Organic nitrates

Nitroglycerin

Approved 29 Nov 2024Intra-analOintment

The FDA lists this product in 60 strengths and forms.

Indications

Nitroglycerin ointment, 0.4% is indicated for the treatment of moderate to severe pain associated with chronic anal fissure. Nitroglycerin ointment, 0.4% is a nitrate vasodilator indicated for the treatment of moderate to severe pain associated with chronic anal fissure ( 1 ).

Contraindications

Use of PDE5 inhibitors (e.g. sildenafil, vardenafil and tadalafil) as these are shown to potentiate the hypotensive effects of organic nitrates. ( 4.1 ). Severe anemia ( 4.2 ) Increased intracranial pressure ( 4.3 ) Known hypersensitivity to nitroglycerin, other nitrates and nitrites, or any components of the ointment. ( 4.4 )

4.1PDE5 Inhibitor Use Administration

of nitroglycerin ointment, 0.4% is contraindicated in patients who are using a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5), such as sildenafil, vardenafil, and tadalafil, as these are shown to potentiate the hypotensive effects of organic nitrates [see

7.1DRUG

INTERACTIONS ].

4.2Severe Anemia

Nitroglycerin ointment, 0.4% is contraindicated in patients with severe anemia.

4.3Increased Intracranial Pressure

Nitroglycerin ointment, 0.4% is contraindicated in patients with increased intracranial pressure.

4.4Hypersensitivity

Nitroglycerin ointment, 0.4% is contraindicated in patients who have shown hypersensitivity to it or to other nitrates or nitrites. Skin reactions consistent with hypersensitivity have been observed with organic nitrates.

Organic nitrates

Nitroglycerin

Approved 29 Nov 2024Intra-analOintment

The FDA lists this product in 60 strengths and forms.

Official labelAsk Osler about it

Indications

Contraindications

4.1PDE5 Inhibitor Use Administration

7.1DRUG

INTERACTIONS ].

4.2Severe Anemia

Nitroglycerin ointment, 0.4% is contraindicated in patients with severe anemia.

4.3Increased Intracranial Pressure

Nitroglycerin ointment, 0.4% is contraindicated in patients with increased intracranial pressure.

4.4Hypersensitivity

Interactions

PDE5 inhibitors: potentiation of hypotensive effects of organic nitrates; concomitant use is contraindicated. ( 4.1 , 7.1 ) Antihypertensives: possible additive hypotensive effects. ( 7.2 ) Aspirin: increased nitroglycerin levels. ( 7.3 ) Tissue-type Plasminogen Activator (t-PA): decreased thrombolytic effect. ( 7.4 ) Heparin: anticoagulant effect of heparin may be reduced. Monitor APTT. ( 7.5 ) Ergotamine: increased bioavailability of ergotamine.

( 7.6 ) Alcohol: Additive vasodilatory effects to nitroglycerin. Consumption of alcohol should be avoided. ( 7.7 )

7.1PDE5 Inhibitors

Phosphodiesterase type 5 (PDE5) inhibitors such as sildenafil, vardenafil, and tadalafil have been shown to potentiate the hypotensive effects of organic nitrates. The time course of the interaction appears to be related to the half-life of the PDE5 inhibitor, however, the dose dependence of this interaction has not been studied. Use of nitroglycerin ointment, 0.4% within a few days of PDE5 inhibitors is contraindicated.

7.2Antihypertensives

Patients receiving antihypertensive drugs, beta-adrenergic blockers, and other nitrates should be observed for possible additive hypotensive effects when using nitroglycerin ointment, 0.4%. Marked orthostatic hypotension has been reported when calcium channel blockers and organic nitrates were used concomitantly. Beta-blockers blunt the reflex tachycardia produced by nitroglycerin without preventing its hypotensive effects.

If beta-blockers are used with nitroglycerin ointment, 0.4% in patients with angina pectoris, additional hypotensive effects may occur.

7.3Aspirin Coadministration

of aspirin (at doses between 500 mg and 1000 mg) and nitroglycerin has been reported to result in increased nitroglycerin maximum concentrations by as much as 67% and AUC by 73% when administered as a single dose. The pharmacological effects of nitroglycerin ointment, 0.4% may be enhanced by concomitant administration of aspirin.

7.4Tissue-type Plasminogen Activator (t-PA)

Intravenous administration of nitroglycerin decreases the thrombolytic effect of tissue-type plasminogen activator (t-PA). Plasma levels of t-PA are reduced when coadministered with nitroglycerin. Therefore, caution should be observed in patients receiving nitroglycerin ointment, 0.4% during t-PA therapy.

7.5Heparin Although

an interaction has been reported between intravenous heparin and intravenous nitroglycerin (resulting in a decrease in the anticoagulant effect of heparin), the data are not consistent. If patients are to receive intravenous heparin and nitroglycerin ointment, 0.4% concurrently, the anticoagulation status of the patient must be checked.

7.6Ergotamine

Oral administration of nitroglycerin markedly decreases the first-pass metabolism of dihydroergotamine and consequently increases its oral bioavailability. Ergotamine is known to precipitate angina pectoris. Therefore the possibility of ergotism in patients receiving nitroglycerin ointment, 0.4% should be considered.

7.7Alcohol

The vasodilating effects of nitroglycerin have been shown to be additive to the effects observed with alcohol.

Nitroglycerin

Indications

Contraindications

4.1PDE5 Inhibitor Use Administration

7.1DRUG

4.2Severe Anemia

4.3Increased Intracranial Pressure

4.4Hypersensitivity

Two medicines in one question?

Nitroglycerin

Indications

Contraindications

4.1PDE5 Inhibitor Use Administration

7.1DRUG

4.2Severe Anemia

4.3Increased Intracranial Pressure

4.4Hypersensitivity

Two medicines in one question?

Warnings and precautions

5.1Cardiovascular Disorders Venous

5.2Headache

Interactions

7.1PDE5 Inhibitors

7.2Antihypertensives

7.3Aspirin Coadministration

7.4Tissue-type Plasminogen Activator (t-PA)

7.5Heparin Although

7.6Ergotamine

7.7Alcohol

Pregnancy and breastfeeding

8.1Pregnancy Pregnancy Category C

Adverse reactions

Composition

Strengths and forms

Official product information

At a glance