Nitro-Dur 0.4mg/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
Sep 1984
DEA Schedule
Not Controlled
Overview
What is this medicine?
Nitro-Dur is a patch applied to the skin that releases nitroglycerin, a medicine that helps relax blood vessels. This relaxation helps more blood and oxygen get to your heart, which can prevent chest pain (angina). It's used to prevent angina, not to treat an acute attack.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Before and after handling the patch, wash your hands thoroughly. Apply the patch at the same time every day.
When applying the patch, make sure to:
- Put it on clean, dry, and healthy skin
- Choose a site without hair
- Wear only one patch at a time
- Place a new patch in a different area each time you change it
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 new location.
Storing and Disposing of Your Medication
Store the patches at room temperature in a dry place, avoiding the bathroom. Dispose of used patches in a sealed container, keeping them out of reach of children and pets. Ensure all medications are stored safely and securely, 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 correctly, follow your doctor's instructions and read all the information provided. Before and after handling the patch, wash your hands thoroughly. Apply the patch at the same time every day.
When applying the patch, make sure to:
- Put it on clean, dry, and healthy skin
- Choose a site without hair
- Wear only one patch at a time
- Place a new patch in a different area each time you change it
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 new location.
Storing and Disposing of Your Medication
Store the patches at room temperature in a dry place, avoiding the bathroom. Dispose of used patches in a sealed container, keeping them out of reach of children and pets. Ensure all medications are stored safely and securely, 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
- Apply the patch to a clean, dry, hairless area of skin (e.g., chest, upper arm, back). Avoid irritated or scarred skin.
- Rotate application sites daily to prevent skin irritation.
- Remove the old patch before applying a new one.
- Remove the patch for 10-12 hours each day (usually overnight) to prevent your body from becoming tolerant to the medication's effects. This is called a 'nitrate-free interval'.
- Do not cut the patch.
- Avoid sudden changes in position (e.g., standing up quickly) to prevent dizziness or lightheadedness.
- Limit or avoid alcohol consumption, as it can increase the risk of low blood pressure.
- Do not use this medication to treat an acute angina attack; use sublingual nitroglycerin for acute attacks as prescribed.
- Inform all healthcare providers, including dentists, that you are using nitroglycerin patches.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Initial dose: 0.2-0.4 mg/hr 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., 0.2 mg/hr, 0.4 mg/hr, 0.6 mg/hr, 0.8 mg/hr) once daily to a hairless area of skin. Remove after 12-14 hours to allow for a 10-12 hour nitrate-free interval to prevent tolerance. Titrate dose based on clinical response and tolerability.
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 accumulation of active metabolites in severe renal impairment.
Dialysis:
Not available
Hepatic Impairment:
Mild:
No specific adjustment recommended.
Moderate:
No specific adjustment recommended.
Severe:
Use with caution; extensive hepatic metabolism. Monitor for increased effects.
Confidence:
Medium
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, increasing intracellular cyclic guanosine monophosphate (cGMP), which leads to dephosphorylation of myosin light chains and relaxation of smooth muscle. This results in venodilation (predominantly) and arterial dilation, leading to decreased preload and afterload, respectively, thereby reducing myocardial oxygen demand and improving myocardial blood flow.
Pharmacokinetics
Absorption:
Bioavailability:
Variable (transdermal absorption bypasses first-pass metabolism, but overall bioavailability is not precisely quantifiable due to sustained release and skin variability).
Tmax:
Approximately 2-6 hours (for steady-state plasma concentrations with transdermal patch).
FoodEffect:
Not applicable for transdermal patch.
Distribution:
Vd:
Approximately 3.3 L/kg (large volume of distribution).
ProteinBinding:
Approximately 60% (to plasma proteins).
CnssPenetration:
Limited
Elimination:
HalfLife:
1-4 minutes (for parent drug, but effective half-life from patch is longer due to sustained release).
Clearance:
High (approximately 13.6 L/min).
ExcretionRoute:
Renal (as metabolites).
Unchanged:
<1%
Pharmacodynamics
OnsetOfAction:
30-60 minutes (for transdermal patch).
PeakEffect:
2-6 hours (for transdermal patch).
DurationOfAction:
8-12 hours (while patch is on, followed by a nitrate-free interval).
Confidence:
High
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
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 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. 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:
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.
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 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. 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:
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 intolerable)
- Dizziness, lightheadedness, or fainting
- Blurred vision
- Unusual weakness or fatigue
- Rash or severe irritation at the patch site
- Chest pain that worsens or does not improve
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
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 change the dose of any medication without 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 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
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 change the dose of any medication without consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
When starting this medication, be cautious when driving or performing tasks that require alertness and clear vision until you understand how it 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 as directed by your healthcare provider. Be aware that this medication may interfere with certain laboratory tests, so inform all your healthcare providers and laboratory personnel that you are taking this drug.
Avoid consuming alcohol while on this medication. If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
Do not use this medication to treat sudden chest pain, as it will not be effective. If you have been taking this medication continuously without interruption, it may lose its effectiveness due to tolerance. To avoid this, ensure you have a daily "nitrate-free" period. Consult your doctor if you notice a decrease in the medication's effectiveness. Adhere to the prescribed dosage and do not exceed it.
If you need to stop taking this medication, do not discontinue it abruptly without consulting your doctor, as this may increase the risk of side effects. Instead, your doctor will guide you on how to gradually stop the medication.
If you are using a patch, be aware that it may contain metal. Remove the patch before undergoing an MRI or cardioversion. After removing the patch, you may experience redness or warmth on your skin, which is usually temporary. However, if these effects persist, contact your doctor.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor to discuss the potential benefits and risks of this medication to you and your baby.
When starting this medication, be cautious when driving or performing tasks that require alertness and clear vision until you understand how it 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 as directed by your healthcare provider. Be aware that this medication may interfere with certain laboratory tests, so inform all your healthcare providers and laboratory personnel that you are taking this drug.
Avoid consuming alcohol while on this medication. If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
Do not use this medication to treat sudden chest pain, as it will not be effective. If you have been taking this medication continuously without interruption, it may lose its effectiveness due to tolerance. To avoid this, ensure you have a daily "nitrate-free" period. Consult your doctor if you notice a decrease in the medication's effectiveness. Adhere to the prescribed dosage and do not exceed it.
If you need to stop taking this medication, do not discontinue it abruptly without consulting your doctor, as this may increase the risk of side effects. Instead, your doctor will guide you on how to gradually stop the medication.
If you are using a patch, be aware that it may contain metal. Remove the patch before undergoing an MRI or cardioversion. After removing the patch, you may experience redness or warmth on your skin, which is usually temporary. However, if these effects persist, contact your doctor.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor to discuss the potential benefits and risks of this medication to you and your baby.
Overdose Information
Overdose Symptoms:
- Severe hypotension (very low blood pressure)
- Persistent throbbing headache
- Flushing
- Palpitations
- Dizziness, vertigo
- Nausea, vomiting
- Diaphoresis (sweating)
- Syncope (fainting)
- Methemoglobinemia (rare, but serious, causing bluish skin, lips, and nail beds, shortness of breath, fatigue)
What to Do:
Seek immediate medical attention. Call 911 or Poison Control (1-800-222-1222). Management is supportive, including elevating legs, administering IV fluids, and if severe methemoglobinemia occurs, methylene blue may be administered.
Drug Interactions
Contraindicated Interactions
- Phosphodiesterase-5 (PDE5) inhibitors (e.g., sildenafil, tadalafil, vardenafil, avanafil) - concurrent use can cause profound hypotension, myocardial ischemia, and death.
- Riociguat (soluble guanylate cyclase stimulator) - concurrent use can cause profound hypotension.
Major Interactions
- Other vasodilators (e.g., alpha-blockers, calcium channel blockers, antihypertensives) - additive hypotensive effects.
- Alcohol - can enhance hypotensive effects.
Moderate Interactions
- Tricyclic antidepressants - 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: Prior to initiation of therapy.
Heart Rate (HR)
Rationale: To establish baseline and monitor 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 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, reduce dose or discontinue.
Heart Rate (HR)
Frequency: Regularly, especially during dose titration.
Target: Maintain within patient's normal range.
Action Threshold: If significant reflex tachycardia occurs, consider dose adjustment or concomitant therapy (e.g., beta-blocker).
Angina symptoms
Frequency: Ongoing assessment.
Target: Reduction in frequency and severity of angina episodes.
Action Threshold: If angina symptoms persist or worsen, re-evaluate therapy.
Headache (frequency, severity)
Frequency: Ongoing assessment.
Target: Manageable or absent.
Action Threshold: If severe or persistent headache, consider dose reduction or alternative therapy.
Symptom Monitoring
- Angina relief
- Headache (common side effect, often indicates drug activity)
- Dizziness or lightheadedness (especially upon standing)
- Flushing
- Nausea
- Weakness
- Blurred vision
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 reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans.
Trimester-Specific Risks:
First Trimester:
Potential risk, use only if clearly needed.
Second Trimester:
Potential risk, use only if clearly needed.
Third Trimester:
Potential risk, use only if clearly needed.
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 decision to discontinue nursing or to discontinue the drug should be made taking into account the importance of the drug to the mother.
Infant Risk:
Risk unknown; potential for hypotension or methemoglobinemia in infant. Monitor infant for adverse effects.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Not recommended for routine use in children.
Geriatric Use
Elderly patients may be more susceptible to the hypotensive effects of nitroglycerin. Start with the lowest effective dose and titrate slowly. Monitor blood pressure closely.
Clinical Information
Clinical Pearls
- The nitrate-free interval (typically 10-12 hours overnight) is crucial to prevent the development of nitrate tolerance, which can render the medication ineffective.
- Headache is a very common side effect, especially at the beginning of therapy, and often indicates that the drug is working. It may lessen with continued use. OTC pain relievers can be used.
- Patients should be advised to sit or lie down if they experience dizziness or lightheadedness.
- Transdermal patches are for prevention of angina, not for acute attacks. Patients should carry sublingual nitroglycerin for acute relief.
- Ensure proper disposal of used patches by folding the adhesive sides together and discarding them out of reach of children and pets.
Alternative Therapies
- Beta-blockers (e.g., metoprolol, atenolol)
- Calcium channel blockers (e.g., amlodipine, diltiazem, verapamil)
- Ranolazine
- Long-acting oral nitrates (e.g., isosorbide mononitrate, isosorbide dinitrate)
Cost & Coverage
Average Cost:
Varies widely by strength and pharmacy; typically $50-$200+ per 30 patches
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generic), Tier 3 or higher (for brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it is 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 it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.