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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. No more than 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. NitroMist (nitroglycerin lingual aerosol) may be used prophylactically 5 to 10 minutes before engaging in activities that might precipitate an acute attack.
Priming the Container
After an initial priming of 10 sprays, each metered spray of NitroMist delivers 33 mg of solution containing 400 mcg of nitroglycerin. It will remain adequately primed for 6 weeks. If the product is not used within 6 weeks, it can be adequately re-primed with 2 sprays. There are 230 metered sprays per container, but the total number of available doses depends on the number of sprays per use (1 or 2 sprays), and the frequency of priming.
During use the patient should rest, ideally in the sitting position. The container should be held vertically with the valve head uppermost and the spray orifice as close to the mouth as possible. The dose should preferably be sprayed into the mouth on or under the tongue by pressing the button firmly and the mouth should be closed immediately after each dose. THE SPRAY SHOULD NOT BE INHALED. Patients should be instructed 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.
- Do not shake container.
- Remove plastic cap
- Press actuator button TO times to ensure proper dose priming (holding unit away from yourself and others).
- Hold container upright with forefinger on top of the actuator button.
- Open mouth and bring the container as close as possible.
- Press the actuator button firmly with forefinger to release spray onto or under the tongue.
- Release button and close mouth. The medication should not be spit out or the mouth rinsed for 5 to 10 minutes following administration.
- If a second administration is required to obtain relief, repeal steps 4, 5, and 6.
- Replace plastic cover.
- If the product is not used for more than 6 weeks, then it can be adequately re-primed with 2 sprays.
The level of the liquid in the container should be periodically checked. While the container is in the upright position, if the liquid reaches the top or middle of the hole on the side of the container, one should order more. When the liquid reaches the bottom of the hole, the remaining doses will have less than label content.
Dosage Forms and Strength
How Supplied/Storage and Handling
Each box of NitroMist (nitroglycerin lingual aerosol) contains one glass bottle coated with red/orange transparent plastic which assists in containing the glass and medication should the bottle be shattered. Each unit contains 8.5 g (Net Content) of nitroglycerin lingual aerosol and will deliver 230 metered sprays containing 400 mcg of nitroglycerin per actuation.
Store at room temperature (25°C, 77°F); excursions permitted to 15-30°C (59- 85°F)
NitroMist (nitroglycerin lingual aerosol) contains a highly flammable propellant (butane). Do not forcefully open a NitroMist (nitroglycerin lingual aerosol) bottle, do not have the container burned after use, and do not spray directly toward flames.
Manufactured for NovaDel Pharma Inc., Flemington, NJ 08822
by INyX USA, Ltd., Road 604 San Jose Industrial Zone,
Cotto North, Manati,
Puerto Rico 00674, and distributed by Par Pharmaceutical,
Woodcliff Lake, NJ 07677.
FDA rev date: 11/2/2006
Last reviewed on RxList: 3/26/2007
Additional NitroMist Information
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