Nitrostat 0.4mg(1/150gr)sublt 25s
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 agent
Pharmacologic Class
Organic nitrate; Vasodilator
Pregnancy Category
Category C
FDA Approved
Jan 1970
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 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 the correct dosage and frequency of taking this medication. Make sure you understand:
What your dose is
How often you can take a dose
* When you may need to seek medical help
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 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 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 the correct dosage and frequency of taking this medication. Make sure you understand:
What your dose is
How often you can take a dose
* When you may need to seek medical help
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 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.
- Keep tablets in their original glass bottle, tightly capped, and away from heat, moisture, and direct light to maintain potency. Do not store in the bathroom.
- Always carry your nitroglycerin with you, especially if you anticipate activities that might trigger angina.
- Do not chew, crush, or swallow the tablet; place it under your tongue and let it dissolve completely.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
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 up to 3 doses in 15 minutes. If pain persists after 3 doses, seek emergency medical attention.
Dose Range:
0.3 - 0.6 mg
Condition-Specific Dosing:
prophylaxis:
0.3 mg or 0.6 mg sublingually 5 to 10 minutes prior to engaging in 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 dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
No specific dose adjustment recommended, use with caution due to potential for accumulation of active metabolites.
Dialysis:
Not well studied, use with caution.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
No specific dose adjustment recommended, use with caution due to extensive hepatic metabolism.
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, 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 smooth muscle cells. This leads to venodilation (predominantly) and arterial dilation, reducing preload and afterload, respectively. The reduction in preload decreases myocardial oxygen demand, alleviating angina.
Pharmacokinetics
Absorption:
Bioavailability:
High (sublingual route bypasses first-pass metabolism)
Tmax:
1-4 minutes
FoodEffect:
Not applicable for sublingual administration.
Distribution:
Vd:
3.3 L/kg
ProteinBinding:
Approximately 60%
CnssPenetration:
Limited
Elimination:
HalfLife:
1-4 minutes
Clearance:
Not readily quantifiable due to rapid metabolism
ExcretionRoute:
Renal (as inactive metabolites)
Unchanged:
<1%
Pharmacodynamics
OnsetOfAction:
1-3 minutes (sublingual)
PeakEffect:
5 minutes
DurationOfAction:
30-60 minutes
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
If you experience any of the following symptoms, call your doctor immediately or seek emergency medical attention, 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
While many people may not experience any side effects or only mild ones, it's essential to be aware of the following potential side effects. If you're concerned about any of these symptoms or if they persist, consult your doctor:
Dizziness or headache
Mouth tingling
Burning sensation
Important Note
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have any 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. Your doctor is available to provide medical advice on side effects, so don't hesitate to contact them.
If you experience any of the following symptoms, call your doctor immediately or seek emergency medical attention, 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
While many people may not experience any side effects or only mild ones, it's essential to be aware of the following potential side effects. If you're concerned about any of these symptoms or if they persist, consult your doctor:
Dizziness or headache
Mouth tingling
Burning sensation
Important Note
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have any 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. Your doctor is available to provide medical advice on side effects, so don't hesitate to contact them.
Seek Immediate Medical Attention If You Experience:
- Severe or persistent headache
- Dizziness or lightheadedness that doesn't go away
- Blurred vision
- Unusual sweating
- Fainting (syncope)
- Chest pain that does not improve 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 and its symptoms.
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 disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you may have.
To ensure your safety, consult with your doctor and pharmacist about all your medications and health conditions to confirm that it is safe to take this medication. Never start, stop, or adjust the dosage of any medication without first 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 and its symptoms.
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 disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you may have.
To ensure your safety, consult with your doctor and pharmacist about all your medications and health conditions to confirm that it is safe to take this medication. Never start, stop, or adjust the dosage of any medication without first 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, 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 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 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.
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 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 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.
Overdose Information
Overdose Symptoms:
- Severe throbbing headache
- Flushing
- Perspiration
- Nausea and vomiting
- Dizziness
- Palpitations
- Visual disturbances
- Syncope
- Methemoglobinemia (rare, but serious, presenting as cyanosis, dyspnea, confusion)
- Marked hypotension
- Bradycardia
- Tachycardia
- Increased intracranial pressure (with cerebral symptoms)
What to Do:
Seek immediate medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222.
Drug Interactions
Contraindicated Interactions
- Phosphodiesterase-5 (PDE5) inhibitors (e.g., sildenafil, tadalafil, vardenafil, avanafil) - risk of severe hypotension and cardiovascular collapse.
- Riociguat (soluble guanylate cyclase stimulator) - risk of severe hypotension.
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 syncope.
Moderate Interactions
- Aspirin - may increase nitroglycerin levels and effects.
- Heparin - may decrease the anticoagulant effect of heparin (monitor aPTT).
Minor Interactions
- Dihydroergotamine - may increase the bioavailability of dihydroergotamine, leading to increased vasoconstriction.
Monitoring
Baseline Monitoring
Blood Pressure (BP)
Rationale: To establish baseline and assess risk of hypotension.
Timing: Prior to initiation, especially in hypotensive patients.
Heart Rate (HR)
Rationale: To establish baseline and assess for reflex tachycardia.
Timing: Prior to initiation.
Routine Monitoring
Blood Pressure (BP)
Frequency: During acute anginal attack, monitor after each dose if possible, or if symptoms of hypotension occur.
Target: Maintain within patient's normal limits, avoid symptomatic hypotension.
Action Threshold: Systolic BP <90 mmHg or symptomatic hypotension (dizziness, syncope).
Angina Symptoms
Frequency: Continuously during an acute attack.
Target: Resolution of chest pain.
Action Threshold: Persistent or worsening chest pain after 3 doses over 15 minutes (seek emergency care).
Headache/Dizziness
Frequency: As needed, patient self-report.
Target: Tolerable level.
Action Threshold: Severe or debilitating headache/dizziness (may require dose adjustment or alternative therapy).
Symptom Monitoring
- Chest pain (angina)
- Headache (nitrate headache)
- Dizziness
- Lightheadedness
- Flushing
- Nausea
- Palpitations
- Blurred vision
- Syncope
Special Patient Groups
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.
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 nitroglycerin or from the underlying maternal condition.
Infant Risk:
Unknown, potential for hypotension or methemoglobinemia in infant.
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 nitroglycerin. Use with caution, starting with the lowest effective dose and titrating slowly. Increased risk of falls due to orthostatic hypotension.
Clinical Information
Clinical Pearls
- Instruct patients to sit down before taking nitroglycerin to minimize the risk of falls due to orthostatic hypotension.
- Patients should be advised that a 'nitrate headache' is a common side effect and often indicates the drug is working. It can be managed with acetaminophen.
- Emphasize the critical importance of calling 911 if chest pain persists after 3 doses in 15 minutes.
- Tablets lose potency quickly when exposed to air, light, or moisture. Stress proper storage in the original amber glass bottle, tightly capped.
- Patients should be educated on the absolute contraindication with PDE5 inhibitors (e.g., Viagra, Cialis) due to life-threatening hypotension.
- Check the expiration date frequently, as potency can diminish over time, even with proper storage.
Alternative Therapies
- Isosorbide dinitrate (long-acting nitrate)
- Isosorbide mononitrate (long-acting nitrate)
- Beta-blockers (e.g., metoprolol, atenolol) for chronic angina prophylaxis
- Calcium channel blockers (e.g., amlodipine, diltiazem) for chronic angina prophylaxis
- Ranolazine (for chronic angina)
- Coronary revascularization procedures (e.g., PCI, CABG) for definitive treatment of CAD.
Cost & Coverage
Average Cost:
Varies, typically $20-$50 per 25 tablets (0.4mg)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (Generic), Tier 3 or 4 (Brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it's 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 be sure to check with your pharmacist for more information. If you have any questions or concerns about your 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 medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to ensure you receive the best possible care.