Nitro-Dur 0.1mg/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
Aug 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 to relax blood vessels, making it easier for your heart to pump blood and reducing its workload. It is not for sudden chest pain.
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, place it on a new area of skin.
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, place it on a new area of skin.
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
- 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.
- Follow the prescribed schedule strictly, including the 'nitrate-free interval' (usually 10-12 hours without a patch) to prevent the body from becoming tolerant to the medication.
- Do not cut the patch.
- Avoid sudden changes in position (e.g., standing up quickly) to prevent dizziness or lightheadedness.
- Avoid alcohol, as it can increase dizziness and lower blood pressure.
- Do not use erectile dysfunction medications (like Viagra, Cialis, Levitra) or riociguat while using nitroglycerin, as this can cause a dangerous drop in blood pressure.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Initial dose: 0.2 mg/hr or 0.4 mg/hr patch applied once daily for 12-14 hours, then removed for 10-12 hours (nitrate-free interval). Nitro-Dur 0.1 mg/hr is a lower starting dose or for titration.
Dose Range:
0.1 - 0.8 mg
Condition-Specific Dosing:
anginaProphylaxis:
Apply one patch daily to a hairless area of skin, typically for 12-14 hours, followed by a 10-12 hour nitrate-free interval to prevent tolerance. Dosage should be individualized based on patient response and tolerance. Common starting doses are 0.2 mg/hr or 0.4 mg/hr, titrating up to 0.8 mg/hr if needed. The 0.1 mg/hr patch may be used for initial titration or in patients sensitive to nitrates.
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 significantly dialyzable. Use with caution, 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:
Use with caution; consider lower starting doses and close monitoring due to impaired metabolism and potential for increased systemic exposure.
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, to a lesser extent, arterial dilation (reducing afterload). These effects decrease myocardial oxygen demand. Nitroglycerin also directly dilates coronary arteries, improving myocardial oxygen supply.
Pharmacokinetics
Absorption:
Bioavailability:
Highly variable (due to extensive first-pass metabolism), but transdermal delivery bypasses first-pass metabolism to some extent, providing sustained systemic absorption.
Tmax:
Approximately 2-4 hours (for steady-state plasma concentrations with transdermal patch).
FoodEffect:
Not applicable for transdermal patch.
Distribution:
Vd:
Approximately 3 L/kg
ProteinBinding:
Approximately 60%
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 1-7 minutes (parent drug); metabolites have longer half-lives (e.g., dinitrates 30-60 minutes). The transdermal patch provides sustained release.
Clearance:
High systemic clearance.
ExcretionRoute:
Primarily renal (as metabolites).
Unchanged:
<1%
Pharmacodynamics
OnsetOfAction:
Approximately 30-60 minutes (for antianginal effect with transdermal patch).
PeakEffect:
Approximately 2-4 hours (for antianginal effect with transdermal patch).
DurationOfAction:
Up to 12-14 hours (while patch is applied, followed by a 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 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 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, 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)
Reporting Side Effects
If you have questions or concerns about side effects, 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 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 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, 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)
Reporting Side Effects
If you have questions or concerns about side effects, 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, lightheadedness, or fainting (especially when standing up)
- Blurred vision
- Unusual sweating
- Nausea or vomiting
- Rash or severe irritation at the patch site
- Worsening 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 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 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
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 first.
Precautions & Cautions
Important Information to Share with Your Healthcare Providers
Inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This will help ensure that you receive the best possible care.
Precautions to Take While Using This Medication
To minimize the risk of accidents, avoid driving and engaging in other activities that require alertness and clear vision until you understand how this medication affects you. When standing up from a sitting or lying down position, rise slowly to reduce the likelihood of dizziness or fainting. Be cautious when navigating stairs.
Monitoring Your Condition
Follow your healthcare provider's instructions for monitoring your blood pressure.
Interactions with Lab Tests and Other Substances
This medication may interfere with certain laboratory tests. Inform all of your healthcare providers and laboratory personnel that you are taking this medication. Additionally, avoid consuming alcohol while using this medication, as it may interact with the drug.
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.
Important Usage Guidelines
Do not use this medication to treat sudden chest pain, as it will not provide relief. Consult your doctor if you experience sudden chest pain. If you have been taking this medication continuously without a break, it may lose its effectiveness due to tolerance. To avoid this, ensure you have a daily "nitrate-free" period. If you find that the medication is no longer working as well, discuss this with your doctor. Do not exceed the prescribed dose, and do not stop taking the 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 taking it.
Precautions for Medical Procedures and Skin Reactions
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 typically a temporary and harmless reaction. 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 using this medication with you.
Inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This will help ensure that you receive the best possible care.
Precautions to Take While Using This Medication
To minimize the risk of accidents, avoid driving and engaging in other activities that require alertness and clear vision until you understand how this medication affects you. When standing up from a sitting or lying down position, rise slowly to reduce the likelihood of dizziness or fainting. Be cautious when navigating stairs.
Monitoring Your Condition
Follow your healthcare provider's instructions for monitoring your blood pressure.
Interactions with Lab Tests and Other Substances
This medication may interfere with certain laboratory tests. Inform all of your healthcare providers and laboratory personnel that you are taking this medication. Additionally, avoid consuming alcohol while using this medication, as it may interact with the drug.
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.
Important Usage Guidelines
Do not use this medication to treat sudden chest pain, as it will not provide relief. Consult your doctor if you experience sudden chest pain. If you have been taking this medication continuously without a break, it may lose its effectiveness due to tolerance. To avoid this, ensure you have a daily "nitrate-free" period. If you find that the medication is no longer working as well, discuss this with your doctor. Do not exceed the prescribed dose, and do not stop taking the 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 taking it.
Precautions for Medical Procedures and Skin Reactions
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 typically a temporary and harmless reaction. 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 using this medication with you.
Overdose Information
Overdose Symptoms:
- Severe throbbing headache
- Profound hypotension (very low blood pressure)
- Flushing
- Perspiration
- Nausea and vomiting
- Vertigo
- Palpitations
- Visual disturbances
- Syncope (fainting)
- Methemoglobinemia (rare, but serious, causing bluish skin, lips, and nail beds, shortness of breath, fatigue)
What to Do:
Immediately remove the patch. Seek emergency medical attention. Call 911 or Poison Control at 1-800-222-1222. Management involves supportive care, including elevating legs, IV fluids for hypotension, and potentially methylene blue for methemoglobinemia.
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
- Alcohol (ethanol) - may enhance hypotensive effects.
- Antihypertensives (e.g., beta-blockers, calcium channel blockers, ACE inhibitors, diuretics) - additive hypotensive effects.
- Ergotamine and related drugs - nitrates may reduce the anti-migraine effect of ergot alkaloids and may precipitate angina in patients on ergotamine.
Moderate Interactions
- Aspirin - may increase nitroglycerin levels and effects.
- Heparin - may decrease the anticoagulant effect of heparin (monitor aPTT).
Monitoring
Baseline Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Rationale: To establish baseline cardiovascular status and identify potential for hypotension or reflex tachycardia.
Timing: Prior to initiation of therapy.
Routine Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Frequency: Regularly, especially during dose titration and if symptoms of hypotension occur.
Target: Maintain BP within patient's normal range, avoiding symptomatic hypotension.
Action Threshold: Symptomatic hypotension (e.g., dizziness, syncope), or significant drop in systolic BP (>20 mmHg) or diastolic BP (>10 mmHg) from baseline.
Angina Symptoms
Frequency: Daily patient self-assessment.
Target: Reduction in frequency, severity, and duration of angina episodes.
Action Threshold: Persistent or worsening angina, indicating inadequate control or development of tolerance.
Headache Severity
Frequency: Daily patient self-assessment.
Target: Manageable headache or absence of headache.
Action Threshold: Severe or persistent headache, requiring dose adjustment or alternative therapy.
Symptom Monitoring
- Headache (common, often indicates drug activity)
- Dizziness or lightheadedness (signs of hypotension)
- Flushing (vasodilation)
- Nausea/vomiting
- Palpitations or rapid heart rate (reflex tachycardia)
- Blurred vision
- Syncope
Special Patient Groups
Pregnancy
Category C. Use 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 for fetal harm based on animal data; use with caution.
Second Trimester:
Use with caution; monitor maternal blood pressure.
Third Trimester:
Use with caution; monitor maternal blood pressure and potential for effects on uterine blood flow.
Lactation
L3 (Moderately Safe). It is not known whether nitroglycerin is excreted in human milk. Caution should be exercised when administered to a nursing mother. Consider the benefits of breastfeeding, the risk of potential infant drug exposure, and the risk of untreated maternal condition.
Infant Risk:
Low to moderate risk. Monitor infant for signs of hypotension, headache, or other adverse effects. Consider alternative if possible, especially in preterm or unstable infants.
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 nitroglycerin. Start with lower doses and titrate slowly. Monitor blood pressure closely. Increased risk of falls due to orthostatic hypotension.
Clinical Information
Clinical Pearls
- Nitroglycerin transdermal patches are for prophylaxis of angina, not for acute angina attacks. Patients should carry sublingual nitroglycerin for acute relief.
- A nitrate-free interval (typically 10-12 hours) is crucial to prevent the development of nitrate tolerance, which can render the medication ineffective.
- Headache is a very common side effect and often indicates the drug is working. It usually diminishes with continued use. Over-the-counter pain relievers may help.
- Patients must be strongly cautioned against the concomitant use of PDE5 inhibitors (e.g., sildenafil, tadalafil) due to the risk of severe, life-threatening hypotension.
- Proper application and rotation of patch sites are important to minimize skin irritation and ensure consistent drug delivery.
- Educate patients on symptoms of hypotension (dizziness, lightheadedness) and advise them to sit or lie down if these occur.
Alternative Therapies
- Oral long-acting nitrates (e.g., isosorbide mononitrate, isosorbide dinitrate)
- Beta-blockers (e.g., metoprolol, atenolol)
- Calcium channel blockers (e.g., amlodipine, diltiazem, verapamil)
- Ranolazine
- Ivabradine (for chronic stable angina with specific heart rate criteria)
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)
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 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 happened.