Drugplain

Colesevelam hydrochloride 3.75 g/1

Colesevelam hydrochloride · POWDER, FOR SUSPENSION · Ascend Laboratories, LLC

No Recall History
Plain English

Colesevelam hydrochloride is a powder, for suspension containing colesevelam hydrochloride at 3.75 g/1, taken oral. Manufactured by Ascend Laboratories, LLC.

Key Facts

Brand Name
Colesevelam hydrochloride
Generic Name
Colesevelam hydrochloride
NDC Code (Product)
67877-523
Manufacturer
Ascend Laboratories, LLC
Strength
3.75 g/1
Dosage Form
POWDER, FOR SUSPENSION
Route
ORAL
Marketing Status
Application #
ANDA210316
Marketing Start
05/09/2019

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

cough131 reports
dyspnoea129 reports
muscle spasms126 reports
nasopharyngitis121 reports
atrial fibrillation112 reports
chest discomfort111 reports
coronary artery disease108 reports
dysphonia107 reports
dyspnoea exertional106 reports
eosinophilia106 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Colesevelam hydrochloride 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 ( 1.1 ). reduce LDL-C levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia (HeFH), unable to reach LDL-C target levels despite an adequate trial of diet and lifestyle modification ( 1.1 ). improve glycemic control in adults with type 2 diabetes mellitus ( 1.2 ). Limitations of Use ( 1.3 ): Do not use for treatment of type 1 diabetes or for diabetic ketoacidosis. Not studied in Fredrickson Type I, III, IV, and V dyslipidemias 1.1 Primary Hyperlipidemia Colesevelam hydrochloride is indicated as an adjunct to diet and exercise to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. Colesevelam hydrochloride is indicated to reduce LDL-C levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia (HeFH) who are unable to reach LDL-C target levels despite an adequate trial of dietary therapy and lifestyle modificati…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Obtain lipid parameters, including serum triglyceride (TG) levels, before starting colesevelam hydrochloride ( 2.1 ). The recommended dosage for adults and for boys and postmenarchal girls aged 10 to 17 years with primary hyperlipidemia is 3.75 grams daily. The recommended dosage for adults with type 2 diabetes mellitus is 3.75 grams daily. Colesevelam hydrochloride should be taken as follows ( 2.2 , 2.4 ): Tablets Take 6 tablets once daily or 3 tablets twice daily with a meal and liquid. For Oral Suspension Take one packet once daily with a meal. To prepare, empty the entire contents of one packet into a glass or cup. Add 1 cup of water, fruit juice, or diet soft drinks. Stir well and drink. 2.1 Testing Prior to Initiation of Colesevelam Hydrochloride Obtain lipid parameters, including triglyceride (TG) levels, before starting colesevelam hydrochloride. Colesevelam hydrochloride is contraindicated in patients with TG levels >500 mg/dL [see Contraindications (4) and Warnings and Precautions (5.1) ] . 2.2 Recommended Dosage in Primary Hyperlipidemia and Type 2 Diabetes Mellitus The recommended dosage of colesevelam hydrochloride for adults and for boys an…

Contraindications

4 CONTRAINDICATIONS Colesevelam hydrochloride is contraindicated in patients with: Serum TG concentrations >500 mg/dL [see Warnings and Precautions (5.1) ] History of hypertriglyceridemia-induced pancreatitis [see Warnings and Precautions (5.1) ] A history of bowel obstruction [see Warnings and Precautions (5.2) ] Patients with serum triglyceride levels >500 mg/dL ( 4 ) Patients with a history of hypertriglyceridemia-induced pancreatitis ( 4 ) Patients with a history of bowel obstruction ( 4 )

Drug Interactions

7 DRUG INTERACTIONS Concomitant use with colesevelam hydrochloride may decrease the exposure of the following drugs: Drugs with a narrow therapeutic index (e.g., cyclosporine), phenytoin, thyroid hormone replacement therapy, warfarin, oral contraceptives containing ethinyl estradiol and norethindrone, olmesartan medoxomil, and sulfonylureas (glimepiride, glipizide, glyburide). Administer these drugs 4 hours prior to colesevelam hydrochloride. For patients on warfarin, monitor International Normalized Ratio (INR) frequently during initiation then periodically ( 7.1 ). Concomitant use with colesevelam hydrochloride may increase the exposure of the following drugs: Metformin extended release. Monitor patients' glycemic control ( 7.2 ). 7.1 Colesevelam Hydrochloride Drug Interactions that Decrease the Exposure of the Concomitant Medication Table 4 includes a list of drugs that decrease exposure of the concomitant medication when administered concomitantly with colesevelam hydrochloride and instructions for preventing or managing them. Table 4 Colesevelam Hydrochloride Drug Interactions that Decrease the Exposure of the Concomitant Medication Drugs with a Narrow Therapeutic Index Clinic…

Adverse Reactions

6 ADVERSE REACTIONS The following important adverse reactions are described below and elsewhere in the labeling: Hypertriglyceridemia and Pancreatitis [see Warnings and Precautions (5.1) ] Gastrointestinal Obstruction [see Warnings and Precautions (5.2) ] Vitamin K or Fat-Soluble Vitamin Deficiencies [see Warnings and Precautions (5.3) ] In clinical trials, the most common (incidence ≥2% and greater than placebo) adverse reactions with colesevelam hydrochloride included constipation, dyspepsia, and nausea ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in clinical studies of another drug and may not reflect the rates observed in practice. Primary Hyperlipidemia In 7 double-blind, placebo-controlled clinical trials, 807 patients with primary hyperlipidemia (age range 18-86 years, 50% women, 90% Caucasians, 7% Blacks, 2% Hispanics, 1% Asians) and elevated LDL-C were treated wi…

Frequently Asked Questions

What is Colesevelam hydrochloride used for?

Colesevelam hydrochloride contains Colesevelam hydrochloride. It is a powder, for suspension taken oral. Consult your doctor for specific uses.

Is Colesevelam hydrochloride a controlled substance?

Colesevelam hydrochloride is not classified as a controlled substance by the DEA.

What is the generic name for Colesevelam hydrochloride?

The generic name for Colesevelam hydrochloride is Colesevelam hydrochloride. There are 8 other brand versions of Colesevelam hydrochloride.

What is the NDC code for Colesevelam hydrochloride 3.75 g/1?

The NDC (National Drug Code) for Colesevelam hydrochloride 3.75 g/1 is 67877-523, listed by Ascend Laboratories, LLC.

Product NDC

67877-523

Package NDC

67877-523-30

Other Colesevelam Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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