isosorbide mononitrate (Rx)

Brand and Other Names:Imdur, Monoket, more...ISMO
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

tablet

  • 10mg
  • 20mg

tablet, extended release

  • 30mg
  • 60mg
  • 120mg

Angina Pectoris

Prevention of angina pectoris caused by coronary artery disease

Immediate release: 5-10 mg PO twice daily initially (5 mg in small patients) given each dose 7 hr apart; increased to 10 mg PO q12hr by day 2 or 3; maintenance: 20 mg PO q12hr

Extended release: 30-60 mg PO once daily in the morning initially; may be increased to 120 mg PO once daily; wait at least 3 days between increases; if warranted may increase up to 240 mg PO once daily (rare)

Dosing considerations

  • Take on empty stomach, 30 minutes before meals or 1 hour after meal
  • Take on empty stomach, 30 minutes before or 1 hour after meal
  • Extended-release tablet should be swallowed whole; must not be chewed, crushed, or split

Safety and efficacy not established

Angina Pectoris

Start with lowest recommended adult dose

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Interactions

Interaction Checker

and isosorbide mononitrate

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    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

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            Contraindicated (5)

            • avanafil

              isosorbide mononitrate, avanafil. Either increases effects of the other by Mechanism: additive vasodilation. Contraindicated. Potentially fatal hypotension.

            • riociguat

              isosorbide mononitrate, riociguat. Either increases effects of the other by additive vasodilation. Contraindicated. Coadministration of nitrates or nitric oxide donors is contraindicated due to risk of hypotension.

            • sildenafil

              isosorbide mononitrate, sildenafil. Mechanism: additive vasodilation. Contraindicated. Potentially fatal hypotension.

            • tadalafil

              isosorbide mononitrate, tadalafil. Mechanism: additive vasodilation. Contraindicated. Contraindicated. Potentially fatal hypotension. Allow 48h after last tadalafil dose before nitrate administration.

            • vardenafil

              isosorbide mononitrate, vardenafil. Mechanism: additive vasodilation. Contraindicated. Potentially fatal hypotension.

            Serious - Use Alternative (17)

            • abametapir

              abametapir will increase the level or effect of isosorbide mononitrate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. For 2 weeks after abametapir application, avoid taking drugs that are CYP3A4 substrates. If not feasible, avoid use of abametapir.

            • apalutamide

              apalutamide will decrease the level or effect of isosorbide mononitrate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration of apalutamide, a strong CYP3A4 inducer, with drugs that are CYP3A4 substrates can result in lower exposure to these medications. Avoid or substitute another drug for these medications when possible. Evaluate for loss of therapeutic effect if medication must be coadministered. Adjust dose according to prescribing information if needed.

            • cabergoline

              isosorbide mononitrate increases effects of cabergoline by decreasing metabolism. Avoid or Use Alternate Drug. Risk of increased SBP, angina pectoris.

            • carbamazepine

              carbamazepine will decrease the level or effect of isosorbide mononitrate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • ergoloid mesylates

              isosorbide mononitrate increases effects of ergoloid mesylates by decreasing metabolism. Avoid or Use Alternate Drug. Risk of increased SBP, angina pectoris.

            • ergotamine

              isosorbide mononitrate increases effects of ergotamine by decreasing metabolism. Avoid or Use Alternate Drug. Risk of increased SBP, angina pectoris.

            • fexinidazole

              fexinidazole will increase the level or effect of isosorbide mononitrate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Fexinidazole inhibits CYP3A4. Coadministration may increase risk for adverse effects of CYP3A4 substrates.

            • fosphenytoin

              fosphenytoin will decrease the level or effect of isosorbide mononitrate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • idelalisib

              idelalisib will increase the level or effect of isosorbide mononitrate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Idelalisib is a strong CYP3A inhibitor; avoid coadministration with sensitive CYP3A substrates

            • ivosidenib

              ivosidenib will decrease the level or effect of isosorbide mononitrate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of sensitive CYP3A4 substrates with ivosidenib or replace with alternate therapies. If coadministration is unavoidable, monitor patients for loss of therapeutic effect of these drugs.

            • levoketoconazole

              levoketoconazole will increase the level or effect of isosorbide mononitrate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • lofexidine

              lofexidine, isosorbide mononitrate. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Avoid coadministration with other drugs that decrease pulse or blood pressure to mitigate risk of excessive bradycardia and hypotension.

            • methylergonovine

              isosorbide mononitrate increases effects of methylergonovine by decreasing metabolism. Avoid or Use Alternate Drug. Risk of increased SBP, angina pectoris.

            • phenobarbital

              phenobarbital will decrease the level or effect of isosorbide mononitrate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • phenytoin

              phenytoin will decrease the level or effect of isosorbide mononitrate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • tucatinib

              tucatinib will increase the level or effect of isosorbide mononitrate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid concomitant use of tucatinib with CYP3A substrates, where minimal concentration changes may lead to serious or life-threatening toxicities. If unavoidable, reduce CYP3A substrate dose according to product labeling.

            • voxelotor

              voxelotor will increase the level or effect of isosorbide mononitrate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Voxelotor increases systemic exposure of sensitive CYP3A4 substrates. Avoid coadministration with sensitive CYP3A4 substrates with a narrow therapeutic index. Consider dose reduction of the sensitive CYP3A4 substrate(s) if unable to avoid.

            Monitor Closely (34)

            • arginine

              isosorbide mononitrate, arginine. Mechanism: additive vasodilation. Use Caution/Monitor. Possible hypotension.

            • belzutifan

              belzutifan will decrease the level or effect of isosorbide mononitrate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. If unable to avoid coadministration of belzutifan with sensitive CYP3A4 substrates, consider increasing the sensitive CYP3A4 substrate dose in accordance with its prescribing information.

            • bosentan

              bosentan will decrease the level or effect of isosorbide mononitrate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • bretylium

              isosorbide mononitrate, bretylium. Either increases effects of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Each drug may cause hypotension.

            • bupivacaine implant

              isosorbide mononitrate, bupivacaine implant. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Local anesthetics may increase the risk of developing methemoglobinemia when concurrently exposed to drugs that also cause methemoglobinemia.

            • captopril

              isosorbide mononitrate, captopril. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Both drugs lower blood pressure. Monitor blood pressure.

            • cenobamate

              cenobamate will decrease the level or effect of isosorbide mononitrate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Increase dose of CYP3A4 substrate, as needed, when coadministered with cenobamate.

            • conivaptan

              conivaptan will increase the level or effect of isosorbide mononitrate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • crofelemer

              crofelemer increases levels of isosorbide mononitrate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Crofelemer has the potential to inhibit CYP3A4 at concentrations expected in the gut; unlikely to inhibit systemically because minimally absorbed.

            • dabrafenib

              dabrafenib will decrease the level or effect of isosorbide mononitrate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely.

            • dapsone topical

              isosorbide mononitrate increases toxicity of dapsone topical by altering metabolism. Modify Therapy/Monitor Closely. May induce methemoglobinemia.

            • dichlorphenamide

              dichlorphenamide and isosorbide mononitrate both decrease serum potassium. Use Caution/Monitor.

            • duvelisib

              duvelisib will increase the level or effect of isosorbide mononitrate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Coadministration with duvelisib increases AUC of a sensitive CYP3A4 substrate which may increase the risk of toxicities of these drugs. Consider reducing the dose of the sensitive CYP3A4 substrate and monitor for signs of toxicities of the coadministered sensitive CYP3A substrate.

            • efavirenz

              efavirenz will decrease the level or effect of isosorbide mononitrate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • elagolix

              elagolix decreases levels of isosorbide mononitrate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Elagolix is a weak-to-moderate CYP3A4 inducer. Monitor CYP3A substrates if coadministered. Consider increasing CYP3A substrate dose if needed.

            • elvitegravir/cobicistat/emtricitabine/tenofovir DF

              elvitegravir/cobicistat/emtricitabine/tenofovir DF increases levels of isosorbide mononitrate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Cobicistat is a CYP3A4 inhibitor; contraindicated with CYP3A4 substrates for which elevated plasma concentrations are associated with serious and/or life-threatening events.

            • encorafenib

              encorafenib, isosorbide mononitrate. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Encorafenib both inhibits and induces CYP3A4 at clinically relevant plasma concentrations. Coadministration of encorafenib with sensitive CYP3A4 substrates may result in increased toxicity or decreased efficacy of these agents.

            • etravirine

              etravirine will decrease the level or effect of isosorbide mononitrate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • fedratinib

              fedratinib will increase the level or effect of isosorbide mononitrate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Adjust dose of drugs that are CYP3A4 substrates as necessary.

            • iloperidone

              iloperidone increases levels of isosorbide mononitrate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Iloperidone is a time-dependent CYP3A inhibitor and may lead to increased plasma levels of drugs predominantly eliminated by CYP3A4.

            • istradefylline

              istradefylline will increase the level or effect of isosorbide mononitrate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Istradefylline 40 mg/day increased peak levels and AUC of CYP3A4 substrates in clinical trials. This effect was not observed with istradefylline 20 mg/day. Consider dose reduction of sensitive CYP3A4 substrates.

            • lorlatinib

              lorlatinib will decrease the level or effect of isosorbide mononitrate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • maraviroc

              maraviroc, isosorbide mononitrate. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of orthostatic hypotension.

            • mitotane

              mitotane decreases levels of isosorbide mononitrate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Mitotane is a strong inducer of cytochrome P-4503A4; monitor when coadministered with CYP3A4 substrates for possible dosage adjustments.

            • nafcillin

              nafcillin will decrease the level or effect of isosorbide mononitrate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • nitroglycerin rectal

              nitroglycerin rectal, isosorbide mononitrate. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Observe for possible additive hypotensive effects during concomitant use. .

            • primidone

              primidone will decrease the level or effect of isosorbide mononitrate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • ribociclib

              ribociclib will increase the level or effect of isosorbide mononitrate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • rifabutin

              rifabutin will decrease the level or effect of isosorbide mononitrate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • rucaparib

              rucaparib will increase the level or effect of isosorbide mononitrate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Adjust dosage of CYP3A4 substrates, if clinically indicated.

            • stiripentol

              stiripentol, isosorbide mononitrate. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Stiripentol is a CYP3A4 inhibitor and inducer. Monitor CYP3A4 substrates coadministered with stiripentol for increased or decreased effects. CYP3A4 substrates may require dosage adjustment.

            • tazemetostat

              tazemetostat will decrease the level or effect of isosorbide mononitrate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • tecovirimat

              tecovirimat will decrease the level or effect of isosorbide mononitrate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Tecovirimat is a weak CYP3A4 inducer. Monitor sensitive CYP3A4 substrates for effectiveness if coadministered.

            • tetracaine

              tetracaine, isosorbide mononitrate. Other (see comment). Use Caution/Monitor. Comment: Monitor for signs of methemoglobinemia when methemoglobin-inducing drugs are coadministered.

            Minor (7)

            • acetazolamide

              acetazolamide will increase the level or effect of isosorbide mononitrate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • acetylcysteine (Antidote)

              acetylcysteine (Antidote) increases effects of isosorbide mononitrate by Other (see comment). Minor/Significance Unknown. Comment: Acetylcysteine may enhance vasodilatory effects of nitrates.

            • anastrozole

              anastrozole will increase the level or effect of isosorbide mononitrate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • cyclophosphamide

              cyclophosphamide will increase the level or effect of isosorbide mononitrate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • larotrectinib

              larotrectinib will increase the level or effect of isosorbide mononitrate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • rifampin

              rifampin will decrease the level or effect of isosorbide mononitrate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • rifapentine

              rifapentine will decrease the level or effect of isosorbide mononitrate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

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            Adverse Effects

            Frequency Not Defined

            Dizziness

            Flushing

            Headache

            Hypotension

            Methemoglobinemia

            Nausea

            Orthostatic hypotension

            Palpitations

            Restlessness

            Syncope

            Tachycardia

            Vomiting

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            Warnings

            Contraindications

            Hypersensitivity to organic nitrates

            PDE-5 inhibitors (eg, avanafil, sildenafil, tadalafil, or vardenafil); concomitant use can cause severe hypotension, syncope, or myocardial ischemia

            Concomitant administration with guanylate stimulator riociguat (may cause hypotension)

            Cautions

            Use caution in acute myocardial infarction, alcohol use, hyperthyroidism, increased intracranial pressure (eg, from head trauma or cerebral hemorrhage; potential contraindication), increased intraocular pressure, postural hypotension, volume depletion, Moderate hypotension, low systolic blood pressure (BP)

            Not recommended for use in patients with acute myocardial infarction or heart failure

            May cause CNS depression, which may in turn impair physical or mental abilities; caution patient about performing tasks that require mental alertness, including operating heavy machinery

            Avoid use in patients with hypertrophic cardiomyopathy with outflow tract obstruction; nitrates may reduce preload, which can exacerbate obstruction and cause hypotension or syncope and/or worsening of heart failure

            Do not change brands unintentionally; formulations are not all bioequivalent; extended release formulation not intended for the immediate relief of acute attacks of angina pectoris

            Treat drug-induced headache with aspirin or acetaminophen

            Provide nitrate-free interval (10-12 hr or overnight) to prevent development of tolerance

            Severe hypotension may occur along with paradoxical bradycardia and increased angina pectoris; ethanol can cause severe hypotension with even small doses; avoid excessive, prolonged hypotension

            Withdraw gradually to prevent acute angina

            Discontinue if blurred vision develops

            Use supportive treatment to manage overdose

            Narrow-angle glaucoma (controversial: may not be clinically significant)

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            Pregnancy & Lactation

            Pregnancy category: C

            Lactation: Unknown whether drug crosses into breast milk; use caution

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Organic nitrate that causes systemic venodilation, decreasing preload; enters vascular smooth muscle and is converted to nitric oxide, leading to activation of cyclic guanosine monophosphate and vasodilation

            Relaxes smooth muscle via dose-dependent dilation of arterial and venous beds to reduce both preload and afterload, as well as myocardial oxygen demand; also improves coronary collateral circulation, lowering blood pressure, increasing heart rate, and causing occasional paradoxical bradycardia

            Absorption

            Bioavailability: Immediate release, 93-100%; extended release, 77-80%

            Onset (antianginal effects): Immediate release, 60 min; extended release, 60 min

            Onset (hemodynamic effects): Immediate release, 10-30 min; extended release, ≥6 hr

            Duration (antianginal effects): Immediate release, 5-7 hr; extended release, 8 hr

            Duration (hemodynamic effects): Immediate release, 10-30 min; extended release, ≥6 hr

            Peak plasma time: Immediate release, 30-60 min; extended release, 3-4.5 hr

            Distribution

            Protein bound: <5%

            Vd: 0.6 L/kg

            Metabolism

            Metabolized in liver via conjugation

            Metabolites: Isosorbide, 5-isosorbide mononitrate glucuronide, sorbitol (inactive)

            Elimination

            Half-life: Parent drug, 6.2-6.6 hr; glucuronide metabolite, 6 hr; sorbitol metabolite, 9 hr

            Total body clearance: 115-140 mL/min

            Excretion: Urine (2%); feces (1%)

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            Images

            BRAND FORM. UNIT PRICE PILL IMAGE
            isosorbide mononitrate oral
            -
            60 mg tablet
            isosorbide mononitrate oral
            -
            30 mg tablet
            isosorbide mononitrate oral
            -
            120 mg tablet
            isosorbide mononitrate oral
            -
            120 mg tablet
            isosorbide mononitrate oral
            -
            60 mg tablet
            isosorbide mononitrate oral
            -
            20 mg tablet
            isosorbide mononitrate oral
            -
            60 mg tablet
            isosorbide mononitrate oral
            -
            30 mg tablet
            isosorbide mononitrate oral
            -
            120 mg tablet
            isosorbide mononitrate oral
            -
            30 mg tablet
            isosorbide mononitrate oral
            -
            30 mg tablet
            isosorbide mononitrate oral
            -
            120 mg tablet
            isosorbide mononitrate oral
            -
            60 mg tablet
            isosorbide mononitrate oral
            -
            30 mg tablet
            isosorbide mononitrate oral
            -
            10 mg tablet
            isosorbide mononitrate oral
            -
            20 mg tablet
            isosorbide mononitrate oral
            -
            30 mg tablet
            isosorbide mononitrate oral
            -
            60 mg tablet
            isosorbide mononitrate oral
            -
            10 mg tablet

            Copyright © 2010 First DataBank, Inc.

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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
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            NC NOT COVERED – Drugs that are not covered by the plan.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.