Niacin 100mg 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, Antihyperlipidemic
Pregnancy Category
Category C (for lipid-lowering doses); Category A (for vitamin deficiency doses)
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Niacin is a B vitamin (B3) that, at higher doses, can help lower 'bad' cholesterol (LDL) and triglycerides, and raise 'good' cholesterol (HDL). It's also used to treat a vitamin deficiency called pellagra. A common side effect is flushing, which is a feeling of warmth, redness, itching, or tingling, especially when you first start taking it.
How to Use This Medicine
Taking Your Medication Correctly
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 closely. 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. Continue taking your medication as directed by your doctor or healthcare provider, even if you start feeling well.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, away from the 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 by your pharmacist. If you're unsure about the best way to dispose of your medication, consult with your pharmacist. You may also want to check if there are 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. Do not take two doses at the same time or take extra doses. If you need to stop taking your medication, consult with your doctor first. You may need to restart at 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 closely. 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. Continue taking your medication as directed by your doctor or healthcare provider, even if you start feeling well.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, away from the 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 by your pharmacist. If you're unsure about the best way to dispose of your medication, consult with your pharmacist. You may also want to check if there are 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. Do not take two doses at the same time or take extra doses. If you need to stop taking your medication, consult with your doctor first. You may need to restart at a lower dose and gradually increase it to minimize potential side effects.
Lifestyle & Tips
- Take with food to reduce stomach upset and flushing.
- Avoid hot beverages or alcohol around the time of dosing, as they can worsen flushing.
- Taking a low-dose aspirin (e.g., 325 mg) 30 minutes before niacin may help reduce flushing, but consult your doctor first.
- Start with a low dose and gradually increase as directed by your doctor to minimize side effects.
- Maintain a healthy diet and exercise regimen as part of your lipid-lowering therapy.
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 (immediate-release): Initial 100 mg orally 2-3 times daily with meals, gradually increasing over several weeks. Maintenance: 1-2 g/day in 2-3 divided doses. Max: 6 g/day. For pellagra: 50-100 mg orally 3-4 times daily.
Dose Range:
100 - 6000 mg
Condition-Specific Dosing:
dyslipidemia_initial:
100 mg 2-3 times daily
dyslipidemia_maintenance:
1-2 g/day in 2-3 divided doses
pellagra:
50-100 mg 3-4 times daily
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
For pellagra: 100-300 mg/day orally in divided doses. For hyperlipidemia: Dosing is highly individualized and generally not recommended without specialist consultation.
Adolescent:
For pellagra: 100-300 mg/day orally in divided doses. For hyperlipidemia: Dosing is highly individualized and generally not recommended without specialist consultation.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment generally needed, monitor for adverse effects.
Moderate:
Use with caution, consider lower doses and close monitoring for adverse effects (e.g., myopathy, hepatotoxicity).
Severe:
Contraindicated or use with extreme caution; significant risk of accumulation and toxicity.
Dialysis:
Not well studied; generally avoided due to risk of accumulation and adverse effects.
Hepatic Impairment:
Mild:
Use with caution, monitor liver function tests closely.
Moderate:
Contraindicated or use with extreme caution; increased risk of hepatotoxicity.
Severe:
Contraindicated due to increased risk of hepatotoxicity and hepatic failure.
Pharmacology
Mechanism of Action
Niacin (nicotinic acid) reduces hepatic synthesis of very-low-density lipoproteins (VLDL), which leads to decreased production of LDL-C. It also reduces the catabolism of apoA-I, leading to increased HDL-C levels. The mechanism for its flushing effect involves prostaglandin D2 release. For pellagra, it acts as a vitamin B3 precursor essential for coenzymes NAD and NADP.
Pharmacokinetics
Absorption:
Bioavailability:
Highly variable, 30-70% (immediate-release)
Tmax:
0.5-2 hours (immediate-release)
FoodEffect:
Food can delay absorption but may reduce flushing. Taking with food is recommended to minimize GI upset and flushing.
Distribution:
Vd:
Not well-defined, distributes widely into tissues.
ProteinBinding:
Not extensively protein bound.
CnssPenetration:
Limited (as nicotinic acid, but crosses as nicotinamide)
Elimination:
HalfLife:
0.5-1.5 hours (immediate-release)
Clearance:
Rapid, primarily hepatic metabolism and renal excretion.
ExcretionRoute:
Renal (as metabolites and unchanged drug)
Unchanged:
Small percentage (less than 30%)
Pharmacodynamics
OnsetOfAction:
Lipid effects: Weeks to months for full effect. Flushing: Minutes.
PeakEffect:
Lipid effects: 3-5 weeks for maximal effect. Flushing: 20-30 minutes.
DurationOfAction:
Lipid effects: Sustained with continued dosing. Flushing: 1-2 hours.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
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 medical help right away:
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
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
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 severe 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 side effects while taking this medication. However, if you notice any of the following side effects or any other unusual symptoms, 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 not mentioned here. If you have questions or concerns about side effects, contact your doctor for medical advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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 medical help right away:
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
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
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 severe 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 side effects while taking this medication. However, if you notice any of the following side effects or any other unusual symptoms, 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 not mentioned here. If you have questions or concerns about side effects, contact your doctor for medical advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe flushing, itching, or rash
- Yellowing of skin or eyes (jaundice)
- Dark urine or pale stools
- Severe stomach pain, nausea, or vomiting
- Unexplained muscle pain, tenderness, or weakness (especially with fever or dark urine)
- Swelling of ankles or feet
- Shortness of breath
- Signs of high blood sugar (increased thirst, urination, fatigue)
- Signs of gout (sudden, severe joint pain, redness, swelling)
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 breastfeeding, as you should not breastfeed 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 issues 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 adjust 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 breastfeeding, as you should not breastfeed 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 issues 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 adjust 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, it is crucial to closely monitor your blood sugar levels. Regularly undergo blood work and other laboratory tests as instructed 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 benefits 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 liver disease and exacerbate flushing symptoms. Be vigilant for signs of gout attacks, as this medication may affect your condition.
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 benefits 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 liver disease and exacerbate flushing symptoms. Be vigilant for signs of gout attacks, as this medication may affect your condition.
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 distress (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 and symptomatic. Gastric lavage or activated charcoal may be considered if ingestion is recent. Monitor vital signs, liver function, blood glucose, and uric acid levels.
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 and reduce its absorption. Administer niacin 4-6 hours after or 1 hour before sequestrants.
Moderate Interactions
- Antihypertensive agents: May potentiate hypotensive effects.
- Aspirin: Can reduce niacin-induced flushing, but high doses of aspirin may increase niacin levels.
- Alcohol: May exacerbate flushing and increase risk of hepatotoxicity.
- Allopurinol/Probenecid: Niacin may increase uric acid levels, potentially counteracting effects of uricosuric agents.
- Diabetes medications (oral hypoglycemics, insulin): Niacin can 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
Liver Function Tests (LFTs) including ALT, AST, alkaline phosphatase, bilirubin
Rationale: To establish baseline liver function and identify pre-existing hepatic impairment, as niacin can cause hepatotoxicity.
Timing: Before initiating therapy
Fasting Lipid Panel (Total Cholesterol, LDL-C, HDL-C, Triglycerides)
Rationale: To establish baseline lipid levels and assess the need for therapy.
Timing: Before initiating therapy
Fasting Blood Glucose or HbA1c
Rationale: Niacin can increase blood glucose levels.
Timing: Before initiating therapy
Uric Acid
Rationale: Niacin can increase uric acid levels, potentially exacerbating or precipitating gout.
Timing: Before initiating therapy
Routine Monitoring
Liver Function Tests (LFTs)
Frequency: Every 6-12 weeks for the first year, then periodically (e.g., every 6 months) or as clinically indicated.
Target: Within normal limits; elevations >3x ULN warrant dose reduction or discontinuation.
Action Threshold: ALT/AST >3x ULN: Reduce dose or discontinue. ALT/AST >2x ULN with symptoms: Reduce dose or discontinue.
Fasting Lipid Panel
Frequency: Every 6-12 weeks until desired lipid levels are achieved, then every 6-12 months.
Target: Individualized based on patient risk factors and treatment goals.
Action Threshold: Failure to meet lipid goals, or significant adverse effects.
Fasting Blood Glucose or HbA1c
Frequency: Periodically, especially in diabetic or pre-diabetic patients.
Target: Individualized based on patient's diabetic status.
Action Threshold: Significant increase in blood glucose requiring adjustment of antidiabetic therapy.
Uric Acid
Frequency: Periodically, especially in patients with a history of gout or hyperuricemia.
Target: Within normal limits or patient's baseline.
Action Threshold: Significant increase in uric acid or onset of gout symptoms.
Symptoms of myopathy (muscle pain, tenderness, weakness)
Frequency: Ongoing patient education and inquiry at each visit, especially if co-administered with statins.
Target: Absence of symptoms.
Action Threshold: Presence of symptoms, especially with elevated CK levels, warrants immediate discontinuation.
Symptom Monitoring
- Flushing (redness, warmth, itching, tingling)
- Gastrointestinal upset (nausea, vomiting, diarrhea, dyspepsia)
- Headache
- Dizziness
- Muscle pain or weakness (especially if co-administered with statins)
- Dark urine, yellowing of skin/eyes (signs of liver injury)
- Unusual fatigue or weakness
- Joint pain or swelling (gout symptoms)
Special Patient Groups
Pregnancy
For lipid-lowering doses, Niacin is generally not recommended unless the potential benefit outweighs the risk, as there are safer alternatives. For treatment of pellagra (vitamin deficiency), it is considered safe and essential.
Trimester-Specific Risks:
First Trimester:
Limited data for high doses; generally avoided for lipid-lowering.
Second Trimester:
Limited data for high doses; generally avoided for lipid-lowering.
Third Trimester:
Limited data for high doses; generally avoided for lipid-lowering.
Lactation
Niacin is excreted in breast milk. While generally considered safe at nutritional doses, high lipid-lowering doses should be used with caution due to potential for adverse effects in the infant and lack of sufficient safety data.
Infant Risk:
Low risk at nutritional doses; potential for gastrointestinal upset, flushing, or other adverse effects at high doses. Monitor infant for adverse reactions.
Pediatric Use
Use for hyperlipidemia is generally not recommended due to limited data and potential for adverse effects; reserved for severe cases under specialist supervision. For pellagra, dosing is established and safe.
Geriatric Use
Use with caution due to increased susceptibility to adverse effects (e.g., flushing, gastrointestinal upset, hepatotoxicity, hyperglycemia). Start with lower doses and titrate slowly. Close monitoring of liver function, glucose, and uric acid is essential.
Clinical Information
Clinical Pearls
- Immediate-release (IR) niacin causes more flushing and GI side effects than extended-release (ER) formulations, but ER formulations have a higher risk of hepatotoxicity at equivalent doses.
- To minimize flushing, advise patients to take niacin with a low-fat meal, avoid hot liquids or alcohol around dosing, and consider taking a low-dose aspirin 30 minutes prior (if not contraindicated).
- Gradual dose titration is crucial to improve tolerability and reduce flushing.
- Niacin can worsen glycemic control in diabetic patients and increase uric acid levels, potentially precipitating gout. Close monitoring is required.
- Liver function tests must be monitored regularly, especially during dose escalation and with long-term use, due to the risk of hepatotoxicity.
Alternative Therapies
- Statins (e.g., atorvastatin, rosuvastatin, simvastatin)
- Fibrates (e.g., gemfibrozil, fenofibrate)
- Ezetimibe
- PCSK9 inhibitors (e.g., evolocumab, alirocumab)
- Bile acid sequestrants (e.g., cholestyramine, colestipol)
- Omega-3 fatty acids (e.g., icosapent ethyl, omega-3-acid ethyl esters)
Cost & Coverage
Average Cost:
$10 - $50 per 30 tablets (100mg IR)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (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 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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.