Nitroglycerin 0.4mg Sub Tab 25s

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; Vasodilator
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Pharmacologic Class
Organic Nitrate
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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 medicine that helps relax and widen your blood vessels. This allows more blood and oxygen to reach your heart, which can relieve chest pain (angina). It works very quickly when placed under your tongue.
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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

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 provide personalized instructions on how to take this medication, including the correct dose, frequency, and potential side effects. Make sure you understand:
Your prescribed dose
How often you can take a dose
* When to seek medical help

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 bathrooms.

Missed Dose

Since this medication is taken as needed, do not take it more frequently than directed by your doctor.
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Lifestyle & Tips

  • Always carry your nitroglycerin with you, especially if you have angina.
  • Store tablets in their original dark glass bottle, tightly capped, away from heat, moisture, and light. Do not store in the bathroom.
  • Do not open the bottle frequently or leave it open, as the medication can lose potency.
  • Avoid sudden changes in position (e.g., standing up quickly) to prevent dizziness or fainting.
  • Avoid alcohol consumption, as it can worsen dizziness and lower blood pressure.
  • Do not use erectile dysfunction medications (e.g., Viagra, Cialis, Levitra) or medications for pulmonary hypertension (e.g., Adempas) while taking nitroglycerin, as this can cause a dangerous drop in blood pressure.

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:

acute_angina: 0.4 mg sublingually, repeat every 5 minutes up to 3 doses in 15 minutes. If pain persists, seek immediate medical attention.
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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 typically required for sublingual use due to rapid metabolism and short half-life.
Moderate: No specific adjustment typically required for sublingual use due to rapid metabolism and short half-life.
Severe: Use with caution; monitor for hypotension. No specific dose adjustment guidelines.
Dialysis: No specific adjustment typically required for sublingual use due to rapid metabolism and short half-life.

Hepatic Impairment:

Mild: No specific adjustment typically required for sublingual use.
Moderate: No specific adjustment typically required for sublingual use.
Severe: Use with caution; monitor for hypotension. No specific dose adjustment guidelines.

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 (predominantly) and arterial dilation, reducing preload and afterload, respectively. The reduction in cardiac work and myocardial oxygen demand alleviates angina.
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Pharmacokinetics

Absorption:

Bioavailability: High (sublingual, bypasses first-pass metabolism); very low (oral)
Tmax: 1-4 minutes (sublingual)
FoodEffect: Not applicable for sublingual administration.

Distribution:

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

Elimination:

HalfLife: 1-4 minutes (parent drug)
Clearance: High (approximately 13 L/min)
ExcretionRoute: Renal (as glucuronide conjugates of metabolites)
Unchanged: <1%
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Pharmacodynamics

OnsetOfAction: 1-3 minutes (sublingual)
PeakEffect: 2-5 minutes (sublingual)
DurationOfAction: 30-60 minutes (sublingual)

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 immediately or seek emergency 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
+ Difficulty 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. Although 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 symptoms that bother you or persist, contact your doctor for guidance:

Dizziness or headache
Mouth tingling
Burning sensation

Reporting Side Effects

This list is not exhaustive, and you may experience other 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 headache (common, but report if unusually severe)
  • Dizziness or lightheadedness that does not improve
  • Fainting
  • Blurred vision
  • Unusual sweating
  • Persistent chest pain after 3 doses in 15 minutes (seek emergency medical help 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 symptoms 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
If you are currently 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. It is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist.

To ensure your safety, it is vital to verify that it is safe to take this medication with all your existing medications and health conditions. Never start, stop, or adjust the dosage of any medication without 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, 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 navigating 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 hypotension (very low blood pressure)
  • Persistent throbbing headache
  • Flushing
  • Palpitations
  • Dizziness, vertigo
  • Nausea, vomiting
  • Syncope (fainting)
  • Methemoglobinemia (rare, but serious, causing bluish skin, shortness of breath, fatigue)

What to Do:

If you suspect an overdose, seek immediate medical attention or call Poison Control at 1-800-222-1222. Lie down with legs elevated. Medical treatment may include intravenous fluids, vasopressors, and methylene blue for 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.
  • Riociguat (soluble guanylate cyclase stimulator) - concurrent use can cause profound hypotension.
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Major Interactions

  • Other vasodilators (e.g., alpha-blockers, calcium channel blockers, ACE inhibitors) - additive hypotensive effects.
  • Alcohol - can enhance hypotensive effects.
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Moderate Interactions

  • Tricyclic antidepressants - may reduce hypotensive effects of nitroglycerin.
  • Phenothiazines - may reduce hypotensive effects of nitroglycerin.
  • Ergot alkaloids (e.g., ergotamine) - may antagonize the antianginal effect of nitrates and cause coronary vasoconstriction.
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Minor Interactions

  • Not many specific minor interactions are clinically significant for sublingual nitroglycerin.

Monitoring

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Baseline Monitoring

Blood Pressure (BP)

Rationale: To establish baseline and assess for hypotension.

Timing: Prior to administration, especially if patient is hypotensive or volume depleted.

Heart Rate (HR)

Rationale: To establish baseline and assess for reflex tachycardia.

Timing: Prior to administration.

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Routine Monitoring

Blood Pressure (BP)

Frequency: During acute anginal attack, after each dose if pain persists or if symptoms of hypotension occur.

Target: Maintain systolic BP > 90 mmHg or within patient's normal range.

Action Threshold: If systolic BP < 90 mmHg or symptomatic hypotension, hold further doses and manage hypotension.

Heart Rate (HR)

Frequency: During acute anginal attack, after each dose if pain persists or if symptoms of hypotension occur.

Target: Maintain within normal limits or patient's usual range.

Action Threshold: If significant bradycardia or reflex tachycardia occurs, assess patient status.

Angina Symptom Relief

Frequency: Continuously during acute attack.

Target: Complete or significant relief 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 is working)
  • Dizziness or lightheadedness
  • Flushing (redness of face/neck)
  • Nausea
  • Weakness
  • Blurred vision (rare, but indicates severe hypotension)

Special Patient Groups

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Pregnancy

Nitroglycerin is Pregnancy Category C. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects, but there are no adequate and well-controlled studies in pregnant women.

Trimester-Specific Risks:

First Trimester: Potential for fetal harm based on animal data; use only if clearly needed.
Second Trimester: Use with caution; monitor maternal blood pressure.
Third Trimester: Use with caution; monitor maternal blood pressure and potential for effects on uterine tone.
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Lactation

It is not known whether nitroglycerin is excreted in human milk. Due to its very short half-life, significant amounts reaching the infant are unlikely. Use with caution; consider the benefits of breastfeeding versus the potential risks to the infant.

Infant Risk: Low (L3 - Moderately Safe) due to short half-life, but monitor infant for signs of hypotension or methemoglobinemia (rare).
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Pediatric Use

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

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Geriatric Use

Elderly patients may be more susceptible to the hypotensive effects of nitroglycerin. Use with caution, starting with the lowest effective dose and monitoring blood pressure closely.

Clinical Information

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Clinical Pearls

  • Instruct patients to sit down before taking nitroglycerin to minimize the risk of dizziness or fainting due to hypotension.
  • Tablets should be placed under the tongue and allowed to dissolve completely; do not chew or swallow.
  • A tingling or burning sensation under the tongue may indicate potency, but its absence does not necessarily mean the tablet is inactive.
  • Patients should be advised to call 911 or seek emergency medical attention if chest pain is not relieved after 3 doses in 15 minutes.
  • Nitroglycerin tablets are sensitive to light, heat, and moisture. They should be stored in their original amber glass bottle with the cap tightly closed.
  • Patients should be instructed to replace their nitroglycerin supply every 6 months after opening, even if not all tablets have been used, as potency can diminish over time.
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Alternative Therapies

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

Average Cost: $10 - $30 per 25 tablets (0.4mg)
Generic Available: Yes
Insurance Coverage: Tier 1 (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, including the amount taken and the time it happened, to facilitate prompt and effective treatment.