Categories: Side effects

Contraindications of nitroglycerin

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Discover the contraindications of nitroglycerin.

1. NAME OF THE MEDICINAL PRODUCT

Nitroglycerin M ylan 5 mg /24h transdermal patches EFG

Nitroglycerin M ylan 10 mg /24h transdermal patches EFG

Nitroglycerin M ylan 15 mg /24h transdermal patches EFG

contraindications of nitroglycerin

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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Nitroglycerine

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Each Nitroglycerin M ylan 5mg /24h transdermal patch contains 20.7mg of nitroglycerin in 7.4cm 2 of surface, and releases 0.2mg of nitroglycerin per hour ( 4.8mg/24h ).

Each transdermal patch of Nitroglycerin M ylan 10mg /24h contains 41.4mg of nitroglycerin in 14.8cm 2 of surface, and releases 0.4mg of nitroglycerin per hour ( 9.6mg/24h ).

Each Nitroglycerin M ylan 15mg /24h transdermal patch contains 62.2mg of nitroglycerin in 22.2cm 2 of surface area, and releases 0.6mg of nitroglycerin per hour ( 14.4mg/24h ).

 

To consult the complete list of excipients see section 6.1.

 

3. PHARMACEUTICAL FORM

transdermal patch

 

Translucent rectangular patch with rounded edges, marked “Nitroglycerin” and the rate of release.

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The following is printed on each patch:

“Nitroglycerin 0.2 mg/h (5 mg/24 h)”

“Nitroglycerin 0.4mg/h (10mg/24h)”

“Nitroglycerin 0.6mg/h (15mg/24h)”

 

4. CLINICAL DATA

4.1. Therapeutic indications

For the prophylaxis of angina pectoris as monotherapy or in combination with other antianginal drugs.

4.2. Dosage and method of administration

Posology

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Adults, including the elderly:

Nitroglycerin M ylan is not indicated for the immediate treatment of angina attacks; if these occur, use fast-acting nitrates (as an aerosol).

To avoid attenuation of effects, intermittent treatment is recommended in patients treated with prolonged-release nitrate preparations.

The recommended initial dose of Nitroglycerin M ylan is 0.2 mg/h, which is equivalent to the cutaneous application of a 5 mg/24 h patch once a day for a period of approximately 12 hours. The patch is then removed to provide a nitrate-free interval of at least 8 hours, which can be increased up to 12 hours, depending on the needs of each patient (daily patch-free period of 8-12 hours).

If this dose is not effective enough, it can be increased progressively up to 0.4 mg/h of Nitroglycerin M ylan , which is equivalent to a patch of 10 mg/24 h once a day and, if necessary, up to a maximum of 0.6 mg/h of Nitroglycerin M ylan , which is equivalent to a patch of 15 mg/24 h per day.

The maximum dose is one Nitroglycerin M ylan patch of 0.6 mg/h in each 24-hour period (15 mg/24 h).

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The nitrate-free interval should correspond to the period of time in which the patient usually does not experience crises, and should be covered by another antianginal treatment (beta-blocker or calcium antagonist). This may be of particular relevance in patients with severe angina.

Physicians must clearly mention the application and removal times of the patch on the prescription.

 

Continuous administration may be appropriate in the rare cases where a patient’s degree of clinical response can be reliably assessed.

 

Patients with nocturnal angina may benefit from overnight treatment, with a nitrate-free interval during the day. This group of patients might need additional antianginal therapy during the day.

 

Pediatric patients:

The safety and efficacy of nitroglycerin in children and adolescents have not been established, so its use in this age group cannot be recommended.

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application method

Nitroglycerin M ylan can be applied to any accessible skin area; the recommended site is the chest or outer upper arm. The application sites should be rotated and, if necessary, the hair in the corresponding areas can be trimmed as much as possible, but not shaved.

Nitroglycerin M ylan should not be applied to the distal extremities.

 

Instructions for use

Nitroglycerin M ylan is applied only to areas of intact skin once removed from the protective sachet. The clear, peelable protective layer that protects the sticky side of the patch has a slit that divides it into two strips.

The patch should be held with the print facing down and the slit facing up. You have to fold the edges out to peel off the transparent protective layer. The protective layer halves are peeled off, taking care not to touch the sticky side of the patch, and applied firmly to the skin. Hands should be carefully washed after each application.

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Patients should be advised to dispose of patches with caution to avoid accidental application or use.

4.3. Contraindications of nitroglycerin

• Hypersensitivity to the active substance, to related organic nitrates or to any of the excipients listed in section 6.1.

• Noticeable anemia.

• Acute circulatory failure associated with marked hypotension (shock).

• Severe hypotension (systolic blood pressure less than 90 mmHg).

• severe hypovolemia.

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• Conditions associated with increased intracranial pressure, e.g. e.g., cerebral hemorrhage or traumatic brain injury.

• Myocardial failure due to obstruction, such as in aortic or mitral stenosis, left ventricular aortic stenosis, hypertrophic obstructive cardiomyopathy, cardiac tamponade, or constrictive pericarditis.

• Narrow angle glaucoma.

 

Concomitant use of Nitroglycerin M ylan and phosphodiesterase type 5 (PDE5) inhibitors such as sildenafil, tadalafil or vardenafil is contraindicated, as PDE5 inhibitors may potentiate the vasodilatory effects of Nitroglycerin M ylan and cause severe hypotension.

 

4.4. Special warnings and precautions for use

Nitroglycerin M ylan is not indicated for the treatment of acute angina attacks.

 

As with other nitrated drugs, when long-term treatment with nitrates is replaced by another drug, nitroglycerin should be gradually withdrawn and overlapped with the new treatment.

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Nitroglycerin M ylan patches should be removed before applying magnetic or electrical fields to the body during techniques such as MRI (Magnetic Resonance Imaging), cardioversion or electrical defibrillation, or diathermy treatment.

 

Caution should be exercised in patients with hypothyroidism, malnutrition, severe renal or hepatic insufficiency, hypothermia, or a recent history of myocardial infarction.

 

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In cases of recent myocardial infarction or acute or congestive heart failure, treatment with Nitroglycerin M ylan should be carried out with caution and under strict medical and/or hemodynamic monitoring.

 

Some patients may experience severe hypotension, especially in the upright position, even with small doses of nitroglycerin. Therefore, Nitroglycerin M ylan should be used with caution in patients who may be hypovolaemic due to diuretic therapy and in patients with low systolic blood pressure. See also section 4.3.

 

Nitroglycerin-induced hypotension may be accompanied by an increased frequency of angina pectoris and paradoxical bradycardia.

Patch removal should be considered as part of administration in patients with significant hypotension.

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Severe postural hypotension with vertigo and dizziness is often seen after alcohol consumption in patients treated with nitroglycerin.

 

Hypoxemia:

Caution should be exercised in patients with arterial hypoxaemia due to severe anemia (including forms induced by G6PD deficiency), since in such patients the biotransformation of nitroglycerin is reduced. Similarly, caution should be exercised in patients with hypoxemia and ventilation/perfusion imbalance due to pulmonary disease or ischemic cardiomyopathy.

In patients with alveolar hypoventilation, pulmonary vasoconstriction occurs to shift perfusion from hypoxic alveolar areas to better ventilated regions of the lung (Euler-Liljestrand mechanism).

Patients with angina pectoris, myocardial infarction or cerebral ischemia frequently suffer from abnormalities of the minor airways (especially alveolar hypoxia).

Under these circumstances, Pulmonary vasoconstriction occurs to shift perfusion from hypoxic alveolar areas to better ventilated regions of the lung.

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Being a potent vasodilator, nitroglycerin can reverse this protective vasoconstriction and result in increased perfusion of poorly ventilated areas, worsening the ventilation/perfusion mismatch and a subsequent decrease in arterial partial pressure of oxygen.

 

Hypertrophic cardiomyopathy:

Nitrate therapy may worsen angina pectoris caused by hypertrophic cardiomyopathy.

 

Increased frequency of angina:

The possibility of an increased frequency of angina pectoris during patch-free periods should be considered. In such cases, the use of concomitant antianginal therapy is advisable.

 

Tolerance to sublingual nitroglycerin:

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When tolerance to nitroglycerin patches develops, the effect of sublingual nitroglycerin on exercise capacity may be partially diminished.

 

This product should be used with extreme caution in patients predisposed to narrow-angle glaucoma.

4.5. Interaction with other medicinal products and other forms of interaction

Interactions resulting in contraindicated concomitant use:

Concomitant administration of Nitroglycerin M ylan with other vasodilators (eg, PDE5 inhibitors such as sildenafil, tadalafil, or vardenafil) potentiates the hypotensive effects of Nitroglycerin M ylan .

 

Interactions to be aware of:

Concomitant treatment with calcium antagonists, ACE inhibitors, beta-blockers, diuretics, antihypertensives, tricyclic antidepressants and major tranquilizers, as well as alcohol may potentiate the hypotensive effect of Nitroglycerin M ylan .

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Simultaneous administration of Nitroglycerin M ylan with dihydroergotamine may increase its bioavailability. This is especially important in patients with coronary artery disease, since dihydroergotamine antagonizes the effect of nitroglycerin and can lead to coronary vasoconstriction.

 

Non-steroidal anti-inflammatory drugs, except acetylsalicylic acid, may decrease the therapeutic response of Nitroglycerin M ylan .

 

Concomitant administration of Nitroglycerin M ylan with amifostine and acetylsalicylic acid may potentiate the hypotensive effects of Nitroglycerin M ylan .

4.6. Fertility, pregnancy and lactation

Fertility

No data are available on the effect of Nitroglycerin M ylan on fertility in humans. Animal studies do not indicate a risk of adverse effects on fertility.

Pregnancy

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The results of reproductive toxicity studies in animals do not indicate a risk of adverse effects on embryonic and fetal development. It is not known whether nitroglycerin in transdermal form can affect reproductive capacity or cause fetal harm in humans.

Therefore, Nitroglycerin Mylan should only be used in pregnant women if the potential benefits to the mother clearly outweigh the potential risks to the foetus. Caution is advised during the first trimester of pregnancy.

Lactation

It is unknown whether nitroglycerin is excreted in breast milk. Therefore, caution should be exercised when Nitroglycerin Mylan is administered to women who are breast-feeding.

A decision should be made whether it is necessary to discontinue breast-feeding or to interrupt/withdraw Nitroglycerin Mylan treatment, taking into account the benefit of breast-feeding for the baby and the benefit of treatment for the mother.

4.7. Effects on ability to drive and use machines

Nitroglycerin M ylan has moderate influence on the ability to drive and use machines.

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Especially at the start of treatment or in case of dose adjustments, Nitroglycerin Mylan may impair responsiveness or, in rare cases, cause orthostatic hypotension and dizziness (as well as exceptionally syncope after overdose). Patients experiencing these effects should not drive or use machines.

4.8. Adverse reactions

Adverse reactions are classified according to MedDRA System Organ Class (SOC). Within each organ class, adverse reactions are ranked by frequency, with the most frequent listed first. Adverse reactions are listed in order of decreasing seriousness within each frequency range.

In addition, the corresponding frequency categories follow the following convention (CIOMS III): very common ( > 1/10); common ( > 1/100 to < 1/10); uncommon ( > 1/1,000 to < 1/100); rare ( > 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (frequency cannot be estimated from the available data).

MedDRA System Organ Class very common Frequent

 

uncommon rare very rare

 

unknown frequency
nervous system disorders Headache 1 dizziness
heart disorders Tachycardia 2 Palpitations 4
vascular disorders

 

Orthostatic hypotension

flushing 2

Gastrointestinal disorders Sickness

vomiting

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Skin and subcutaneous tissue disorders contact dermatitis Generalized rash 4
General disorders and administration site conditions Application site erythema

Pruritus

burning

irritation 3

Complementary explorations increased heart rate

 

1 Like other nitrate drugs, Nitroglycerin Mylan frequently produces dose-dependent headaches due to cerebral vasodilation. These usually remit within a few days despite maintaining treatment.

If headaches persist during intermittent therapy they should be treated with mild analgesics. If they do not respond to treatment, the dose of nitroglycerin should be reduced or treatment should be discontinued.

 

2 A slight reflex-induced increase in heart rate can be avoided by resorting, if necessary, to combination therapy with a beta-blocker.

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3 After removing the patch, any slight redness of the skin will usually disappear within a few hours. The application site should be changed regularly to prevent local irritation.

 

4 Adverse reactions have been derived from post-marketing experience with Nitroglycerin M ylan through spontaneous and published case reports. Because these reactions are reported spontaneously from a population of imprecise size, their frequency cannot be reliably estimated and they are therefore classified as unknown.

 

4.9. Overdose

signs

High doses of nitroglycerin can cause severe hypotension and reflex tachycardia or collapse and syncope. Methemoglobinemia has also been reported following accidental overdosage.

Treatment

The effect of Nitroglycerin M ylan nitrate can be quickly eliminated by simply removing the patch or reducing the dose, depending on severity.

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Deep exfoliation of the underlying skin layer may reduce absorption more quickly after removal. An intravenous infusion of isotonic saline or similar fluid may be needed to increase central fluid volume.

Arterial hypotension or signs of collapse that may occur can be treated with general supportive or resuscitative measures.

For example by elevating the patient’s legs or, if necessary, bandaging them with compression bandages. Adrenaline and related products are not effective in reversing cases of severe hypotension associated with overdose.

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Tags: contraindications contraindications of nitroglycerin contraindications of nitroglycerin in stemi dangers disadvantages health side effects

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