Nitrostat 0.3mg(1/200gr)sublt 100
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, Vasodilator
Pharmacologic Class
Organic Nitrate
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 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 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 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 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 quickly) to prevent dizziness or fainting.
- Limit or avoid alcohol consumption, as it can worsen dizziness and lower blood pressure.
- Maintain a healthy lifestyle, including a balanced diet, regular exercise (as advised by your doctor), and stress management, to help manage your heart condition.
- Carry your nitroglycerin with you at all times, especially during activities that might trigger angina.
Available Forms & Alternatives
Available Strengths:
Generic 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 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:
acuteAngina:
0.3 mg to 0.6 mg sublingually, repeat every 5 minutes for up to 3 doses in 15 minutes.
anginaProphylaxis:
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 accumulation of metabolites in severe renal failure.
Dialysis:
Considerations: Not well studied, but due to rapid metabolism and short half-life, significant accumulation of parent drug is unlikely. Monitor for adverse effects.
Hepatic Impairment:
Mild:
No specific adjustment recommended.
Moderate:
No specific adjustment recommended.
Severe:
Use with caution; severe hepatic impairment may reduce metabolism and increase risk of adverse effects. Monitor closely.
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, 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 of veins (venodilation), which reduces venous return to the heart (preload). This decreases myocardial wall tension and oxygen demand. It also causes some arterial dilation, reducing afterload and improving coronary blood flow, especially to ischemic areas.
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 (parent drug)
Clearance:
Very rapid
ExcretionRoute:
Primarily renal (as inactive metabolites)
Unchanged:
<1%
Pharmacodynamics
OnsetOfAction:
1-3 minutes
PeakEffect:
Approximately 5 minutes
DurationOfAction:
30-60 minutes
Confidence:
High
Safety & Warnings
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 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
Reporting Side Effects
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.
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 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
Reporting Side Effects
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.
Seek Immediate Medical Attention If You Experience:
- Severe headache (common, but can be intense)
- Dizziness, lightheadedness, or fainting (signs of low blood pressure)
- Blurred vision
- Unusual sweating
- Nausea or vomiting
- Persistent chest pain after 3 doses (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. 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, vitamins, or health problems, as this is not an exhaustive list of potential interactions.
To ensure safe use, consult your doctor and pharmacist about all your medications and health conditions. Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor to verify the safety of this medication in conjunction with your other treatments and health status.
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, vitamins, or health problems, as this is not an exhaustive list of potential interactions.
To ensure safe use, consult your doctor and pharmacist about all your medications and health conditions. Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor to verify the safety of this medication in conjunction with your other treatments and health status.
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 operating a vehicle or engaging in any 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 your healthcare providers and laboratory personnel that you are taking this drug.
Refrain from 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.
Be aware that taking more of this medication than prescribed or taking it more frequently than directed 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 possible outcome for you and your baby.
When starting this medication, avoid operating a vehicle or engaging in any 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 your healthcare providers and laboratory personnel that you are taking this drug.
Refrain from 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.
Be aware that taking more of this medication than prescribed or taking it more frequently than directed 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 possible outcome for you and your baby.
Overdose Information
Overdose Symptoms:
- Severe throbbing headache
- Profound hypotension (very low blood pressure)
- Palpitations
- Flushing
- Perspiration
- Nausea and vomiting
- Dizziness and syncope (fainting)
- Visual disturbances
- Methemoglobinemia (rare, but serious, causing bluish skin and difficulty breathing)
- Bradycardia (slow heart rate)
- Paralysis
- Coma
- Convulsions
What to Do:
If overdose is suspected, seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Management typically involves supportive care, including elevating legs, administering IV fluids, and potentially vasopressors for severe hypotension. Methylene blue may be used for methemoglobinemia.
Drug Interactions
Contraindicated Interactions
- Phosphodiesterase-5 (PDE5) inhibitors (e.g., sildenafil, tadalafil, vardenafil, avanafil) - concurrent use can cause profound hypotension, myocardial infarction, and death.
- Riociguat (soluble guanylate cyclase stimulator) - 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 - may enhance hypotensive effects and cause syncope.
Moderate Interactions
- Aspirin - may increase nitroglycerin levels and effects.
- Heparin - may decrease the anticoagulant effect of heparin.
- Tricyclic antidepressants and phenothiazines - may cause orthostatic hypotension.
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 for hypotension risk.
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.
Routine Monitoring
Blood Pressure (BP)
Frequency: During acute use, monitor frequently (e.g., every 5 minutes) until stable or symptoms resolve. For prophylactic use, periodically.
Target: Maintain within patient's normal range, avoid symptomatic hypotension.
Action Threshold: If systolic BP drops significantly (e.g., >20 mmHg from baseline or <90 mmHg) or patient becomes symptomatic (dizziness, syncope), discontinue and manage hypotension.
Heart Rate (HR)
Frequency: During acute use, monitor frequently. For prophylactic use, periodically.
Target: Maintain within patient's normal range, avoid significant tachycardia.
Action Threshold: If significant reflex tachycardia occurs, consider dose adjustment or concomitant therapy (e.g., beta-blocker if appropriate).
Angina Symptoms
Frequency: Continuously during acute use.
Target: Resolution or significant reduction of chest pain.
Action Threshold: If pain persists after 3 doses in 15 minutes, seek emergency medical attention.
Symptom Monitoring
- Headache (common side effect, often indicates drug activity)
- Dizziness or lightheadedness (signs of hypotension)
- Flushing
- Nausea/vomiting
- Weakness
- Palpitations
- Blurred vision
Special Patient Groups
Pregnancy
Category C. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Potential for fetal harm not ruled out; use only if clearly needed.
Second Trimester:
Potential for fetal harm not ruled out; use only if clearly needed.
Third Trimester:
Potential for fetal harm not ruled out; use only if clearly needed.
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 the drug or from the underlying maternal condition.
Infant Risk:
Unknown; potential for adverse effects on the infant cannot be ruled out.
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. Start with the lowest effective dose and titrate carefully. Monitor blood pressure closely to avoid orthostatic hypotension and falls.
Clinical Information
Clinical Pearls
- Instruct patients to sit down before taking nitroglycerin to minimize the risk of dizziness or fainting due to hypotension.
- Tablets should be placed under the tongue and allowed to dissolve completely; do not chew, crush, or swallow.
- Keep tablets in their original amber glass bottle with the cap tightly closed to protect from light, moisture, and air. Do not store in pillboxes.
- Discard any unused tablets 6 months after opening the bottle, as potency may decrease.
- A mild headache is a common side effect and often indicates the drug is working. If headache is severe or persistent, consult a healthcare provider.
- If chest pain is not relieved after the first dose, or if it worsens, take a second dose after 5 minutes. If still no relief after a second dose, take a third dose after another 5 minutes. If pain persists after 3 doses in 15 minutes, call 911 immediately.
- Patients should be advised to avoid concurrent use of PDE5 inhibitors (e.g., Viagra, Cialis, Levitra) due to the risk of profound and life-threatening hypotension.
Alternative Therapies
- Isosorbide dinitrate (oral, sublingual)
- Isosorbide mononitrate (oral)
- Beta-blockers (e.g., metoprolol, atenolol) for chronic angina prevention
- Calcium channel blockers (e.g., amlodipine, diltiazem) for chronic angina prevention
- Ranolazine (for chronic angina)
- Coronary revascularization procedures (e.g., angioplasty, bypass surgery) for severe or refractory angina
Cost & Coverage
Average Cost:
Varies, typically low for generic per 100 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (Generic)
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 this 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 emergency medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to facilitate prompt and effective treatment.