Please wait while the formulary information is being retrieved.
Drug overview for ISOSORBIDE MONONITRATE ER (isosorbide mononitrate):
Generic name: ISOSORBIDE MONONITRATE (EYE-soe-SOR-bide MON-oh-NYE-trate)
Drug class: Nitrates
Therapeutic class: Cardiovascular Therapy Agents
Isosorbide dinitrate and isosorbide mononitrate, organic nitrates, are vasodilating agents.
No enhanced Uses information available for this drug.
Generic name: ISOSORBIDE MONONITRATE (EYE-soe-SOR-bide MON-oh-NYE-trate)
Drug class: Nitrates
Therapeutic class: Cardiovascular Therapy Agents
Isosorbide dinitrate and isosorbide mononitrate, organic nitrates, are vasodilating agents.
No enhanced Uses information available for this drug.
DRUG IMAGES
ISOSORBIDE MONONIT ER 60 MG TB
ISOSORBIDE MONONIT ER 30 MG TB
The following indications for ISOSORBIDE MONONITRATE ER (isosorbide mononitrate) have been approved by the FDA:
Indications:
Prevention of anginal pain associated with coronary artery disease
Professional Synonyms:
Prevention of anginal pain associated with CAD
Indications:
Prevention of anginal pain associated with coronary artery disease
Professional Synonyms:
Prevention of anginal pain associated with CAD
The following dosing information is available for ISOSORBIDE MONONITRATE ER (isosorbide mononitrate):
Dosage of isosorbide dinitrate and isosorbide mononitrate must be carefully adjusted according to the patient's requirements and response and the smallest effective dosage should be used.
When isosorbide dinitrate is used in fixed combination with hydralazine, the cautions, precautions, and contraindications associated with hydralazine must be considered in addition to those associated with isosorbide dinitrate (see Cautions and Precautions and Contraindications in the Nitrates and Nitrites General Statement 24:12.08).
Clinical studies of isosorbide dinitrate alone or in fixed combination with hydralazine did not include sufficient numbers of patients 65 years of age and older to determine whether geriatric patients respond differently than younger patients. Although other clinical experience has not revealed age-related differences in response or tolerance, drug dosage generally should be titrated carefully in geriatric patients, usually initiating therapy at the low end of the dosage range. The greater frequency of decreased hepatic, renal, and/or cardiac function and of concomitant disease and drug therapy observed in the elderly also should be considered.
Elimination of isosorbide dinitrate and its metabolites may occur more slowly in geriatric patients than in younger adults.
Clinical studies of isosorbide mononitrate did not include sufficient numbers of patients 65 years of age and older to determine whether geriatric patients respond differently than younger patients. Other clinical experience has not identified any differences in responses between geriatric and younger patients. One manufacturer of isosorbide mononitrate states that if isosorbide mononitrate is used in geriatric patients, dosage of the drug should be selected with caution, usually initiating therapy at the low end of the dosage range, although age, renal, hepatic, and cardiovascular dysfunction do not appear to have a significant effect on the clearance of the drug.
When isosorbide dinitrate is used in fixed combination with hydralazine, the cautions, precautions, and contraindications associated with hydralazine must be considered in addition to those associated with isosorbide dinitrate (see Cautions and Precautions and Contraindications in the Nitrates and Nitrites General Statement 24:12.08).
Clinical studies of isosorbide dinitrate alone or in fixed combination with hydralazine did not include sufficient numbers of patients 65 years of age and older to determine whether geriatric patients respond differently than younger patients. Although other clinical experience has not revealed age-related differences in response or tolerance, drug dosage generally should be titrated carefully in geriatric patients, usually initiating therapy at the low end of the dosage range. The greater frequency of decreased hepatic, renal, and/or cardiac function and of concomitant disease and drug therapy observed in the elderly also should be considered.
Elimination of isosorbide dinitrate and its metabolites may occur more slowly in geriatric patients than in younger adults.
Clinical studies of isosorbide mononitrate did not include sufficient numbers of patients 65 years of age and older to determine whether geriatric patients respond differently than younger patients. Other clinical experience has not identified any differences in responses between geriatric and younger patients. One manufacturer of isosorbide mononitrate states that if isosorbide mononitrate is used in geriatric patients, dosage of the drug should be selected with caution, usually initiating therapy at the low end of the dosage range, although age, renal, hepatic, and cardiovascular dysfunction do not appear to have a significant effect on the clearance of the drug.
No enhanced Administration information available for this drug.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| ISOSORBIDE MONONIT ER 30 MG TB | Maintenance | Adults take 1 tablet (30 mg) by oral route once daily in the morning |
| ISOSORBIDE MONONIT ER 60 MG TB | Maintenance | Adults take 1 tablet (60 mg) by oral route once daily in the morning |
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| ISOSORBIDE MONONIT ER 30 MG TB | Maintenance | Adults take 1 tablet (30 mg) by oral route once daily in the morning |
| ISOSORBIDE MONONIT ER 60 MG TB | Maintenance | Adults take 1 tablet (60 mg) by oral route once daily in the morning |
The following drug interaction information is available for ISOSORBIDE MONONITRATE ER (isosorbide mononitrate):
There are 2 contraindications.
These drug combinations generally should not be dispensed or administered to the same patient. A manufacturer label warning that indicates the contraindication warrants inclusion of a drug combination in this category, regardless of clinical evidence or lack of clinical evidence to support the contraindication.
| Drug Interaction | Drug Names |
|---|---|
| CGMP Specific PDE Type-5 Inhibitors/Nitrates SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient. MECHANISM OF ACTION: Nitrates activate guanyl cyclase, an enzyme that increases levels of cyclic guanosine monophosphate (cGMP). cGMP produces smooth muscle relaxation. Avanafil,(1) sildenafil,(2) tadalafil,(3,4) and vardenafil (5-7) inhibit phosphodiesterase type 5 (PDE5), which is responsible for the breakdown of cGMP. Concurrent use of nitrates with avanafil,(1) sildenafil,(2) tadalafil,(3,4) or vardenafil(5-7) results in potentiation of the effect of nitrates. CLINICAL EFFECTS: The concurrent use of CGMP specific PDE type-5 inhibitors and nitrates potentiates the hypotensive effects of nitrates(1-7) which may result in dizziness, syncope, heart attack, or stroke.(4) The concurrent use of sildenafil and sodium nitroprusside may potentiate the antiaggregatory effect of sodium nitroprusside in addition to increased hypotensive effects.(2) PREDISPOSING FACTORS: Plasma levels of the PDE type-5 inhibitor may be higher in the following patients: those older than 65, with hepatic impairment, with severe renal impairment, or using concomitant CYP3A4 inhibitors. This may increase the severity of the interaction. PATIENT MANAGEMENT: The administration of avanafil to patients receiving organic nitrates, either regularly and/or intermittently, is contraindicated. In a patient who has taken avanafil, at least 12 hours should elapse after the last dose of avanafil before nitrate administration is considered and it should only be administered under close medical supervision with appropriate hemodynamic monitoring.(1) The administration of sildenafil to patients receiving organic nitrates, either regularly and/or intermittently, in any form is contraindicated.(2) The administration of tadalafil to patients receiving any form of organic nitrate, either regularly and/or intermittently, is contraindicated.(3,4) Patients should be instructed to seek immediate medical attention if they experience anginal chest pain following tadalafil. In such cases where nitrate administration is considered medically necessary, at least 48 hours should elapse after tadalafil administration before nitrate administration is considered. In such cases, nitrates should only be administered under close medical supervision with appropriate hemodynamic monitoring.(4) The administration of vardenafil to patients receiving nitrates or nitric oxide donors is contraindicated.(5-7) In patients prescribed vardenafil in whom nitrate administration is deemed medically necessary in a life-threatening situation, the Canadian manufacturer of vardenafil states that at least 24 hours should have elapsed after the last dose of vardenafil before the nitrate administration is considered. Nitrates should only be administered under close medical supervision with appropriate hemodynamic monitoring.(7) The concomitant use of nicorandil(8) or subinguinal nitroglycerin(9) and PDE type-5 inhibitors is contraindicated. Treat hypotension resulting from concurrent use as a nitrate overdose, with elevation of the extremities and central volume expansion.(10) DISCUSSION: Nitrates activate guanylate cyclase, an enzyme that increases levels of cGMP. cGMP produces smooth muscle relaxation. Avanafil,(1) sildenafil,(2) tadalafil,(3,4) and vardenafil (5-7) inhibit PDE5, which is responsible for the breakdown of cGMP. Concurrent use of nitrates with avanafil,(1) sildenafil,(2) tadalafil,(3,4) or vardenafil(5-7) results in potentiation of the effect of nitrates. It is unknown when nitrates, if necessary, can be safely administered to patients who have taken CGMP specific PDE type-5 inhibitors. Following a single 100 mg oral dose of sildenafil, peak plasma levels are approximately 440 ng/mL and levels 24 hours post dose are approximately 2 ng/ml. Sildenafil plasma levels at 24 hours post dose are three to eight times higher in the following patients: those age greater than 65, those with hepatic impairment, those with severe renal impairment (creatinine clearance less than 30 ml/min), and those with concomitant use of potent CYP P-450-3A4 inhibitors (erythromycin). Although plasma levels of sildenafil are lower at 24 hours post dose, the manufacturer of sildenafil states that it is still unknown whether nitrates can safely be coadministered at that time.(2) In vitro studies with human platelets have shown that sildenafil potentiates the antiaggregatory effect of sodium nitroprusside.(2) In a study of 150 subjects who received tadalafil (20 mg) daily for 7 days, sublingual nitroglycerin was administered at 2, 4, 8, 24, 48, 72, and 96 hours after tadalafil. A significant interaction between tadalafil and nitroglycerin was observed up to and including 24 hours post-tadalafil. At 48 hours, the interaction was not observed by most hemodynamic measures. After 48 hours, the interaction was not detectable.(4) In a population-based cohort study of 61,487 men who received nitrates, 5,710 (9%) concurrently received PDE Type-5 inhibitors (PDE5i). Crude hazard ratios found a significant and inverse association between combination use of nitrates and PDE5i and all cause, cardiovascular, and non-cardiovascular mortality. All-cause mortality incidence rates were 2.69 cases per 100 person-years for the nitrate and PDE5i group vs 3.83 cases per 100 person-years in the nitrate-only group. Concurrent use of nitrates and PDE5i found a multivariate adjusted HR for all-cause mortality of 1.39 (95% CI: 1.28-1.51). Concurrent use of nitrates and PDE5i found an adjusted HR for cardiovascular death, non-cardiovascular death, myocardial infarction, heart failure, revascularization, and major adverse cardiovascular event (MACE) in patients treated with both nitrates and PDE5i was 1.34 (95% CI: 1.11-1.62), 1.40 (95% CI: 1.27-1.54), 1.72 (95% CI: 1.55-1.90), 1.67 (95% CI: 1.48-1.90), 1.95 (95% CI: 1.78-2.13), and 1.70 (95% CI: 1.58-1.83), respectively, compared with patients with nitrates only.(11) |
ADCIRCA, ALYQ, AVANAFIL, CIALIS, ENTADFI, OPSYNVI, REVATIO, SILDENAFIL CITRATE, STENDRA, TADALAFIL, TADLIQ, VARDENAFIL HCL, VIAGRA |
| Riociguat/Nitrates & Nitric Oxide Donors SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient. MECHANISM OF ACTION: Nitrates activate guanyl cyclase, an enzyme that increases levels of cyclic guanosine monophosphate (cGMP), which produces smooth muscle relaxation. Riociguat stimulates the nitric oxide-soluble guanylate cyclase-cGMP pathway and also increases cGMP. Concurrent use of nitrates with riociguat results in potentiation of the effect of both agents.(1) CLINICAL EFFECTS: The concurrent use riociguat and nitrates potentiates the hypotensive effects of both agents, which may result in dizziness, syncope, heart attack, or stroke.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The administration of riociguat to patients receiving nitrates, or nitric oxide donors, in any form is contraindicated.(1) DISCUSSION: Riociguat (2.5 mg) potentiated the blood pressure lowering effect of sublingual nitroglycerin (0.4 mg) when taken 4 hour and 8 hours after riociguat. Syncope was reported in some patients.(1) |
ADEMPAS |
There are 1 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| Ergot Alkaloids/Nitrates SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Decreased first-pass metabolism of ergot alkaloids. Ergot alkaloids may precipitate angina pectoris. CLINICAL EFFECTS: Increased standing systolic blood pressure and angina attacks may occur. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Avoid administration of ergot alkaloids to patients receiving nitroglycerin for angina. When it is necessary to give this combination, monitor the patient for increased effects of the ergot alkaloid. Reduce the dose of ergot alkaloid as necessary. DISCUSSION: Dihydroergotamine has been reported to precipitate angina pectoris. Nitroglycerin administration to patients receiving dihydroergotamine increased the plasma dihydroergotamine level and area under the plasma concentration-time curve. An increase in the mean standing systolic blood pressure was measured. |
DIHYDROERGOTAMINE MESYLATE, ERGOLOID MESYLATES, ERGOMAR, ERGOTAMINE TARTRATE, ERGOTAMINE-CAFFEINE, METHYLERGONOVINE MALEATE, METHYSERGIDE MALEATE, MIGERGOT, MIGRANAL, TRUDHESA |
There are 1 moderate interactions.
The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.
| Drug Interaction | Drug Names |
|---|---|
| Apomorphine/Selected Antihypertensives and Vasodilators SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Apomorphine causes dose-dependent decreases in blood pressure. Concurrent use with antihypertensive agents may result in additive effects on blood pressure.(1) CLINICAL EFFECTS: Concurrent use of antihypertensives and apomorphine may result in orthostatic hypotension with or without dizziness, nausea, or syncope.(1) PREDISPOSING FACTORS: The risk of orthostatic hypotension may be increased during dose escalation of apomorphine and in patients with renal or hepatic impairment.(1) PATIENT MANAGEMENT: Patients receiving concurrent therapy should be monitored for hypotension. Counsel patients about the risk of orthostatic hypotension.(1) DISCUSSION: Healthy volunteers who took sublingual nitroglycerin (0.4 mg) concomitantly with apomorphine experienced a mean largest decrease in supine systolic blood pressure (SBP) of 9.7 mm Hg and in supine diastolic blood pressure (DBP) of 9.3 mm Hg, and a mean largest decrease in standing SBP and DBP of 14.3 mm Hg and 13.5 mm Hg, respectively. The maximum decrease in SBP and DBP was 65 mm Hg and 43 mm Hg, respectively. When apomorphine was taken alone, the mean largest decrease in supine SBP and DBP was 6.1 mm Hg and 7.3 mm Hg, respectively, and in standing SBP and DBP was 6.7 mm Hg and 8.4 mm Hg, respectively.(1) |
APOKYN, APOMORPHINE HCL, ONAPGO |
The following contraindication information is available for ISOSORBIDE MONONITRATE ER (isosorbide mononitrate):
Drug contraindication overview.
No enhanced Contraindications information available for this drug.
No enhanced Contraindications information available for this drug.
There are 0 contraindications.
There are 5 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Glucose-6-phosphate dehydrogenase (g6Pd) deficiency |
| Intracerebral hemorrhage |
| Intracranial hypertension |
| Methemoglobinemia |
| Severe anemia |
There are 4 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Acute myocardial infarction |
| Hypertrophic cardiomyopathy |
| Hypotension |
| Malabsorption states |
The following adverse reaction information is available for ISOSORBIDE MONONITRATE ER (isosorbide mononitrate):
Adverse reaction overview.
No enhanced Common Adverse Effects information available for this drug.
No enhanced Common Adverse Effects information available for this drug.
There are 10 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Syncope |
None. |
| Rare/Very Rare |
|---|
|
Allergic dermatitis Anaphylaxis Blurred vision Exfoliative dermatitis Hypoxia Methemoglobinemia Severe headache disorder Stevens-johnson syndrome Xerostomia |
There are 20 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Dizziness Flushing Headache disorder Hypotension Nervousness Orthostatic hypotension Paresthesia |
Nausea Palpitations Tachycardia Vomiting |
| Rare/Very Rare |
|---|
|
Accidental fall Drowsy Dyspnea Fatigue General weakness Hyperhidrosis Pallor Skin rash Vertigo |
The following precautions are available for ISOSORBIDE MONONITRATE ER (isosorbide mononitrate):
No enhanced Pediatric Use information available for this drug.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
No enhanced Pregnancy information available for this drug.
No enhanced Lactation information available for this drug.
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for ISOSORBIDE MONONITRATE ER (isosorbide mononitrate):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for ISOSORBIDE MONONITRATE ER (isosorbide mononitrate)'s list of indications:
| Prevention of anginal pain in coronary artery disease | |
| I20.2 | Refractory angina pectoris |
| I20.81 | Angina pectoris with coronary microvascular dysfunction |
| I20.89 | Other forms of angina pectoris |
| I20.9 | Angina pectoris, unspecified |
| I25.112 | Atherosclerotic heart disease of native coronary artery with refractory angina pectoris |
| I25.118 | Atherosclerotic heart disease of native coronary artery with other forms of angina pectoris |
| I25.119 | Atherosclerotic heart disease of native coronary artery with unspecified angina pectoris |
| I25.702 | Atherosclerosis of coronary artery bypass graft(s), unspecified, with refractory angina pectoris |
| I25.708 | Atherosclerosis of coronary artery bypass graft(s), unspecified, with other forms of angina pectoris |
| I25.709 | Atherosclerosis of coronary artery bypass graft(s), unspecified, with unspecified angina pectoris |
| I25.712 | Atherosclerosis of autologous vein coronary artery bypass graft(s) with refractory angina pectoris |
| I25.718 | Atherosclerosis of autologous vein coronary artery bypass graft(s) with other forms of angina pectoris |
| I25.719 | Atherosclerosis of autologous vein coronary artery bypass graft(s) with unspecified angina pectoris |
| I25.722 | Atherosclerosis of autologous artery coronary artery bypass graft(s) with refractory angina pectoris |
| I25.728 | Atherosclerosis of autologous artery coronary artery bypass graft(s) with other forms of angina pectoris |
| I25.729 | Atherosclerosis of autologous artery coronary artery bypass graft(s) with unspecified angina pectoris |
| I25.732 | Atherosclerosis of nonautologous biological coronary artery bypass graft(s) with refractory angina pectoris |
| I25.738 | Atherosclerosis of nonautologous biological coronary artery bypass graft(s) with other forms of angina pectoris |
| I25.739 | Atherosclerosis of nonautologous biological coronary artery bypass graft(s) with unspecified angina pectoris |
| I25.752 | Atherosclerosis of native coronary artery of transplanted heart with refractory angina pectoris |
| I25.758 | Atherosclerosis of native coronary artery of transplanted heart with other forms of angina pectoris |
| I25.759 | Atherosclerosis of native coronary artery of transplanted heart with unspecified angina pectoris |
| I25.762 | Atherosclerosis of bypass graft of coronary artery of transplanted heart with refractory angina pectoris |
| I25.768 | Atherosclerosis of bypass graft of coronary artery of transplanted heart with other forms of angina pectoris |
| I25.769 | Atherosclerosis of bypass graft of coronary artery of transplanted heart with unspecified angina pectoris |
| I25.792 | Atherosclerosis of other coronary artery bypass graft(s) with refractory angina pectoris |
| I25.798 | Atherosclerosis of other coronary artery bypass graft(s) with other forms of angina pectoris |
| I25.799 | Atherosclerosis of other coronary artery bypass graft(s) with unspecified angina pectoris |
Formulary Reference Tool