Nitrolingual oral / sublingual

Nitroglycerin is a nitrate that dilates (widens) blood vessels, making it easier for blood to flow through them and easier for the heart to pump.

Nitroglycerin is used to treat or prevent attacks of chest pain (angina).

Nitroglycerin may also be used for purposes not listed in this medication guide.

You should not use this medicine if you are also using medicine to treat pulmonary arterial hypertension (PAH). Do not take erectile dysfunction medicine (Viagra, Cialis, Levitra and others) while you are taking nitroglycerin.

You should not use sublingual nitroglycerin if you have severe anemia, increased pressure inside your skull, or symptoms of circulation problems or shock (pale skin, cold sweat, irregular heartbeats, sudden weakness or feeling like you might pass out).

Seek emergency medical attention if you have early symptoms of a heart attack (chest pain or pressure, pain spreading to your jaw or shoulder, sweating, general ill feeling).

You should not use nitroglycerin if you are allergic to it, or if you are using medicine to treat pulmonary arterial hypertension (PAH), such as riociguat (Adempas), sildenafil (Revatio), or tadalafil (Adcirca).

Do not take erectile dysfunction medicine (Viagra, Cialis, Levitra, Stendra, Staxyn, sildenafil, avanafil, tadalafil, vardenafil) while you are taking nitroglycerin. Using erectile dysfunction medicine with nitroglycerin can cause a sudden and serious decrease in blood pressure.

You should not use sublingual nitroglycerin if you have:

• severe anemia (low red blood cells);

• a head injury, brain tumor, or other condition that causes increased pressure inside the skull; or

• symptoms of circulation problems or shock (pale skin, cold sweat, fast or irregular heartbeats, sudden weakness or feeling like you might pass out).

To make sure nitroglycerin is safe for you, tell your doctor if you have:

• congestive heart failure, or a heart rhythm disorder (especially if you take medicine to treat this condition);

• a history of heart attack, stroke, or head injury;

• low blood pressure, or if you are dehydrated;

• glaucoma; or

• migraine headaches.

It is not known whether nitroglycerin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether nitroglycerin passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended. If you use too much nitroglycerin, it might stop working as well in controlling your symptoms.

Nitroglycerin is usually taken at the first sign of chest pain. Try to rest or stay seated when you take nitroglycerin (may cause dizziness or fainting).

You may use nitroglycerin sublingual within 5 to 10 minutes before an activity you think might cause chest pain. Follow your doctor's instructions.

Do not crush, chew, break, or open an extended-release capsule. Swallow it whole.

The sublingual tablet should be placed under your tongue and allowed to dissolve slowly. Do not chew or swallow it. Do not use more than 3 tablets in 15 minutes.

If you use nitroglycerin sublingual spray: At the first sign of an attack, apply the spray directly on or under your tongue. Close your mouth after each spray. Do not inhale the spray. Do not shake the spray before or during use. You may use additional sprays every 5 minutes, but not more than 3 sprays in 15 minutes.

You may need to use 1 or 2 packets of nitroglycerin sublingual powder. Follow your doctor's instructions. Do not use more than 3 packets within 15 minutes.

Seek emergency medical attention if your chest pain gets worse or lasts more than 5 minutes, especially if you have trouble breathing or feel weak, dizzy, or nauseated, or lightheaded.

You may feel a slight burning or stinging in your mouth when you use this medicine. This is not a sign of how well the medicine is working. Do not use more just because you do not feel a burning or stinging.

This medicine can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using nitroglycerin.

If you take nitroglycerin on a regular schedule to prevent angina, do not stop taking it suddenly or you could have a severe attack of angina. Keep this medicine on hand at all times. Get your prescription refilled before you run out of medicine completely.

Store at room temperature away from moisture and heat. Keep the tablets in the original glass container, tightly closed when not in use.

Keep the spray away from open flame or high heat, such as in a car on a hot day. The canister may explode if it gets too hot.

Applies to nitroglycerin: buccal tablet extended release, intravenous solution, oral capsule extended release, rectal ointment, sublingual powder, sublingual spray, sublingual tablet, transdermal film extended release, transdermal ointment

General

The most common side effect is headache.[Ref]

Nervous system

Very common (10% or more): Headache (up to 64%)
Common (1% to 10%): Dizziness, lightheadedness, syncope, vertigo, drowsiness
Rare (0.1% to 0.01%): Severe and prolonged headache
Very rare (less than 0.01%): Cerebral ischemia
Frequency not reported: Faintness, somnolence[Ref]

Cardiovascular

Common (1% to 10%): Hypotension, angina increased, paradoxical bradycardia, tachycardia, orthostatic hypotension, blood pressure decreased, facial flushing
Uncommon (0.1 to 1%): Circulatory collapse
Rare (less than 0.1%): Bradycardia, cyanosis, flushing, heart rate increase
Frequency not reported: Crescendo angina, rebound hypertension, palpitations, hypertension, decreased arterial oxygen tension, severe arterial hypotension with bradycardia, transient flushing[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, vomiting
Rare (0.01% to 0.1%): Dry mouth
Very rare (less than 0.01%): Heartburn, halitosis
Frequency not reported: Abdominal pain, retching, lip and tongue swelling[Ref]

Dermatologic

Uncommon (0.1% to 1%): Dermatitis contact, erythema, pruritus, burning, irritation, eczema, urticaria
Rare (0.01 to 0.1%): Allergic skin reactions, rash
Very rare (less than 0.01%): Exfoliative dermatitis, drug rash
Frequency not reported: Cutaneous flushing, diaphoresis, angioedema
Postmarketing reports: Rash generalized[Ref]

Other

Common (1% to 10%): Asthenia, weakness
Frequency not reported: Retrosternal discomfort[Ref]

Hypersensitivity

Rare (less than 0.1%): Hypersensitivity reactions, anaphylaxis
Frequency not reported: Allergic reaction, anaphylactoid reaction[Ref]

Psychiatric

Common (1% to 10%): Restlessness
Frequency not reported: Apprehension[Ref]

Respiratory

Very rare (less than 0.01%): Impairment of respiration
Frequency not reported: Hypoxemia, dyspnea[Ref]

Hematologic

Very rare (less than 0.01%): Methemoglobinemia[Ref]

Ocular

Rare (less than 0.1%): Blurred vision
Frequency not reported: Increased ocular pressure[Ref]

Musculoskeletal

Frequency not reported: Muscle twitching[Ref]

Some side effects of Nitrolingual Pumpspray may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.