Sterile Dobutamine Hydrochloride Solution 250mg in 20ml – patient leaflet, side effects, dosage

1. What Dobutamine Hydrochloride Solution is and what it is used for

Dobutamine Hydrochloride Solution belongs to a group of medicines known as inotropes. Dobutamine Hydrochloride Solution is a heart stimulant and is used to increase the strength of the heart beat.

Dobutamine Hydrochloride Solution is used to increase the output of the heart in some conditions of heart failure caused by disease of the heart muscle or shock, after a heart attack or after heart surgery. It may also be used to improve the performance of the heart during artificial ventilation. Sometimes dobutamine hydrochloride may be used to stimulate the heart instead of exercise during special stress testing of the heart.

2. What you need to know before you are given Dobutamine Hydrochloride Solution

Do not use Dobutamine Hydrochloride Solution if you:

• Are hypersensitive (allergic) to dobutamine, sodium metabisulphate (E223) or any other ingredients contained in the injection (listed in section 6)
• Suffer from high blood pressure due to a tumour near the kidney (phaeochromocytoma) - Have certain heart or blood vessel disorders. Dobutamine Hydrochloride Solution should not be used to detect poor blood supply to your heart (a cardiac stress test known as Dobutamine Stress Echocardiography).

Warnings and precautions

Talk to your doctor or pharmacist or nurse before using this medicine if you: - Have recently had a heart attack

• Have had a heart transplant
• Are asthmatic
• Have unstable angina
• Have heart disease
• Have high blood pressure
• Have any condition that would make exercise dangerous for you.

You will be closely monitored during your treatment with Dobutamine Hydrochloride Solution. Other medicines and Dobutamine Hydrochloride Solution:

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

• Beta blockers (medicines used to relieve certain heart conditions, anxiety and migraine e.g carvedilol)
• Anaesthetics in particular cyclopropane, halothane
• Entacapone (a medicine used to treat Parkinson's Disease).

Pregnancy and breast-feeding:

Please tell your doctor or nurse before being given this medicine if you are pregnant or breast-feeding. The doctor will then decide if this medicine is suitable for you.

Driving and using machines:

You should not drive or use any machinery if you think you are affected after receiving this medicine.

Dobutamine Hydrochloride Solution contains sodium metabisulpite (E223):

This may rarely cause severe hypersensitivity reactions and bronchospasm.

3. How to use Dobutamine Hydrochloride Solution

Dobutamine Hydrochloride Solution is diluted prior to being administered by intravenous infusion. Your nurse or doctor will administer the infusion. Your doctor will decide the correct dosage for you and how and when the infusion will be given. They can give you more information if you need it.

Adults and the elderly:

The solution must be diluted to at least 50ml before being administered but it must not be added to any solution which is alkaline. Because it has a very short duration of action, dobutamine is given by continuous infusion into a vein. If your blood volume is low for any reason, you may be given an infusion of blood or plasma before treatment with dobutamine starts.

Dobutamine Hydrochloride Solution must be diluted to at least 50ml with one of the following intravenous solutions before use:

• Sodium chloride intravenous infusion BP 0.9% w/v
• Dextrose intravenous infusion BP 5% w/v
• 5% dextrose and 0.9% sodium chloride intravenous infusion BP
• 5% dextrose and 0.45% sodium chloride intravenous infusion BP
• Sodium lactate intravenous infusion BP.

Heart Failure

When dobutamine is used for the treatment of heart failure, the rate of administration will be adjusted according to the effect but the usual dose is between 2.5 and 10 micrograms per kilogram body weight per minute. The dose can be as low as 0.5 micrograms/kg/minute or as high as 40 micrograms/kg/minute. It is better to reduce the dose gradually than stop it suddenly.

Stress testing

When dobutamine is being used instead of exercise during stress testing, the starting dose is 5 micrograms/kg/minute and increased at 8 minute intervals by 5 micrograms/kg/minute to a maximum of 20 micrograms/kg/min.

During this time, continuous electrocardiogram (ECG) monitoring should be done and the infusion stopped if the heart rate or blood pressure rises too high, or there are abnormalities on the ECG trace.

Use in children

This medicine is not for use in children.

If you are given too much Dobutamine Hydrochloride solution

Your dose will be carefully calculated by the doctors so overdose is unlikely. However, if too much is given, you may feel sick, or be sick, lose your appetite, feel shaky, anxious, have palpitations, have a headache, feel short of breath and have chest pain. You should tell the doctor or nurse straight away.

4. Possible side effects

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

Your doctor will examine your heart before giving you this medicine to decide if you are suitable to receive the drug.

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)
• Asthma-like symptoms (bronchospasm)
• Shortness of breath
• Increase in white blood cells (eosinophilia)
• Inhibition of blood clot formation
• 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
• Narrowing of the blood vessels supplying the heart (coronary vasospasm).

Not known (cannot be estimated from the available data)

• Chest pain caused by stress (stress cardiomyopathy)
• Allergic reactions (hypersensitivity reactions) including symptoms of rash, fever, increase in white blood cells (eosinophilia) and asthma-like symptoms (bronchospasm) - Severe allergic reactions (anaphylactic reactions) and severe life-threatening asthmatic episodes possibly due to sensitivity to sodium metabisulphite (see Section 2)
• Muscle cramp (myoclonus) in patients with severe renal failure receiving dobutamine - Abnormal heart function test (electrocardiogram ST segment elevation) - Inflammation of heart muscle (eosinophilic myocarditis) in heart transplant patients - Heart block (left ventricular outflow tract obstruction)
• Fatal heart rupture
• Restlessness
• Feeling sick (nausea)
• Headache
• Pins and needles (paraesthesia)
• Tremor
• Increased desire to urinate (at high doses)
• Feelings of heat and anxiety
• Muscle cramp (myoclonic spasm)

• Problems with your heart muscle (stress cardiomyopathy also known as Takotsubo syndrome)

  that present with chest pain, shortness of breath, dizziness, fainting, irregular heartbeat when dobutamine is used for stress echocardiography test

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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Dobutamine Hydrochloride solution

The solution will be stored below 21°C and protected from light. The nurse or doctor will check that the solution is not past its expiry date before administering the infusion. After dilution the solution should be administered immediately or it may be stored at 2-8°C for a maximum of 24 hours.

Keep out of the sight and reach of children.

6. Contents of the pack and other information

What Dobutamine Hydrochloride Solution contains:

The solution contains the active ingredient dobutamine hydrochloride. Each 20 ml of solution contains dobutamine hydrochloride equivalent to 250 mg dobutamine in a sterile solution for infusion. The solution contains the following inactive ingredients:

Sodium metabisulphate (E223)

Sodium hydroxide

Hydrochloric acid

Water for injection.

What Dobutamine Hydrochloride Solution looks like and the contents of the pack:

Dobutamine Hydrochloride Solution is supplied in 20ml clear glass ampoules. Dobutamine Hydrochloride Solution is available in cartons containing 1, 5 or 10 ampoules.

Marketing Authorisation Holder and Manufacturer:

Ennogen IP Ltd

Unit G4, Riverside Industrial Estate,

Riverside Way, Dartford, DA1 5BS, UK

Manufacturer

EGIS Pharmaceutical Works

RTLACTAT Apszergy Ara, 9900 Kormend

Ma Ty As Kiral Y Uta

Hungary

This leaflet was revised in April 2026.

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