Nitro-Dur 0.2mg/hr Patch
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
Pharmacologic Class
Organic Nitrate; Vasodilator
Pregnancy Category
Category C
FDA Approved
Jul 1984
DEA Schedule
Not Controlled
Overview
What is this medicine?
Nitroglycerin transdermal patch is a medication placed on the skin to prevent chest pain (angina) caused by heart disease. It works by relaxing blood vessels, which helps more blood and oxygen reach your heart. It's important to wear the patch for a specific time each day and then remove it for several hours to prevent your body from getting used to the medication.
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. Wash your hands before and after handling the patch. 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 this 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 you remember, after removing the old one. 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. Wash your hands before and after handling the patch. 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 this 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 you remember, after removing the old one. 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
- Avoid sudden changes in position (e.g., standing up quickly) to prevent dizziness or fainting.
- Limit or avoid alcohol consumption, as it can worsen side effects like dizziness and low blood pressure.
- Do not use this medication for sudden chest pain; use your fast-acting nitroglycerin (e.g., sublingual tablets or spray) for acute attacks.
- Maintain a nitrate-free interval (typically 10-12 hours) each day by removing the patch to prevent tolerance.
- Store patches at room temperature, away from moisture and heat.
- Apply the patch to a clean, dry, hairless area of skin on the chest, upper arm, or back. Rotate application sites daily.
- Wash hands thoroughly after applying or removing the patch.
- Do not cut or damage the patch.
- Inform all healthcare providers, including dentists, that you are using nitroglycerin, especially before any procedures or if new medications are prescribed.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Initial dose: 0.2 mg/hr patch applied once daily for 12-14 hours, followed by a 10-12 hour nitrate-free interval. Titrate as needed.
Dose Range:
0.2 - 0.8 mg
Condition-Specific Dosing:
anginaProphylaxis:
Apply one patch (0.2 mg/hr to 0.8 mg/hr) once daily to a hairless area of skin. Remove after 12-14 hours to allow for a nitrate-free interval of 10-12 hours to prevent tolerance.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended.
Moderate:
No specific adjustment recommended.
Severe:
No specific adjustment recommended, but use with caution due to potential for accumulation of metabolites.
Dialysis:
Considerations: Not well studied, but parent drug has short half-life. Metabolites may accumulate. Monitor for adverse effects.
Hepatic Impairment:
Mild:
No specific adjustment recommended.
Moderate:
No specific adjustment recommended, but use with caution due to extensive hepatic metabolism.
Severe:
No specific adjustment recommended, but use with caution due to extensive hepatic metabolism. Monitor for increased effects.
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, which then 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 (decreased preload) and, at higher doses, arterial dilation (decreased afterload), reducing myocardial oxygen demand and improving myocardial oxygen supply.
Pharmacokinetics
Absorption:
Bioavailability:
Variable (due to first-pass metabolism), but transdermal delivery bypasses initial first-pass effect.
Tmax:
2-8 hours (for steady-state plasma concentrations with transdermal patch)
FoodEffect:
Not applicable for transdermal patch.
Distribution:
Vd:
Approximately 3.3 L/kg
ProteinBinding:
Approximately 60%
CnssPenetration:
Limited
Elimination:
HalfLife:
1-7 minutes (parent drug); effective half-life for transdermal delivery is longer due to sustained release.
Clearance:
Approximately 13.6 L/min
ExcretionRoute:
Renal (as inactive metabolites)
Unchanged:
<1%
Pharmacodynamics
OnsetOfAction:
30-60 minutes (transdermal patch)
PeakEffect:
2-8 hours (transdermal patch)
DurationOfAction:
Up to 12-14 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 for advice:
Dizziness or headache
Skin irritation
* Headaches (common when starting the medication, but often improve over time); do not adjust your dosage without consulting your doctor, as they can help you 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.
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 for advice:
Dizziness or headache
Skin irritation
* Headaches (common when starting the medication, but often improve over time); do not adjust your dosage without consulting your doctor, as they can help you 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.
Seek Immediate Medical Attention If You Experience:
- Severe or persistent headache (common, but report if intolerable)
- Dizziness or lightheadedness upon standing
- Blurred vision
- Unusual sweating
- Fainting (syncope)
- Rash or severe irritation at the patch site
- Worsening chest pain or new chest pain
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.
Certain health conditions, including:
+ Anemia
+ Increased pressure in the head, which may be caused by bleeding in the brain or a head injury
+ Recent heart attack
+ Heart problems
+ Low blood volume
If you are currently taking any of the following medications:
+ Avanafil
+ Riociguat
+ Sildenafil
+ Tadalafil
+ Vardenafil
+ Dihydroergotamine
+ Ergonovine
+ Ergotamine
+ Methylergonovine
If you have an allergy to adhesives
Please note that this is not an exhaustive list of all potential interactions. It is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist to ensure safe use. 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 and its symptoms.
Certain health conditions, including:
+ Anemia
+ Increased pressure in the head, which may be caused by bleeding in the brain or a head injury
+ Recent heart attack
+ Heart problems
+ Low blood volume
If you are currently taking any of the following medications:
+ Avanafil
+ Riociguat
+ Sildenafil
+ Tadalafil
+ Vardenafil
+ Dihydroergotamine
+ Ergonovine
+ Ergotamine
+ Methylergonovine
If you have an allergy to adhesives
Please note that this is not an exhaustive list of all potential interactions. It is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist to ensure safe use. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
Precautions & Cautions
Important Warnings and Precautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
Until you know how this medication affects you, avoid driving and other tasks that require alertness or clear vision.
Preventing Dizziness and Falls
To minimize the risk of dizziness or fainting, stand up slowly after sitting or lying down. Be cautious when climbing stairs.
Monitoring Your Blood Pressure
Follow your healthcare provider's instructions for checking your blood pressure regularly.
Interference with Lab Tests
Inform all your healthcare providers and laboratory personnel that you are taking this medication, as it may affect certain lab test results.
Alcohol Consumption
Avoid consuming alcohol while taking this medication.
Special Considerations for Older Adults
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
Not for Sudden Chest Pain
Do not use this medication to treat sudden chest pain, as it will not provide relief. Consult your doctor for alternative treatments.
Long-Term Use and Tolerance
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 daily "nitrate-free" period. If you notice the medication is not working as well, consult your doctor. Do not exceed the prescribed dose.
Stopping the Medication
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 the medication, your doctor will guide you on how to gradually stop it.
MRI and Cardioversion Precautions
The patch may contain metal, so remove it before undergoing an MRI or cardioversion. After removing the patch, your skin may appear red or feel warm, but this is usually temporary. If these effects persist, contact your doctor.
Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor to discuss the potential benefits and risks to you and your baby.
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
Until you know how this medication affects you, avoid driving and other tasks that require alertness or clear vision.
Preventing Dizziness and Falls
To minimize the risk of dizziness or fainting, stand up slowly after sitting or lying down. Be cautious when climbing stairs.
Monitoring Your Blood Pressure
Follow your healthcare provider's instructions for checking your blood pressure regularly.
Interference with Lab Tests
Inform all your healthcare providers and laboratory personnel that you are taking this medication, as it may affect certain lab test results.
Alcohol Consumption
Avoid consuming alcohol while taking this medication.
Special Considerations for Older Adults
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
Not for Sudden Chest Pain
Do not use this medication to treat sudden chest pain, as it will not provide relief. Consult your doctor for alternative treatments.
Long-Term Use and Tolerance
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 daily "nitrate-free" period. If you notice the medication is not working as well, consult your doctor. Do not exceed the prescribed dose.
Stopping the Medication
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 the medication, your doctor will guide you on how to gradually stop it.
MRI and Cardioversion Precautions
The patch may contain metal, so remove it before undergoing an MRI or cardioversion. After removing the patch, your skin may appear red or feel warm, but this is usually temporary. If these effects persist, contact your doctor.
Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor to discuss the potential benefits and risks to you and your baby.
Overdose Information
Overdose Symptoms:
- Severe throbbing headache
- Profound hypotension (very low blood pressure)
- Palpitations
- Flushing
- Perspiration
- Nausea
- Vomiting
- Dizziness
- Vertigo
- Visual disturbances
- Syncope (fainting)
- Tachycardia (fast heart rate)
- Methemoglobinemia (rare, but serious, characterized by cyanosis, shortness of breath, fatigue)
What to Do:
Immediately remove the patch. Lay the patient down with legs elevated. Administer oxygen. If severe hypotension persists, administer intravenous fluids. Vasopressors may be used if fluid resuscitation is insufficient. For 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) - severe hypotension and cardiovascular collapse.
- Riociguat (soluble guanylate cyclase stimulator) - severe hypotension.
Major Interactions
- Alcohol (ethanol) - may cause severe hypotension and collapse.
- Other vasodilators (e.g., hydralazine, minoxidil) - additive hypotensive effects.
- Antihypertensive agents (e.g., beta-blockers, calcium channel blockers, ACE inhibitors, ARBs, diuretics) - additive hypotensive effects.
- Ergot alkaloids (e.g., ergotamine, dihydroergotamine) - may reduce antianginal effect of nitroglycerin and cause coronary vasoconstriction.
Moderate Interactions
- Aspirin - may increase nitroglycerin levels and effects.
- Heparin - may decrease the anticoagulant effect of heparin (monitor aPTT).
Minor Interactions
- Not available
Monitoring
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.
Angina frequency/severity
Rationale: To assess the effectiveness of therapy.
Timing: Prior to initiation of therapy.
Routine Monitoring
Blood Pressure (BP)
Frequency: Periodically, especially during dose titration or if symptoms of hypotension occur.
Target: Maintain within patient's normal range, avoiding symptomatic hypotension.
Action Threshold: Symptomatic hypotension (e.g., dizziness, lightheadedness, syncope) or significant drop from baseline.
Heart Rate (HR)
Frequency: Periodically, especially during dose titration.
Target: Maintain within patient's normal range, avoiding significant reflex tachycardia.
Action Threshold: Significant reflex tachycardia or palpitations.
Angina symptoms
Frequency: Daily patient self-assessment.
Target: Reduction in frequency and severity of angina episodes.
Action Threshold: No improvement in angina, worsening angina, or development of nitrate tolerance.
Headache
Frequency: Daily patient self-assessment.
Target: Manageable or absent.
Action Threshold: Severe or persistent headache that interferes with quality of life (may indicate need for dose adjustment or alternative therapy).
Symptom Monitoring
- Headache (common, often indicates drug activity)
- Dizziness
- Lightheadedness
- Flushing
- Nausea
- Vomiting
- Hypotension
- Palpitations
- Syncope
Special Patient Groups
Pregnancy
Category C. Animal studies have shown adverse effects, 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 risk, but human data limited.
Second Trimester:
Potential risk, but human data limited.
Third Trimester:
Potential risk, but human data limited.
Lactation
It is not known whether nitroglycerin is excreted in human milk. Caution should be exercised when nitroglycerin is administered to a nursing woman.
Infant Risk:
Unknown
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Not recommended for use in this population.
Geriatric Use
Elderly patients may be more susceptible to the hypotensive effects of nitrates. Start with the lowest effective dose and titrate slowly. Monitor blood pressure closely.
Clinical Information
Clinical Pearls
- Nitrate tolerance is a significant issue with continuous use; a daily nitrate-free interval (typically 10-12 hours) is crucial to maintain efficacy.
- Headache is a very common side effect and often indicates the drug is working. It usually lessens with continued use but can be managed with mild analgesics.
- Patients should be instructed to remove the patch before MRI procedures to prevent skin burns.
- This patch is for prevention of angina, not for acute attacks. Patients should have a fast-acting nitrate (e.g., sublingual nitroglycerin) for acute relief.
- Rotate application sites to minimize skin irritation.
Alternative Therapies
- Oral nitrates (e.g., isosorbide mononitrate, isosorbide dinitrate)
- Beta-blockers (e.g., metoprolol, atenolol)
- Calcium channel blockers (e.g., amlodipine, diltiazem)
- Ranolazine
- Ivabradine (for chronic stable angina with normal sinus rhythm)
Cost & Coverage
Average Cost:
Varies widely by strength and quantity, e.g., $50-$200+ per 30 patches
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (generic)
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 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 details about the medication taken, the amount, and the time it happened.