NitroMist

Generic Name: nitroglycerin lingual aerosol
Date of Approval: November 2, 2006
Company: NovaDel Pharma

Treatment for: Angina Pectoris

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The U.S. Food and Drug Administration (FDA) has approved NitroMist (Nitroglycerin Lingual Aerosol) for acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.

Data from the NitroMist clinical trials demonstrate the drug's efficacy in the treatment of angina. In a double-blind, single-center, placebo-controlled, 4-period crossover study in 30 subjects with stable angina pectoris, doses of 0.2, 0.4, and 0.8 mg of nitroglycerin delivered by NitroMist were compared to placebo. The primary efficacy endpoint was exercise tolerance as measured by time to development of moderate angina while on an exercise treadmill. The primary endpoint was achieved with all three nitroglycerin oral spray groups demonstrating statistically significantly increase in time to angina compared to placebo (p less than or equal to 0.0003).

About NitroMist

NitroMist is an oral spray formulation of the drug most often used to treat angina pectoris, nitroglycerin. Angina is pain in the chest due to lack of blood and oxygen supply to the heart muscle resulting from an acute coronary syndrome and must be treated emergently. The American Heart Association estimates that over six million people in the United States suffer from angina.

Important Safety Information

Administration of NitroMist is contraindicated in patients who are using PDE5 inhibitors such as Viagra (sildenafil), Levitra (vardenafil), and Cialis (tadalafil). These products have been shown to potentiate the hypotensive effects of nitrate drugs such as NitroMist. NitroMist is also contraindicated in patients with severe anemia, increased intracranial pressure, or with a known hypersensitivity to nitrates or nitrites. Excessive use may lead to the development of tolerance. Severe hypotension, particularly with upright posture, may occur even with small doses of nitroglycerin. The drug should therefore be used with caution in patients who may be volume-depleted or who are already hypotensive. Nitroglycerin produces dose-related headaches, which may be severe.

Source: NovaDel Pharma Inc.

NitroMist - Highlights of Prescribing Information

These highlights do not include all the information needed to use nitromist safely and effectively. See full prescribing information for NitroMist.

NitroMist Indications and Usage

NitroMist is a nitrate vasodilator indicated for acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.

NitroMist Dosage and Administration

• At the onset of an attack, one or two metered sprays should be administered 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, prompt medical attention is recommended.
• May be used prophylactically 5 to 10 minutes before engaging in activities that might precipitate an acute attack.

NitroMist Dosage Forms and Strengths

Lingual aerosol, 400 mcg per spray, 230 metered sprays per container

NitroMist Contraindications

• Use of a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5 inhibitors), such as sildenafil, vardenafil, and tadalafil.
• Severe anemia
• Increased intracranial pressure
• History of hypersensitivity to NitroMist or to other nitrates or nitrites

NitroMist Warnings and Precautions

• Tolerance: Excessive use may lead to tolerance.

NitroMist Adverse Reactions

Most common adverse reactions are headache, flushing, hypotension, and syncope.

To report SUSPECTED ADVERSE REACTIONS, contact NovaDel Pharma at 1-908-782-3431 and or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

NitroMist Drug Interactions

• PDE5 inhibitors: Concomitant use contraindicated
• Antihypertensives: Possible additive hypotensive effects
• Aspirin: increased nitroglycerin levels
• Tissue-type plasminogen activator (t-PA): decreased thrombolytic effect
• Heparin: anticoagulant effect of heparin may be reduced. Monitor APTT.
• Ergotamine: increased bioavailability of ergotamine. Avoid concomitant use.

NitroMist Patient Counseling Information

1. Interaction with PDE5 inhibitors
   NitroMist should not be used in patients who are using medications for erectile dysfunction such as sildenafil, vardenafil, and tadalafil. These products have been shown to increase the hypotensive effects of nitrate drug such as NitroMist.
2. Administration
   NitroMist is meant to be sprayed on or under the tongue at the beginning of angina or to prevent an angina attack. Treatment with nitroglycerin products such as NitroMist may be associated with lightheadedness on standing, especially just after rising from a laying or seated position. This effect may be more frequent in patients who have consumed alcohol, since alcohol use contributes to hypotension. If possible, patients should be seated when taking NitroMist. This reduces the likelihood of falling due to lightheadedness or dizziness.
3. Headache
   Headaches can sometimes accompany treatment with nitroglycerin. In patients who get these headaches, the headaches may indicate activity of the drug. Tolerance to headaches develops.
4. Flushing
   Flushing, drug rash and exfoliative dermatitis have been reported in patients receiving nitrate therapy.
5. Container information
   The NitroMist bottle should not be forcefully opened. Because NitroMist contains a highly flammable propellant (butane), do not have the container burned after use and do not spray directly towards flames.
   While the container is in the upright position, if the liquid reaches the top to middle of the hole on the side of the container, a new supply should be obtained. When the liquid reaches the bottom of the hole, the remaining doses will have less than label content.

For more information, please see NitroMist Professional Information

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