Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Isosorbide Dinitrate 0.05% w/v Solution for Injection or Infusion
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Isosorbide dinitrate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for lsosorbide 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 solution for injection or infusion 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.
What you need to know before you take it
e Isosorbide Dinitrate 0.05% w/v Solution for Injection or Infusion Please tell your doctor if you are taking any other medication. DO NOT use Isosorbide Dinitrate 0.05% w/v Solution for Injection or Infusion if:
- You are allergic to isosorbide dinitrate or any other medication containing nitrate, mononitrate or dinitrate or any of the other ingredients listed in this medicine (listed in section 6)
- You have ever had a ruptured blood vessel in your brain (cerebral haemorrhage)
- You have had a head injury (head trauma) or raised intracranial pressure (high pressure within your skull)
- You suffer from anaemia (reduced number of red blood cells or iron level)
- You have low blood pressure
- Your blood has stopped circulating around your body properly (circulatory failure)
- You have cardiogenic shock (your heart is not delivering enough oxygen around your body)
- You have constrictive pericarditis (inflammation of the sack-like covering of the heart)
- You have cardiac tamponade or hypertrophic obstructive cardiomyopathy (conditions which affect the ability of your heart to function as a pump)
- You have aortic or mitral valve stenosis (narrowing of the heart valves)
- You have a low blood volume because of injury or another reason
- You have an eye disease called glaucoma
- You have been taking sildenafil or any other phosphodiesterase inhibitor If any of the above applies to you talk to your doctor or pharmacist. Warnings and Precautions Talk to your doctor or pharmacist before using Isosorbide Dinitrate 0.05% w/v Solution for Injection or Infusion if:
- You are pregnant or breastfeeding
- You have hypothyroidism (an underactive thyroid gland which can cause tiredness or weight gain)
- You are malnourished (severely underfed)
- You suffer from hypothermia (a very low body temperature)
- You suffer from liver or kidney disease
- You have other heart problems or a family history of heart problems
- You suffer from orthostatic syndrome (where you may have a rapid heart rate and light-headedness on standing) Other medicines and Isosorbide Dinitrate 0.05% w/v Solution for Injection or Infusion Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. You should not be given Isosorbide Dinitrate with phosphodiesterase inhibitors such as Sildenafil ("Viagra") used for impotence. Using Isosorbide Dinitrate with these medicines could cause your blood pressure to fall to a dangerously low level. Tell your doctor or pharmacist if you are taking any of the following medicines:
- Medicines to lower your blood pressure. They could increase the effect of Isosorbide Dinitrate and lower your blood pressure too much.
- Tricyclic antidepressants (used to treat depression) and neuroleptics (used to treat anxiety). These may also increase the effect of Isosorbide Dinitrate.
- Dihydroergotamine (used to treat migraine). This could increase your blood pressure too much.
- Any other medicine, including medicines obtained without a prescription.
- Sapropterin used for phenylketonuria (PKU). Using Isosorbide Dinitrate 0.05% w/v Solution for Injection or Infusion with alcohol Do not drink alcohol. It could increase the effect of Isosorbide Dinitrate and lower your blood pressure too much. If this happens, you may feel dizzy or faint. Pregnancy and breast-feeding If you are pregnant, trying to become pregnant or breast-feeding, ask your doctor or pharmacist for advice before being given Isosorbide Dinitrate 0.05% w/v Solution for Injection or Infusion. Your doctor will decide whether you should be given this medicine. Driving and using machines Isosorbide Dinitrate may give you a headache, or make you feel dizzy or tired. If this happens to you, do not drive or operate machinery. Isosorbide Dinitrate 0.05% w/v Solution for Injection or Infusion contains Sodium Chloride This medicine contains less than 1mmol sodium (23mg) per 0.5mg per 1mL, that is to say it is essentially 'sodium-free'.
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 Dosage: Adults, including the elderly. Avoid administration through PVC or PU tubing and giving sets, because of adsorption of isosorbide dinitrate onto plastic. 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. lsosorbide Dinitrate 0.05% w/v can be administrated undiluted by slow intravenous infusion using a syringe pump.
How to take it
Isosorbide Dinitrate 0.05% w/v Solution for Injection or Infusion Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. 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 can be administered undiluted or may be diluted with sodium chloride or glucose. The recommended does is: Adults 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, although sometimes as much as 20mg per hour is necessary. The normal dose for direct injection into the coronary artery is 1mg. Further doses may be given if your doctor thinks it is necessary. The injection is for single use only, so once the vial is opened the medicine should be used immediately and any unused medicine discarded. As this medicine is used in hospital, your heartbeat (pulse) and blood pressure will be carefully monitored whilst you are being given Isosorbide Dinitrate. This is to make sure that your medicine is working properly and that the dose you are taking is right for you. Use in Children This medicine is not suitable for children. If you have any further questions about the use of this medicine, ask your doctor or pharmacist. If you are given more Isosorbide Dinitrate 0.05% w/v Solution for Injection or Infusion than you should Tell your doctor as soon as possible. If you are a medical practitioner administering this medicine please refer to the Summary of Product Characteristics. An overdose of Isosorbide Dinitrate may cause your blood pressure to be too low resulting in paleness, sweating, weak pulse, fast heartbeat, light-headedness on standing, headache, weakness, dizziness, feeling sick, being sick and diarrhoea. If you have any concerns about this tell your doctor or nurse. If a dose of Isosorbide Dinitrate 0.05% w/v Solution for Injection or Infusion 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. Do not take a double dose to make up for a forgotten dose. 4. Possible Side Effects Like all medicines, this medicine can cause side effects, although not everyone gets them. Stop taking this medicine and tell your doctor immediately if you experience:
- Swelling of the face, lips or throat which makes it difficult to swallow or breathe, as well as itching and rashes. This could be a sign of severe allergic reaction.
- Fainting which is sometimes accompanied by a slowing heartbeat.
- Swelling of the face or blistering of the skin, mouth, eyes or genitals (Stevens-Johnson syndrome) Other side effects
- Headache
- Drowsiness
- Increased heartbeat
- Weakness
- Light-headedness on standing
- Nausea
- Vomiting
- Feeling faint or dizzy as this may be caused by a reduced blood flow to the brain and heart.
- Worsening symptoms or angina (chest pain)
- Skin rash or flushing
- Heartburn 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: Website: 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.
How to store it
Isosorbide Dinitrate 0.05% w/v Solution for Injection or Infusion
- Keep this medicine out of the sight and reach of children.
- The medicine has an expiry date printed on the vial and carton label. Do not use the medicine after the expiry date. 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.
- After the expiry date, return any unused medicine to a pharmacy.
- Only use this medicine if it is particle free.
- This medicine is for single use only, so once the vial is opened the medicine should be used immediately and any unused medicine discarded.
- Keep the container in the outer carton to protect it from light.
- Do not throw away any medicines via waste water. These measures will help to protect the environment.
Contents of the pack and other information
What Isosorbide Dintirate 0.05% w/v Solution for Injection or Infusion contains
- The active ingredient is isosorbide dinitrate at a strength of 0.5mg in 1mL.
- The other ingredients are sodium chloride and Water for Injections. What Isosorbide Dinitrate 0.05% w/v Solution for Injection or Infusion looks like and contents of the pack This medicine is a clear and colourless solution. This medicine is available in 50mL single use vials. The medicine is packed into cartons containing 1 vial or 10 vials. Both pack sizes of vials may not be available at the same time. Marketing Authorisation Holder and Manufacturer: Torbay Pharmaceuticals Limited Wilkins Drive Paignton Devon TQ4 7FG UK +44 (1803) 664707 [email protected] This leaflet was last revised in: October 2023 PL 56021/0002 PIL/2/7
lntracoronary administration: lsosorbide Dinitrate 0.05% w/v can be injected directly by this route according to the proposed dosage schedule. 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 lsosorbide Dinitrate 0.05% w/v has not been established in children. No modifications to the dosage are necessary for elderly patients. lsosorbide Dinitrate 0.05% w/v is presented in 50mL vials intended for single use only. Incompatibilities The use of polyvinyl chloride (PVC) or polyurethane (PU) giving sets and containers should be avoided as significant losses of the active ingredient by adsorption can occur. Materials made of polyethylene (PE), polypropylene (PP) or polytetrafluroethylene (PTFE) have been proven to be suitable for infusing this medicine.
Frequently asked questions about Isosorbide Dinitrate 0.05% w/v Solution for Injection or Infusion
How do I take Isosorbide Dinitrate 0.05% w/v Solution for Injection or Infusion?
Isosorbide Dinitrate 0.05% w/v Solution for Injection or Infusion comes as injection. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Isosorbide Dinitrate 0.05% w/v Solution for Injection or Infusion?
The active substance in Isosorbide Dinitrate 0.05% w/v Solution for Injection or Infusion is isosorbide dinitrate.
Are there equivalent medicines to Isosorbide Dinitrate 0.05% w/v Solution for Injection or Infusion?
Medicines with the same active substance, strength and form include: Isosorbide Dinitrate 0.1% w/v Concentrate for Solution for Injection or Infusion. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Isosorbide Dinitrate 0.05% w/v Solution for Injection or Infusion, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Isosorbide Dinitrate 0.05% w/v Solution for Injection or Infusion without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: isosorbide dinitrate
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. 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.
4.2. Posology and method of administration
Dosage: Adults, including the elderly.
Avoid administration through PVC or PU tubing and giving sets, because of adsorption of ISDN onto plastic.
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.
Isosorbide Dinitrate 0.05% w/v can be administrated undiluted by slow intravenous infusion using a syringe pump.
Intracoronary administration: Isosorbide Dinitrate 0.05% w/v can be injected directly by this route according to the proposed dosage schedule. 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 0.05% w/v has not been established in children.
No modifications to the dosage are necessary for elderly patients.
Isosorbide Dinitrate 0.05% w/v is presented in 50mL vials intended for single use only.
4.3. Contraindications
Use of Isosorbide Dinitrate 0.05% w/v is contraindicated in patients with known hypersensitivity to nitrates, hypersensitivity to the active substance or to any of the substances listed in section 6.1, marked anaemia, cerebral haemorrhage, head trauma, diseases associated with an increased intracranial pressure, hypovolaemia and severe hypotension (systolic blood pressure less than 90mm Hg), aortic and/or mitral valve stenosis, closed angle glaucoma.
Isosorbide Dinitrate 0.05% w/v must not be used in cases of circulatory collapse or low filling pressure.
Treatment of cardiogenic shock with Isosorbide Dinitrate 0.05% w/v should only be undertaken if means of maintaining an adequate diastolic pressure is available.
Isosorbide Dinitrate 0.05% w/v should not be used in the treatment of hypertrophic obstructive cardiomyopathy, constrictive pericarditis or cardiac tamponade. Phosphodiesterase type-5 inhibitors (e.g. sildenafil, tadalafil and vardenafil) have been shown to potentiate the hypotensive effects of nitrates, and its co-administration with nitrates or nitric oxide donors is therefore contraindicated (see section 4.5).
4.4. Special warnings and precautions for use
Isosorbide Dinitrate 0.05% w/v should be used with caution and under medical supervision in patients who are suffering from
• hypothyroidism
• malnutrition
• severe liver or renal disease
• hypothermia
• orthostatic syndrome
The development of tolerance (decrease in efficacy) as well as cross tolerance towards other nitrate-type drugs (decrease in effect in case of a prior therapy with another nitrate drug) has been described. For a decrease in, or loss of, effect to be prevented, continuously high dosages must be avoided.
Blood pressure and pulse rate should always be monitored and the dose adjusted according to the patient's response.
Isosorbide Dinitrate 0.05% w/v contains 0.15mmol (3.54mg) of sodium per mL and should be taken into consideration by patients on a controlled sodium diet.
4.5. Interaction with other medicinal products and other forms of interaction
Concurrent intake of drugs with blood pressure lowering properties e.g. beta-blockers, calcium antagonists, vasodilators etc. and/or alcohol may potentiate the hypotensive effect of isosorbide dinitrate. This might also occur with neuroleptics and tricyclic antidepressants.
Also phosphodiesterase-5 inhibitors e.g. sildenafil, potentiate the hypotensive effects of isosorbide dinitrate. This might lead to life-threatening cardiovascular complications, see section 4.3.
Reports suggest that, when administered concomitantly, isosorbide dinitrate may increase the blood level of dihydroergotamine and its hypertensive effect.
4.6. Pregnancy and lactation
The safety of this medicinal product for human use in pregnancy has not been established. However, no data have been reported that suggest adverse effects occur as a result of using isosorbide dinitrate during pregnancy. Isosorbide dinitrate should only be used during pregnancy and lactation if the benefits of treatment outweigh the possible hazards.
4.7. Effects on ability to drive and use machines
As for other drugs which produce changes in blood pressure, patients taking Isosorbide Dinitrate 0.05% w/v should be warned not to drive or operate machinery if they experience dizziness or related symptoms.
4.8. Undesirable effects
During administration of Isosorbide Dinitrate 0.05% w/v the following undesirable effects may be observed:
Nervous system disorders: headache, dizziness, somnolence.
Cardiac disorders: tachycardia, angina pectoris aggravated.
Vascular disorders: orthostatic hypotension, collapse (sometimes accompanied by bradyarrhythmia and syncope).
Gastrointestinal disorders: nausea, vomiting, heartburn.
Skin and subcutaneous tissue disorders: allergic skin reactions (e.g. rash), flush, angioedema, Stevens-Johnson-Syndrome, in single cases: exfoliative dermatitis.
General disorders and administration site conditions: asthenia
Severe hypotensive responses have been reported for organic nitrates including nausea, vomiting, restlessness, pallor, and excessive perspiration.
During treatment with Isosorbide Dinitrate 0.05% w/v a temporary hypoxemia may occur due to a relative redistribution of the blood flow in hypoventilated alveolar areas. Particularly in patients with coronary artery disease this may lead to a myocardial hypoxia.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
Symptoms:
• Fall of blood pressure ≤90 mmHg
• Pallor
• Sweating
• Weak pulse
• Tachycardia
• Postural dizziness
• Headache
• Asthenia
• Dizziness
• Nausea
• Vomiting
• Diarrhoea
• Methaemoglobinaemia has been reported in patients receiving other organic nitrates. During isosorbide dinitrate biotransformation nitrite ions are released, which may induce methaemoglobinaemia and cyanosis with subsequent tachypnoea, anxiety, loss of consciousness and cardiac arrest. It cannot be excluded that an overdose of isosorbide dinitrate may cause this adverse reaction.
• In very high doses the intracranial pressure may be increased. This might lead to cerebral symptoms.
General procedure:
• Stop delivery of the drug
• General procedures in the event of nitrate-related hypotension:
- The patient must be laid down with lowered head and raised legs
- Supply oxygen
- Expand plasma volume (i.v. fluids)
- Specific shock treatment (admit patient to intensive care unit)
Special procedure:
• Raise the blood pressure if the blood pressure is very low.
• Additional administration of noradrenaline or other vasoconstrictors.
• Treatment of methaemoglobinaemia
- Reduction therapy of choice with vitamin C, methylene-blue, or toluidine-blue
- Administer oxygen (if necessary)
- Initiate artificial ventilation
• Resuscitation measures
In case of signs of respiratory and circulatory arrest, initiate resuscitation measures immediately.
💬 Ask about this leaflet
Ask anything about Isosorbide Dinitrate 0.05% w/v Solution for Injection or Infusion. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.