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
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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

          Minor

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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 mycardial 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 hypertorphic cardiomyopathy with outflow tract obstruction; nitrates may reduce preload, which can exacerbate obstruction and cause hypotensioin 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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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            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.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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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.