Nitroglycerin

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

• 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 )

4.1 PDE5 inhibitor use Administration of nitroglycerin ointment 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 DRUG INTERACTIONS (7.1) ].

4.2 Severe anemia Nitroglycerin ointment is contraindicated in patients with severe anemia.

4.3 Increased intracranial pressure Nitroglycerin ointment is contraindicated in patients with increased intracranial pressure.

4.4Hypersensitivity

Nitroglycerin ointment 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.

• Cardiovascular Disorders: Venous and arterial dilatation as a consequence of nitroglycerin treatment can result in hypotension. Exercise caution when treating patients with any of the following conditions: blood volume depletion, existing hypotension, cardiomyopathies, congestive heart failure, acute myocardial infarction, or poor cardiac function for other reasons ( 5.1 ).