Nitroglycerin 0.6mg Sub Tabs 100

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
Jun 1938
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Nitroglycerin is a medication used to 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. It's taken by placing a small tablet 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. Read all the information provided with your medication and follow the instructions closely.

Administration

Before taking your medication, sit down. Place the tablet under your tongue and let it dissolve completely. Do not chew, suck, or swallow the tablet. 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, how often to take it, and when to seek medical attention 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 the 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 when taking nitroglycerin to prevent dizziness or fainting from a sudden drop in blood pressure.
  • Avoid sudden changes in position (e.g., standing up quickly) to prevent orthostatic hypotension.
  • Avoid alcohol consumption, as it can worsen dizziness and low blood pressure.
  • Do not take sildenafil (Viagra), tadalafil (Cialis), vardenafil (Levitra), or avanafil (Stendra) if you are taking nitroglycerin, as this combination can cause a dangerous drop in blood pressure.
  • Keep tablets in their original amber glass bottle, tightly capped, away from heat, moisture, and light. Do not put cotton in the bottle, as it can absorb the medication.
  • Replace tablets after 6 months of opening the bottle, as they can lose potency.

Dosing & Administration

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Adult Dosing

Standard Dose: 0.3 mg to 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 to 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.
Moderate: No specific adjustment recommended.
Severe: Use with caution; monitor for adverse effects due to potential accumulation of metabolites.
Dialysis: Not available

Hepatic Impairment:

Mild: No specific adjustment recommended.
Moderate: No specific adjustment recommended.
Severe: Use with caution; monitor for adverse effects 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, 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 systemic vasodilation, primarily affecting venous capacitance vessels (reducing preload) and, to a lesser extent, arterial vessels (reducing afterload). It also dilates coronary arteries, improving myocardial oxygen supply.
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Pharmacokinetics

Absorption:

Bioavailability: High (sublingual route bypasses first-pass metabolism)
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: Very rapid
ExcretionRoute: Primarily renal excretion of metabolites
Unchanged: Less than 1%
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Pharmacodynamics

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

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

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 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 dizziness or fainting
  • Blurred vision
  • Unusual sweating
  • Pale skin
  • Persistent or worsening chest pain after 3 doses
  • Severe headache that is intolerable
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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 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
Note that this is not an exhaustive list of all potential interactions. Therefore, 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.

To guarantee your safety, always verify with your doctor before starting, stopping, or adjusting the dosage of any 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 ensure the best outcome for you and your baby.
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Overdose Information

Overdose Symptoms:

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

What to Do:

Immediately seek emergency medical attention or call Poison Control at 1-800-222-1222. Lay the patient down with legs elevated. Administer IV fluids. Vasopressors may be used if fluid resuscitation is insufficient. For methemoglobinemia, methylene blue may be administered.

Drug Interactions

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Contraindicated Interactions

  • Phosphodiesterase-5 (PDE5) inhibitors (e.g., sildenafil, tadalafil, vardenafil, avanafil) - concurrent use can cause severe hypotension, syncope, or myocardial ischemia.
  • Riociguat (soluble guanylate cyclase stimulator) - concurrent use can cause severe 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, ARBs, diuretics) - additive hypotensive effects.
  • Alcohol - may enhance hypotensive effects and cause orthostatic hypotension.
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Moderate Interactions

  • Tricyclic antidepressants - may cause orthostatic hypotension.
  • Phenothiazines - may cause orthostatic hypotension.
  • Ergotamine - nitrates may reduce the therapeutic effect of ergotamine and enhance its 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 for hypotension risk.

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: During acute anginal attack (after each dose if possible), periodically during chronic use.

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

Action Threshold: Systolic BP < 90 mmHg or symptomatic hypotension; consider holding dose or reducing frequency.

Heart Rate (HR)

Frequency: During acute anginal attack, periodically during chronic use.

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

Action Threshold: Significant reflex tachycardia; consider concomitant beta-blocker if appropriate.

Angina Symptoms (frequency, severity, duration)

Frequency: Continuously by patient, periodically by clinician.

Target: Reduction or elimination of anginal episodes.

Action Threshold: Persistent or worsening angina after maximum doses; seek emergency care.

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Symptom Monitoring

  • Headache (common, often indicates drug activity)
  • Dizziness
  • Lightheadedness
  • Flushing
  • Nausea
  • Palpitations
  • Blurred vision (rare, severe hypotension)

Special Patient Groups

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Pregnancy

Nitroglycerin is Pregnancy Category C. 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: Risk not ruled out; use only if potential benefit justifies potential risk to fetus.
Second Trimester: Risk not ruled out; use only if potential benefit justifies potential risk to fetus.
Third Trimester: Risk not ruled out; use only if potential benefit justifies potential risk to fetus.
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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. The decision to discontinue nursing or to discontinue the drug should take into account the importance of the drug to the mother.

Infant Risk: Risk unknown; potential for adverse effects on the infant.
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Pediatric Use

Safety and effectiveness in pediatric patients have not been established. Use is generally not recommended.

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Geriatric Use

Elderly patients may be more susceptible to the hypotensive effects of nitroglycerin. Initiate therapy 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 when taking nitroglycerin to minimize the risk of orthostatic hypotension and syncope.
  • A common side effect is headache ('nitrate headache'), which often indicates the drug is working. This can be managed with acetaminophen or ibuprofen.
  • Tablets should cause a slight burning or tingling sensation under the tongue; absence of this sensation does not necessarily mean the tablet is ineffective, but it can be an indicator of potency loss.
  • Patients should be advised to call 911 or seek emergency medical attention if chest pain is not relieved after 3 doses taken 5 minutes apart.
  • Proper storage is crucial: keep in the original amber glass bottle, tightly capped, away from heat, moisture, and light. Do not store in pill organizers or cotton-filled containers, as this can lead to loss of potency.
  • Tolerance to the effects of nitroglycerin can develop with continuous or frequent use. A nitrate-free interval (e.g., 8-12 hours overnight) may be necessary to restore sensitivity.
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Alternative Therapies

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

Average Cost: $20 - $50 per 100 tablets (0.4mg or 0.6mg)
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 for further guidance. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may have additional patient information leaflets, 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 reporting the incident, be prepared to provide detailed information about the medication taken, the amount, and the time it occurred.