Nitrostat 0.4mg(1/150gr)sublt 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
Organic nitrate; Vasodilator
Pregnancy Category
Category C
FDA Approved
Jun 1938
DEA Schedule
Not Controlled
Overview
What is this medicine?
Nitroglycerin is a medication 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.
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
- Avoid sudden changes in position (e.g., standing up too quickly) to prevent dizziness or fainting.
- Avoid alcohol consumption, as it can worsen side effects like dizziness and low blood pressure.
- Store tablets in their original dark glass bottle with the cap tightly closed, away from heat, moisture, and direct light. Do not store in the bathroom.
- Do not open the bottle until ready to use, and replace the cap immediately after taking a tablet.
- Tablets may lose potency over time once the bottle is opened; replace unused tablets after 6 months of opening or by the expiration date, whichever comes first.
- Carry your nitroglycerin with you at all times if prescribed for angina.
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 be repeated approximately 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:
0.3 mg to 0.6 mg sublingually, repeat every 5 minutes for up to 3 doses in 15 minutes. If pain persists, seek immediate medical attention.
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
Dialysis:
Consideration for close monitoring of blood pressure due to potential for hypotension, but no specific dose adjustment typically required for acute use.
Hepatic Impairment:
Mild:
No specific adjustment recommended
Moderate:
No specific adjustment recommended
Severe:
No specific adjustment recommended
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 cyclic GMP (cGMP), which leads to dephosphorylation of myosin light chains and relaxation of smooth muscle. This results in venodilation (primary effect, reducing preload and myocardial oxygen demand) and arterial dilation (reducing afterload), as well as dilation of coronary arteries, improving myocardial blood flow.
Pharmacokinetics
Absorption:
Bioavailability:
Highly variable (sublingual route bypasses first-pass metabolism, leading to higher bioavailability than oral)
Tmax:
1-4 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
ExcretionRoute:
Renal (as inactive metabolites)
Unchanged:
Less than 1%
Pharmacodynamics
OnsetOfAction:
1-3 minutes (sublingual)
PeakEffect:
5 minutes (sublingual)
DurationOfAction:
30-60 minutes (sublingual)
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
If you experience any of the following symptoms, call your doctor or seek medical attention immediately, as they may be signs of a severe and potentially life-threatening reaction:
Allergic reaction symptoms, 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
Most people do not experience significant side effects, but some may occur. If you are bothered by any of the following side effects or if they do not go away, contact your doctor:
Dizziness or headache
Mouth tingling
Burning sensation
This is not an exhaustive list of all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, you can also contact your doctor. Additionally, you can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
If you experience any of the following symptoms, call your doctor or seek medical attention immediately, as they may be signs of a severe and potentially life-threatening reaction:
Allergic reaction symptoms, 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
Most people do not experience significant side effects, but some may occur. If you are bothered by any of the following side effects or if they do not go away, contact your doctor:
Dizziness or headache
Mouth tingling
Burning sensation
This is not an exhaustive list of all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, you can also contact your doctor. Additionally, you can 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 intolerable)
- Dizziness, lightheadedness, or fainting (signs of low blood pressure)
- Blurred vision
- Unusual sweating
- Pale skin
- Weakness
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 medications, including prescription and over-the-counter drugs, natural products, and vitamins, as this is not an exhaustive list of potential interactions.
To ensure safe use, it is crucial to discuss all your medications and health problems with your doctor and pharmacist. Do not initiate, discontinue, or modify the dose of any medication without first consulting your doctor to confirm that it is safe to do so in conjunction with this medication.
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 medications, including prescription and over-the-counter drugs, natural products, and vitamins, as this is not an exhaustive list of potential interactions.
To ensure safe use, it is crucial to discuss all your medications and health problems with your doctor and pharmacist. Do not initiate, discontinue, or modify the dose of any medication without first consulting your doctor to confirm that it is safe to do so in conjunction with this medication.
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 drug, 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, get up slowly from a sitting or lying position. Be cautious when climbing stairs to reduce the risk of falls. Monitor your blood pressure as directed by your healthcare provider.
This medication may interfere with certain laboratory tests. Be sure to notify all your healthcare providers and laboratory personnel that you are taking this drug. Additionally, avoid consuming alcohol while on this medication, as it may interact with the drug.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. Taking more than the prescribed dose or frequency can lead to tolerance, reducing the medication's effectiveness. If you find that the drug is no longer working as well, consult your doctor. Do not exceed the recommended dose.
If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the potential benefits and risks with your doctor to ensure the best decision for you and your baby.
To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying position. Be cautious when climbing stairs to reduce the risk of falls. Monitor your blood pressure as directed by your healthcare provider.
This medication may interfere with certain laboratory tests. Be sure to notify all your healthcare providers and laboratory personnel that you are taking this drug. Additionally, avoid consuming alcohol while on this medication, as it may interact with the drug.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. Taking more than the prescribed dose or frequency can lead to tolerance, reducing the medication's effectiveness. If you find that the drug is no longer working as well, consult your doctor. Do not exceed the recommended dose.
If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the potential benefits and risks with your doctor to ensure the best decision for you and your baby.
Overdose Information
Overdose Symptoms:
- Severe throbbing headache
- Flushing
- Perspiration
- Nausea and vomiting
- Dizziness
- Syncope (fainting)
- Tachycardia (fast heart rate)
- Hypotension (low blood pressure)
- 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 your local emergency number. For advice, call a poison control center at 1-800-222-1222.
Drug Interactions
Contraindicated Interactions
- Phosphodiesterase-5 (PDE5) inhibitors (e.g., sildenafil, tadalafil, vardenafil, avanafil) - concurrent use can cause profound and prolonged hypotension, syncope, or myocardial ischemia/infarction.
- Riociguat (soluble guanylate cyclase stimulator) - concurrent use can cause severe hypotension.
Major Interactions
- Other vasodilators (e.g., hydralazine, minoxidil, alpha-blockers) - 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.
Moderate Interactions
- Aspirin - may increase nitroglycerin levels and effects.
- Heparin - may decrease the anticoagulant effect of heparin (requires close monitoring of aPTT).
Minor Interactions
- Dihydroergotamine - may increase the bioavailability of dihydroergotamine and its vasoconstrictive effects.
Monitoring
Baseline Monitoring
Blood Pressure (BP)
Rationale: To establish baseline and assess for hypotension before administration.
Timing: Before first dose, especially in patients prone to hypotension.
Heart Rate (HR)
Rationale: To establish baseline and assess for reflex tachycardia.
Timing: Before first dose.
Routine Monitoring
Blood Pressure (BP)
Frequency: Immediately after administration, then as needed based on patient response and symptoms.
Target: Maintain within patient's normal limits, avoid symptomatic hypotension.
Action Threshold: Systolic BP < 90 mmHg or symptomatic hypotension (dizziness, syncope).
Heart Rate (HR)
Frequency: Immediately after administration, then as needed.
Target: Maintain within patient's normal limits, avoid significant tachycardia.
Action Threshold: Significant reflex tachycardia (>100 bpm or >20 bpm increase from baseline).
Angina symptoms (pain relief)
Frequency: Continuously after administration.
Target: Complete or significant relief of chest pain.
Action Threshold: Persistent or worsening chest pain after 3 doses; seek emergency medical attention.
Symptom Monitoring
- Headache (common side effect, often indicates drug activity)
- Dizziness or lightheadedness (sign of hypotension)
- Flushing
- Nausea
- Palpitations
- Blurred vision
Special Patient Groups
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:
Potential for fetal harm based on animal data; use with caution.
Third Trimester:
Potential for fetal harm based on animal data; use with caution.
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 benefits of breastfeeding, the risk of infant exposure, and the risk of untreated maternal condition.
Infant Risk:
Not available (unknown)
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Not recommended for use in children.
Geriatric Use
Elderly patients may be more susceptible to the hypotensive effects of nitrates and may experience increased dizziness and lightheadedness. Use with caution, starting with the lowest effective dose and monitoring blood pressure closely.
Clinical Information
Clinical Pearls
- Instruct patients to sit down when taking nitroglycerin to minimize dizziness or fainting due to hypotension.
- If chest pain is not relieved after the first dose, the patient should call 911 or seek immediate medical attention while continuing to take up to 2 more doses at 5-minute intervals.
- Patients should be advised that a mild headache is a common side effect and often indicates the drug is working. This headache can be managed with mild analgesics.
- Nitroglycerin tablets are sensitive to light, heat, and moisture. Proper storage in the original amber glass bottle, tightly capped, is crucial for maintaining potency.
- Tolerance to the effects of nitroglycerin can develop with continuous or frequent use. This is less common with intermittent sublingual use for acute angina.
- The tingling or burning sensation under the tongue is not a reliable indicator of potency; lack of sensation does not mean the tablet is ineffective.
Alternative Therapies
- Long-acting nitrates (e.g., isosorbide mononitrate, isosorbide dinitrate) for angina prophylaxis.
- Beta-blockers (e.g., metoprolol, atenolol) for angina prophylaxis.
- Calcium channel blockers (e.g., amlodipine, diltiazem, verapamil) for angina prophylaxis.
- Ranolazine (for chronic angina).
Cost & Coverage
Average Cost:
Varies widely, typically $10-$50 per 25 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (generic), Tier 3 (brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it is 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 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 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 details about the medication taken, the amount, and the time it happened.