Nitro-Time 6.5mg 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, Vasodilator
Pharmacologic Class
Organic Nitrate
Pregnancy Category
Category C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Nitroglycerin extended-release capsules are used to prevent chest pain (angina) caused by heart disease. It works by relaxing blood vessels, which allows blood to flow more easily to the heart and reduces 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 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.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication, store it at room temperature in a dry place, avoiding bathrooms. 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.
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. It's crucial to avoid taking two doses at the same time or taking extra doses, as this can increase the risk of adverse effects.
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 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.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication, store it at room temperature in a dry place, avoiding bathrooms. 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.
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. It's crucial to avoid taking two doses at the same time or taking extra doses, as this can increase the risk of adverse effects.
Lifestyle & Tips
- Take the capsule whole; do not crush, chew, or open it.
- Take at the same time(s) each day, usually every 12 hours, to maintain consistent blood levels.
- Maintain a nitrate-free interval (e.g., 10-14 hours overnight) as directed by your doctor to prevent tolerance.
- 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 or dentist that you are taking nitroglycerin before any medical or dental procedures.
- Do not stop taking this medication suddenly without consulting your doctor, as it may worsen angina.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
6.5 mg extended-release capsule orally every 12 hours
Dose Range:
2.5 - 9 mg
Condition-Specific Dosing:
angina_prophylaxis:
Initial dose may be 2.5 mg or 6.5 mg extended-release capsule orally every 12 hours. Dosage may be titrated up to 9 mg every 12 hours as needed and tolerated. A 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:
No specific adjustment recommended
Dialysis:
Considerations: Nitroglycerin is extensively metabolized; renal excretion of unchanged drug is minimal. Metabolites are renally excreted, but clinical significance in severe renal impairment is not well-established for ER formulations.
Hepatic Impairment:
Mild:
Caution advised, monitor for increased effects
Moderate:
Caution advised, monitor for increased effects
Severe:
Caution advised, monitor for increased effects. Nitroglycerin is extensively metabolized by the liver; severe hepatic impairment may lead to increased systemic exposure and risk of adverse effects.
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, leading to an increase in cyclic guanosine monophosphate (cGMP). Increased cGMP causes dephosphorylation of myosin light chains, resulting in relaxation of vascular smooth muscle. This leads to venodilation (predominant effect at therapeutic doses), which reduces preload by decreasing venous return to the heart. At higher doses, it also causes arterial dilation, reducing afterload. Both effects decrease myocardial oxygen demand, thereby relieving angina.
Pharmacokinetics
Absorption:
Bioavailability:
Low (1-20% for immediate release oral due to extensive first-pass metabolism; extended-release formulations are designed to provide more consistent absorption)
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; Effective half-life for ER formulation is longer due to sustained release.
Clearance:
Very high systemic clearance (approximately 13 L/min)
ExcretionRoute:
Metabolites primarily excreted renally
Unchanged:
<1%
Pharmacodynamics
OnsetOfAction:
Approximately 30-60 minutes for extended-release capsules
PeakEffect:
Approximately 2-4 hours for extended-release capsules
DurationOfAction:
Approximately 8-12 hours for extended-release capsules
Confidence:
Medium
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
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 mild 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:
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
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
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 mild 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:
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
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 report if intolerable)
- Dizziness or lightheadedness, especially when standing up
- Fainting (syncope)
- Blurred vision
- Unusual weakness
- Rash or itching
- Worsening chest pain
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.
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
Medications you are currently taking, particularly:
+ Avanafil
+ Riociguat
+ Sildenafil
+ Tadalafil
+ Vardenafil
+ Dihydroergotamine
+ Ergonovine
+ Ergotamine
+ Methylergonovine
Other prescription or over-the-counter medications, natural products, and vitamins you are taking, as this is not an exhaustive list of potential interactions.
To ensure your safety, it is crucial to discuss all your medications and health problems with your doctor and pharmacist. They will help you determine whether it is safe to take this medication with your existing treatments and health conditions. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.
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.
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
Medications you are currently taking, particularly:
+ Avanafil
+ Riociguat
+ Sildenafil
+ Tadalafil
+ Vardenafil
+ Dihydroergotamine
+ Ergonovine
+ Ergotamine
+ Methylergonovine
Other prescription or over-the-counter medications, natural products, and vitamins you are taking, as this is not an exhaustive list of potential interactions.
To ensure your safety, it is crucial to discuss all your medications and health problems with your doctor and pharmacist. They will help you determine whether it is safe to take this medication with your existing treatments and health conditions. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.
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.
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.
Do not use this medication to treat sudden chest pain, as it will not be effective. If you experience sudden chest pain, 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 previously did, discuss this with your doctor. Never 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. Instead, your doctor will guide you on how to gradually discontinue the medication.
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.
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.
Do not use this medication to treat sudden chest pain, as it will not be effective. If you experience sudden chest pain, 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 previously did, discuss this with your doctor. Never 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. Instead, your doctor will guide you on how to gradually discontinue the medication.
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 throbbing headache
- Profound hypotension (very low blood pressure)
- Palpitations
- Flushing
- Perspiration
- Nausea and vomiting
- Dizziness and fainting
- Visual disturbances
- Methemoglobinemia (rare, but serious, characterized by cyanosis, dyspnea, fatigue)
- Bradycardia (slow heart rate)
- Paralysis
- Coma
- Seizures
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. Treatment is supportive, 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 infarction, and death.
- Riociguat (a 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
- Tricyclic antidepressants - may cause orthostatic hypotension.
- Phenothiazines - may cause orthostatic hypotension.
- Ergot alkaloids (e.g., ergotamine) - nitrates may antagonize the therapeutic effect of ergotamine and increase the risk of angina.
Minor Interactions
- Aspirin - may increase nitroglycerin levels and effects (though clinical significance is often minor).
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: Significant reflex tachycardia (e.g., >100 bpm or significant increase from baseline) may warrant dose adjustment or addition of a beta-blocker.
Angina Symptoms (frequency, severity, duration)
Frequency: Continuously throughout therapy.
Target: Reduction or elimination of angina episodes.
Action Threshold: Persistent or worsening angina may indicate inadequate dosing or need for alternative therapy.
Headache (severity, frequency)
Frequency: Continuously throughout therapy.
Target: Manageable or absent.
Action Threshold: Severe or persistent headache may indicate excessive vasodilation and require dose adjustment or symptomatic treatment.
Symptom Monitoring
- Headache (common, often indicates drug activity)
- Dizziness
- Lightheadedness
- Flushing
- Nausea
- Hypotension (especially orthostatic)
- Palpitations
- Weakness
- Blurred vision
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 the potential benefit justifies the potential risk to the fetus.
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. Risk of maternal hypotension affecting placental perfusion.
Lactation
It is not known whether nitroglycerin is excreted in human milk. Caution should be exercised when nitroglycerin is administered to a nursing woman. Due to its very short half-life, significant amounts in breast milk are unlikely, but data are insufficient.
Infant Risk:
Unknown; potential for hypotension or methemoglobinemia in infant, though unlikely with typical doses due to short half-life.
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 and may require lower doses or more careful titration. Increased risk of falls due to orthostatic hypotension. Monitor blood pressure closely.
Clinical Information
Clinical Pearls
- Nitrate tolerance is a common issue with chronic use; a daily nitrate-free interval (typically 10-14 hours) is crucial to maintain efficacy and prevent tolerance.
- Headache is a very common side effect and often indicates that the drug is working. It usually diminishes with continued use. Over-the-counter pain relievers may be used.
- Patients should be advised not to abruptly discontinue nitroglycerin ER capsules, as this can lead to withdrawal symptoms or worsening angina.
- Always inquire about the use of PDE5 inhibitors (e.g., Viagra, Cialis) before prescribing nitroglycerin due to the absolute contraindication and risk of profound hypotension.
- Educate patients on the importance of proper storage (tightly closed container, away from light and moisture) as nitroglycerin is volatile and light-sensitive.
Alternative Therapies
- Other long-acting nitrates (e.g., isosorbide mononitrate, isosorbide dinitrate)
- Beta-blockers (e.g., metoprolol, atenolol) for angina prophylaxis
- Calcium channel blockers (e.g., amlodipine, diltiazem) for angina prophylaxis
- Ranolazine (for chronic angina)
- Nicorandil (in some countries)
Cost & Coverage
Average Cost:
Varies widely, typically $30-$100+ per 30 capsules
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is 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 it's a good idea to check with your pharmacist. 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 medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.