It is a well known fact that breastfeeding is best source of nutrition for infants. Breast milk provides minerals, vitamins and antibodies in most acceptable format when they need it. Nutrition taken by mother passes to breast-milk and same thing applies to medicines taken by mothers. Not all drugs cause problem for baby but some do. Lets analyze if Colesevelam Hcl Tablet is safe for baby while breastfed.
What is Colesevelam Hcl Tablet used for?
1 INDICATIONS & USAGE Colesevelam hydrochloride tablets is a bile acid sequestrant indicated as an adjunct to diet and exercise to · reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia as monotherapy or in combination with a hydroxymethyl-glutaryl-coenzyme A (HMG CoA) reductase inhibitor (statin) (1.1). · reduce LDL-C levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia as monotherapy or in combination with a statin after failing an adequate trial of diet therapy. Important Limitations of Use (1.3) Do not use for glycemic control in type 1 diabetes or for treating diabetic ketoacidosis. Colesevelam hydrochloride has not been studied in type 2 diabetes in combination with a dipeptidyl peptidase 4 inhibitor. Colesevelam hydrochloride has not been studied in Fredrickson Type I, III, IV, and V dyslipidemias. Colesevelam hydrochloride has not been studied in children younger than 10 years of age or in pre-menarchal girls. 1.1 Primary Hyperlipidemia Colesevelam hydrochloride tablets is indicated as an adjunct to diet and exercise to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia (Fredrickson Type IIa) as monotherapy or in combination with a hydroxymethyl-glutaryl-coenzyme A (HMG CoA) reductase inhibitor (statin). Colesevelam hydrochloride tablets is indicated as monotherapy or in combination with a statin to reduce LDL-C levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia if after an adequate trial of diet therapy the following findings are present: a. LDL-C remains ≥ 190 mg/dL or b. LDL-C remains ≥ 160 mg/dL and · there is a positive family history of premature cardiovascular disease or · two or more other CVD risk factors are present in the pediatric patient. 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 Clinical Studies (14.1)]. In patients with coronary heart disease (CHD) or CHD risk equivalents such as diabetes mellitus, LDL-C treatment goals are < 100 mg/dL. An LDL-C goal of < 70 mg/dL is a therapeutic option on the basis of recent trial evidence. If LDL-C is at goal but the serum triglyceride (TG) value is > 200 mg/dL, then non-HDL cholesterol (non-HDL-C) (total cholesterol [TC] minus high density lipoprotein cholesterol [HDL-C]) becomes a secondary target of therapy. The goal for non-HDL-C in persons with high serum TG is set at 30 mg/dL higher than that for LDL-C. 1.3 Important Limitations of Use Colesevelam hydrochloride should not be used for the treatment of type 1 diabetes or for the treatment of diabetic ketoacidosis. Colesevelam hydrochloride has not been studied in type 2 diabetes in combination with a dipeptidyl peptidase 4 inhibitor. Colesevelam hydrochloride has not been studied in pediatric patients with type 2 diabetes. Colesevelam hydrochloride has not been studied in Fredrickson Type I, III, IV, and V dyslipidemias. Colesevelam hydrochloride has not been studied in children younger than 10 years of age or in premenarchal girls.
Is Colesevelam Hcl Tablet usage safe while breastfeeding? If a lactating mother is using it can there be any effect on growth or development of infant?
Colesevelam hydrochloride is the only one ingredient used in manufacturing of Colesevelam Hcl Tablet, Which makes it easier to analyze its effect in breastfeeding. As per our analysis of Colesevelam hydrochloride it is safe to use Colesevelam Hcl Tablet while lactating. We suggest you to check further details below about Colesevelam hydrochloride usage in breastfeeding.
Statement of Manufacturer/Labeler about breastfeeding usage
8.3 Nursing Mothers Colesevelam hydrochloride is not expected to be excreted in human milk because colesevelam hydrochloride is not absorbed systemically from the gastrointestinal tract.
Colesevelam Hcl Tablet Breastfeeding Analsys
Colesevelam hydrochloride while Breastfeeding Safe
CAS Number: 182815-43-6
We are working on a comment for this product.
Colesevelam Hcl Tablet Breastfeeding Analsys - 2
Colesevelam hydrochloride while Breastfeeding
CAS Number: 182815-43-6
Colesevelam is a nonabsorbable resin. Because it does not enter the mother's bloodstream, it will not reach the infant via breastmilk. It is acceptable for use during lactation.
What should I do if already breastfed my kid after using Colesevelam Hcl Tablet?
It is always a good idea to keep your healthcare provider or doctor informed about your drug usage during pregnancy and breastfeeding but if you have not informed your doctor about Colesevelam Hcl Tablet and have used it then do not panic as Colesevelam Hcl Tablet is mostly safe in breastfeeding and should not cause any harm to your baby.
I am nursing mother and my doctor has suggested me to use Colesevelam Hcl Tablet, is it safe?
Definitely, Colesevelam Hcl Tablet is safe in lactation for baby. No wonder your doctor has recommended it.
If I am using Colesevelam Hcl Tablet, will my baby need extra monitoring?
No extra baby monitoring required while mother is using Colesevelam Hcl Tablet
Who can I talk to if I have questions about usage of Colesevelam Hcl Tablet 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