Niacin 750mg ER Tablets
It is used to lower bad cholesterol, lower triglycerides, and raise good cholesterol (HDL).It may be given to you for other reasons. Talk with the doctor.
Drug Class
Antihyperlipidemic
Pharmacologic Class
Vitamin B3 derivative; Nicotinic acid
Pregnancy Category
Category C
FDA Approved
Aug 1997
DEA Schedule
Not Controlled
Overview
What is this medicine?
Niacin is a form of Vitamin B3 that helps lower 'bad' cholesterol (LDL and triglycerides) and raise 'good' cholesterol (HDL) in your blood. This extended-release tablet is designed to reduce side effects like flushing and is usually taken once a day at bedtime.
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 this medication with food, swallowing the tablet whole without chewing or crushing it. Avoid consuming alcohol, hot drinks, or spicy foods when taking this medication.
Continue taking this medication as directed by your doctor or healthcare provider, even if you start feeling well. If you're unsure whether your specific product can be broken in half, consult with your doctor. Some products are designed to be taken at bedtime, while others can be taken at any time. Check with your pharmacist for guidance on the best time to take your medication.
Storing and Disposing of Your Medication
Store this medication at room temperature in a dry place, avoiding storage in a bathroom. Keep all medications in a safe location, 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 disposing of your medication, consult with your pharmacist. You may also want to explore drug take-back programs 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 dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses. If you stop taking this medication, consult with your doctor, as you may need to restart with a lower dose and gradually increase it.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take this medication with food, swallowing the tablet whole without chewing or crushing it. Avoid consuming alcohol, hot drinks, or spicy foods when taking this medication.
Continue taking this medication as directed by your doctor or healthcare provider, even if you start feeling well. If you're unsure whether your specific product can be broken in half, consult with your doctor. Some products are designed to be taken at bedtime, while others can be taken at any time. Check with your pharmacist for guidance on the best time to take your medication.
Storing and Disposing of Your Medication
Store this medication at room temperature in a dry place, avoiding storage in a bathroom. Keep all medications in a safe location, 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 disposing of your medication, consult with your pharmacist. You may also want to explore drug take-back programs 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 dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses. If you stop taking this medication, consult with your doctor, as you may need to restart with a lower dose and gradually increase it.
Lifestyle & Tips
- Take the tablet whole; do not crush, chew, or break it.
- Take Niacin ER at bedtime with a low-fat snack to help reduce flushing and stomach upset.
- Avoid taking Niacin ER with hot beverages or alcohol, as these can worsen flushing.
- To further reduce flushing, your doctor may recommend taking a low-dose aspirin (e.g., 325 mg or 81 mg) about 30 minutes before your niacin dose.
- Maintain a heart-healthy diet low in saturated and trans fats, and cholesterol.
- Engage in regular physical activity as recommended by your doctor.
- Limit alcohol consumption, as it can increase side effects and liver risk.
- Inform your doctor about all medications, supplements, and herbal products you are taking.
Available Forms & Alternatives
Available Strengths:
- Niacin 250mg Tablets
- Niacin TR 1000mg Tablets
- Niacin 500mg Tablets
- Niacin 100mg Tablets
- Niacin 500mg SR Capsules
- Niacin ER 1000mg Tablets
- Niacin 750mg ER Tablets
- Niacin 500mg ER Tablets
- Niacin ER 1000mg Tablets
- Niacin 500mg ER Tablets
- Niacin 750mg ER Tablets
- Niacin 250mg TR Capsules
- Niacin 500mg TR Tablets
- Niacin 500mg TR Tablets
Dosing & Administration
Adult Dosing
Standard Dose:
Initial: 500 mg orally once daily at bedtime for 4 weeks. Titrate: May increase to 1000 mg once daily for 4 weeks, then to 1500 mg once daily for 4 weeks, then to 2000 mg once daily. Maintenance: 1000-2000 mg once daily.
Dose Range:
500 - 2000 mg
Condition-Specific Dosing:
dyslipidemia:
Initial titration to minimize flushing and other side effects. Administer at bedtime after a low-fat snack. Avoid administering with hot beverages or alcohol.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment required, but use with caution.
Moderate:
Use with caution. Monitor renal function and adverse effects closely. Consider lower doses or slower titration.
Severe:
Contraindicated in severe renal impairment (CrCl < 30 mL/min) due to increased risk of adverse effects, including myopathy and rhabdomyolysis.
Dialysis:
Not recommended. Contraindicated.
Hepatic Impairment:
Mild:
Use with caution. Monitor liver function tests closely.
Moderate:
Contraindicated in active liver disease or unexplained persistent elevations of hepatic transaminases.
Severe:
Contraindicated in active liver disease or unexplained persistent elevations of hepatic transaminases.
Pharmacology
Mechanism of Action
Niacin (nicotinic acid) reduces hepatic synthesis of very-low-density lipoprotein (VLDL), which in turn reduces the synthesis of low-density lipoprotein (LDL). It also inhibits the mobilization of free fatty acids from adipose tissue, thereby reducing the substrate for hepatic triglyceride synthesis. Additionally, niacin increases the plasma concentration of high-density lipoprotein (HDL) cholesterol by decreasing its catabolism.
Pharmacokinetics
Absorption:
Bioavailability:
Variable, generally good. Extended-release formulation provides sustained absorption.
Tmax:
Approximately 5 hours for extended-release formulation.
FoodEffect:
Food enhances absorption and reduces the incidence and severity of flushing. Should be taken with a low-fat snack at bedtime.
Distribution:
Vd:
Not extensively studied, but widely distributed.
ProteinBinding:
Low (<20%)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 2-3 hours (for extended-release formulation)
Clearance:
Not precisely quantified, but primarily renal.
ExcretionRoute:
Renal (urine)
Unchanged:
Small percentage (less than 10% of dose)
Pharmacodynamics
OnsetOfAction:
Lipid-lowering effects are gradual, typically observed within weeks of initiating therapy.
PeakEffect:
Maximal lipid-lowering effects may take several weeks to months of consistent therapy.
DurationOfAction:
Extended-release formulation provides sustained therapeutic levels over 24 hours.
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
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes (jaundice)
Signs of high blood sugar, such as:
+ Confusion
+ Drowsiness
+ Increased thirst or hunger
+ Frequent urination
+ Flushing
+ Rapid breathing
+ Fruity-smelling breath
Chest pain or pressure
Abnormal heartbeat
Dizziness or fainting
Shortness of breath
Excessive sweating
Black, tarry, or bloody stools
Rarely, a severe muscle problem (rhabdomyolysis) can occur, especially when used with certain cholesterol-lowering medications like atorvastatin and simvastatin. This can lead to kidney problems and be life-threatening. Seek medical help immediately if you experience:
+ Muscle pain
+ Tenderness
+ Weakness (with or without fever or feeling unwell)
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 or seek medical help:
Flushing (taking aspirin 30 minutes before taking this medication may help; if you wake up at night with flushing, get up slowly if you feel dizzy or lightheaded)
Itching
Diarrhea
Upset stomach or vomiting
Cough
Dry skin
* Headache
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, contact 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
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes (jaundice)
Signs of high blood sugar, such as:
+ Confusion
+ Drowsiness
+ Increased thirst or hunger
+ Frequent urination
+ Flushing
+ Rapid breathing
+ Fruity-smelling breath
Chest pain or pressure
Abnormal heartbeat
Dizziness or fainting
Shortness of breath
Excessive sweating
Black, tarry, or bloody stools
Rarely, a severe muscle problem (rhabdomyolysis) can occur, especially when used with certain cholesterol-lowering medications like atorvastatin and simvastatin. This can lead to kidney problems and be life-threatening. Seek medical help immediately if you experience:
+ Muscle pain
+ Tenderness
+ Weakness (with or without fever or feeling unwell)
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 or seek medical help:
Flushing (taking aspirin 30 minutes before taking this medication may help; if you wake up at night with flushing, get up slowly if you feel dizzy or lightheaded)
Itching
Diarrhea
Upset stomach or vomiting
Cough
Dry skin
* Headache
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, contact 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 flushing, itching, or tingling.
- Unusual fatigue, weakness, or muscle pain (especially if you are also taking a statin).
- Dark urine, yellowing of the skin or eyes (jaundice), or persistent nausea/vomiting (signs of liver problems).
- Severe stomach pain, diarrhea, or heartburn.
- Swelling in your ankles or feet.
- Increased thirst or urination (signs of high blood sugar).
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 symptoms you experienced.
Certain health conditions, including:
+ Bleeding problems
+ Liver problems or elevated liver enzymes
+ Ulcer disease
* If you are breast-feeding, as you should not breast-feed while taking this medication.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change 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. Be sure to describe the symptoms you experienced.
Certain health conditions, including:
+ Bleeding problems
+ Liver problems or elevated liver enzymes
+ Ulcer disease
* If you are breast-feeding, as you should not breast-feed while taking this medication.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change 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. If you have diabetes, you will need to closely monitor your blood sugar levels.
Regular blood work and other laboratory tests should be conducted as directed by your doctor. Be aware that this medication may interfere with certain lab tests, so it is crucial to notify all your healthcare providers and laboratory personnel that you are taking this drug.
Adhere to the diet and exercise plan recommended by your doctor. When taking this medication, avoid taking colesevelam, colestipol, or cholestyramine within a 4-hour window before or after taking your dose.
Limit your alcohol consumption to fewer than 3 drinks per day, as excessive alcohol intake may increase your risk of liver disease and exacerbate flushing symptoms. Be vigilant for signs of gout attacks.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. If you are pregnant or plan to become pregnant, consult your doctor to discuss the potential benefits and risks of using this medication during pregnancy.
Regular blood work and other laboratory tests should be conducted as directed by your doctor. Be aware that this medication may interfere with certain lab tests, so it is crucial to notify all your healthcare providers and laboratory personnel that you are taking this drug.
Adhere to the diet and exercise plan recommended by your doctor. When taking this medication, avoid taking colesevelam, colestipol, or cholestyramine within a 4-hour window before or after taking your dose.
Limit your alcohol consumption to fewer than 3 drinks per day, as excessive alcohol intake may increase your risk of liver disease and exacerbate flushing symptoms. Be vigilant for signs of gout attacks.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. If you are pregnant or plan to become pregnant, consult your doctor to discuss the potential benefits and risks of using this medication during pregnancy.
Overdose Information
Overdose Symptoms:
- Severe flushing
- Gastrointestinal upset (nausea, vomiting, diarrhea)
- Dizziness
- Hypotension (low blood pressure)
- Tachycardia (rapid heart rate)
- Headache
- Pruritus (itching)
What to Do:
In case of suspected overdose, seek immediate medical attention or call a poison control center (e.g., 1-800-222-1222). Treatment is supportive and symptomatic. There is no specific antidote.
Drug Interactions
Contraindicated Interactions
- Active liver disease
- Unexplained persistent elevations of hepatic transaminases
- Active peptic ulcer disease
- Arterial hemorrhage
Major Interactions
- Statins (HMG-CoA reductase inhibitors): Increased risk of myopathy/rhabdomyolysis, especially with higher doses of niacin or statins. Co-administration should be approached with caution and close monitoring.
- Bile acid sequestrants (e.g., cholestyramine, colestipol): May bind niacin and reduce its absorption. Administer niacin at least 4-6 hours after bile acid sequestrants.
Moderate Interactions
- Alcohol: May exacerbate flushing and increase the risk of hepatotoxicity.
- Antihypertensive agents (e.g., ACE inhibitors, beta-blockers, calcium channel blockers): May cause additive hypotensive effects.
- Aspirin: May potentiate the flushing effect of niacin by inhibiting prostaglandin synthesis. Low-dose aspirin taken 30 minutes before niacin can reduce flushing.
- Oral hypoglycemic agents/Insulin: Niacin can increase blood glucose levels, requiring adjustment of antidiabetic therapy.
- Uricosuric agents (e.g., probenecid): Niacin can increase uric acid levels, potentially reducing the effectiveness of uricosuric agents.
Minor Interactions
- Herbal supplements (e.g., ginkgo biloba): Potential for additive effects on bleeding risk, though not well-established for niacin.
Monitoring
Baseline Monitoring
Fasting Lipid Panel (Total Cholesterol, LDL-C, HDL-C, Triglycerides)
Rationale: To establish baseline lipid levels and assess therapeutic efficacy.
Timing: Prior to initiation of therapy.
Liver Function Tests (ALT, AST, Alkaline Phosphatase, Bilirubin)
Rationale: To assess baseline hepatic function and monitor for drug-induced hepatotoxicity.
Timing: Prior to initiation of therapy.
Fasting Blood Glucose or HbA1c
Rationale: Niacin can increase blood glucose levels.
Timing: Prior to initiation of therapy.
Uric Acid
Rationale: Niacin can increase uric acid levels, potentially exacerbating gout.
Timing: Prior to initiation of therapy.
Routine Monitoring
Fasting Lipid Panel
Frequency: Every 6-12 weeks during titration, then every 6-12 months or as clinically indicated.
Target: Individualized based on patient risk factors and treatment goals.
Action Threshold: Lack of therapeutic response or worsening lipid profile may require dose adjustment or alternative therapy.
Liver Function Tests (ALT, AST)
Frequency: Every 6-12 weeks for the first year of therapy, then periodically (e.g., every 6-12 months) or as clinically indicated.
Target: Within normal limits. Elevations >3 times upper limit of normal (ULN) are concerning.
Action Threshold: Discontinue if transaminase levels exceed 3 times ULN or if accompanied by symptoms of liver dysfunction (e.g., fatigue, anorexia, dark urine, jaundice).
Fasting Blood Glucose or HbA1c
Frequency: Periodically (e.g., every 6-12 months) or as clinically indicated, especially in diabetic patients.
Target: Individualized based on patient's diabetic status.
Action Threshold: Significant increase may require adjustment of antidiabetic therapy or niacin discontinuation.
Uric Acid
Frequency: Periodically (e.g., every 6-12 months) or as clinically indicated, especially in patients with a history of gout.
Target: Within normal limits or individualized for gout management.
Action Threshold: Significant increase may require management of hyperuricemia or niacin discontinuation.
Symptom Monitoring
- Flushing (redness, warmth, itching, tingling)
- Gastrointestinal upset (nausea, vomiting, diarrhea, dyspepsia)
- Muscle pain, tenderness, or weakness (signs of myopathy/rhabdomyolysis, especially if co-administered with statins)
- Symptoms of liver dysfunction (unusual fatigue, anorexia, dark urine, yellowing of skin or eyes, right upper quadrant pain)
- Symptoms of hyperglycemia (increased thirst, urination, fatigue)
- Symptoms of gout (joint pain, swelling, redness)
Special Patient Groups
Pregnancy
Niacin is Pregnancy Category C. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Cholesterol and other lipid products are essential for fetal development.
Trimester-Specific Risks:
First Trimester:
Potential risks not fully established; generally avoided unless clearly indicated.
Second Trimester:
Potential risks not fully established; generally avoided unless clearly indicated.
Third Trimester:
Potential risks not fully established; generally avoided unless clearly indicated.
Lactation
Niacin is excreted into breast milk. The American Academy of Pediatrics considers niacin compatible with breastfeeding. However, caution is advised, and the infant should be monitored for adverse effects.
Infant Risk:
Low to Moderate. Potential for flushing or gastrointestinal upset in the infant, though unlikely with typical doses. Monitor for adverse effects.
Pediatric Use
Safety and efficacy have not been established in pediatric patients. Use is generally not recommended.
Geriatric Use
Use with caution in elderly patients due to increased susceptibility to adverse effects, particularly flushing, gastrointestinal upset, and potential for liver enzyme elevations. Start with lower doses and titrate slowly, monitoring closely for adverse reactions.
Clinical Information
Clinical Pearls
- Extended-release niacin is generally better tolerated than immediate-release niacin due to reduced flushing and hepatotoxicity risk, but proper titration is still crucial.
- Always advise patients to take niacin ER at bedtime with a low-fat snack to minimize flushing and GI upset.
- Pre-treatment with 325 mg or 81 mg aspirin 30 minutes before the niacin dose can significantly reduce prostaglandin-mediated flushing.
- Educate patients to avoid hot showers/baths, hot beverages, and spicy foods around the time of dosing, as these can exacerbate flushing.
- Regular monitoring of liver function tests, fasting lipid panel, glucose, and uric acid is essential due to potential adverse effects.
- Counsel patients on the importance of adherence to diet and exercise in conjunction with niacin therapy for optimal lipid management.
Alternative Therapies
- Statins (e.g., atorvastatin, rosuvastatin, simvastatin)
- Fibrates (e.g., fenofibrate, gemfibrozil)
- Ezetimibe
- PCSK9 inhibitors (e.g., evolocumab, alirocumab)
- Omega-3 fatty acid ethyl esters (e.g., icosapent ethyl, omega-3-acid ethyl esters)
- Bile acid sequestrants (e.g., cholestyramine, colestipol, colesevelam)
Cost & Coverage
Average Cost:
$30 - $150 per 30 tablets
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 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. If you have any questions or concerns about this 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.