NITROGLYCERIN LINGUAL 400 ug/1

Nitroglycerin · SPRAY · Allegis Pharmaceuticals, LLC

1 Recall on RecordCurrently in Shortage

Plain English

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

Key Facts

Brand Name: NITROGLYCERIN LINGUAL
Generic Name: Nitroglycerin
NDC Code (Product): 28595-120
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

1 Recall on Record

Class II12/27/2021

Padagis US LLC

Defective Delivery System

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

dyspnoea3,361 reports

pain3,094 reports

myocardial infarction2,687 reports

fatigue2,682 reports

nausea2,575 reports

fall2,377 reports

chest pain2,333 reports

dizziness2,304 reports

drug ineffective2,278 reports

headache2,099 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS & USAGE Nitroglycerin Lingual Spray is indicated for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease.

Dosage & Administration

2 DOSAGE & ADMINISTRATION 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. Nitroglycerin Lingual Spray 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 Nitroglycerin Lingual Spray 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 is not used within 6 weeks it can be adequately re-primed with one spray. If the product is not used within 3 months it can be adequately re-primed with up to five 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 …

Contraindications

4 CONTRAINDICATIONS 4.1 PDE-5-Inhibitors and sGC-Stimulators Do not use Nitroglycerin Lingual Spray 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 Nitroglycerin Lingual Spray in patients who are taking the soluble guanylate cyclase (sGC) stimulator riociguat. Concomitant use can cause hypotension. 4.2 Severe Anemia Nitroglycerin Lingual Spray 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 Intracranial Pressure Nitroglycerin Lingual Spray may precipitate or aggravate increased intracranial pressure and thus should not be used in patients with possible increased intracranial pressure (e. g. cerebral hemorrhage or traumatic brain injury). 4.4 Hypersensitivity Nitroglycerin Lingual Spray is contraindicated in patients who are allergic to nitroglycerin, other nitrates or nitrites or any excipient. 4.5 Circulatory Failure and Shock Nitroglycerin Lingual Spray is contraindicated in patients w…

Drug Interactions

7 DRUG INTERACTIONS 7.1 PDE-5-inhibitors and sGC-Stimulators Nitroglycerin Lingual Spray is contraindicated in patients who are using a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). PDE5 inhibitors such as avanafil, sildenafil, vardenafil, and tadalafil have been shown to potentiate the hypotensive effects of organic nitrates. Do not use Nitroglycerin Lingual Spray in patients who are taking the soluble guanylate cyclase (sGC) stimulator riociguat. 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 cannot be 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 effects. Marked orthostatic hypotension has been reported when calcium channel blockers and organic nitrates were used concomitantly. Beta-adr…

Adverse Reactions

6 ADVERSE REACTIONS 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 postapproval use of nitroglycerin lingual spray 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 dermatitis Gastrointestinal: nausea, vomiting Respiratory: transient hypoxemia Cardiovascular: tachycardia

Frequently Asked Questions

What is NITROGLYCERIN LINGUAL used for?

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

Is NITROGLYCERIN LINGUAL a controlled substance?

NITROGLYCERIN LINGUAL is not classified as a controlled substance by the DEA.

What is the generic name for NITROGLYCERIN LINGUAL?

The generic name for NITROGLYCERIN LINGUAL is Nitroglycerin. There are 11 other brand versions of Nitroglycerin.

What is the NDC code for NITROGLYCERIN LINGUAL 400 ug/1?

The NDC (National Drug Code) for NITROGLYCERIN LINGUAL 400 ug/1 is 28595-120, listed by Allegis Pharmaceuticals, LLC.

Product NDC

28595-120

Package NDC

28595-120-12

Other Nitroglycerin Brands

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

Data from openFDA · Public domain (CC0 1.0)