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1. 31104, Gt
2. Cholestagel
3. Colesevelam Hcl
4. Colesevelam Hydrochloride
5. Gt 31104
6. Gt-31104
7. Gt31 104
8. Gt31-104
9. Gt31104
10. Hcl, Colesevelam
11. Hydrochloride, Colesevelam
12. Welchol
1. Welchol
2. Colesevelam Hcl
3. 2-(chloromethyl)oxirane;prop-2-en-1-amine;n-prop-2-enyldecan-1-amine;trimethyl-[6-(prop-2-enylamino)hexyl]azanium;chloride;hydrochloride
4. Gt 31-104hb
5. Unii-p4sg24wi5q
6. Gt-31104
7. Gt 31-104
8. Colesevelam Hydrochloride [usan]
9. P4sg24wi5q
10. Gt31-104hb
11. Cholestagel, Colesevelam Hydrochloride
12. Akos037653488
13. Hs-0084
14. Nsc 760126
15. 1-hexaminium, N,n,n-trimethyl-6-(2-propenylamino)-, Chloride, Polymer With (chloromethyl)oxirane, 2-propen-4-amine And N-2-propenyl-1-decanamine, Hydrochloride
16. 2-propen-1-amine Polymer With (chloromethyl)oxirane, N,n,n-trimethyl-6-(2-propenylamino)-1-hexanaminium Chloride, And N-2-propenyl-1-decanamine, Hydrochloride
17. Allylamine Polymer With 1-chloro-2,3-epoxypropane, (6-(allylamino)hexyl)trimethylammonium Chloride And N-allyldecylamine, Hydrochloride
18. Ft-0697863
19. Ab01563397_01
20. Q899036
Molecular Weight | 618.2 g/mol |
---|---|
Molecular Formula | C31H67Cl3N4O |
Hydrogen Bond Donor Count | 4 |
Hydrogen Bond Acceptor Count | 5 |
Rotatable Bond Count | 22 |
Exact Mass | 616.438046 g/mol |
Monoisotopic Mass | 616.438046 g/mol |
Topological Polar Surface Area | 62.6 Ų |
Heavy Atom Count | 39 |
Formal Charge | 0 |
Complexity | 301 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 0 |
Undefined Atom Stereocenter Count | 1 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 6 |
1 of 2 | |
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Drug Name | Welchol |
PubMed Health | Colesevelam (By mouth) |
Drug Classes | Antihyperlipidemic |
Drug Label | WELCHOL (colesevelam hydrochloride) is a non-absorbed, polymeric, lipid-lowering and glucose-lowering agent intended for oral administration. Colesevelam hydrochloride is a high-capacity bile acid-binding molecule. Colesevelam hydrochloride is poly(a... |
Active Ingredient | Colesevelam hydrochloride |
Dosage Form | Tablet; For suspension |
Route | Oral |
Strength | 625mg; 1.875gm/packet; 3.75gm/packet |
Market Status | Prescription |
Company | Daiichi Sankyo |
2 of 2 | |
---|---|
Drug Name | Welchol |
PubMed Health | Colesevelam (By mouth) |
Drug Classes | Antihyperlipidemic |
Drug Label | WELCHOL (colesevelam hydrochloride) is a non-absorbed, polymeric, lipid-lowering and glucose-lowering agent intended for oral administration. Colesevelam hydrochloride is a high-capacity bile acid-binding molecule. Colesevelam hydrochloride is poly(a... |
Active Ingredient | Colesevelam hydrochloride |
Dosage Form | Tablet; For suspension |
Route | Oral |
Strength | 625mg; 1.875gm/packet; 3.75gm/packet |
Market Status | Prescription |
Company | Daiichi Sankyo |
For use, alone or in combination with an HMG-CoA reductase inhibitor, as adjunctive therapy to diet and exercise for the reduction of elevated LDL cholesterol in patients with primary hypercholesterolemia (Fredrickson Type IIa).
FDA Label
Cholestagel co-administered with a 3-hydroxy-3-methyl-glutaryl-coenzyme-A (HMG-CoA)-reductase inhibitor (statin) is indicated as adjunctive therapy to diet to provide an additive reduction in low-density-lipoprotein-cholesterol (LDL-C) levels in adult patients with primary hypercholesterolaemia who are not adequately controlled with a statin alone.
Cholestagel as monotherapy is indicated as adjunctive therapy to diet for reduction of elevated total cholesterol and LDL-C in adult patients with primary hypercholesterolaemia, in whom a statin is considered inappropriate or is not well tolerated.
Cholestagel can also be used in combination with ezetimibe, with or without a statin, in adult patients with primary hypercholesterolaemia, including patients with familial hypercholesterolaemia (see section 5. 1).
Colesevelam is a high capacity bile-acid binding molecule. Colesevelam binds to bile acids in the intestine which reduces the amount of bile acids that are returned to the liver via enterohepatic circulation. Clinical studies have demonstrated that elevated levels of total cholesterol (total-C), LDL-C, and apolipoprotein B (Apo B, a protein associated with LDL-C) are associated with an increased risk of atherosclerosis in humans. Similarly, decreased levels of high-density lipoprotein cholesterol (HDL-C) are associated with the development of atherosclerosis. Epidemiological investigations have established that cardiovascular morbidity and mortality vary directly with the levels of total-C and LDL-C, and inversely with the level of HDL-C. The combination of colesevelam and an HMG-CoA reductase inhibitor is effective in further lowering serum total-C and LDL-C levels beyond that achieved by either agent alone.
Anticholesteremic Agents
Substances used to lower plasma cholesterol levels. (See all compounds classified as Anticholesteremic Agents.)
C10AC04
C - Cardiovascular system
C10 - Lipid modifying agents
C10A - Lipid modifying agents, plain
C10AC - Bile acid sequestrants
C10AC04 - Colesevelam
Absorption
Not hydrolyzed by digestive enzymes and is not absorbed.
Route of Elimination
Excretion: In 16 healthy volunteers, an average of 0.05% of administered radioactivity from a single 14C-labeled colesevelam hydrochloride dose was excreted in the urine.
Not applicable (not hydrolyzed by digestive enzymes and not absorbed).
Colesevelam binds bile acids in the intestine and prevents their reabsorption. Colesevelam is not absorbed itself. The depletion of bile acid causes the upregulation of cholesterol 7-alpha-hydroxylase and conversion of cholesterol to bile acid. this increases the production and activity of hydroxymethyl-glutaryl-coenzyme A (HMG-CoA) reductase in the liver as well as an increase in the number of low density lipoprotein (LDL) receptors. This process clears LDL cholesterol from the blood. Serum triglyceride levels may increase or remain unchanged. The end result is increased clearance of LDL-cholesterol from the blood with decreased serum LDL-cholesterol.
API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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ABOUT THIS PAGE
A Colesevelam Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Colesevelam Hydrochloride, including repackagers and relabelers. The FDA regulates Colesevelam Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Colesevelam Hydrochloride API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Colesevelam Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Colesevelam Hydrochloride supplier is an individual or a company that provides Colesevelam Hydrochloride active pharmaceutical ingredient (API) or Colesevelam Hydrochloride finished formulations upon request. The Colesevelam Hydrochloride suppliers may include Colesevelam Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Colesevelam Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Colesevelam Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Colesevelam Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Colesevelam Hydrochloride DMFs exist exist since differing nations have different regulations, such as Colesevelam Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Colesevelam Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Colesevelam Hydrochloride USDMF includes data on Colesevelam Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Colesevelam Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Colesevelam Hydrochloride suppliers with USDMF on PharmaCompass.
A Colesevelam Hydrochloride written confirmation (Colesevelam Hydrochloride WC) is an official document issued by a regulatory agency to a Colesevelam Hydrochloride manufacturer, verifying that the manufacturing facility of a Colesevelam Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Colesevelam Hydrochloride APIs or Colesevelam Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Colesevelam Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Colesevelam Hydrochloride suppliers with Written Confirmation (WC) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Colesevelam Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Colesevelam Hydrochloride API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Colesevelam Hydrochloride as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Colesevelam Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Colesevelam Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Colesevelam Hydrochloride suppliers with NDC on PharmaCompass.
Colesevelam Hydrochloride Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Colesevelam Hydrochloride GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Colesevelam Hydrochloride GMP manufacturer or Colesevelam Hydrochloride GMP API supplier for your needs.
A Colesevelam Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Colesevelam Hydrochloride's compliance with Colesevelam Hydrochloride specifications and serves as a tool for batch-level quality control.
Colesevelam Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Colesevelam Hydrochloride CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Colesevelam Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Colesevelam Hydrochloride EP), Colesevelam Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Colesevelam Hydrochloride USP).
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