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About Nitrolingual Pumpspray
What Nitrolingual Pumpspray is used for
NITROLINGUAL PUMPSPRAY is used for the treatment of acute attacks of angina pectoris—chest pain which occurs when the heart muscle does not get as much blood (hence as much oxygen) as it needs.
What Nitrolingual Pumpspray does
NITROLINGUAL PUMPSPRAY belongs to a group of drugs, which reduce the oxygen demand of the heart.
When Nitrolingual Pumpspray should not be used
You should not use NITROLINGUAL PUMPSPRAY if you have any of the following conditions:
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Known allergy or sensitivity to nitroglycerin or any of the other components of NITROLINGUAL PUMPSPRAY (see What the important nonmedicinal ingredients are:) or to any other medication of the same group of medicines called nitrates
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An eye disease called closed angle glaucoma
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Heart attack (myocardial infarction)
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Low iron levels in your blood or low red blood cell count (severe anemia)
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Low blood pressure (hypotension) or a diagnosis of heart failure
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A condition caused by an increase in normal brain pressure (increased intracranial pressure)
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If you are taking CIALIS (tadalafil), LEVITRA (vardenafil), VIAGRA (sildenafil citrate) or any similar medication for impotence (erectile dysfunction).
What the medicinal ingredient is
Nitroglycerin
What the important nonmedicinal ingredients for Nitrolingual Pumpspray are
Ethanol anhydrous, medium chain partial glycerides, medium chain triglycerides, and peppermint oil.
What dosage forms Nitrolingual Pumpspray comes in
Spray bottles delivering 75 or 200 metered doses of 0.4 mg nitroglycerin per spray emission.
Warnings and Precautions
Serious Warnings and Precautions
If you are currently taking medication for the treatment of impotence (erectile dysfunction) such as CIALIS (tadalafil), LEVITRA (vardenafil), VIAGRA (sildenafil citrate) or any other similar medication (PDE5 inhibitors), the use of NITROLINGUAL PUMPSPRAY may lead to extreme low blood pressure resulting in fainting, heart attack and death.
BEFORE you use NITROLINGUAL PUMPSPRAY talk to your doctor or pharmacist if:
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You are currently taking any other medications, whether on prescription or otherwise (see Interactions with This Medication:)
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You have headaches, weakness or dizziness especially when getting up suddenly from a laying down or sitting position, or symptoms of low blood pressure (hypotension)
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You are breast feeding, pregnant, or think you might be pregnant
Tolerance to NITROLINGUAL PUMPSPRAY and similar drugs can occur after long periods of use. Chronic use can lead to angina attacks being brought on more easily.
NITROLINGUAL PUMPSPRAY is not for use in children.
Temporary dizziness may be associated with the use of NITROLINGUAL PUMPSPRAY. Make sure you know how you react to this medicine before you drive, operate machinery, or do anything requiring you to be alert.
Avoid alcoholic beverages until you have discussed their use with your doctor.
The spray should be kept away from the eyes and it should not be inhaled.
Interactions with Nitrolingual Pumpspray
| Drugs that may interact with NITROLINGUAL PUMPSPRAY | Consequences/Effects |
| Some medications used to treat impotence (erectile dysfunction), such as sildenafil citrate (Viagra), tadalafil (Cialis) or vardenafil (Levitra). | Combination with NITROLINGUAL PUMPSPSRAY can produce severe lowering of blood pressure resulting in fainting, heart attack and possibly death. If you are being treated with any of these drugs and need NITROLINGUAL PUMPSPSRAY (e.g. in case of chest pain caused by an acute attack of angina pectoris) please seek emergency medical assistance immediately. |
Consuming alcoholic beverages and using NITROLINGUAL PUMPSPRAY may cause a negative lowering of your blood pressure.
Proper Use of Nitrolingual Pumpspray
(see package insert for illustrations).
Ideally, you should sit and rest while taking this medication.
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Holding container in upright position, remove the plastic cover.
DO NOT SHAKE.
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The container must be primed prior to the first use. To prime, point away from face, press the button firmly with the forefinger to release one spray. Repeat this 3 times. Now your container is primed and ready for use.
Repriming is only necessary when the container has not been used for more than 14 days. To reprime, release 1 spray as directed previously. There is no need to reprime the container between more frequent usage.
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Hold the container upright with forefinger on top of the grooved button. There is no need to shake the container.
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Open your mouth and bring the container as close to it as possible.
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Press the button firmly with the forefinger to release the spray onto or under the tongue.
DO NOT INHALE THE SPRAY.
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Release button and close mouth.
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If you require a second dose, repeat steps 4, 5 and 6.
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Replace the plastic cover.
When using this product for the first time, familiarize yourself with how to use it by testing the spray into the air (away from yourself and others). Get the feel of the finger resting on the groove button so that you can use the spray in the dark.
Usual dose
NITROLINGUAL PUMPSPRAY should be taken as prescribed by your doctor.
During an anginal attack, one or two doses should be sprayed onto or under the tongue, without inhaling. Your doctor can help you to discover the exact dose which will be best for you. Administer at rest, ideally in the sitting position. A dose may be repeated twice at 5-10 minute intervals. If the pain persists, seek emergency medical assistance.
MAKE SURE THAT YOU HAVE A SPARE PUMPSPRAY READILY AVAILABLE (TO PREVENT RUNNING OUT WHEN NEEDED).
Overdose
Symptoms of overdosage may include: flushing, headache, nausea, dizziness, and hypotension. If you suspect overdosage seek emergency medical assistance immediately.
Side Effects for Nitrolingual Pumpspray and What to Do About Them
Along with its intended action, any medication, including NITROLINGUAL PUMPSPRAY, may cause side effects. After you have started taking NITROLINGUAL PUMPSPRAY, it is important that you tell your doctor at once about any unexplained symptom you might experience.
Side effects such as severe and persistent headache, episodes of dizziness, weakness, flushing, palpitation (irregular heart rate) and occasionally nausea and vomiting may occur.
If you develop an allergic reaction involving swelling of the face, lips and/or tongue, stop using NITROLINGUAL PUMSPRAY and contact your doctor immediately.
This is not a complete list of side effects. For any unexpected effects while taking NITROLINGUAL PUMPSPRAY, contact your doctor or pharmacist.
| Serious Side Effects, How Often They Happen and What to Do About Them |
| Symptom/Effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist |
| Only if severe | In all cases |
| Allergic reaction involving swelling of the face, lips and/or tongue accompanied by difficulty breathing | | • | • |
| Common | Headache | • | | |
| Sore throat | • | | |
| Runny nose | • | | |
| Dizziness | | • | |
| Flushing | | • | |
| Abdominal pain | | • | |
| Swelling of the ankles | | • | |
| Tingling or pins and needles of a limb | | • | |
| Shortness of breath | | • | |
| Uncommon | Sore mouth | • | | |
| Restlessness | • | | |
| Sweating | • | | |
| Rash | • | | |
| Restlessness | • | | |
| Chest pain | | • | |
| Racing heart rate | | • | |
| Pallor | | • | |
| Vomiting | | | • |
| Low blood pressure (hypotension) | | | • |
| Fainting | | | • |
Technical InformationDrug Interactions
Interactions with herbal products have not been established.
Interactions with other drugs have not been established.
Interactions with lifestyle have not been established.
Interactions with food have not been established.
Interactions with laboratory tests have not been established.
Alcohol may enhance sensitivity to the hypotensive effects of nitrates.
Information for the Patient
Nitrolingual Pumpspray
Special Handling Instructions
Do not place NITROLINGUAL PUMPSPRAY in hot water or near radiators, stoves or other sources of heat. Do not open forcefully or incinerate container or expose to temperature over 40°C.
Dosage and Administration
The spray should not be inhaled.
The spray should be kept away from eyes.
This spray formulation is intended to be applied and absorbed on or under the tongue.
Upon initiating therapy with NITROLINGUAL PUMPSPRAY (nitroglycerin), especially when changing from another form of nitroglycerin administration, patients should be followed closely by their physicians in order to determine the minimal effective dose for each patient.
Each metered dose contains 0.4 mg nitroglycerin. With the onset of an acute attack of angina pectoris, 1 or 2 metered doses (0.4 or 0.8 mg of nitroglycerin), as determined by experience, may be administered onto or under the tongue,without inhaling. The optimal dose may be repeated twice at 5 10 minute intervals. Dosage must be individualized and should be sufficient to provide relief without producing untoward reactions.
During administration the patient should be at rest, ideally in the sitting position, and the container kept vertical with the nozzle head up. The opening in the nozzle head should be kept as close to the mouth as possible. Patients should familiarize themselves with the position of the spray orifice, identified by the finger rest on top of the valve, in order to facilitate administration at night.
Adverse Reactions
collapse, flushing, pallor, postural hypotension.
retrosternal discomfort, weakness.
System Organ Class
Adverse Event | Frequency |
Nitrolingual Pumpspray
0.4–1.6 mg
n=51
% | Placebo
n=49
% |
| Gastrointestinal disorders |
| Abdominal Pain | 2 | 0 |
| Stomatitis | 0 | 2 |
| General disorders and Administration Site Conditions |
| Asthenia | 2 | 0 |
| Peripheral Edema | 2 | 0 |
| Infections and Infestations |
| Pharyngitis | 4 | 0 |
| Rhinitis | 2 | 2 |
| Nervous System disorders |
| Headache | 16 | 0 |
| Dizziness | 6 | 2 |
| Paresthesia | 4 | 0 |
| Respiratory, Thoracic and Mediastinal disorders |
| Dyspnea | 4 | 0 |
| Vascular disorders |
| Vasodilatation | 2 | 0 |
Adverse reactions to NITROLINGUAL PUMPSPRAY (nitroglycerin) are generally dose-related. In a clinical trial studying patients with chronic stable angina, the following adverse events were reported during the use of NITROLINGUAL PUMPSPRAY: headache, dizziness, paresthesia and dyspnea. All adverse events were mild to moderate.
Clinically significant methemoglobinemia is rare at conventional doses, but may occur, especially in patients with genetic hemoglobin abnormalities.
exfoliative dermatitis, perspiration, rash.
Indications and Clinical Use
NITROLINGUAL PUMPSPRAY (nitroglycerin) is indicated for:
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the management and treatment of acute attacks of angina pectoris.
Overdosage
Symptoms of overdosage are primarily related to vasodilation, that could lead to severe hypotension and possible reflex tachycardia. These include cutaneous flushing, headache, nausea, dizziness, and hypotension. Methemoglobinemia has been reported in association with high dose of glyceryl nitrate therapy. This may possibly be clinically significant, especially in the context of hemoglobin reductase deficiencies or in congenital methemoglobin variants.
No specific antidote is available. Treatment should be symptomatic and supportive.
Dosage Forms, Composition and Packaging
Each metered dose contains: nitroglycerin 0.4 mg in an aromatized oily solution. Nonmedicinal ingredients: ethanol anhydrous, medium chained partial glycerides, medium chained triglycerides and peppermint oil. Spray bottles delivering 75 (hospital trade pack) or 200 metered doses.
Warnings and Precautions
The safety and effectiveness of nitroglycerin in the elderly population have not been established.
Especially during treatment start, nitroglycerin may induce symptoms related to orthostatic hypotension such as dizziness, which can possibly impact the ability to drive or use machines (See Adverse Reactions).
Tolerance to this drug and cross-tolerance to other nitrates or nitrites may occur. Physical dependence has also been described. With the chronic use of nitrates, there have been reports of anginal attacks being more easily provoked as well as reports of rebound in hemodynamic effects, occurring soon after nitrate withdrawal.
The use of nitroglycerin in patients with congestive heart failure requires careful clinical and/or hemodynamic monitoring.
Animal reproduction studies have not been conducted with nitroglycerin. It is not known whether nitroglycerin can cause fetal harm when administered to a pregnant woman. Therefore use NITROLINGUAL PUMPSPRAY only if the potential benefit justifies the risk to the fetus.
The safety and effectiveness of nitroglycerin in children have not been established.
It is not known whether nitroglycerin is excreted into breast milk. Benefits to the mother must be weighed against the risks to the child.
Nitroglycerin is a potent vasodilator and causes a slight decrease in mean blood pressure (approximately 10-15 mmHg) in some patients when used in therapeutic dosages. Caution should be exercised in using the drug in patients who are prone to, or who might be affected by hypotension.
Storage and Stability
NITROLINGUAL PUMPSPRAY (nitroglycerin) should be stored at room temperature: 15 to 30°C.
Action and Clinical Pharmacology
Nitroglycerin and its major metabolites are approximately 60% protein bound.
In a pharmacokinetic study when a single 0.8 mg dose of NITROLINGUAL PUMPSPRAY (nitroglycerin) was administered to 24 healthy volunteers, the mean Cmax and tmax were 1.04 ng/mL and 7.5 min, respectively. Additionally, in these subjects the mean AUC was 12.8 ng.min/mL.
The principal action of NITROLINGUAL PUMPSPRAY (nitroglycerin) is that of all nitrates, namely, relaxation of vascular smooth muscle. Nitrates act primarily by reducing myocardial oxygen demand rather than increasing its oxygen supply. This effect is thought to be brought about predominantly by peripheral action. Although venous effects predominate, nitroglycerin produces, in a dose-related manner, dilation of both arterial and venous beds. Dilation of the post capillary vessels, including large veins, promotes peripheral pooling of blood and decreases venous return to the heart, reducing left ventricular end-diastolic pressure (pre-load). Arteriolar relaxation reduces systemic vascular resistance and arterial pressure (after-load). Left ventricular end-diastolic pressure and volume are decreased, resulting in reduction of ventricular size and wall tension. The reduction in ventricular wall tension results in a net decrease in myocardial oxygen consumption and a favorable net balance between myocardial oxygen supply and demand.
Nitroglycerin is excreted by the renal route primarily as the two dinitro-metabolites, which have an excretion half-life of approximately 3-4 hours.
Nitroglycerin is rapidly metabolized in the liver by hepatic enzymes. The two active major metabolites are the hydrolysis products, 1,3- and 1,2-dinitro-glycerols. There are also two inactive minor metabolites, the 1- and 2-mononitroglycerols, which are considered biologically inactive.
Contraindications
NITROLINGUAL PUMPSPRAY (nitroglycerin) is contraindicated in:
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Patients with known hypersensitivity to nitroglycerin or any of the excipients, or with previous idiosyncratic reaction to organic nitrates. For a complete listing, see Dosage Forms, Composition and Packaging.
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Patients with severe anemia;
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Patients with closed angle glaucoma;
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Patients with increased intracranial pressure;
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Patients with myocardial infarction;
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Patients with acute circulatory failure (cardiogenic shock, severe hypovolemia or severe hypotension)
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Patients with heart failure (aortic or mitral stenosis, constrictive pericarditis or hypertrophic obstructive cardiomyopathy).
Concomitant use of NITROLINGUAL PUMPSPRAY (nitroglycerin) either regularly and/or intermittently, with phosphodiesterase type 5 (PDE5) inhibitors such as VIAGRA (sildenafil), CIALIS (tadalafil) and LEVITRA (vardenafil) is absolutely contraindicated, because PDE5 inhibitors amplify the vasodilatory effects of NITROLINGUAL PUMPSPRAY (nitroglycerin) which can lead to severe hypotension.
