Isosorbide Dinitrate 30mg Oral Tabs

Manufacturer PAR 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
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Pharmacologic Class
Organic Nitrate
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Pregnancy Category
C
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FDA Approved
Jun 1955
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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 more blood and oxygen reach your 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 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 this medication, your doctor will advise you on how to taper off slowly.

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 lid 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 due to blood pressure drop.
  • Avoid alcohol consumption, as it can increase the blood pressure-lowering effects and cause severe dizziness.
  • Maintain adequate hydration.
  • Adhere strictly to the prescribed dosing schedule, including the nitrate-free interval, to prevent tolerance (when the medication stops working as effectively).
  • 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: 30 mg orally two to three times daily, with a nitrate-free interval of 10-14 hours to prevent tolerance.
Dose Range: 5 - 40 mg

Condition-Specific Dosing:

anginaPectorisProphylaxis: Initial dose typically 5-20 mg two to three times daily, titrated up to 10-40 mg two to three times daily. The 30 mg tablet is suitable for maintenance dosing.
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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: Considerations: Not significantly dialyzable. 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 vascular smooth muscle. This results in dephosphorylation of myosin light chains and subsequent relaxation of smooth muscle cells. 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: 20-30% (due to extensive first-pass metabolism)
Tmax: 1 hour (oral tablet)
FoodEffect: Food may delay absorption but does not significantly alter the extent of absorption.

Distribution:

Vd: 2-4 L/kg
ProteinBinding: <30%
CnssPenetration: Limited

Elimination:

HalfLife: Isosorbide dinitrate: ~1 hour; Isosorbide-5-mononitrate: ~5 hours; Isosorbide-2-mononitrate: ~2 hours
Clearance: High systemic clearance
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)
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 heart rhythms, including fast or slow heartbeat

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'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 for guidance:

Headaches, which may occur when you start taking this medication. In most cases, these headaches improve over time. Do not adjust your dosage or stop taking the medication without consulting your doctor. Instead, talk to your doctor about ways to manage this side effect.

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)
  • Excessive dizziness or lightheadedness
  • Fainting spells (syncope)
  • Blurred vision
  • Unusual weakness or fatigue
  • Worsening chest pain or new chest pain (paradoxical effect or tolerance)
  • Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
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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 you experienced, including any symptoms that occurred.
Certain health conditions, including:
+ Heart failure (a weakened heart)
+ A recent heart attack
If you are currently taking any of the following medications:
+ Avanafil
+ Riociguat
+ Sildenafil
+ Tadalafil
+ Vardenafil

Please note that this list is not exhaustive, and it is crucial to discuss all your medications and health conditions with your doctor.

To ensure your safety, inform your doctor and pharmacist about:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
Your overall health status

It is vital to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change the dosage 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, it is crucial to understand that it will not provide immediate relief during an attack. Instead, this medication 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 are familiar with 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 climbing stairs. Monitor your blood pressure and heart rate as directed by your doctor.

Before consuming alcohol, discuss its potential effects 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 this 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, it is essential to discuss the potential benefits and risks of this medication with your doctor to make an informed decision about its use.
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Overdose Information

Overdose Symptoms:

  • Severe hypotension (very low blood pressure)
  • Reflex tachycardia (very fast heart rate)
  • Flushing
  • Sweating
  • Nausea
  • Vomiting
  • Headache
  • Dizziness
  • Syncope (fainting)
  • Methemoglobinemia (rare, but serious, characterized by bluish skin, lips, and nail beds, shortness of breath, fatigue, confusion)

What to Do:

In case of suspected overdose, seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Management typically involves supportive care, including maintaining blood pressure and treating methemoglobinemia if present.

Drug Interactions

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Contraindicated Interactions

  • Phosphodiesterase-5 (PDE5) inhibitors (e.g., sildenafil, tadalafil, vardenafil) - risk of severe hypotension and cardiovascular collapse.
  • Riociguat (soluble guanylate cyclase stimulator) - risk of severe hypotension.
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Major Interactions

  • Other vasodilators (e.g., alpha-blockers, calcium channel blockers, other antihypertensives) - additive hypotensive effects.
  • Alcohol - may enhance hypotensive effects and cause syncope.
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Moderate Interactions

  • Beta-blockers - may mask reflex tachycardia associated with nitrate-induced hypotension.
  • Tricyclic antidepressants - may enhance hypotensive effects.
  • Phenothiazines - may enhance hypotensive effects.

Monitoring

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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.

Angina Symptom Assessment

Rationale: To establish baseline frequency, severity, and precipitating factors of angina.

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: Individualized, generally within patient's normal range without 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: Individualized.

Action Threshold: Significant reflex tachycardia or bradycardia.

Angina Symptom Diary

Frequency: Daily or as needed to track efficacy.

Target: Reduction in frequency and severity of angina episodes.

Action Threshold: No improvement or worsening of angina symptoms, indicating need for dose adjustment or alternative therapy.

Headache Frequency/Severity

Frequency: As needed, especially during initial therapy.

Target: Tolerable or diminishing over time.

Action Threshold: Severe or persistent headache impacting quality of life.

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Symptom Monitoring

  • Headache (common, often diminishes with continued use)
  • Dizziness
  • Lightheadedness
  • Flushing
  • Orthostatic hypotension
  • Syncope
  • Palpitations
  • Nausea
  • Vomiting
  • Worsening angina (paradoxical effect or tolerance)

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 during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Trimester-Specific Risks:

First Trimester: Potential for fetal harm based on animal data; avoid if possible.
Second Trimester: Potential for fetal harm based on animal data; use with caution.
Third Trimester: Potential for fetal harm based on animal data; use with caution, monitor for maternal hypotension.
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Lactation

It is not known whether isosorbide dinitrate or its metabolites are excreted in human milk. Due to the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Infant Risk: Not available; caution advised due to potential for hypotension or methemoglobinemia in infant.
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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 isosorbide dinitrate. Start with lower doses and titrate slowly, monitoring blood pressure closely to avoid orthostatic hypotension and falls.

Clinical Information

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Clinical Pearls

  • Nitrate Tolerance: To maintain efficacy and prevent tolerance, a daily nitrate-free interval (typically 10-14 hours) is crucial. This often means taking the last dose in the late afternoon or early evening.
  • Headache: Headache is a very common side effect, especially at the beginning of therapy. It is often a sign that the medication is working and usually diminishes with continued use. Over-the-counter pain relievers may help.
  • Not for Acute Angina: Isosorbide dinitrate oral tablets are for prophylaxis (prevention) of angina, not for the immediate relief of an acute angina attack. Patients should be instructed to use sublingual nitroglycerin for acute attacks.
  • Hypotension Risk: Counsel patients on symptoms of hypotension (dizziness, lightheadedness, fainting) and advise them to sit or lie down if these occur. Avoid sudden position changes.
  • Drug Interactions: Emphasize the absolute contraindication with PDE5 inhibitors (e.g., Viagra, Cialis, Levitra) due to the risk of life-threatening hypotension.
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Alternative Therapies

  • Other organic nitrates (e.g., nitroglycerin oral, transdermal, isosorbide mononitrate)
  • Beta-blockers (e.g., metoprolol, atenolol)
  • Calcium channel blockers (e.g., amlodipine, diltiazem, verapamil)
  • Ranolazine
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Cost & Coverage

Average Cost: Varies widely, typically low cost for generic. per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (most insurance plans)
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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 information. If you have any questions or concerns about this 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 emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.