Isosorbide Mononitrate 60mg ER Tabs
It is used to prevent chest pain (angina pectoris) in people with heart disease.Do not use this drug to treat sudden chest pain. It will not help. Talk with your doctor.
Drug Class
Antianginal
Pharmacologic Class
Nitrate; Vasodilator
Pregnancy Category
Category B
FDA Approved
Jul 1991
DEA Schedule
Not Controlled
Overview
What is this medicine?
Isosorbide mononitrate extended-release is a medication used to prevent chest pain (angina) caused by heart disease. It works by relaxing and widening blood vessels, which helps blood flow more easily to the heart and reduces the heart's workload. It is not for immediate relief of an angina attack.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, it's essential to follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions closely. Do not stop taking this medication abruptly without consulting your doctor, as this may increase your risk of side effects. If you need to stop taking this medication, your doctor will advise you on how to taper off slowly.
Daily Dosage
If you take this medication once a day, take it in the morning when you wake up, unless your doctor instructs you otherwise. Swallow the medication whole; do not chew, break, or crush it. However, some products may be broken in half; consult with your doctor to confirm.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding the bathroom. Keep all medications in a safe location, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist. If you have questions about disposing of your medication, consult with your pharmacist, who may be aware of drug take-back programs in your area.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
To get the most benefit from your medication, it's essential to follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions closely. Do not stop taking this medication abruptly without consulting your doctor, as this may increase your risk of side effects. If you need to stop taking this medication, your doctor will advise you on how to taper off slowly.
Daily Dosage
If you take this medication once a day, take it in the morning when you wake up, unless your doctor instructs you otherwise. Swallow the medication whole; do not chew, break, or crush it. However, some products may be broken in half; consult with your doctor to confirm.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding the bathroom. Keep all medications in a safe location, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist. If you have questions about disposing of your medication, consult with your pharmacist, who may be aware of drug take-back programs in your area.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Take the tablet whole; do not crush, chew, or break it.
- Take the medication at the same time each morning, typically upon waking.
- Maintain a nitrate-free interval (e.g., 14 hours) to prevent tolerance. This is usually achieved by taking the dose in the morning and not taking another dose until the next morning.
- Avoid or limit alcohol consumption, as it can increase the risk of dizziness and fainting.
- Stand up slowly from a sitting or lying position to prevent dizziness or lightheadedness.
- Do not stop taking this medication suddenly without consulting your doctor, as it may worsen your angina.
- Inform your doctor or pharmacist about all other medications you are taking, especially erectile dysfunction drugs (e.g., Viagra, Cialis) or medications for pulmonary hypertension (e.g., Adempas), as these can cause dangerous drops in blood pressure.
Available Forms & Alternatives
Available Strengths:
- Isosorbide Dinitrate 30mg Oral Tabs
- Isosorbide Dinitrate 5mg Oral Tabs
- Isosorbide Dinitrate 20mg Tablets
- Isosorbide Dinitrate 10mg Oral Tabs
- Isosorbide Mononitrate 10mg Tabs
- Isosorbide Mononitrate 120mg ER Tab
- Isosorbide Mononitrate 30mg ER Tabs
- Isosorbide Mononitrate 60mg ER Tabs
- Isosorbide Mononitrate 60mg ER Tabs
- Isosorbide Dinitrate 40mg Tablets
- Isosorbide Mononitrate 30mg ER Tabs
- Isosorbide Mononitrate 120mg ER Tab
- Isosorbide Mononitrate 20mg Tabs
- Isosorbide Mononitrate 20mg Tabs
- Isosorbide Mononitrate 10mg Tabs
Dosing & Administration
Adult Dosing
Standard Dose:
60 mg orally once daily in the morning
Dose Range:
30 - 120 mg
Condition-Specific Dosing:
anginaProphylaxis:
30 mg or 60 mg orally once daily in the morning; may be titrated up to 120 mg once daily. A nitrate-free interval of 14 hours is recommended to prevent tolerance.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended
Moderate:
No specific adjustment recommended
Severe:
Use with caution; consider lower starting dose and careful monitoring due to potential for accumulation of active metabolites. No specific dose adjustment guidelines available.
Dialysis:
Not significantly dialyzable. Use with caution; monitor for adverse effects.
Hepatic Impairment:
Mild:
No specific adjustment recommended
Moderate:
No specific adjustment recommended
Severe:
Use with caution; consider lower starting dose and careful monitoring due to potential for altered metabolism. No specific dose adjustment guidelines available.
Pharmacology
Mechanism of Action
Isosorbide mononitrate is an organic nitrate that acts as a vasodilator. It is metabolized to nitric oxide (NO), which activates guanylate cyclase, resulting in an increase in cyclic guanosine monophosphate (cGMP) in smooth muscle. This leads to dephosphorylation of myosin light chains, causing relaxation of vascular smooth muscle. The primary effect is venodilation, which reduces preload and myocardial oxygen demand. It also causes arterial dilation, reducing afterload and improving coronary blood flow.
Pharmacokinetics
Absorption:
Bioavailability:
90-100%
Tmax:
3-4 hours (extended-release)
FoodEffect:
Food does not significantly affect the bioavailability or absorption of isosorbide mononitrate extended-release tablets.
Distribution:
Vd:
0.6 L/kg
ProteinBinding:
<5%
CnssPenetration:
Limited
Elimination:
HalfLife:
5 hours
Clearance:
Not available
ExcretionRoute:
Renal (primarily as inactive metabolites)
Unchanged:
<2% (renal)
Pharmacodynamics
OnsetOfAction:
Within 1 hour
PeakEffect:
3-9 hours
DurationOfAction:
Up to 12 hours (with once-daily dosing due to sustained release and nitrate-free interval)
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help right away:
- Signs of an allergic reaction, such as rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
- Severe dizziness or fainting
- Fast or slow heartbeat
- New or worsening chest pain
Other Possible Side Effects
Like all medications, this drug can cause side effects, although many people experience none or only mild effects. If you are bothered by any of the following side effects or if they do not go away, contact your doctor for advice:
- Dizziness
- Headaches, especially when first starting the medication (these often improve over time; do not adjust your dosage without consulting your doctor, and discuss ways to manage this side effect with your doctor)
Important Note
This list does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help right away:
- Signs of an allergic reaction, such as rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
- Severe dizziness or fainting
- Fast or slow heartbeat
- New or worsening chest pain
Other Possible Side Effects
Like all medications, this drug can cause side effects, although many people experience none or only mild effects. If you are bothered by any of the following side effects or if they do not go away, contact your doctor for advice:
- Dizziness
- Headaches, especially when first starting the medication (these often improve over time; do not adjust your dosage without consulting your doctor, and discuss ways to manage this side effect with your doctor)
Important Note
This list does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe or persistent headache (common, but report if debilitating)
- Severe dizziness or lightheadedness
- Fainting (syncope)
- Blurred vision
- Unusual weakness
- Chest pain that worsens or does not improve
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you have a history of heart failure, which means your heart is not pumping blood as well as it should.
If you have recently had a heart attack.
If you are currently taking any of the following medications: Avanafil, riociguat, sildenafil, tadalafil, or vardenafil.
Please note that this is not an exhaustive list of all potential interactions. To ensure your safety, it is crucial to discuss all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. Additionally, inform them about any health problems you have. Before starting, stopping, or changing the dose of any medication, always consult with your doctor to confirm that it is safe to do so in conjunction with this medication.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you have a history of heart failure, which means your heart is not pumping blood as well as it should.
If you have recently had a heart attack.
If you are currently taking any of the following medications: Avanafil, riociguat, sildenafil, tadalafil, or vardenafil.
Please note that this is not an exhaustive list of all potential interactions. To ensure your safety, it is crucial to discuss all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. Additionally, inform them about any health problems you have. Before starting, stopping, or changing the dose of any medication, always consult with your doctor to confirm that it is safe to do so in conjunction with this medication.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
When starting this medication, be cautious when driving or performing tasks that require alertness, as it may affect your ability to stay alert. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying position, and be careful when climbing stairs.
Follow your healthcare provider's instructions for monitoring your blood pressure. Additionally, be aware that this medication may interfere with certain laboratory tests, so it is crucial to notify all your healthcare providers and laboratory personnel that you are taking this drug.
Before consuming alcohol, consult with your doctor to discuss any potential risks. If you experience new or worsening chest pain or pressure, seek emergency medical attention immediately.
Long-term use of this medication without interruption can lead to reduced effectiveness, a phenomenon known as tolerance. To avoid this, your doctor may recommend a daily "nitrate-free" period. If you find that the medication is no longer working as well as it should, consult with your doctor. Do not exceed the prescribed dosage.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
You may notice the appearance of a tablet-like substance in your stool, but this is a normal occurrence and not a cause for concern. However, if you have any questions or concerns, discuss them with your doctor.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor, as they will need to discuss the potential benefits and risks of this medication to both you and your baby.
When starting this medication, be cautious when driving or performing tasks that require alertness, as it may affect your ability to stay alert. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying position, and be careful when climbing stairs.
Follow your healthcare provider's instructions for monitoring your blood pressure. Additionally, be aware that this medication may interfere with certain laboratory tests, so it is crucial to notify all your healthcare providers and laboratory personnel that you are taking this drug.
Before consuming alcohol, consult with your doctor to discuss any potential risks. If you experience new or worsening chest pain or pressure, seek emergency medical attention immediately.
Long-term use of this medication without interruption can lead to reduced effectiveness, a phenomenon known as tolerance. To avoid this, your doctor may recommend a daily "nitrate-free" period. If you find that the medication is no longer working as well as it should, consult with your doctor. Do not exceed the prescribed dosage.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
You may notice the appearance of a tablet-like substance in your stool, but this is a normal occurrence and not a cause for concern. However, if you have any questions or concerns, discuss them with your doctor.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor, as they will need to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Severe throbbing headache
- Persistent dizziness or lightheadedness
- Flushing
- Nausea and vomiting
- Diaphoresis (sweating)
- Cold, clammy skin
- Visual disturbances
- Syncope (fainting)
- Palpitations
- Hypotension (very low blood pressure)
- Methemoglobinemia (rare, but serious, characterized by cyanosis, dyspnea, confusion)
What to Do:
Seek immediate medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222. Management typically involves supportive care, including maintaining blood pressure (e.g., with IV fluids, Trendelenburg position), and in severe cases of methemoglobinemia, methylene blue may be administered.
Drug Interactions
Contraindicated Interactions
- Phosphodiesterase-5 (PDE5) inhibitors (e.g., sildenafil, tadalafil, vardenafil, avanafil) - concurrent use can cause profound and prolonged hypotension.
- Riociguat (soluble guanylate cyclase stimulator) - concurrent use can cause profound hypotension.
Major Interactions
- Other vasodilators (e.g., alpha-blockers, calcium channel blockers, antihypertensives) - increased risk of hypotension.
- Alcohol - may enhance hypotensive effects.
Moderate Interactions
- Ergot alkaloids (e.g., ergotamine, dihydroergotamine) - nitrates may antagonize the vasoconstrictive effects of ergot alkaloids.
- Sapropterin - theoretical increased risk of hypotension.
Minor Interactions
- Aspirin - may increase isosorbide mononitrate levels (minor effect).
Monitoring
Baseline Monitoring
Blood Pressure (BP)
Rationale: To establish baseline and assess risk of hypotension.
Timing: Prior to initiation of therapy.
Heart Rate (HR)
Rationale: To establish baseline and assess for reflex tachycardia.
Timing: Prior to initiation of therapy.
Routine Monitoring
Blood Pressure (BP)
Frequency: Regularly, especially during dose titration and if symptoms of hypotension occur.
Target: Maintain within patient's normal range, avoiding symptomatic hypotension.
Action Threshold: Symptomatic hypotension (e.g., dizziness, lightheadedness, syncope) or significant drop from baseline.
Heart Rate (HR)
Frequency: Regularly, especially during dose titration.
Target: Maintain within patient's normal range.
Action Threshold: Significant reflex tachycardia or bradycardia.
Angina Symptoms
Frequency: Ongoing assessment
Target: Reduction in frequency, severity, and duration of angina episodes.
Action Threshold: Worsening or no improvement in angina symptoms, indicating inadequate control or development of tolerance.
Symptom Monitoring
- Headache (common, often resolves with continued use)
- Dizziness
- Lightheadedness
- Flushing
- Nausea
- Weakness
- Blurred vision
- Syncope (fainting)
Special Patient Groups
Pregnancy
Category B. Animal reproduction studies have shown no evidence of impaired fertility or harm to the fetus. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if clearly needed.
Trimester-Specific Risks:
First Trimester:
No increased risk of congenital anomalies observed in animal studies.
Second Trimester:
No specific risks identified beyond general pregnancy considerations.
Third Trimester:
No specific risks identified beyond general pregnancy considerations.
Lactation
It is not known whether isosorbide mononitrate is excreted in human milk. Caution should be exercised when administered to a nursing woman. The benefits of breastfeeding should be weighed against the potential risks to the infant.
Infant Risk:
L3 (Moderate risk) - Monitor infant for signs of hypotension, poor feeding, or other adverse effects. Consider alternative if concerns arise.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Not recommended for routine use in children.
Geriatric Use
Elderly patients may be more susceptible to the hypotensive effects of nitrates. Start with the lowest effective dose and titrate slowly. Monitor blood pressure closely.
Clinical Information
Clinical Pearls
- Isosorbide mononitrate ER is for prophylaxis of angina, not for acute angina attacks. Patients should have sublingual nitroglycerin for acute relief.
- A daily nitrate-free interval (typically 14 hours) is crucial to prevent the development of nitrate tolerance. This is why the ER formulation is dosed once daily in the morning.
- Headache is a very common side effect, especially at the beginning of therapy. It often diminishes with continued use and can be managed with mild analgesics (e.g., acetaminophen). It indicates the drug is working.
- Counsel patients on the absolute contraindication with PDE5 inhibitors (e.g., sildenafil, tadalafil) due to the risk of profound and life-threatening hypotension.
- Patients should be advised to stand up slowly to avoid orthostatic hypotension.
Alternative Therapies
- Beta-blockers (e.g., metoprolol, atenolol)
- Calcium channel blockers (e.g., amlodipine, diltiazem, verapamil)
- Ranolazine
- Long-acting nitrates (e.g., isosorbide dinitrate, nitroglycerin transdermal patch - with appropriate nitrate-free interval)
Cost & Coverage
Average Cost:
$15 - $50 per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (preferred generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to ensure you receive the best possible care.