Nitroglycerin 0.4mg Sub Tabs 25s

Manufacturer ADVAGEN PHARMA 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 medicine 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

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 instruct you on how to take this medication, including the correct dose, frequency, and when to seek medical attention if needed. If you are unsure about any aspect of taking this medication, consult with 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 Doses

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

  • Sit down before taking the tablet to prevent dizziness or fainting.
  • Avoid sudden changes in position (e.g., standing up too quickly) to prevent orthostatic hypotension.
  • Limit alcohol consumption as it can worsen dizziness and low blood pressure.
  • Store tablets in their original amber glass bottle, tightly capped, away from heat, light, and moisture. Do not store in the bathroom.
  • Replace tablets after 6 months of opening the bottle, as they lose potency.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: 0.3 mg, 0.4 mg, or 0.6 mg sublingually at the first sign of an acute anginal attack. May repeat every 5 minutes for a maximum of 3 doses within 15 minutes. If pain persists after 3 doses, seek emergency medical attention.
Dose Range: 0.3 - 0.6 mg

Condition-Specific Dosing:

angina_prophylaxis: 0.3 mg, 0.4 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 adjustment recommended, use with caution.
Moderate: No specific adjustment recommended, use with caution.
Severe: No specific adjustment recommended, use with caution.
Dialysis: Not available

Hepatic Impairment:

Mild: No specific adjustment recommended, use with caution.
Moderate: No specific adjustment recommended, use with caution.
Severe: No specific adjustment recommended, use with caution.

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, which then activates guanylate cyclase, leading to an increase in cyclic guanosine monophosphate (cGMP). Increased cGMP causes dephosphorylation of myosin light chains, resulting in relaxation of vascular smooth muscle. This leads to venodilation (reducing preload and myocardial oxygen demand) and, to a lesser extent, arterial dilation (reducing afterload).
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Pharmacokinetics

Absorption:

Bioavailability: High (avoids first-pass metabolism via sublingual route)
Tmax: 1-3 minutes
FoodEffect: Not applicable for sublingual administration

Distribution:

Vd: Not available
ProteinBinding: Approximately 60%
CnssPenetration: Limited

Elimination:

HalfLife: 1-4 minutes
Clearance: Not available
ExcretionRoute: Primarily renal (as inactive metabolites)
Unchanged: Less than 1%
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Pharmacodynamics

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

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, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
- Severe dizziness or fainting
- Fast, slow, or irregular heartbeat
- 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 or may only have mild symptoms. If any of the following side effects bother you or do not go away, contact your doctor or seek medical help:
- Dizziness or headache
- Mouth tingling
- Burning sensation

Important Note
This list does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, 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 dizziness or fainting
  • Blurred vision
  • Unusual sweating
  • Persistent headache (beyond mild, expected nitrate headache)
  • Chest pain that does not go away after 3 doses in 15 minutes (call 911 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. 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
* Medications you are currently taking, particularly:
+ 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 conditions with your doctor and pharmacist. They will help you determine whether it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dosage 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, 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 the 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 ensure the best outcome for you and your baby.
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Overdose Information

Overdose Symptoms:

  • Severe hypotension (very low blood pressure)
  • Persistent throbbing headache
  • Palpitations
  • Flushing
  • Nausea and vomiting
  • Dizziness and fainting
  • Visual disturbances
  • Diaphoresis (excessive sweating)
  • Cyanosis (bluish discoloration of skin/lips)
  • Methemoglobinemia (rare, but serious)

What to Do:

Call 1-800-222-1222 (Poison Control) or seek immediate medical attention. Management typically involves supportive care, elevation of legs, and IV fluids for hypotension. 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 ischemia, 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 - may enhance hypotensive effects.
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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

  • Tricyclic antidepressants, phenothiazines - may cause orthostatic hypotension.

Monitoring

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Baseline Monitoring

Blood Pressure (BP)

Rationale: To establish baseline and assess for hypotension.

Timing: Prior to initiation and during initial treatment.

Heart Rate (HR)

Rationale: To establish baseline and assess for reflex tachycardia.

Timing: Prior to initiation and during initial treatment.

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Routine Monitoring

Blood Pressure (BP)

Frequency: As needed during acute anginal attacks; periodically during chronic use.

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

Action Threshold: Symptomatic hypotension (e.g., dizziness, syncope) or systolic BP < 90 mmHg.

Heart Rate (HR)

Frequency: As needed during acute anginal attacks; periodically during chronic use.

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

Action Threshold: Significant reflex tachycardia (>100 bpm or significant increase from baseline) if symptomatic or concerning.

Angina Symptoms

Frequency: Continuously during acute attacks; regularly during chronic use.

Target: Resolution or reduction of chest pain.

Action Threshold: Persistence or worsening of chest pain after 3 doses (seek emergency care).

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Symptom Monitoring

  • Headache (common, often indicates drug activity)
  • Dizziness
  • Lightheadedness
  • Flushing
  • Nausea
  • Palpitations

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, but there are no adequate and well-controlled studies in pregnant women.

Trimester-Specific Risks:

First Trimester: Potential risk, use with caution.
Second Trimester: Potential risk, use with caution.
Third Trimester: Potential risk, use with caution.
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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 developmental and health benefits of breastfeeding along with the mother’s clinical need for nitroglycerin and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition.

Infant Risk: Not available
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Pediatric Use

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

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Geriatric Use

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

Clinical Information

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Clinical Pearls

  • Instruct patients to sit down before taking nitroglycerin to minimize the risk of syncope due to hypotension.
  • Headache is a common side effect and often indicates the drug is working; it can be managed with mild analgesics.
  • Tablets lose potency quickly once the bottle is opened; patients should be advised to replace their supply every 6 months.
  • Emphasize the critical importance of calling 911 if chest pain persists after 3 doses taken 5 minutes apart.
  • Nitroglycerin sublingual tablets are for acute relief and prophylaxis; they are not for daily maintenance therapy (unless specifically prescribed for prophylaxis).
  • Patients should be educated on proper storage: original amber glass bottle, tightly capped, away from heat, light, and moisture (e.g., not in the bathroom or car glove compartment).
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Alternative Therapies

  • Isosorbide dinitrate (sublingual/oral)
  • Isosorbide mononitrate (oral)
  • Beta-blockers (for chronic angina prevention)
  • Calcium channel blockers (for chronic angina prevention)
  • Ranolazine (for chronic angina prevention)
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Cost & Coverage

Average Cost: Inexpensive per 25 tablets
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 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's a good idea 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 happened.