Nitrostat 0.3mg Sl Tabs 100s
It is used to treat or prevent chest pain or pressure.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Antianginal
Pharmacologic Class
Vasodilator; Organic Nitrate
Pregnancy Category
Category C
FDA Approved
Jul 1956
DEA Schedule
Not Controlled
Overview
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. It's placed under the tongue and dissolves quickly.
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 let it 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, how often to take it, and when to seek medical help 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.
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 let it 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, how often to take it, and when to seek medical help 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.
Lifestyle & Tips
- Always carry your nitroglycerin with you, but keep it in its original dark glass bottle, tightly capped, away from heat, moisture, and direct light.
- Do not open the bottle frequently or leave it open, as the medication can lose potency.
- Replace your supply every 6 months after opening, even if there are pills left.
- Avoid sudden changes in position (e.g., standing up too quickly) to prevent dizziness.
- Avoid alcohol consumption, as it can worsen side effects like dizziness and low blood pressure.
- If you experience chest pain, sit down before taking the tablet to reduce the risk of fainting.
- Do not chew, crush, or swallow the tablet; let it dissolve completely under your tongue.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
0.3 mg to 0.6 mg sublingually at the first sign of an acute anginal attack. May repeat approximately every 5 minutes for a maximum of 3 doses within a 15-minute period. If pain persists, seek immediate 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.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended.
Moderate:
No specific adjustment recommended.
Severe:
No specific adjustment recommended, but use with caution due to potential for hypotension.
Dialysis:
No specific adjustment recommended, but monitor for hypotension.
Hepatic Impairment:
Mild:
No specific adjustment recommended.
Moderate:
No specific adjustment recommended.
Severe:
No specific adjustment recommended, but use with caution due to potential for hypotension.
Pharmacology
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 (predominant effect, reducing preload) and arterial dilation (reducing afterload), thereby decreasing myocardial oxygen demand. It also dilates coronary arteries, improving oxygen supply to ischemic areas.
Pharmacokinetics
Absorption:
Bioavailability:
High (sublingual, ~36% due to first-pass metabolism, but rapid absorption bypasses initial hepatic metabolism)
Tmax:
1-4 minutes
FoodEffect:
Not applicable for sublingual administration.
Distribution:
Vd:
3.3 L/kg
ProteinBinding:
60%
CnssPenetration:
Limited
Elimination:
HalfLife:
1-3 minutes
Clearance:
Not readily quantifiable due to rapid and extensive metabolism.
ExcretionRoute:
Renal (as inactive metabolites)
Unchanged:
<1%
Pharmacodynamics
OnsetOfAction:
1-3 minutes
PeakEffect:
5 minutes
DurationOfAction:
30-60 minutes
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
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 medical help right away:
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 stomach upset 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.
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 medical help right away:
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 stomach upset 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.
Seek Immediate Medical Attention If You Experience:
- Severe headache (common, but report if unusually severe or persistent)
- Dizziness or lightheadedness that doesn't go away
- Blurred vision
- Fainting (syncope)
- Persistent chest pain after 3 doses in 15 minutes (call 911 immediately)
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
+ Elevated intracranial pressure (e.g., due to bleeding in the brain or head injury)
+ Recent heart attack
+ Heart problems
+ Low blood volume (hypovolemia)
* Concurrent use of specific medications, such as:
+ 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 disclose all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems to your doctor and pharmacist. They will help you 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 consulting 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
+ Elevated intracranial pressure (e.g., due to bleeding in the brain or head injury)
+ Recent heart attack
+ Heart problems
+ Low blood volume (hypovolemia)
* Concurrent use of specific medications, such as:
+ 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 disclose all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems to your doctor and pharmacist. They will help you 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 consulting your doctor.
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, be cautious when performing tasks that require alertness and clear vision, such as driving, 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 ensure the best outcome for you and your baby.
When starting this medication, be cautious when performing tasks that require alertness and clear vision, such as driving, 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 ensure the best outcome for you and your baby.
Overdose Information
Overdose Symptoms:
- Profound hypotension (very low blood pressure)
- Persistent throbbing headache
- Palpitations
- Flushing
- Nausea and vomiting
- Dizziness and syncope
- Visual disturbances
- Diaphoresis (sweating)
- Bradycardia (slow heart rate)
- Methemoglobinemia (rare, but serious, causing bluish skin, lips, and nail beds, shortness of breath, fatigue)
What to Do:
Seek immediate medical attention. Call 911 or Poison Control (1-800-222-1222). Management involves supportive care, elevating legs, IV fluids for hypotension. Methylene blue may be used for severe methemoglobinemia.
Drug Interactions
Contraindicated Interactions
- Phosphodiesterase-5 (PDE5) inhibitors (e.g., sildenafil, tadalafil, vardenafil, avanafil) - concurrent use can cause profound hypotension, myocardial ischemia, and death.
- Riociguat - concurrent use can cause profound hypotension.
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 - can enhance hypotensive effects and cause syncope.
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 (contraindicated in some sources).
Minor Interactions
- Aspirin - may increase nitroglycerin levels and effects (minor clinical significance for sublingual).
Monitoring
Baseline Monitoring
Blood Pressure (BP)
Rationale: To establish baseline and assess risk of hypotension.
Timing: Prior to first dose, especially in hypotensive-prone patients.
Heart Rate (HR)
Rationale: To establish baseline and assess for reflex tachycardia.
Timing: Prior to first dose.
Routine Monitoring
Blood Pressure (BP)
Frequency: During acute anginal attack, after each dose if pain persists; periodically during chronic use.
Target: Maintain within patient's normal range, avoid symptomatic hypotension.
Action Threshold: If systolic BP drops significantly (e.g., <90 mmHg or >30 mmHg drop from baseline) or patient becomes symptomatic (dizziness, syncope), discontinue and manage hypotension.
Heart Rate (HR)
Frequency: During acute anginal attack, after each dose if pain persists; periodically during chronic use.
Target: Maintain within patient's normal range, avoid significant tachycardia.
Action Threshold: If significant reflex tachycardia occurs, consider managing with beta-blockers if appropriate and not contraindicated.
Angina Symptoms (frequency, severity, duration)
Frequency: Continuously during acute attack; regularly during chronic use.
Target: Complete relief of angina.
Action Threshold: If angina persists after 3 doses in 15 minutes, seek immediate medical attention. If angina worsens or changes pattern, re-evaluate treatment.
Symptom Monitoring
- Headache (common, often indicates drug activity)
- Dizziness/Lightheadedness
- Flushing
- Nausea/Vomiting
- Palpitations
- Weakness
- Blurred vision
- Syncope (fainting)
Special Patient Groups
Pregnancy
Nitroglycerin is 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; use with caution.
Second Trimester:
Use with caution; monitor maternal blood pressure.
Third Trimester:
Use with caution; monitor maternal blood pressure, especially close to delivery.
Lactation
Nitroglycerin is excreted in human milk. The amount is likely small due to its short half-life and extensive metabolism. However, caution should be exercised when administered to a nursing woman. Monitor the infant for signs of hypotension or methemoglobinemia.
Infant Risk:
Low to moderate risk. Monitor for signs of hypotension (lethargy, poor feeding) or methemoglobinemia (cyanosis).
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Not routinely used for angina in children.
Geriatric Use
Elderly patients may be more susceptible to the hypotensive effects of nitroglycerin. Use with caution, starting with the lowest effective dose and titrating slowly. Monitor blood pressure closely.
Clinical Information
Clinical Pearls
- Instruct patients to sit down immediately when experiencing chest pain before taking nitroglycerin to minimize the risk of syncope due to hypotension.
- Patients should be advised that a mild headache or flushing is a common side effect and often indicates the drug is working. However, severe or persistent headache should be reported.
- Emphasize the importance of proper storage: original dark glass bottle, tightly capped, away from heat, moisture, and light. Tablets lose potency quickly if not stored correctly.
- Advise patients to call 911 if chest pain is not relieved after 3 doses in 15 minutes, or if the pain worsens.
- Tolerance to nitrates can develop with frequent use. For sublingual use, this is less common with intermittent dosing for acute attacks but can occur with very frequent prophylactic use.
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 (Ranexa) for chronic angina.
- Percutaneous coronary intervention (PCI) or Coronary Artery Bypass Graft (CABG) for revascularization.
Cost & Coverage
Average Cost:
$50 - $150 per 100 tablets (0.3mg generic)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (generic)
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.