NIACIN

Other

Brand names: Niacin

Oral

Mechanism of Action

12.1 Mechanism of Action The mechanism by which niacin alters lipid profiles has not been well defined. It may involve several actions including partial inhibition of release of free fatty acids from adipose tissue, and increased lipoprotein lipase activity, which may increase the rate of chylomicron triglyceride removal from plasma. Niacin decreases the rate of hepatic synthesis of VLDL and LDL, and does not appear to affect fecal excretion of fats, sterols, or bile acids.

Indications

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

Contraindications

• which may include unexplained persistent elevations in hepatic transaminase levels. ( 4
• 5.3 ) Active peptic ulcer disease. ( 4 ) Arterial bleeding. ( 4 ) Known hypersensitivity to product components. ( 4
• 6.1 )

FDA Warnings

5 WARNINGS AND PRECAUTIONS Niacin extended-release tablet preparations should not be substituted for equivalent doses of immediate-release (crystalline) niacin
Niacin extended-release tablets are contraindicated in patients with significant or unexplained hepatic impairment [see Contraindications (4) and Warnings and Precautions (5
The risk for myopathy and rhabdomyolysis are increased among elderly patients; patients with diabetes, renal failure, or uncontrolled hypothyroidism; and patients being treated with a statin
The primary outcome was an ITT composite of the first study occurrence of coronary heart disease death, nonfatal myocardial infarction, ischemic stroke, hospitalization for acute coronary syndrome or symptom-driven coronary or cerebral revascularization procedures

Known Side Effects

13 documented side effects by frequency

Fatigue

1-10%

Drug Not Working

1-10%

Nausea

1-10%

Diarrhea

1-10%

Dizziness

1-10%

Shortness of Breath

1-10%

Headache

1-10%

Weakness

1-10%

Joint Pain

1-10%

Falls

1-10%

Limb Pain

0.1-1%

Rash

0.1-1%

Vomiting

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Oral