Isosorbide Dinitrate 10mg Oral Tabs

Manufacturer WEST-WARD Active Ingredient Isosorbide Dinitrate Tablets(eye soe SOR bide dye NYE trate) Pronunciation EYE-soe-SOR-bide DYE-NYE-trate
It is used to prevent chest pain (angina pectoris) in people with heart disease.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Antianginal; Vasodilator
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Pharmacologic Class
Organic Nitrate
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Pregnancy Category
C
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FDA Approved
Jan 1951
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Isosorbide dinitrate 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 follow the instructions precisely. 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 this 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

To maintain the quality and safety of your medication, store it at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom. Keep the container tightly closed, and store all medications in a secure location out of the reach of children and pets.

Missing a Dose

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. Do not take two doses at the same time or take extra doses to make up for a missed dose.
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Lifestyle & Tips

  • Avoid sudden changes in position (e.g., standing up quickly) to prevent dizziness or fainting.
  • 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.
  • Maintain a nitrate-free interval as instructed by your doctor (e.g., 10-14 hours daily) to prevent tolerance.
  • Store medication in a cool, dry place away from light and moisture.

Dosing & Administration

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Adult Dosing

Standard Dose: 10-20 mg orally 2-3 times daily
Dose Range: 5 - 40 mg

Condition-Specific Dosing:

anginaProphylaxis: Initially 5-20 mg orally 2-3 times daily; titrate up to 10-40 mg orally 2-3 times daily. Doses should be given with an 18-hour nitrate-free interval to prevent tolerance (e.g., 7 AM, 12 PM, 5 PM).
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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, use with caution
Severe: No specific adjustment recommended, use with caution due to potential accumulation of active metabolites
Dialysis: Not well studied, use with caution

Hepatic Impairment:

Mild: No specific adjustment recommended
Moderate: No specific adjustment recommended, use with caution
Severe: No specific adjustment recommended, use with caution due to extensive hepatic metabolism

Pharmacology

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Mechanism of Action

Isosorbide dinitrate 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 (venous return to the heart), thereby decreasing myocardial oxygen demand. It also causes arterial dilation, reducing afterload and improving coronary blood flow, especially in epicardial arteries.
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Pharmacokinetics

Absorption:

Bioavailability: 20-25% (highly variable due to significant first-pass metabolism)
Tmax: 1 hour (oral tablet)
FoodEffect: Food may delay absorption but does not significantly affect the extent of absorption.

Distribution:

Vd: Not available
ProteinBinding: Not available
CnssPenetration: Limited

Elimination:

HalfLife: 1 hour (parent drug); 2-5 hours (isosorbide-2-mononitrate); 5 hours (isosorbide-5-mononitrate)
Clearance: Not available
ExcretionRoute: Renal (primarily as glucuronide conjugates of metabolites)
Unchanged: <1%
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Pharmacodynamics

OnsetOfAction: 20-60 minutes (oral tablet)
PeakEffect: 1-2 hours (oral tablet)
DurationOfAction: 4-6 hours (oral tablet)

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Attention Immediately

Although rare, some people may experience severe and potentially life-threatening side effects while 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
+ Swelling of the mouth, face, lips, tongue, or throat
Severe dizziness or fainting
Abnormal heartbeat (fast or slow)

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 persist, contact your doctor for guidance:

Headaches: You may experience headaches when starting this medication, but they often improve over time. Do not adjust your dosage without consulting your doctor. Instead, discuss ways to manage this side effect with your doctor.

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, contact your doctor for 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 debilitating)
  • Dizziness or lightheadedness that does not improve
  • Fainting spells (syncope)
  • Blurred vision
  • Unusual weakness or fatigue
  • Signs of very low blood pressure (e.g., extreme dizziness, confusion, cold clammy skin)
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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 symptoms you experienced.
Certain health conditions, including:
+ Heart failure (weak heart)
+ Recent heart attack
If you are currently taking any of the following medications:
+ Avanafil
+ Riociguat
+ Sildenafil
+ Tadalafil
+ 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:

Prescription and over-the-counter (OTC) medications
Natural products
Vitamins
* Health problems

with your doctor and pharmacist. They will help you determine whether it is safe to take this medication in combination with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
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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. If you are using this drug to manage chest pain, be aware that it will not provide immediate relief during an attack. Instead, it is designed to help prevent or reduce the frequency of chest pain episodes. If you experience new or worsening chest pain or pressure, seek emergency medical attention immediately.

To ensure your safety, avoid driving and other activities that require alertness until you understand how this medication affects you. To minimize the risk of dizziness or fainting, stand up slowly after sitting or lying down, and exercise caution when navigating stairs. Monitor your blood pressure and heart rate as directed by your doctor.

Before consuming alcohol, discuss the potential risks and benefits with your doctor. 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 notice that the medication is no longer working as well as it should, consult your doctor; do not exceed the prescribed dosage.

If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor to discuss the potential benefits and risks to both you and your baby. This will enable you to make an informed decision about your treatment.
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Overdose Information

Overdose Symptoms:

  • Severe hypotension (low blood pressure)
  • Persistent throbbing headache
  • Palpitations
  • Flushing
  • Dizziness
  • Nausea and vomiting
  • Diaphoresis (sweating)
  • Vertigo
  • Syncope (fainting)
  • Visual disturbances
  • Methemoglobinemia (rare, but serious, characterized by cyanosis, dyspnea, fatigue, confusion)

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is supportive, including elevation of legs, IV fluids, and vasopressors if needed. For methemoglobinemia, methylene blue may be administered.

Drug Interactions

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Contraindicated Interactions

  • Phosphodiesterase-5 (PDE5) inhibitors (e.g., sildenafil, tadalafil, vardenafil, avanafil) - concurrent use can cause severe hypotension and cardiovascular collapse.
  • Riociguat (soluble guanylate cyclase stimulator) - concurrent use can cause severe hypotension.
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Major Interactions

  • Alcohol - may enhance hypotensive effects.
  • Antihypertensives (e.g., beta-blockers, calcium channel blockers, ACE inhibitors, diuretics) - additive hypotensive effects.
  • Ergot alkaloids (e.g., ergotamine) - nitrates may reduce the anti-migraine effect of ergot alkaloids and may cause severe vasoconstriction.
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Moderate Interactions

  • Aspirin - may increase isosorbide dinitrate levels and enhance its effects.
  • Dihydroergotamine - risk of severe hypotension.

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 range, avoiding symptomatic hypotension.

Action Threshold: If systolic BP <90 mmHg or symptomatic hypotension occurs, consider dose reduction or discontinuation.

Heart Rate (HR)

Frequency: Regularly, especially during dose titration.

Target: Maintain within patient's normal range.

Action Threshold: Significant reflex tachycardia (e.g., >100 bpm or symptomatic) may require intervention.

Angina Symptoms (frequency, severity, nitroglycerin use)

Frequency: Ongoing assessment at each visit.

Target: Reduction in angina episodes and nitroglycerin use.

Action Threshold: Persistent or worsening angina may indicate inadequate dosing or need for alternative therapy.

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Symptom Monitoring

  • Headache (common, often transient)
  • Dizziness/Lightheadedness (especially upon standing)
  • Flushing
  • Nausea/Vomiting
  • Weakness
  • Blurred vision
  • Syncope

Special Patient Groups

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Pregnancy

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

Trimester-Specific Risks:

First Trimester: Potential for fetal harm based on animal data, but human data limited.
Second Trimester: Limited human data, consider risk vs. benefit.
Third Trimester: Limited human data, consider risk vs. benefit. Risk of hypotension in mother could affect placental perfusion.
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Lactation

L3 (Moderately Safe). It is not known whether isosorbide dinitrate or its metabolites are excreted in human milk. Use with caution. Monitor infant for signs of hypotension or methemoglobinemia.

Infant Risk: Low to moderate. Potential for hypotension or methemoglobinemia in the infant, especially with high maternal doses or in premature infants. Monitor for adverse effects.
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Pediatric Use

Safety and efficacy have not been established in pediatric patients. Use is generally not recommended.

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Geriatric Use

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

Clinical Information

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Clinical Pearls

  • To prevent nitrate tolerance, an 18-hour nitrate-free interval is crucial. This often means taking the last dose of the day earlier (e.g., 5 PM) and skipping a nighttime dose.
  • Headache is a very common side effect, especially at the beginning of therapy. It often diminishes with continued use. Patients can be advised to take an analgesic (e.g., acetaminophen) for headache.
  • Educate patients about the importance of avoiding PDE5 inhibitors (e.g., Viagra, Cialis) due to the risk of severe, life-threatening hypotension.
  • Isosorbide dinitrate is for prophylaxis of angina, not for acute angina attacks (sublingual nitroglycerin is preferred for acute relief).
  • Patients should be advised to sit or lie down if they experience dizziness or lightheadedness.
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Alternative Therapies

  • Other organic nitrates (e.g., isosorbide mononitrate, nitroglycerin)
  • Beta-blockers (e.g., metoprolol, carvedilol)
  • Calcium channel blockers (e.g., amlodipine, diltiazem, verapamil)
  • Ranolazine
  • Ivabradine (for specific indications)
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Cost & Coverage

Average Cost: $10 - $50 per 30 tablets (generic 10mg)
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'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 details. 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 information about the medication taken, the amount, and the time it happened.