Drug Detail:Endur-acin (Niacin (nicotinic acid) [ nye-a-sin ])
Drug Class: Miscellaneous antihyperlipidemic agents
Usual Adult Dose for Hyperlipoproteinemia Type IV (Elevated VLDL)
Immediate-release:
- Initial dose: 250 mg orally once a day following the evening meal; increase frequency and/or dose every 4 to 7 days to the desired effect or first-level therapeutic dose (1.5 to 2 g/day in 2 to 3 divided doses); if the response is inadequate after 2 months, the dose can be increased at 2 to 4 week intervals to 1
- Maintenance dose: 1 to 2 g orally 2 to 3 times a day
- Maximum dose: 6 g/day (in 2 to 3 divided doses)
Sustained-release:
- Weeks 1 to 4: 500 mg orally at bedtime
- Weeks 5 to 8: 1000 mg orally at bedtime
- After week 8: Titrate to patient response and tolerance; if response to 1000 mg a day is inadequate, increase to 1500 mg a day; may subsequently increase to 2000 mg a day: daily dose should not be increased more than 500 mg in a 4-week period
- Maintenance dose: 1000 to 2000 mg orally at bedtime
- Maximum dose: 2000 mg/day
Comments:
- Individualize doses according to patient response.
- Women may respond at lower doses than men.
- Tolerance to flushing develops rapidly over the course of several weeks; flushing, pruritus, and GI distress can be reduced by slowly increasing the dose and avoiding administration on an empty stomach.
- Concomitant alcoholic drinks, hot drinks, or spicy foods may increase the side effects of flushing and pruritus and should be avoided near the time this drug is taken.
- If therapy with the extended-release formulation is discontinued for an extended period, reinstitution of therapy should include a titration phase.
- The extended-release formulation should be taken whole and should not be broken, crushed, or chewed before swallowing.
- Flushing can be minimized by pretreatment with aspirin or nonsteroidal anti-inflammatory drugs.
- Flushing, pruritus, and GI distress can be reduced by slowly increasing the dose and avoiding administration on an empty stomach.
Uses:
- To reduce elevated TC, LDL-C, Apo B and TG, and to increase HDL-C in patients with primary hyperlipidemia and mixed dyslipidemia; to reduce the risk of recurrent nonfatal myocardial infarction in patients with a history of myocardial infarction and hyperlipidemia
- In combination with a bile acid binding resin: Slows progression or promotes regression of atherosclerotic disease in patients with a history of coronary artery disease (CAD) and hyperlipidemia
- As an adjunct to diet to reduce elevated TC and LDL-C in adult patients with primary hyperlipidemia
- To reduce TG in adult patients with severe hypertriglyceridemia
Usual Adult Dose for Hyperlipoproteinemia Type V (Elevated Chylomicrons + VLDL)
Immediate-release:
- Initial dose: 250 mg orally once a day following the evening meal; increase frequency and/or dose every 4 to 7 days to the desired effect or first-level therapeutic dose (1.5 to 2 g/day in 2 to 3 divided doses); if the response is inadequate after 2 months, the dose can be increased at 2 to 4 week intervals to 1
- Maintenance dose: 1 to 2 g orally 2 to 3 times a day
- Maximum dose: 6 g/day (in 2 to 3 divided doses)
Sustained-release:
- Weeks 1 to 4: 500 mg orally at bedtime
- Weeks 5 to 8: 1000 mg orally at bedtime
- After week 8: Titrate to patient response and tolerance; if response to 1000 mg a day is inadequate, increase to 1500 mg a day; may subsequently increase to 2000 mg a day: daily dose should not be increased more than 500 mg in a 4-week period
- Maintenance dose: 1000 to 2000 mg orally at bedtime
- Maximum dose: 2000 mg/day
Comments:
- Individualize doses according to patient response.
- Women may respond at lower doses than men.
- Tolerance to flushing develops rapidly over the course of several weeks; flushing, pruritus, and GI distress can be reduced by slowly increasing the dose and avoiding administration on an empty stomach.
- Concomitant alcoholic drinks, hot drinks, or spicy foods may increase the side effects of flushing and pruritus and should be avoided near the time this drug is taken.
- If therapy with the extended-release formulation is discontinued for an extended period, reinstitution of therapy should include a titration phase.
- The extended-release formulation should be taken whole and should not be broken, crushed, or chewed before swallowing.
- Flushing can be minimized by pretreatment with aspirin or nonsteroidal anti-inflammatory drugs.
- Flushing, pruritus, and GI distress can be reduced by slowly increasing the dose and avoiding administration on an empty stomach.
Uses:
- To reduce elevated TC, LDL-C, Apo B and TG, and to increase HDL-C in patients with primary hyperlipidemia and mixed dyslipidemia; to reduce the risk of recurrent nonfatal myocardial infarction in patients with a history of myocardial infarction and hyperlipidemia
- In combination with a bile acid binding resin: Slows progression or promotes regression of atherosclerotic disease in patients with a history of coronary artery disease (CAD) and hyperlipidemia
- As an adjunct to diet to reduce elevated TC and LDL-C in adult patients with primary hyperlipidemia
- To reduce TG in adult patients with severe hypertriglyceridemia
Usual Adult Dose for Vitamin/Mineral Supplementation
Recommended Dietary Allowance (RDA):
- Males: 16 mg/day
- Females: 14 mg/day
- Pregnancy: 18 mg/day
- Lactation: 17 mg/day
Comments:
- Niacin may be given orally and also parenterally as a component of injectable multivitamin additives contained in parenteral nutrition products.
- The best way to get the daily requirement of essential vitamins is to eat a balanced diet that contains a variety of foods.
Uses:
- Recommended Dietary Allowance (RDA): Average daily level of intake that is enough to meet the nutrient requirements of nearly all (97 to 98%) healthy people.
Usual Adult Dose for Vitamin/Mineral Supplementation during Pregnancy/Lactation
Recommended Dietary Allowance (RDA):
- Males: 16 mg/day
- Females: 14 mg/day
- Pregnancy: 18 mg/day
- Lactation: 17 mg/day
Comments:
- Niacin may be given orally and also parenterally as a component of injectable multivitamin additives contained in parenteral nutrition products.
- The best way to get the daily requirement of essential vitamins is to eat a balanced diet that contains a variety of foods.
Uses:
- Recommended Dietary Allowance (RDA): Average daily level of intake that is enough to meet the nutrient requirements of nearly all (97 to 98%) healthy people.
Usual Pediatric Dose for Vitamin/Mineral Supplementation
Adequate Intake (AI):
- Infants 0 to 6 months: 2 mg/day
- Infants 7 to 12 months: 4 mg/day
Recommended Dietary Allowance (RDA):
- Children 1 to 3 years: 6 mg/day
- Children 4 to 8 years: 8 mg/day
- Children 9 to 13 years: 12 mg/day
- Males: 14 to 18 years: 16 mg/day
- Females: 14 to 18 years: 14 mg/day
- Pregnancy: 18 mg/day
- Lactation: 17 mg/day
Comments:
- Niacin may be given orally and also parenterally as a component of injectable multivitamin additives contained in parenteral nutrition products.
- The best way to get the daily requirement of essential vitamins is to eat a balanced diet that contains a variety of foods.
Uses:
- Adequate Intake (AI): When there is not enough evidence to develop an RDA, the AI is set at a level that is thought to ensure enough nutrition.
- Recommended Dietary Allowance (RDA): Average daily level of intake that is enough to meet the nutrient requirements of nearly all (97 to 98%) healthy people.
Usual Pediatric Dose for Vitamin/Mineral Supplementation during Pregnancy/Lactation
Adequate Intake (AI):
- Infants 0 to 6 months: 2 mg/day
- Infants 7 to 12 months: 4 mg/day
Recommended Dietary Allowance (RDA):
- Children 1 to 3 years: 6 mg/day
- Children 4 to 8 years: 8 mg/day
- Children 9 to 13 years: 12 mg/day
- Males: 14 to 18 years: 16 mg/day
- Females: 14 to 18 years: 14 mg/day
- Pregnancy: 18 mg/day
- Lactation: 17 mg/day
Comments:
- Niacin may be given orally and also parenterally as a component of injectable multivitamin additives contained in parenteral nutrition products.
- The best way to get the daily requirement of essential vitamins is to eat a balanced diet that contains a variety of foods.
Uses:
- Adequate Intake (AI): When there is not enough evidence to develop an RDA, the AI is set at a level that is thought to ensure enough nutrition.
- Recommended Dietary Allowance (RDA): Average daily level of intake that is enough to meet the nutrient requirements of nearly all (97 to 98%) healthy people.
Renal Dose Adjustments
Data not available
Liver Dose Adjustments
- Mild to moderate liver dysfunction with alcohol use: No specific dose adjustment guidelines have been suggested; however, caution is recommended.
- Severe or unexplained hepatic dysfunction: Contraindicated
Precautions
Safety and efficacy of the extended-release formulation have not been established in patients younger than 16 years.
Consult WARNINGS section for additional precautions.
Dialysis
Data not available
Other Comments
Administration advice:
- Switching from immediate release to extended release products: Patients previously receiving other niacin products should be started with the recommended niacin extended-release tablets titration schedule, and the dose should subsequently be individualized based on patient response.
- This drug should be administered at bedtime following a snack.
- Concomitant alcohol or hot drinks may increase flushing and pruritus and should be avoided at the time of dosing.
General:
- Equivalent doses of niacin extended-release tablets should not be substituted for sustained-release (modified-release, timed-release) niacin preparations or immediate-release (crystalline) niacin.
- Extended-release formulations should not be broken, crushed, or chewed before swallowing.
Frequently asked questions
- How long does niacin stay in the human system?
