ISOSORBIDE DINITRATE

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. 05% w/v can be administrated undiluted by slow intravenous infusion using a syringe pump.

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. 05% w/v has not been established in children.

No modifications to the dosage are necessary for elderly patients. 05% w/v is presented in 50mL vials intended for single use only.

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. 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.

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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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. 54mg) of sodium per mL and should be taken into consideration by patients on a controlled sodium diet.

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.

05% w/v must not be used in cases of circulatory collapse or low filling pressure. 05% w/v should only be undertaken if means of maintaining an adequate diastolic pressure is available. 05% w/v should not be used in the treatment of hypertrophic obstructive cardiomyopathy, constrictive pericarditis or cardiac tamponade.

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