NITROLINGUAL PUMPSPRAY

AbsorptionNitroglycerin is rapidly absorbed following sublingual administration of nitroglycerin sublingual tablets. Mean peak nitroglycerin plasma concentrations occur at a mean time of approximately 6 to 7 minutes postdose (Table 1). Maximum plasma nitroglycerin concentrations (C max ) and area under the plasma concentration-time curves (AUC) increase dose-proportionally following 0.3 to 0.6 mg nitroglycerin sublingual tablets. The absolute bioavailability of nitroglycerin from nitroglycerin ...

The following adverse reactions are discussed in more detail elsewhere in the label:

• Hypotension [see Warnings and Precautions (5.2) ]
• Headache [see Warnings and Precautions (5.4) ]
• Hypersensitivity [see Contraindications (4.4) ] Vertigo, dizziness, weakness, palpitation, and other manifestations of postural hypotension may develop occasionally, particularly in erect, immobile patients. Marked sensitivity to the hypotensive effects of nitrates (manifested by nausea, vomiting, weakness, dia...

• Use of phosphodiesterase type 5 (PDE-5) inhibitors, such as avanafil, sildenafil, tadalafil, or vardenafil, or soluble guanylate cyclase (sGC) stimulators. ( 4.1 , 7.1 )
• Severe anemia ( 4.2 )
• Increased intracranial pressure ( 4.3 )
• Hypersensitivity to nitroglycerin or to other nitrates or nitrites or any excipient ( 4.4 )
• Circulatory failure and shock ( 4.5 ) 4.1 PDE-5-Inhibitors and sGC...

• Tolerance: Excessive use may lead to tolerance. ( 5.1 )
• Hypotension: Severe hypotension may occur. ( 5.2 ) 5.1 Tolerance Excessive use may lead to the development of tolerance. Only the smallest dose required for effective relief of the acute angina attack should be used. A decrease in therapeutic effect of sublingual nitroglycerin may result from use of long-acting nitrates. 5.2 Hypotension Severe hypotension, particularly with upright posture, may occur with small doses of nitroglycerin pa...

7 DRUG INTERACTIONS Ergotamine: increased bioavailability of ergotamine. Avoid concomitant use. ( 7.2 ) 7.1 PDE-5-Inhibitors and sGC-Stimulators Nitroglycerin sublingual tablets are contraindicated in patients who are using a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE-5). PDE-5-Inhibitors such as avanafil, sildenafil, vardenafil, and tadalaf...