Niacin 250mg Tablets
It is used to lower bad cholesterol, lower triglycerides, and raise good cholesterol (HDL).Some products are used to treat niacin deficiency.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Antilipemic agent; Vitamin B3
Pharmacologic Class
Nicotinic acid derivative; Water-soluble vitamin
Pregnancy Category
Category C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Niacin is a B vitamin (B3) that can help lower 'bad' cholesterol (LDL) and triglycerides, and raise 'good' cholesterol (HDL). It's also used to treat a condition called pellagra, which is caused by a lack of vitamin B3. When used for cholesterol, it's usually taken in higher doses than for vitamin deficiency.
How to Use This Medicine
Taking Your Medication
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions exactly. Take your medication with food to help your body absorb it properly. When it's time to take your dose, avoid consuming alcohol, hot drinks, or spicy foods, as they may interfere with the medication's effectiveness. Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better.
Storing and Disposing of Your Medication
To keep your medication effective and safe, 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 your medication is no longer needed or has expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist or healthcare provider. If you're unsure about the best way to dispose of your medication, consult with your pharmacist, who may be aware of 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 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 one. If you need to stop taking your medication, consult with your doctor, as you may need to restart with a lower dose and gradually increase it to minimize potential side effects.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions exactly. Take your medication with food to help your body absorb it properly. When it's time to take your dose, avoid consuming alcohol, hot drinks, or spicy foods, as they may interfere with the medication's effectiveness. Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better.
Storing and Disposing of Your Medication
To keep your medication effective and safe, 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 your medication is no longer needed or has expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist or healthcare provider. If you're unsure about the best way to dispose of your medication, consult with your pharmacist, who may be aware of 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 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 one. If you need to stop taking your medication, consult with your doctor, as you may need to restart with a lower dose and gradually increase it to minimize potential side effects.
Lifestyle & Tips
- Take with food or a low-fat snack to reduce stomach upset and flushing.
- Avoid hot beverages or alcohol around the time of dosing, as they can worsen flushing.
- Taking a non-enteric coated aspirin (325 mg) or ibuprofen (200 mg) 30 minutes before niacin may help reduce flushing.
- Start with a low dose and increase gradually as directed by your doctor to minimize side effects.
- Maintain a healthy diet low in saturated and trans fats, and regular exercise, as these are crucial for managing cholesterol.
- Report any unusual muscle pain, weakness, dark urine, or yellowing of skin/eyes immediately.
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:
For dyslipidemia: Initial 250 mg once daily at bedtime, titrated slowly. For pellagra: 50-100 mg 3-4 times daily.
Dose Range:
250 - 2000 mg
Condition-Specific Dosing:
Hyperlipidemia (Immediate-Release):
Initial 250 mg once daily at bedtime for 1 week, then 500 mg at bedtime for 1 week, then 750 mg at bedtime for 1 week, then 1000 mg at bedtime. May increase to 1500-2000 mg/day in divided doses. Max 6000 mg/day.
Pellagra:
50-100 mg 3-4 times daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Pellagra: 100-300 mg/day in divided doses. Hyperlipidemia: Not routinely recommended, consult specialist.
Adolescent:
Pellagra: 100-300 mg/day in divided doses. Hyperlipidemia: Not routinely recommended, consult specialist.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment required, monitor for adverse effects.
Moderate:
Use with caution, consider lower doses and close monitoring of renal function and adverse effects.
Severe:
Contraindicated or use with extreme caution; significant risk of toxicity due to reduced excretion.
Dialysis:
Contraindicated or use with extreme caution; significant risk of toxicity.
Hepatic Impairment:
Mild:
Use with caution, monitor liver function tests (LFTs) closely.
Moderate:
Contraindicated or use with extreme caution; increased risk of hepatotoxicity.
Severe:
Contraindicated.
Pharmacology
Mechanism of Action
Niacin (nicotinic acid) reduces hepatic synthesis of very-low-density lipoprotein (VLDL), which leads to decreased synthesis of low-density lipoprotein (LDL). It also inhibits the mobilization of free fatty acids from peripheral adipose tissue, reducing the substrate for hepatic triglyceride synthesis. Additionally, it increases high-density lipoprotein (HDL) cholesterol levels by reducing the catabolism of apoA-I and HDL particles. As a vitamin, it is a precursor to NAD and NADP, essential coenzymes in metabolic processes.
Pharmacokinetics
Absorption:
Bioavailability:
Highly variable (30-70%) depending on formulation and dose.
Tmax:
Immediate-release: 0.5-2 hours; Extended-release: 4-5 hours.
FoodEffect:
Food can delay absorption and reduce peak concentrations, but may also reduce flushing.
Distribution:
Vd:
Not well-characterized, but widely distributed.
ProteinBinding:
Low (<20%).
CnssPenetration:
Limited
Elimination:
HalfLife:
Immediate-release: 0.9-1.4 hours; Extended-release: 3-4.5 hours.
Clearance:
Highly variable, dose-dependent.
ExcretionRoute:
Renal (primarily as metabolites, small amount unchanged).
Unchanged:
Varies with dose and formulation; typically <30% of dose excreted unchanged in urine.
Pharmacodynamics
OnsetOfAction:
Lipid effects: Weeks to months for maximal effect. Flushing: Minutes to hours.
PeakEffect:
Lipid effects: 3-5 weeks for initial changes, maximal effect over several months. Flushing: 30-60 minutes after dose.
DurationOfAction:
Lipid effects: Sustained with continued dosing. Flushing: 1-2 hours (IR), longer with ER/SR.
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 medical attention immediately:
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
Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Signs of high blood sugar, such as:
+ Confusion
+ Feeling sleepy
+ Unusual 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
Muscle pain, tenderness, or weakness (with or without fever or feeling unwell), which can be a sign of a rare but serious muscle problem (rhabdomyolysis) that may lead to kidney problems and can be life-threatening, especially when used with certain cholesterol-lowering medications like atorvastatin and simvastatin.
Other Possible Side Effects
Most people experience either no side effects or only mild ones. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention if they bother you or persist:
Flushing (taking aspirin 30 minutes before taking this medication may help; if you experience flushing at night, get up slowly to avoid dizziness or fainting)
Itching
Diarrhea
Upset stomach or vomiting
Cough
Dry skin
* Headache
Reporting Side Effects
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, 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.
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 medical attention immediately:
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
Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Signs of high blood sugar, such as:
+ Confusion
+ Feeling sleepy
+ Unusual 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
Muscle pain, tenderness, or weakness (with or without fever or feeling unwell), which can be a sign of a rare but serious muscle problem (rhabdomyolysis) that may lead to kidney problems and can be life-threatening, especially when used with certain cholesterol-lowering medications like atorvastatin and simvastatin.
Other Possible Side Effects
Most people experience either no side effects or only mild ones. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention if they bother you or persist:
Flushing (taking aspirin 30 minutes before taking this medication may help; if you experience flushing at night, get up slowly to avoid dizziness or fainting)
Itching
Diarrhea
Upset stomach or vomiting
Cough
Dry skin
* Headache
Reporting Side Effects
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, 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 flushing, itching, or rash that doesn't subside
- Unexplained muscle pain, tenderness, or weakness
- Dark urine
- Yellowing of the skin or eyes (jaundice)
- Severe stomach pain, nausea, or vomiting
- Swelling of the face, lips, tongue, or throat (signs of allergic reaction)
- Difficulty breathing
- Chest pain
- Fainting or severe dizziness
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.
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 dose 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 allergic reaction you experienced, including any symptoms.
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 dose 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, it is crucial to closely monitor your blood sugar levels. Regularly undergo blood work and other laboratory tests as directed by your doctor. Be aware that this medication may interfere with certain lab tests, so notify all your healthcare providers and laboratory personnel that you are taking this drug.
To maximize the effectiveness of this medication, 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 developing liver disease. Additionally, be aware that alcohol may exacerbate flushing symptoms. Be vigilant for signs of gout attacks, which can be a potential side effect of this medication.
If you are 65 years or older, exercise caution when using this medication, as you may be more susceptible to side effects. If you are pregnant or planning to become pregnant, consult your doctor to discuss the potential benefits and risks of using this medication during pregnancy.
To maximize the effectiveness of this medication, 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 developing liver disease. Additionally, be aware that alcohol may exacerbate flushing symptoms. Be vigilant for signs of gout attacks, which can be a potential side effect of this medication.
If you are 65 years or older, exercise caution when using this medication, as you may be more susceptible to side effects. If you are pregnant or planning 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
- Tachycardia
- Liver damage (elevated LFTs, jaundice)
- Hyperglycemia
- Hyperuricemia
What to Do:
Call 1-800-222-1222 (Poison Control). Treatment is supportive. Gastric lavage or activated charcoal may be considered if ingestion is recent. Monitor vital signs, liver function, blood glucose, and uric acid. Manage symptoms as they arise.
Drug Interactions
Major Interactions
- Statins (HMG-CoA reductase inhibitors): Increased risk of myopathy/rhabdomyolysis, especially with higher doses of niacin.
- Bile acid sequestrants (e.g., cholestyramine, colestipol): May bind niacin, reducing its absorption. Administer niacin 4-6 hours after or 1 hour before sequestrants.
Moderate Interactions
- Antihypertensive agents (especially ganglionic blocking agents, vasodilators): May potentiate hypotensive effects.
- Alcohol: May exacerbate flushing and increase risk of hepatotoxicity.
- Aspirin: May reduce niacin-induced flushing, but high doses of aspirin may increase niacin levels.
- Allopurinol/Probenecid: Niacin may increase uric acid levels, potentially counteracting effects of these agents.
- Oral hypoglycemic agents/Insulin: Niacin may increase blood glucose levels, requiring adjustment of antidiabetic therapy.
Minor Interactions
- Herbal supplements (e.g., ginkgo biloba, garlic): Potential for additive antiplatelet effects.
Monitoring
Baseline Monitoring
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 establish baseline liver function and monitor for hepatotoxicity.
Timing: Prior to initiation of therapy.
Fasting Blood Glucose or HbA1c
Rationale: To establish baseline glucose control, as niacin can elevate blood glucose.
Timing: Prior to initiation of therapy.
Uric Acid
Rationale: To establish baseline uric acid levels, as niacin can elevate uric acid.
Timing: Prior to initiation of therapy.
Routine Monitoring
Lipid Panel
Frequency: Every 6-12 weeks initially, then every 6-12 months once stable.
Target: Individualized based on treatment goals (e.g., LDL-C <100 mg/dL, HDL-C >40 mg/dL, Triglycerides <150 mg/dL).
Action Threshold: Lack of therapeutic response or worsening lipid profile.
Liver Function Tests (ALT, AST)
Frequency: Every 6-12 weeks for the first year, then periodically (e.g., every 6-12 months) or as clinically indicated.
Target: Within normal limits.
Action Threshold: Persistent elevations >3 times the upper limit of normal (ULN) or any elevation accompanied by symptoms of liver injury; consider discontinuation or dose reduction.
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 or persistent elevation; consider dose adjustment or discontinuation, or adjustment of antidiabetic therapy.
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 patient's baseline.
Action Threshold: Significant or persistent elevation, or onset of gout symptoms.
Symptom Monitoring
- Flushing (redness, warmth, itching, tingling)
- Gastrointestinal upset (nausea, vomiting, diarrhea, dyspepsia)
- Headache
- Dizziness
- Muscle pain or weakness (myalgia, myopathy, rhabdomyolysis)
- Dark urine, yellowing of skin/eyes (signs of liver injury)
- Unusual fatigue or weakness
- Joint pain or swelling (gout symptoms)
Special Patient Groups
Pregnancy
Generally not recommended for lipid-lowering during pregnancy unless the benefits outweigh the risks. High doses may be teratogenic in animals. For pellagra, it is essential and safe at recommended doses.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity at high doses (animal data).
Second Trimester:
Limited data, generally avoided for lipid-lowering.
Third Trimester:
Limited data, generally avoided for lipid-lowering.
Lactation
Niacin is excreted into breast milk. While generally considered compatible with breastfeeding at typical vitamin doses, high doses used for dyslipidemia should be used with caution. Monitor infant for flushing or gastrointestinal upset.
Infant Risk:
Low risk at vitamin doses; potential for mild GI upset or flushing at higher therapeutic doses.
Pediatric Use
Not routinely recommended for dyslipidemia due to lack of long-term safety and efficacy data. Used for pellagra. Close monitoring for adverse effects is crucial if used off-label for dyslipidemia.
Geriatric Use
Use with caution due to increased susceptibility to adverse effects (e.g., flushing, gastrointestinal upset, hepatotoxicity) and potential for polypharmacy. Start with lower doses and titrate slowly. Monitor liver function and glucose closely.
Clinical Information
Clinical Pearls
- Niacin-induced flushing is prostaglandin-mediated. Taking aspirin or ibuprofen 30 minutes before niacin can significantly reduce flushing.
- Taking niacin with food, especially a low-fat snack, can help reduce gastrointestinal upset and flushing.
- Extended-release (ER) formulations are generally preferred for lipid-lowering due to reduced flushing and less hepatotoxicity compared to immediate-release (IR) or sustained-release (SR) formulations at equivalent doses.
- Slow titration of the dose is critical to improve tolerability and minimize adverse effects.
- Patients should be advised to avoid hot showers/baths, hot beverages, and alcohol around the time of dosing, as these can exacerbate flushing.
- Monitor liver function tests, blood glucose, and uric acid regularly, especially during dose titration and at higher doses.
- Niacin can cause acanthosis nigricans, a skin condition characterized by dark, velvety patches, which usually resolves upon discontinuation.
Alternative Therapies
- Statins (e.g., Atorvastatin, Rosuvastatin, Simvastatin)
- Fibrates (e.g., Fenofibrate, Gemfibrozil)
- PCSK9 inhibitors (e.g., Alirocumab, Evolocumab)
- Ezetimibe
- Bile acid sequestrants (e.g., Cholestyramine, Colesevelam)
- Omega-3 fatty acid ethyl esters (e.g., Icosapent ethyl, Omega-3-acid ethyl esters)
Cost & Coverage
Average Cost:
Price range varies widely by formulation and quantity per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (generic), Tier 3 or higher (brand)
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.