Colesevelam Hydrochloride (Colesevelam Hydrochloride)

Trade Name : Colesevelam Hydrochloride

Amneal Pharmaceuticals of New York LLC

TABLET, COATED

Strength 625 mg/1

COLESEVELAM HYDROCHLORIDE Bile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Colesevelam Hydrochloride (Colesevelam Hydrochloride) which is also known as Colesevelam Hydrochloride and Manufactured by Amneal Pharmaceuticals of New York LLC. It is available in strength of 625 mg/1 per ml. Read more

Colesevelam Hydrochloride (Colesevelam Hydrochloride) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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Indications and Usage () u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 04/2019
Dosage and Administration () u00a0u00a0u00a0u00a0u00a0u00a0u00a0 04/2019
Warnings and Precautions () u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 04/2019

Colesevelam hydrochloride is a bile acid sequestrant indicated as an adjunct to diet and exercise to:
Limitations of Use ():

Tablets
Take 6 tablets once daily or 3 tablets twice daily with a meal and liquid.

Obtain lipid parameters, including serum triglyceride (TG) levels and non-HDL C, before starting colesevelam hydrochloride tablets. ()
The recommended dosage for adults and children 10 to 17 years old with primary hyperlipidemia is 3.75 grams daily. Colesevelam hydrochloride tablets should be taken as follows (, ):

No data

Tablets: 625 mg. ()

Colesevelam hydrochloride is contraindicated in patients with:

Patients with serum triglyceride levels > 500 mg/dL. ()
Patients with a history of hypertriglyceridemia-induced pancreatitis. ()
Patients with a history of bowel obstruction. ()

No data

Hypertriglyceridemia and Pancreatitis:
Gastrointestinal Obstruction:
Vitamin K or Fat-Soluble Vitamin Deficiencies:
Drug Interactions:

The following important adverse reactions are described below and elsewhere in the labeling:
In clinical trials, the most common (incidence u2265 2% and greater than placebo) adverse reactions with colesevelam hydrochloride included constipation, dyspepsia, and nausea. ()

Concomitant use with colesevelam hydrochloride may decrease the exposure of the following drugs:
Concomitant use with colesevelam hydrochloride may increase the exposure of the following drugs:

No data

Colesevelam hydrochloride is not absorbed and the risk of systemic toxicity is low. Excessive doses of colesevelam hydrochloride may cause more severe local gastrointestinal effects (e.g., constipation).

Colesevelam hydrochloride is a non-absorbed, polymeric, lipid-lowering and glucose-lowering agent for oral administration. Colesevelam hydrochloride is a high-capacity bile acid-binding molecule.
Colesevelam hydrochloride is poly (allylamine hydrochloride) cross-linked with epichlorohydrin and alkylated with 1-bromodecane and (6-bromohexyl)-trimethylammonium bromide. The chemical name (IUPAC) of colesevelam hydrochloride is allylamine polymer with 1-chloro-2,3-epoxypropane, [6-(allylamino)-hexyl]trimethylammonium chloride and N-allyldecylamine, hydrochloride. The chemical structure of colesevelam hydrochloride is represented by the following formula:
wherein (a) represents allyl amine monomer units that have not been alkylated by either of the 1-bromodecane or (6-bromohexyl)-trimethylammonium bromide alkylating agents or cross-linked by epichlorohydrin; (b) represents allyl amine units that have undergone cross-linking with epichlorohydrin; (c) represents allyl amine units that have been alkylated with a decyl group; (d) represents allyl amine units that have been alkylated with a (6-trimethylammonium) hexyl group, and m represents a number u2265 100 to indicate an extended polymer network. A small amount of the amines are dialkylated, and are not depicted in the formula above. No regular order of the groups is implied by the structure; cross-linking and alkylation are expected to occur randomly along the polymer chains. A large amount of the amines are protonated. The polymer is depicted in the hydrochloride form; a small amount of the halides are bromide. Colesevelam hydrochloride is hydrophilic and insoluble in water.
Colesevelam hydrochloride tablets are an off-white to pale yellow film-coated, oval tablets, debossed with u201cL61u201d on one side and plain on the other side, containing 625 mg colesevelam hydrochloride. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, copovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and talc.

No data

No data

Colesevelam hydrochloride reduces TC, LDL-C, apolipoprotein B (Apo B), and non-HDL-C when administered alone or in combination with a statin in patients with primary hyperlipidemia.
Approximately 1600 patients were studied in 9 clinical trials with treatment durations ranging from 4 to 50 weeks. With the exception of one open-label, uncontrolled, long-term extension study, all studies were multicenter, randomized, double-blind, and placebo-controlled. A maximum therapeutic response to colesevelam hydrochloride was achieved within 2 weeks and was maintained during long-term therapy.
Monotherapy
As shown in Table 7, the mean LDL-C reductions were 15% and 18% at the 3.8 g and 4.5 g doses. The respective mean TC reductions were 7% and 10%. The mean Apo B reductions were 12% in both treatment groups. Colesevelam hydrochloride at both doses increased HDL-C by 3%. Increases in TG of 9% to 10% were observed at both colesevelam hydrochloride doses but the changes were not statistically different from placebo.
Table 7: Response to Colesevelam Hydrochloride Monotherapy in a 24-Week Trial - Percent Change in Lipid Parameters from Baseline
In a study in 98 patients with LDL-C between 145 mg/dL and 250 mg/dL (mean 169 mg/dL), colesevelam hydrochloride 3.8 g was given for 6 weeks as a single-dose with breakfast, as a single-dose with dinner, or as divided doses with breakfast and dinner. The mean LDL-C reductions were 18%, 15%, and 18% for the 3 dosing regimens, respectively. The reductions with these 3 regimens were not statistically different from one another.
Combination Therapy
Table 8: Response to Colesevelam Hydrochloride in Combination with Atorvastatin, Simvastatin, or Lovastatin - Percent Change in Lipid Parameters
In all 3 studies, the LDL-C reduction achieved with the combination of colesevelam hydrochloride and any given dose of statin therapy was statistically superior to that achieved with colesevelam hydrochloride or that dose of the statin alone. The LDL-C reduction with atorvastatin 80 mg was not statistically significantly different from the combination of colesevelam hydrochloride 3.8 g and atorvastatin 10 mg.
Pediatric Therapy
During the double-blind treatment period, patients were assigned randomly to treatment: Colesevelam hydrochloride 3.8 g/day (n=64), colesevelam hydrochloride 1.9 g/day (n=65), or placebo (n=65). In total, 186 patients completed the double-blind treatment period. After 8 weeks of treatment, colesevelam hydrochloride 3.8 g/day significantly decreased plasma levels of LDL-C, non-HDL-C, TC, and Apo B and significantly increased HDL-C. A moderate, non-statistically significant increase in TG was observed versus placebo (Table 9).
Table 9: Response to
C
olesevelam Hydrochloride 3.8 g Compared to Placebo in Pediatric Patients 10 to 17 Years of Age u2013 Mean Percent Change in Lipid Parameters from Baseline to Week 8
During the open-label treatment period patients were treated with colesevelam hydrochloride 3.8 g/day. In total, 173 (89%) patients completed 26 weeks of treatment. Results at Week 26 were consistent with those at Week 8.

Colesevelam Hydrochloride Tablets, are supplied as off-white to pale yellow film-coated oval tablets, debossed with u201cL61u201d on one side and plain on the other side. Colesevelam hydrochloride tablets are available as follows:
Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [see USP Controlled Room Temperature]. Protect from moisture.

Hypertriglyceridemia and pancreatitis:
Inform patients that colesevelam hydrochloride may increase their serum triglycerides which can lead to hypertriglyceridemia and pancreatitis. Instruct patients to discontinue colesevelam hydrochloride and seek prompt medical attention if the symptoms of acute pancreatitis occur (e.g., severe abdominal pain with or without nausea and vomiting) n
Gastrointestinal:
Inform patients that colesevelam hydrochloride may cause bowel obstruction. Instruct patients to promptly discontinue colesevelam hydrochloride and seek medical attention if severe abdominal pain or severe constipation occurs n
Drug and Vitamin interactions:
Advise patients that colesevelam hydrochloride has drug interactions and colesevelam hydrochloride may decrease the absorption of fat-soluble vitamins A, D, E, and K. Instruct patients to take oral vitamins at least 4 hours prior to colesevelam hydrochloride. Instruct patients to inform their physician about all the drugs and vitamins that they are prescribed or take over the counter and n
Hypertriglyceridemia and cardiovascular disease:
Inform patients that colesevelam hydrochloride may increase serum triglycerides and that the long-term effect of hypertriglyceridemia on the risk of coronary artery disease is uncertain n
Administration [see ]:
Tablets:
Advise patients to take colesevelam hydrochloride tablets with a meal and liquid. Inform patients that colesevelam hydrochloride tablets can be taken as 6 tablets once daily or 3 tablets twice daily.
Females of Reproductive Potential:
Advise females of reproductive potential that colesevelam hydrochloride may reduce the effectiveness of oral contraceptives, and to take oral contraceptives at least 4 hours before taking colesevelam hydrochloride and n
Manufactured by:
Bora Pharmaceutical Laboratories Inc.
Jhunan, Taiwan
Distributed by:
Amneal Pharmaceuticals LLC
Bridgewater, NJ 08807
Active Ingredient:
1025-11
Rev. 06-2019-02

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Colesevelam Hydrochloride (Colesevelam Hydrochloride)

Trade Name : Colesevelam Hydrochloride

TABLET, COATED

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Colesevelam Hydrochloride (Colesevelam Hydrochloride)

Trade Name : Colesevelam Hydrochloride

TABLET, COATED

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

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CONTACT US

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