Nitroglycerin 0.2 Mg/hr Patch

Manufacturer MYLAN Active Ingredient Nitroglycerin Transdermal Patch(nye troe GLI ser in) Pronunciation nye troe GLI ser in
It is used to prevent chest pain or pressure.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Antianginal
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Pharmacologic Class
Organic Nitrate; Vasodilator
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Pregnancy Category
C
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FDA Approved
Mar 1984
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Nitroglycerin patches are used to prevent chest pain (angina) by relaxing blood vessels and improving blood flow to the heart. It's a patch you stick on your skin once a day.
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How to Use This Medicine

Taking Your Medication Correctly

To use this medication safely and effectively, follow your doctor's instructions carefully. Before starting, read all the information provided to you and follow the instructions closely.

1. Applying the Patch: Wash your hands before and after handling the patch. Apply the patch at the same time every day. Avoid applying the patch immediately after a shower or bath. Choose a clean, dry, and healthy skin area without hair to apply the patch. Use only one patch at a time. Each time you change the patch, apply it to a new area of skin.

2. Continuing Your Medication: Continue using this medication as directed by your doctor or healthcare provider, even if you start feeling well.

3. Replacing a Fallen Patch: If the patch falls off, replace it with a new one at a different skin site.

Storing and Disposing of Your Medication

1. Storage: Store the patches at room temperature in a dry place, avoiding storage in a bathroom.
2. Disposal: 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 to prevent accidental ingestion.

Missing a Dose

If you miss a dose, apply a new patch as soon as you remember, 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 dosing schedule. Do not apply more than one patch at a time.
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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 patch after 12-14 hours each day to allow for a nitrate-free interval (usually overnight) to prevent the body from becoming tolerant to the medication.
  • Do not cut or trim the patch.
  • Wash hands thoroughly after applying or removing the patch.
  • Avoid sudden changes in position (e.g., standing up quickly) to prevent dizziness or lightheadedness.
  • Avoid alcohol consumption, as it can worsen side effects like dizziness and low blood pressure.
  • Do not use erectile dysfunction medications (e.g., Viagra, Cialis, Levitra) or riociguat while using nitroglycerin, as this can cause a dangerous drop in blood pressure.

Dosing & Administration

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Adult Dosing

Standard Dose: Initial dose typically 0.2 to 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) to a hairless area of skin once daily. Titrate dose based on patient response and tolerance. A nitrate-free interval of 10-12 hours is crucial to prevent tolerance.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment generally required.
Moderate: No specific dose adjustment generally required.
Severe: Use with caution; monitor for hypotension and adverse effects. No specific dose adjustment guidelines.
Dialysis: Not available

Hepatic Impairment:

Mild: No specific dose adjustment generally required.
Moderate: Use with caution; monitor for hypotension and adverse effects. No specific dose adjustment guidelines.
Severe: Use with caution; monitor for hypotension and adverse effects. No specific dose adjustment guidelines.
Confidence: Medium

Pharmacology

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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 cyclic GMP (cGMP), which leads to dephosphorylation of myosin light chains and relaxation of smooth muscle. This results in venodilation (predominant effect, reducing preload and myocardial oxygen demand) and, at higher doses, arterial dilation (reducing afterload). It also dilates coronary arteries, improving blood flow to ischemic areas.
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Pharmacokinetics

Absorption:

Bioavailability: Highly variable (due to extensive first-pass metabolism orally), but transdermal bypasses first-pass, leading to more consistent absorption.
Tmax: Approximately 2-8 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); dinitrate metabolites have longer half-lives (up to 2 hours).
Clearance: High systemic clearance.
ExcretionRoute: Primarily renal (as metabolites).
Unchanged: <1%
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Pharmacodynamics

OnsetOfAction: Approximately 30-60 minutes (for transdermal patch).
PeakEffect: Approximately 2-8 hours (for transdermal patch).
DurationOfAction: Up to 10-12 hours (while patch is on, followed by nitrate-free interval).

Safety & Warnings

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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 in some people. Although many individuals 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 for advice:

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 not mentioned here. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Severe dizziness or fainting
  • Blurred vision
  • Unusual sweating
  • Nausea or vomiting
  • Severe or persistent headache (especially if new or worsening)
  • Rash or severe irritation at the patch site
  • Chest pain that worsens or does not improve
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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
Medications you are currently taking, particularly:
+ Avanafil, riociguat, sildenafil, tadalafil, or vardenafil
+ Dihydroergotamine, ergonovine, ergotamine, or methylergonovine
Any 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.
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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 performing tasks 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 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 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. Consult your doctor if you experience a decrease in the medication's efficacy.
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 Instructions

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 temporary and harmless. However, if these effects persist, contact your doctor.

Pregnancy and Breastfeeding

If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor, as they will need to discuss the potential benefits and risks of this medication to you and your baby.
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Overdose Information

Overdose Symptoms:

  • Severe hypotension (very low blood pressure)
  • Persistent throbbing headache
  • Palpitations
  • Flushing
  • Dizziness
  • Nausea and vomiting
  • Syncope (fainting)
  • Methemoglobinemia (rare, but serious, characterized by cyanosis, dyspnea, fatigue)

What to Do:

Immediately remove the patch. Lay the patient down with legs elevated. Seek emergency medical attention. Call 911 or Poison Control at 1-800-222-1222.

Drug Interactions

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Contraindicated Interactions

  • Phosphodiesterase-5 (PDE5) inhibitors (e.g., sildenafil, tadalafil, vardenafil, avanafil) - severe hypotension and cardiovascular collapse.
  • Riociguat (soluble guanylate cyclase stimulator) - severe hypotension.
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Major Interactions

  • Other vasodilators (e.g., alpha-blockers, calcium channel blockers) - additive hypotensive effects.
  • Alcohol - enhanced hypotensive effects.
  • Ergot alkaloids (e.g., ergotamine, dihydroergotamine) - may reduce antianginal effect of nitrates and increase risk of angina.
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Moderate Interactions

  • Antihypertensives (e.g., beta-blockers, ACE inhibitors, diuretics) - additive hypotensive effects.
  • Tricyclic antidepressants, phenothiazines - may enhance hypotensive effects.
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Minor Interactions

  • Aspirin - may increase nitroglycerin levels (minor clinical significance).

Monitoring

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Baseline Monitoring

Blood Pressure (BP)

Rationale: To establish baseline and assess risk of hypotension.

Timing: Prior to initiation.

Heart Rate (HR)

Rationale: To establish baseline and assess for reflex tachycardia.

Timing: Prior to initiation.

Angina frequency/severity

Rationale: To assess efficacy.

Timing: Prior to initiation.

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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: Symptomatic hypotension (dizziness, lightheadedness, syncope) or systolic BP <90 mmHg.

Heart Rate (HR)

Frequency: Regularly, especially during dose titration.

Target: Maintain within patient's normal range, avoiding significant reflex tachycardia.

Action Threshold: Persistent tachycardia or symptomatic palpitations.

Headache severity

Frequency: Daily, especially during initial therapy.

Target: Mild to tolerable.

Action Threshold: Severe or persistent headache requiring intervention (e.g., analgesics, dose reduction).

Angina symptoms

Frequency: Ongoing patient self-assessment.

Target: Reduction in frequency and severity of angina episodes.

Action Threshold: Increased angina frequency/severity, indicating potential tolerance or inadequate dosing.

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Symptom Monitoring

  • Headache (common, often resolves with continued use)
  • Dizziness
  • Lightheadedness
  • Flushing
  • Nausea
  • Hypotension (especially orthostatic)
  • Palpitations (reflex tachycardia)
  • Skin irritation at patch site

Special Patient Groups

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Pregnancy

Category C. Use only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects, but human data are limited.

Trimester-Specific Risks:

First Trimester: Limited data, theoretical risk of teratogenicity.
Second Trimester: Limited data.
Third Trimester: Limited data, potential for maternal hypotension affecting fetal perfusion.
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Lactation

L3 (Moderately Safe). It is not known if nitroglycerin is excreted in human milk. Use with caution. Consider potential infant exposure, drug effects on milk production, and benefits of breastfeeding.

Infant Risk: Potential for hypotension or methemoglobinemia in the infant, though unlikely with typical transdermal doses. Monitor infant for adverse effects.
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Pediatric Use

Safety and efficacy not established in pediatric patients. Not recommended for use.

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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.

Clinical Information

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Clinical Pearls

  • The nitrate-free interval (typically 10-12 hours) is crucial to prevent tolerance (tachyphylaxis) to the antianginal effects of nitroglycerin. Patients should be instructed to remove the patch for this period.
  • Headache is a very common side effect, especially at the beginning of therapy, and often diminishes with continued use. It can be managed with mild analgesics.
  • Patients should be advised to sit or lie down if they experience dizziness or lightheadedness.
  • Transdermal patches are for prophylaxis of angina, not for acute angina attacks. Sublingual nitroglycerin is used for acute relief.
  • Ensure patients understand the absolute contraindication with PDE5 inhibitors (e.g., sildenafil) due to the risk of profound hypotension.
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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)
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Cost & Coverage

Average Cost: $30 - $100 per 30 patches
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (Generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.