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Niacin

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Active ingredient
Niacin 500–1000 mg
Other brand names
Drug class
Nicotinic Acid
Dosage form
Tablet, Extended Release
Route
Oral
Prescription status
Rx (prescription)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2014
Label revision date
October 6, 2023
FDA Insert
Prescribing information, PDF file
Active ingredient
Niacin 500–1000 mg
Other brand names
Drug class
Nicotinic Acid
Dosage form
Tablet, Extended Release
Route
Oral
Prescription status
Rx (prescription)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2014
Label revision date
October 6, 2023
Manufacturer
Lupin Pharmaceuticals, Inc.
Registration numbers
ANDA090860, ANDA090892, ANDA090446
NDC roots
68180-221, 68180-222, 68180-223
FDA Insert
Prescribing information, PDF file
Packaging Info (6 NDCs)
Packaging & NDC Codes (6)

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Drug Overview

Niacin extended-release tablets contain niacin (also known as nicotinic acid), which is a medication used to help manage cholesterol levels in the body. It works as an antihyperlipidemic agent, meaning it helps lower elevated levels of total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), and triglycerides (TG), while increasing high-density lipoprotein cholesterol (HDL-C). This medication is typically prescribed for individuals with primary hyperlipidemia (high cholesterol) and mixed dyslipidemia, as well as for those with a history of heart attacks to reduce the risk of future heart issues.

The exact way niacin alters lipid profiles is not fully understood, but it may involve reducing the release of free fatty acids from fat tissue and increasing the removal of triglycerides from the blood. Additionally, niacin can decrease the liver's production of certain types of cholesterol. It is often used alongside other treatments to help slow the progression of heart disease in patients with a history of coronary artery disease.

Uses

This medication is used to help manage cholesterol levels in your body. If you have high total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), or triglycerides (TG), it can help lower these levels while also increasing high-density lipoprotein cholesterol (HDL-C), which is often referred to as "good" cholesterol.

If you have a history of heart attacks and high cholesterol, this medication can also reduce your risk of having another nonfatal heart attack. Additionally, when taken with a bile acid binding resin, it can slow down the progression or even help reverse atherosclerotic disease (a condition where arteries become narrowed due to plaque buildup) in those with coronary artery disease (CAD) and high cholesterol. It can also assist in lowering elevated TC and LDL-C when combined with a healthy diet, and it is effective in reducing TG in adults with severe hypertriglyceridemia.

Dosage and Administration

When you start taking niacin extended-release tablets, it's important to take them at bedtime along with a low-fat snack. This helps your body adjust to the medication and can reduce side effects. You will begin with a dose of 500 mg, and you should not increase this dose by more than 500 mg every four weeks. The typical maintenance dose ranges from 1000 mg to 2000 mg once a day, but remember that doses higher than 2000 mg daily are not recommended.

Make sure to follow this dosing schedule closely to ensure the best results while minimizing any potential side effects. Always consult with your healthcare provider if you have any questions or concerns about your dosage.

What to Avoid

It's important to be aware of certain conditions that may prevent you from using this medication safely. You should avoid using it if you have active liver disease, which can include unexplained ongoing increases in liver enzymes. Additionally, if you have active peptic ulcer disease, arterial bleeding, or a known hypersensitivity (allergic reaction) to any of the components in the product, you should not take this medication.

While there are no specific "do not take" or "do not use" instructions provided, always consult with your healthcare provider if you have any concerns or questions about your health conditions and how they may interact with this medication. Your safety is the top priority, so it's essential to discuss any potential risks.

Side Effects

You may experience some common side effects while taking this medication, including flushing, diarrhea, nausea, vomiting, increased cough, and itching (pruritus). It's important to be aware of more serious reactions as well. Severe liver toxicity can occur, especially if you switch from immediate-release to sustained-release niacin at the same dose. Myopathy, a condition that affects muscle tissue, has been reported, particularly in older adults or those with certain health conditions like diabetes or kidney issues.

Additionally, this medication can lead to elevated liver enzymes, so monitoring is necessary before and during treatment. If you have active liver disease, peptic ulcers, or a known allergy to any components of the medication, you should avoid using it. Lastly, be cautious as it may increase blood sugar levels, which requires careful monitoring if you have diabetes or are at risk.

Warnings and Precautions

It's important to be aware of some serious risks when using niacin extended-release tablets. If you are switching from immediate-release niacin to sustained-release niacin at the same dose, be cautious, as this can lead to severe liver damage (hepatotoxicity). Additionally, myopathy (muscle pain or weakness) has been reported, especially in older adults or those with conditions like diabetes, kidney failure, or uncontrolled thyroid issues, particularly if you are also taking a statin medication.

You should have your liver enzymes checked before starting treatment and monitored regularly during use, as persistent elevations can occur. If you have unstable angina (chest pain) or are in the acute phase of a heart attack, use niacin with caution. Be aware that niacin can also raise blood sugar levels, so if you have diabetes or are at risk, closely monitor your glucose levels, especially during the first few months of treatment or when adjusting your dose.

If you experience severe muscle pain, weakness, or any signs of liver problems, such as yellowing of the skin or eyes, stop using niacin and call your doctor immediately. Always seek emergency help if you have severe symptoms or concerns about your health.

Overdose

If you suspect an overdose, it's important to take immediate action. Supportive measures, which are steps taken to help manage the situation, should be initiated right away. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or if you believe an overdose has occurred, seek medical help immediately. It's crucial to get professional assistance to ensure your safety and well-being. Remember, acting quickly can make a significant difference.

Pregnancy Use

If you are taking niacin extended-release tablets for high cholesterol or triglycerides and find out you are pregnant, it’s important to stop using the medication right away. You should also talk to your healthcare provider about your pregnancy, as they can help assess the risks and benefits of continuing treatment during this time.

Currently, there is not enough information to determine the potential risks of niacin extended-release tablets on pregnancy outcomes, such as major birth defects or miscarriage. While treatment for high cholesterol is usually not necessary during pregnancy, discontinuing lipid-lowering medications like niacin typically does not affect long-term health outcomes for most patients. Remember, the general risk of major birth defects in recognized pregnancies is about 2-4%, and the risk of miscarriage is around 15-20%. Always consult your healthcare provider for personalized advice.

Lactation Use

Niacin is found in human milk, and the levels can increase if you take niacin supplements. However, there is limited information about how the doses in niacin extended-release tablets might affect your breastfeeding infant or your milk production.

Due to the risk of serious side effects in nursing infants, such as liver damage (hepatotoxicity), it is recommended that you avoid breastfeeding while using niacin extended-release tablets. Always consult with your healthcare provider for personalized advice regarding breastfeeding and medication use.

Pediatric Use

When considering niacin therapy for your child, it's important to know that its safety and effectiveness have not been established for children aged 16 years and younger. This means that there isn't enough research to confirm that niacin is safe or works well for kids in this age group. Always consult with your child's healthcare provider before starting any new treatment to ensure it is appropriate for their specific needs.

Geriatric Use

In clinical studies involving niacin extended-release tablets, about 21% of participants were aged 65 and older. The results showed no significant differences in safety and effectiveness between older adults and younger patients. However, it's important to note that while most older individuals responded similarly to the treatment, some may be more sensitive to the medication.

If you are caring for an older adult or are one yourself, it's essential to monitor for any unusual reactions or side effects, as individual responses can vary. Always consult with a healthcare provider to ensure the best approach to treatment, considering any specific health needs or concerns.

Renal Impairment

If you have kidney problems, it's important to be aware of the potential risks associated with taking niacin extended-release tablets. Myopathy, which is muscle weakness or pain, has been reported in some patients using this medication. The risk of developing myopathy or a more severe condition called rhabdomyolysis (a serious breakdown of muscle tissue) is higher for certain groups, including older adults, those with diabetes, individuals with renal failure (kidney failure), and patients with uncontrolled hypothyroidism.

If you fall into any of these categories, please consult your healthcare provider for guidance on the appropriate use of niacin and any necessary dosage adjustments or monitoring that may be required to ensure your safety.

Hepatic Impairment

If you have liver problems, it's important to be aware of the potential risks associated with certain medications. For instance, switching from immediate-release niacin to sustained-release niacin at the same dose can lead to severe liver toxicity. This means that your liver may become damaged or not function properly.

To ensure your safety, your doctor will likely recommend monitoring your liver enzymes (substances in your blood that indicate liver health) before starting treatment and regularly during your therapy. Persistent elevations in these enzymes can signal that your liver is under stress, so it's crucial to keep an eye on these levels throughout your treatment. Always discuss any concerns with your healthcare provider to manage your liver health effectively.

Drug Interactions

It's important to be aware of how certain medications can interact with each other. For instance, if you are taking statins (medications used to lower cholesterol), using niacin alongside them can increase the risk of muscle problems, such as myopathy or rhabdomyolysis. This is why it's crucial to discuss all your medications with your healthcare provider to ensure your safety.

Additionally, if you are using bile acid sequestrants (medications that help lower cholesterol by binding bile acids), you should take them at least 4 to 6 hours before taking niacin extended-release tablets. This timing helps prevent any potential interactions. Always consult your healthcare provider about your medications and any lab tests to avoid complications and ensure effective treatment.

Storage and Handling

To ensure the best performance of your product, store it at a temperature of 25°C (77°F). It’s acceptable for the temperature to vary between 15 to 30°C (59 to 86°F) occasionally, as this range is considered safe according to USP Controlled Room Temperature guidelines.

When handling the product, make sure to do so in a clean environment to maintain its integrity and effectiveness. Always follow any specific instructions provided for use to ensure safety and optimal results.

Additional Information

While taking niacin extended-release tablets, it's important to have regular check-ups to monitor your liver function. This includes testing your liver enzymes (AST and ALT) before starting treatment, then every 6 to 12 weeks for the first year, and at least every six months afterward. You should also have your blood sugar levels checked frequently to ensure the medication isn't causing any issues. If you're taking anticoagulants (medications that help prevent blood clots), your platelet counts and prothrombin time (a measure of blood clotting) should be monitored closely. Additionally, if you're at risk for low phosphorus levels, periodic checks of your phosphorus levels are recommended.

If you have diabetes or are at risk for diabetes, be especially vigilant during the first few months of treatment, as you may need to adjust your diet or diabetes medications. Caution is advised if you're taking niacin with anticoagulants, and those predisposed to gout should also use this medication carefully.

FAQ

What is Niacin extended-release tablets USP used for?

Niacin extended-release tablets are used to reduce elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), and triglycerides (TG), and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary hyperlipidemia and mixed dyslipidemia.

What are the common side effects of Niacin extended-release tablets?

Common side effects include flushing, diarrhea, nausea, vomiting, increased cough, and pruritus.

How should Niacin extended-release tablets be taken?

You should take Niacin extended-release tablets at bedtime with a low-fat snack to help reduce side effects.

What is the recommended starting dose for Niacin extended-release tablets?

The therapy should be initiated at 500 mg at bedtime, and the dose should not be increased by more than 500 mg in any 4-week period.

Are there any contraindications for using Niacin extended-release tablets?

Yes, contraindications include active liver disease, active peptic ulcer disease, arterial bleeding, and known hypersensitivity to the product components.

Can Niacin extended-release tablets be used during pregnancy?

Niacin extended-release tablets should be discontinued when pregnancy is recognized, and the risks and benefits of continuing treatment should be assessed.

What should be monitored during treatment with Niacin extended-release tablets?

Liver enzyme levels, blood glucose, platelet counts, and prothrombin time should be monitored during treatment.

What are the potential severe adverse reactions of Niacin extended-release tablets?

Severe hepatic toxicity and myopathy have been reported, particularly in patients with certain risk factors such as diabetes or those taking statins.

Is Niacin extended-release safe for elderly patients?

While no overall differences in safety were observed, caution is advised as older individuals may have greater sensitivity.

Can Niacin extended-release tablets be taken with statins?

Caution should be used when prescribing niacin with statins due to an increased risk of myopathy and rhabdomyolysis.

Packaging Info

The table below lists all NDC Code configurations of Niacin, the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Niacin.
Details

FDA Insert (PDF)

This is the full prescribing document for Niacin, submitted to the U.S. Food and Drug Administration (FDA). It contains official information for healthcare providers, including how to use the medication, possible side effects, and safety warnings.

View FDA-approved insert (PDF)

Description

Niacin extended-release tablets USP are film-coated, unscored, orange tablets intended for oral administration, available in three strengths: 500 mg, 750 mg, and 1000 mg of niacin. Niacin, also known as nicotinic acid or 3-pyridinecarboxylic acid, is a white, crystalline powder that is highly soluble in water and functions as an antihyperlipidemic agent at therapeutic doses. The tablets contain inactive ingredients including colloidal silicon dioxide, hypromellose, microcrystalline cellulose, povidone, polyethylene glycol, stearic acid, and coloring agents such as iron oxide red, iron oxide yellow, FD&C yellow #6/sunset yellow FCF aluminum lake, polyethylene glycol, and titanium dioxide. Niacin extended-release tablets USP comply with USP Dissolution Test 2.

Uses and Indications

This drug is indicated for the reduction of elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), and triglycerides (TG), as well as for the increase of high-density lipoprotein cholesterol (HDL-C) in patients with primary hyperlipidemia and mixed dyslipidemia.

Additionally, it is indicated to reduce the risk of recurrent nonfatal myocardial infarction in patients with a history of myocardial infarction and hyperlipidemia. When used in combination with a bile acid binding resin, this drug may slow the progression or promote regression of atherosclerotic disease in patients with a history of coronary artery disease (CAD) and hyperlipidemia. It is also indicated as an adjunct to diet for the reduction of elevated TC and LDL-C in adult patients with primary hyperlipidemia. Furthermore, this drug is indicated for the reduction of TG in adult patients with severe hypertriglyceridemia.

No teratogenic or nonteratogenic effects have been reported.

Dosage and Administration

Niacin extended-release tablets should be administered at bedtime alongside a low-fat snack to enhance tolerability. The initial dose for therapy should be set at 500 mg once daily at bedtime, which is essential for minimizing the incidence and severity of side effects that may arise during the early stages of treatment. Subsequent dose adjustments should not exceed an increase of 500 mg within any 4-week period.

The recommended maintenance dose ranges from 1000 mg to 2000 mg once daily. It is important to note that doses exceeding 2000 mg daily are not recommended.

Contraindications

Use of this product is contraindicated in the following conditions:

Patients with active liver disease, including those with unexplained persistent elevations in hepatic transaminase levels, should not use this product due to the potential for exacerbating liver dysfunction.

Active peptic ulcer disease is another contraindication, as the product may aggravate gastrointestinal conditions.

The presence of arterial bleeding contraindicates the use of this product, given the risk of worsening bleeding complications.

Additionally, individuals with known hypersensitivity to any components of the product should avoid its use to prevent allergic reactions.

Warnings and Precautions

Severe hepatic toxicity has been reported in patients who substitute sustained-release niacin for immediate-release niacin at equivalent doses. Healthcare professionals should exercise caution when making such substitutions and closely monitor patients for signs of liver dysfunction.

Myopathy has been observed in patients taking niacin extended-release tablets. The risk of developing myopathy and rhabdomyolysis is particularly heightened in elderly patients, those with diabetes, renal failure, or uncontrolled hypothyroidism, as well as in patients concurrently treated with statins. Regular assessment of muscle symptoms and function is recommended for these high-risk groups.

Monitoring liver enzyme levels is essential, as persistent elevations in hepatic transaminases can occur during treatment. It is advised that liver enzymes be evaluated prior to initiating therapy and periodically throughout the treatment course to detect any abnormalities early.

Caution is warranted when prescribing niacin extended-release tablets to patients with unstable angina or during the acute phase of a myocardial infarction (MI). The potential for exacerbating these conditions necessitates careful consideration of the risk-benefit profile in such patients.

Additionally, niacin extended-release tablets may elevate serum glucose levels. Therefore, glucose levels should be closely monitored in diabetic patients or those at risk of developing diabetes, particularly during the initial months of therapy or following any dose adjustments. Regular monitoring will help manage any potential hyperglycemia effectively.

Side Effects

Patients may experience a range of adverse reactions while using the medication. The most common adverse reactions reported include flushing, diarrhea, nausea, vomiting, increased cough, and pruritus.

Severe adverse reactions have also been observed. Notably, severe hepatic toxicity has occurred in patients who substituted sustained-release niacin for immediate-release niacin at equivalent doses. Myopathy has been reported in patients taking niacin extended-release tablets, with an increased risk for myopathy and rhabdomyolysis particularly among elderly patients, those with diabetes, renal failure, or uncontrolled hypothyroidism, and patients concurrently treated with a statin.

Monitoring of liver enzymes is essential, as persistent elevations in hepatic transaminase levels can occur. Liver enzyme levels should be assessed before and during treatment. Additionally, niacin extended-release tablets may elevate serum glucose levels; therefore, glucose levels should be closely monitored in diabetic or potentially diabetic patients, especially during the initial months of treatment or following dose adjustments.

Other important considerations include the presence of active liver disease, which may manifest as unexplained persistent elevations in hepatic transaminase levels, active peptic ulcer disease, arterial bleeding, and known hypersensitivity to the product components.

Drug Interactions

Caution is advised when prescribing niacin in conjunction with statins, as the combination may elevate the risk of myopathy and rhabdomyolysis. Clinicians should monitor patients closely for signs of muscle-related adverse effects and consider dosage adjustments as necessary.

Bile acid sequestrants possess a high binding capacity for niacin. Therefore, it is recommended that these agents be administered at least 4 to 6 hours prior to the administration of niacin extended-release tablets to minimize potential interactions and ensure optimal therapeutic efficacy.

Packaging & NDC

The table below lists all NDC Code configurations of Niacin, the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Niacin.
Details

Pediatric Use

The safety and effectiveness of niacin therapy in pediatric patients aged 16 years and younger have not been established. Therefore, caution is advised when considering the use of niacin in this population. Further studies are needed to determine appropriate dosing and outcomes in children and adolescents.

Geriatric Use

In clinical studies involving niacin extended-release tablets, 21% of the 979 patients evaluated were aged 65 years and older. The data indicate that there are no overall differences in safety and effectiveness between elderly patients and their younger counterparts. However, it is important to note that while the clinical experience has not identified significant differences in responses between geriatric patients and younger individuals, the possibility of greater sensitivity in some older patients cannot be excluded.

Healthcare providers should exercise caution when prescribing niacin extended-release tablets to elderly patients. Monitoring for potential adverse effects and therapeutic responses is recommended, as individual variability may occur. No specific dosage adjustments are indicated based solely on age; however, clinical judgment should guide treatment decisions in this population.

Pregnancy

Pregnant patients receiving niacin extended-release tablets for the treatment of hyperlipidemia should discontinue the medication upon recognition of pregnancy. For those being treated for hypertriglyceridemia, healthcare providers should assess the individual risks and benefits of continuing therapy during pregnancy. It is essential for patients to inform their healthcare provider of any known or suspected pregnancy.

The potential for embryofetal toxicity associated with the doses of niacin in niacin extended-release tablets remains unknown. Current data on the use of niacin extended-release tablets in pregnant women are insufficient to determine a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Furthermore, animal reproduction studies have not been conducted with niacin or niacin extended-release tablets.

The treatment of hypercholesterolemia is generally not necessary during pregnancy, as atherosclerosis is a chronic process. The discontinuation of lipid-lowering drugs during pregnancy is unlikely to significantly impact the long-term outcomes of primary hypercholesterolemia for most patients. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown; however, in the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Lactation

Niacin is present in human milk, and the concentration of niacin increases with maternal supplementation. However, there is no information available regarding the effects of the doses of niacin in niacin extended-release tablets on breastfed infants or on milk production.

Due to the potential for serious adverse reactions in breastfeeding infants, including hepatotoxicity, it is advised that lactating mothers refrain from breastfeeding during treatment with niacin extended-release tablets.

Renal Impairment

Patients with renal impairment may experience an increased risk of myopathy and rhabdomyolysis when taking niacin extended-release tablets. This risk is particularly heightened in elderly patients, those with diabetes, and individuals with uncontrolled hypothyroidism. Careful monitoring is advised for patients with reduced kidney function, especially when niacin is used in conjunction with statins. Dosing adjustments may be necessary based on the patient's renal status to mitigate these risks.

Hepatic Impairment

Patients with hepatic impairment may experience severe hepatic toxicity when substituting sustained-release niacin for immediate-release niacin at equivalent doses. It is essential to monitor liver enzymes, as persistent elevations in hepatic transaminases can occur. Therefore, liver function should be assessed before initiating treatment and periodically during therapy to ensure patient safety and to manage any potential adverse effects related to liver function.

Overdosage

In the event of an overdose, it is imperative that healthcare professionals implement supportive measures to manage the patient's condition effectively.

Potential symptoms of overdose may vary depending on the specific substance involved; however, general signs may include altered mental status, cardiovascular instability, and respiratory distress.

Management of an overdose should focus on the immediate stabilization of the patient. This includes monitoring vital signs, ensuring airway patency, and providing supplemental oxygen if necessary. Intravenous fluids may be administered to maintain hydration and support hemodynamic stability.

In cases where specific antidotes are available, they should be utilized according to established protocols. Continuous observation and supportive care are essential until the patient is stabilized and any toxic effects have resolved.

Healthcare professionals are advised to consult local poison control centers or toxicology experts for guidance on specific management strategies tailored to the substance involved in the overdose.

Nonclinical Toxicology

Niacin administered to mice for a lifetime as a 1% solution in drinking water did not demonstrate carcinogenic potential. The dosage received by the mice was approximately 6 to 8 times the human dose of 3000 mg/day, calculated on a mg/m² basis. Additionally, niacin was found to be negative for mutagenicity in the Ames test.

No studies have been conducted to evaluate the effects of niacin on impairment of fertility. Furthermore, there are no available data regarding carcinogenesis, mutagenesis, or impairment of fertility for niacin extended-release tablets.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. Reports have included muscle pain, tenderness, or weakness. Flushing, characterized by warmth, redness, itching, and/or tingling of the skin, is a common side effect of niacin therapy. This reaction may diminish after several weeks of consistent use of niacin extended-release tablets. The severity of flushing can vary and is more likely to occur upon initiation of therapy or during dose increases.

Patients who experience flushing at night are advised to rise slowly, particularly if they feel dizzy, faint, or are taking blood pressure medications. It is important to inform patients about the symptoms of flushing and to distinguish these from the symptoms of a myocardial infarction.

Patient Counseling

Patients should be advised to adhere to the National Cholesterol Education Program (NCEP) recommended diet, engage in a regular exercise program, and undergo periodic testing of a fasting lipid panel to effectively manage their cholesterol levels.

It is important for patients to inform any healthcare professionals prescribing new medications that they are currently taking niacin extended-release tablets. These tablets should be taken at bedtime, following a low-fat snack, as administration on an empty stomach is not recommended. Patients should be instructed to swallow the tablets whole and not to break, crush, or chew them.

In the event of an interruption in dosing, patients should contact their physician prior to restarting therapy, as re-titration is recommended. They should also promptly notify their physician of any unexplained muscle pain, tenderness, or weakness, and discuss all medications they are taking, including both prescription and over-the-counter drugs.

Flushing, characterized by warmth, redness, itching, and/or tingling of the skin, is a common side effect of niacin therapy. Patients should be informed that this side effect may subside after several weeks of consistent use and is more likely to occur with the initiation of therapy or during dose increases. By taking the medication at bedtime, flushing will most likely occur during sleep. If patients are awakened by flushing at night, they should get up slowly, especially if they feel dizzy or faint, or if they are taking blood pressure medications. It is essential to educate patients on the symptoms of flushing and how they differ from those of a myocardial infarction.

To minimize flushing, patients may take aspirin (up to the recommended dose of 325 mg) approximately 30 minutes before dosing. They should also avoid alcohol, hot beverages, and spicy foods around the time of taking niacin extended-release tablets.

Patients should notify their physician if they are taking vitamins or other nutritional supplements that contain niacin or nicotinamide. Additionally, they should inform their physician if they experience any symptoms of dizziness or if they are diabetic and notice changes in their blood glucose levels.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a controlled room temperature of 25°C (77°F). Temporary excursions are permissible within the range of 15 to 30°C (59 to 86°F), in accordance with USP guidelines for controlled room temperature. Proper storage conditions are essential to maintain the integrity and efficacy of the product.

Additional Clinical Information

Liver-related tests are essential for all patients undergoing therapy with niacin extended-release tablets. Clinicians should monitor serum transaminase levels, including AST and ALT, prior to treatment, every 6 to 12 weeks during the first year, and periodically thereafter, approximately every six months. Additionally, frequent blood glucose monitoring is recommended to ensure the absence of adverse effects. In patients receiving niacin extended-release tablets alongside anticoagulants, close monitoring of platelet counts and prothrombin time is necessary. Phosphorus levels should also be periodically assessed in patients at risk for hypophosphatemia.

Patients with diabetes or those at risk for diabetes require careful observation during treatment, especially in the initial months or during dose adjustments, as dietary modifications or changes in hypoglycemic therapy may be needed. Caution is advised when administering niacin extended-release tablets with anticoagulants, and in patients predisposed to gout.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Niacin as submitted by Lupin Pharmaceuticals, Inc.. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Niacin, retrieved by a validated AI data-extraction workflow.

All FDA-approved dosage forms and strengths are listed in the Packaging & NDC Codes section above. Regulatory status, pharmacologic class (EPC), and mechanism of action (MoA) were cross-checked against the FDA Orange Book (ANDA090860) and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

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Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.