Nitro-Dur 0.3mg/hr Patch 30s
It is used to prevent chest pain or pressure.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Antianginal agent
Pharmacologic Class
Organic nitrate; Vasodilator
Pregnancy Category
Category C
FDA Approved
Sep 1984
DEA Schedule
Not Controlled
Overview
What is this medicine?
Nitroglycerin transdermal patches are used to prevent chest pain (angina) caused by heart disease. The patch releases medicine slowly through your skin, which helps relax blood vessels, allowing more blood and oxygen to reach your heart. This reduces the heart's workload and prevents angina attacks.
How to Use This Medicine
Taking Your Medication Correctly
To use this medication effectively, follow your doctor's instructions and read all accompanying information carefully. Before and after handling the patch, wash your hands thoroughly. Apply the patch at the same time every day, but not immediately after showering or bathing. Choose a clean, dry, and healthy skin area without hair to apply the patch. Use only one patch at a time, and when it's time to change the patch, place a new one in a different area. Continue using the medication as directed by your doctor or healthcare provider, even if you're feeling well.
Replacing a Fallen Patch
If the patch falls off, replace it with a new one in a different location.
Storing and Disposing of Your Medication
Store the patches at room temperature in a dry place, avoiding bathrooms. Dispose of used patches in a sealed container, keeping them out of reach of children and pets. Store all medications in a safe location, inaccessible to children and pets.
Missing a Dose
If you miss a dose, apply a new patch as soon as possible after removing the old one. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular schedule. Do not apply more than one patch at a time.
To use this medication effectively, follow your doctor's instructions and read all accompanying information carefully. Before and after handling the patch, wash your hands thoroughly. Apply the patch at the same time every day, but not immediately after showering or bathing. Choose a clean, dry, and healthy skin area without hair to apply the patch. Use only one patch at a time, and when it's time to change the patch, place a new one in a different area. Continue using the medication as directed by your doctor or healthcare provider, even if you're feeling well.
Replacing a Fallen Patch
If the patch falls off, replace it with a new one in a different location.
Storing and Disposing of Your Medication
Store the patches at room temperature in a dry place, avoiding bathrooms. Dispose of used patches in a sealed container, keeping them out of reach of children and pets. Store all medications in a safe location, inaccessible to children and pets.
Missing a Dose
If you miss a dose, apply a new patch as soon as possible after removing the old one. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular schedule. Do not apply more than one patch at a time.
Lifestyle & Tips
- Apply the patch to a clean, dry, hairless area of skin (e.g., chest, upper arm, back). Rotate application sites daily to prevent skin irritation.
- Remove the patch after 12-14 hours each day to allow for a 'nitrate-free' period (typically 10-12 hours). This is crucial to prevent the body from becoming tolerant to the medication's effects.
- Do not cut or trim the patch.
- Wash hands thoroughly after applying or removing the patch.
- Avoid sudden changes in position (e.g., standing up quickly) to prevent dizziness or lightheadedness.
- Avoid alcohol consumption, as it can increase the hypotensive effects.
- Avoid excessive heat (hot baths, saunas, direct sunlight) as it can increase drug absorption and lead to hypotension.
- Inform all healthcare providers, including dentists, that you are using nitroglycerin.
- Do not stop using the patch suddenly without consulting your doctor, as this can lead to withdrawal symptoms or worsening angina.
- Remove the patch before an MRI, cardioversion, or defibrillation to prevent burns or arcing.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Initial dose: 0.2 mg/hr or 0.3 mg/hr patch applied once daily for 12-14 hours, then removed for 10-12 hours (nitrate-free interval).
Dose Range:
0.2 - 0.8 mg
Condition-Specific Dosing:
anginaProphylaxis:
Apply one patch (e.g., 0.3 mg/hr) to a hairless area of skin once daily. Remove after 12-14 hours to allow for a nitrate-free interval of 10-12 hours to prevent tolerance. Dosage may be titrated based on clinical response and tolerability, up to 0.8 mg/hr.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended, use with caution.
Moderate:
No specific adjustment recommended, use with caution.
Severe:
No specific adjustment recommended, use with caution.
Dialysis:
No specific adjustment recommended, use with caution. Monitor for hypotension.
Hepatic Impairment:
Mild:
No specific adjustment recommended, use with caution.
Moderate:
No specific adjustment recommended, use with caution.
Severe:
No specific adjustment recommended, use with caution. Monitor for hypotension.
Pharmacology
Mechanism of Action
Nitroglycerin is an organic nitrate that acts as a vasodilator. It is converted to nitric oxide (NO) in vascular smooth muscle cells. NO activates guanylate cyclase, leading to an increase in cyclic guanosine monophosphate (cGMP). Increased cGMP causes dephosphorylation of myosin light chains, resulting in relaxation of vascular smooth muscle. This leads to venodilation (primary effect, reducing preload) and arterial dilation (reducing afterload), thereby decreasing myocardial oxygen demand and improving myocardial blood flow.
Pharmacokinetics
Absorption:
Bioavailability:
Variable (due to first-pass metabolism), but provides continuous systemic absorption from transdermal patch.
Tmax:
Approximately 2-8 hours for steady-state plasma concentrations with transdermal patch.
FoodEffect:
Not applicable for transdermal administration.
Distribution:
Vd:
Approximately 3.3 L/kg (large volume of distribution).
ProteinBinding:
Approximately 60% (low).
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 1-7 minutes (parent drug); dinitrate metabolites have longer half-lives (up to 2 hours).
Clearance:
High systemic clearance (approximately 13.6 L/min).
ExcretionRoute:
Primarily renal excretion of metabolites.
Unchanged:
<1%
Pharmacodynamics
OnsetOfAction:
30-60 minutes (transdermal patch)
PeakEffect:
1-3 hours (transdermal patch)
DurationOfAction:
Up to 10-12 hours (while patch is on, followed by nitrate-free interval)
Safety & Warnings
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, slow, or irregular)
Flushing
Blurred vision
Dry mouth
Excessive sweating
Pale skin
Severe stomach upset or vomiting
Restlessness
Feeling extremely tired or weak
New or worsening chest pain
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although 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 symptoms that bother you or persist, contact your doctor:
Dizziness or headache
Skin irritation
* Headaches (common when starting the medication, but often improve over time; consult your doctor for ways to manage this side effect)
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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. Your doctor can provide medical advice and guidance on managing side effects.
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, slow, or irregular)
Flushing
Blurred vision
Dry mouth
Excessive sweating
Pale skin
Severe stomach upset or vomiting
Restlessness
Feeling extremely tired or weak
New or worsening chest pain
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although 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 symptoms that bother you or persist, contact your doctor:
Dizziness or headache
Skin irritation
* Headaches (common when starting the medication, but often improve over time; consult your doctor for ways to manage this side effect)
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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. Your doctor can provide medical advice and guidance on managing side effects.
Seek Immediate Medical Attention If You Experience:
- Severe or persistent headache (common, but report if debilitating)
- Dizziness or lightheadedness, especially when standing up
- Fainting (syncope)
- Blurred vision
- Worsening chest pain or new chest pain
- Rash, itching, or severe irritation at the patch application site
- Signs of allergic reaction (hives, difficulty breathing, swelling of face/lips/tongue/throat)
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:
+ Anemia
+ Increased pressure in the head, which can be caused by bleeding in the brain or a head injury
+ Recent heart attack
+ Heart problems
+ Low blood volume
Medications you are currently taking, particularly:
+ Avanafil, riociguat, sildenafil, tadalafil, or vardenafil
+ Dihydroergotamine, ergonovine, ergotamine, or methylergonovine
If you have an allergy to adhesives
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine if it is safe to take this medication 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 symptoms you experienced.
Certain health conditions, including:
+ Anemia
+ Increased pressure in the head, which can be caused by bleeding in the brain or a head injury
+ Recent heart attack
+ Heart problems
+ Low blood volume
Medications you are currently taking, particularly:
+ Avanafil, riociguat, sildenafil, tadalafil, or vardenafil
+ Dihydroergotamine, ergonovine, ergotamine, or methylergonovine
If you have an allergy to adhesives
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
Precautions & Cautions
Important Information About Your Medication
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This will help ensure your safety and prevent any potential interactions with other treatments.
Precautions and Warnings
Avoid driving, operating machinery, or performing tasks that require alertness and clear vision until you understand how this medication affects you.
To minimize the risk of dizziness or fainting, stand up slowly when rising from a sitting or lying down position, and be cautious when climbing stairs.
Monitor your blood pressure as directed by your healthcare provider.
Be aware that this medication may interfere with certain laboratory tests. Inform all your healthcare providers and laboratory personnel that you are taking this medication.
Avoid consuming alcohol while taking this medication, as it may increase the risk of side effects.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
Special Considerations
Do not use this medication to treat sudden chest pain, as it will not provide relief. Consult your doctor for alternative treatments.
If you have been taking this medication continuously without a break, it may lose its effectiveness over time (a phenomenon known as tolerance). To avoid this, ensure you have a "nitrate-free" period each day. Consult your doctor if you experience a decrease in the medication's effectiveness.
Do not exceed the prescribed dose, and do not stop taking this medication abruptly without consulting your doctor, as this may increase the risk of side effects. If you need to discontinue this medication, your doctor will guide you on how to gradually stop taking it.
Patch-Specific Instructions
The patch may contain metal, so it is essential to remove it before undergoing an MRI or cardioversion.
After removing the patch, your skin may appear red or feel warm, which is a normal reaction. However, if these effects persist, contact your doctor.
Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor, as they will need to discuss the potential benefits and risks of this medication with you and the baby.
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This will help ensure your safety and prevent any potential interactions with other treatments.
Precautions and Warnings
Avoid driving, operating machinery, or performing tasks that require alertness and clear vision until you understand how this medication affects you.
To minimize the risk of dizziness or fainting, stand up slowly when rising from a sitting or lying down position, and be cautious when climbing stairs.
Monitor your blood pressure as directed by your healthcare provider.
Be aware that this medication may interfere with certain laboratory tests. Inform all your healthcare providers and laboratory personnel that you are taking this medication.
Avoid consuming alcohol while taking this medication, as it may increase the risk of side effects.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
Special Considerations
Do not use this medication to treat sudden chest pain, as it will not provide relief. Consult your doctor for alternative treatments.
If you have been taking this medication continuously without a break, it may lose its effectiveness over time (a phenomenon known as tolerance). To avoid this, ensure you have a "nitrate-free" period each day. Consult your doctor if you experience a decrease in the medication's effectiveness.
Do not exceed the prescribed dose, and do not stop taking this medication abruptly without consulting your doctor, as this may increase the risk of side effects. If you need to discontinue this medication, your doctor will guide you on how to gradually stop taking it.
Patch-Specific Instructions
The patch may contain metal, so it is essential to remove it before undergoing an MRI or cardioversion.
After removing the patch, your skin may appear red or feel warm, which is a normal reaction. However, if these effects persist, contact your doctor.
Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor, as they will need to discuss the potential benefits and risks of this medication with you and the baby.
Overdose Information
Overdose Symptoms:
- Severe throbbing headache
- Profound hypotension (very low blood pressure)
- Palpitations
- Flushing
- Perspiration
- Nausea
- Vomiting
- Dizziness
- Vertigo
- Syncope (fainting)
- Visual disturbances
- Methemoglobinemia (rare, but serious, characterized by cyanosis, shortness of breath, fatigue)
What to Do:
Seek immediate medical attention. Call 911 or your local emergency number. If possible, remove the patch. Management is supportive, including elevating legs, administering IV fluids for hypotension. For severe methemoglobinemia, methylene blue may be administered. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Contraindicated Interactions
- Phosphodiesterase-5 (PDE5) inhibitors (e.g., sildenafil, tadalafil, vardenafil, avanafil) - concurrent use can cause profound hypotension, myocardial infarction, and death.
- Riociguat (soluble guanylate cyclase stimulator) - concurrent use can cause profound hypotension.
Major Interactions
- Other vasodilators (e.g., hydralazine, minoxidil) - additive hypotensive effects.
- Alcohol - can enhance hypotensive effects and cause syncope.
- Antihypertensive agents (e.g., beta-blockers, calcium channel blockers, ACE inhibitors, diuretics) - additive hypotensive effects.
Moderate Interactions
- Tricyclic antidepressants (TCAs) - may reduce hypotensive effects of nitrates.
- Aspirin (high dose) - may increase nitroglycerin levels and effects.
- Heparin - may decrease the anticoagulant effect of heparin (monitor aPTT).
Minor Interactions
- Dihydroergotamine - may increase the risk of angina in patients with coronary artery disease.
Monitoring
Baseline Monitoring
Blood Pressure (BP)
Rationale: To establish baseline and assess for 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.
Angina Symptoms (frequency, severity, precipitating factors)
Rationale: To assess efficacy of therapy.
Timing: Prior to initiation of therapy.
Routine Monitoring
Blood Pressure (BP)
Frequency: Regularly, especially during dose titration or if symptoms of hypotension occur.
Target: Maintain within patient's normal range, 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 range.
Action Threshold: Significant reflex tachycardia or bradycardia.
Angina Symptoms
Frequency: Ongoing patient self-assessment.
Target: Reduction in frequency and severity of angina episodes.
Action Threshold: Worsening or no improvement in angina symptoms.
Headache
Frequency: Ongoing patient self-assessment.
Target: Manageable or absent.
Action Threshold: Severe or persistent headache (may indicate need for dose adjustment or alternative therapy).
Symptom Monitoring
- Headache (common, often indicates drug activity)
- Dizziness
- Lightheadedness
- Flushing
- Nausea
- Vomiting
- Palpitations
- Syncope
- Blurred vision
- Rash or irritation at application site
Special Patient Groups
Pregnancy
Use during pregnancy 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 risk, Category C.
Second Trimester:
Potential risk, Category C.
Third Trimester:
Potential risk, Category C.
Lactation
It is not known whether nitroglycerin is excreted in human milk. Caution should be exercised when nitroglycerin is administered to a nursing woman. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for nitroglycerin and any potential adverse effects on the breastfed infant from nitroglycerin or from the underlying maternal condition.
Infant Risk:
Not available (unknown)
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 and may require lower doses. Start with the lowest effective dose and titrate carefully. Monitor closely for dizziness and falls.
Clinical Information
Clinical Pearls
- Nitrate tolerance is a significant issue with continuous nitrate exposure. A daily nitrate-free interval (typically 10-12 hours) is essential for transdermal patches to maintain efficacy.
- Headache is a very common side effect, especially at the beginning of therapy, and often indicates the drug is working. It usually diminishes with continued use. Over-the-counter pain relievers may help.
- Patients should be advised to remove the patch before undergoing MRI, cardioversion, or defibrillation to prevent burns or arcing due to the metallic backing of some patches.
- Skin irritation at the application site is common. Rotate patch sites daily to minimize this.
- Nitroglycerin patches are for prophylaxis of angina, not for acute angina attacks. Patients should carry sublingual nitroglycerin for acute relief.
Alternative Therapies
- Other long-acting nitrates (e.g., isosorbide mononitrate, isosorbide dinitrate)
- Beta-blockers (e.g., metoprolol, atenolol)
- Calcium channel blockers (e.g., amlodipine, diltiazem, verapamil)
- Ranolazine
Cost & Coverage
Average Cost:
$100 - $300 per 30 patches
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (generic), Tier 3 (brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective 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 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 medication taken, the amount, and the time it happened.