Nitroglycerin 400mcg Spray 60 Doses
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
Pregnancy Category
Category C
FDA Approved
Mar 1997
DEA Schedule
Not Controlled
Overview
What is this medicine?
Nitroglycerin spray is a medicine used to quickly relieve chest pain (angina) caused by heart disease. It works by relaxing and widening your 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. Read all the information provided with your medication and follow the instructions closely.
Before using your medication for the first time, prime the pump according to the manufacturer's instructions or as directed by your doctor. Some pumps may need to be primed if they have not been used for a while. Be sure to follow the specific priming instructions for your device.
When taking your medication:
Sit down before use to minimize the risk of dizziness or lightheadedness.
Do not shake the container.
Spray the medication on or under your tongue, as directed.
Avoid inhaling the spray to prevent unnecessary absorption.
Do not swallow for 5 to 10 minutes after using the medication to allow for proper absorption.
Refrain from spitting out the medication or rinsing your mouth for 5 to 10 minutes after use.
Monitoring Your Medication Supply
Regularly check the fluid level in your pump to ensure you have an adequate supply. Know when you need to refill your prescription to avoid running out of medication.
Important Safety Precautions
This medication is flammable, so do not use it near an open flame or while smoking.
Understanding Your Dosage
Your doctor will provide specific instructions on how to take this medication, including the dose, frequency, and potential side effects. If you are unsure about any aspect of your medication regimen, 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.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, away from the bathroom.
Missing a Dose
Since this medication is taken as needed, do not take more frequent doses than prescribed by your doctor. If you have any questions or concerns about your medication regimen, consult with your doctor.
To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions closely.
Before using your medication for the first time, prime the pump according to the manufacturer's instructions or as directed by your doctor. Some pumps may need to be primed if they have not been used for a while. Be sure to follow the specific priming instructions for your device.
When taking your medication:
Sit down before use to minimize the risk of dizziness or lightheadedness.
Do not shake the container.
Spray the medication on or under your tongue, as directed.
Avoid inhaling the spray to prevent unnecessary absorption.
Do not swallow for 5 to 10 minutes after using the medication to allow for proper absorption.
Refrain from spitting out the medication or rinsing your mouth for 5 to 10 minutes after use.
Monitoring Your Medication Supply
Regularly check the fluid level in your pump to ensure you have an adequate supply. Know when you need to refill your prescription to avoid running out of medication.
Important Safety Precautions
This medication is flammable, so do not use it near an open flame or while smoking.
Understanding Your Dosage
Your doctor will provide specific instructions on how to take this medication, including the dose, frequency, and potential side effects. If you are unsure about any aspect of your medication regimen, 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.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, away from the bathroom.
Missing a Dose
Since this medication is taken as needed, do not take more frequent doses than prescribed by your doctor. If you have any questions or concerns about your medication regimen, consult with your doctor.
Lifestyle & Tips
- Always carry your nitroglycerin spray with you, especially if you have angina.
- Sit down before using the spray to prevent dizziness or fainting from a sudden drop in blood pressure.
- Avoid sudden changes in position (e.g., standing up too quickly) to prevent dizziness.
- Do not use alcohol while taking nitroglycerin, as it can worsen dizziness and lower blood pressure.
- Store the spray at room temperature, away from heat and direct light, in its original container. Do not refrigerate or freeze.
- Do not shake the canister. Prime the pump before first use or if not used for a long time (spray 5-10 times into the air until a fine mist appears).
Available Forms & Alternatives
Available Strengths:
- Nitroglycerin 0.2 Mg/hr Patch
- Nitroglycerin 0.6 Mg/hr Patch
- Nitroglycerin 0.4 Mg/hr Patch
- Nitroglycerin 0.1 Mg/hr Patch
- Nitroglycerin 400mcg Spray 60 Doses
- Nitroglycerin 400mcg Spray 200 Dose
- Nitroglycerin 0.6mg Sub Tabs 100
- Nitroglycerin 0.4mg Sub Tab 25s
- Nitroglycerin 0.3mg Sl Tabs 100
- Nitroglycerin 0.4mg Sub Tabs 100s
- Nitroglycerin 0.3mg Sl Tabs 100
- Nitroglycerin 0.4% Ointment
Dosing & Administration
Adult Dosing
Standard Dose:
1-2 sprays (400-800 mcg) sublingually at the onset of an acute anginal attack. May repeat every 5 minutes for a maximum of 3 doses within a 15-minute period.
Dose Range:
400 - 800 mg
Condition-Specific Dosing:
acute_angina:
1-2 sprays (400-800 mcg) 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 for acute use.
Moderate:
No specific adjustment recommended for acute use; use with caution.
Severe:
No specific adjustment recommended for acute use; use with caution.
Dialysis:
No specific adjustment recommended for acute use; use with caution.
Hepatic Impairment:
Mild:
No specific adjustment recommended for acute use.
Moderate:
No specific adjustment recommended for acute use; use with caution.
Severe:
No specific adjustment recommended for acute use; use with caution.
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 (predominantly) and arterial dilation, leading to decreased preload, reduced myocardial oxygen demand, and improved coronary blood flow.
Pharmacokinetics
Absorption:
Bioavailability:
High (sublingual, avoids first-pass metabolism)
Tmax:
1-3 minutes
FoodEffect:
Not applicable for sublingual spray
Distribution:
Vd:
3.3 L/kg
ProteinBinding:
Approximately 60%
CnssPenetration:
Limited
Elimination:
HalfLife:
1-4 minutes (parent drug)
Clearance:
Not available (very rapid)
ExcretionRoute:
Renal (as inactive metabolites)
Unchanged:
<1%
Pharmacodynamics
OnsetOfAction:
1-3 minutes
PeakEffect:
2-5 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 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 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 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 or persistent headache (common side effect, but can be severe)
- Dizziness, lightheadedness, or fainting (signs of low blood pressure)
- Blurred vision
- Unusual sweating
- Nausea or vomiting
- Chest pain that worsens or 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
Please note that this is not an exhaustive list of all potential interactions.
To ensure your safety, it is crucial to discuss all of your medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. This will help determine whether it is safe to take this medication in conjunction with your other treatments. 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
Please note that this is not an exhaustive list of all potential interactions.
To ensure your safety, it is crucial to discuss all of your medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. This will help determine whether it is safe to take this medication in conjunction with your other treatments. 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 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 reduced 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 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 reduced 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 hypotension (very low blood pressure)
- Reflex tachycardia (very fast heart rate)
- Flushing
- Severe throbbing headache
- Dizziness, vertigo, syncope
- Palpitations
- Visual disturbances
- Nausea, vomiting
- Diaphoresis (excessive sweating)
- Cyanosis (bluish skin discoloration, rare, due to methemoglobinemia)
- Methemoglobinemia (rare, but serious, can cause tissue hypoxia)
What to Do:
If you suspect an overdose, seek immediate medical attention or call 911. For non-emergencies, call Poison Control at 1-800-222-1222. Management typically involves elevating the patient's legs, administering IV fluids, and if necessary, vasopressors. 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 (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 (monitor aPTT).
Monitoring
Baseline Monitoring
Blood Pressure (BP)
Rationale: To establish baseline and monitor for hypotension.
Timing: Prior to administration, especially in patients prone to hypotension.
Heart Rate (HR)
Rationale: To establish baseline and monitor for reflex tachycardia.
Timing: Prior to administration.
Angina Symptoms
Rationale: To assess severity and guide initial dosing.
Timing: At onset of chest pain.
Routine Monitoring
Blood Pressure (BP)
Frequency: Immediately after each dose, then as needed.
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 each dose, 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 Relief
Frequency: After each dose.
Target: Complete or significant reduction in chest pain.
Action Threshold: No relief or worsening pain after 1st dose (call 911).
Headache
Frequency: During and after administration.
Target: Mild to moderate, tolerable.
Action Threshold: Severe, persistent headache (may indicate excessive vasodilation).
Symptom Monitoring
- Chest pain (for relief or worsening)
- Dizziness or lightheadedness (signs of hypotension)
- Headache (common side effect, can indicate efficacy or excessive vasodilation)
- Flushing (common side effect)
- Nausea/vomiting
- Palpitations
Special Patient Groups
Pregnancy
Nitroglycerin is 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:
Risk of fetal harm cannot be ruled out.
Second Trimester:
Risk of fetal harm cannot be ruled out.
Third Trimester:
Risk of fetal harm cannot be ruled out.
Lactation
It is not known whether nitroglycerin is excreted in human milk. Caution should be exercised when nitroglycerin is administered to a nursing woman. The decision to discontinue nursing or discontinue the drug should take into account the importance of the drug to the mother.
Infant Risk:
Risk level L3 (Moderately safe) - potential for adverse effects on the infant, but controlled studies are lacking. Monitor infant for hypotension, flushing, or headache.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Use is generally not recommended.
Geriatric Use
Elderly patients may be more susceptible to the hypotensive effects of nitroglycerin. Use with caution, starting with the lowest effective dose and monitoring blood pressure closely.
Clinical Information
Clinical Pearls
- Instruct patients to sit down before using the spray to minimize the risk of syncope due to hypotension.
- Emphasize the importance of calling 911 immediately if chest pain is not relieved or worsens after the first dose, or after 3 doses in 15 minutes.
- Patients should be advised not to inhale the spray and to avoid swallowing immediately after administration to ensure proper sublingual absorption.
- Headache is a common side effect and often indicates the drug is working; however, severe or persistent headache should be reported.
- Tolerance to the effects of nitrates can develop with continuous exposure; however, this is less common with intermittent acute use of sublingual spray.
- Ensure patients understand the critical contraindication with PDE5 inhibitors (e.g., Viagra, Cialis) due to the risk of life-threatening hypotension.
Alternative Therapies
- 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 that is not adequately controlled with other antianginals)
- Percutaneous coronary intervention (PCI) or Coronary Artery Bypass Graft (CABG) for revascularization in appropriate patients.
Cost & Coverage
Average Cost:
$50 - $150 per 60 dose spray
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (often preferred 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's a good idea 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.