Nitroglycerin 0.3mg Sl Tabs 100

Manufacturer GLENMARK 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 agent
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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 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 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.

Understanding Your Dosage

Your doctor will provide guidance on how to take this medication, including the correct dose, frequency, and potential need for medical attention. 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. If you have questions or concerns about taking your medication, consult with your doctor for guidance.
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Lifestyle & Tips

  • Always carry your nitroglycerin with you.
  • Store tablets in their original amber glass bottle, tightly capped, away from light, heat, and moisture. Do NOT store in plastic pillboxes, as the medication can lose potency.
  • Replace tablets every 6-8 months after opening, even if not expired, as they can lose potency.
  • Avoid sudden changes in position (e.g., standing up quickly) to prevent dizziness or fainting.
  • Avoid alcohol while taking nitroglycerin, as it can increase dizziness and lower blood pressure.
  • Do not take this medication if you have recently taken medications for erectile dysfunction (e.g., Viagra, Cialis, Levitra) or pulmonary hypertension (e.g., Adempas), as this can cause a dangerous drop in blood pressure.

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 a 15-minute period. If pain persists after 3 doses, seek immediate 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 an anginal attack.
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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.
Moderate: No specific dose adjustment recommended.
Severe: No specific dose adjustment recommended, but use with caution due to potential for accumulation of metabolites.
Dialysis: Not specifically studied; use with caution.

Hepatic Impairment:

Mild: No specific dose adjustment recommended.
Moderate: No specific dose adjustment recommended.
Severe: No specific dose adjustment recommended, but use with caution 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. NO 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 (predominantly) and arterial dilation, reducing preload and to a lesser extent afterload, thereby decreasing myocardial oxygen demand. It also causes redistribution of coronary blood flow to ischemic areas.
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Pharmacokinetics

Absorption:

Bioavailability: High first-pass metabolism when taken orally; sublingual route bypasses first-pass metabolism, leading to rapid and complete absorption.
Tmax: 1-3 minutes (sublingual)
FoodEffect: Not applicable for sublingual administration.

Distribution:

Vd: 3.3 L/kg
ProteinBinding: 60%
CnssPenetration: Limited

Elimination:

HalfLife: 1-4 minutes (parent drug)
Clearance: Not available (very rapid)
ExcretionRoute: Renal (as metabolites)
Unchanged: <1%
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Pharmacodynamics

OnsetOfAction: 1-3 minutes (sublingual)
PeakEffect: 3-5 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 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 for advice:

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, don't hesitate to reach out to 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 or lightheadedness
  • Blurred vision
  • Fainting (syncope)
  • Persistent chest pain 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
+ Elevated intracranial pressure (e.g., due to bleeding in the brain or a head injury)
+ Recent heart attack
+ Heart problems
+ Low blood volume (hypovolemia)
Concurrent use of specific medications, such as:
+ Phosphodiesterase type 5 inhibitors: avanafil, riociguat, sildenafil, tadalafil, or vardenafil
+ Ergot alkaloids: dihydroergotamine, ergonovine, ergotamine, or methylergonovine
Other prescription or over-the-counter (OTC) medications, natural products, or vitamins you are taking, as this is not an exhaustive list of potential interactions.

To ensure your safety, it is crucial to discuss all your medications and health problems with your doctor and pharmacist. They will help determine whether it is safe to take this medication with your existing treatments and health conditions. Never start, stop, or adjust 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 reduced 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 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 (sweating)
  • Syncope (fainting)
  • Orthostatic hypotension (severe drop in BP upon standing)
  • Methemoglobinemia (rare, but serious, causing bluish skin, shortness of breath, fatigue)

What to Do:

If overdose is suspected, seek immediate medical attention or call a poison control center (1-800-222-1222). Management is supportive, including elevating legs, IV fluids for hypotension, and 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 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., alpha-blockers, calcium channel blockers, ACE inhibitors, ARBs) - increased risk of hypotension.
  • Alcohol - increased risk of hypotension and dizziness.
  • Ergot alkaloids (e.g., ergotamine, dihydroergotamine) - nitrates may enhance the vasoconstrictive effects of ergot alkaloids, leading to severe vasoconstriction and ischemia.
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Moderate Interactions

  • Antihypertensives (general) - additive hypotensive effects.
  • Tricyclic antidepressants (TCAs) - may cause orthostatic hypotension.
  • Phenothiazines - may cause orthostatic hypotension.
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Minor Interactions

  • Aspirin - may increase nitroglycerin levels and effects (though clinical significance is often minor).

Monitoring

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Baseline Monitoring

Blood Pressure (BP)

Rationale: To establish baseline and assess for hypotension.

Timing: Prior to initiation, especially in patients prone to hypotension.

Heart Rate (HR)

Rationale: To establish baseline and assess for reflex tachycardia.

Timing: Prior to initiation.

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Routine Monitoring

Blood Pressure (BP)

Frequency: During acute anginal attack (if feasible), or periodically if used for prophylaxis.

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

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

Heart Rate (HR)

Frequency: During acute anginal attack (if feasible).

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

Action Threshold: Significant reflex tachycardia (>100 bpm or >20 bpm increase from baseline) that is symptomatic.

Angina Symptoms

Frequency: Continuously during an anginal attack.

Target: Resolution of chest pain.

Action Threshold: Persistence of chest pain after 3 doses in 15 minutes (seek emergency care).

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Symptom Monitoring

  • Headache (common, often indicates drug is working)
  • Dizziness
  • Lightheadedness
  • Flushing
  • Nausea
  • Palpitations
  • Blurred vision
  • Syncope (fainting)

Special Patient Groups

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Pregnancy

Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects at high doses, but human data are limited.

Trimester-Specific Risks:

First Trimester: Limited data, theoretical risk of teratogenicity at high doses.
Second Trimester: Limited data.
Third Trimester: Limited data, 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 woman. Consider the benefit of breastfeeding versus the potential risk to the infant.

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 children.

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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. Increased risk of falls due to orthostatic hypotension.

Clinical Information

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Clinical Pearls

  • Patients should be instructed to sit down before taking nitroglycerin to minimize the risk of syncope due to hypotension.
  • A tingling or burning sensation under the tongue after administration indicates the tablet is potent; absence of this sensation does not necessarily mean the tablet is inactive.
  • Tablets should be stored in their original amber glass bottle, tightly capped, and protected from light, moisture, and extreme temperatures. Do not transfer to plastic pillboxes, as the drug can be absorbed by plastic.
  • Patients should be advised to call 911 immediately if chest pain is not relieved after 3 doses in 15 minutes.
  • Headache is a very common side effect and often indicates the drug is working. It can be managed with acetaminophen or ibuprofen, but patients should be aware of it.
  • Tolerance to the effects of nitroglycerin can develop with continuous or frequent use. This is less common with intermittent sublingual use for acute angina.
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Alternative Therapies

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

Average Cost: Varies, typically $20-$50 per 100 tablets (0.3mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (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 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's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't 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.