Nitrolingual

(Nitroglycerin)

The active ingredient in Nitrolingual is nitroglycerin. Nitroglycerin is an organic nitrate and a vasodilator that relaxes blood vessels. By widening blood vessels, it improves blood flow to the heart muscle and reduces the workload on the heart. These effects of nitroglycerin help relieve chest pain during an acute attack of angina.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Nitrolingual. However, the following is a synopsis of the general guidelines for the use of Nitrolingual:

• Sit down before using the spray to reduce the risk of falling due to low blood pressure. Hold the container upright and close to the mouth. Spray once or as directed onto or under the tongue and close the mouth after spraying. Do not rinse or spit immediately after use.
• If you are using the spray for the first time or if it has not been used for several days, priming may be required according to the product instructions.
• During an angina attack, one spray may be used at the first sign of chest pain. Additional sprays may be used if pain continues, as directed by your health care professional. Nitrolingual may also be used 5 to 10 minutes before activities known to trigger angina. If chest pain persists after the recommended number of sprays, seek medical attention right away.
• Nitrolingual is for lingual use only and should not be inhaled or swallowed.

Some mild or common side effects of Nitrolingual seen in clinical trials as compared to placebo include:

• Severe headache.
• Lightheadedness or dizziness.
• Low blood pressure or hypotension.
• Flushing.
• Nausea.
• Fast heart rate.
• Tingling or burning feeling in the mouth.

Some individuals may experience serious side effects while using Nitrolingual. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Fainting or extreme low blood pressure.
• Chest pain that does not improve may signal a heart attack.
• Swelling of the face, lips, tongue, or throat may indicate an allergic reaction.
• Skin rash with itching or hives.
• Shortness of breath or worsening symptoms of heart failure.
• Bluish skin or lips, which may be a sign of methemoglobinemia.

These are not all of the possible side effects of Nitrolingual. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Nitrolingual, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

• Heart disease, coronary artery disease, or cardiomyopathy.
• Heart failure or a recent heart attack.
• Low blood pressure or a history of fainting.
• High blood pressure or hypertension that is not well controlled.
• Anemia or a history of methemoglobinemia.
• Sensitivity to peppermint oil or other inactive ingredients.

• Known hypersensitivity or allergic reaction to nitroglycerin or other organic nitrates.
• Use with phosphodiesterase type 5 inhibitors used for erectile dysfunction, including sildenafil, tadalafil, or vardenafil, due to the risk of severe hypotension.
• Use with riociguat, as this combination can cause dangerously low blood pressure.
• Severe anemia.
• Increased pressure in the head following a head injury.

Nitrolingual usually begins to work within one to three minutes after spraying under the tongue. Peak effects often occur within five minutes. The half-life of nitroglycerin is short, which is why it is used for rapid relief rather than long-term control.

When Nitrolingual is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Sildenafil, tadalafil, or vardenafil, as combination use can cause severe and dangerous drops in blood pressure.
• Riociguat, as it increases the risk of profound hypotension.
• Ergotamine or dihydroergotamine, like nitroglycerin, may reduce their effectiveness.
• Alcohol may increase the blood pressure-lowering effects and cause dizziness or fainting.

Nitrolingual is available as a lingual spray delivering 400 mcg of nitroglycerin per spray. The number of sprays used depends on the severity of symptoms and the guidance of a health care professional.

Nitrolingual should be stored at room temperature. Keep the container upright, tightly closed, and away from heat or open flame. It should be stored at room temperature, away from the reach of children or pets.

Nitrolingual is manufactured by Pohl-Boskamp.

There is no generic nitroglycerin pump spray. Other dosage forms of nitroglycerin, such as tablets or patches, are available.

Nitrolingual is used as needed for acute angina attacks. Do not stop or change how you use Nitrolingual without speaking to your healthcare provider. If you find you need it more often, seek medical advice, as this may indicate worsening heart disease.

Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you. Nitrolingual should only be used during pregnancy if the potential benefit outweighs the risk.

Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you. It is not known if nitroglycerin passes into breast milk, and caution is advised during breastfeeding.