Nitro-Time 9mg 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, 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 prevent 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
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take the medication as directed, and be sure to:
Swallow the tablet whole without chewing, breaking, or crushing it.
Continue taking the medication as prescribed by your doctor or healthcare provider, even if you start feeling well.
Storing and Disposing of Your Medication
To store your medication properly:
Keep it at room temperature in a dry place, avoiding the bathroom.
Store all medications in a safe location, out of the reach of children and pets.
* Dispose of unused or expired medications responsibly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions, consult your pharmacist. You may also want to check if there are drug take-back programs available in your area.
Missing 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 use this medication correctly, follow your doctor's instructions and read all the information provided. Take the medication as directed, and be sure to:
Swallow the tablet whole without chewing, breaking, or crushing it.
Continue taking the medication as prescribed by your doctor or healthcare provider, even if you start feeling well.
Storing and Disposing of Your Medication
To store your medication properly:
Keep it at room temperature in a dry place, avoiding the bathroom.
Store all medications in a safe location, out of the reach of children and pets.
* Dispose of unused or expired medications responsibly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions, consult your pharmacist. You may also want to check if there are drug take-back programs available in your area.
Missing 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 with a nitrate-free interval (e.g., 10-14 hours off the medication) to prevent the body from becoming tolerant to its effects.
- Do not crush, chew, or break the extended-release capsules; swallow them whole.
- Avoid sudden changes in position (e.g., standing up quickly) to prevent dizziness or fainting due to blood pressure drop.
- Limit or avoid alcohol consumption, as it can increase the blood pressure-lowering effects.
- Inform your doctor about all other medications you are taking, especially erectile dysfunction drugs (e.g., Viagra, Cialis) as they are strictly contraindicated.
- Continue other prescribed treatments for heart disease (e.g., diet, exercise, other medications).
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
9 mg orally once or twice daily, typically with a 10-14 hour nitrate-free interval to prevent tolerance.
Dose Range:
2.5 - 9 mg
Condition-Specific Dosing:
chronicStableAngina:
Initial dose typically 2.5-6.5 mg once or twice daily, titrated up to 9 mg as needed and tolerated. A nitrate-free interval (e.g., 10-14 hours) is crucial 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:
No specific adjustment recommended
Dialysis:
Not significantly dialyzable; no specific adjustment recommended, but monitor for adverse effects.
Hepatic Impairment:
Mild:
Caution advised, monitor for increased effects
Moderate:
Caution advised, monitor for increased effects
Severe:
Caution advised, monitor for increased effects; dose reduction may be necessary 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 (reducing preload) and, at higher doses, arterial dilation (reducing afterload), thereby decreasing myocardial oxygen demand and improving myocardial blood flow.
Pharmacokinetics
Absorption:
Bioavailability:
1% to 20% (highly variable due to extensive first-pass metabolism)
Tmax:
Approximately 2-4 hours for extended-release capsules
FoodEffect:
Food may delay absorption but generally does not significantly alter the extent of absorption for ER formulations.
Distribution:
Vd:
Approximately 3 L/kg
ProteinBinding:
Approximately 60%
CnssPenetration:
Limited
Elimination:
HalfLife:
Parent drug: 1-4 minutes; Metabolites: up to several hours (e.g., dinitrates 30-60 minutes, mononitrates 2-4 hours)
Clearance:
Very high systemic clearance (approximately 13 L/min)
ExcretionRoute:
Primarily renal excretion of metabolites
Unchanged:
<1%
Pharmacodynamics
OnsetOfAction:
Approximately 30-60 minutes for ER capsules
PeakEffect:
Approximately 2-4 hours for ER capsules
DurationOfAction:
Approximately 8-12 hours for ER capsules (depending on dose and formulation)
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
New or worsening chest pain
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 do not go away, 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, contact your doctor for medical advice. 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
New or worsening chest pain
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 do not go away, 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, contact your doctor for medical advice. 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 report if debilitating)
- Dizziness or lightheadedness that does not improve
- Fainting spells
- Blurred vision
- Rash or itching
- Unusual weakness or fatigue
- Persistent nausea or vomiting
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
+ Increased pressure in the head, which can 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
If you are taking any of the following medications:
+ 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 (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist to ensure safe use. Do not initiate, discontinue, or modify 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. Describe the allergic reaction you experienced, including the symptoms that occurred.
Certain health conditions, including:
+ Anemia
+ Increased pressure in the head, which can 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
If you are taking any of the following medications:
+ 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 (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist to ensure safe use. Do not initiate, discontinue, or modify 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.
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.
To ensure your safety, 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 for appropriate treatment. Long-term, uninterrupted use of this medication can lead to tolerance, reducing its effectiveness. To avoid this, your doctor may recommend a daily "nitrate-free" period. If you notice the medication is not working as well as it should, discuss this with your doctor. Never exceed the prescribed dose, and do not stop taking this medication abruptly without consulting your doctor, as this may increase your risk of side effects. If you need to discontinue this medication, your doctor will guide you on how to gradually stop taking it.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor, as they will need to discuss the potential benefits and risks of this medication to both 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.
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.
To ensure your safety, 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 for appropriate treatment. Long-term, uninterrupted use of this medication can lead to tolerance, reducing its effectiveness. To avoid this, your doctor may recommend a daily "nitrate-free" period. If you notice the medication is not working as well as it should, discuss this with your doctor. Never exceed the prescribed dose, and do not stop taking this medication abruptly without consulting your doctor, as this may increase your risk of side effects. If you need to discontinue this medication, your doctor will guide you on how to gradually stop taking it.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor, as they will need to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Profound hypotension (very low blood pressure)
- Persistent throbbing headache
- Palpitations
- Flushing
- Dizziness
- Nausea and vomiting
- Diaphoresis (sweating)
- Syncope (fainting)
- Methemoglobinemia (rare, but serious, causing bluish skin, lips, and nail beds, shortness of breath, fatigue)
What to Do:
Seek immediate medical attention. Call 911 or your local emergency number. For advice, call a poison control center at 1-800-222-1222. Management typically involves supportive care, elevation of legs, IV fluids for hypotension, and potentially methylene blue for 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., alpha-blockers, other antihypertensives) - additive hypotensive effects.
- Alcohol - may enhance hypotensive effects and cause syncope.
- Ergotamine - nitrates may reduce the anti-migraine effect of ergotamine and can lead to severe vasoconstriction.
Moderate Interactions
- Tricyclic antidepressants (TCAs) - may cause orthostatic hypotension.
- Anticholinergics - may reduce absorption of oral nitroglycerin by delaying gastric emptying.
- Aspirin - may increase nitroglycerin levels and effects.
Minor Interactions
- Heparin - may decrease the anticoagulant effect of heparin (monitor aPTT).
Monitoring
Baseline Monitoring
Blood Pressure (BP)
Rationale: To establish baseline and assess for hypotension risk.
Timing: Before initiation
Heart Rate (HR)
Rationale: To establish baseline and assess for reflex tachycardia.
Timing: Before initiation
Angina frequency and severity
Rationale: To assess the need for therapy and establish baseline symptom control.
Timing: Before initiation
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: Systolic BP <90 mmHg or symptomatic hypotension (dizziness, lightheadedness) requires dose reduction or discontinuation.
Heart Rate (HR)
Frequency: Regularly, especially during dose titration.
Target: Maintain within patient's normal range.
Action Threshold: Significant reflex tachycardia (e.g., >100 bpm or symptomatic) may require dose adjustment or concomitant therapy (e.g., beta-blocker).
Angina symptoms (frequency, severity, duration)
Frequency: Continuously by patient self-report.
Target: Reduction in angina episodes and severity.
Action Threshold: Persistent or worsening angina may indicate inadequate dosing, tolerance, or disease progression, requiring re-evaluation.
Headache (severity, frequency)
Frequency: Continuously by patient self-report.
Target: Manageable or absent.
Action Threshold: Severe or persistent headache may require dose reduction or symptomatic treatment (e.g., acetaminophen).
Symptom Monitoring
- Headache (common, often indicates drug activity)
- Dizziness
- Lightheadedness
- Flushing (redness of face/neck)
- Nausea
- Weakness
- Blurred vision
- Fainting (syncope)
Special Patient Groups
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; monitor maternal hemodynamics.
Third Trimester:
Use with caution; monitor maternal hemodynamics and potential for neonatal effects.
Lactation
L3 (Limited data - probably compatible). It is unknown if nitroglycerin is excreted in human milk. Caution should be exercised when administered to a nursing mother. Monitor infant for adverse effects (e.g., hypotension).
Infant Risk:
Low to moderate; potential for hypotension or methemoglobinemia in infant, though unlikely with typical doses due to low oral bioavailability.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Not indicated for use in children.
Geriatric Use
Elderly patients may be more susceptible to the hypotensive effects of nitroglycerin, including orthostatic hypotension. Start with lower doses and titrate slowly, monitoring blood pressure closely.
Clinical Information
Clinical Pearls
- Nitrate tolerance is a significant issue with chronic use; a daily nitrate-free interval (typically 10-14 hours) is essential to maintain efficacy and prevent tolerance.
- Headache is a very common side effect, often indicating the drug is working. It usually diminishes with continued use but can be managed with mild analgesics (e.g., acetaminophen).
- Patients should be advised to sit or lie down if they experience dizziness or lightheadedness after taking the medication.
- Emphasize the absolute contraindication with PDE5 inhibitors (e.g., sildenafil, tadalafil) due to the risk of life-threatening hypotension.
- Extended-release capsules must be swallowed whole; crushing or chewing can lead to rapid release and increased side effects or reduced duration of action.
Alternative Therapies
- Beta-blockers (e.g., metoprolol, atenolol) - first-line for chronic stable angina.
- Calcium channel blockers (e.g., amlodipine, diltiazem, verapamil) - alternative or add-on for angina.
- Ranolazine - antianginal agent that does not affect heart rate or blood pressure significantly.
- Long-acting nitrates (e.g., isosorbide mononitrate, isosorbide dinitrate) - other forms of long-acting nitrates, also requiring nitrate-free intervals.
Cost & Coverage
Average Cost:
Varies widely, typically $20-$100+ per 30 capsules
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generic formulations)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. 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 happened.