NitroMist

Name: NitroMist

What should i avoid while taking nitroglycerin (nitrolingual, nitrolingual duo pack, nitromist, nitrostat, nitro-time)?

Nitroglycerin can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid drinking alcohol. It can increase some of the side effects of nitroglycerin, such as dizziness, drowsiness, feeling light-headed, or fainting.

Side Effects of NitroMist

NitroMist may cause the following side effects:

  • headache
  • flushing (warm or red condition of your skin)
  • low blood pressure
  • lightheadedness on standing, especially just after rising from a laying or seated position. 
  • dizziness
  • weakness
  • nausea and vomiting
  • sweating
  • paleness
  • fainting

Tell your doctor if you are concerned about any side effects you experience. These are not all the possible side effects of NitroMist. For a complete list, ask your doctor or pharmacist.

NitroMist Interactions

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

  • any medicines that are used to treat angina, heart failure, or an irregular heartbeat.
  • any medicines that reduce blood pressure.
  • any diuretics (water pills).
  • medications to treat depression or psychiatric illness.
  • ergotamine or similar drugs for migraine headaches.
  • aspirin.
  • the blood thinner medicine heparin.
  • any medicines for erectile dysfunction.

Do not consume alcohol while taking NitroMist, as this can lower your blood pressure.

This is not a complete list of NitroMist drug interactions. Ask your doctor or pharmacist for more information.

NitroMist Dosage

Use NitroMist as directed by your doctor. 

At the onset of an attack, administer one metered spray or two metered sprays on or under the tongue. A spray may be repeated approximately every 5 minutes as needed.

Maximum of 3 metered sprays are recommended within a 15-minute period. If chest pain persists after a total of 3 sprays, call for medical attention.

To prevent an attack, NitroMist may be used prophylactically 5 minutes to 10 minutes before engaging in activities that might precipitate an acute attack.

Uses For NitroMist

Nitroglycerin is used to prevent angina (chest pain) caused by coronary artery disease. This medicine is also used to relieve an angina attack that is already occurring.

Nitroglycerin belongs to the group of medicines called nitrates. It works by relaxing the blood vessels and increasing the supply of blood and oxygen to the heart while reducing its work load. When used regularly on a long-term basis, or just before exercise or a stressful event, this helps prevent angina attacks from occurring.

This medicine is available only with your doctor's prescription.

NitroMist Side Effects

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:

Less common
  • 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
Rare
  • Bluish-colored lips, fingernails, or palms
  • dark urine
  • fever
  • pale skin
  • rapid heart rate
  • sore throat
  • unusual bleeding or bruising
  • unusual tiredness or weakness
Incidence not known
  • 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:

Symptoms of overdose
  • 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:

Less common
  • 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.

What are some other side effects of NitroMist?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Dizziness.
  • Headache.
  • Mouth tingling.
  • Burning.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Drug interactions

7.1 PDE5 Inhibitors

Administration of NitroMist is contraindicated in patients who are using a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). PDE5 inhibitors such as sildenafil, vardenafil, and tadalafil have been shown to potentiate the hypotensive effects of organic nitrates. Do not use NitroMist in patients who are taking the soluble guanylate cyclase (sGC) stimulator riociguat. Concomitant use may result in severe hypotension, syncope, or myocardial ischemia.

The time course and dose dependence of this interaction have not been studied, and use within a few days of one another cannot be recommended. Appropriate supportive care for the severe hypotension has not been studied, but it seems reasonable to treat this as a nitrate overdose, with elevation of the extremities and with central volume expansion. The use of any form of nitroglycerin during the early days of acute myocardial infarction requires particular attention to hemodynamic monitoring and clinical status.

7.2 Antihypertensives

Patients receiving antihypertensive drugs, beta-adrenergic blockers, and nitrates should be observed for possible additive hypotensive effects. Marked orthostatic hypotension has been reported when calcium channel blockers and organic nitrates were used concomitantly.

Labetolol blunts the reflex tachycardia produced by nitroglycerin without preventing its hypotensive effects. If labetolol is used with nitroglycerin in patients with angina pectoris, additional hypotensive effects may occur.

7.3 Aspirin

Coadministration of aspirin and nitroglycerin has been reported to result in increased nitroglycerin maximum concentrations by as much as 67% and AUC by 73% when administered as a single dose. The vasodilatory and hemodynamic effects of nitroglycerin may be enhanced by concomitant administration of aspirin.

7.4 Tissue-type Plasminogen Activator (t-PA)

Intravenous administration of nitroglycerin decreases the thrombolytic effect of tissue-type plasminogen activator (t-PA). Plasma levels of t-PA are reduced when coadministered with nitroglycerin. Therefore, caution should be observed in patients receiving nitroglycerin during t-PA therapy.

7.5 Heparin

Intravenous nitroglycerin reduces the anticoagulant effect of heparin. Activated partial thromboplastin times (APTT) should be monitored in patients receiving heparin and intravenous nitroglycerin. It is not known if this effect occurs following single nitroglycerin doses.

7.6 Ergotamine

Oral administration of nitroglycerin markedly decreases the first-pass metabolism of dihydroergotamine and subsequently increases its oral bioavailability. Ergotamine is known to precipitate angina pectoris. Therefore, patients receiving sublingual nitroglycerin should avoid ergotamine and related drugs or be monitored for symptoms of ergotism if this is not possible.

Use in specific populations

8.1 Pregnancy

Pregnancy category C: Animal reproduction and teratogenicity studies have not been conducted with NitroMist or nitroglycerin sublingual tablets. It is also not known whether NitroMist can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. A teratogenicity study was conducted in the third mating of F0 generation female rats administered dietary nitroglycerin for gestation day 6 to day 15 at dose levels used in the 3-generation reproduction study. In offspring of the high-dose nitroglycerin group, increased incidence of diaphragmatic hernias and decreased hyoid bone ossification were seen. The latter finding probably reflects delayed development rather than a potential teratogenic effect, thus indicating no clear evidence of teratogenicity of nitroglycerin.

There are no adequate and well controlled studies in pregnant women. NitroMist should be given to a pregnant woman only if clearly needed.

8.3 Nursing Mothers

It is not known whether nitroglycerin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when NitroMist is administered to a nursing woman.

8.4 Pediatric Use

The safety and effectiveness of nitroglycerin in pediatric patients have not been established.

8.5 Geriatric Use

Clinical studies of NitroMist did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between elderly (greater than or equal to 65 years) and younger (less than65 years) patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

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