Nitrolingual

Nitrolingual Pumpspray is a prescription medication used to treat or prevent episodes of angina (sudden chest pain). Nitrolingual Pumpspray belongs to a group of drugs called nitrates which work by relaxing (widening) blood vessels making it easier for the heart to pump blood.

This medication comes in an oral spray. It is usually sprayed onto or under the tongue at the onset of an attack. If needed, the dose can be repeated every 5 minutes. Seek emergency medical attention if the pain persists after 3 doses.

It can also be used when needed 5 to 10 minutes before activities that may cause attacks. 

Common side effects of Nitrolingual Pumpspray include headache, dizziness, and the sensation of tingling. 

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Nitrolingual Pumpspray falls into category C. No studies have been done in animals, and no well-controlled studies have been done in pregnant women. Nitrolingual Pumpspray should be given to a pregnant woman only if clearly needed.

Use Nitrolingual Pumpspray exactly as prescribed.

Nitrolingual Pumpspray comes as a spray. It is usually sprayed onto or under the tongue at the onset of an attack. If needed, the dose can be repeated every 5 minutes. Seek emergency medical attention if the pain persists after 3 doses.

Do up to three metered sprays within a 15-minute period. If chest pain persists, advise prompt medical attention.

It can also be used when needed 5 to 10 minutes before activities that may cause attacks. 

Do not inhale Nitrolingual Pumpspray.

Priming Nitrolingual Pumpspray:

Before you use Nitrolingual Pumpspray for the first time, you must prime it. To prime your Nitrolingual Pumpspray, follow the steps below:

• Remove the plastic cap from the container. 
• Hold the container upright and facing away from yourself and others. Press down on the top of the grooved button 5 times. 
• Your Nitrolingual Pumpspray is now primed. You are ready to give your first dose.
• If you do not use your Nitrolingual Pumpspray within 6 weeks, you will need to prime it again by pressing down on the top of the grooved button 1 time.
• If you do not use your Nitrolingual Pumpsray within 3 months, you will need to re-prime it by pressing down on the top of the grooved button up to 5 times.

• Hold your Nitrolingual Pumpspray container upright with your index finger on top of the grooved button.
• Open your mouth and bring the Nitrolingual Pumpspray container as close to your mouth as possible.
• Press down on the top of the grooved button firmly with your index finger to release the spray onto or under your tongue. The grooved button can help you make sure the canister is turned to the correct position if you are administering the spray in the dark.
• Release the grooved button and close your mouth right away. Avoid swallowing right after using Nitrolingual Pumpspray. Do not spit out Nitrolingual Pumpspray or rinse your mouth for 5 to 10 minutes after using Nitrolingual Pumpspray.
• If a second dose of Nitrolingual Pumpspray is needed, repeat Steps 3 through 6 above.
• Replace the plastic cap.

In the U.S.

• Gonitro
• Nitrocot
• Nitrolingual
• NitroMist
• Nitroquick
• Nitrostat
• Nitrotab
• Nitro-Time

In Canada

• Gen-Nitro
• Nitrolingual Pumpspray

Available Dosage Forms:

• Spray
• Tablet, Extended Release
• Tablet
• Capsule, Extended Release
• Packet

Therapeutic Class: Antianginal

Chemical Class: Nitrate

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Bloating or swelling of the face, arms, hands, lower legs, or feet
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• difficult or labored breathing
• feeling faint, dizzy, or lightheadedness
• feeling of warmth or heat
• flushing or redness of the skin, especially on the face and neck
• headache
• rapid weight gain
• sweating
• tightness in the chest
• tingling of the hands or feet
• unusual weight gain or loss

• Bluish-colored lips, fingernails, or palms
• dark urine
• fever
• pale skin
• rapid heart rate
• sore throat
• unusual bleeding or bruising
• unusual tiredness or weakness

• Arm, back, or jaw pain
• blurred vision
• chest pain or discomfort
• chest tightness or heaviness
• confusion
• cough
• cracks in the skin
• difficulty with swallowing
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fainting
• fast, irregular, pounding, or racing heartbeat or pulse
• feeling of constant movement of self or surroundings
• feeling of warmth
• hives, itching, or rash
• increased sweating
• loss of heat from the body
• nausea or vomiting
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• red, swollen skin
• redness of the face, neck, arms, and occasionally, upper chest
• scaly skin
• sensation of spinning
• weakness

Get emergency help immediately if any of the following symptoms of overdose occur:

• Bluish-colored lips, fingernails, or palms
• blurred or loss of vision
• bulging soft spot on the head of an infant
• change in consciousness
• change in the ability to see colors, especially blue or yellow
• cold, clammy skin
• dark urine
• difficulty breathing
• disturbed color perception
• dizziness or lightheadedness
• double vision
• fever
• flushed skin
• halos around lights
• headache, severe and throbbing
• increased sweating
• loss of appetite
• loss of consciousness
• night blindness
• overbright appearance of lights
• pale skin
• paralysis
• slow or irregular heartbeat
• sore throat
• tunnel vision
• unusual bleeding or bruising
• unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Abdominal or stomach pain
• body aches or pain
• congestion
• hoarseness
• lack or loss of strength
• runny nose
• sneezing
• stuffy nose
• tender, swollen glands in the neck
• voice changes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Recommended dosage

Instruct the patient to administer one or two metered sprays (400 mcg of nitroglycerin per spray) at the onset of an attack onto or under the tongue. A spray may be repeated approximately every five minutes as needed. No more than three metered sprays are recommended within a 15-minute period. If the chest pain persists after a total of three sprays, advise prompt medical attention. Nitrolingual Pumpspray may be used prophylactically 5 to 10 minutes prior to engaging in activities that might precipitate an acute attack.

Priming

The pump must be primed prior to the first use. Each metered spray of Nitrolingual Pumpspray delivers 48 mg of solution containing 400 mcg of nitroglycerin after an initial priming of five sprays. It will remain adequately primed for 6 weeks. If the product is not used within 6 weeks it can be adequately re-primed with one spray. If the product is not used within 3 months it can be adequately re-primed with up to five sprays. There are 60 or 200 metered sprays per bottle. The total number of available doses is dependent, however, on the number of sprays per use (1 or 2 sprays), and the frequency of priming.

Administration

Instruct patients that during administration, the patient should rest, ideally in the sitting position. Hold the container vertically with the valve head uppermost and the spray orifice as close to the mouth as possible. Spray the dose preferably onto or under the tongue by pressing the grooved-button firmly and the mouth closed immediately after each dose. THE SPRAY SHOULD NOT BE INHALED. The medication should not be expectorated or the mouth rinsed for 5 to 10 minutes following administration. Instruct patients to familiarize themselves with the position of the spray orifice, which can be identified by the finger rest on top of the valve, in order to facilitate orientation for administration at night [see Patient Information (17)].

The amount of liquid remaining in the container should be checked periodically. The transparent container can be used for continuous monitoring of the consumption. With the container upright and level, check to be sure the end of the center tube extends below the level of the liquid. Once fluid falls below the level of the center tube, remaining sprays will not deliver intended dose.

Signs and symptoms, methemoglobinemia

Nitrate overdosage may result in: severe hypotension, persistent throbbing headache, vertigo, palpitation, visual disturbance, flushing and perspiring skin (later becoming cold and cyanotic), nausea and vomiting (possibly with colic and even bloody diarrhea), syncope (especially in the upright posture), methemoglobinemia with cyanosis and anorexia, initial hyperpnea, dyspnea and slow breathing, slow pulse (dicrotic and intermittent), heart block, increased intracranial pressure with cerebral symptoms of confusion and moderate fever, paralysis and coma followed by clonic convulsions, and possibly death due to circulatory collapse.

Case reports of clinically significant methemoglobinemia are rare at conventional doses of organic nitrates. The formation of methemoglobin is dose-related and in the case of genetic abnormalities of hemoglobin that favor methemoglobin formation, even conventional doses of organic nitrates could produce harmful concentrations of methemoglobin.

Treatment of overdosage

As hypotension associated with nitroglycerin overdose is the result of venodilatation and arterial hypovolemia, prudent therapy in this situation should be directed toward increase in central fluid volume. No specific antagonist to the vasodilator effects of nitroglycerin is known. Keep the patient recumbent in a shock position and comfortably warm. Passive movement of the extremities may aid venous return. Intravenous infusion of normal saline or similar fluid may also be necessary. Administer oxygen and artificial ventilation, if necessary. If methemoglobinemia is present, administration of methylene blue (1% solution), 1-2 mg per kilogram of body weight intravenously, may be required unless the patient is known to have G-6-PD deficiency. If an excessive quantity of Nitrolingual Pumpspray has been recently swallowed gastric lavage may be of use.

As epinephrine is ineffective in reversing the severe hypotensive events associated with overdosage, it is not recommended for resuscitation.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Animal carcinogenesis studies with sublingual nitroglycerin have not been performed.

Rats receiving up to 434 mg/kg/day of dietary nitroglycerin for 2 years developed dose-related fibrotic and neoplastic changes in liver, including carcinomas, and interstitial cell tumors in testes. At high dose, the incidences of hepatocellular carcinomas in both sexes were 52% vs. 0% in controls, and incidences of testicular tumors were 52% vs. 8% in controls. Lifetime dietary administration of up to 1058 mg/kg/day of nitroglycerin was not tumorigenic in mice.

Nitroglycerin was weakly mutagenic in Ames tests performed in two different laboratories. There was no evidence of mutagenicity in an in vivo dominant lethal assay with male rats treated with doses up to about 363 mg/kg/day, p.o., or in in vitro cytogenic tests in rat and dog tissues and for chromosomal aberration in Chinese hamster ovary cells.

In a three-generation reproduction study, rats received dietary nitroglycerin at doses up to about 434 mg/kg/day for six months prior to mating of the F0 generation with treatment continuing through successive F1 and F2 generations. The high dose was associated with decreased feed intake and body weight gain in both sexes at all matings. No specific effect on the fertility of the F0 generation was seen. Infertility noted in subsequent generations, however, was attributed to increased interstitial cell tissue and aspermatogenesis in the high-dose males. In this three-generation study there was no clear evidence of teratogenicity.

Each box of Nitrolingual Pumpspray contains one glass bottle coated with red transparent plastic which assists in containing the glass and medication should the bottle be shattered. Each bottle contains 4.9 g or 14.6 g (Net Content) of nitroglycerin lingual spray which will deliver 60 or 200 metered sprays containing 400 mcg of nitroglycerin per spray after priming.

Nitrolingual Pumpspray is available as:

• 60-dose (4.9 g) single bottle NDC 24338-300-65
• 200-dose (14.6 g) single bottle NDC 24338-300-20

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Note: Nitrolingual Pumpspray contains 20% alcohol. Do not forcefully open or burn container after use. Do not spray toward flames.

Rx Only.