Nitrostat 0.6mg(1/100gr)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
Pharmacologic Class
Vasodilator; Nitrate
Pregnancy Category
C
FDA Approved
Jan 1970
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 get to 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. If you have any questions or concerns about taking your medication, consult with 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. If you have any questions or concerns about taking your medication, consult with your doctor.
Lifestyle & Tips
- Avoid sudden changes in position (e.g., standing up too quickly) to prevent dizziness or fainting.
- Limit alcohol consumption, as it can worsen dizziness and lower blood pressure.
- Store tablets in their original, tightly closed glass bottle, away from heat, moisture, and light. Do not store in the bathroom.
- Do not open the bottle until ready to use, and keep cotton out of the bottle after opening.
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 every 5 minutes for up to 3 doses. If pain persists after 3 doses, seek emergency medical attention.
Dose Range:
0.3 - 0.6 mg
Condition-Specific Dosing:
acute_angina:
0.3 mg to 0.6 mg sublingually, repeated every 5 minutes for up to 3 doses if needed.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended due to rapid metabolism and short half-life.
Moderate:
No specific adjustment recommended.
Severe:
Use with caution; monitor for exaggerated hypotensive effects.
Dialysis:
Considerations: No specific recommendations, but monitor closely.
Hepatic Impairment:
Mild:
No specific adjustment recommended.
Moderate:
No specific adjustment recommended.
Severe:
Use with caution; monitor for exaggerated hypotensive effects.
Pharmacology
Mechanism of Action
Nitroglycerin 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 vasodilation, primarily of veins (reducing preload) and to a lesser extent arteries (reducing afterload), thereby decreasing myocardial oxygen demand and relieving angina.
Pharmacokinetics
Absorption:
Bioavailability:
Variable (sublingual administration bypasses first-pass metabolism, but still subject to some degradation)
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
Clearance:
High (approximately 13 L/min)
ExcretionRoute:
Renal (as metabolites)
Unchanged:
<1%
Pharmacodynamics
OnsetOfAction:
1-3 minutes
PeakEffect:
5 minutes
DurationOfAction:
30-60 minutes
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 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 symptoms that bother you or persist, contact your doctor:
Dizziness or headache
Mouth tingling
Burning sensation
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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. Your doctor can provide medical advice on managing side effects.
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 symptoms that bother you or persist, contact your doctor:
Dizziness or headache
Mouth tingling
Burning sensation
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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. Your doctor can provide medical advice on managing side effects.
Seek Immediate Medical Attention If You Experience:
- Severe or persistent headache (common, but report if intolerable)
- Dizziness, lightheadedness, or fainting (especially when standing up)
- Blurred vision
- Dry mouth
- Unusual sweating
- 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. Be sure to describe the symptoms you experienced.
Certain health conditions, including:
+ Anemia
+ Increased pressure in the head, which may be caused by bleeding in the brain or a head injury
+ A 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 discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist to ensure safe use.
Remember, before starting, stopping, or adjusting the dose of any medication, you must consult with your doctor to confirm it is safe to do so in conjunction with this medication and your individual health profile.
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 symptoms you experienced.
Certain health conditions, including:
+ Anemia
+ Increased pressure in the head, which may be caused by bleeding in the brain or a head injury
+ A 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 discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist to ensure safe use.
Remember, before starting, stopping, or adjusting the dose of any medication, you must consult with your doctor to confirm it is safe to do so in conjunction with this medication and your individual health profile.
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 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 make an informed decision about its use.
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 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 make an informed decision about its use.
Overdose Information
Overdose Symptoms:
- Severe throbbing headache
- Flushing
- Dizziness
- Palpitations
- Visual disturbances
- Nausea, vomiting
- Diaphoresis (sweating)
- Syncope (fainting)
- Orthostatic hypotension
- Methemoglobinemia (rare, but serious, indicated by cyanosis)
What to Do:
Seek immediate medical attention. Call 911 or Poison Control (1-800-222-1222). Management involves supportive care, including elevating legs, IV fluids for hypotension, and potentially methylene blue 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 (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.
Moderate Interactions
- Tricyclic antidepressants - may reduce the hypotensive effect of nitroglycerin.
- Ergotamine - nitrates may antagonize the effects of ergotamine; avoid concurrent use.
Monitoring
Baseline Monitoring
Blood Pressure (BP)
Rationale: To establish baseline and assess risk of hypotension.
Timing: Prior to administration, especially in patients prone to hypotension.
Heart Rate (HR)
Rationale: To establish baseline and assess for reflex tachycardia.
Timing: Prior to administration.
Routine Monitoring
Blood Pressure (BP)
Frequency: During acute anginal attack, after each dose if multiple doses are given.
Target: Maintain within patient's normal limits, 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 use and manage hypotension.
Heart Rate (HR)
Frequency: During acute anginal attack, after each dose if multiple doses are given.
Target: Maintain within patient's normal limits, avoid significant tachycardia.
Action Threshold: If significant reflex tachycardia occurs, consider management.
Symptom Monitoring
- Angina relief (reduction or cessation of chest pain)
- Headache (common side effect, often indicates drug activity)
- Dizziness or lightheadedness (signs of hypotension)
- Flushing
- Nausea
Special Patient Groups
Pregnancy
Pregnancy Category C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. Use only if clearly needed.
Trimester-Specific Risks:
First Trimester:
Potential for fetal harm based on animal data; human data lacking.
Second Trimester:
Potential for fetal harm based on animal data; human data lacking.
Third Trimester:
Potential for fetal harm based on animal data; human data lacking.
Lactation
It is not known whether nitroglycerin is excreted in human milk. Caution should be exercised when nitroglycerin is administered to a nursing woman.
Infant Risk:
Unknown; potential for adverse effects on the infant. Monitor for hypotension or other signs of toxicity.
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 require lower doses or more careful monitoring. Increased risk of falls due to orthostatic hypotension.
Clinical Information
Clinical Pearls
- Instruct patients to sit down before taking nitroglycerin to minimize dizziness or fainting.
- A burning or tingling sensation under the tongue is common and indicates the tablet is potent, but its absence does not mean the tablet is ineffective.
- Headache is a very common side effect and often indicates the drug is working. It can be managed with mild analgesics.
- Tablets lose potency over time, especially if exposed to air, moisture, or heat. Advise patients to keep them in the original amber glass bottle, tightly capped, and to replace them every 6 months after opening or by the expiration date.
- If chest pain is not relieved after 1 dose, the patient should call 911 immediately and may take a second dose while awaiting emergency medical attention. A third dose may be taken if instructed by emergency personnel.
- Patients should be advised to carry their nitroglycerin with them at all times.
Alternative Therapies
- Isosorbide dinitrate (for chronic angina prophylaxis, not acute relief)
- Isosorbide mononitrate (for chronic angina prophylaxis, not acute relief)
- Beta-blockers (for chronic angina prophylaxis)
- Calcium channel blockers (for chronic angina prophylaxis)
- Ranolazine (for chronic angina prophylaxis)
Cost & Coverage
Average Cost:
Varies widely, typically $10-$50 per 100 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'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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.