Nitroglycerin 400mcg Spray 200 Dose

Manufacturer PERRIGO Active Ingredient Nitroglycerin Spray(nye troe GLI ser in) Pronunciation nye troe GLI ser in
It is used to treat or prevent chest pain or pressure.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Antianginal
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Pharmacologic Class
Organic nitrate; Vasodilator
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Pregnancy Category
Category C
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FDA Approved
Aug 1985
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Nitroglycerin spray 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 reach your heart, and reduces the heart's workload.
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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 to you and follow the instructions closely.

Before using the medication for the first time, prime the pump as directed. The priming process may vary depending on the product, and some pumps may need to be re-primed if not used for a certain period. Follow the specific instructions you have been given on how and when to prime the pump.

When taking your medication:

Sit down before use
Do not shake the container
Spray the medication on or under your tongue
Avoid inhaling the spray
Do not swallow for 5 to 10 minutes after using the medication
Do not spit out the medication or rinse your mouth for 5 to 10 minutes after use

Regularly check the fluid level in the pump to ensure you have enough medication and know when to request a refill.

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 when to seek medical help. If you are unsure about any aspect of your 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.

Storing and Disposing of Your Medication

Store your medication at room temperature in a dry place, avoiding bathrooms.

Missing a Dose

This medication is taken as needed, so do not take it more frequently than directed by your doctor.
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Lifestyle & Tips

  • Avoid sudden changes in position (e.g., standing up too quickly) to prevent dizziness or fainting.
  • Limit or avoid alcohol consumption, as it can worsen side effects like dizziness and low blood pressure.
  • Store the spray at room temperature, away from heat, direct sunlight, and moisture. Do not refrigerate or freeze.
  • Keep the spray in its original container. Do not transfer it to another bottle.
  • Do not shake the spray bottle.
  • Always carry your nitroglycerin spray with you, especially if you have a history of angina.

Dosing & Administration

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Adult Dosing

Standard Dose: 1-2 sprays (400-800 mcg) sublingually at the onset of an acute anginal attack.
Dose Range: 400 - 800 mg

Condition-Specific Dosing:

acute_angina: 1-2 sprays (400-800 mcg) sublingually. May repeat every 5 minutes for a maximum of 3 doses within a 15-minute period. If pain persists, seek immediate medical attention.
prophylaxis_exertional_angina: 1-2 sprays (400-800 mcg) sublingually 5-10 minutes prior to activities known to precipitate angina.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment recommended.
Moderate: No specific dose adjustment recommended.
Severe: No specific dose adjustment recommended, but use with caution due to potential for accumulation of metabolites.
Dialysis: Not significantly removed by dialysis; use with caution.

Hepatic Impairment:

Mild: No specific dose adjustment recommended.
Moderate: No specific dose adjustment recommended.
Severe: Use with caution due to extensive hepatic metabolism; consider lower initial doses and close monitoring.
Note: Nitroglycerin is extensively metabolized by the liver, but due to its very short half-life and rapid onset, severe hepatic impairment may theoretically prolong effects, though clinical significance for acute sublingual use is limited.

Pharmacology

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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 the intracellular concentration of cyclic guanosine monophosphate (cGMP). Increased cGMP leads to dephosphorylation of myosin light chains, resulting in relaxation of vascular smooth muscle. This causes venodilation (primary effect, reducing preload and myocardial oxygen demand) and, to a lesser extent, arterial dilation (reducing afterload). It also dilates coronary arteries, improving myocardial blood flow.
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Pharmacokinetics

Absorption:

Bioavailability: High (sublingual, avoids first-pass metabolism)
Tmax: 1-4 minutes (sublingual)
FoodEffect: Not applicable for sublingual spray.

Distribution:

Vd: Approximately 3 L/kg
ProteinBinding: Approximately 60%
CnssPenetration: Limited

Elimination:

HalfLife: 1-3 minutes (parent drug)
Clearance: High (approximately 13.6 L/min)
ExcretionRoute: Renal (as inactive metabolites)
Unchanged: <1% (parent drug)
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Pharmacodynamics

OnsetOfAction: 1-3 minutes
PeakEffect: 2-5 minutes
DurationOfAction: 30-60 minutes
Note: Hemodynamic effects may persist longer than the parent drug's half-life due to active metabolites.

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Attention Immediately
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help right away:

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. While 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 guidance:

Dizziness or headache
Mouth tingling
Burning sensation

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.
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Seek Immediate Medical Attention If You Experience:

  • Severe dizziness or fainting (signs of very low blood pressure)
  • Blurred vision or other vision changes
  • Unusual sweating
  • Persistent or worsening headache (beyond mild, expected headache)
  • Chest pain that does not go away after 3 doses in 15 minutes (call 911 immediately)
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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 you experienced, including any symptoms that occurred.
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. It is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. This will help ensure your safety while taking this medication.

Remember, do not start, stop, or change the dosage of any medication without first consulting your doctor. It is vital to verify that it is safe to take this medication in combination with your other medications and health conditions.
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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, be cautious when driving or performing tasks 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 care 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.

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 this 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.
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Overdose Information

Overdose Symptoms:

  • Severe throbbing headache
  • Flushing
  • Profound hypotension (very low blood pressure)
  • Palpitations
  • Dizziness, lightheadedness, fainting
  • Nausea, vomiting
  • Diaphoresis (excessive sweating)
  • Cyanosis (bluish discoloration of skin/lips)
  • Methemoglobinemia (rare, but serious, especially with large doses)

What to Do:

If you suspect an overdose, seek immediate medical attention or call Poison Control at 1-800-222-1222. Lay the patient down with legs elevated to improve venous return. Administer oxygen. Treat hypotension with IV fluids. Vasopressors may be used if fluids are insufficient. Methemoglobinemia may require methylene blue.

Drug Interactions

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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.
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Major Interactions

  • Other vasodilators (e.g., hydralazine, minoxidil)
  • Antihypertensive agents (e.g., beta-blockers, calcium channel blockers, ACE inhibitors, ARBs, diuretics) - increased risk of hypotension.
  • Alcohol - may enhance hypotensive effects.
  • Ergot alkaloids (e.g., ergotamine, dihydroergotamine) - may reduce antianginal effect and cause severe vasoconstriction.
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Moderate Interactions

  • Aspirin - may increase nitroglycerin levels and effects.
  • Heparin - may decrease heparin's anticoagulant effect (monitor aPTT).
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Minor Interactions

  • Tricyclic antidepressants (TCAs) and phenothiazines - may cause orthostatic hypotension.

Monitoring

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Baseline Monitoring

Blood Pressure (BP)

Rationale: To establish baseline and assess for hypotension.

Timing: Prior to first administration, especially in hypotensive patients.

Heart Rate (HR)

Rationale: To establish baseline and assess for reflex tachycardia.

Timing: Prior to first administration.

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Routine Monitoring

Blood Pressure (BP)

Frequency: After each dose, especially if symptoms persist or multiple doses are given.

Target: Maintain within patient's normal range, avoid symptomatic hypotension.

Action Threshold: Systolic BP <90 mmHg or symptomatic hypotension; hold dose and reassess.

Heart Rate (HR)

Frequency: After each dose, especially if symptoms persist or multiple doses are given.

Target: Maintain within patient's normal range, avoid significant tachycardia.

Action Threshold: Significant reflex tachycardia (>100 bpm or >20 bpm increase from baseline) with symptoms; reassess.

Angina Symptoms (pain relief)

Frequency: Continuously during acute attack.

Target: Complete or significant relief of chest pain.

Action Threshold: No relief after 3 doses in 15 minutes; seek immediate medical attention.

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Symptom Monitoring

  • Chest pain relief
  • Headache (common side effect, often indicates drug activity)
  • Dizziness/lightheadedness (signs of hypotension)
  • Flushing
  • Palpitations

Special Patient Groups

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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: Use with caution; risk vs. benefit should be carefully weighed.
Third Trimester: Use with caution; risk vs. benefit should be carefully weighed. May affect maternal blood pressure.
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Lactation

L3 (Moderately Safe). 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: Potential for hypotension or methemoglobinemia in the infant, though unlikely with typical acute use due to short half-life. Monitor infant for signs of adverse effects.
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Pediatric Use

Safety and effectiveness in pediatric patients have not been established. Not indicated for routine use in children.

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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

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Clinical Pearls

  • Instruct patients to sit down before using the spray to minimize the risk of dizziness or fainting due to hypotension.
  • Patients should be advised to call 911 immediately if chest pain is not relieved after 3 doses in 15 minutes.
  • Tolerance (tachyphylaxis) can develop with continuous or frequent use. A nitrate-free interval (typically 8-12 hours) is often recommended for long-acting nitrates to restore responsiveness, though less relevant for acute sublingual spray.
  • Headache is a very common side effect and often indicates the drug is working. It can be managed with mild analgesics.
  • Ensure patients understand how to properly administer the spray: hold upright, do not shake, spray onto or under the tongue, do not inhale, close mouth immediately after spraying.
  • The spray should be primed before first use or if not used for a long period (e.g., 6 weeks).
  • Check the expiration date regularly. Nitroglycerin loses potency over time, especially if not stored correctly.
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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)
  • Percutaneous coronary intervention (PCI)
  • Coronary artery bypass grafting (CABG)
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Cost & Coverage

Average Cost: $30 - $100 per 200 dose spray
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (Generic)
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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 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 overdose, including the medication taken, the amount, and the time it occurred.