ISOSORBIDE DINITRATE

Dosage:

Adults, including the elderly. Isosorbide Dinitrate is a concentrated solution. It should never be injected directly and must be diluted. 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. 6). 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 has not been established in children.

Isosorbide Dinitrate is presented in 10mL ampoules and 50mL vials intended for single use only.

During administration of Isosorbide Dinitrate 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. 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 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Isosorbide Dinitrate 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. 6mg) of sodium per mL and should be taken into consideration by patients on a controlled sodium diet.

Use of Isosorbide Dinitrate is contraindicated in patients with known hypersensitivity to nitrates, marked anaemia, cerebral haemorrhage, head trauma, diseases associated with an increased intracranial pressure, hypovolaemia, severe hypotension (systolic blood pressure less than 90mm Hg), aortic and/or mitral valve stenosis, closed angle glaucoma.

Isosorbide Dinitrate must not be used in cases of circulatory collapse or low filling pressure. Treatment of cardiogenic shock with Isosorbide Dinitrate should only be undertaken if means of maintaining an adequate diastolic pressure is available.

Isosorbide Dinitrate should not be used in the treatment of hypertrophic obstructive cardiomyopathy, constrictive pericarditis or cardiac tamponade. g. 5).