NITROLINGUAL 400 ug/1

Nitroglycerin · SPRAY · Allegis Pharmaceuticals, LLC

No Recall HistoryCurrently in Shortage

Plain English

NITROLINGUAL is a spray containing nitroglycerin at 400 ug/1, taken oral. Manufactured by Allegis Pharmaceuticals, LLC.

Key Facts

Brand Name: NITROLINGUAL
Generic Name: Nitroglycerin
NDC Code (Product): 28595-550
Manufacturer: Allegis Pharmaceuticals, LLC
Strength: 400 ug/1
Dosage Form: SPRAY
Route: ORAL
Marketing Status
Application #: NDA018705
Drug Class: Nitrate Vasodilator [EPC]
Marketing Start: 07/01/2019

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

dyspnoea3,502 reports

pain3,153 reports

fatigue2,813 reports

myocardial infarction2,797 reports

nausea2,696 reports

fall2,431 reports

chest pain2,418 reports

dizziness2,418 reports

drug ineffective2,314 reports

diarrhoea2,153 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Nitrolingual Pumpspray is indicated for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease. Nitrolingual Pumpspray is a nitrate vasodilator indicated for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease ( 1 ).

Dosage & Administration

2 DOSAGE AND ADMINISTRATION At the onset of an attack, administer onto or under the tongue. Repeat every 5 minutes as needed ( 2.1 ). Do up to three metered sprays within a 15-minute period. If chest pain persists, advise prompt medical attention ( 2.1 ). May be used prophylactically 5 to 10 minutes prior to engaging in activities that might precipitate an acute attack ( 2.1 ). 2.1 Recommended Dosage Instruct the patient to administer one or two metered sprays (400 mcg of nitroglycerin per spray) at the onset of an attack onto or under the tongue. A spray may be repeated approximately every five minutes as needed. No more than three metered sprays are recommended within a 15-minute period. If the chest pain persists after a total of three sprays, advise prompt medical attention. Nitrolingual Pumpspray may be used prophylactically 5 to 10 minutes prior to engaging in activities that might precipitate an acute attack. 2.2 Priming The pump must be primed prior to the first use. Each metered spray of Nitrolingual Pumpspray delivers 48 mg of solution containing 400 mcg of nitroglycerin after an initial priming of five sprays. It will remain adequately primed for 6 weeks. If the product …

Contraindications

4 CONTRAINDICATIONS Use of phosphodiesterase type 5 (PDE-5) Inhibitors, such as avanafil, sildenafil, tadalafil, or vardenafil, or soluble guanylate cyclase (sGC) stimulator (riociguat). ( 4.1 , 7.1 ) Severe anemia. ( 4.2 ) Increased intracranial pressure. ( 4.3 ) Hypersensitivity to Nitrolingual Pumpspray or to other nitrates or nitrites or any excipient. ( 4.4 ) 4.1 P DE-5 - I nhibitors and sGC- S timulators Do not use Nitrolingual Pumpspray in patients who are taking PDE-5-Inhibitors, such as avanafil, sildenafil, tadalafil, or vardenafil. Concomitant use can cause severe hypotension, syncope, or myocardial ischemia [see Drug Interactions (7.1) ]. Do not use Nitrolingual Pumpspray in patients who are taking soluble guanylate cyclase (sGC) stimulators, such as riociguat. Concomitant use can cause hypotension. 4.2 Severe Anemia Nitrolingual Pumpspray is contraindicated in patients with severe anemia (large doses of nitroglycerin may cause oxidation of hemoglobin to methemoglobin and could exacerbate anemia). 4.3 Increased I ntracranial P ressure Nitrolingual Pumpspray may precipitate or aggravate increased intracranial pressure and thus should not be used in patients with possible…

Drug Interactions

7 DRUG INTERACTIONS Antihypertensives: possible additive hypotensive effects. ( 7.2 ) Ergotamine: increased bioavailability of ergotamine. Avoid concomitant use ( 7.3 ) 7. 1 P DE -5- I nhibitors and sGC- S timulators Nitrolingual Pumpspray is contraindicated in patients who are using a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE-5). PDE-5-Inhibitors such as avanafil, sildenafil, vardenafil, and tadalafil have been shown to potentiate the hypotensive effects of organic nitrates. Nitrolingual Pumpspray is contraindicated in patients who are taking soluble guanylate cyclase (sGC) stimulators. Concomitant use can cause hypotension. The time course and dose dependence of these interactions have not been studied, and use within a few days of one another is not recommended. Appropriate supportive care for the severe hypotension has not been studied, but it seems reasonable to treat this as a nitrate overdose, with elevation of the extremities and with central volume expansion. 7. 2 Antihypertensives Patients receiving antihypertensive drugs, beta-adrenergic blockers, and nitrates should be observed for possible additive hypotensive e…

Adverse Reactions

6 ADVERSE REACTIONS Most common adverse reactions occurring at a frequency greater than 2 % are headache, dizzinesss and paresthesia ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact Independence Pharmaceuticals, LLC at 1-866-525-0688 or FDA at 1-800-FDA-1088 or www.fda. gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Adverse reactions occurring at a frequency greater than 2 % and greater than placebo included: headache, dizziness, and paresthesia. 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of Nitrolingual Pumpspray and other nitroglycerin drugs. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or establish a causal relationship to drug exposure. Neurologic: weakness, drowsiness Dermatologic: cutaneous vasodilation, flushing, drug rash, exfoliative der…

Frequently Asked Questions

What is NITROLINGUAL used for?

NITROLINGUAL contains Nitroglycerin. It is a spray taken oral. Consult your doctor for specific uses.

Is NITROLINGUAL a controlled substance?

NITROLINGUAL is not classified as a controlled substance by the DEA.

What is the generic name for NITROLINGUAL?

The generic name for NITROLINGUAL is Nitroglycerin. There are 12 other brand versions of Nitroglycerin.

What is the NDC code for NITROLINGUAL 400 ug/1?

The NDC (National Drug Code) for NITROLINGUAL 400 ug/1 is 28595-550, listed by Allegis Pharmaceuticals, LLC.

Product NDC

28595-550

Package NDC

28595-550-12

Other Nitroglycerin Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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