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ISOSORBIDE DINITRATE 0.1% CONCENTRATE FOR SOLUTION FOR INJECTION

Active substance(s): ISOSORBIDE DINITRATE

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Patient Information Leaflet
Isosorbide Dinitrate 0.1% Concentrate for Solution for Injection




Please read this leaflet carefully before you start using this medicine.
Keep this leaflet in a safe place, you may wish to read it again.
If you have any questions or are not sure about anything, ask your
doctor or pharmacist.
• If any side effect gets serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Isosorbide Dinitrate Concentrate for Solution for Injection is and what it
is used for
2. Before you are given Isosorbide Dinitrate Concentrate for Solution for
Injection
3. How Isosorbide Dinitrate Concentrate for Solution for Injection is used
4. Possible Side Effects
5. How to store Isosorbide Dinitrate Concentrate for Solution for Injection
6. Further Information
1. What Isosorbide Dinitrate Concentrate for Solution for Injection is and what it is
used for
Isosorbide Dinitrate, the active ingredient, belongs to a group of medicines called
vasodilators used in the treatment of heart disease. It works by widening the arteries and
veins so decreasing the resistance to blood flow and lowering blood pressure.
This medicine is a concentrated solution for injection and is used for the treatment of heart
problems. It is specifically used for:
• Treatment of severe chest pain (angina) which may start suddenly and gets increasingly
worse
• Treatment of heart failure, which may have occurred after a heart attack
• Surgical procedures treating narrowing of heart arteries
2. Before you are given Isosorbide Dinitrate Concentrate for Solution for Injection
Please tell your doctor if you are taking any other medication.
This medicine should NOT BE USED if you:
• Are allergic to isosorbide dinitrate or any other medication containing nitrate,
mononitrate or dinitrate
• Have ever had a ruptured blood vessel in your brain (cerebral haemorrhage)
• Suffer from anaemia (reduced number of red blood cells or iron level)
• Have low blood pressure
• Have a low blood volume because of injury or another reason
• Have been taking sildenafil
This medicine should be used with caution in patients who:
• Are taking any other medication
• Are pregnant or breastfeeding
• Suffer from glaucoma (a type of eye disease)
• Suffer from thyroid problems
• Suffer from malnutrition or hypothermia (low body temperature)
• Suffer from liver or kidney disease
Taking other medicines:
This medicine may not be suitable for you to take; please tell your doctor if you:
• Are taking medicines to treat depression
• Are taking medicines to make you sleep such as hypnotics or sedatives
• Are taking medicines to reduce high blood pressure
• Drink alcohol
Check with your doctor if you are concerned about any of the above.
Important information about some of the ingredients in this medicine
This medicine contains up to 3mmol sodium per dose. Take into consideration if you are on
a low-sodium diet.
3. How Isosorbide Dinitrate Concentrate for Solution for Injection is used
The doctor will decide what dose of this medicine you should be given. Check the label
carefully. If you are not sure, ask your doctor, nurse or pharmacist.
This medicine must be diluted before use with Sodium Chloride Injection or Glucose
Injection. It should never be used undiluted.
This medicine is either given by infusion into a vein or by direct injection into the coronary
artery. Doses will be adjusted by your doctor, but the usual dose is between 2mg and 12mg
per hour. The normal dose for direct injection into the coronary artery is 1mg.
The injection is for single use only, so once the ampoule or vial is opened the medicine
should be used immediately and any unused medicine discarded.
If a dose of this medicine is not given at the correct time – the dose should be given as
soon as it is remembered. The next dose should be given at the usual time. A double dose
should not be given.
If more of this medicine is given than should be – tell your doctor as soon as possible. If
you are a medical practitioner administering this medicine please refer to the Summary of
Product Characteristics.



Additional information for Healthcare Professionals
(as stated on the Summary of Product Characteristics)
Therapeutic indications
• Treatment of unresponsive left ventricular failure, secondary to acute myocardial infarction.
• Unresponsive left ventricular failure of various aetiologies.
• Severe or unstable angina pectoris.
• To facilitate or prolong balloon inflation and to prevent or relieve coronary spasm during
percutaneous transluminal coronary angioplasty.
Posology and method of administration
Isosorbide Dinitrate 0.1% Concentrate for Solution for Injection is a concentrated solution. It
should never be injected directly and must be diluted.
Avoid administration through PVC tubing and giving sets, because of adsorption of
isosorbide dinitrate into plastic.

4. Possible side effects
As with all medicines, there may be some side effects with this medicine although not
everyone gets them.
The most common side effects that may occur during administration are:
• Headache
• Nausea
• Increased heart beat
• Drop in blood pressure when given the medicine
Your pulse and blood pressure may be monitored during administration (because of these
effects).
Tell your doctor, nurse or pharmacist immediately if you think you have any of these,
or other problems.
Reporting of Side Effects
If you get any side effects, talk to your doctor, nurse or pharmacist. 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.
5. How to store Isosorbide Dinitrate Concentrate for Solution for Injection
The medicine has an expiry date printed on the ampoule or vial and carton label.
Before use the doctor or nurse will check the medicine has not passed this date and that the
medicine does not show any sign of deterioration. The expiry date refers to the last day of
the month.
Only use this medicine if it is particle free. This medicine is for single use only, so once the
ampoule or vial is opened the medicine should be used immediately and any unused
medicine discarded.
After the expiry date, return any unused medicine to a pharmacy.
Store this medicine in a safe place where children cannot see or reach it.
Keep the container in the outer carton to protect it from light.
6.
6. Further information
What this medicine contains:
• The active ingredient is Isosorbide Dinitrate at a strength of 1mg in 1mL.
• It also contains the inactive ingredients Sodium Chloride and Water for Injections.
What this medicine looks like and contents of the pack:
This medicine is a clear and colourless solution. This medicine comes in 10mL single use
ampoules and 50mL single use vials. The medicine is packed into cartons containing 10
ampoules, 1 vial or 10 vials. Both pack sizes of vials may not be available at the same time.
Marketing Authorisation Holder: Torbay and South Devon NHS Foundation Trust,
Torbay Pharmaceuticals, Wilkins Drive, Paignton, Devon, TQ4 7FG
Sites of Manufacture:
Torbay and South Devon NHS Foundation
Trust
Torbay Pharmaceuticals
Long Road
Paignton
Devon
TQ4 7TW

Torbay and South Devon NHS Foundation
Trust
Torbay Pharmaceuticals
Wilkins Drive
Paignton
Devon
TQ4 7FG

This leaflet was last revised in: 12/2015
PL 13079/0003

PIL/3/7


Intravenous administration: Dosage should be adjusted according to patient response.
Typically, a dose of between 2mg and 12mg per hour is suitable, although doses of up to
20mg per hour may be necessary.
Prepared admixtures are always given by intravenous infusion or using a syringe pump
incorporating a glass or rigid plastic syringe. The patient’s blood pressure and pulse should
be monitored closely during administration.
Intracoronary administration: A dilution of 50% is recommended. The usual dose is 1mg
given as a bolus injection prior to balloon inflation. Additional doses may be given, not
exceeding 5mg over 30 minutes.
The safety and efficacy of Isosorbide Dinitrate 0.1% Concentrate for Solution for Injection
has not been established in children. No modifications to the dosage are necessary for
elderly patients.
Isosorbide Dinitrate 0.1% Concentrate for Solution for Injection is presented in 10mL
ampoules and 50mL vials intended for single use only.
Incompatibilities
The use of PVC giving sets and containers should be avoided as significant losses of the
active ingredient by adsorption can occur.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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