Nitro-Time 2.5mg ER Capsules
It is used to 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; Vasodilator
Pregnancy Category
Category C
FDA Approved
Aug 1975
DEA Schedule
Not Controlled
Overview
What is this medicine?
Nitroglycerin is a medication used to prevent chest pain (angina) caused by heart disease. It works by relaxing and widening blood vessels, which helps more blood and oxygen reach your heart, reducing the heart's workload.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, it's essential to take it exactly as directed by your doctor. Carefully read all the information provided with your prescription, and follow the instructions closely. When taking your medication, swallow the tablets or capsules whole - do not chew, break, or crush them.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better. This will help ensure that you receive the full benefits of the treatment.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication, store it at room temperature in a dry place, away from the bathroom. Keep all medications in a secure location, out of the reach of children and pets.
When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless specifically instructed to do so. Instead, consult with your pharmacist for guidance on the best disposal method. You may also want to inquire about drug take-back programs in your area, which can provide a safe and environmentally friendly way to dispose of unwanted medications.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
To get the most benefit from your medication, it's essential to take it exactly as directed by your doctor. Carefully read all the information provided with your prescription, and follow the instructions closely. When taking your medication, swallow the tablets or capsules whole - do not chew, break, or crush them.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better. This will help ensure that you receive the full benefits of the treatment.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication, store it at room temperature in a dry place, away from the bathroom. Keep all medications in a secure location, out of the reach of children and pets.
When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless specifically instructed to do so. Instead, consult with your pharmacist for guidance on the best disposal method. You may also want to inquire about drug take-back programs in your area, which can provide a safe and environmentally friendly way to dispose of unwanted medications.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Take the medication exactly as prescribed, usually once or twice daily, with a nitrate-free interval (e.g., 10-14 hours off the medication) to prevent tolerance.
- Do not crush, chew, or open the extended-release capsules; swallow them whole.
- Avoid sudden changes in position (e.g., standing up quickly) to prevent dizziness or fainting.
- Limit or avoid alcohol consumption, as it can increase the risk of low blood pressure.
- Inform your doctor about all other medications you are taking, especially erectile dysfunction drugs (e.g., Viagra, Cialis) or riociguat, as these can cause dangerously low blood pressure when taken with nitroglycerin.
- Headache is a common side effect and often indicates the medication is working; it may lessen with continued use. Do not stop taking the medication without consulting your doctor.
- Maintain a healthy lifestyle, including a balanced diet, regular exercise (as advised by your doctor), and stress management.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
2.5 mg orally once daily, or every 12 hours
Dose Range:
2.5 - 9 mg
Condition-Specific Dosing:
anginaProphylaxis:
Initial dose: 2.5 mg or 6.5 mg extended-release capsule once daily or every 12 hours. Titrate as needed to control symptoms, up to 9 mg every 12 hours. A daily nitrate-free interval of 10-14 hours is recommended to prevent tolerance.
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:
Use with caution; monitor for adverse effects due to potential accumulation of active metabolites.
Dialysis:
Not specifically studied; use with caution and monitor for adverse effects.
Hepatic Impairment:
Mild:
No specific adjustment recommended
Moderate:
Use with caution; monitor for adverse effects due to extensive hepatic metabolism.
Severe:
Use with caution; monitor for adverse effects 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. 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 (predominant effect, reducing preload) and arterial dilation (reducing afterload), thereby decreasing myocardial oxygen demand. It also causes coronary artery dilation, improving oxygen supply to ischemic areas.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 1% to 20% (highly variable due to extensive first-pass metabolism)
Tmax:
Approximately 2.5 to 4 hours (for ER capsules)
FoodEffect:
Food may delay absorption but does not significantly alter the extent of absorption.
Distribution:
Vd:
Approximately 3.3 L/kg
ProteinBinding:
Approximately 60%
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 1 to 4 minutes (parent drug); 2 to 3 hours (dinitrate metabolites)
Clearance:
Approximately 13.6 L/min
ExcretionRoute:
Renal (primarily as glucuronide conjugates of metabolites)
Unchanged:
<1%
Pharmacodynamics
OnsetOfAction:
Approximately 30-60 minutes (for ER capsules)
PeakEffect:
Approximately 2.5-4 hours (for ER capsules)
DurationOfAction:
Approximately 8-12 hours (for ER capsules)
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
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 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
Fast, slow, or irregular heartbeat
Flushing
Blurred vision
Dry mouth
Excessive sweating
Pale skin
Severe nausea or vomiting
Restlessness
Feeling extremely tired or weak
New or worsening chest pain
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 symptoms that bother you or persist, contact your doctor:
Dizziness or headache (note: headaches may occur when starting this medication, but they often improve over time; do not adjust your dosage without consulting your doctor)
Other side effects not listed here
Reporting Side Effects
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.
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 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
Fast, slow, or irregular heartbeat
Flushing
Blurred vision
Dry mouth
Excessive sweating
Pale skin
Severe nausea or vomiting
Restlessness
Feeling extremely tired or weak
New or worsening chest pain
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 symptoms that bother you or persist, contact your doctor:
Dizziness or headache (note: headaches may occur when starting this medication, but they often improve over time; do not adjust your dosage without consulting your doctor)
Other side effects not listed here
Reporting Side Effects
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
- Dizziness, lightheadedness, or fainting
- Blurred vision
- Unusual weakness or fatigue
- Rapid or irregular heartbeat
- Bluish discoloration of lips, fingernails, or palms (rare, sign of methemoglobinemia)
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 can be caused by conditions such as 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 discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist to ensure safe use.
To guarantee your safety, do not start, stop, or adjust the dosage of any medication without first consulting your doctor. It is your responsibility to verify that it is safe to take this medication in conjunction with all your other medications and health conditions.
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 can be caused by conditions such as 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 discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist to ensure safe use.
To guarantee your safety, do not start, stop, or adjust the dosage of any medication without first consulting your doctor. It is your responsibility to verify that it is safe to take this medication in conjunction with all your other medications and health conditions.
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 caution when navigating stairs.
As directed by your healthcare provider, regularly monitor 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.
This medication is not intended to treat sudden chest pain, so do not use it for this purpose. Instead, consult your doctor. Long-term, uninterrupted use of this medication can lead to tolerance, reducing its effectiveness. To avoid this, ensure you have a daily "nitrate-free" period. If you notice the medication is not working as well as it should, discuss this with your doctor. Do not exceed the prescribed dosage.
If you need to stop taking this medication, do not do so abruptly without consulting your doctor, as this may increase your risk of side effects. Your doctor will guide you on how to gradually discontinue the medication if necessary.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor, as you will need to discuss the potential benefits and risks of this medication to both you and your baby.
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 caution when navigating stairs.
As directed by your healthcare provider, regularly monitor 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.
This medication is not intended to treat sudden chest pain, so do not use it for this purpose. Instead, consult your doctor. Long-term, uninterrupted use of this medication can lead to tolerance, reducing its effectiveness. To avoid this, ensure you have a daily "nitrate-free" period. If you notice the medication is not working as well as it should, discuss this with your doctor. Do not exceed the prescribed dosage.
If you need to stop taking this medication, do not do so abruptly without consulting your doctor, as this may increase your risk of side effects. Your doctor will guide you on how to gradually discontinue the medication if necessary.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor, as you will need to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Severe hypotension (very low blood pressure)
- Persistent throbbing headache
- Palpitations
- Flushing
- Nausea and vomiting
- Dizziness and syncope (fainting)
- Visual disturbances
- Diaphoresis (sweating)
- Bradycardia (slow heart rate) or tachycardia (fast heart rate)
- Methemoglobinemia (rare, characterized by cyanosis, dyspnea, confusion, seizures, coma)
What to Do:
Seek immediate medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222. Management typically involves supportive care, including elevating legs, IV fluids, and vasopressors for hypotension. 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 infarction, and death.
- Riociguat (soluble guanylate cyclase stimulator) - concurrent use can cause profound hypotension.
Major Interactions
- Alcohol - may enhance hypotensive effects.
- Other vasodilators (e.g., hydralazine, minoxidil) - additive hypotensive effects.
- Antihypertensive agents (e.g., beta-blockers, calcium channel blockers, ACE inhibitors, diuretics) - additive hypotensive effects.
- Ergot alkaloids (e.g., ergotamine) - nitrates may reduce the therapeutic effect of ergot alkaloids and can precipitate angina in patients taking ergot alkaloids.
Moderate Interactions
- Tricyclic antidepressants and phenothiazines - may enhance hypotensive effects.
- Aspirin - may increase nitroglycerin levels and effects.
Monitoring
Baseline Monitoring
Blood Pressure (BP)
Rationale: To establish baseline and assess for hypotension risk.
Timing: Prior to initiation of therapy.
Heart Rate (HR)
Rationale: To establish baseline and assess for reflex tachycardia.
Timing: Prior to initiation of therapy.
Routine Monitoring
Blood Pressure (BP)
Frequency: Regularly, especially during dose titration and if symptoms of hypotension occur.
Target: Maintain within patient's normal range, avoiding symptomatic hypotension.
Action Threshold: If systolic BP < 90 mmHg or symptomatic hypotension occurs, consider dose reduction or discontinuation.
Heart Rate (HR)
Frequency: Regularly, especially during dose titration.
Target: Maintain within patient's normal range.
Action Threshold: If significant reflex tachycardia occurs, consider dose adjustment or concomitant therapy (e.g., beta-blocker).
Angina Symptoms (frequency, severity, duration)
Frequency: Continuously by patient self-report.
Target: Reduction or elimination of angina episodes.
Action Threshold: If angina symptoms worsen or are not adequately controlled, re-evaluate therapy.
Headache (frequency, severity)
Frequency: Continuously by patient self-report.
Target: Manageable or tolerable headache.
Action Threshold: Severe or persistent headache may indicate excessive vasodilation; consider dose adjustment or symptomatic treatment.
Symptom Monitoring
- Headache (common, often indicates drug activity)
- Dizziness or lightheadedness (especially upon standing)
- Flushing (reddening of face/neck)
- Nausea/vomiting
- Weakness
- Blurred vision
- Palpitations
Special Patient Groups
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.
Trimester-Specific Risks:
First Trimester:
Limited data; use only if clearly needed.
Second Trimester:
Limited data; use only if clearly needed.
Third Trimester:
Limited data; 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. The decision to discontinue nursing or to discontinue the drug should take into account the importance of the drug to the mother.
Infant Risk:
Unknown; potential for adverse effects on the infant.
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. Initiate therapy at the lower end of the dosing range and titrate carefully, monitoring blood pressure closely. Renal and hepatic function may be decreased in the elderly, potentially affecting drug clearance.
Clinical Information
Clinical Pearls
- Nitrate tolerance is a significant issue with chronic use. A daily nitrate-free interval (typically 10-14 hours) is crucial to restore sensitivity and maintain efficacy. For ER capsules, this is usually achieved by once-daily dosing or by taking the second dose early in the evening to allow for a drug-free period overnight.
- Headache is a very common side effect, often indicating the drug's vasodilatory effect. It usually diminishes with continued use. Patients should be counseled not to discontinue the medication due to headache without consulting their physician.
- Patients should be advised to avoid concurrent use of PDE5 inhibitors (e.g., sildenafil, tadalafil) due to the risk of severe, life-threatening hypotension.
- Nitroglycerin ER capsules are for prophylaxis of angina, not for acute angina attacks. For acute attacks, sublingual nitroglycerin is used.
- Monitor blood pressure closely, especially during initiation and dose titration, as hypotension is a common adverse effect.
Alternative Therapies
- Beta-blockers (e.g., metoprolol, atenolol) - reduce heart rate and contractility, decreasing myocardial oxygen demand.
- Calcium channel blockers (e.g., amlodipine, diltiazem, verapamil) - cause vasodilation and/or reduce heart rate/contractility.
- Ranolazine - reduces myocardial oxygen demand by inhibiting the late sodium current.
- Long-acting nitrates (e.g., isosorbide mononitrate, isosorbide dinitrate) - other forms of organic nitrates for angina prophylaxis.
Cost & Coverage
Average Cost:
Varies widely, typically $30-$100+ per 30 capsules
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 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 discuss them with 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 happened.