Nitromist label

Nitromist

Nitromist Recall

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Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

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

History

There is currently no drug history available for this drug.

Other Information

Nitroglycerin, an organic nitrate, is a vasodilator which has effects on both arteries and veins. The chemical name for nitroglycerin is 1,2,3-propanetriol trinitrate (C3H5N3O9). The compound has a molecular weight of 227.09. The chemical structure is:

Image from Drug Label Content

NitroMist (nitroglycerin) lingual aerosol is a metered-dose spray containing 230 metered sprays of nitroglycerin. This product delivers 400 mcg of nitroglycerin per actuation in the form of spray droplets on or under the tongue. Inactive ingredients: caprylic/capric diglycerol succinate, peppermint oil, L(‑)‑menthol, n-butane.

Nitromist Manufacturers

  • Nitromist |
    No Recall

    Nitromist |

    Nitromist |
    2.1 Recommended Dosage

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

    2.2 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.

    2.3 Administration

    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 10 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, repeat 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.

  • Nitromist | Akrimax Pharmaceuticals, Llc
    No Recall

    Nitromist | Akrimax Pharmaceuticals, Llc

    Nitromist | Akrimax Pharmaceuticals, Llc
    2.1 Recommended Dosage

    At the onset of an attack, one metered spray or two metered sprays should be administered on or under the tongue. A spray may be repeated approximately every 5 minutes as needed. If two sprays are used initially, the patient may only administer one more spray after waiting 5 minutes. 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 may be used prophylactically 5 minutes to 10 minutes before engaging in activities that might precipitate an acute attack.

    2.2 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. NitroMist is available in either 230 metered sprays or 90 metered sprays per container, but the total number of available doses depends on the number of sprays per use (1 spray or 2 sprays), and the frequency of priming.

    2.3 Administration

    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. If this is the first time using the bottle, press actuator button 10 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(s) onto or under the tongue. Release button and close mouth. The medication should not be spit out or the mouth rinsed for 5 minutes to 10 minutes following administration. If a second administration is required to obtain relief, repeat steps 4, 5, and 6. No more than 3 metered sprays can be given within a 15-minute period. 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.