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MYLAN-NITRO is a brand name for Nitroglycerin, supplied as a patch (extended release). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USES ...................................................................................... 3 CONTRAINDICATIONS ............................................................................................................... 4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
• Patients who are hypersensitive to this drug, other nitrates or to any ingredient in the formulation or component of the container. For a complete listing, see the Dosage Forms, Composition and Packaging section of the product monograph.
• Allergy to the adhesive used in nitroglycerin patches has been reported and constitutes a contraindication to the use of this product. • Acute circulatory failure associated with marked hypotension (shock and states of collapse). • Postural hypotension.
g. in the presence of aortic or mitral stenosis or of constrictive pericarditis). • Increased intracranial pressure. • Increased intraocular pressure. • Severe anemia. g. g. REVATIO* (sildenafil citrate) or ADCIRCA* (tadalafil) is absolutely contraindicated.
Concomitant use can cause severe drops in blood pressure. • Do not use Mylan-Nitro Patch (nitroglycerin transdermal system) in patients who are taking the soluble guanylate cyclase stimulator ADEMPAS* (riociguat) for chronic thromboembolic pulmonary hypertension or pulmonary arterial hypertension.
Concomitant use can cause hypotension. WARNINGS AND PRECAUTIONS Cardiovascular The benefits and safety of transdermal nitroglycerin in patients with acute myocardial infarction or congestive heart failure have not been established. If one elects to use Mylan-Nitro Patch in these conditions, careful clinical or hemodynamic monitoring must be used to avoid the hazards of hypotension and tachycardia.
Mylan-Nitro Patch must be removed before cardioversion or DC defibrillation is attempted, as well as before applying diathermy treatment, since it may be associated with damage to the paddles and burns to the patient. Headaches or symptoms of hypotension, such as weakness or dizziness, particularly when arising suddenly from a recumbent position, may occur.
A reduction in dose or discontinuation of treatment may be necessary. Caution should be exercised when using nitroglycerin in patients prone to, or who might be affected by hypotension. g. below 90 mmHg). Paradoxical bradycardia and increased angina pectoris may accompany nitroglycerin- induced hypotension.
Nitrate therapy may aggravate the angina caused by hypertrophic cardiomyopathy. Dependence/Tolerance In industrial workers who have had long-term exposure to unknown (presumably high) doses of nitroglycerin, tolerance clearly occurs.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Nitroglycerin in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
There is moreover, physical dependence since chest pain, acute myocardial infarction, and even sudden death have occurred during temporary withdrawal of nitroglycerin from these workers. In clinical trials of angina patients, there are reports of anginal attacks being more easily provoked and of rebound in the hemodynamic effects soon after nitrate withdrawal.
The importance of these observations to the routine clinical use of nitroglycerin has not been fully elucidated, but patients should be monitored closely for increased anginal symptoms during drug-free periods. Tolerance to nitroglycerin with cross tolerance to other nitrates or nitrites may occur.
As tolerance to nitroglycerin patches develops, the effect of sublingual nitroglycerin on exercise tolerance, although still observable, is somewhat blunted. As patients may experience faintness and/or dizziness, reaction time when driving or operating machinery may be impaired, especially at the start of treatment.
e. complete loss of effect) within the first 24 hours after therapy was initiated. Dose adjustments even to levels much higher than generally used did not prevent the development of tolerance. Tolerance can be prevented or attenuated by use of an intermittent dosage schedule.
Although the minimum nitrate-free interval has not been defined, clinical trials have demonstrated that an appropriate dosing schedule for nitroglycerin patches would provide for a daily patch-on period of 12 - 14 hours and a daily patch-off period of 10 - 12 hours.
The patch-free time should coincide with the period in which angina pectoris is least likely to occur (usually at night). Patients should be watched carefully for an increase of angina pectoris during the patch- free period. Adjustment of background medication may be required.
The dose of Mylan- Nitro Patch should be periodically reviewed in relation to continuing antianginal control. 6 Respiratory Caution should be exercised in patients with arterial hypoxemia due to anemia (See CONTRAINDICATIONS), because in such patients the biotransformation of nitroglycerin is reduced.
Similarly, caution is called for in patients with hypoxemia and a ventilation/perfusion imbalance due to lung disease or ischemic heart failure. Patients with angina pectoris, myocardial infarction, or cerebral ischemia frequently suffer from abnormalities of the small airways (especially alveolar hypoxia).
Under these circumstances vasoconstriction occurs within the lung to shift perfusion from areas of alveolar hypoxia to better ventilated regions of the lung. As a potent vasodilator, nitroglycerin could reverse this protective vasoconstriction and thus result in increased perfusion to poorly ventilated areas, worsening of the ventilation/perfusion imbalance, and a further decrease in the arterial partial pressure of oxygen.
Special Populations Pregnant Women:
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