Dobutamine Hydrochloride Injection

Generic Name: dobutamine hydrochloride injection
Product Name: Dobutamine Sandoz

Indication: What dobutamine is used for

This medicine is used to treat heart failure following a heart attack or heart surgery.

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason.

This medicine is not addictive.

This medicine is available only with a doctor’s prescription.

Dobutamine Sandoz is not recommended for use in children. The safety and effectiveness of Dobutamine Sandoz in children have not been established.

Action: How dobutamine works

The name of your medicine is Dobutamine Sandoz. It contains the active ingredient dobutamine hydrochloride.

This medicine belongs to a group of medicines called adrenergic stimulants. Dobutamine Sandoz works by helping the heart to beat more strongly.

Each ampoule of Dobutamine Sandoz contains 250mg of the active ingredient, dobutamine, as the hydrochloride salt.

It also contains the inactive ingredients sodium metabisulfite, sodium hydroxide, hydrochloric acid, and water for injections.

This medicine does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.

Dose advice: How to use Dobutamine Sandoz

Before you are given Dobutamine Sandoz

When you must not be given it

Do not use Dobutamine Sandoz if you have an allergy to dobutamine or any of the ingredients listed here. Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin.

Do not use Dobutamine Sandoz if you have a heart condition known as idiopathic hypertrophic subaortic stenosis.

This medicine should not be used after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.

If you are not sure whether you should be given this medicine, talk to your doctor.

Before you are given it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you have an allergy to sodium metabisulfite.

Tell your doctor if you have or have had any medical conditions, including:

• High or low blood pressure;
• Any heart problems;
• Asthma.

Tell your doctor if you are pregnant or plan to become pregnant or are breastfeeding or intend to breastfeed. Your doctor can discuss with you the risks and benefits involved.

If you have not told your doctor about any of the above, tell them before you are given Dobutamine Sandoz.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and Dobutamine Sandoz may interfere with each other. These include:

• Some medicines used to treat high blood pressure;
• Some medicines used to treat heart problems;
• Some anaesthetics;
• Some adrenergic agents (adrenaline-like agents).

These medicines may be affected by Dobutamine Sandoz or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.

How Dobutamine Sandoz is given

Dobutamine Sandoz is given as a slow injection into a vein. Dobutamine Sandoz is a concentrated injection which will be diluted before being injected.

Dobutamine Sandoz will be given to you in the hospital by highly trained medical personnel.

Your doctor will decide on the dose and how long you will receive Dobutamine Sandoz. This will depend on your condition, whether you are taking any other medicines and how well you respond to the medicine.

If you are given too much (overdose)

If you have been given too much Dobutamine Sandoz your doctor has information on how to recognise and treat an overdose.

If you have been given too much Dobutamine Sandoz you may experience symptoms such as loss of appetite, nausea, vomiting, tremor, anxiety, headache, shortness of breath, fast heartbeat or chest pain.

However, immediately telephone your doctor or the Poisons Information Centre on 13 11 26 for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have been given too much Dobutamine Sandoz. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

While you are using Dobutamine Sandoz

Things you must do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are being given Dobutamine Sandoz.

Tell any other doctors, dentists, and pharmacists who are treating you that you are using this medicine.

If you are going to have surgery, tell the surgeon or anaesthetist that you are being given this medicine. It may affect other medicines used during surgery.

If you are about to have any blood tests tell your doctor that you are having Dobutamine Sandoz. It may interfere with the results of some tests.

If you become pregnant while using this medicine, tell your doctor immediately.

After using Dobutamine Sandoz

Storage

Dobutamine Sandoz will be stored on the pharmacy or on the ward in a cool dry place where the temperature stays below 25^oC.

Schedule of dobutamine

Dobutamine Hydrochloride Injection is a Schedule 4 – prescription only medicine.

Side effects of dobutamine

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are being given Dobutamine Sandoz. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor or nurse if you notice any of the following and they worry you:

• Nausea;
• Headache;
• Fever;
• Pain, redness or swelling at the site of the injection;
• Dizziness, lightheadedness.

The above list includes the more common side effects of your medicine. They are usually mild.

Tell your doctor or nurse immediately if you notice any of the of the following:

• Shortness of breath, wheezing or difficulty breathing;
• Skin rash, itching or hives;
• Swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing;
• Swelling of the hands or feet;
• Chest pain;
• Fast heartbeat;
• Feeling faint;
• Bleeding or bruising more easily than normal.

The above list includes serious side effects which may require urgent medical attention. Serious side effects are rare.

Tell your doctor or pharmacist if you notice anything that is making you feel unwell. Other side effects not listed above may also occur in some people.

Do not be alarmed by this list of side effects. You may not experience any of them.

For further information talk to your doctor.

References

1.  Dobutamine Sandoz Consumer Medicine Information (CMI). Macquarie Park, NSW: Sandoz Pty Ltd. February 2016. [PDF]
2. Dobutamine Sandoz Product Information (PI). Macquarie Park, NSW: Sandoz Pty Ltd. February 2016. [PDF]