Nitroglycerin 0.6 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
Category C
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FDA Approved
Jan 1970
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Nitroglycerin is a medication that comes as a patch you stick on your skin. It helps to relax blood vessels, which makes it easier for your heart to pump blood and reduces chest pain (angina). It's used to prevent angina attacks, not to treat them once they start.
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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 with each new application, place the patch on a different area of skin.

Continue using this medication as directed by your doctor or healthcare provider, even if you start feeling better. 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 and secure location, inaccessible to children and pets.

What to Do If You Miss a Dose

If you forget to apply a new patch, do so 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 application schedule. Never 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 on the chest, upper arm, or back. 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 getting used to the medication (tolerance).
  • Avoid sudden changes in position (e.g., standing up quickly) to prevent dizziness or fainting.
  • Limit or avoid alcohol consumption, as it can increase the risk of low 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.
  • Remove the patch before an MRI, defibrillation, or cardioversion to prevent skin burns or electrical arcing.
  • Store patches at room temperature, away from moisture and heat.

Dosing & Administration

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Adult Dosing

Standard Dose: Apply one 0.6 mg/hr patch once daily for 12-14 hours, then remove for a 10-12 hour nitrate-free interval.
Dose Range: 0.2 - 0.8 mg

Condition-Specific Dosing:

anginaProphylaxis: Initial dose typically 0.2-0.4 mg/hr, titrated up to 0.6-0.8 mg/hr based on response and tolerability. 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 adjustment needed
Moderate: No specific adjustment needed
Severe: No specific adjustment needed
Dialysis: No specific adjustment needed; extensively metabolized

Hepatic Impairment:

Mild: No specific adjustment needed
Moderate: No specific adjustment needed
Severe: Caution advised, but no specific dose adjustment guidelines due to extensive metabolism and short half-life of parent drug. Monitor for adverse effects.
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 intracellular cyclic guanosine monophosphate (cGMP), which leads to dephosphorylation of myosin light chains and relaxation of smooth muscle. This results in venodilation (predominant effect, reducing preload) and, at higher doses, arterial dilation (reducing afterload), thereby decreasing myocardial oxygen demand and improving myocardial blood flow.
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Pharmacokinetics

Absorption:

Bioavailability: High (transdermal, avoids first-pass metabolism)
Tmax: Variable, typically 2-8 hours for steady-state plasma concentrations with transdermal patch
FoodEffect: Not applicable for transdermal administration

Distribution:

Vd: Approximately 3 L/kg
ProteinBinding: Approximately 60%
CnssPenetration: Limited

Elimination:

HalfLife: Parent drug: 1-7 minutes (very short); Metabolites: 2-3 hours
Clearance: Very high, approximately 13.6 L/min
ExcretionRoute: Primarily renal (as metabolites)
Unchanged: <1%
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Pharmacodynamics

OnsetOfAction: 30-60 minutes (for transdermal patch)
PeakEffect: 1-3 hours (for transdermal patch)
DurationOfAction: Up to 12-14 hours (while patch is applied, 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. 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 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. 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 or persistent headache (common, but report if debilitating)
  • Severe dizziness or lightheadedness
  • Fainting (syncope)
  • Blurred vision
  • Unusual sweating
  • Persistent nausea or vomiting
  • Worsening chest pain or new angina attacks (may indicate tolerance or inadequate control)
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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, including any symptoms that occurred.
Certain health conditions, including:
+ Anemia
+ Increased pressure in the head, which can be caused by conditions such as 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 for you to take this medication with your existing medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
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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.

Follow your healthcare provider's instructions for monitoring your blood pressure. Additionally, 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 efficacy, a phenomenon known as tolerance. To avoid this, ensure you have a daily "nitrate-free" period. If you notice the medication is no longer effective, discuss this with your doctor. Do not exceed the prescribed dose.

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 it.

The patch may contain metal, so remove it before undergoing an MRI or cardioversion. After removing the patch, you may experience redness or warmth on your skin, 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 to you and your baby.
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Overdose Information

Overdose Symptoms:

  • Severe throbbing headache
  • Flushing
  • Profound hypotension (very low blood pressure)
  • Palpitations
  • Dizziness
  • Syncope (fainting)
  • Nausea and vomiting
  • Diaphoresis (excessive sweating)
  • Cyanosis (bluish discoloration of skin/lips)
  • Methemoglobinemia (rare, but serious, leading to bluish skin and shortness of breath)
  • Bradycardia (slow heart rate)
  • Tachycardia (fast heart rate)
  • Increased intracranial pressure (with cerebral symptoms)

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) - concurrent use can cause profound hypotension, myocardial infarction, and death.
  • Riociguat (soluble guanylate cyclase stimulator) - concurrent use can cause profound hypotension.
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Major Interactions

  • Other vasodilators (e.g., hydralazine, minoxidil) - additive hypotensive effects.
  • Antihypertensive agents (e.g., beta-blockers, calcium channel blockers, ACE inhibitors, diuretics) - additive hypotensive effects.
  • Alcohol - can enhance hypotensive effects and cause severe orthostatic hypotension.
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Moderate Interactions

  • Aspirin - may increase nitroglycerin levels and effects.
  • Heparin - may decrease the anticoagulant effect of heparin (monitor aPTT).
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Minor Interactions

  • Dihydroergotamine - may increase the bioavailability of dihydroergotamine, leading to increased vasoconstriction.

Monitoring

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Baseline Monitoring

Blood Pressure (BP)

Rationale: To establish baseline and assess for hypotension risk.

Timing: Prior to initiation

Heart Rate (HR)

Rationale: To establish baseline and assess for reflex tachycardia.

Timing: Prior to initiation

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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: Systolic BP <90 mmHg or symptomatic hypotension (dizziness, lightheadedness, syncope).

Heart Rate (HR)

Frequency: Periodically, especially during dose titration.

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

Action Threshold: Significant increase in HR (>20 bpm or >100 bpm) associated with symptoms.

Angina symptoms

Frequency: Daily

Target: Reduction or elimination of angina episodes.

Action Threshold: Persistent or worsening angina, indicating inadequate control or tolerance development.

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Symptom Monitoring

  • Headache (common, often indicates drug activity)
  • Dizziness
  • Lightheadedness
  • Flushing
  • Nausea
  • Hypotension (especially orthostatic)
  • Palpitations
  • Syncope

Special Patient Groups

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Pregnancy

Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects at high doses, but human data is limited.

Trimester-Specific Risks:

First Trimester: Limited data, theoretical risk of teratogenicity.
Second Trimester: Limited data.
Third Trimester: Limited data.
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Lactation

Caution is advised. It is unknown if nitroglycerin is excreted in human milk. The decision to breastfeed should consider the importance of the drug to the mother and the potential risks to the infant.

Infant Risk: Low risk, but monitor for hypotension or methemoglobinemia in the infant.
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Pediatric Use

Safety and efficacy have not been established in pediatric patients. Not recommended for use in this population.

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Geriatric Use

Elderly patients may be more sensitive to the hypotensive effects of nitroglycerin. Initiate therapy at the lower end of the dosing range and titrate slowly with careful monitoring of blood pressure.

Clinical Information

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Clinical Pearls

  • Nitrate tolerance is a significant issue with continuous nitrate exposure. A daily nitrate-free interval (typically 10-12 hours) is essential for transdermal patches to maintain efficacy and prevent tolerance.
  • Headache is a very common side effect, especially at the beginning of therapy. It often indicates the drug is working and may decrease with continued use. OTC pain relievers (e.g., acetaminophen) can be used.
  • Patients should be instructed to remove the patch before showering, bathing, swimming, or engaging in activities where the patch might get wet or dislodged, although some patches are designed to be water-resistant.
  • Always remove the patch before an MRI, defibrillation, or cardioversion due to the metallic backing of some patches, which can cause burns or electrical arcing.
  • Rotate application sites to minimize skin irritation and ensure consistent absorption.
  • Transdermal nitroglycerin is for prophylaxis of angina, not for acute angina attacks. Patients should have a rapid-acting nitrate (e.g., sublingual nitroglycerin) for acute relief.
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Alternative Therapies

  • Other long-acting nitrates (e.g., isosorbide mononitrate, isosorbide dinitrate)
  • Beta-blockers (e.g., metoprolol, atenolol)
  • Calcium channel blockers (e.g., amlodipine, diltiazem, verapamil)
  • Ranolazine
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Cost & Coverage

Average Cost: Price range varies widely (e.g., $30-$200+) per 30 patches
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (for 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 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 medication taken, the amount, and the time it occurred.