Nitroglycerin 0.4 Mg/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 agent
Pharmacologic Class
Organic nitrate; Vasodilator
Pregnancy Category
C
FDA Approved
Aug 1984
DEA Schedule
Not Controlled
Overview
What is this medicine?
Nitroglycerin patches are used to prevent chest pain (angina) caused by heart disease. The patch releases medicine through your skin to relax blood vessels, making it easier for blood to flow to your heart. This helps reduce the heart's workload and oxygen demand.
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 avoid putting it on 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 possible after removing the old one. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular schedule. Do not apply more than one patch at a time.
To use this medication effectively, follow your doctor's instructions and read all accompanying information carefully. Before and after handling the patch, wash your hands thoroughly. Apply the patch at the same time every day, but avoid putting it on 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 possible after removing the old one. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular schedule. Do not apply more than one patch at a time.
Lifestyle & Tips
- Apply the patch to a clean, dry, hairless area of skin (e.g., chest, upper arm, back). Rotate application sites daily to prevent skin irritation.
- Remove the old patch before applying a new one.
- It is crucial to remove the patch for 10-12 hours each day (usually overnight) to prevent the body from becoming tolerant to the medication. This 'nitrate-free interval' helps the medication remain effective.
- Avoid sudden changes in position (e.g., standing up quickly) to prevent dizziness or lightheadedness.
- Avoid alcohol, as it can increase the risk of low blood pressure.
- Do not use erectile dysfunction medications (like Viagra, Cialis, Levitra) while using nitroglycerin, as this can cause a dangerous drop in blood pressure.
- Inform all healthcare providers, including dentists, that you are using nitroglycerin.
Available Forms & Alternatives
Available Strengths:
- Nitroglycerin 0.2 Mg/hr Patch
- Nitroglycerin 0.6 Mg/hr Patch
- Nitroglycerin 0.4 Mg/hr Patch
- Nitroglycerin 0.1 Mg/hr Patch
- Nitroglycerin 400mcg Spray 60 Doses
- Nitroglycerin 400mcg Spray 200 Dose
- Nitroglycerin 0.6mg Sub Tabs 100
- Nitroglycerin 0.4mg Sub Tab 25s
- Nitroglycerin 0.3mg Sl Tabs 100
- Nitroglycerin 0.4mg Sub Tabs 100s
- Nitroglycerin 0.3mg Sl Tabs 100
- Nitroglycerin 0.4% Ointment
Dosing & Administration
Adult Dosing
Standard Dose:
One 0.4 mg/hr patch applied once daily for 12-14 hours, then removed for a 10-12 hour nitrate-free interval.
Dose Range:
0.1 - 0.8 mg
Condition-Specific Dosing:
anginaProphylaxis:
Initial dose typically 0.2-0.4 mg/hr, adjusted based on patient response and tolerance. Patches are typically worn for 12-14 hours daily, followed by a 10-12 hour nitrate-free interval to prevent tolerance.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment generally required.
Moderate:
No specific dose adjustment generally required.
Severe:
Use with caution; monitor for exaggerated effects due to potential accumulation of active metabolites.
Dialysis:
Not well studied; use with caution and monitor closely.
Hepatic Impairment:
Mild:
No specific dose adjustment generally required.
Moderate:
Use with caution; monitor for exaggerated effects due to impaired metabolism.
Severe:
Use with caution; monitor for exaggerated effects due to impaired metabolism.
Pharmacology
Mechanism of Action
Nitroglycerin is an organic nitrate that acts as a prodrug. It is converted to nitric oxide (NO) in vascular smooth muscle cells, primarily through enzymatic reactions. 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 (predominant effect at therapeutic doses), which reduces preload and myocardial oxygen demand. At higher doses, arterial dilation also occurs, reducing afterload and further decreasing myocardial oxygen demand. It also causes redistribution of coronary blood flow to ischemic subendocardial regions.
Pharmacokinetics
Absorption:
Bioavailability:
Highly variable (transdermal bypasses first-pass metabolism, but absorption can vary)
Tmax:
Approximately 2-8 hours (for steady-state plasma concentrations with patch)
FoodEffect:
Not applicable for transdermal patch
Distribution:
Vd:
Approximately 3.3 L/kg
ProteinBinding:
Approximately 60%
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 1-7 minutes (parent drug); metabolites have longer half-lives (e.g., 1,2-dinitroglycerin: ~2 hours, 1,3-dinitroglycerin: ~4 hours)
Clearance:
High systemic clearance
ExcretionRoute:
Renal (as metabolites)
Unchanged:
<1%
Pharmacodynamics
OnsetOfAction:
Approximately 30-60 minutes (for antianginal effect with patch)
PeakEffect:
Approximately 2-8 hours (for steady-state plasma concentrations with patch)
DurationOfAction:
Up to 12-14 hours (while patch is applied, 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 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 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); do not adjust your dosage without consulting your doctor, as they can provide guidance on managing 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 on managing side effects.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Severe dizziness or fainting
Abnormal heartbeat (fast, slow, or irregular)
Flushing
Blurred vision
Dry mouth
Excessive sweating
Pale skin
Severe 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 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); do not adjust your dosage without consulting your doctor, as they can provide guidance on managing 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 on managing side effects.
Seek Immediate Medical Attention If You Experience:
- Severe or persistent headache
- Dizziness or lightheadedness, especially when standing up
- Blurred vision
- Fainting (syncope)
- Unusual sweating
- Nausea or vomiting
- 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 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
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.
Regularly 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.
This medication is not intended to treat sudden chest pain, so consult your doctor if you experience such symptoms. Long-term, uninterrupted use of this medication may lead to reduced effectiveness, a phenomenon known as tolerance. To avoid this, ensure you have a daily "nitrate-free" period. If you find that the medication is no longer working as well as it should, discuss this with your doctor. Do not exceed the prescribed dosage.
Do not stop taking this medication abruptly without consulting your doctor, as this may increase your risk of side effects. If you need to discontinue the medication, your doctor will guide you on how to gradually stop taking it.
The transdermal patch may contain metal, so 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 temporary. 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 both 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.
Regularly 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.
This medication is not intended to treat sudden chest pain, so consult your doctor if you experience such symptoms. Long-term, uninterrupted use of this medication may lead to reduced effectiveness, a phenomenon known as tolerance. To avoid this, ensure you have a daily "nitrate-free" period. If you find that the medication is no longer working as well as it should, discuss this with your doctor. Do not exceed the prescribed dosage.
Do not stop taking this medication abruptly without consulting your doctor, as this may increase your risk of side effects. If you need to discontinue the medication, your doctor will guide you on how to gradually stop taking it.
The transdermal patch may contain metal, so 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 temporary. 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 both you and your baby.
Overdose Information
Overdose Symptoms:
- Severe throbbing headache
- Flushing
- Dizziness
- Palpitations
- Visual disturbances
- Nausea and vomiting
- Diaphoresis (excessive sweating)
- Syncope (fainting)
- Orthostatic hypotension
- Methemoglobinemia (rare, but serious, characterized by cyanosis, dyspnea, confusion)
What to Do:
Seek immediate medical attention or call 911. Remove the patch immediately. Keep the patient in a recumbent position with legs elevated. Administer oxygen. If methemoglobinemia is suspected, methylene blue may be administered. Call 1-800-222-1222 for 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
- Other vasodilators (e.g., alpha-blockers, calcium channel blockers, hydralazine) - additive hypotensive effects.
- Alcohol - enhanced hypotensive effects.
- Ergot alkaloids (e.g., ergotamine, dihydroergotamine) - may reduce antianginal effect and increase risk of angina due to vasoconstriction.
Moderate Interactions
- Antihypertensive agents (e.g., beta-blockers, ACE inhibitors, diuretics) - additive hypotensive effects.
- Tricyclic antidepressants, phenothiazines - may enhance hypotensive effects.
Minor Interactions
- Aspirin - may increase nitroglycerin levels (minor clinical significance).
Monitoring
Baseline Monitoring
Blood Pressure (BP)
Rationale: To establish baseline and assess for hypotension risk.
Timing: Before initiation
Heart Rate (HR)
Rationale: To establish baseline and assess for reflex tachycardia.
Timing: Before initiation
Angina frequency and severity
Rationale: To assess the need for therapy and establish baseline for efficacy monitoring.
Timing: Before initiation
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 (dizziness, lightheadedness, syncope) or systolic BP <90 mmHg.
Heart Rate (HR)
Frequency: Periodically, especially during dose titration.
Target: Maintain within patient's normal range.
Action Threshold: Significant reflex tachycardia (>100 bpm or significant increase from baseline).
Angina symptoms (frequency, severity, duration)
Frequency: Regularly, at each follow-up visit.
Target: Reduction or elimination of angina episodes.
Action Threshold: Persistent or worsening angina, indicating inadequate control or development of tolerance.
Headache (frequency, severity)
Frequency: Regularly, especially during initiation.
Target: Manageable or absent.
Action Threshold: Severe or persistent headache, requiring dose adjustment or alternative therapy.
Symptom Monitoring
- Headache
- Dizziness
- Lightheadedness
- Flushing
- Nausea
- Hypotension (especially orthostatic)
- Palpitations
- Blurred vision
- Syncope
Special Patient Groups
Pregnancy
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects at high doses, but human data are limited.
Trimester-Specific Risks:
First Trimester:
Limited data; theoretical risk of teratogenicity, but not well-established.
Second Trimester:
Limited data; generally considered if clearly needed.
Third Trimester:
Limited data; generally considered if clearly needed. May cause hypotension in mother, potentially affecting placental perfusion.
Lactation
It is not known whether nitroglycerin is excreted in human milk. Caution should be exercised when administered to a nursing mother. The decision to breastfeed should consider the potential for infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.
Infant Risk:
L3 (Moderate risk - no human data, but molecular weight is low enough for potential transfer; potential for hypotension or methemoglobinemia in infant is theoretical but not documented).
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Not indicated for pediatric use.
Geriatric Use
Elderly patients may be more susceptible to the hypotensive effects of nitroglycerin. Start with lower doses and titrate carefully. Monitor blood pressure closely, especially for orthostatic hypotension.
Clinical Information
Clinical Pearls
- Nitrate tolerance is a significant issue with continuous use; a daily nitrate-free interval (typically 10-14 hours) is essential for maintaining efficacy.
- Headache is a very common side effect, often indicating the drug is working. It usually diminishes with continued use but may require mild analgesics.
- Patients should be advised to sit or lie down if they experience dizziness or lightheadedness.
- The patch should be applied to a clean, dry, hairless area of skin and rotated daily to prevent irritation.
- Patients must be explicitly warned about the absolute contraindication with PDE5 inhibitors due to the risk of profound and life-threatening hypotension.
- Nitroglycerin patches are for prevention of angina, not for acute angina attacks (for which sublingual nitroglycerin is used).
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 - also require nitrate-free interval)
Cost & Coverage
Average Cost:
$30 - $100+ per 30 patches
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 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 this medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.