monoket
Monoket (Isosorbide Mononitrate) is a nitrate vasodilator used to treat Angina Pectoris, Coronary Disease, Cyanosis, Gastroesophageal Reflux.
Isosorbide Mononitrate · by Omnivium Pharms
Available as a generic: Isosorbide Mononitrate
Key facts
- Active ingredient
- Isosorbide Mononitrate
- Drug class
- Nitrate Vasodilator
- Form
- Tablet
- Strength
- Isosorbide Mononitrate 10MG · Isosorbide Mononitrate 20MG
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- angina pectoris, coronary disease, cyanosis
- Manufacturer
- Omnivium Pharms
- FDA application
- NDA020215
What is Monoket?
From the FDA label:Isosorbide mononitrate, an organic nitrate, is a vasodilator with effects on both arteries and veins. The empirical formula is C 6 H 9 NO 6 and the molecular weight is 191.14. The chemical name for isosorbide mononitrate is 1,4:3,6-Dianhydro-D-glucitol 5-nitrate and the compound has the following structural formula: Isosorbide Mononitrate Tablets, USP are available as 10 mg and 20 mg tablets. Each tablet also contains as inactive ingredients: lactose, talc, colloidal silicon dioxide, starch, microcrystalline cellulose and aluminum stearate.
How to use
The recommended regimen of Isosorbide Mononitrate Tablets is 20 mg twice daily, with the doses seven hours apart. A starting dose of 5 mg (½ tablet of the 10 mg dosing strength) might be appropriate for persons of particularly small stature but should be increased to at least 10 mg by the second or third day of therapy. Dosage adjustments are not necessary for elderly patients or patients with altered hepatic or renal function. As noted above ( Clinical Pharmacology ), multiple studies of organic nitrates have shown that maintenance of continuous 24-hour plasma levels results in refractory tolerance. The asymmetric (2 doses, 7 hours apart) dosing regimen for Isosorbide Mononitrate Tablets provides a daily nitrate-free interval to minimize the development of tolerance. As also noted under Clinical Pharmacology , well-controlled studies have shown that tolerance to Isosorbide Mononitrate Tablets occurs to some extent when using the twice-daily regimen in which the two doses are given seven hours apart. This regimen has been shown to have antianginal efficacy beginning one hour after the first dose and lasting at least seven hours after the second dose. The duration (if any) of antianginal activity beyond fourteen hours has not been studied. In clinical trials, isosorbide mononitrate has been administered in a variety of regimens and doses. Doses above 20 mg twice a day (with the…
Side effects
To report SUSPECTED ADVERSE REACTIONS, contact Omnivium Pharmaceuticals LLC at 1-888-807-1048 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Headache is the most frequent side effect and was the cause of 2% of all dropouts from controlled-clinical trials. Headache decreased in incidence after the first few days of therapy. The following table shows the frequency of adverse reactions observed in 1% or more of subjects in 6 placebo-controlled trials, conducted in the United States and abroad. The same table shows the frequency of withdrawal for these adverse reactions. In many cases the adverse reactions were of uncertain relation to drug treatment. Frequency of Adverse Reactions (Discontinuations)* 6 Placebo-Controlled Studies Dose Placebo 5 mg 10 mg 20 mg Patients 160 54 52 159 Headache 6% (0%) 17% (0%) 13% (0%) 35% (5%) Fatigue 2% (0%) 0% (0%) 4% (0%) 1% (0%) Upper Respiratory Infection <1% (0%) 0% (0%) 4% (0%) 1% (0%) Pain <1% (0%) 4% (0%) 0% (0%) <1% (0%) Dizziness 1% (0%) 0% (0%) 0% (0%) 4% (0%) Nausea <1% (0%) 0% (0%) 0% (0%) 3% (2%) Increased Cough <1% (0%) 0% (0%) 2% (0%) <1% (0%) Rash 0% (0%) 2% (2%) 0% (0%) <1% (0%) Abdominal Pain <1% (0%) 0% (0%) 2% (0%) 0% (0%) Allergic Reaction 0% (0%) 0% (0%) 2% (0%) 0% (0%) Cardiovascular Disorder 0% (0%) 2% (0%) 0% (0%) 0% (0%) Chest Pain <1% (0%) 0% (0%) 2% (0%) <1% (0%) Diarrhea 0% (0%) 0% (0%) 2% (0%) 0% (0%) Flushing 0%…
Warnings
Important safety information
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 isosorbide mononitrate 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.
Who should not take Monoket
Isosorbide mononitrate is contraindicated in patients who are allergic to it. Do not use isosorbide mononitrate in patients who are taking certain drugs for erectile dysfunction (phosphodiesterase inhibitors), such as sildenafil, tadalafil, or vardenafil. Concomitant use can cause severe hypotension, syncope, or myocardial ischemia. Do not use isosorbide mononitrate in patients who are taking the soluble guanylate cyclase stimulator riociguat. Concomitant use can cause hypotension.
Overdose — what happens if you take too much
Hemodynamic Effects: The ill effects of isosorbide mononitrate overdose are generally the results 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 oral doses of 1965 mg/kg and 2581 mg/kg, respectively. No data are available to suggest physiological maneuvers (e.g., maneuvers to change the pH of the urine) that might accelerate elimination of isosorbide mononitrate. Isosorbide mononitrate is…
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Drug class
How this class works, per Nitrates - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
See how Monoket ranks — best-rated nitrate vasodilator for:
Dosage forms
Tablet
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
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Frequently asked questions
- What does Monoket treat?
- Monoket (Isosorbide Mononitrate) may be used to treat angina pectoris, coronary disease, cyanosis, gastroesophageal reflux, heart failure, poisoning, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Monoket work?
- Monoket is a nitrate vasodilator. Nitrate vasodilators are converted in the body into nitric oxide, which relaxes the smooth muscle in blood vessel walls and widens them. This mainly opens up the veins, reducing how hard the heart must work and relieving chest pain.
- Is there a coupon or discount for Monoket?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Monoket. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Monoket?
- Monoket is marketed by Omnivium Pharms. You can see Omnivium Pharms's full profile, rating, and other products on pharmaranks.
- Is Monoket a brand-name or generic drug?
- Monoket is a brand-name product with the active ingredient Isosorbide Mononitrate. Lower-cost generic equivalents containing Isosorbide Mononitrate are available — ask your pharmacist.
- Is Monoket available over the counter?
- No. Monoket is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Monoket come in?
- Monoket is currently marketed as tablet, per the FDA's National Drug Code Directory.
- What class of drug is Monoket?
- Monoket is classified as nitrate vasodilator, per the FDA's Established Pharmacologic Class.
- Is Monoket FDA-registered?
- Monoket is on record with the U.S. FDA under application number NDA020215. You can verify this on its official FDA label.
- Is Monoket safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Monoket. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Monoket?
- Monoket's side effects are taken directly from its FDA label. From the label: To report SUSPECTED ADVERSE REACTIONS, contact Omnivium Pharmaceuticals LLC at 1-888-807-1048 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Headache is the most frequent side effect and was the cause of 2% of all dropouts from controlled-clinical trials.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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