Source: Υπουργείο Υγείας (CY) Revision Year: 2003 Publisher: Pharmaceutical Trading Co Ltd, 33, Artemidos Av., 6025 Larnaca, Cyprus
These are common to all nitrates; known hypersensitivity to nitrates, marked anaemia, cerebral haemorrhage, head trauma, hypovolaemia, and severe hypotension. Use in circulatory collapse or low filling pressure is also contraindicated. Cedocard should not be used in the treatment of cardiogenic shock, unless some means of maintaining an adequate diastolic pressure is undertaken. Sildenafil has been shown to potentiate the hypotensive effects of nitrates, and its co-administration with nitrates or nitric oxide donors is therefore contraindicated.
Cedocard should be used with caution in patients who are suffering from hypothyroidism, malnutrition, severe liver or renal disease or hypothermia. Close attention to pulse and blood pressure is necessary during the administration of Cedocard infusions.
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 Cedocard 0.1%. The hypotensive effect of nitrates is potentiated by concurrent administration of sildenafil (Viagra). This might also occur with neuroleptics and tricyclic antidepressants.
No data have been reported which would indicate the possibility of adverse effects resulting from the use of isosorbide dinitrate in pregnancy. Safety in pregnancy, however, has not been established. Isosorbide dinitrate should only be used in pregnancy and during lactation if, in the opinion of the physician, the possible benefits of treatment outweigh the possible hazards.
None known.
In common with other nitrates, headaches, nausea and tachycardia may occur during administration. Whilst sharp falls in systemic arterial pressure can give rise to symptoms of cerebral flow deficiency and decreased coronary perfusion, clinical experience with Cedocard has shown that this is not normally a problem.
Cedocard contains isosorbide dinitrate in isotonic saline and is compatible with commonly employed infusion fluids, no incompatibilities have so far been demonstrated. Cedocard is compatible with glass infusion bottles and infusion packs made from polyethylene. Cedocard may be infused slowly using a syringe pump with glass or plastic syringe. The use of PVC giving sets and containers should be avoided since significant losses of the active ingredient by adsorption can occur.
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