Pregnancy Risk Category X
How supplied
Tablets: 10 mg, 20 mg, 40 mg
Action
Inhibits 3-hydroxy-3-methylglutaryl-
coenzyme A reductase, an early (and rate-limiting) step in cholesterol biosynthesis.
Indications & dosage
Adjunct to diet to reduce low-density lipoprotein (LDL), total cholesterol, apo B, and triglyceride levels in patients with primary hypercholesterolemia and mixed dyslipidemia (Fredrickson types IIa and IIb); primary dysbetalipoproteinemia (Fredrickson type III) that doesn't respond adequately to diet; adjunctive therapy to diet for elevated serum triglyceride levels (Fredrickson type IV)--
Adults: initially, 10 mg P.O. once daily. Dosage increased, p.r.n., to maximum single dose of 80 mg daily. Dosage based on blood lipid levels drawn within 2 to 4 weeks after starting therapy.
Alone or as an adjunct to lipid-lowering treatments such as LDL apheresis in patients with homozygous familial hypercholesterolemia--
Adults: 10 to 80 mg P.O. once daily.
Adjunct to diet to increase high-density lipoprotein cholesterol in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Fredrickson types IIa and IIb)--
Adults: Initially, 10 mg P.O. daily. Adjust dosage based on blood lipid levels drawn within 2 to 4 weeks after starting therapy. Dosage range is 10 to 80 mg daily as single dose.
Adverse reactions
CNS: headache, asthenia, insomnia.
EENT: rhinitis, pharyngitis, sinusitis.
GI: abdominal pain, dyspepsia, flatulence, nausea, constipation, diarrhea.
GU: urinary tract infection.
Hepatic: increased liver function test results.
Musculoskeletal: arthritis, arthralgia, myalgia.
Respiratory: bronchitis.
Skin: rash.
Other: infection, flulike syndrome, allergic reaction, peripheral edema.
Interactions
Drug-drug. Antacids: may decrease plasma levels of drug. Monitor patient.
Azole antifungals, cyclosporine, erythromycin, fibric acid derivatives, niacin: possible risk of rhabdomyolysis. Avoid concomitant use.
Colestipol: may decrease plasma levels of drug. Monitor patient.
Digoxin: may increase plasma digoxin levels. Monitor serum digoxin levels.
Erythromycin: will increase plasma level of drug. Monitor patient.
Oral contraceptives: increased levels of hormones. Consider when selecting an oral contraceptive.
Effects on diagnostic tests
None reported.
Contraindications
Contraindicated in patients hypersensitive to drug and in those with active liver disease or conditions associated with unexplained persistent elevations of serum transaminase levels. Also contraindicated in pregnant and breast-feeding women and in women of childbearing age (except those not at risk for becoming pregnant).
Nursing considerations
Patient teaching
*Liquid contains alcohol. **May contain tartrazine. †Canada ‡Australia §U.K. OTCOver the counter
Reactions may be common, uncommon, life-threatening, or COMMON AND LIFE-THREATENING