adult patients than in small children. Accordingly, the use of Dobutamine in children should be monitored closely.

Caution is advised in giving high doses of Dobutamine to children. Your doctor will adjust the required dose for your child carefully.

Other medicines and Dobutamine

Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including medicines you can get without a prescription. This is especially important with the following medicines as they may interact with your Dobutamine:

  • beta blockers (treatment of high blood pressure and irregular heart rhythms),
  • alpha blockers (treatment of high blood pressure and prostate enlargement),
  • vasodilators (expanding blood vessels, used to treat an angina attack or severe heart failure),
  • antidiabetics (treatment of diabetes),
  • ACE inhibitors (treatment of high blood pressure and heart failure),
  • dopamine (used to increasing heart rate and blood pressure),
  • inhaled anaesthetics.

It may still be all right for you to receive Dobutamine and your doctor will be able to decide what is suitable for you.

Pregnancy and breast-feeding

Dobutamine should not be given to pregnant women unless medically justified. It is recommended that you stop breast-feeding during your treatment with Dobutamine. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

If you have any concerns ask your doctor or pharmacist.

Dobutamine contains sodium metabisulfite (E 223), which may rarely cause allergic reactions (hypersensitivity) and asthma-like symptoms (bronchospasm).

This medicinal product contains 3.05 mg sodium per 1 ml. This should be taken into consideration by patients on a controlled sodium diet.

How to use Dobutamine

Dobutamine will be given to you by specifically trained health care professionals and emergency equipment will be available.

Dosage

The required rate of infusion depends on your response to therapy and any side effects. Your doctor will decide the dose of Dobutamine you will be given and will adjust the flow rate and duration of your infusion.

Dosage in adults

Most patients respond to doses of 2.5-10 micrograms of Dobutamine per kg body weight per minute. Doses up to 40 micrograms of Dobutamine per kg body weight per minute have been given.

Dosage in children

For all paediatric age groups (neonates to 18 years) an initial dose of 5 micrograms/kg/minute, adjusted according to clinical response to 2-20 micrograms/kg/minute is recommended. Occasionally, a dose as low as 0.5-1.0 micrograms/kg/minute will produce a response. The required dose for children should be titrated in order to allow for the supposedly smaller “therapeutic width” in children.

Possible Side Effects

Like all medicines, Dobutamine can cause side effects, although not everybody gets them.

The following side effects have been reported

Very common (more than 1 in 10 patients)

  • increased heart rate
  • chest pain
  • heartbeat disturbances

Common (in less than 1 in 10, but more than 1 in 100 patients)

  • blood pressure increase or decrease
  • narrowing of the blood vessels (vasoconstriction)
  • irregular heartbeat (palpitations)
  • headache
  • asthma-like symptoms (bronchospasm)
  • shortness of breath
  • increase in white blood cells (eosinophilia)
  • inhibition of blood clot formation
  • increased desire to urinate (at high doses)
  • feeling sick (nausea)
  • rash (exanthema)
  • fever
  • inflammation of the vein at the injection site (phlebitis)

Uncommon (in less than 1 in 100, but more than 1 in 1000 patients)

  • fast contractions of the ventricles of the heart (ventricular tachycardia)
  • uncontrolled contractions of the ventricles of the heart (ventricular fibrillation)
  • heart attack (myocardial infarction)

Very rare (in less than 1 in 10 000, including isolated cases)

  • slow heartbeat (bradycardia)
  • not enough blood supplied to the heart (myocardial ischaemia)
  • low potassium (hypokalaemia)
  • spots on the skin (petechial bleeding) - heart block
  • heart block
  • narrowing of the blood vessels supplying the heart (coronary vasospasm)
  • restlessness
  • pins and needles (paraesthesia)
  • tremor
  • feelings of heat and anxiety
  • muscle cramp (myoclonic spasm)

Not known (cannot be estimated from the available data)

  • coronary artery disease by stress (stress cardiomyopathy)

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse:
This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

How to Store Dobutamine

  • Your doctor or pharmacist is responsible for storing Dobutamine. They are also responsible for disposing of any unused Dobutamine correctly.
  • Keep this medicine out of the sight and reach of children.
  • Do not use Dobutamine after the expiry date (EXP:) printed on the pack. The expiry date refers to the last day of that month.
  • Do not use Dobutamine if you notice the solution is not clear and free of particles or if the container is damaged.
  • Keep the ampoules/vials in the outer carton in order to protect from light.
  • Do not store above 25°C. Do not refrigerate or freeze.

Contents of the pack and other information

What Dobutamine contains

The active substance is dobutamine hydrochloride.

1 ml solution contains 5 mg dobutamine.

Each 50 ml ampoule/vial Dobutamine contains dobutamine hydrochloride corresponding to 250 mg dobutamine.

The other ingredients are sodium metabisulfite (E 223), sodium chloride, hydrochloric acid and water for injections.

What Dobutamine looks like and contents of the pack

Dobutamine is a clear colourless or almost colourless solution for infusion.

Dobutamine is supplied in 50 ml clear glass ampoules or vials. It is available in original packages containing 1, 5 and 10 ampoules and packs containing 1, 5, 10 and 20 vials.

Not all pack sizes may be marketed.

Marketing authorisation Holder

hameln pharma plus gmbh
31789 Hameln
Germany

Manufacturer

hameln pharmaceuticals gmbh
Langes Feld 13
31789 Hameln
Germany