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Isosorbide Mononitrate 60 mg Tablet, Extended Release, 100-count — NDC 42799-0959-01 package photo

Isosorbide Mononitrate 60 mg Tablet, Extended Release, 100-count

by Edenbridge Pharmaceuticals LLC. · 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42799-959-01)
NDC 42799-0959-01
🏷️ FDA NDC (as labeled) 42799-959-01 billing pads the product segment with a zero
This package
Contains100-count Cost per ea$0.0977 NADAC Per package$9.77 / 100 tablets Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.2779/unit · Part D plans $0.1819/unit — full pricing hub ↓
Also comes in: 500 tablets 42799-0959-02
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 →

🆔 Identity & classification

FDA NDC (as labeled) 42799-959-01
Product NDC 42799-959
11-digit billing NDC 42799095901
NCPDP billing unit EA — each (per item)
RxCUI 317110, 353538
UNII LX1OH63030
UPC 0342799958019, 0342799959016
Application # ANDA075522
SPL Set ID 0e3c4461-2e04-481f-a9e5-29f21cc71ec5
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 2010-06-07
Route ORAL
Dosage form TABLET, EXTENDED RELEASE
Substance ISOSORBIDE MONONITRATE
GPI-14 32100025007530
GCN Seq No 017297
GCN 48102
HICL code 006341
Ingredient (HICL) Isosorbide Mononitrate
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 ISOSORBIDE MONONIT ER 60 MG TB
FDB brand name Isosorbide Mononitrate Er
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 42799-959-01 — 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 → 42799-0959-01. 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
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

LabelerEdenbridge Pharmaceuticals LLC.
Application holderDEXCEL LTD
FDA applicationANDA075522 (ANDA)
Labeler code42799
First marketedJun 2010
Product typeHuman Prescription Drug
Portfolio43 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 ISOSORBIDE MONONIT ER 60 MG TB Ingredient Isosorbide Mononitrate
📗 Our plain-language guide HelloPharmacist
  • Isosorbide is designed to prevent chest pain (angina) from starting in the first place, not to stop an attack that's already happening. It works by relaxing and widening your blood...
  • What exactly does this medication do — will it stop my chest pain when it happens?
  • Yes, headaches are very common when you first start isosorbide — they happen because the medication widens blood vessels, including in your head. The good news is that headaches us...
  • I keep getting headaches since starting this — is that normal, and will it go away?
📖 Read our full Isosorbide 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.

🧪 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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 eaPer package
Retail pharmacies payNADAC · weekly $0.098 $9.77 / 100 tablets
Medicaid paysCMS SDUD · 12 mo $0.2779 $27.79 / 100 tablets
Medicare drug plans payPart D · Q2 2026 $0.1819 $18.19 / 100 tablets
NADAC price history (per ea) — tap or hover for the price & month
Dec 2023 Dec 2025 Apr 2026 Aug 2026 $0.112 $0.093
▼ Down 10% over the last 12 months.
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
Isosorbide Mononitrate 60 mg 00904-6450-61 Major 1 tablet $0.098 AB Availability likely
Isosorbide Mononitrate 60 mg 13668-0105-01 Torrent 100 tablets $0.098 AB Availability likely
Isosorbide Mononitrate 60 mgthis 42799-0959-01 Edenbridge 100 tablets $0.098 AB Availability likely
Isosorbide Mononitrate 60 mg 50742-0176-01 Ingenus 100 tablets $0.098 AB Availability likely
Isosorbide Mononitrate 60 mg 59651-0540-01 Aurobindo 100 tablets $0.098 AB Availability likely
Isosorbide Mononitrate 60 mg 60687-0794-01 American 1 tablet $0.098 AB Availability likely
Isosorbide Mononitrate 60 mg 62135-0587-90 Chartwell 90 tablets $0.098 AB Availability likely
Isosorbide Mononitrate 60 mg 00615-7768-05 NCS 15 tablets AB FDA listed
Isosorbide Mononitrate 60 mg 42677-0306-01 Shandong 60 tablets AB FDA listed
Isosorbide Mononitrate 60 mg 50090-6661-00 A-S 30 tablets AB FDA listed
Isosorbide Mononitrate 60 mg 51407-0209-01 Golden 100 tablets AB FDA listed
Isosorbide Mononitrate 60 mg 55154-7292-00 Cardinal 1 tablet AB FDA listed
Isosorbide Mononitrate 60 mg 67046-1632-03 Coupler 30 tablets AB FDA listed
Isosorbide Mononitrate 60 mg 71335-2192-01 Bryant 100 tablets AB FDA listed
Isosorbide Mononitrate 60 mg 71335-2532-01 Bryant 100 tablets AB FDA listed
Isosorbide Mononitrate 60 mg 71610-0772-30 Aphena 30 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

🏛️
2010
On the market since
Jun 2010
📍
2026
Currently FDA-listed
16 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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 42799-0959-01, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
6K
Units reimbursed last 4 qtrs
265.5K
Gross reimbursed last 4 qtrs
$73.8K
Avg / prescription
$12.37
Avg / unit
$0.2779
Latest quarter Q1 2026
1.9KRx
Medicaid pays / ea
$0.2779
gross reimbursed
vs
NADAC / ea
$0.0977
acquisition cost
=
Spread
+$0.1802
+184% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care
42% FFS 58% MCO
Fee-for-service · 2,527 Rx Managed care · 3,439 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 3,859 units · 49.4 per 100k residents WA Idaho: 1,939 units · 98.7 per 100k residents ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 545 units · 9.5 per 100k residents MN Wisconsin: 8,762 units · 148 per 100k residents WI Michigan: 23,007 units · 229 per 100k residents MI New York: 29,822 units · 152 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 2,070 units · 48.9 per 100k residents OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 2,267 units · 70.7 per 100k residents IA Illinois: 4,416 units · 35.2 per 100k residents IL Indiana: 2,590 units · 37.7 per 100k residents IN Ohio: 10,178 units · 86.4 per 100k residents OH Pennsylvania: 5,321 units · 41.1 per 100k residents PA New Jersey: 4,827 units · 52.0 per 100k residents NJ Massachusetts: no data reported MA California: 60,788 units · 156 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: 1,995 units · 101 per 100k residents NE Missouri: 5,154 units · 83.2 per 100k residents MO Kentucky: 9,949 units · 220 per 100k residents KY West Virginia: 2,979 units · 168 per 100k residents WV Virginia: 3,597 units · 41.3 per 100k residents VA Maryland: 2,141 units · 34.6 per 100k residents MD Connecticut: 6,544 units · 181 per 100k residents CT Rhode Island: no data reported RI Arizona: 2,138 units · 28.8 per 100k residents AZ New Mexico: no data reported NM Kansas: 322 units · 11.0 per 100k residents KS Arkansas: 1,179 units · 38.4 per 100k residents AR Tennessee: 3,692 units · 51.8 per 100k residents TN North Carolina: 4,479 units · 41.3 per 100k residents NC South Carolina: 930 units · 17.3 per 100k residents SC Delaware: no data reported DE Oklahoma: 946 units · 23.3 per 100k residents OK Louisiana: 17,189 units · 376 per 100k residents LA Mississippi: 3,224 units · 110 per 100k residents MS Alabama: 650 units · 12.7 per 100k residents AL Georgia: 5,501 units · 49.9 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 16,269 units · 53.3 per 100k residents TX Florida: 4,790 units · 21.2 per 100k residents FL
Units reimbursed · per 100k residents
9.5376
gray = no data reported
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Louisiana 376 /100k
2 Michigan 229 /100k
3 Kentucky 220 /100k
4 Connecticut 181 /100k
5 West Virginia 168 /100k
6 California 156 /100k
7 New York 152 /100k
8 Wisconsin 148 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
500 tablets42799-0959-02 5,089 Rx · $66,229
Drug total (last 4 qtrs): 11,055 Rx · 481,548 units · $140,001 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Isosorbide Mononitrate — the program that covers self-administered drugs. 2 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 Isosorbide Mononitrate. 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
$1.1M
Claims incl. refills
12.3K
Beneficiaries
7.5K
Spend / beneficiary
$146.52
Spend / claim
$89.68
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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for ISOSORBIDE MONONITRATE — the ingredient across all brands.

Top reported reactions

Dyspnoea1,568
Dizziness1,464
Fatigue1,314
Diarrhoea1,311
Nausea1,284
Chest Pain1,227
Headache1,078

Reporter sex

20,621 reports
Male · 54%
Female · 46%
Unknown · 0%

Serious outcomes

Death2,596
Life-threatening1,563
Disabling961
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1,416 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
42799-0959-01 You're viewing this 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42799-959-01) $0.0977 / ea $9.77 2023-07-01 Active
42799-0959-02 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (42799-959-02) $0.0977 / ea $48.87 2023-07-01 Active

You're viewing the smallest of 2 pack sizes for this product.

This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.0977 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 54% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 42799-0959-01?
NDC 42799-0959-01 is a 100-count package — 100 tablet, extended release in 1 bottle.
What is the difference between NDC 42799-0959-01 and NDC 42799-0959-02?
Both are Isosorbide Mononitrate 60 mg Tablet, Extended Release — the drug itself is identical. NDC 42799-0959-01 is the 100-count package, while NDC 42799-0959-02 is the 500 tablets package.
What NDC number is used to bill for this package of Isosorbide Mononitrate 60 mg Tablet, Extended Release?
Bill NDC 42799-0959-01 — the 11-digit billing format is 42799095901. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 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 44 words

INDICATIONS & USAGE Isosorbide mononitrate extended-release tablets are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of oral isosorbide mononitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.

⏱️ Dosage and Administration 118 words

DOSAGE & ADMINISTRATION The recommended starting dose of Isosorbide Mononitrate Extended-Release Tablets, USP is 30 mg (given as a single 30 mg tablet or as 1/2 of a 60 mg tablet) or 60 mg (given as a single tablet) once daily. After several days, the dosage may be increased to 120 mg (given as a single 120 mg tablet or as two 60 mg tablets) once daily. Rarely, 240 mg may be required.

The daily dose of Isosorbide Mononitrate Extended-Release Tablets, USP should be taken in the morning on arising. Isosorbide Mononitrate Extended-Release Tablets, USP should not be chewed or crushed and should be swallowed together with a half-glassful of fluid. Do not break the 30 mg tablet.

Contraindications 21 words

CONTRAINDICATIONS Isosorbide mononitrate extended-release tablets are contraindicated in patients who have shown hypersensitivity or idiosyncratic reactions to other nitrates or nitrites.

⚠️ Warnings 118 words

WARNINGS Amplification of the vasodilatory effects of isosorbide mononitrate by sildenafil can result in severe hypotension. The time course and dose dependence of this interaction have not been studied. Appropriate supportive care 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.

The benefits of ISMN in patients with acute myocardial infarction or congestive heart failure have not been established; because the effects of isosorbide mononitrate are difficult to terminate rapidly, this drug is not recommended in these settings. If isosorbide mononitrate is used in these conditions, careful clinical or hemodynamic monitoring must be used to avoid the hazards of hypotension and tachycardia.

🤒 Adverse Reactions ~2 min read

ADVERSE REACTIONS The table below shows the frequencies of the adverse events that occurred in >5% of the subjects in three placebo-controlled North American studies in which patients in the active treatment arm received 30 mg, 60 mg, 120 mg, or 240 mg of isosorbide mononitrate extended-release tablets once daily. In parentheses, the same table shows the frequencies with which these adverse events were associated with the discontinuation of treatment. Overall, 8% of the patients who received 30 mg, 60 mg, 120 mg, or 240 mg of isosorbide mononitrate in the three placebo-controlled North American studies discontinued treatment because of adverse events.

Most of these discontinued because of headache. Dizziness was rarely associated with withdrawal from these studies. Since headache appears to be a dose-related adverse effect and tends to disappear with continued treatment, it is recommended that isosorbide mononitrate extended-release tablets treatment be initiated at low doses for several days before being increased to desired levels.

FREQUENCY AND ADVERSE EVENTS (DISCONTINUED) a Three Controlled North American Studies Dose Placebo 30 mg 60 mg 120 mg* 240 mg* Patients 96 60 102 65 65 Headache 15% (0%) 38% (5%) 51% (8%) 42% (5%) 57% (8%) Dizziness 4% (0%) 8% (0%) 11% (1%) 9% (2%) 9% (2%) a Some individuals discontinued for multiple reasons. * Patients were started on 60 mg and titrated to their final dose. In addition, the three North American trials were pooled with 11 controlled trials conducted in Europe. Among the 14 controlled trials, a total of 711 patients were randomized to isosorbide mononitrate extended-release tablets.

When the pooled data were reviewed, headache and dizziness were the only adverse events that were reported by >5% of patients. Other adverse events, each reported by ≤5% of exposed patients, and in many cases of uncertain relation to drug treatment, were: Autonomic Nervous System Disorders : Dry mouth, hot flushes. Body as a Whole : Asthenia, back pain, chest pain, edema, fatigue, fever, flu-like symptoms, malaise, rigors.

Cardiovascular Disorders, General : Cardiac failure, hypertension, hypotension. Central and Peripheral Nervous System Disorders : Dizziness, headache, hypoesthesia, migraine, neuritis, paresis, paresthesia, ptosis, tremor, vertigo. Gastrointestinal System Disorders : Abdominal pain, constipation, diarrhea, dyspepsia, flatulence, gastric ulcer, gastritis, glossitis, hemorrhagic gastric ulcer, hemorrhoids, loose stools, melena, nausea, vomiting.

Hearing and Vestibular Disorders : Earache, tinnitus, tympanic membrane perforation. Heart Rate and Rhythm Disorders : Arrhythmia, arrhythmia atrial, atrial fibrillation, bradycardia, bundle branch block, extrasystole, palpitation, tachycardia, ventricular tachycardia. Liver and Biliary System Disorders : SGOT increase, SGPT increase.

Metabolic and Nutritional Disorders : Hyperuricemia, hypokalemia. Musculoskeletal System Disorders : Arthralgia, frozen shoulder, muscle weakness, musculoskeletal pain, myalgia, myositis, tendon disorder, torticollis. Myo-, Endo-, Pericardial and Valve Disorders : Angina pectoris aggravated, heart murmur, heart sound abnormal, myocardial infarction, Q wave abnormality.

Platelet, Bleeding and Clotting Disorders : Purpura, thrombocytopenia. Psychiatric Disorders : Anxiety, concentration impaired, confusion, decreased libido, depression, impotence, insomnia, nervousness, paroniria, somnolence. Red Blood Cell Disorder : Hypochromic anemia.

Reproductive Disorders, Female : Atrophic vaginitis, breast pain. Resistance Mechanism Disorders : Bacterial infection, moniliasis, viral infection. Respiratory System Disorders : Bronchitis, bronchospasm, coughing, dyspnea, increased sputum, nasal congestion, pharyngitis, pneumonia, pulmonary infiltration, rales, rhinitis, sinusitis.

Skin and Appendages Disorders : Acne, hair texture abnormal, increased sweating, pruritus, rash, skin nodule. Urinary System Disorders : Polyuria, rena…

🔄 Drug Interactions 57 words

DRUG INTERACTIONS The vasodilating effects of isosorbide mononitrate may be additive with those of other vasodilators. Alcohol, in particular, has been found to exhibit additive effects of this variety. Marked symptomatic orthostatic hypotension has been reported when calcium channel blockers and organic nitrates were used in combination. Dose adjustments of either class of agents may be necessary.

🔄 Drug / Laboratory Test Interactions 21 words

DRUG/LABORATORY TEST INTERACTIONS Nitrates and nitrites may interfere with the Zlatkis-Zak color reaction, causing falsely low readings in serum cholesterol determinations.

🤰 Pregnancy 207 words

PREGNANCY Teratogenic effects Pregnancy Category B In studies designed to detect effects of isosorbide mononitrate on embryo-fetal development, doses of up to 240 or 248 mg/kg/day, administered to pregnant rats and rabbits, were unassociated with evidence of such effects. These animal doses are about 100 times the maximum recommended human dose (120 mg in a 50 kg woman) when comparison is based on body weight; when comparison is based on body surface area, the rat dose is about 17 times the human dose and the rabbit dose is about 38 times the human dose.

There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, isosorbide mononitrate extended-release tablets should be used during pregnancy only if clearly needed. Nonteratogenic effects Neonatal survival and development and incidence of stillbirths were adversely affected when pregnant rats were administered oral doses of 750 (but not 300) mg isosorbide mononitrate/kg/day during late gestation and lactation.

This dose (about 312 times the human dose when comparison is based on body weight and 54 times the human dose when comparison is based on body surface area) was associated with decreases in maternal weight gain and motor activity and evidence of impaired lactation.

🧒 Pediatric Use 15 words

PEDIATRIC USE The safety and effectiveness of ISMN in pediatric patients have not been established.

🧓 Geriatric Use 209 words

GERIATRIC USE Clinical studies of isosorbide mononitrate extended-release tablets did not include sufficient information on patients age 65 and over to determine if they respond differently from younger patients. Other reported clinical experience for isosorbide mononitrate extended-release tablets has not identified differences in response between elderly and younger patients. Clinical experience for organic nitrates reported in the literature identified a potential for severe hypotension and increased sensitivity to nitrates in the elderly.

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. Elderly patients may have reduced baroreceptor function and may develop severe orthostatic hypotension when vasodilators are used. Isosorbide mononitrate extended-release tablets should therefore be used with caution in elderly patients who may be volume depleted, on multiple medications or who, for whatever reason, are already hypotensive.

Hypotension induced by isosorbide mononitrate may be accompanied by paradoxical bradycardia and increased angina pectoris. Elderly patients may be more susceptible to hypotension and may be at a greater risk of falling at therapeutic doses of nitroglycerin. Nitrate therapy may aggravate the angina caused by hypertrophic cardiomyopathy, particularly in the elderly.

🆘 Overdosage ~3 min read

OVERDOSAGE Hemodynamic Effects The ill effects of isosorbide mononitrate overdose are generally the result of isosorbide mononitrate'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; visual disturbances; nausea and vomiting (possibly with colic and even bloody diarrhea); syncope (especially in the upright posture); air hunger and 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.

Laboratory determinations of serum levels of isosorbide mononitrate and its metabolites are not widely available, and such determinations have, in any event, no established role in the management of isosorbide mononitrate overdose. There are no data suggesting what dose of isosorbide mononitrate is likely to be life threatening in humans. In rats and mice, there is significant lethality at doses of 2000 mg/kg and 3000 mg/kg, respectively.

No data are available to suggest physiological maneuvers (eg, maneuvers to change the pH of the urine) that might accelerate elimination of isosorbide mononitrate. In particular, dialysis is known to be ineffective in removing isosorbide mononitrate from the body. No specific antagonist to the vasodilator effects of isosorbide mononitrate is known, and no intervention has been subject to controlled study as a therapy of isosorbide mononitrate overdose.

Because the hypotension associated with isosorbide mononitrate overdose is the result of venodilatation and arterial hypovolemia, prudent therapy in this situation should be directed toward an 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 isosorbide mononitrate overdose in these patients may be subtle and difficult, and invasive monitoring may be required. Methemoglobinemia Methemoglobinemia has been reported in patients receiving other organic nitrates, and it probably could also occur as a side effect of isosorbide mononitrate.

Certainly nitrate ions liberated during metabolism of isosorbide mononitrate can oxidize hemoglobin into methemoglobin. Even in patients totally without cytochrome b5 reductase activity, however, and even assuming that the nitrate moiety of isosorbide mononitrate is quantitatively applied to oxidation of hemoglobin, about 2 mg/kg of isosorbide mononitrate should be required before any of these patients manifest clinically significant (≥10%) methemoglobinemia. In patients with normal reductase function, significant production of methemoglobin should require even larger doses of isosorbide mononitrate.

In one study in which 36 patients received 2 to 4 weeks of continuous nitroglycerin therapy at 3.1 to 4.4 mg/hr (equivalent, in total administered dose of nitrate ions, to 7.8 to 11.1 mg of isosorbide mononitrate per hour), the average methemoglobin level measured was 0.2%; this was comparable to that observed in parallel patients who received placebo. Not with standing these observations, there are case reports of significant methemoglobinemia in association with moderate overdoses of organic nitrates. None of the affected patients had been thought to be unusually susceptible.

Methemoglobin levels are available from most clinical laboratories. The diagnosis should be suspected in patients who exhibit signs of impaired oxygen delivery despite adequate cardiac output and adequate arterial pO2. Class…

🧬 Clinical Pharmacology ~3 min read

CLINICAL PHARMACOLOGY Mechanism of Action Isosorbide mononitrate extended-release tablet are an oral extended-release formulation of ISMN, the major active metabolite of isosorbide dinitrate; most of the clinical activity of the dinitrate is attributable to the mononitrate. The principal pharmacological action of ISMN and all organic nitrates in general is relaxation of vascular smooth muscle, producing dilatation of peripheral arteries and veins, especially the latter. Dilatation of the veins promotes peripheral pooling of blood and decreases venous return to the heart, thereby reducing left ventricular end-diastolic pressure and pulmonary capillary wedge pressure (preload).

Arteriolar relaxation reduces systemic vascular resistance, systolic arterial pressure and mean arterial pressure (afterload). Dilatation of the coronary arteries also occurs. The relative importance of preload reduction, afterload reduction, and coronary dilatation remains undefined.

Pharmacodynamics Dosing regimens for most chronically used drugs are designed to provide plasma concentrations that are continuously greater than a minimally effective concentration. This strategy is inappropriate for organic nitrates. Several well-controlled clinical trials have used exercise testing to assess the antianginal efficacy of continuously delivered nitrates.

In the large majority of these trials, active agents were indistinguishable from placebo after 24 hours (or less) of continuous therapy. Attempts to overcome tolerance by dose escalation, even to doses far in excess of those used acutely, have consistently failed. Only after nitrates have been absent from the body for several hours has their antianginal efficacy been restored.

Isosorbide mononitrate extended-release tablets, during long-term use over 42 days dosed at 120 mg once daily, continued to improve exercise performance at 4 hours and at 12 hours after dosing but its effects (although better than placebo) are less than or at best equal to the effects of the first dose of 60 mg. Pharmacokinetics and Metabolism After oral administration of ISMN as a solution or immediate-release tablets, maximum plasma concentrations of ISMN are achieved in 30 to 60 minutes, with an absolute bioavailability of approximately 100%.

After intravenous administration, ISMN is distributed into total body water in about 9 minutes with a volume of distribution of approximately 0.6 to

0.7L/kg. Isosorbide mononitrate is approximately 5% bound to human plasma proteins and is distributed into blood cells and saliva. Isosorbide mononitrate is primarily metabolized by the liver, but unlike oral isosorbide dinitrate, it is not subject to first-pass metabolism.

Isosorbide mononitrate is cleared by denitration to isosorbide and glucuronidation as the mononitrate, with 96% of the administered dose excreted in the urine within 5 days and only about 1% eliminated in the feces. At least six different compounds have been detected in urine, with about 2% of the dose excreted as the unchanged drug and at least five metabolites. The metabolites are not pharmacologically active.

Renal clearance accounts for only about 4% of total body clearance. The mean plasma elimination half-life of ISMN is approximately 5 hours. The disposition of ISMN in patients with various degrees of renal insufficiency, liver cirrhosis, or cardiac dysfunction was evaluated and found to be similar to that observed in healthy subjects.

The elimination half-life of ISMN was not prolonged, and there was no drug accumulation in patients with chronic renal failure after multiple oral dosing. The pharmacokinetics and/or bioavailability of isosorbide mononitrate extended-release tablets have been studied in both normal volunteers and patients following single- and multiple-dose administration. Data from these studies suggest that the pharmacokinetics of ISMN administered as isosorbide mononitrate extended-release tablets are similar between normal healthy volunteers and patien…

📦 How Supplied / Storage and Handling 128 words

HOW SUPPLIED Isosorbide Mononitrate Extended-Release Tablets, USP 30 mg are white, biconvex oval shaped tablets, scored and embossed "30" on one side. Bottles of 100 NDC 42799-958-01 Bottles of 500 NDC 42799-958-02 Isosorbide Mononitrate Extended-Release Tablets, USP 60 mg are light yellow, biconvex oval shaped tablets, scored on both sides and embossed ‘DX 31’ on one side. Bottles of 100 NDC 42799-959-01 Bottles of 500 NDC 42799-959-02 Isosorbide Mononitrate Extended-Release Tablets, USP 120 mg are white, biconvex, oval-shaped tablets, embossed with '120' on one side.

Bottles of 100 NDC 42799-960-01 Store at 20° to 25°C (68° to 77°F) (see USP Controlled Room Temperature). Protect from excessive moisture. Manufactured for: Edenbridge Pharmaceuticals, LLC DBA Dexcel Pharma USA Parsippany, NJ 07054 877-381-3336 Manufactured by: Dexcel Ltd., Israel Revised: March 2025

📋 Description ~1 min read

DESCRIPTION Isosorbide mononitrate (ISMN), an organic nitrate and the major biologically active metabolite of isosorbide dinitrate (ISDN), is a vasodilator with effects on both arteries and veins. Isosorbide mononitrate tablets contain either 30 mg, 60 mg or 120 mg of isosorbide mononitrate in an extended-release formulation. In addition, ISMN 30 mg tablets, USP contains the following inactive ingredients: colloidal silicon dioxide, compressible sugar, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate.

ISMN 60 mg tablets, USP contains the following inactive ingredients: colloidal silicon dioxide, compressible sugar, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, yellow iron oxide. ISMN 120 mg tablets, USP contains the following inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate and talc. The molecular formula of ISMN is C 6 H 9 NO 6 and the molecular weight is 191.14.

The chemical name for ISMN is 1,4:3,6-dianhydro-,D-glucitol 5-nitrate; the compound has the following structural formula: ISMN is a white, crystalline, odorless compound which is stable in air and in solution, has a melting point of about 90°C, and an optical rotation of +140° to 146° (2% in water, 20°C). Isosorbide mononitrate is freely soluble in water, acetic acid, alcohol, acetone and ethyl acetate; soluble in ether and chloroform, slightly soluble in toluene; practically insoluble in aliphatic hydrocarbons. Isosorbide mononitrate extended-release 120 mg tablets, USP meets USP Dissolution Test 7.

Isosorbide mononitrate extended-release 30 mg and 60 mg tablets, USP meets USP Dissolution Test 5. structure

💬 Information for Patients 152 words

INFORMATION FOR PATIENTS Patients should be told that the antianginal efficacy of isosorbide mononitrate extended-release tablets can be maintained by carefully following the prescribed schedule of dosing. For most patients, this can be accomplished by taking the dose on arising. As with other nitrates, daily headaches sometimes accompany treatment with isosorbide mononitrate.

In patients who get these headaches, the headaches are a marker of the activity of the drug. Patients should resist the temptation to avoid headaches by altering the schedule of their treatment with isosorbide mononitrate, since loss of headache may be associated with simultaneous loss of antianginal efficacy. Aspirin or acetaminophen often successfully relieves isosorbide mononitrate-induced headaches with no deleterious effect on isosorbide mononitrate's antianginal efficacy.

Treatment with isosorbide mononitrate may be associated with light-headedness on standing, especially just after rising from a recumbent or seated position. This effect may be more frequent in patients who have also consumed alcohol.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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