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Primary Hypercholesterolemia Or Mixed Dyslipidemia
Triglide is indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), Triglycerides, and apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hypercholesterolemia or mixed dyslipidemia.
Triglide is also indicated as adjunctive therapy to diet for treatment of adult patients with severe hypertriglyceridemia. Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually reduce fasting triglycerides and eliminate chylomicronemia thereby obviating the need for pharmacologic intervention.
Markedly elevated levels of serum triglycerides (e.g., > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been adequately studied.
Important Limitations Of Use
DOSAGE AND ADMINISTRATION
The dose of Triglide is 160 mg once daily.
Patients should be placed on an appropriate lipid-lowering diet before receiving Triglide and should continue this diet during treatment with Triglide.
Lipid levels should be monitored periodically. Therapy should be withdrawn in patients who do not have an adequate response after two months of treatment.
Triglide tablets can be given without regard to meals. Patients should be advised to swallow Triglide tablets whole. Do not crush, break, dissolve, or chew tablets.
Dosage Forms And Strengths
- 160 mg: Round off-white tablets. Debossed “FH 160”
Storage And Handling
The tablets are supplied as follows:
NDC 59630-485-30: bottles of 30 tablets. 160 mg, off-white round tablets, debossed “FH 160”.
Only dispense Triglide tablets in the original manufacturer bottle with the original desiccant cap. Do not repackage Triglide tablets into standard amber pharmacy vials.
Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Store tablets only in the moisture protective container.
Distributed by: Shionogi Inc. Florham Park, NJ 07932. Manufactured by: Aenova France SAS, 38291 Saint-Quentin-Fallavier, France. Rev. April 2015This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 4/30/2015
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