Isoket IV Special Precautions

Medical Supervision required: Isosorbide Dinitrate (Isoket) should be used with caution and under medical supervision in patients who are suffering from: hypothyroidism, hypothermia, malnutrition, severe liver disease or renal disease, orthostatic syndrome.
Tolerance: 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 monitoring: Blood pressure and pulse rate should always be monitored and the dose adjusted according to the patient's response.
Hypoxia: During treatment with Isosorbide Dinitrate (Isoket), 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 myocardial hypoxia.
Phosphodiesterase inhibitors containing products: Patients who undergo a maintenance treatment with Isosorbide Dinitrate (Isoket) should be informed that they must not use phosphodiesterase inhibitors containing products (eg, sildenafil, tadalafil, vardenafil). Isosorbide Dinitrate (Isoket) therapy should not be interrupted to take phosphodiesterase inhibitors containing products (eg, sildenafil, tadalafil, vardenafil), because the risk of inducing an attack of angina pectoris could increase by doing so (see Contraindications; Drug Interactions).
Acute therapy with isosorbide dinitrate must not be used in patients who have recently taken phosphodiesterase inhibitors (eg, sildenafil, tadalafil, vardenafil). Patients who receive Isosorbide Dinitrate (Isoket) as acute therapy must be warned not to take phosphodiesterase inhibitors containing products (eg, sildenafil, vardenafil, tadalafil).
Effects on ability to drive and use machines: As for other drugs which produce changes in blood pressure, patients taking Isosorbide Dinitrate (Isoket) should be warned not to drive or operate machinery if they experience dizziness or related symptoms.
Isosorbide Dinitrate (Isoket) may affect the patient's reactivity to an extent that her/his ability to drive or to operate machinery is impaired. This effect is increased in combination with alcohol.
Use in Pregnancy & Lactation: Isosorbide Dinitrate (Isoket) should only be used in pregnancy if, in the opinion of the physician, the possible benefits of treatment outweigh the possible hazards.
No data have been reported which would indicate the possibility of adverse effects resulting from the use of Isosorbide Dinitrate (Isoket) in pregnancy. Safety in pregnancy, however, has not been established.
Isosorbide Dinitrate (Isoket) should only be used during lactation if, in the opinion of the physician, the possible benefits of treatment outweigh the possible hazards.
Available evidence is inconclusive or inadequate for determining infant risk when used during breastfeeding. There is data that nitrates are excreted in breast milk and may cause methaemoglobinemia in infants. The extent of excretion of isosorbide dinitrate and its metabolites in human breast milk has not been determined. Therefore, caution is appropriate when administering this agent to lactating women.