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.
What is Fenofibrate Capsule used for?
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)
Is Fenofibrate Capsule usage safe while breastfeeding? If a lactating mother is using it can there be any effect on growth or development of infant?
Fenofibrate is the one and only active ingredient present in Fenofibrate Capsule. Fenofibrate in itself is a low risk drug for lactation so it is easy to understand that Fenofibrate Capsule also comes in category of Low Risk item while breastfeeding. Below is the summary of Fenofibrate in breastfeeding.
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.
Fenofibrate Capsule Breastfeeding Analsys
Fenofibrate while Breastfeeding Low Risk
CAS Number: 49562-28-9
Fenofibrate, like other fibrates, decreases elevated blood lipids (triglycerides and cholesterol) by increasing the activity of lipases that catabolize triglyceride-rich lipoproteins and slightly decreasing cholesterol biosynthesis (AEMPS 2017, BGP 2015, Miller 1998). In general, fibrates have a discrete effect on the increase of high density lipoprotein (HDL) concentration and the reduction of low density lipoprotein (LDL). Since the last update we have not found published data in relation to breastfeeding. Its high binding to plasma proteins makes it unlikely it will pass into breast milk. Cholesterol levels in milk are very stable even in hypercholesterolemic women and are not severely affected by diet or nutritional status of the mother, suggesting that 3 is synthesized, at least in part, in the mammary gland (Lawrence 2016, p 289-90).It is not probable therefore, but it is not known if the fibrates are able to alter the lipid composition of the milk. Infants need to ingest large amounts of cholesterol, as it is critical to the proper development of the nervous system, cell membranes and is a precursor of several hormones and vitamins. Until there is more data in relation to breastfeeding, it is prudent to avoid using it, at least while breastfeeding exclusively. Suspending the pharmacological treatment of hyperlipidemia during breastfeeding is not likely to alter the long-term outcome of the disease, especially when breastfeeding can be considered therapeutic (Lawrence 2016, p.393). It is advisable to follow a lipid-lowering diet. In case of administering a fibrate during breastfeeding it is advisable to choose those with a shorter half-life: bezafibrate, gemfibrozil.
Fenofibrate Capsule Breastfeeding Analsys - 2
Fenofibrate while Breastfeeding
CAS Number: 49562-28-9
No relevant published information exists on the use of fenofibrate during breastfeeding. Because of a concern with disruption of infant lipid metabolism, fenofibrate is best avoided during breastfeeding. An alternate drug is preferred, especially while nursing a newborn or preterm infant. The manufacturer recommends that breastfeeding be avoided during fenofibrate therapy and for 5 days after the final dose.
What should I do if already breastfed my kid after using Fenofibrate Capsule?
Fenofibrate Capsule is in the category of low risk, if you have already used it then its not a big deal if health and behavior of baby is good. However your health care provider shall be aware of the fact that you have used Fenofibrate Capsule so you should inform him based on your convenience.
I am nursing mother and my doctor has suggested me to use Fenofibrate Capsule, is it safe?
Fenofibrate Capsule comes in category of low risk and if your doctor is aware that you are breastfeeding it should be ok to use without much concerns.
If I am using Fenofibrate Capsule, will my baby need extra monitoring?
Not much monitoring required while using Fenofibrate Capsule
Who can I talk to if I have questions about usage of Fenofibrate Capsule in breastfeeding?
National Womens Health and Breastfeeding Helpline: 800-994-9662 (TDD 888-220-5446) 9 a.m. and 6 p.m. ET, Monday through Friday
National Breastfeeding Helpline: 0300-100-0212 9.30am to 9.30pm, daily
Association of Breastfeeding Mothers: 0300-330-5453
La Leche League: 0345-120-2918
The Breastfeeding Network supporter line in Bengali and Sylheti: 0300-456-2421
National Childbirth Trust (NCT): 0300-330-0700
National Breastfeeding Helpline: 1800-686-268 24 hours a day, 7 days a week
Telehealth Ontario for breastfeeding: 1-866-797-0000 24 hours a day, 7 days a week