Isosorbide Mononitrate 30mg 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
Organic Nitrate; Vasodilator
Pregnancy Category
Category B
FDA Approved
Aug 1991
DEA Schedule
Not Controlled
Overview
What is this medicine?
Isosorbide mononitrate extended-release tablets are used to prevent chest pain (angina) caused by heart disease. It works by relaxing blood vessels, which helps more blood and oxygen reach your heart. This medicine is not for treating sudden chest pain attacks.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, it's essential to take it exactly as directed by your doctor. Carefully read all the information provided with your prescription, and follow the instructions closely. If you need to stop taking this medication, do not stop suddenly without consulting your doctor, as this may increase your risk of side effects. Instead, your doctor will advise you on how to gradually stop taking the medication.
When taking this medication once daily, take it in the morning after waking up, unless your doctor instructs you otherwise. Swallow the tablet whole; do not chew, break, or crush it. However, some products may be broken in half - consult with your doctor to determine if this is an option for you.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication, store it at room temperature in a dry place, avoiding bathrooms. Keep all medications in a secure 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 the best way to dispose of your medication, consult with your pharmacist, who can also inform you about potential drug take-back programs in your area.
What to Do If You Miss 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 scheduled dose, skip the missed dose and resume your regular dosing 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 take it exactly as directed by your doctor. Carefully read all the information provided with your prescription, and follow the instructions closely. If you need to stop taking this medication, do not stop suddenly without consulting your doctor, as this may increase your risk of side effects. Instead, your doctor will advise you on how to gradually stop taking the medication.
When taking this medication once daily, take it in the morning after waking up, unless your doctor instructs you otherwise. Swallow the tablet whole; do not chew, break, or crush it. However, some products may be broken in half - consult with your doctor to determine if this is an option for you.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication, store it at room temperature in a dry place, avoiding bathrooms. Keep all medications in a secure 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 the best way to dispose of your medication, consult with your pharmacist, who can also inform you about potential drug take-back programs in your area.
What to Do If You Miss 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 scheduled dose, skip the missed dose and resume your regular dosing 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 it at the same time each morning, usually upon waking, to allow for a nitrate-free interval.
- Avoid sudden changes in position (e.g., standing up quickly) to prevent dizziness or fainting.
- Limit or avoid alcohol consumption, as it can increase dizziness and lower blood pressure.
- Inform your doctor about all medications you are taking, especially erectile dysfunction drugs (e.g., Viagra, Cialis) as they can cause dangerously low blood pressure when taken with this medicine.
- Report persistent headaches, which are common initially but may lessen over time. Do not stop taking the medication without consulting your doctor.
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:
30 mg orally once daily in the morning
Dose Range:
30 - 120 mg
Condition-Specific Dosing:
angina_prophylaxis:
Initial: 30 mg once daily; Titrate up to 60 mg or 120 mg once daily as needed, with a nitrate-free interval to prevent tolerance.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed, but use with caution due to potential for accumulation of active metabolites in end-stage renal disease.
Dialysis:
Not significantly removed by dialysis; no specific dose adjustment recommended, but monitor for adverse effects.
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed, but use with caution due to extensive hepatic metabolism.
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, leading to an increase in cyclic guanosine monophosphate (cGMP) in smooth muscle cells. This results in 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 (for ER formulation)
FoodEffect:
Food does not significantly affect the bioavailability of isosorbide mononitrate ER.
Distribution:
Vd:
0.6 L/kg
ProteinBinding:
<5%
CnssPenetration:
Limited
Elimination:
HalfLife:
5 hours
Clearance:
Not available
ExcretionRoute:
Renal (primarily as glucuronide conjugates)
Unchanged:
<2% (in urine)
Pharmacodynamics
OnsetOfAction:
Within 1 hour
PeakEffect:
3-9 hours
DurationOfAction:
Up to 12 hours (for ER formulation, allowing for a nitrate-free interval)
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Attention Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience 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
+ Swelling of the mouth, face, lips, tongue, or throat
Severe dizziness or fainting
Abnormal heartbeat (fast or slow)
New or worsening chest pain
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor:
Dizziness
Headaches (common when starting the medication, but often improves over time; do not adjust your dosage without consulting your doctor)
If you have questions or concerns about side effects, consult your doctor for medical advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience 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
+ Swelling of the mouth, face, lips, tongue, or throat
Severe dizziness or fainting
Abnormal heartbeat (fast or slow)
New or worsening chest pain
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor:
Dizziness
Headaches (common when starting the medication, but often improves over time; do not adjust your dosage without consulting your doctor)
If you have questions or concerns about side effects, consult your doctor for medical advice. 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 dizziness or lightheadedness
- Fainting
- Blurred vision
- Unusual sweating
- Pale skin
- Bluish lips or fingernails (signs of methemoglobinemia, rare but serious)
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 allergic reaction you experienced, including any symptoms that occurred.
A history of heart failure, also known as a weak heart.
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 with this medication. To ensure your safety, it is crucial to disclose all of your:
Prescription and over-the-counter (OTC) medications
Natural products
Vitamins
Health problems
Your doctor and pharmacist need this information to determine whether it is safe for you to take this medication in conjunction with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting 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 allergic reaction you experienced, including any symptoms that occurred.
A history of heart failure, also known as a weak heart.
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 with this medication. To ensure your safety, it is crucial to disclose all of your:
Prescription and over-the-counter (OTC) medications
Natural products
Vitamins
Health problems
Your doctor and pharmacist need this information to determine whether it is safe for you to take this medication in conjunction with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
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 your full attention, as it may affect your alertness. 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, uninterrupted use of this medication may 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 weigh the benefits and risks of this medication for both you and your baby.
When starting this medication, be cautious when driving or performing tasks that require your full attention, as it may affect your alertness. 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, uninterrupted use of this medication may 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 weigh the benefits and risks of this medication for both you and your baby.
Overdose Information
Overdose Symptoms:
- Severe hypotension (very low blood pressure)
- Persistent throbbing headache
- Palpitations
- Flushing
- Dizziness
- Nausea and vomiting
- Diaphoresis (excessive sweating)
- Syncope (fainting)
- Methemoglobinemia (rare, but can cause cyanosis, dyspnea, confusion, seizures, coma)
What to Do:
Seek immediate medical attention. Call 911 or your local emergency number. For suspected poisoning, call a poison control center at 1-800-222-1222.
Drug Interactions
Contraindicated Interactions
- Phosphodiesterase-5 (PDE5) inhibitors (e.g., sildenafil, tadalafil, vardenafil, avanafil) - severe hypotension and cardiovascular collapse.
- Riociguat (soluble guanylate cyclase stimulator) - severe hypotension.
Major Interactions
- Other vasodilators (e.g., alpha-blockers, calcium channel blockers, other nitrates) - additive hypotensive effects.
- Alcohol - enhanced hypotensive effects.
Moderate Interactions
- Antihypertensives (e.g., ACE inhibitors, ARBs, diuretics) - additive hypotensive effects.
- Tricyclic antidepressants - may reduce hypotensive effect of nitrates.
Minor Interactions
- Aspirin - may increase nitrate levels (minor clinical significance).
Monitoring
Baseline Monitoring
Blood Pressure (BP)
Rationale: To establish baseline and assess for hypotension risk.
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, 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.
Angina Symptoms
Frequency: Continuously
Target: Reduction in frequency and severity of angina episodes.
Action Threshold: Persistent or worsening angina, indicating inadequate control or development of tolerance.
Symptom Monitoring
- Headache (common, often transient)
- Dizziness/Lightheadedness
- Nausea
- Flushing
- Hypotension (especially orthostatic)
- Syncope
Special Patient Groups
Pregnancy
Category B. Animal studies have not shown harm to the fetus, but there are no adequate and well-controlled studies in pregnant women. Use only if clearly needed.
Trimester-Specific Risks:
First Trimester:
No increased risk of congenital anomalies suggested by animal data.
Second Trimester:
No specific risks identified.
Third Trimester:
No specific risks identified.
Lactation
L3 (Moderately Safe). It is not known if isosorbide mononitrate is excreted in human milk. Caution should be exercised when administered to a nursing mother. Monitor infant for hypotension or methemoglobinemia.
Infant Risk:
Low to moderate risk; monitor for adverse effects.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Not recommended for use in children.
Geriatric Use
Elderly patients may be more susceptible to the hypotensive effects of nitrates. Start with lower doses and titrate carefully, monitoring for dizziness and falls.
Clinical Information
Clinical Pearls
- Isosorbide mononitrate ER is for prophylaxis of angina, not for acute angina attacks.
- A daily nitrate-free interval (typically 14-18 hours) is crucial to prevent the development of nitrate tolerance.
- 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.
- Patients should be advised to avoid PDE5 inhibitors (e.g., sildenafil) due to the risk of severe, life-threatening hypotension.
- Orthostatic hypotension is a risk; advise patients to rise slowly from a sitting or lying position.
Alternative Therapies
- Beta-blockers (e.g., metoprolol, atenolol)
- Calcium channel blockers (e.g., amlodipine, diltiazem, verapamil)
- Ranolazine
- Nitroglycerin (sublingual for acute attacks, transdermal patch or oral for prophylaxis)
Cost & Coverage
Average Cost:
$10 - $50 per 30 tablets (generic 30mg ER)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generic)
General Drug Facts
If your symptoms or health condition do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication. Some medications may come with additional patient information leaflets, so it is a good idea to consult with your pharmacist to see if this applies to your prescription. If you have any questions or concerns about your medication, do not hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider for clarification and guidance. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the name of the medication taken, the amount consumed, and the time it occurred.