There are high number of clear evidence that breastfeeding provides best nutrition that you can give to your baby. It is also evident that lactation is good for mothers health as well. Evolution has designed breastfeeding in a way that it caters all nutritional need of your child. However modern medicine is quite new for evolution, that is why mothers body is not well prepared to filter unnecessary chemical found in medicines. It becomes a necessity to figure out which drug is safe and which drug is dangerous for your newborn while nursing. In this article we will understand function of Zetia | Merck Sharp & Dohme Corp. and its suitability with breastfeeding.
What is Zetia | Merck Sharp & Dohme Corp. used for?
Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. ZETIA is an inhibitor of intestinal cholesterol (and related phytosterol) absorption indicated as an adjunct to diet to: Reduce elevated total-C, LDL-C, Apo B, and non-HDL-C in patients with primary hyperlipidemia, alone or in combination with an HMG-CoA reductase inhibitor (statin) (1.1) Reduce elevated total-C, LDL-C, Apo B, and non-HDL-C in patients with mixed hyperlipidemia in combination with fenofibrate (1.1) Reduce elevated total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH), in combination with atorvastatin or simvastatin (1.2) Reduce elevated sitosterol and campesterol in patients with homozygous sitosterolemia (phytosterolemia) (1.3) Limitations of Use (1.4) The effect of ZETIA on cardiovascular morbidity and mortality has not been determined. ZETIA has not been studied in Fredrickson Type I, III, IV, and V dyslipidemias. 1.1 Primary Hyperlipidemia Monotherapy ZETIA ® , administered alone, is indicated as adjunctive therapy to diet for the reduction of elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), and non-high-density lipoprotein cholesterol (non-HDL-C) in patients with primary (heterozygous familial and non-familial) hyperlipidemia. Combination Therapy with HMG-CoA Reductase Inhibitors (Statins) ZETIA, administered in combination with a 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor (statin), is indicated as adjunctive therapy to diet for the reduction of elevated total-C, LDL-C, Apo B, and non-HDL-C in patients with primary (heterozygous familial and non-familial) hyperlipidemia. Combination Therapy with Fenofibrate ZETIA, administered in combination with fenofibrate, is indicated as adjunctive therapy to diet for the reduction of elevated total-C, LDL-C, Apo B, and non-HDL-C in adult patients with mixed hyperlipidemia. 1.2 Homozygous Familial Hypercholesterolemia (HoFH) The combination of ZETIA and atorvastatin or simvastatin is indicated for the reduction of elevated total-C and LDL-C levels in patients with HoFH, as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable. 1.3 Homozygous Sitosterolemia ZETIA is indicated as adjunctive therapy to diet for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolemia. 1.4 Limitations of Use The effect of ZETIA on cardiovascular morbidity and mortality has not been determined. ZETIA has not been studied in Fredrickson Type I, III, IV, and V dyslipidemias.
Zetia | Merck Sharp & Dohme Corp. while breastfeeding safe or not? Can there be any side effects for infant while using it during breastfeeding?
Ezetimibe is the one and only active ingredient present in Zetia | Merck Sharp & Dohme Corp.. Ezetimibe in itself is a low risk drug for lactation so it is easy to understand that Zetia | Merck Sharp & Dohme Corp. also comes in category of Low Risk item while breastfeeding. Below is the summary of Ezetimibe in breastfeeding.
Statement of Manufacturer/Labeler about breastfeeding usage
8.3 Nursing Mothers It is not known whether ezetimibe is excreted into human breast milk. In rat studies, exposure to total ezetimibe in nursing pups was up to half of that observed in maternal plasma. Because many drugs are excreted in human milk, caution should be exercised when ZETIA is administered to a nursing woman. ZETIA should not be used in nursing mothers unless the potential benefit justifies the potential risk to the infant.
Zetia | Merck Sharp & Dohme Corp. Breastfeeding Analsys
Ezetimibe while Breastfeeding Low Risk
CAS Number: 163222-33-1
Reduces intestinal absorption of cholesterol and phytosterols (AEMPS 2016, Merck 2007). 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 Ezetimibe is 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.
Zetia | Merck Sharp & Dohme Corp. Breastfeeding Analsys - 2
Ezetimibe while Breastfeeding
CAS Number: 163222-33-1
No relevant published information exists on the use of ezetimibe during breastfeeding. Because of a concern with disruption of infant lipid metabolism, ezetimibe is best avoided during breastfeeding. An alternate drug is preferred, especially while nursing a newborn or preterm infant. Ezetimibe treatment in combination with a statin (e.g., atorvastatin, simvastatin) should be avoided in nursing mothers.
What should I do if I am breastfeeding mother and I am already exposed to Zetia | Merck Sharp & Dohme Corp.?
Zetia | Merck Sharp & Dohme Corp. 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 Zetia | Merck Sharp & Dohme Corp. so you should inform him based on your convenience.
I am nursing mother and my doctor has suggested me to use Zetia | Merck Sharp & Dohme Corp., is it safe?
Zetia | Merck Sharp & Dohme Corp. 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 Zetia | Merck Sharp & Dohme Corp., will my baby need extra monitoring?
Not much monitoring required while using Zetia | Merck Sharp & Dohme Corp.
Who can I talk to if I have questions about usage of Zetia | Merck Sharp & Dohme Corp. 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