Nitroglycerin 0.1 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
Aug 1984
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Nitroglycerin is a medicine that helps relax blood vessels, making it easier for blood to flow to your heart. This helps prevent chest pain (angina). The patch delivers the medicine slowly through your skin.
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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. Read all the information provided to you and follow the instructions closely. Before and after handling the patch, wash your hands thoroughly.

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.

Continue using this medication as directed by your doctor or healthcare provider, even if you feel well. If the patch falls off, replace it with a new one at a different site.

Storing and Disposing of Your Medication

Store the patches at room temperature in a dry place, away from the bathroom. Dispose of used patches in a sealed container, keeping them out of reach of children and pets. Keep all medications in a safe place, inaccessible to children and pets.

What to Do If You Miss 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.
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Lifestyle & Tips

  • Avoid sudden changes in position (e.g., standing up too quickly) to prevent dizziness.
  • Limit alcohol consumption, as it can worsen side effects like dizziness and low blood pressure.
  • Do not stop using the patch suddenly without consulting your doctor, as this can worsen angina.
  • Remove the patch before MRI, cardioversion, or defibrillation to prevent skin burns.
  • Avoid applying the patch to skin that is irritated, scarred, or hairy. Rotate application sites daily.
  • Do not cut the patch unless specifically instructed by the manufacturer or your doctor.

Dosing & Administration

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Adult Dosing

Standard Dose: Apply one transdermal system (patch) delivering 0.1 mg/hr (or higher, up to 0.6 mg/hr) once daily for 12-14 hours, followed by a 10-12 hour nitrate-free interval.
Dose Range: 0.1 - 0.6 mg

Condition-Specific Dosing:

angina_prophylaxis: Initial dose typically 0.1 mg/hr or 0.2 mg/hr, adjusted based on clinical response and tolerance. A nitrate-free interval of 10-12 hours daily 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 recommended.
Moderate: No specific dose adjustment recommended.
Severe: No specific dose adjustment recommended, but use with caution due to potential for accumulation of metabolites.
Dialysis: Not specifically studied, use with caution.

Hepatic Impairment:

Mild: No specific dose adjustment recommended.
Moderate: No specific dose adjustment recommended.
Severe: No specific dose adjustment recommended, but use with caution due to extensive hepatic metabolism.
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 guanosine monophosphate (cGMP), which leads to dephosphorylation of myosin light chains and relaxation of smooth muscle. This results in venodilation (primary 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 when administered orally); transdermal bypasses first-pass, but absorption can be variable depending on skin characteristics.
Tmax: Approximately 2-8 hours (for steady-state plasma concentrations with transdermal patch)
FoodEffect: Not applicable for transdermal administration.

Distribution:

Vd: Approximately 3.3 L/kg
ProteinBinding: Approximately 60%
CnssPenetration: Limited

Elimination:

HalfLife: Approximately 1-4 minutes (parent drug); metabolites have longer half-lives (e.g., 1,2-dinitroglycerin ~2 hours)
Clearance: High (due to rapid metabolism)
ExcretionRoute: Primarily renal (as metabolites)
Unchanged: <1%
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Pharmacodynamics

OnsetOfAction: Approximately 30-60 minutes (for transdermal patch)
PeakEffect: Approximately 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 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 guidance:

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
  • Persistent or worsening headache
  • Chest pain that does not improve or worsens despite patch use
  • Rash or severe irritation at the patch site
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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. Describe the allergic reaction you experienced, including the symptoms that occurred.
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.
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Precautions & Cautions

Important Information to Share with Your Healthcare Team

Inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This will help ensure your safety and prevent potential interactions with other treatments.

Precautions to Take While Using This Medication

To minimize the risk of accidents, avoid driving and other activities that require alertness and clear vision until you understand how this medication affects you. When changing positions, such as standing up from a sitting or lying down position, do so slowly to reduce the likelihood of dizziness or fainting. Be cautious when navigating stairs.

Monitoring Your Condition

Follow your healthcare provider's instructions for checking your blood pressure regularly. 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 medication.

Interactions to Avoid

Do not consume alcohol while taking this medication, as it may increase the risk of adverse effects. If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.

Special Considerations

This medication is not intended to treat sudden chest pain, so do not use it for this purpose. If you have been taking this medication continuously without a break, it may lose its effectiveness over time, a phenomenon known as tolerance. To avoid this, your healthcare provider may recommend a daily "nitrate-free" period. If you experience a decrease in the medication's effectiveness, consult your doctor. Do not exceed the prescribed dose, 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 on how to do so gradually.

Additional Safety Precautions

The patch form of this medication 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 usually temporary and harmless. 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 this medication with you and determine the best course of action for you and your baby.
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Overdose Information

Overdose Symptoms:

  • Severe throbbing headache
  • Profound hypotension (very low blood pressure)
  • Palpitations
  • Flushing
  • Perspiration
  • Nausea and vomiting
  • Dizziness and fainting
  • Visual disturbances
  • 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. Treatment is supportive, focusing on maintaining blood pressure and oxygenation. Methylene blue may be used for severe methemoglobinemia.

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

  • Alcohol (ethanol) - may enhance hypotensive effects.
  • Antihypertensives (e.g., beta-blockers, calcium channel blockers, diuretics, ACE inhibitors) - additive hypotensive effects.
  • Ergot alkaloids (e.g., ergotamine, dihydroergotamine) - nitrates may reduce the anti-anginal effect of nitrates and lead to increased vasoconstriction.
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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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Confidence Interactions

Monitoring

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Baseline Monitoring

Blood Pressure (BP)

Rationale: To establish baseline and assess for hypotension.

Timing: Prior to initiation of therapy.

Heart Rate (HR)

Rationale: To establish baseline and assess for reflex tachycardia.

Timing: Prior to initiation of therapy.

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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: If systolic BP <90 mmHg or symptomatic hypotension occurs, reduce dose or discontinue.

Heart Rate (HR)

Frequency: Periodically.

Target: Maintain within patient's normal range.

Action Threshold: If significant reflex tachycardia occurs, consider dose adjustment or concomitant beta-blocker.

Angina symptoms (frequency, severity, duration)

Frequency: Daily patient self-assessment.

Target: Reduction or elimination of angina episodes.

Action Threshold: If angina worsens or is not controlled, reassess therapy and consider dose adjustment or alternative treatments.

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Symptom Monitoring

  • Headache (common, often transient, may indicate efficacy)
  • Dizziness or lightheadedness (signs of hypotension)
  • Flushing
  • Nausea
  • Palpitations
  • Blurred vision

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 at high doses, 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. Monitor infant for signs of hypotension or methemoglobinemia.

Infant Risk: Low to moderate; potential for hypotension or methemoglobinemia, though systemic absorption in infant is likely low.
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Pediatric Use

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

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Geriatric Use

Use with caution in elderly patients, who may be more susceptible to hypotensive effects and falls. Start with lower doses and titrate slowly. Monitor blood pressure closely.

Clinical Information

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Clinical Pearls

  • The nitrate-free interval (typically 10-12 hours daily) is critical 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. It often diminishes with continued use and can be managed with mild analgesics (e.g., acetaminophen). It can also be an indicator of drug efficacy.
  • Patients should be advised to remove the patch before showering or bathing, although some patches are designed to be water-resistant. Always follow specific product instructions.
  • Proper disposal of used patches is important, as they still contain residual drug. Fold the adhesive sides together and dispose of them out of reach of children and pets.
  • Inform patients about the severe and potentially fatal interaction with PDE5 inhibitors (e.g., Viagra, Cialis) and riociguat. Emphasize that these drugs must not be taken concurrently.
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Alternative Therapies

  • Oral nitrates (e.g., isosorbide mononitrate, isosorbide dinitrate)
  • Beta-blockers (e.g., metoprolol, atenolol)
  • Calcium channel blockers (e.g., amlodipine, diltiazem, verapamil)
  • Ranolazine
  • Sublingual nitroglycerin (for acute angina attacks, not prophylaxis)
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Cost & Coverage

Average Cost: $30 - $100 per 30 patches (0.1-0.6 mg/hr)
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 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.