Chemical formula: C₆H₉NO₆ Molecular mass: 191.139 g/mol PubChem compound: 27661
Isosorbide mononitrate interacts in the following cases:
Concurrent administration of isosorbide mononitrate with drugs with blood pressure lowering properties, e.g. beta-blockers, calcium channel blockers, vasodilators, alprostadil, aldesleukin, angiotensin II receptor antagonists etc. and/or alcohol may potentiate the hypotensive effects of isosorbide mononitrate. This may occur with neuroleptics and tricyclic antidepressants.
Reports suggest that concomitant administration of isosorbide mononitrate may increase the blood levels of dihydroergotamine and its hypertensive effects.
No data have been reported which would indicate the possibility of adverse effects resulting from the use of isosorbide mononitrate in pregnancy. Safety in pregnancy however has not been established, isosorbide mononitrate should only be used in pregnancy, in the opinion of the physician, the possible benefits of treatment outweigh the hazards.
The safety and efficacy of isosorbide mononitrate during lactation in humans has not been established. It is not known whether nitrates are excreted in human milk and therefore caution should be exercised when administered to nursing women. Isosorbide mononitrate should only be used during lactation if, in the opinion of the physician, the possible benefits of treatment outweigh the hazards.
There is no data available on the effect of isosorbide mononitrate on fertility in humans.
Dizziness, tiredness or blurred vision might occur at the start of the treatment. The patient should therefore be advised that if affected, they should not drive or operate machinery. This effect may be increased by alcohol.
Most of the adverse reactions are pharmacodynamically mediated and dose dependent.
Undesirable effects frequencies are defined as: very common (≥1/10), common (≥1/100<1/10), uncommon (≥1/1,000<1/100), rare (≥1/10,000<1/1,000), very rare (<10,000), not known (cannot be estimated from the available data).
Very common:Headache1
Not Known: Restlessness, Somnolence, Pituitary haemorrhage
Rare: Tachycardia2, Paroxysmal bradycardia2
Vascular disorders
Common: Hypotension3, Light-headedness in the upright position (orthostatic hypotension) (may be associated with flushing, dizziness, drowsiness, tachycardia, feeling of weakness).
Uncommon: Collapse4
Not Known: Hypoxia
Uncommon: Nausea, Vomiting, Heartburn5
Not Known: Diarrhoea
Uncommon: Hyperhidrosis
Not Known: Pruritus, Exfoliative dermatitis, Allergic skin reaction (e.g. rash)
Not Known: Myalgia
Not Known: Asthenia
1 The incidence of headache usually disappears after 1-2 weeks of treatment.
2 These symptoms generally disappear during long-term treatment.
3 Severe hypotensive responses have been reported with organic nitrates with nausea, vomiting, restlessness, pallor, and excessive perspiration. Uncommonly, severe hypotension may lead to enhanced angina pectoris symptom.
4 Sometimes accompanied by bradyarrhythmia, bradycardia and syncope.
5 Most likely due to a nitrate-induced sphincter relaxation.
A very common (>10% of patients) adverse reaction to isosorbide mononitrate is throbbing headache. The incidence of headache diminishes gradually with time and continued use.
At the start of therapy or when the dosage is increased, hypotension and/or light-headedness in the upright position are commonly observed (i.e. in 1-10% of patients). These symptoms may be associated with dizziness, drowsiness, reflex tachycardia and a feeling of weakness.
Infrequently (i.e. in less than 1% patients) nausea, vomiting, flushing and allergic skin reactions (e.g. rash) may occur sometimes severely.
Severe hypotensive responses have been reported for organic nitrates and include nausea, vomiting, restlessness pallor and excessive perspiration. During treatment with Isosorbide Mononitrate Tablets, 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. Uncommonly severe hypotension may lead to enhanced angina symptoms.
A few reports of heartburn most likely due to a nitrate induced sphincter relaxation have been reported.
Tachycardia and paroxysmal bradycardia have been reported.
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