Isosorbide Mononitrate 10mg Tabs

Manufacturer OMNIVIUM PHARMACEUTICALS Active Ingredient Isosorbide Mononitrate Tablets(eye soe SOR bide mon oh NYE trate) Pronunciation eye-soe-SOR-bide MON-oh-NYE-trate
It is used to prevent or treat 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.
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Drug Class
Antianginal
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Pharmacologic Class
Organic Nitrate; Vasodilator
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Pregnancy Category
C
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FDA Approved
Mar 1991
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Isosorbide mononitrate 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.
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How to Use This Medicine

Taking Your Medication Correctly

To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided with your prescription, and adhere to the dosage 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 discontinue the medication, your doctor will advise you on how to gradually taper off the dosage to minimize potential side effects.

Storing and Disposing of Your Medication

Store your medication at room temperature in a dry location, avoiding storage in a bathroom. Keep all medications in a secure place, 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 or healthcare provider. If you have questions about the proper disposal of your medication, consult your pharmacist, who can also inform you about potential drug take-back programs in your area.

Managing Missed Doses

If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Avoid taking two doses at the same time or taking extra doses, as this can increase the risk of side effects.
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Lifestyle & Tips

  • Take the medication exactly as prescribed, usually twice a day with a nitrate-free interval (e.g., 7 hours between doses for immediate-release).
  • Do not crush, chew, or break extended-release tablets.
  • Avoid sudden changes in position (e.g., standing up quickly) to prevent dizziness or lightheadedness.
  • Avoid alcohol consumption, as it can increase the risk of low blood pressure.
  • Do not stop taking this medication suddenly without consulting your doctor, as it can worsen angina.
  • This medication is for preventing angina, not for treating an acute angina attack. For acute attacks, use sublingual nitroglycerin as prescribed.

Dosing & Administration

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Adult Dosing

Standard Dose: Immediate-release: 20 mg twice daily, with the two doses given 7 hours apart (e.g., 8 AM and 3 PM) to allow for a nitrate-free interval. For 10mg tabs, initial dose may be 10 mg twice daily.
Dose Range: 10 - 40 mg

Condition-Specific Dosing:

anginaProphylaxis: Immediate-release: Initially 5-10 mg twice daily, increasing to 20 mg twice daily. Extended-release: 30-120 mg once daily.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment recommended
Moderate: No specific adjustment recommended
Severe: Use with caution; monitor for exaggerated effects. Dose reduction may be considered.
Dialysis: Not specifically studied; use with caution.

Hepatic Impairment:

Mild: No specific adjustment recommended
Moderate: No specific adjustment recommended
Severe: Use with caution; monitor for exaggerated effects. Dose reduction may be considered.
Confidence: Medium

Pharmacology

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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, increasing intracellular cyclic guanosine monophosphate (cGMP). This leads to dephosphorylation of myosin light chains, resulting in 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.
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Pharmacokinetics

Absorption:

Bioavailability: Nearly 100%
Tmax: 30-60 minutes (immediate-release)
FoodEffect: Food does not significantly affect absorption.

Distribution:

Vd: 0.6 L/kg
ProteinBinding: Less than 5%
CnssPenetration: Limited

Elimination:

HalfLife: Approximately 5 hours
Clearance: Not available
ExcretionRoute: Renal (primarily as glucuronide conjugates and denitrated metabolites)
Unchanged: Less than 2%
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Pharmacodynamics

OnsetOfAction: 20-60 minutes
PeakEffect: 1-4 hours
DurationOfAction: Up to 8-10 hours (immediate-release, with nitrate-free interval)
Confidence: High

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

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 immediate medical attention:

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. Although many people do not experience any side effects or only have mild ones, it is essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other 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)
* Other side effects not listed here

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.
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Seek Immediate Medical Attention If You Experience:

  • Severe or persistent headache (common, but report if intolerable)
  • Dizziness, lightheadedness, or fainting
  • Blurred vision
  • Unusual weakness or fatigue
  • Rash or itching
  • Swelling of the face, lips, tongue, or throat (signs of allergic reaction)
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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 and its symptoms.
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 experienced 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. This includes any health problems you may 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.
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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, avoid driving and other activities that require alertness until you understand how it affects you. To minimize the risk of dizziness or fainting, stand up slowly after sitting or lying down, and exercise caution 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. If you experience new or worsening chest pain or pressure, seek immediate emergency medical attention.

Long-term, uninterrupted use of this medication can lead to reduced effectiveness, a phenomenon known as tolerance. To avoid this, ensure you have a daily "nitrate-free" period. If you notice the medication is not working as well as it previously did, discuss this 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.

If you are pregnant, planning to become pregnant, or breastfeeding, consult your doctor to discuss the potential benefits and risks to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Severe throbbing headache
  • Profound hypotension (very low blood pressure)
  • Palpitations
  • Flushing
  • Perspiration
  • Nausea and vomiting
  • Dizziness and vertigo
  • Syncope (fainting)
  • Tachycardia (fast heart rate)
  • Methemoglobinemia (rare, but serious, causing bluish skin, shortness of breath, fatigue)

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Management may include elevating legs, administering IV fluids, and in severe cases of methemoglobinemia, methylene blue.

Drug Interactions

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Contraindicated Interactions

  • Phosphodiesterase-5 (PDE5) inhibitors (e.g., sildenafil, tadalafil, vardenafil, avanafil) - concurrent use can cause profound and prolonged hypotension.
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Major Interactions

  • Riociguat (soluble guanylate cyclase stimulator) - concurrent use can cause severe hypotension.
  • Other vasodilators (e.g., alpha-blockers, calcium channel blockers, other antihypertensives) - may potentiate hypotensive effects.
  • Alcohol - may potentiate hypotensive effects.
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Moderate Interactions

  • Ergot alkaloids (e.g., ergotamine) - nitrates may reduce the anti-migraine effect of ergot alkaloids.
  • Sapropterin - may increase hypotensive effects.

Monitoring

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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.

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Routine Monitoring

Blood Pressure (BP)

Frequency: Regularly, especially during dose titration and if symptoms of hypotension occur.

Target: Maintain within patient's normal limits, avoiding symptomatic hypotension.

Action Threshold: Systolic BP < 90 mmHg or symptomatic hypotension (dizziness, syncope).

Heart Rate (HR)

Frequency: Regularly, especially during dose titration.

Target: Maintain within patient's normal limits.

Action Threshold: Significant tachycardia or bradycardia.

Angina Symptoms

Frequency: Ongoing assessment by patient report.

Target: Reduction in frequency, severity, and duration of angina episodes.

Action Threshold: Worsening or uncontrolled angina.

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Symptom Monitoring

  • Headache (common, often transient)
  • Dizziness or lightheadedness (especially upon standing)
  • Flushing
  • Nausea
  • Hypotension symptoms (e.g., blurred vision, weakness, syncope)

Special Patient Groups

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Pregnancy

Pregnancy Category C. Animal studies have shown adverse effects on the fetus, but there are no adequate and well-controlled studies in pregnant women. Use only if the potential benefit justifies the potential risk to the fetus.

Trimester-Specific Risks:

First Trimester: Potential for developmental risk based on animal data; human data lacking.
Second Trimester: Potential for developmental risk based on animal data; human data lacking.
Third Trimester: Potential for developmental risk based on animal data; human data lacking.
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Lactation

It is not known whether isosorbide mononitrate is excreted in human milk. Caution should be exercised when administered to a nursing mother. The decision to breastfeed during therapy should consider the potential for infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.

Infant Risk: Unknown; potential for infant exposure is low due to short half-life, but monitor for adverse effects.
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Pediatric Use

Safety and effectiveness in pediatric patients have not been established. Not recommended for routine use in children.

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Geriatric Use

Elderly patients may be more susceptible to the hypotensive effects of nitrates. Start with lower doses and titrate carefully, monitoring blood pressure closely.

Clinical Information

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Clinical Pearls

  • To prevent nitrate tolerance, immediate-release isosorbide mononitrate should be dosed to allow for a daily nitrate-free interval (e.g., 7 hours between doses).
  • Headache is a very common side effect, especially at the beginning of therapy. It often diminishes with continued use. Patients should be counseled that this indicates the drug is working.
  • This medication is for prophylaxis of angina, not for acute relief. Patients should have sublingual nitroglycerin for acute attacks.
  • Counsel patients on the absolute contraindication with PDE5 inhibitors (e.g., Viagra, Cialis) due to the risk of severe, life-threatening hypotension.
  • Patients should be advised to avoid alcohol due to additive hypotensive effects.
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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 patches)
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Cost & Coverage

Average Cost: Varies widely, typically $10-$50 per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 1 (Generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, 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 an additional patient information leaflet, so it's a good idea 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 for clarification. 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 medication taken, the amount, and the time it occurred.