"The U.S. Food and Drug Administration today approved Clinolipid (lipid injectable emulsion, USP) for intravenous feeding (parenteral nutrition) in adult patients, providing a source of calories and essential fatty acids for adult patients who are"...
(Generic versions may still be available.)
- Patient Information:
Details with Side Effects
Excess body weight and alcoholic intake may be important factors in hypertriglyceridemia and should be addressed prior to any drug therapy. Physical exercise can be an important ancillary measure. Estrogen therapy, some beta-blockers, and thiazide diuretics may also be associated with increases in plasma triglycerides. Discontinuation of such products may obviate the need for specific antilipidemic therapy. Contributory diseases such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. The use of drugs should be considered only when reasonable attempts have been made to obtain satisfactory results with nondrug methods. If the decision ultimately is to use drugs, the patient should be instructed that this does not reduce the importance of adhering to diet.
Because Atromid-S (clofibrate) is associated with certain serious adverse findings reported in two large clinical trials (see WARNINGS ), agents other than clofibrate may be more suitable for a particular patient.
Atromid-S (clofibrate) is indicated for Primary Dysbetalipoproteinemia (Type III hyperlipidemia) that does not respond adequately to diet.
Atromid-S (clofibrate) may be considered for the treatment of adult patients with very high serum-triglyceride levels (Type IV and V hyperlipidemia) who present a risk of abdominal pain and pancreatitis and who do not respond adequately to a determined dietary effort to control them. Patients who present such risk typically have serum triglycerides over 2000 mg/dl and have elevations of VLDL-cholesterol as well as fasting chylomicrons (Type V hyperlipidemia). Subjects who consistently have total serum or plasma triglycerides below 1000 mg/dl are unlikely to present a risk of pancreatitis. Atromid-S (clofibrate) therapy may be considered for those subjects with triglyceride elevations between 1000 and 2000 mg/dl who have a history of pancreatitis or of recurrent abdominal pain typical of pancreatitis. It is recognized that some Type IV patients with triglycerides under 1000 mg/dl may, through dietary or alcoholic indiscretion, convert to a Type V pattern with massive triglyceride elevations accompanying fasting chylomicronemia, but the influence of Atromid-S (clofibrate) therapy on the risk of pancreatitis in such situations has not been adequately studied.
Atromid-S (clofibrate) is not useful for the hypertriglyceridemia of Type I hyperlipidemia, where elevations of chylomicrons and plasma triglycerides are accompanied by normal levels of very low-density lipoprotein (VLDL). Inspection of plasma refrigerated for 12 to 14 hours is helpful in distinguishing Types I, IV, and V hyperlipoproteinemia. 2
Atromid-S (clofibrate) has not been shown to be effective for prevention of coronary heart disease.
The biochemical response to Atromid-S (clofibrate) is variable, and it is not always possible to predict from the lipoprotein type or other factors which patients will obtain favorable results. LDL cholesterol, as well as triglycerides, should be rechecked during the first several months of therapy in order to detect rises in LDL cholesterol that often accompany fibric-acid-type drug-induced reductions in elevated triglycerides. It is essential that lipid levels be reassessed periodically and that the drug be discontinued in any patient in whom lipids do not show significant improvement.
DOSAGE AND ADMINISTRATION
Initial: The recommended dosage for adults is 2 g daily in divided doses. Some patients may respond to a lower dosage.
Maintenance: Same as for initial dosage.
Atromid-S Capsules (clofibrate capsules) Each orange, oblong, soft-gelatin capsule contains 500 mg clofibrate, in bottles of 100 (NDC 0046-0243-81).
The appearance of these orange, oblong, soft-gelatin capsules is a trademark of Wyeth-Ayerst Laboratories.
Store at room temperature, approximately 25° C (77° F).
Dispense in a well-closed, light-resistant container as defined in the USP.
Avoid freezing and excessive heat.
- Coronary Risk Handbook (1973). American Heart Association.
- Nikkila, EA: Familial lipoprotein lipase deficiency and related disorders of chylomicron metabolism. In Stanbury JB et al (eds): The Metabolic Basis of Inherited Disease, 5th ed., McGraw-Hill, 1983, Chap. 30. p.622-642.
- Report from the Committee of Principal Investigators: A cooperative trial in the primary prevention of ischaemic heart disease using clofibrate. Br Heart J 40 :1069, 1978.
- The Coronary Drug Project Research Group: Clofibrate and niacin in coronary heart disease. JAMA 231 :360, 1975.
Ayerst Laboratories Inc.
A Wyeth-Ayerst Company
Philadelphia, PA 19101
Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.
Additional Atromid-S Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.