Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk fo.
From the official label (Dec 2025). Your prescription and pharmacist come first.
What the official label says. If a doctor prescribed it, follow the prescription. Your pack's leaflet comes first if it is different.
Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hyperlipidemia. Niacin therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. Niacin extended-release tablets are indicated to reduce elevated TC, LDL-C, Apo B and TG levels, and to increase HDL-C in patients with primary hyperlipidemia and mixed dyslipidemia. …
500 mg unscored, red, round, film-coated, convex tablet debossed with “KU” on one side, “320” on the other side. 1000 mg unscored, red, oval, film-coated, convex tablet debossed with “KU” on one side, “322” on the other side. Unscored film-coated tablets for oral administration: 500 and 1000 mg niacin extended-release. ( 3 )
Of 979 patients in clinical studies of niacin extended-release tablets, 21% of the patients were age 65 and over. No overall differences in safety and effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
Niacin extended-release tablets are contraindicated in the following conditions: Active liver disease or unexplained persistent elevations in hepatic transaminases [see Warnings and Precautions ( 5.3 )] Patients with active peptic ulcer disease Patients with arterial bleeding Hypersensitivity to niacin or any component of this medication [see Adverse Reactions ( 6.1 )] Active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels ( 4 , 5.3 ) Active pept …
Statins: Caution should be used when prescribing niacin with statins as these agents can increase risk of myopathy/rhabdomyolysis. ( 5.2 , 7.1 ) Bile Acid Sequestrants: Bile acid sequestrants have a high niacin-binding capacity and should be taken at least 4 to 6 hours before niacin extended-release administration. ( 7.2 ) 7.1 Statins Caution should be used when prescribing niacin (≥1 gm/day) with statins as these drugs can increase risk of myopathy/rhabdomyolysis [see Warnings and Precautions ( 5 ) and Clinical Pharmacology ( 12.3 )] . 7.2 Bile Acid Sequestrants An in vitro study results suggest that the bile acid-binding resins have high niacin binding capacity. …
Niacin extended-release tablets preparations should not be substituted for equivalent doses of immediate-release (crystalline) niacin. For patients switching from immediate-release niacin to niacin extended-release tablets, therapy with niacin extended-release tablets should be initiated with low doses (i.e., 500 mg at bedtime) and the niacin extended-release tablets dose should then be titrated to the desired therapeutic response [see Dosage and Administration ( 2.1 )] . …
The following adverse reactions are discussed in greater detail in other sections of the labeling: Mortality and Coronary Heart Disease Morbidity [see Warnings and Precautions ( 5.1 ) ] Skeletal Muscle (rhabdomyolysis) [see Warnings and Precautions ( 5.2 ) ] Liver Dysfunction [see Warnings and Precautions ( 5.3 ) ] Laboratory Abnormalities [see Warnings and Precautions ( 5.4 ) ] Most common adverse reactions (incidence >5% and greater than placebo) are flushing, diarrhea, nausea, vomiting, increased cough, and pruritus. …
8.1 Pregnancy Risk Summary Discontinue niacin extended-release tablets when pregnancy is recognized in patients receiving the drug for the treatment of hyperlipidemia. Assess the individual risks and benefits of continuing niacin extended-release tablets during pregnancy in patients receiving the drug for the treatment of hypertriglyceridemia. Advise patients to inform their healthcare provider of a known or suspected pregnancy. …
Supportive measures should be undertaken in the event of an overdose.
Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.
Products with Niacin as the active ingredient. Names differ between countries.
Other countries: check your pack's registration number and we point you to your regulator.
Type the registration number on the pack, or scan it with your camera.
Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hyperlipidemia. Niacin therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. Niacin extended-release tab (From the official U.S. FDA label.)
Follow your prescription or the leaflet in your pack. The official label says: Niacin extended-release tablets should be taken at bedtime with a low-fat snack. ( 2.1 ) Dose range: 500 mg to 2000 mg once daily. ( 2.1 ) Therapy with niacin extended-release tablets must be initiated at 500 mg at bedtime in order to reduce the incidence and severity of side effects which may occur during early therapy and should not be increased by more than 500 mg in any 4-w…
Administration on an empty stomach is not recommended.
Usually yes. Niacin is a prescription medicine in most countries. Rules differ by country.
Niacin is sold under names such as Folivane-f, Endur-acin, Irospan Tablet, Vitafol-one, Concept Ob, Endur-amide, Endur-thine, Niacor. Brand names differ between countries.
The official label lists: The following adverse reactions are discussed in greater detail in other sections of the labeling: Mortality and Coronary Heart Disease Morbidity [see Warnings and Precautions ( 5.1 ) ] Skeletal Muscle (rhabdomyolysis) [see Warnings and Precautions ( 5.2 ) ] Liver Dysfunction [see Warnings and Precautions ( 5.3 ) ] Laboratory Abnormalities [see Warnings and Precautions ( 5.4 )… Tell your doctor about any side effect that bothers you or does not go away.
Safety and effectiveness of niacin therapy in pediatric patients (≤16 years) have not been established. Always use the dose for the child's age or weight on the pack or prescription.
8.1 Pregnancy Risk Summary Discontinue niacin extended-release tablets when pregnancy is recognized in patients receiving the drug for the treatment of hyperlipidemia. Assess the individual risks and benefits of continuing niacin extended-release tablets during pregnancy in patients receiving the drug for the treatment of hypertriglyceridemia. Advise patients to inform their he… Ask your doctor or midwife first.
Statins: Caution should be used when prescribing niacin with statins as these agents can increase risk of myopathy/rhabdomyolysis. ( 5.2 , 7.1 ) Bile Acid Sequestrants: Bile acid sequestrants have a high niacin-binding capacity and should be taken at least 4 to 6 hours before niacin extended-release administration. ( 7.2 ) 7.1 Statins Caution should be used when prescribing nia… Use the free interaction checker before combining medicines.
Supportive measures should be undertaken in the event of an overdose. Get medical help right away.
Scan the registration number on your pack with PillVera (NAFDAC number in Nigeria, NDC in the United States, DIN in Canada), check the expiry date and buy only from licensed pharmacies.
This page shows what official sources say, in plain words. It is not medical advice: your prescription and your doctor or pharmacist come first. Brand names, strengths and rules differ between countries.