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Nitroglycerin .4 mg Tablet, 60-count

by Proficient Rx LP · 60 TABLET in 1 BOTTLE (71205-225-60)
NDC 71205-0225-60
🏷️ FDA NDC (as labeled) 71205-225-60 billing pads the product segment with a zero
This package
Contains60-count Pack sizes4 compare ↓
Also priced by: Part D plans $0.1595/unit — full pricing hub ↓
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
Other active recalls for Nitroglycerin (different manufacturers) — 3 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Jul 24, 2026 — Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde (American Regent, Inc.) · FDA recall D-0791-2026
Class II · Mar 13, 2025 — CGMP Deviations (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0324-2025
Class II · Mar 13, 2025 — CGMP Deviations (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0331-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 71205-225-60
Product NDC 71205-225
11-digit billing NDC 71205022560
RxCUI 198039
UNII G59M7S0WS3
UPC 0371205225254
Application # ANDA208191
SPL Set ID 67a15ee9-a6ae-4a60-8333-e06c608cfd71
Established class (EPC) Nitrate Vasodilator
Physiologic effect Vasodilation
Chemical class Nitrates
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2016-08-29
Route SUBLINGUAL
Dosage form TABLET
Substance NITROGLYCERIN
GPI-14 32100030000715
GPI class Nitroglycerin
GCN Seq No 000475
GCN 01772
HICL code 000159
Ingredient (HICL) Nitroglycerin
HIC1 code A
Therapeutic class — broad (HIC1) Cardiovascular System
HIC2 code A7
Therapeutic class — intermediate (HIC2) Vasoactive Drugs
HIC3 code A7B
Therapeutic class — specific (HIC3) Vasodilators,Coronary
AHFS code 24:08.08.00
AHFS class Nitrates And Nitrites
FDB label name NITROGLYCERIN 0.4 MG TABLET SL
FDB brand name Nitroglycerin
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 71205-225-60 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 71205-0225-60. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Nitrate Vasodilator class.

Pharmacologic class Nitrate Vasodilator
Drug family (ATC) Organic nitrates, Muscle relaxants
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerProficient Rx LP
Application holderDR REDDYS LABORATORIES INC
FDA applicationANDA208191 (ANDA)
Labeler code71205
First marketedAug 2016
Product typeHuman Prescription Drug
Portfolio1,723 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name NITROGLYCERIN 0.4 MG TABLET SL Ingredient Nitroglycerin
📖 What it is MedlinePlus · NLM

Nitroglycerin sublingual tablets are used to treat episodes of angina (chest pain) in people who have coronary artery disease (narrowing of the blood vessels that supply blood to the heart). It is also used just before activities that may cause episodes of angina in order to prevent the angina from occurring. Nitroglycerin is in a class of medications called vasodilators. It works by relaxing the blood vessels so the heart does not need to work as hard and therefore does not need as much oxygen.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Great question — it's actually the same active ingredient, just in very different forms for very different places. The tablets, sprays, patches, and capsules all work by widening b...
  • What's the difference between nitroglycerin for chest pain and the kind used for anal fissure pain?
  • No — this is one of the most important safety warnings with nitroglycerin. Both drugs work on the same pathway, and combining them can cause a sudden, severe drop in blood pressure...
  • Can I use nitroglycerin if I take sildenafil (Viagra) or tadalafil (Cialis)?
📖 Read our full Nitroglycerin guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color White
ShapeRectangle
ImprintCL;4
Size4 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 776XM7047L
    Calcium stearate is a white powder derived from stearic acid and calcium. It works as a lubricant and glidant to help the medicine flow smoothly during manufacturing and prevent ingredients from sticking to equipment.
  • UNII Z82Y2C65EA
    Hydrogenated cottonseed oil is a solid fat made by adding hydrogen to cottonseed oil. It's used in medicines as a binder and lubricant to help hold ingredients together and make tablets easier to compress and release.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.

5 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMedingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.1595 $9.57 / 60 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Nitroglycerin .4 mg 43598-0436-01 Dr. 100 tablets $0.084 AB Availability likely
Nitroglycerin .4 mg 59651-0658-00 Aurobindo 100 tablets $0.084 AB Availability likely
Nitroglycerin .4 mg 59762-3304-01 Mylan 100 tablets $0.084 AB Availability likely
Nitroglycerin .4 mg 68462-0639-01 Glenmark 100 tablets $0.084 AB Availability likely
Nitroglycerin .4 mg 69339-0174-01 Natco 100 tablets $0.084 AB Availability likely
Nitroglycerin .4 mg 72888-0139-01 Advagen 100 tablets $0.084 AB Availability likely
Nitroglycerin .4 mg 43547-0986-04 Solco 100 tablets $0.128 AB Availability likely
nitroglycerin .4 mg 70756-0014-02 Lifestar 100 tablets $0.128 AB Availability likely
nitroglycerin .4 mg 72603-0266-04 NorthStar 100 tablets $0.128 AB Availability likely
Nitrostat .4 mg 00404-9800-01 Henry 25 tablets AB FDA listed
Nitroglycerin .4 mg 50090-3266-00 A-S 100 tablets AB FDA listed
Nitroglycerin .4 mg 50090-6818-00 A-S 100 tablets AB FDA listed
Nitrostat .4 mg 50090-7203-00 A-S 25 tablets AB FDA listed
Nitroglycerin .4 mg 51662-1282-01 HF 25 tablets AB Discontinued
Nitroglycerin .4 mg 51662-1676-03 HF 600 tablets AB FDA listed
Nitrostat .4 mg 58151-0310-01 Viatris 100 tablets AB FDA listed
Nitroglycerin .4 mg 60429-0840-01 Golden 100 tablets AB FDA listed
Nitrostat .4 mg 63187-0884-25 Proficient 25 tablets AB FDA listed
Nitroglycerin .4 mg 67296-2177-02 Redpharm 100 tablets AB FDA listed
Nitroglycerin .4 mg 68071-2941-05 NuCare 25 tablets AB FDA listed
Nitroglycerin .4 mg 68071-3773-05 NuCare 100 tablets AB FDA listed
nitroglycerin .4 mg 70518-4277-00 REMEDYREPACK 100 tablets AB FDA listed
Nitroglycerin .4 mgthis 71205-0225-60 Proficient 60 tablets AB FDA listed
Nitroglycerin .4 mg 71872-7010-01 Medical 25 tablets AB FDA listed
Nitroglycerin .4 mg 71872-7033-01 Medical 25 tablets AB FDA listed
Nitroglycerin .4 mg 71872-7300-01 Medical 25 tablets AB FDA listed
nitroglycerin .4 mg 71872-7338-01 Medical 25 tablets AB FDA listed
Nitroglycerin .4 mg 71872-7368-01 Medical 25 tablets AB FDA listed
Nitroglycerin .4 mg 82804-0077-25 Proficient 25 tablets AB FDA listed
Nitroglycerin .4 mg 82804-0122-25 Proficient 25 tablets AB FDA listed
Nitroglycerin .4 mg 84549-0639-45 ProPharma 25 tablets AB FDA listed
Nitroglycerin .4 mg 85766-0116-00 Sportpharm 100 tablets AB FDA listed
Nitroglycerin .4 mg 70518-2910-00 REMEDYREPACK 25 tablets AB FDA listed
nitroglycerin .4 mg 67296-2313-02 Redpharm 25 tablets AB FDA listed
Nitroglycerin .4 mg 51662-1445-03 HF 600 tablets AB FDA listed
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2016
On the market since
Aug 2016
📍
2026
Currently FDA-listed
10 years listed
🔓
·
Generic on the market
this product is a generic
This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Nitroglycerin — the program that covers self-administered drugs. 16 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Nitroglycerin. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$8.16M
Claims incl. refills
600.2K
Beneficiaries
480.2K
Spend / beneficiary
$17.00
Spend / claim
$13.60
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
71205-0225-25 25 TABLET in 1 BOTTLE (71205-225-25) 2019-02-01 Active
71205-0225-30 30 TABLET in 1 BOTTLE (71205-225-30) 2019-02-01 Active
71205-0225-60 You're viewing this 60 TABLET in 1 BOTTLE (71205-225-60) 2019-02-01 Active
71205-0225-90 90 TABLET in 1 BOTTLE (71205-225-90) 2019-02-01 Active

You're viewing one of 4 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 71205-0225-60?
NDC 71205-0225-60 is a 60-count package — 60 tablet in 1 bottle.
What is the difference between NDC 71205-0225-60 and NDC 71205-0225-25?
Both are Nitroglycerin .4 mg Tablet — the drug itself is identical. NDC 71205-0225-60 is the 60-count package, while NDC 71205-0225-25 is the 25 tablets package.
What NDC number is used to bill for this package of Nitroglycerin .4 mg Tablet?
Bill NDC 71205-0225-60 — the 11-digit billing format is 71205022560. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 71205-225-60, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 71205-0225-60, written without dashes as 71205022560. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 71205-0225-60, the first segment (71205) is the labeler code FDA assigned to Proficient Rx LP; the middle segment (0225) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (60) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Proficient Rx LP. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 3 other package presentations of this same product, including 25 tablets (71205-0225-25), 30 tablets (71205-0225-30), 90 tablets (71205-0225-90). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Proficient Rx LP is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 26 words

INDICATIONS AND USAGE Nitroglycerin sublingual tablets are indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.

⏱️ Dosage and Administration 108 words

DOSAGE AND ADMINISTRATION One tablet should be dissolved under the tongue or in the buccal pouch at the first sign of an acute anginal attack. The dose may be repeated approximately every 5 minutes until relief is obtained. If the pain persists after a total of 3 tablets in a 15-minute period, or if the pain is different than is typically experienced, prompt medical attention is recommended.

Nitroglycerin may be used prophylactically 5 to 10 minutes prior to engaging in activities that might precipitate an acute attack. During administration the patient should rest, preferably in the sitting position. No dosage adjustment is required in patients with renal failure.

Contraindications 95 words

CONTRAINDICATIONS Nitroglycerin sublingual tablets are contraindicated in patients who are allergic to it. Sublingual nitroglycerin therapy is contraindicated in patients with early myocardial infarction, severe anemia, increased intracranial pressure, and those with a known hypersensitivity to nitroglycerin. Administration of nitroglycerin sublingual tablets are contraindicated in patients who are using a phosphodiesterase-5 (PDE-5) inhibitor (e.g., sildenafil citrate, tadalafil, vardenafil hydrochloride) since these compounds have been shown to potentiate the hypotensive effects of organic nitrates.

Do not use nitroglycerin sublingual tablets in patients who are taking the soluble guanylate cyclase stimulator riociguat. Concomitant use can cause hypotension.

⚠️ Warnings 45 words

WARNINGS The benefits of sublingual nitroglycerin in patients with acute myocardial infarction or congestive heart failure have not been established. If one elects to use nitroglycerin in these conditions, careful clinical or hemodynamic monitoring must be used because of the possibility of hypotension and tachycardia.

🤒 Adverse Reactions 76 words

ADVERSE REACTIONS Headache that may be severe and persistent may occur immediately after use. Vertigo, dizziness, weakness, palpitation, and other manifestations of postural hypotension may develop occasionally, particularly in erect, immobile patients. Marked sensitivity to the hypotensive effects of nitrates (manifested by nausea, vomiting, weakness, diaphoresis, pallor, and collapse) may occur at therapeutic doses.

Syncope due to nitrate vasodilatation has been reported. Flushing, drug rash, and exfoliative dermatitis have been reported in patients receiving nitrate therapy.

🔄 Drug Interactions ~1 min read

Drug Interactions Concomitant use of nitroglycerin with soluble guanylate cyclasestimulators is contraindicated (see CONTRAINDICATIONS ). Concomitant use of nitrates and alcohol may cause hypotension. The vasodilatory and hemodynamic effects of nitroglycerin may be enhanced by concomitant administration of aspirin.

Intravenous administration of nitroglycerin decreases the thrombolytic effect of alteplase. Therefore, caution should be observed in patients receiving sublingual nitroglycerin during alteplase therapy. Intravenous nitroglycerin reduces the anticoagulant effect of heparin and activated partial thromboplastin times (APTT) should be monitored in patients receiving heparin and intravenous nitroglycerin.

It is not known if this effect occurs following single sublingual nitroglycerin doses. Tricyclic antidepressants (amitriptyline, desipramine, doxepin, others) and anticholinergic drugs may cause dry mouth and diminished salivary secretions. This may make dissolution of sublingual nitroglycerin difficult.

Increasing salivation with chewing gum or artificial saliva products may prove useful in aiding dissolution of sublingual nitroglycerin. Oral administration of nitroglycerin markedly decreases the first-pass metabolism of dihydroergotamine and subsequently increases its oral bioavailability. Ergotamine is known to precipitate angina pectoris.

Therefore, patients receiving sublingual nitroglycerin should avoid ergotamine and related drugs or be monitored for symptoms of ergotism if this is not possible. Administration of nitroglycerin is contraindicated in patients who are using PDE-5 inhibitors (e.g., sildenafil citrate, tadalafil, vardenafil hydrochloride). These compounds have been shown to potentiate the hypotensive effects of organic nitrates.

A decrease in therapeutic effect of sublingual nitroglycerin may result from use of long-acting nitrates.

🔄 Drug / Laboratory Test Interactions 19 words

Drug/Laboratory Test Interactions Nitrates may interfere with the Zlatkis-Zak color reaction, causing a false report of decreased serum cholesterol.

🤰 Pregnancy 69 words

Pregnancy: Category B. Animal reproduction and teratogenicity studies have not been conducted with nitroglycerin sublingual tablets. However, teratology studies conducted in rats and rabbits with topically applied nitroglycerin ointment at dosages up to 80 mg/kg/day and 240 mg/kg/day, respectively revealed no toxic effects on dams or fetuses.

There are no adequate and well-controlled studies in pregnant women. Nitroglycerin should be given to a pregnant woman only if clearly needed.

🧒 Pediatric Use 15 words

Pediatric Use The safety and effectiveness of nitroglycerin in pediatric patients have not been established.

🧓 Geriatric Use 82 words

Geriatric Use Clinical studies of nitroglycerin did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

🆘 Overdosage ~1 min read

OVERDOSAGE Hemodynamic Effects: The effects of nitroglycerin overdose are generally the results of nitroglycerin’s capacity to induce vasodilatation, venous pooling, reduced cardiac output, and hypotension. These hemodynamic changes may have protean manifestations, including increased intracranial pressure, with any or all of persistent throbbing headache, confusion, and moderate fever; vertigo; palpitations; tachycardia; visual disturbances; nausea and vomiting (possibly with colic and even bloody diarrhea); syncope (especially in the upright posture); dyspnea, later followed by reduced ventilatory effort; diaphoresis, with the skin either flushed or cold and clammy; heart block and bradycardia; paralysis; coma; seizures; and death.

No specific antagonist to the vasodilator effects of nitroglycerin is known, and no intervention has been subject to controlled study as a therapy of nitroglycerin overdose. Because the hypotension associated with nitroglycerin overdose is the result of venodilatation and arterial hypovolemia, prudent therapy in this situation should be directed toward increase in central fluid volume. Passive elevation of the patient’s legs may be sufficient, but intravenous infusion of normal saline or similar fluid may also be necessary.

The use of epinephrine or other arterial vasoconstrictors in this setting is likely to do more harm than good. In patients with renal disease or congestive heart failure, therapy resulting in central volume expansion is not without hazard. Treatment of nitroglycerin overdose in these patients may be subtle and difficult, and invasive monitoring may be required.

Methemoglobinemia: Methemoglobinemia has been rarely reported in association with organic nitrates. The diagnosis should be suspected in patients who exhibit signs of impaired oxygen delivery despite adequate cardiac output and adequate arterial PO 2 . Classically, methemoglobinemic blood is described as chocolate brown, without color change on exposure to air.

If methemoglobinemia is present, intravenous administration of methylene blue, 1 to 2 mg/kg of body weight, may be required.

🧬 Clinical Pharmacology ~3 min read

CLINICAL PHARMACOLOGY The principal pharmacological action of nitroglycerin is relaxation of vascular smooth muscle. Although venous effects predominate, nitroglycerin produces, in a dose-related manner, dilation of both arterial and venous beds. Dilation of postcapillary vessels, including large veins, promotes peripheral pooling of blood, decreases venous return to the heart, and reduces left ventricular end-diastolic pressure (preload).

Nitroglycerin also produces arteriolar relaxation, thereby reducing peripheral vascular resistance and arterial pressure (afterload), and dilates large epicardial coronary arteries; however, the extent to which this latter effect contributes to the relief of exertional angina is unclear. Therapeutic doses of nitroglycerin may reduce systolic, diastolic, and mean arterial blood pressure. Effective coronary perfusion pressure is usually maintained, but can be compromised if blood pressure falls excessively, or increased heart rate decreases diastolic filling time.

Elevated central venous and pulmonary capillary wedge pressures, and pulmonary and systemic vascular resistance are also reduced by nitroglycerin therapy. Heart rate is usually slightly increased, presumably due to a compensatory response to the fall in blood pressure. Cardiac index may be increased, decreased, or unchanged.

Myocardial oxygen consumption or demand (as measured by the pressure-rate product, tension-time index, and stroke-work index) is decreased and a more favorable supply-demand ratio can be achieved. Patients with elevated left ventricular filling pressures and increased systemic vascular resistance in association with a depressed cardiac index are likely to experience an improvement in cardiac index. In contrast, when filling pressures and cardiac index are normal, cardiac index may be slightly reduced following nitroglycerin administration.

Mechanism of Action: Nitroglycerin forms free radical nitric oxide (NO) which activates guanylate cyclase, resulting in an increase of guanosine 3'5' monophosphate (cyclic GMP) in smooth muscle and other tissues. These events lead to dephosphorylation of myosin light chains, which regulate the contractile state in smooth muscle, and result in vasodilatation. Pharmacodynamics: Consistent with the symptomatic relief of angina, digital plethysmography indicates that onset of the vasodilatory effect occurs approximately 1 to 3 minutes after sublingual nitroglycerin administration and reaches a maximum by 5 minutes postdose.

Effects persist for at least 25 minutes following nitroglycerin administration. Pharmacokinetics and Drug Metabolism Absorption: Nitroglycerin is rapidly absorbed following sublingual administration of nitroglycerin sublingual tablets. Mean peak nitroglycerin plasma concentrations occur at a mean time of approximately 6 to 7 minutes postdose (Table 1).

Maximum plasma nitroglycerin concentrations (C max ) and area under the plasma concentration-time curves (AUC) increase dose-proportionally following 0.3 to 0.6 mg nitroglycerin. The absolute bioavailability of nitroglycerin from nitroglycerin sublingual tablets is approximately 40% but tends to be variable due to factors influencing drug absorption, such as sublingual hydration and mucosal metabolism. Table 1 Parameter Mean Nitroglycerin (SD) Values 2 x 0.3 mg Nitroglycerin Sublingual Tablets 1 x 0.6 mg Nitroglycerin Sublingual Tablets C max , ng/mL 2.3 (1.7) 2.1 (1.5) T max , min 6.4 (2.5) 7.2 (3.2) AUC (0–∞) , min 14.9 (8.2) 14.9 (11.4) t ½ , min 2.8 (1.1) 2.6 (0.6) Distribution: The volume of distribution (V Area ) of nitroglycerin following intravenous administration is

3.3L/kg. At plasma concentrations between 50 and 500 ng/mL, the binding of nitroglycerin to plasma proteins is approximately 60%, while that of 1,2- and 1,3-dinitroglycerin is 60% and 30%, respectively. Metabolism: A liver reductase enzyme is of primary importance in the metabolism of nitroglycerin to glycerol di- and mononitrate metabolites…

📦 How Supplied / Storage and Handling 87 words

HOW SUPPLIED Nitroglycerin sublingual tablets are supplied in 1 strength 0.4 mg, in bottles containing 25,30,60 & 90 tablets each, with color-coded labels. Bottle of 25 NDC 71205-225-25 Bottle of 30 NDC 71205-225-30 Bottle of 60 NDC 71205-225-60 Bottle of 90 NDC 71205-225-90 Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Rx only Manufactured by: Ingenus Pharmaceuticals NJ, LLC Fairfield, NJ 07004, USA Manufactured for: Dr.

Reddy’s Laboratories Inc . Princeton, New Jersey 08540, USA Relabeled by: Proficient Rx LP Thousand Oaks, CA 91320 Revised: 0217

📋 Description 65 words

DESCRIPTION Nitroglycerin is a stabilized sublingual compressed nitroglycerin tablet that contains 0.3 mg, 0.4 mg, or 0.6 mg nitroglycerin USP; as well as calcium stearate powder, colloidal silicon dioxide, hydrogenated vegetable oil, lactose monohydrate, and pregelatinized starch. Nitroglycerin, an organic nitrate, is a vasodilating agent. The chemical name for nitroglycerin is 1, 2, 3 propanetriol trinitrate and the chemical structure is: Molecular weight: 227.09 structure

💬 Information for Patients ~1 min read

Information for Patients Nitroglycerin is a sublingual tablet and should not be chewed, crushed, or swallowed. If possible, patients should sit down when taking nitroglycerin sublingual tablets and should use caution when returning to a standing position. This eliminates the possibility of falling due to lightheadedness or dizziness.

One tablet should be dissolved under the tongue or in the buccal pouch at the first sign of an acute anginal attack. The dose may be repeated approximately every 5 minutes until relief is obtained. If chest pain persists after a total of 3 tablets in a 15-minute period, or if the pain is different than is typically experienced, prompt medical attention is recommended.

Nitroglycerin may be used prophylactically 5 to 10 minutes prior to engaging in activities that might precipitate an acute attack. Nitroglycerin may produce a burning or tingling sensation when administered sublingually; however, the ability to produce a burning or tingling sensation should not be considered a reliable method for determining the potency of the tablets. Headaches can sometimes accompany treatment with nitroglycerin.

In patients who get these headaches, the headaches may be a marker of the activity of the drug. Treatment with nitroglycerin may be associated with lightheadedness upon standing, especially just after rising from a recumbent or seated position. This effect may be more frequent in patients who have also consumed alcohol.

Nitroglycerin should be kept in the original glass container and must be tightly capped after each use to prevent loss of tablet potency.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.