Simvastatin | Ranbaxy Pharmaceuticals Inc. 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 Simvastatin | Ranbaxy Pharmaceuticals Inc. while breastfeeding. We will also discuss about common side effects and warnings associated with Simvastatin | Ranbaxy Pharmaceuticals Inc..

What is Simvastatin | Ranbaxy Pharmaceuticals Inc. 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. In patients with coronary heart disease (CHD) or at high risk of CHD, simvastatin tablets, USP can be started simultaneously with diet. Simvastatin tablets, USP are an HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet to: Reduce the risk of total mortality by reducing CHD deaths and reduce the risk of non-fatal myocardial infarction, stroke, and the need for revascularization procedures in patients at high risk of coronary events. (1.1) Reduce elevated total-C, LDL-C, Apo B, TG and increase HDL-C in patients with primary hyperlipidemia (heterozygous familial and nonfamilial) and mixed dyslipidemia. (1.2) Reduce elevated TG in patients with hypertriglyceridemia and reduce TG and VLDL-C in patients with primary dysbetalipoproteinemia. (1.2) Reduce total-C and LDL-C in adult patients with homozygous familial hypercholesterolemia. (1.2) Reduce elevated total-C, LDL-C, and Apo B in boys and postmenarchal girls, 10 to 17 years of age with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy. (1.2, 1.3) Limitations of Use Simvastatin tablets, USP have not been studied in Fredrickson Types I and V dyslipidemias. (1.4) 1.1 Reductions in Risk of CHD Mortality and Cardiovascular Events In patients at high risk of coronary events because of existing coronary heart disease, diabetes, peripheral vessel disease, history of stroke or other cerebrovascular disease, simvastatin tablets, USP are indicated to: Reduce the risk of total mortality by reducing CHD deaths. Reduce the risk of non-fatal myocardial infarction and stroke. Reduce the need for coronary and non-coronary revascularization procedures. 1.2 Hyperlipidemia Simvastatin tablets, USP are indicated to: Reduce elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), and triglycerides (TG), and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary hyperlipidemia (Fredrickson type IIa, heterozygous familial and nonfamilial) or mixed dyslipidemia (Fredrickson type IIb). Reduce elevated TG in patients with hypertriglyceridemia (Fredrickson type IV hyperlipidemia). Reduce elevated TG and VLDL-C in patients with primary dysbetalipoproteinemia (Fredrickson type III hyperlipidemia). Reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH) as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable. 1.3 Adolescent Patients with Heterozygous Familial Hypercholesterolemia (HeFH) Simvastatin tablets, USP are indicated as an adjunct to diet to reduce total-C, LDL-C, and Apo B levels in adolescent boys and girls who are at least one year post-menarche, 10 to 17 years of age, with HeFH, if after an adequate trial of diet therapy the following findings are present: LDL cholesterol remains ≥ 190 mg/dL; or LDL cholesterol remains ≥ 160 mg/dL and There is a positive family history of premature cardiovascular disease (CVD) or Two or more other CVD risk factors are present in the adolescent patient. The minimum goal of treatment in pediatric and adolescent patients is to achieve a mean LDL-C < 130 mg/dL. The optimal age at which to initiate lipid-lowering therapy to decrease the risk of symptomatic adulthood CAD has not been determined. 1.4 Limitations of Use Simvastatin tablets, USP have not been studied in conditions where the major abnormality is elevation of chylomicrons (i.e., hyperlipidemia Fredrickson types I and V).

I am currently breastfeeding and I want to know if using Simvastatin | Ranbaxy Pharmaceuticals Inc. is safe for my kid? Does it have any effect on milk production?

Simvastatin | Ranbaxy Pharmaceuticals Inc. high risk while breastfeeding
As Simvastatin | Ranbaxy Pharmaceuticals Inc. is made of only Simvastatin, and Simvastatin is unsafe to use in breastfeeding we can safely reach on conclusion that Simvastatin | Ranbaxy Pharmaceuticals Inc. is also unsafe to use while breastfeeding. Below is detailed analysis of Simvastatin and Simvastatin | Ranbaxy Pharmaceuticals Inc. during location. We recommend you to go through provided detailed analysis as below take decision accordingly. We also recommend you talk to your health care provider before making final decision.

Statement of Manufacturer/Labeler about breastfeeding usage
8.3 Nursing Mothers It is not known whether simvastatin is excreted in human milk. Because a small amount of another drug in this class is excreted in human milk and because of the potential for serious adverse reactions in nursing infants, women taking simvastatin should not nurse their infants. A decision should be made whether to discontinue nursing or discontinue drug, taking into account the importance of the drug to the mother [see Contraindications (4)].

Simvastatin | Ranbaxy Pharmaceuticals Inc. Breastfeeding Analsys


Simvastatin while Breastfeeding

Unsafe

CAS Number: 79902-63-9

Statins work by blocking cholesterol synthesis. At latest update no published data on breastfeeding were found. A high plasma protein-binding capacity makes it unlikely its passage into milk.Their low oral bioavailability hinders the passage toward infant’s plasma from ingested mother’s milk, except in preterm infants and immediate neonatal period, in which the infant may have an increased intestinal permeability. It is unknown whether it is capable of altering the lipid composition of milk, albeit it is known and that the infants need to ingest high amounts of cholesterol because it is essential for a proper development of cell membranes of the nervous system and as a precursor of various hormones and vitamins. It is prudent to avoid its use, at least while breastfeeding is exclusive. Atorvastatin is possibly the safest statin drug, for its high molecular weight makes it even more difficult the passage into the milk. With Pravastatin a poor secretion into milk has been reported. Simvastatin is the one with lowest oral bioavailability. Discontinuing the treatment of hypercholesterolemia during lactation with such kind of drugs will not likely alter the long-term outcome of the disease. A low-fat diet should be recommended.


Simvastatin | Ranbaxy Pharmaceuticals Inc. Breastfeeding Analsys - 2


Simvastatin while Breastfeeding

CAS Number: 79902-63-9

Simvastatin | Ranbaxy Pharmaceuticals Inc. and breastfeeding

No relevant published information exists on the use of simvastatin during breastfeeding. Because of a concern with disruption of infant lipid metabolism, the consensus is that simvastatin should not be used during breastfeeding. However, others have argued that children homozygous for familial hypercholesterolemia are treated with statins beginning at 1 year of age, that statins have low oral bioavailability, and risks to the breastfed infant are low, especially with rosuvastatin and pravastatin.[1] Until more data become available, an alternate drug may be preferred, especially while nursing a newborn or preterm infant.


Is Simvastatin | Ranbaxy Pharmaceuticals Inc. safe while breastfeeding

What should I do if already breastfed my kid after using Simvastatin | Ranbaxy Pharmaceuticals Inc.?

We have already established that Simvastatin | Ranbaxy Pharmaceuticals Inc. is unsafe in breastfeeding and breastfeeding while using Simvastatin | Ranbaxy Pharmaceuticals Inc. is not a good idea however if have already used and then breastfed the baby then you shall monitor the behavior and health of baby closely and inform your doctor as soon as possible. In case of emergency please call 911.


My health care provider has asked me to use Simvastatin | Ranbaxy Pharmaceuticals Inc., what to do?

If your doctor knows that you are breastfeeding mother and still prescribes Simvastatin | Ranbaxy Pharmaceuticals Inc. then there must be good reason for that as Simvastatin | Ranbaxy Pharmaceuticals Inc. is considered unsafe, It usually happens when doctor finds that overall advantage of taking outweighs the overall risk.


If I am using Simvastatin | Ranbaxy Pharmaceuticals Inc., will my baby need extra monitoring?

Yes, Extra monitoring is required if mother is using Simvastatin | Ranbaxy Pharmaceuticals Inc. and breastfeeding as it is considered unsafe for baby.


Who can I talk to if I have questions about usage of Simvastatin | Ranbaxy Pharmaceuticals Inc. in breastfeeding?

US
National Womens Health and Breastfeeding Helpline: 800-994-9662 (TDD 888-220-5446) 9 a.m. and 6 p.m. ET, Monday through Friday

UK
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

Australia
National Breastfeeding Helpline: 1800-686-268 24 hours a day, 7 days a week

Canada
Telehealth Ontario for breastfeeding: 1-866-797-0000 24 hours a day, 7 days a week