Nitro-Dur 0.6mg/hr Patch

Manufacturer INGENUS PHARMACEUTICALS 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
Mar 1984
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Nitroglycerin is a medicine that comes as a patch you stick on your skin. It helps to relax blood vessels, which makes it easier for blood to flow to your heart. This can help prevent chest pain (angina) caused by heart disease.
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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 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. If the patch falls off, replace it with a new one in a new 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. Keep all medications in a safe and secure 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.
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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 old patch before applying a new one.
  • Follow the prescribed schedule, including the patch-free interval (usually 10-12 hours per day) to prevent the body from becoming tolerant to the medication.
  • Avoid sudden changes in position (e.g., standing up quickly) to prevent dizziness or fainting due to a drop in blood pressure.
  • Avoid alcohol consumption, as it can increase the risk of low blood pressure.
  • Do not apply heat (e.g., heating pads, hot baths, saunas) over the patch, as this can increase drug absorption and lead to severe hypotension.
  • Inform your doctor or dentist that you are using nitroglycerin, especially before any procedures or if you are prescribed other medications.

Dosing & Administration

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Adult Dosing

Standard Dose: One Nitro-Dur 0.6 mg/hr patch applied once daily for 12-14 hours, followed by a 10-12 hour patch-free interval. Dosage should be individualized based on patient response and tolerance.
Dose Range: 0.1 - 0.8 mg

Condition-Specific Dosing:

angina_prophylaxis: Initial dose typically 0.2-0.4 mg/hr, titrated up to 0.6 mg/hr or higher as needed, maintaining a patch-free interval 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 generally required, use with caution.
Moderate: No specific adjustment generally required, use with caution.
Severe: No specific adjustment generally required, use with caution; monitor for adverse effects.
Dialysis: Not specifically studied; monitor for exaggerated hypotensive effects.

Hepatic Impairment:

Mild: No specific adjustment generally required, use with caution.
Moderate: No specific adjustment generally required, use with caution.
Severe: No specific adjustment generally required, use with caution due to extensive hepatic metabolism; monitor for adverse effects.

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 (reducing preload) and, to a lesser extent, arterial dilation (reducing afterload), thereby decreasing myocardial oxygen demand and improving myocardial blood flow.
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Pharmacokinetics

Absorption:

Bioavailability: High (transdermal, bypassing first-pass metabolism)
Tmax: 2-8 hours (for transdermal patch)
FoodEffect: Not applicable (transdermal)

Distribution:

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

Elimination:

HalfLife: 1-7 minutes (parent drug); effective half-life from patch is longer due to sustained release
Clearance: High (approximately 13 L/min)
ExcretionRoute: Renal (as metabolites)
Unchanged: <1%
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Pharmacodynamics

OnsetOfAction: 30-60 minutes (for transdermal patch)
PeakEffect: 2-8 hours (for transdermal patch)
DurationOfAction: Up to 24 hours (with patch, but typically removed after 12-14 hours to prevent tolerance)

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 stomach upset 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 mild 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; 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. 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.
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Seek Immediate Medical Attention If You Experience:

  • Severe or persistent headache (common, but report if debilitating)
  • Dizziness or lightheadedness, especially when standing up
  • Blurred vision
  • Fainting (syncope)
  • Unusual sweating
  • Nausea or vomiting
  • Severe skin rash or 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. Be sure to describe the allergic reaction and its symptoms.
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

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

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, avoid driving and other activities 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. Be aware that this medication may interfere with certain laboratory tests, so inform all your healthcare providers and lab 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.

Do not use this medication to treat sudden chest pain, as it will not be effective. If you have been taking this medication continuously for an extended period, it may lose its effectiveness due to tolerance. To avoid this, ensure you have a daily "nitrate-free" period. Consult your doctor if you notice a decrease in the medication's effectiveness. Never exceed the prescribed dose.

To avoid potential side effects, do not stop taking this medication abruptly without consulting your doctor. 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 usually 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 hypotension (low blood pressure)
  • Persistent throbbing headache
  • Palpitations
  • Flushing
  • Dizziness
  • Nausea and vomiting
  • Diaphoresis (sweating)
  • Syncope (fainting)
  • Visual disturbances
  • Methemoglobinemia (rare, but serious, characterized by cyanosis, dyspnea, fatigue, confusion)

What to Do:

Seek immediate medical attention or call a poison control center (e.g., 1-800-222-1222). Remove the patch immediately. Lay the patient down with legs elevated. Administer intravenous fluids. If methemoglobinemia is suspected, methylene blue may be administered.

Drug Interactions

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Contraindicated Interactions

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

  • Alcohol (ethanol) - may enhance hypotensive effects.
  • Other vasodilators (e.g., hydralazine, minoxidil) - additive hypotensive effects.
  • Antihypertensive agents (e.g., beta-blockers, calcium channel blockers, ACE inhibitors, diuretics) - additive hypotensive effects.
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Moderate Interactions

  • Tricyclic antidepressants (TCAs) - may reduce hypotensive effect of nitrates.
  • Ergot alkaloids (e.g., ergotamine) - nitrates may reduce anti-migraine effect of ergot alkaloids; risk of increased ergot toxicity.
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Blood Pressure (BP)

Rationale: To establish baseline and assess risk of 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.

Angina frequency and severity

Rationale: To assess the efficacy of treatment.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Blood Pressure (BP)

Frequency: Regularly, especially during dose titration or if symptoms of hypotension occur.

Target: Maintain within patient's normal range, avoiding symptomatic hypotension.

Action Threshold: If symptomatic hypotension (e.g., dizziness, syncope) or significant drop in BP (e.g., >20 mmHg systolic) occurs, reduce dose or discontinue.

Heart Rate (HR)

Frequency: Regularly, especially during dose titration.

Target: Maintain within patient's normal range.

Action Threshold: If persistent reflex tachycardia occurs, consider dose adjustment or concomitant therapy (e.g., beta-blocker).

Angina symptoms (frequency, severity, duration)

Frequency: Continuously by patient self-report.

Target: Reduction or elimination of anginal episodes.

Action Threshold: If angina worsens or does not improve, re-evaluate therapy.

Headache

Frequency: Continuously by patient self-report.

Target: Manageable or absent.

Action Threshold: If severe or persistent headache, consider dose reduction or analgesic use. May indicate therapeutic effect.

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Symptom Monitoring

  • Headache (common, often indicates drug activity)
  • Dizziness
  • Lightheadedness
  • Flushing
  • Nausea
  • Palpitations
  • Syncope (fainting)
  • Blurred vision
  • Skin irritation at patch site

Special Patient Groups

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Pregnancy

Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Trimester-Specific Risks:

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

It is not known whether nitroglycerin is excreted in human milk. Caution should be exercised when nitroglycerin is administered to a nursing mother. The decision to breastfeed during treatment should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.

Infant Risk: Unknown; potential for adverse effects on the infant (e.g., hypotension, methemoglobinemia) if excreted in milk.
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Pediatric Use

Safety and effectiveness in pediatric patients have not been established. Not recommended for routine use in children.

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Geriatric Use

Elderly patients may be more susceptible to the hypotensive effects of nitroglycerin. Initiate therapy with lower doses and titrate carefully. Monitor blood pressure closely.

Clinical Information

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Clinical Pearls

  • Nitrate tolerance is a common issue with continuous nitrate therapy. A daily nitrate-free interval (typically 10-12 hours) is crucial to restore sensitivity and maintain efficacy.
  • Headache is a very common side effect, often indicating that the drug is working. It usually diminishes with continued use. Over-the-counter analgesics may be used for relief.
  • 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 minimize skin irritation.
  • Avoid using nitroglycerin patches in situations where external heat (e.g., sauna, hot tub, heating pad, electric blanket) might be applied over the patch, as this can significantly increase absorption and lead to severe hypotension.
  • Patients should be educated on the absolute contraindication with PDE5 inhibitors (e.g., Viagra, Cialis, Levitra) due to the risk of life-threatening hypotension.
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Alternative Therapies

  • Beta-blockers (e.g., metoprolol, atenolol) for angina prophylaxis
  • Calcium channel blockers (e.g., amlodipine, diltiazem, verapamil) for angina prophylaxis
  • Ranolazine (for chronic angina)
  • Coronary revascularization procedures (e.g., PCI, CABG) for severe or refractory angina
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Cost & Coverage

Average Cost: Highly variable per patch
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (for generic), Tier 3 (for brand)
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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 is a good idea to check with your pharmacist for more information. If you have any questions or concerns about this medication, do not hesitate to discuss them with 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.