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Triglide Generic Name & Formulations
Legal Class
Rx
General Description
Fenofibrate 160mg; tabs.
Pharmacological Class
Fibrate.
How Supplied
Tabs—30
Manufacturer
Generic Availability
NO
Triglide Indications
Indications
Adjunct to diet in severe hypertriglyceridemia, to reduce elevated total-C, LDL-C, apo B, TG, and to increase HDL-C in primary hypercholesterolemia or mixed dyslipidemia.
Limitations of Use
Not shown to reduce coronary heart disease morbidity and mortality in 2 controlled trials of patients with type 2 diabetes mellitus.
Triglide Dosage and Administration
Adult
Swallow whole. 160mg once daily. Discontinue if inadequate response after 2 months.
Children
Not established.
Triglide Contraindications
Contraindications
Severe renal impairment (including dialysis). Active liver disease. Unexplained persistent liver function abnormalities. Primary biliary cirrhosis. Gallbladder disease. Nursing mothers.
Triglide Boxed Warnings
Not Applicable
Triglide Warnings/Precautions
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, or paradoxical decreases in HDL occur (do not reinitiate). Diabetes. Hypothyroidism. Mild to moderate renal impairment: avoid. Elderly. Pregnancy (Cat.C).
Triglide Pharmacokinetics
See Literature
Triglide Interactions
Interactions
Avoid statins. Potentiates oral anticoagulants (reduce anticoagulant dose and monitor PT/INR); caution. Allow at least 1 hour before or 4–6 hours after bile acid sequestrants. Caution with colchicine, immunosuppressants (eg, cyclosporine, tacrolimus), other nephrotoxic drugs.
Triglide Adverse Reactions
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.
Triglide Clinical Trials
See Literature
Triglide Note
Not Applicable
Triglide Patient Counseling
See Literature
