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Nitrolingual

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Overview

What is Nitrolingual?

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 (CHNO). The compound has a molecular weight of 227.09. The chemical structure is:  Nitrolingual Pumpspray (nitroglycerin lingual spray 400 mcg) is a metered dose spray containing nitroglycerin. This product delivers nitroglycerin (400 mcg per spray, 60 or 200 metered sprays) in the form of spray droplets onto or under the tongue. Inactive ingredients: medium-chain triglycerides, dehydrated alcohol, medium-chain partial glycerides, peppermint oil.



What does Nitrolingual look like?



What are the available doses of Nitrolingual?

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What should I talk to my health care provider before I take Nitrolingual?

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How should I use Nitrolingual?

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

At the onset of an attack, one or two metered sprays should be administered onto or under the tongue. No more than three metered sprays are recommended within a 15-minute period. If the chest pain persists, prompt medical attention is recommended. Nitrolingual Pumpspray may be used prophylactically five to ten minutes prior to engaging in activities which might precipitate an acute attack. Each metered spray of Nitrolingual Pumpspray delivers 48 mg of solution containing 400 mcg of nitroglycerin after an initial priming of 5 sprays. It will remain adequately primed for 6 weeks.If the product is not used within 6 weeks it can be adequately reprimed with 1 spray. Longer storage periods without use may require up to 5 repriming 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 repriming. The transparent container can be used for continuous monitoring of the consumption. . Once fluid falls below the level of the center tube, sprays will not be adequate and the container should be replaced. As with all other sprays, there is a residual volume of fluid at the bottom of the bottle which cannot be used.  During application 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 onto the tongue by pressing the button firmly and the mouth should be 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. 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.


What interacts with Nitrolingual?

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What are the warnings of Nitrolingual?

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What are the precautions of Nitrolingual?

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What are the side effects of Nitrolingual?

Adverse reactions to oral nitroglycerin dosage forms, particularly headache and hypotension, are generally dose-related. In clinical trials at various doses of nitroglycerin, the following adverse effects have been observed: Headache, which may be severe and persistent, is the most commonly reported side effect of nitroglycerin with an incidence on the order of about 50% in some studies. Cutaneous vasodilation with flushing may occur. Transient episodes of dizziness and weakness, as well as other signs of cerebral ischemia associated with postural hypotension, may occasionally develop. Occasionally, an individual may exhibit marked sensitivity to the hypotensive effects of nitrates and severe responses (nausea, vomiting, weakness, restlessness, pallor, perspiration and collapse) may occur even with therapeutic doses. Drug rash and/or exfoliative dermatitis have been reported in patients receiving nitrate therapy. Nausea and vomiting appear to be uncommon. Nitrolingual Pumpspray given to 51 chronic stable angina patients in single doses of 0.4, 0.8 and 1.6 mg as part of a double-blind, 5-period single-dose cross-over study exhibited an adverse event profile that was generally mild to moderate. Adverse events occurring at a frequency greater than 2% included: headache, dizziness, and paresthesia. Less frequently reported events in this trial included  (≤2%): dyspnea, pharyngitis, rhinitis, vasodilation, peripheral edema, asthenia, and abdominal pain.


What should I look out for while using Nitrolingual?

Allergic reactions to organic nitrates are rare.  Nitroglycerin is contraindicated in patients who are allergic to it.  Nitrolingual Pumpspray is contraindicated in patients taking certain drugs for erectile dysfunction (phosphodiesterase inhibitors), as their concomitant use can cause severe hypotension.  The time course and dose-dependency of this interaction are not known.

Epinephrine is ineffective in reversing the severe hypotensive events associated with overdosage. It and related compounds are contraindicated in this situation.


What might happen if I take too much Nitrolingual?


How should I store and handle Nitrolingual?

Store below 30°C (86°F).Manufactured by:DANBURY PHARMACAL, INC.Danbury, CT 06810Store below 30°C (86°F).Manufactured by:DANBURY PHARMACAL, INC.Danbury, CT 06810Each box of Nitrolingual Pumpspray, contains one clear glass bottle coated with red transparent plastic which assists in containing the glass and medication should the bottle be shattered. Each unit contains 4.9 g (NDC 59630- 300-65) or 12 g (NDC 59630-300-20) (Net Content) of nitroglycerin lingual spray which will deliver 60 or 200 metered sprays containing 400 mcgs of nitroglycerin per spray after priming. 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.  NLPS-PI-2Rev. 10/05