Hyperlipoproteinemias:

Indications for: LIPOFEN

Adjunct to diet in severe hypertriglyceridemia and to reduce elevated LDL-C, total-C, TG, and apo B, and to increase HDL-C, in primary hyperlipidemia or mixed dyslipidemia.

Limitations of Use:

Not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes.

Adult Dosage:

Swallow whole. Take with food. Hypertriglyceridemia: 50–150mg/day, adjust at 4–8 week intervals; max 150mg/day. Hypercholesterolemia, dyslipidemia: 150mg/day. Mild to moderate renal impairment: initially 50mg/day. Elderly: select dose based on renal function. Discontinue if inadequate response after 2 months on max dose.

Children Dosage:

Not established.

LIPOFEN Contraindications:

Severe renal impairment (including dialysis). Active liver disease. Unexplained persistent liver function abnormalities. Primary biliary cirrhosis. Gallbladder disease. Nursing mothers (during and for 5 days after last dose).

LIPOFEN Warnings/Precautions:

Risk of serious liver injury. Monitor liver function at baseline and periodically during therapy; discontinue if liver injury develops or if elevated enzymes persist (ALT or AST >3×ULN, or if accompanied by elevated bilirubin); do not restart if no alternative explanation. Monitor CBCs during the first year. Discontinue if markedly elevated CPK levels, myopathy, gallstones, hypersensitivity reactions (acute and delayed), or paradoxical decreases in HDL occur (do not reinitiate). Mild to moderate renal impairment: reduce dose; monitor. Elderly. Pregnancy.

LIPOFEN Classification:

Fibrate.

LIPOFEN Interactions:

Avoid statins. Potentiates oral anticoagulants (reduce anticoagulant dose and monitor PT/INR); caution. Allow at least 1hr before or 4–6hrs after bile acid sequestrants. Caution with immunosuppressants (eg, cyclosporine, tacrolimus), colchicine, other nephrotoxic drugs.

Adverse Reactions:

Abnormal liver function tests, increased AST, ALT, CPK, rhinitis; respiratory or GI effects, myopathy, cholelithiasis, pancreatitis, increased serum creatinine, rash, hypersensitivity reactions (may be severe); rare: rhabdomyolysis, transient hematologic changes, blood dyscrasias.

Generic Drug Availability:

YES

How Supplied:

Caps—30, 90