Nitro-Dur 0.8mg/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
Mar 1984
DEA Schedule
Not Controlled
Overview
What is this medicine?
Nitro-Dur is a patch that you stick on your skin to release medicine slowly. This medicine, nitroglycerin, helps to relax your blood vessels, which can prevent chest pain (angina) by improving blood flow to your heart. It's important to wear the patch for a certain amount of time each day and then take it off for a few hours to make sure it keeps working effectively.
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 each time you change the patch, apply a new one to a different area.
Continue using this medication as directed by your doctor or healthcare provider, even if you start feeling well. 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. When disposing of used patches, seal them in a container and keep 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. 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 each time you change the patch, apply a new one to a different area.
Continue using this medication as directed by your doctor or healthcare provider, even if you start feeling well. 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. When disposing of used patches, seal them in a container and keep 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 too quickly) to prevent dizziness or fainting due to blood pressure drop.
- Limit or avoid alcohol consumption, as it can increase the risk of low blood pressure.
- Maintain a nitrate-free interval (usually 10-12 hours off the patch per day) as instructed by your doctor to prevent the medicine from losing its effectiveness (tolerance).
- Do not cut the patch.
- Apply the patch to a clean, dry, hairless area of skin on your chest, upper arm, or back. Rotate application sites daily to minimize skin irritation.
- Wash hands thoroughly after applying or removing the patch.
- Remove the patch before undergoing an MRI, cardioversion, or defibrillation to prevent skin burns or arcing.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Apply one 0.8 mg/hr patch once daily to a hairless area of skin for 12-14 hours, then remove for 10-12 hours to allow for a nitrate-free interval.
Dose Range:
0.1 - 0.8 mg
Condition-Specific Dosing:
anginaProphylaxis:
Initial dose typically 0.2-0.4 mg/hr, titrated up to 0.8 mg/hr or higher as needed and tolerated, maintaining a nitrate-free interval.
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:
Not significantly dialyzable; no specific adjustment recommended, monitor for adverse effects.
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.
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 activates guanylyl 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 (reducing preload) and, at higher doses, arterial dilation (reducing afterload), thereby decreasing myocardial oxygen demand. It also dilates coronary arteries, improving myocardial oxygen supply.
Pharmacokinetics
Absorption:
Bioavailability:
Variable (transdermal bypasses significant first-pass metabolism compared to oral)
Tmax:
Approximately 2-8 hours (for transdermal patch)
FoodEffect:
Not applicable for transdermal administration
Distribution:
Vd:
Approximately 3 L/kg
ProteinBinding:
Approximately 60%
CnssPenetration:
Limited
Elimination:
HalfLife:
1-7 minutes (parent drug, but sustained release from patch)
Clearance:
High (approximately 13 L/min)
ExcretionRoute:
Primarily renal as glucuronide conjugates of metabolites
Unchanged:
<1%
Pharmacodynamics
OnsetOfAction:
30-60 minutes (transdermal)
PeakEffect:
2-8 hours (transdermal)
DurationOfAction:
Up to 12-14 hours (while patch is on)
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 nausea 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 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 unusual symptoms that bother you or do not go away, contact your doctor:
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)
Reporting Side Effects
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.
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 nausea 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 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 unusual symptoms that bother you or do not go away, contact your doctor:
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)
Reporting Side Effects
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.
Seek Immediate Medical Attention If You Experience:
- Severe or persistent headache (common, but report if unmanageable)
- Dizziness, lightheadedness, or fainting (signs of low blood pressure)
- Blurred vision
- Unusual sweating or clammy skin
- Worsening chest pain or new chest pain
- Severe skin irritation, redness, itching, or blistering at the patch site
- Difficulty breathing or unusual weakness
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.
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 consulting your doctor first.
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.
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 consulting your doctor first.
Precautions & Cautions
Important Information About Your Medication
It is crucial that you inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Precautions and Warnings
Avoid operating a vehicle or engaging in activities 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 after sitting or lying down, and exercise caution when navigating stairs.
Monitor your blood pressure as directed by your healthcare provider.
Be aware that this medication may interfere with certain laboratory tests. Inform all of your healthcare providers and laboratory personnel that you are taking this medication.
Refrain from consuming alcohol while taking this medication, as it may exacerbate 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 with your doctor for alternative treatments.
If you have been taking this medication continuously without interruption, it may lose its effectiveness over time, a phenomenon known as tolerance. To mitigate this risk, ensure you have a daily "nitrate-free" period. If you experience a decrease in the medication's efficacy, consult with your doctor.
Do not exceed the prescribed dosage, 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 through a gradual tapering process.
Patch-Specific Information
The patch may contain metal, so it is essential to remove it before undergoing an MRI or cardioversion.
After removing the patch, you may experience redness or warmth at the application site, which is typically 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 you will need to discuss the potential benefits and risks of this medication to both you and your baby.
It is crucial that you inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Precautions and Warnings
Avoid operating a vehicle or engaging in activities 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 after sitting or lying down, and exercise caution when navigating stairs.
Monitor your blood pressure as directed by your healthcare provider.
Be aware that this medication may interfere with certain laboratory tests. Inform all of your healthcare providers and laboratory personnel that you are taking this medication.
Refrain from consuming alcohol while taking this medication, as it may exacerbate 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 with your doctor for alternative treatments.
If you have been taking this medication continuously without interruption, it may lose its effectiveness over time, a phenomenon known as tolerance. To mitigate this risk, ensure you have a daily "nitrate-free" period. If you experience a decrease in the medication's efficacy, consult with your doctor.
Do not exceed the prescribed dosage, 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 through a gradual tapering process.
Patch-Specific Information
The patch may contain metal, so it is essential to remove it before undergoing an MRI or cardioversion.
After removing the patch, you may experience redness or warmth at the application site, which is typically 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 you will need to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Severe throbbing headache
- Flushing
- Dizziness
- Palpitations
- Visual disturbances
- Nausea and vomiting
- Orthostatic hypotension (dizziness upon standing)
- Syncope (fainting)
- Perspiration
- Cold and clammy skin
- Methemoglobinemia (rare, but serious, characterized by cyanosis, shortness of breath, fatigue)
What to Do:
If you suspect an overdose, remove the patch immediately and seek emergency medical attention. Call 911 or your local poison control center (e.g., 1-800-222-1222 in the US). Treatment may involve elevating the patient's legs, administering intravenous fluids, and vasopressors if hypotension is severe. Methylene blue may be used for methemoglobinemia.
Drug Interactions
Contraindicated Interactions
- Phosphodiesterase-5 (PDE5) inhibitors (e.g., sildenafil, tadalafil, vardenafil, avanafil) - risk of severe hypotension and cardiovascular collapse.
- Riociguat (soluble guanylate cyclase stimulator) - risk of severe hypotension.
Major Interactions
- Other vasodilators (e.g., hydralazine, minoxidil) - additive hypotensive effects.
- Antihypertensives (e.g., beta-blockers, calcium channel blockers, ACE inhibitors, ARBs, diuretics) - additive hypotensive effects.
- Alcohol - enhances hypotensive effects.
Moderate Interactions
- Tricyclic antidepressants (TCAs) - may cause orthostatic hypotension.
- Phenothiazines - may cause orthostatic hypotension.
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Blood Pressure (BP)
Rationale: To establish baseline and monitor for hypotension.
Timing: Before initiation of therapy
Heart Rate (HR)
Rationale: To establish baseline and monitor for reflex tachycardia.
Timing: Before initiation of therapy
Angina frequency and severity
Rationale: To assess efficacy of treatment.
Timing: Before initiation of therapy
Routine Monitoring
Blood Pressure (BP)
Frequency: Regularly, especially during initiation and dose titration; periodically thereafter.
Target: Maintain within patient's normal range, avoiding symptomatic hypotension.
Action Threshold: Symptomatic hypotension (dizziness, lightheadedness, syncope) or significant drop from baseline.
Heart Rate (HR)
Frequency: Regularly, especially during initiation and dose titration; periodically thereafter.
Target: Maintain within patient's normal range, avoiding significant tachycardia.
Action Threshold: Significant reflex tachycardia or symptomatic palpitations.
Angina symptoms
Frequency: Continuously by patient self-report.
Target: Reduction or elimination of angina episodes.
Action Threshold: Worsening or persistent angina, requiring re-evaluation of therapy.
Headache
Frequency: Continuously by patient self-report.
Target: Manageable headache, often indicates drug activity.
Action Threshold: Severe or persistent headache requiring intervention or dose adjustment.
Patch site for irritation/rash
Frequency: Daily upon patch application/removal.
Target: Minimal to no skin irritation.
Action Threshold: Significant redness, itching, swelling, or blistering requiring site rotation or discontinuation.
Symptom Monitoring
- Headache (common, often indicates efficacy)
- Dizziness
- Lightheadedness
- Flushing
- Nausea
- Hypotension (especially orthostatic)
- Syncope
- Palpitations
- Blurred vision
- Worsening angina (paradoxical effect or tolerance)
- Skin irritation/rash at application site
Special Patient Groups
Pregnancy
Nitroglycerin is Pregnancy Category C. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects at high doses, but human data are limited.
Trimester-Specific Risks:
First Trimester:
Limited human data; animal studies suggest potential risk at high doses.
Second Trimester:
Limited human data; animal studies suggest potential risk at high doses.
Third Trimester:
Limited human data; animal studies suggest potential risk at high doses.
Lactation
It is not known whether nitroglycerin is excreted in human milk. Caution should be exercised when nitroglycerin is administered to a nursing woman. The potential benefits of breastfeeding should be weighed against the potential risks to the infant.
Infant Risk:
L3 (Moderately safe; possible risk to infant, but controlled studies are lacking or are inadequate to determine infant risk. Use only if potential benefit justifies potential risk to the infant.)
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Use is generally not recommended.
Geriatric Use
Elderly patients may be more susceptible to the hypotensive effects of nitroglycerin. Initiate therapy with lower doses and titrate slowly, monitoring blood pressure closely. They may also be more prone to falls due to orthostatic hypotension.
Clinical Information
Clinical Pearls
- The nitrate-free interval (typically 10-12 hours off the patch) is crucial to prevent the development of tolerance (tachyphylaxis) to nitroglycerin's effects.
- Headache is a very common side effect, especially at the beginning of therapy, and often indicates that the drug is working. It can usually be managed with mild analgesics (e.g., acetaminophen).
- Patients should be advised to remove the patch before showering or bathing, although some patches are designed to be water-resistant. Always refer to specific product instructions.
- Do not apply the patch to irritated, broken, or scarred skin. Rotate application sites daily to minimize local irritation.
- Patients should be educated on the importance of not discontinuing the patch abruptly, as this can lead to withdrawal symptoms or rebound angina.
- Always remove the patch before any medical procedures involving electrical currents (e.g., MRI, defibrillation, cardioversion) due to the risk of burns or arcing.
Alternative Therapies
- Beta-blockers (e.g., metoprolol, atenolol) for angina prophylaxis
- Calcium channel blockers (e.g., amlodipine, diltiazem, verapamil) for angina prophylaxis
- Ranolazine (Ranexa) for chronic angina
- Long-acting oral nitrates (e.g., isosorbide mononitrate, isosorbide dinitrate) with appropriate nitrate-free interval
- Sublingual nitroglycerin (for acute angina attacks, not prophylaxis)
Cost & Coverage
Average Cost:
Varies widely by strength, quantity, and pharmacy; typically $30-$100+ per 30 patches
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generic versions) on most commercial and Medicare Part D plans.
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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.