Nitroglycerin 0.4mg Sub Tabs 100s

Manufacturer GREENSTONE Active Ingredient Nitroglycerin Sublingual Tablets(nye troe GLI ser in) Pronunciation nye troe GLI ser in
It is used to treat or 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 used to quickly relieve chest pain (angina) caused by heart disease. It works by relaxing blood vessels, which helps more blood and oxygen reach your heart and reduces the heart's workload.
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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 taking your medication, read all the information provided to you and follow the instructions closely.

Administration Instructions

1. Sit down before taking your medication.
2. Place the tablet under your tongue and allow it to dissolve completely. Do not chew, suck, or swallow the tablet.
3. If you have a dry mouth, taking a small sip of water before placing the tablet under your tongue may help it dissolve more easily.

Dosage and Frequency

Your doctor will inform you about the correct dosage, frequency of use, and when to seek medical help if needed. If you are unsure about any aspect of taking this medication, consult your doctor.

Preventing Chest Pain

If you are using this medication to prevent chest pain, take it 5 to 10 minutes before engaging in activities that may trigger chest pain.

Storage and Disposal

Store your medication at room temperature in a dry place, avoiding storage in a bathroom.

Missed Dose

Since this medication is taken as needed, do not take it more frequently than prescribed by your doctor. If you have any questions or concerns, consult your doctor for guidance.
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Lifestyle & Tips

  • Sit down before taking the tablet to prevent dizziness or fainting from a sudden drop in blood pressure.
  • Avoid sudden changes in position (e.g., standing up too quickly) to minimize dizziness.
  • Avoid alcohol consumption, as it can worsen dizziness and lower blood pressure.
  • Do not take sildenafil (Viagra), tadalafil (Cialis), vardenafil (Levitra), or avanafil (Stendra) if you are taking nitroglycerin, as this can cause a dangerous drop in blood pressure.
  • Keep the tablets in their original amber glass bottle, tightly capped, and away from heat, moisture, and direct light. Do not store in the bathroom or refrigerator.
  • Check the expiration date regularly; expired tablets may not be effective. Replace them every 6-8 months after opening, even if not expired, as potency can decrease.

Dosing & Administration

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Adult Dosing

Standard Dose: 0.4 mg sublingually at the first sign of an acute anginal attack. May repeat every 5 minutes for a maximum of 3 doses within a 15-minute period.
Dose Range: 0.3 - 0.6 mg

Condition-Specific Dosing:

anginaProphylaxis: 0.3 mg or 0.6 mg sublingually 5 to 10 minutes prior to activities known to precipitate angina.
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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, use with caution.
Moderate: No specific dose adjustment recommended, use with caution.
Severe: No specific dose adjustment recommended, use with caution.
Dialysis: No specific recommendations, use with caution and monitor for hypotension.

Hepatic Impairment:

Mild: No specific dose adjustment recommended, use with caution.
Moderate: No specific dose adjustment recommended, use with caution.
Severe: No specific dose adjustment recommended, use with caution and monitor for hypotension.

Pharmacology

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Mechanism of Action

Nitroglycerin 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 systemic vasodilation, primarily of veins, leading to decreased preload and reduced myocardial oxygen demand. It also causes coronary artery vasodilation, improving oxygen supply to ischemic areas.
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Pharmacokinetics

Absorption:

Bioavailability: Variable (sublingual bypasses first-pass metabolism, leading to rapid absorption and onset)
Tmax: 1-4 minutes
FoodEffect: Not applicable for sublingual administration

Distribution:

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

Elimination:

HalfLife: 1-4 minutes
Clearance: High (rapidly cleared)
ExcretionRoute: Renal (as metabolites)
Unchanged: Less than 1%
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Pharmacodynamics

OnsetOfAction: 1-3 minutes
PeakEffect: 3-5 minutes
DurationOfAction: Up to 30-60 minutes

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience 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

Other Possible Side Effects

Like all medications, this drug can cause side effects. While 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 unusual symptoms that bother you or persist, contact your doctor:

Dizziness or headache
Mouth tingling
Burning sensation

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 headache (common, but report if intolerable)
  • Dizziness, lightheadedness, or fainting (especially when standing up)
  • Blurred vision
  • Unusual sweating
  • Pale skin
  • Persistent chest pain after 3 doses in 15 minutes (seek emergency medical attention immediately)
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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 can be caused by bleeding in the brain or a head injury
+ A recent heart attack
+ Heart problems
+ Low blood volume
* If you are taking any of the following medications:
+ Avanafil
+ Riociguat
+ Sildenafil
+ Tadalafil
+ Vardenafil
+ Dihydroergotamine
+ Ergonovine
+ Ergotamine
+ Methylergonovine

Please note that this is not an exhaustive list of all potential interactions. To ensure your safety, it is crucial to discuss all of your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. Before starting, stopping, or changing the dose of any medication, consult with your doctor to confirm that it is safe to do so in conjunction with this medication.
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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. Additionally, be aware that this medication may interfere with certain laboratory tests, so it is crucial to notify 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.

Be aware that taking more of this medication than prescribed or taking it more frequently can lead to decreased effectiveness, a phenomenon known as tolerance. If you find that this medication is no longer working as well as it should, consult your doctor. Do not exceed the recommended dosage.

If you are pregnant, planning to become pregnant, or breastfeeding, discuss the potential benefits and risks of this medication with your doctor to make an informed decision about its use.
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Overdose Information

Overdose Symptoms:

  • Severe throbbing headache
  • Flushing
  • Dizziness
  • Palpitations
  • Visual disturbances
  • Nausea and vomiting
  • Diaphoresis (excessive sweating)
  • Syncope (fainting)
  • Orthostatic hypotension (severe drop in BP upon standing)
  • Methemoglobinemia (rare, but serious, causing bluish skin and shortness of breath)

What to Do:

Call 911 or your local emergency number immediately. For non-emergencies, call Poison Control at 1-800-222-1222. Treatment involves supportive care, including elevating legs, IV fluids for hypotension, and potentially methylene blue 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 and prolonged hypotension.
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Major Interactions

  • Riociguat (soluble guanylate cyclase stimulator) - concurrent use can cause severe hypotension.
  • Other vasodilators (e.g., hydralazine, minoxidil) - additive hypotensive effects.
  • Antihypertensive agents (e.g., beta-blockers, calcium channel blockers, ACE inhibitors, ARBs, diuretics) - additive hypotensive effects.
  • Alcohol - can enhance hypotensive effects and cause syncope.
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Moderate Interactions

  • Tricyclic antidepressants (TCAs) - may cause orthostatic hypotension.
  • Phenothiazines - may cause orthostatic hypotension.
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Minor Interactions

  • Not available (most significant interactions are major or contraindicated)

Monitoring

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Baseline Monitoring

Blood Pressure (BP)

Rationale: To establish baseline and assess for hypotension.

Timing: Prior to first dose, especially in patients prone to hypotension.

Heart Rate (HR)

Rationale: To establish baseline and assess for reflex tachycardia.

Timing: Prior to first dose.

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Routine Monitoring

Blood Pressure (BP)

Frequency: Immediately after administration if symptoms persist or if multiple doses are given; periodically during therapy.

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

Action Threshold: Hold dose if systolic BP < 90 mmHg or significant symptomatic hypotension occurs.

Heart Rate (HR)

Frequency: Immediately after administration if symptoms persist or if multiple doses are given; periodically during therapy.

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

Action Threshold: Monitor for reflex tachycardia; consider beta-blocker if persistent and problematic.

Angina Symptoms

Frequency: Continuously during acute attacks.

Target: Resolution or significant reduction of chest pain.

Action Threshold: If pain persists after 3 doses in 15 minutes, seek emergency medical attention.

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Symptom Monitoring

  • Headache (common side effect, often indicates drug activity)
  • Dizziness or lightheadedness (sign of hypotension)
  • Flushing
  • Nausea
  • Weakness
  • Blurred vision

Special Patient Groups

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Pregnancy

Category C. Animal studies have shown adverse effects, but there are no adequate and well-controlled studies in pregnant women. Use only if the potential benefit justifies the potential risk to the fetus.

Trimester-Specific Risks:

First Trimester: Potential for fetal harm based on animal data, but human data limited.
Second Trimester: Potential for fetal harm based on animal data, but human data limited.
Third Trimester: Potential for fetal harm based on animal data, but human data limited.
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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 woman. Consider the benefits of breastfeeding, the risk of potential infant drug exposure, and the risk of untreated maternal condition.

Infant Risk: Unknown, potential for infant exposure and adverse effects (e.g., hypotension, methemoglobinemia) cannot be ruled out.
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Pediatric Use

Safety and effectiveness in pediatric patients have not been established. Not routinely used in this population for angina.

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Geriatric Use

Elderly patients may be more susceptible to the hypotensive effects of nitroglycerin and may experience more pronounced dizziness or lightheadedness. Start with the lowest effective dose and titrate carefully. Monitor blood pressure closely.

Clinical Information

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Clinical Pearls

  • Patients should be instructed to sit down before taking nitroglycerin to minimize the risk of orthostatic hypotension and syncope.
  • A common side effect is headache, which often indicates the drug is working. Patients should be advised not to stop taking it due to headache, but to report severe or persistent headaches.
  • Tablets must be kept in their original amber glass bottle, tightly capped, and protected from light, heat, and moisture to maintain potency. Do not store in pill organizers or cotton-filled containers.
  • Patients should be educated on the '3 doses in 15 minutes' rule and to call emergency services (911) if chest pain persists after the third dose.
  • Tolerance to the effects of nitrates can develop with frequent or continuous use. This is less common with intermittent sublingual use for acute angina but can occur with long-acting nitrates.
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Alternative Therapies

  • Other short-acting nitrates (e.g., nitroglycerin spray)
  • Long-acting nitrates (e.g., isosorbide mononitrate, isosorbide dinitrate) for chronic angina prevention
  • Beta-blockers (e.g., metoprolol, carvedilol) for chronic angina prevention
  • Calcium channel blockers (e.g., amlodipine, diltiazem) for chronic angina prevention
  • Ranolazine (Ranexa) for chronic angina
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Cost & Coverage

Average Cost: Typically $10-$50 per 100 tablets (generic)
Generic Available: Yes
Insurance Coverage: Tier 1 (preferred generic) or Tier 2 (non-preferred generic) on most insurance formularies.
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, 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 consult with your pharmacist. 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.