Niacin 500mg TR Tablets

Niacin (nicotinic acid) exerts its lipid-modifying effects primarily by inhibiting hepatic synthesis of very-low-density lipoproteins (VLDL), which leads to a reduction in LDL-C and triglycerides. It also reduces the catabolism of apolipoprotein A-I, leading to increased HDL-C levels. The exact molecular mechanisms are complex and involve binding to specific G-protein coupled receptors (e.g., HM74A or GPR109A) on adipocytes and immune cells, leading to inhibition of lipolysis and reduced free fatty acid flux to the liver.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ 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
+ Breath that smells like fruit
Chest pain or pressure
Abnormal heartbeat
Dizziness or fainting
Shortness of breath
Excessive sweating
Black, tarry, or bloody stools
Rarely, a severe muscle problem (rhabdomyolysis) can occur, especially when used with certain cholesterol-lowering medications like atorvastatin and simvastatin. This can lead to kidney problems and be life-threatening. If you experience muscle pain, tenderness, or weakness (with or without fever or feeling unwell), contact your doctor immediately.

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or persist, contact your doctor or seek medical help:

Flushing (taking aspirin 30 minutes before taking this medication may help; if you wake up at night with flushing, get up slowly if you feel dizzy or lightheaded)
Itching
Diarrhea
Upset stomach or vomiting
Cough
Dry skin
* Headache

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

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 that occurred.
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 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 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 it is vital to notify all your healthcare providers and laboratory personnel that you are taking this drug.

Adhere to the diet and exercise plan recommended by your doctor. When taking this medication, avoid taking colesevelam, colestipol, or cholestyramine within a 4-hour window before or after taking your dose.

Limit your alcohol consumption to fewer than 3 drinks per day, as excessive alcohol intake may increase your risk of developing liver disease and exacerbate flushing symptoms. Be vigilant for signs of gout attacks.

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.

• Statins (HMG-CoA Reductase Inhibitors): Increased risk of myopathy/rhabdomyolysis, especially with higher doses of niacin or statins. Monitor for muscle pain, tenderness, or weakness.
• Bile Acid Sequestrants (e.g., Cholestyramine, Colestipol): May bind niacin and reduce its absorption. Administer niacin at least 4-6 hours before or after bile acid sequestrants.

• Antihypertensive agents (e.g., ACE inhibitors, beta-blockers, calcium channel blockers): May cause additive hypotensive effects, especially at initiation or dose titration of niacin.
• Alcohol: May exacerbate flushing and pruritus.
• Aspirin: May reduce niacin-induced flushing, but high doses of aspirin may increase niacin levels.
• Oral Hypoglycemic Agents/Insulin: Niacin can increase blood glucose levels, requiring adjustment of antidiabetic therapy.
• Uricosuric agents (e.g., Probenecid): Niacin can increase uric acid levels, potentially antagonizing the effects of uricosuric agents.

• Herbal supplements (e.g., Red Yeast Rice): Potential for additive effects on lipids or liver toxicity.

• Severe flushing, itching, or rash
• Unexplained muscle pain, tenderness, or weakness (myopathy/rhabdomyolysis)
• Nausea, vomiting, diarrhea, or abdominal pain
• Yellowing of skin or eyes (jaundice), dark urine, light-colored stools (signs of liver injury)
• Fatigue, loss of appetite
• Symptoms of gout (joint pain, swelling, redness)

Generally not recommended for dyslipidemia during pregnancy. Lipid-lowering drugs are usually discontinued. Niacin is Pregnancy Category C (animal studies show adverse effects, but no adequate human studies; benefits may outweigh risks in specific situations).

Niacin is excreted into breast milk. Due to potential for adverse effects in the infant and the lack of clear benefit for the mother during lactation, use is generally not recommended. Consider alternative lipid-lowering strategies or discontinue breastfeeding.

Safety and efficacy not established for routine use in children. Use only in severe familial hyperlipidemias under strict medical supervision due to potential for adverse effects and long-term safety concerns.

Use with caution in elderly patients, as they may be more susceptible to adverse effects, particularly flushing, gastrointestinal upset, and hepatotoxicity. Start with lower doses and titrate slowly. Monitor liver function and blood glucose closely.

• Controlled-release niacin formulations are designed to reduce flushing compared to immediate-release, but they may carry a higher risk of hepatotoxicity, especially at higher doses. Monitor LFTs diligently.
• To minimize flushing, advise patients to take niacin with a low-fat snack at bedtime. Avoid taking with hot liquids or alcohol.
• Slow titration is crucial for patient tolerability and to minimize side effects. Do not increase the dose more frequently than recommended.
• Patients should be advised to report any signs of muscle pain, tenderness, or weakness, especially if taking a statin concurrently.
• Niacin can increase blood glucose and uric acid levels; monitor these parameters, especially in patients with diabetes or a history of gout.
• Over-the-counter niacin products are not regulated for purity or potency and should not be used for lipid-lowering therapy; only use prescription or pharmaceutical-grade niacin.

• Statins (e.g., Atorvastatin, Rosuvastatin, Simvastatin)
• Fibrates (e.g., Fenofibrate, Gemfibrozil)
• Ezetimibe
• PCSK9 inhibitors (e.g., Alirocumab, Evolocumab)
• Bile Acid Sequestrants (e.g., Cholestyramine, Colesevelam)
• Omega-3 Fatty Acid Esters (e.g., Icosapent ethyl, Omega-3-acid ethyl esters)

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.