Fenofibrate Capsule while Breastfeeding

Most health expert recommend six month of exclusive breastfeeding but statics suggest that numbers are not good, almost 95% mothers start breastfeeding but this number drops to 40% in first three month and further it drops to 15% till fifth month. Sometime its due to need of medication usage. Because of these statics its important to provide good information on safety of drugs in breastfeeding so that it can be improved when possible. In this FAQ sheet we will discuss about exposure to Fenofibrate Capsule while breastfeeding. We will also discuss about common side effects and warnings associated with Fenofibrate Capsule.

Treatment of Hypercholesterolemia Fenofibrate capsules, USP are indicated as adjunctive therapy to diet for the reduction of LDLC, total-C, Triglycerides and apo B in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa and IIb). Lipid altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacological interventions alone has been inadequate (see National Cholesterol Education Program [NCEP] Treatment Guidelines, below). Treatment of Hypertriglyceridemia Fenofibrate capsules, USP are also indicated as adjunctive therapy to diet for treatment of adult patients with hypertriglyceridemia (Fredrickson Types IV and V hyperlipidemia). 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. Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (VLDL). Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV and V hyperlipoproteinemia 2. The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess 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. Diseases contributory to hyperlipidemia, such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy, like thiazide diuretics and beta-blockers, is sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of the specific etiologic agent may obviate the need for specific drug therapy of hypertriglyceridemia. The use of drugs should be considered only when reasonable attempts have been made to obtain satisfactory results with non-drug methods. If the decision is made to use drugs, the patient should be instructed that this does not reduce the importance of adhering to diet (See WARNINGS and PRECAUTIONS). Fredrickson Classification of Hyperlipoproteinemias C = cholesterol TG = triglycerides LDL = low density lipoprotein VLDL = very lot density lipoprotein IDL = intermediate density lipoprotein Lipid Elevation Type Lipoprotein Elevated Major Minor I (rare) IIa IIb III (rare) IV V (rare) Chylomicrons LDL LDL, VLDL IDL VLDL Chylomicrons, VLDL TG C C C, TG TG TG ↑ ↔ C - TG - ↑ ↔ C ↑ ↔ The NCEP Treatment Guidelines Definite Atherosclerotic Two or More Other LDL-Cholesterol mg/dL (mmol/L) Disease Coronary heart disease or peripheral vascular disease (including symptomatic carotid artery disease). Risk Factors Other risk factors for coronary heart disease (CHD) include: age (males: ≥ 45 years; females: ≥ 55 years or premature menopause without estrogen replacement therapy); family history of premature CHD; current cigarette smoking; hypertension; confirmed HDL-C < 35 mg/dL (< 0.91 mmol/L); and diabetes mellitus. Subtract I risk favor if HDL-C is ≥ 60 mg/dL (≥ 1.6 mmol/L) Initiation Level Goal No No Yes No Yes Yes or No ≥ 190 (≥ 4.9) ≥ 160 (≥ 4.1) ≥ 130 In CHD patients with LDL-C levels 100 to 129 mg/dL, the physician should exercise clinical judgment in deciding whether to initiate drug treatment. (≥ 3.4) < 160 (< 4.1) < 130 (< 3.4) < 100 (< 2.6)

Statement of Manufacturer/Labeler about breastfeeding usage
Nursing Mothers It is not known whether fenofibrate is excreted into milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from fenofibrate, a decision should be made whether to discontinue nursing or administration of fenofibrate taking into account the importance of the drug to the lactating woman.