Niacin [Nicotinic Acid]
Indications:
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 have been inadequate.
Description:
Therapeutic Class: Cardiovascular
Indications:
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 have been inadequate.
- Niacin is 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.
- In patients with a history of myocardial infarction and hyperlipidemia, niacin is indicated to reduce the risk of recurrent nonfatal myocardial infarction.
- In patients with a history of coronary artery disease (CAD) and hyperlipidemia, niacin, in combination with a bile acid-binding resin, is indicated to slow the progression or promote regression of atherosclerotic disease.
- Niacin in combination with a bile acid-binding resin is indicated to reduce elevated TC and LDL-C levels in adult patients with primary hyperlipidemia.
- Niacin is also indicated as adjunctive therapy for the treatment of adult patients with severe hypertriglyceridemia who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them.
Presentation
Niacin 500: Each extended-release tablet contains Niacin (nicotinic acid) USP 500 mg.Description:
Niacin is a preparation of Nicotinic acid. It is proven effective at lowering VLDL, LDL, total cholesterol, and triglyceride levels while raising HDL levels. So Niacin has been prescribed for the treatment of cardiovascular disease particularly hyperlipidemias.
Dosage:
Niacin can be administered as a single dose at bedtime, after a snack or meal and doses should be individualized according to patient response. Therapy with Niacin must be initiated at 500 mg to reduce the incidence and severity of side effects that may occur during early therapy.
Maintenance Dose: The daily dosage of Niacin should not be increased by more than 500 mg in any 4-week period. The recommended maintenance dose is 1000 mg (two 500 mg tablets or one 1000 mg tablet) to 2000 mg (two 1000 mg tablets or four 500 mg tablets) once daily at bedtime. Doses greater than 2000 mg daily are not recommended. Women may respond at lower Niacin doses than men.
Single-dose bioavailability studies have demonstrated that two of the 500 mg and one of the 1000 mg tablet strengths are interchangeable but three of the 500 mg and two of the 750 mg tablet strengths are not interchangeable.
Flushing of the skin may be reduced in frequency or severity by pretreatment with aspirin (up to the recommended dose of 325 mg taken 30 minutes before the Niacin dose). Tolerance to this flushing develops rapidly over the course of several weeks. Flushing, pruritus, and gastrointestinal distress are also greatly reduced by slowly increasing the dose of niacin and avoiding administration on an empty stomach. Concomitant alcoholic, hot drinks, or spicy foods may increase the side effects of flushing and pruritus and should be avoided around the time of Niacin ingestion.
Equivalent doses of Niacin should not be substituted for sustained-release (modified-release, timed-release) niacin preparations or immediate-release (crystalline) niacin. Patients previously receiving other niacin products should be started with the recommended Niacin titration schedule, and the dose should subsequently be individualized based on patient response.
If Niacin therapy is discontinued for an extended period, reinstitution of therapy should include a titration phase.
Administration:
Niacin tablets should be taken whole and should not be broken, crushed, or chewed before swallowing.
Interaction:
Niacin may potentiate the effects of ganglionic blocking agents and vasoactive drugs resulting in postural hypotension. Concomitant aspirin may decrease the metabolic clearance of nicotinic acid. The clinical relevance of this finding is unclear. About 98% of available Niacin was bound to colestipol, with 10 to 30% binding to cholestyramine. These results suggest that 4 to 6 hours, or as great an interval as possible, should elapse between the ingestion of bile acid-binding resins and the administration of Niacin.
Contraindications:
Niacin is contraindicated in patients with a known hypersensitivity to Niacin or any component of this medication, significant or unexplained hepatic dysfunction, active peptic ulcer disease, or arterial bleeding.
Side Effects:
Niacin is generally well tolerated; adverse reactions have been mild and transient. The most frequent adverse effects were flushing, itching, pruritis, nausea and GI upset, jaundice, hypotension, tachycardia, increased serum blood glucose and uric acid levels, myalgia.
Pregnancy & Lactation:
Niacin cannot be used in pregnancy and lactation because of a lack of information.
Precautions & Warnings:
Before instituting therapy with Niacin, an attempt should be made to control hyperlipidemia with appropriate diet, exercise, and weight reduction in obese patients and to treat other underlying medical problems. Patients with a past history of jaundice, hepatobiliary disease, or peptic ulcer should be observed closely during Niacin therapy. Frequent monitoring of liver function tests and blood glucose should be performed to ascertain that the drug is producing no adverse effects on these organ systems. Diabetic patients may experience a dose-related rise in glucose intolerance, the clinical significance of which is unclear. Diabetic or potentially diabetic patients should be observed closely. Adjustment of diet and/or hypoglycemic therapy may be necessary.
Caution should also be used when Niacin is used in patients with unstable angina or in the acute phase of MI, particularly when such patients are also receiving vasoactive drugs such as nitrates, calcium channel blockers, or adrenergic blocking agents. Elevated uric acid levels have occurred with Niacin therapy, therefore use with caution in patients predisposed to gout. Niacin has been associated with small but statistically significant dose-related reductions in platelet count and increases in prothrombin time. Caution should be observed when Niacin is administered concomitantly with anticoagulants; prothrombin time and platelet counts should be monitored closely in such patients. Niacin has been associated with small but statistically significant, dose-related reductions in phosphorus levels (mean of -13% with 2000 mg). So phosphorus levels should be monitored periodically in patients at risk.
Overdose:
Dosage:
Niacin can be administered as a single dose at bedtime, after a snack or meal and doses should be individualized according to patient response. Therapy with Niacin must be initiated at 500 mg to reduce the incidence and severity of side effects that may occur during early therapy.
Maintenance Dose: The daily dosage of Niacin should not be increased by more than 500 mg in any 4-week period. The recommended maintenance dose is 1000 mg (two 500 mg tablets or one 1000 mg tablet) to 2000 mg (two 1000 mg tablets or four 500 mg tablets) once daily at bedtime. Doses greater than 2000 mg daily are not recommended. Women may respond at lower Niacin doses than men.
Single-dose bioavailability studies have demonstrated that two of the 500 mg and one of the 1000 mg tablet strengths are interchangeable but three of the 500 mg and two of the 750 mg tablet strengths are not interchangeable.
Flushing of the skin may be reduced in frequency or severity by pretreatment with aspirin (up to the recommended dose of 325 mg taken 30 minutes before the Niacin dose). Tolerance to this flushing develops rapidly over the course of several weeks. Flushing, pruritus, and gastrointestinal distress are also greatly reduced by slowly increasing the dose of niacin and avoiding administration on an empty stomach. Concomitant alcoholic, hot drinks, or spicy foods may increase the side effects of flushing and pruritus and should be avoided around the time of Niacin ingestion.
Equivalent doses of Niacin should not be substituted for sustained-release (modified-release, timed-release) niacin preparations or immediate-release (crystalline) niacin. Patients previously receiving other niacin products should be started with the recommended Niacin titration schedule, and the dose should subsequently be individualized based on patient response.
If Niacin therapy is discontinued for an extended period, reinstitution of therapy should include a titration phase.
Administration:
Niacin tablets should be taken whole and should not be broken, crushed, or chewed before swallowing.
Interaction:
Niacin may potentiate the effects of ganglionic blocking agents and vasoactive drugs resulting in postural hypotension. Concomitant aspirin may decrease the metabolic clearance of nicotinic acid. The clinical relevance of this finding is unclear. About 98% of available Niacin was bound to colestipol, with 10 to 30% binding to cholestyramine. These results suggest that 4 to 6 hours, or as great an interval as possible, should elapse between the ingestion of bile acid-binding resins and the administration of Niacin.
Contraindications:
Niacin is contraindicated in patients with a known hypersensitivity to Niacin or any component of this medication, significant or unexplained hepatic dysfunction, active peptic ulcer disease, or arterial bleeding.
Side Effects:
Niacin is generally well tolerated; adverse reactions have been mild and transient. The most frequent adverse effects were flushing, itching, pruritis, nausea and GI upset, jaundice, hypotension, tachycardia, increased serum blood glucose and uric acid levels, myalgia.
Pregnancy & Lactation:
Niacin cannot be used in pregnancy and lactation because of a lack of information.
Precautions & Warnings:
Before instituting therapy with Niacin, an attempt should be made to control hyperlipidemia with appropriate diet, exercise, and weight reduction in obese patients and to treat other underlying medical problems. Patients with a past history of jaundice, hepatobiliary disease, or peptic ulcer should be observed closely during Niacin therapy. Frequent monitoring of liver function tests and blood glucose should be performed to ascertain that the drug is producing no adverse effects on these organ systems. Diabetic patients may experience a dose-related rise in glucose intolerance, the clinical significance of which is unclear. Diabetic or potentially diabetic patients should be observed closely. Adjustment of diet and/or hypoglycemic therapy may be necessary.
Caution should also be used when Niacin is used in patients with unstable angina or in the acute phase of MI, particularly when such patients are also receiving vasoactive drugs such as nitrates, calcium channel blockers, or adrenergic blocking agents. Elevated uric acid levels have occurred with Niacin therapy, therefore use with caution in patients predisposed to gout. Niacin has been associated with small but statistically significant dose-related reductions in platelet count and increases in prothrombin time. Caution should be observed when Niacin is administered concomitantly with anticoagulants; prothrombin time and platelet counts should be monitored closely in such patients. Niacin has been associated with small but statistically significant, dose-related reductions in phosphorus levels (mean of -13% with 2000 mg). So phosphorus levels should be monitored periodically in patients at risk.
Overdose:
Supportive measures should be undertaken in the event of overdosage. Symptoms may include nausea, dizziness, itching, vomiting, upset stomach, and flushing
Storage:
Keep in a dry place away from light and heat. Keep out of the reach of children.
Keep in a dry place away from light and heat. Keep out of the reach of children.
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