Nitro-Time 9mg CR 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 also reduces the workload on your heart.
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 precisely. When taking this medication, swallow the tablet whole - do not chew, break, or crush it. Continue taking this medication as directed by your doctor or healthcare provider, even if you start to feel better.
Storing and Disposing of Your Medication
Store this medication at room temperature in a dry location, avoiding storage in a bathroom. Keep all medications in a secure place, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about the best way to dispose of your medication, consult your pharmacist. You may also want to check if there are any 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 is 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 a missed dose.
To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions precisely. When taking this medication, swallow the tablet whole - do not chew, break, or crush it. Continue taking this medication as directed by your doctor or healthcare provider, even if you start to feel better.
Storing and Disposing of Your Medication
Store this medication at room temperature in a dry location, avoiding storage in a bathroom. Keep all medications in a secure place, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about the best way to dispose of your medication, consult your pharmacist. You may also want to check if there are any 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 is 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 a missed dose.
Lifestyle & Tips
- Take the medication exactly as prescribed, usually with a nitrate-free interval (e.g., 10-14 hours off the medication each day) to prevent the body from becoming tolerant to its effects.
- Do not crush, chew, or break the controlled-release capsules; swallow them whole.
- Avoid sudden changes in position (e.g., standing up quickly from sitting or lying down) to prevent dizziness or fainting due to a drop in blood pressure.
- Avoid alcohol consumption, as it can increase the blood pressure-lowering effects of nitroglycerin.
- Inform your doctor about all other medications you are taking, especially drugs for erectile dysfunction (e.g., Viagra, Cialis, Levitra) as combining them with nitroglycerin can cause a dangerous drop in blood pressure.
- Headaches are a common side effect and often indicate the medication is working. They usually lessen with continued use. Do not stop taking the medication due to headaches without consulting your doctor.
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:
chronic_stable_angina_prophylaxis:
Initial dose typically 2.5 mg to 6.5 mg orally 2-3 times daily, or 9 mg once or twice daily. Titrate to effect and tolerability. A daily 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, use with caution.
Moderate:
No specific adjustment recommended, use with caution.
Severe:
No specific adjustment recommended, use with caution due to potential for hypotension.
Dialysis:
Considerations: Not dialyzable. Monitor for exaggerated hypotensive response.
Hepatic Impairment:
Mild:
No specific adjustment recommended, use with caution.
Moderate:
No specific adjustment recommended, use with caution.
Severe:
No specific adjustment recommended, use with caution due to extensive hepatic metabolism and potential for increased sensitivity to hypotensive 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, primarily by mitochondrial aldehyde dehydrogenase (ALDH-2). NO activates guanylyl 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 (reducing preload and myocardial oxygen demand) and, at higher doses, arterial dilation (reducing afterload). It also dilates coronary arteries, improving myocardial blood flow.
Pharmacokinetics
Absorption:
Bioavailability:
Highly variable (typically <10-20% for oral forms due to extensive first-pass metabolism), controlled-release formulations aim to improve consistency.
Tmax:
2-4 hours (for controlled-release capsules)
FoodEffect:
Variable; some formulations may have altered absorption with food. Generally, administer consistently with or without food.
Distribution:
Vd:
Approximately 3 L/kg (large volume of distribution)
ProteinBinding:
Approximately 60%
CnssPenetration:
Limited
Elimination:
HalfLife:
1-7 minutes (parent drug); metabolites have longer half-lives (up to several hours)
Clearance:
Very high (approximately 13 L/min)
ExcretionRoute:
Primarily renal (as metabolites)
Unchanged:
<1%
Pharmacodynamics
OnsetOfAction:
30-60 minutes (for controlled-release capsules)
PeakEffect:
2-4 hours (for controlled-release capsules)
DurationOfAction:
Up to 8-12 hours (for controlled-release capsules, depending on dose and formulation)
Confidence:
Medium
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 immediately or seek emergency 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. 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 (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 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.
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 immediately or seek emergency 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. 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 (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 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 dizziness or lightheadedness
- Fainting (syncope)
- Blurred vision
- Unusual sweating
- Persistent or worsening headache
- Chest pain that does not improve or worsens
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 inform your doctor and pharmacist about all the medications you are taking, including:
Prescription and over-the-counter (OTC) medications
Natural products
Vitamins
Your doctor needs to be aware of all your medications and health conditions to determine if it is safe for you to take this medication. Never start, stop, or change the dose 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 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 inform your doctor and pharmacist about all the medications you are taking, including:
Prescription and over-the-counter (OTC) medications
Natural products
Vitamins
Your doctor needs to be aware of all your medications and health conditions to determine if it is safe for you to take this medication. Never start, stop, or change the dose 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, 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 inform 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.
Adhere to the prescribed dosage and do not exceed it. Suddenly stopping this medication without consulting your doctor can increase your risk of side effects. If you need to discontinue the medication, your doctor will guide you on how to gradually stop taking it to minimize potential side effects.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor. You and your doctor 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.
Follow your healthcare provider's instructions for monitoring your blood pressure. Additionally, be aware that this medication may interfere with certain laboratory tests, so inform 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.
Adhere to the prescribed dosage and do not exceed it. Suddenly stopping this medication without consulting your doctor can increase your risk of side effects. If you need to discontinue the medication, your doctor will guide you on how to gradually stop taking it to minimize potential side effects.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor. You and your doctor 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
- Dizziness
- Visual disturbances
- Nausea and vomiting
- Diaphoresis (excessive sweating)
- Cyanosis (bluish discoloration of skin/lips)
- Methemoglobinemia (rare, but serious, causing bluish skin and shortness of breath)
What to Do:
Immediately seek emergency medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222. Management typically involves elevating legs, IV fluids, and if severe hypotension persists, vasopressors. For methemoglobinemia, methylene blue may be administered.
Drug Interactions
Contraindicated Interactions
- Phosphodiesterase-5 (PDE5) inhibitors (e.g., sildenafil, tadalafil, vardenafil, avanafil) - severe hypotension and cardiovascular collapse
- Riociguat (soluble guanylate cyclase stimulator) - severe hypotension
Major Interactions
- Other vasodilators (e.g., hydralazine, minoxidil) - additive hypotensive effects
- Antihypertensives (e.g., beta-blockers, calcium channel blockers, ACE inhibitors, ARBs, diuretics) - additive hypotensive effects
- Alcohol - enhanced hypotensive effects and increased risk of syncope
Moderate Interactions
- Tricyclic antidepressants - may enhance orthostatic hypotension
- Phenothiazines - may enhance orthostatic hypotension
- Ergot alkaloids (e.g., ergotamine) - may antagonize antianginal effects of nitrates and cause coronary vasoconstriction
Minor Interactions
- Aspirin - may increase nitroglycerin levels (minor clinical significance)
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.
Angina frequency and severity
Rationale: To assess efficacy of therapy.
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: Systolic BP <90 mmHg or significant drop from baseline, or symptomatic hypotension (dizziness, syncope).
Heart Rate (HR)
Frequency: Regularly, especially during dose titration.
Target: Maintain within patient's normal range.
Action Threshold: Significant reflex tachycardia.
Angina symptoms
Frequency: Daily patient self-assessment.
Target: Reduction or elimination of angina episodes.
Action Threshold: Persistent or worsening angina, indicating inadequate control or development of tolerance.
Headache frequency and severity
Frequency: Daily patient self-assessment.
Target: Manageable or tolerable headache.
Action Threshold: Intolerable headache, requiring dose adjustment or alternative therapy.
Symptom Monitoring
- Headache (common, often indicates drug activity)
- Dizziness
- Lightheadedness
- Fainting (syncope)
- Flushing
- Nausea
- Palpitations
- Blurred vision
Special Patient Groups
Pregnancy
Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects, but there are no adequate and well-controlled studies in pregnant women.
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.
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:
Unknown; potential for adverse effects on the infant due to vasodilation or hypotension.
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. Initiate therapy with lower doses and titrate slowly, monitoring blood pressure closely. Increased risk of falls due to orthostatic hypotension.
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.
- Nitroglycerin controlled-release capsules are for prophylaxis of angina, not for acute angina attacks (sublingual nitroglycerin is used for acute relief).
- Headache is a very common side effect and often indicates the drug is working; it usually diminishes with continued use. Patients should be counseled not to discontinue the drug due to headache without consulting their physician.
- Patients must be strongly cautioned against concomitant use with PDE5 inhibitors (e.g., sildenafil) due to the risk of profound and life-threatening hypotension.
- Orthostatic hypotension is a common side effect; advise patients to rise slowly from a sitting or lying position.
Alternative Therapies
- Isosorbide dinitrate (oral, sublingual)
- Isosorbide mononitrate (oral, extended-release)
- Beta-blockers (e.g., metoprolol, atenolol) - first-line for chronic stable angina
- Calcium channel blockers (e.g., amlodipine, diltiazem, verapamil)
- Ranolazine
- Nicorandil (in some countries)
Cost & Coverage
Average Cost:
Varies widely by pharmacy and formulation (e.g., $30-$200+) per 30 capsules
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (for generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it's 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 be sure 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.