Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2016 Publisher: Merus Labs Luxco II S.à r.l., 26-28, rue Edward Steichen, L-2540 Luxembourg
These are common to all nitrates: hypersensitivity to isosorbide dinitrate, other nitrates or any of the excipients, marked anaemia, cerebral haemorrhage, head trauma, diseases associated with an increased intracranial pressure, hypovolaemia, severe hypotension (systolic blood pressure less than 90 mmHg), aortic and/or mitral valve stenosis, closed angle glaucoma.
Use in circulatory collapse or low filling pressure is also contraindicated.
Isoket should not be used in the treatment of cardiogenic shock (unless some means of maintaining an adequate diastolic pressure is undertaken), 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. Therefore, Isoket must not be given to patients receiving phosphodiesterase-5 inhibitors (see section 4.5).
Isoket should be used with caution and under medical supervision in patients who are suffering from:
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.
Isoket contains 0.15mmol (3.54mg) of sodium per ml and should be taken into consideration by patients on a controlled sodium diet.
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 Isoket. This might also occur with neuroleptics and tricyclic antidepressants.
Also phosphodiesterase-5 inhibitors e.g. sildenafil, potentiate the hypotensive effects of Isoket. This might lead to life-threatening cardiovascular complications, see section 4.3.
Reports suggest that, when administered concomitantly, Isoket may increase the blood level of dihydroergotamine and its hypertensive effect.
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.
As for other drugs which produce changes in blood pressure, patients taking Isoket should be warned not to drive or operate machinery if they experience dizziness or related symptoms.
During administration of Isoket 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 Isoket 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.
Polyvinyl chloride (PVC) or polyurethane (PU) giving sets and containers should not be used since significant losses of the active ingredient by adsorption occur and it has not been verified how the dose can be adjusted to suit the patient’s needs to account for this adsorption.
Materials made of glass, polyethylene (PE), polypropylene (PP) or polytetrafluoroethylene (PTFE) have been shown to be suitable for infusing Isoket 0.5 mg/ml.
This medicinal product must not be mixed with other medicinal products except those mentioned in Section 6.6.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
