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Pharmacologic classification: HMG coenzyme A inhibitor/vitamin
Therapeutic classification: antilipemic
Pregnancy risk category: X
AVAILABLE FORMS
Tablets: 500, 750, or 1,000 mg extended-release niacin with 20 mg simvastatin
INDICATIONS AND DOSAGES
To reduce total cholesterol, low-density lipids, and triglycerides and to increase high-density lipids in patients with primary hypercholesterolemia and mixed dyslipidemia when monotherapy alone isn’t enough; hypertriglyceridemia when monotherapy alone isn’t enough--
Adults: Initially, one 500-mg/20-mg tablet P.O. daily. Maintenance dose, 1,000 mg/20 mg to 2,000 mg/40 mg daily. Maximum dose, 2,000 mg/40 mg daily.
CONTRAINDICATIONS AND CAUTIONS
Contraindicated in patients hypersensitive to any component of the drug.
Contraindicated in those with active liver disease, active peptic ulcer, or arterial bleeding.
Contraindicated in pregnant or breast-feeding women.
Use cautiously in those with hepatic impairment or diabetes.
In children, safety and efficacy aren’t established.
INTERACTIONS
Drug-drug.
Amiodarone, verapamil: May increase risk of rhabdomyolysis. Limit simvastatin dose to 20 mg/day, and monitor patient closely.
Cyclosporine, danazol, potent CYP3A4 inhibitors, gemfibrozil, fibrates: May increase risk of toxicity. Avoid using together.
Digoxin: May increase digoxin level. Monitor patient closely, and adjust digoxin dose as needed.
Warfarin: May increase risk of bleeding. Monitor patient very closely, and adjust dosage as needed.
Drug-food.
Grapefruit juice( in large quantities): May increase risk of toxicity. Discourage use together.
ADVERSE REACTIONS
CNS: headache, dizziness, vertigo.
CV: flushing.
GU: nausea, diarrhea, abdominal pain, constipation, dyspepsia, flatulence.
Hepatic: hepatotoxicity.
Metabolic: hyperglycemia.
Musculoskeletal: back pain, myalgia, rhabdomyolysis.
Respiratory: rhinitis, upper respiratory infection.
Skin: pruritus.
Reactions may be common, uncommon, life-threatening,
or COMMON AND LIFE-THREATENING.
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