Niacin TR 1000mg Tablets

Niacin (nicotinic acid) reduces hepatic synthesis of VLDL (which is a precursor to LDL) by inhibiting the synthesis and esterification of fatty acids in the liver. It also reduces the catabolism of apoA-I, leading to increased HDL-C levels. The exact mechanism for HDL increase is not fully understood but involves reduced hepatic uptake of HDL particles and increased reverse cholesterol transport. It also binds to GPR109A (HM74A) receptors in adipocytes, leading to reduced free fatty acid release, which in turn reduces hepatic triglyceride synthesis.

Serious Side Effects: Seek Medical Help Immediately

Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention right away:

Signs of an allergic reaction: 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, or swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems: dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, vomiting, or yellow skin or eyes
Signs of high blood sugar: confusion, feeling sleepy, unusual thirst or hunger, frequent urination, flushing, rapid breathing, or 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 can lead to kidney problems and be life-threatening, especially when used with certain cholesterol-lowering medications like atorvastatin and simvastatin

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 do not go away, 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 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.

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. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, such as:
+ 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 you determine whether 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 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. 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 it is crucial to 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 consumption may increase your risk of liver disease and exacerbate flushing symptoms.

Be vigilant for signs of gout attacks, and if you experience any, consult your doctor promptly. 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 planning to become pregnant, discuss the potential benefits and risks of using this medication during pregnancy with your doctor to make an informed decision.

• Statins (high doses of Niacin with statins significantly increase risk of myopathy/rhabdomyolysis, especially with simvastatin >20mg/day. Co-administration with simvastatin 80mg is contraindicated.)
• Alcohol (increases flushing and risk of hepatotoxicity)
• Anticoagulants (e.g., Warfarin - increased risk of bleeding)

• Bile Acid Sequestrants (e.g., Cholestyramine, Colestipol - Niacin absorption may be reduced; administer Niacin at least 4-6 hours after sequestrants)
• Antihypertensive agents (e.g., ACE inhibitors, calcium channel blockers - additive hypotensive effects)
• Aspirin (may reduce niacin-induced flushing, but high doses of aspirin can increase niacin levels)
• Other hepatotoxic drugs (increased risk of liver injury)

• Allopurinol (Niacin can increase uric acid levels, potentially counteracting allopurinol's effect)
• Diabetes medications (Niacin can increase blood glucose levels, requiring adjustment of antidiabetic therapy)
• Herbal supplements (e.g., Red Yeast Rice - potential for additive myopathy risk if taken with statins)

• Hot beverages/spicy foods (may exacerbate flushing)

• Flushing (redness, warmth, itching, tingling)
• Gastrointestinal upset (nausea, vomiting, diarrhea, dyspepsia)
• Myalgia or muscle weakness (signs of myopathy/rhabdomyolysis)
• Unexplained fatigue, dark urine, yellowing of skin/eyes (signs of liver injury)
• Dizziness or lightheadedness (hypotension)
• Rash or itching (allergic reaction)
• Joint pain or swelling (gout flare)

Generally not recommended for dyslipidemia treatment during pregnancy unless the potential benefit justifies the potential risk to the fetus. Niacin is a vitamin, but high pharmacological doses are not typically indicated for lipid management in pregnancy. Category C.

Use with caution. Niacin is excreted in breast milk. While vitamin doses are safe, pharmacological doses for dyslipidemia may pose a risk to the infant. Monitor infant for adverse effects (e.g., flushing, GI upset). L3.

Not established for dyslipidemia treatment in children. Safety and efficacy have not been demonstrated. Use for vitamin deficiency is at much lower doses.

Use with caution due to increased susceptibility to adverse effects (e.g., flushing, GI upset, hepatotoxicity, myopathy). Start with lower doses and titrate slowly. Monitor closely for adverse effects and drug interactions.

• Controlled-release (CR) niacin formulations are designed to reduce flushing compared to immediate-release (IR) niacin, but they carry a higher risk of hepatotoxicity than IR niacin.
• To minimize flushing, advise patients to take Niacin TR at bedtime with a low-fat snack. Pre-treatment with 325 mg of non-enteric coated aspirin 30 minutes before the niacin dose can also help reduce flushing, but this should be discussed with a healthcare provider due to aspirin's own risks.
• Strict adherence to monitoring of liver function tests (LFTs) is crucial, especially during dose titration and the first year of therapy. Discontinue if LFTs are persistently elevated (>3x ULN).
• Educate patients about the symptoms of myopathy (muscle pain, tenderness, weakness) and liver injury (jaundice, dark urine, severe fatigue) and to report them immediately.
• Niacin can increase blood glucose and uric acid levels; monitor these parameters, especially in patients with diabetes or gout.
• Avoid concomitant use of Niacin with large amounts of alcohol, as this can exacerbate flushing and increase the risk of hepatotoxicity.
• The clinical benefit of niacin in reducing cardiovascular events, particularly when added to statin therapy, has been questioned by recent large clinical trials (e.g., AIM-HIGH, HPS2-THRIVE). Its role is primarily for patients who cannot tolerate statins or have very high triglycerides/low HDL despite statin therapy, and only after careful consideration of risks vs. benefits.

• Statins (e.g., Atorvastatin, Rosuvastatin, Simvastatin, Pravastatin, Lovastatin, Fluvastatin, Pitavastatin) - first-line for LDL-C reduction.
• Ezetimibe (cholesterol absorption inhibitor)
• PCSK9 Inhibitors (e.g., Alirocumab, Evolocumab) - for severe hypercholesterolemia.
• Fibrates (e.g., Fenofibrate, Gemfibrozil) - primarily for hypertriglyceridemia.
• Bile Acid Sequestrants (e.g., Cholestyramine, Colesevelam, Colestipol)
• Omega-3 Fatty Acid Esters (e.g., Icosapent ethyl, Omega-3-acid ethyl esters) - for severe hypertriglyceridemia.
• Bempedoic Acid (ATP citrate lyase inhibitor)
• Inclisiran (siRNA)

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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.