colesevelam

REMS

Adjunctive therapy to diet and exercise for the reduction of LDL cholesterol in patients with primary hypercholesterolemia; may be used alone or in combination with statins.
Adjunctive therapy to diet and exercise for the reduction of LDL cholesterol in children 10–17 yr with heterozygous familial hypercholesterolemia if diet therapy fails (LDL cholesterol remains ≥190 mg/dL or remains ≥160 mg/dL [with family history of premature cardiovascular disease or ≥2 risk factors for cardiovascular disease]); may be used alone or in combination with statin.
Adjunctive therapy to diet and exercise to improve glycemic control in patients with type 2 diabetes.

Contraindicated in:

Hypersensitivity;
Bowel obstruction;
Triglycerides >500 mg/dL;
History of pancreatitis due to hypertriglyceridemia.

Use Cautiously in:

Triglycerides >300 mg/dL;
Dysphagia, swallowing disorders, severe GI motility disorders, or major GI tract surgery;
Phenylketonuria (oral suspension packets contain phenylalanine);
OB: Use during pregnancy not expected to result in fetal exposure (not systemically absorbed);
Lactation: Not expected to be present in breast milk (not systemically absorbed);
Pedi: Safety and effectiveness not established in children <10 yr (hyperlipidemia) or <18 yr (type 2 diabetes).

GI: constipation, dyspepsia

(Generic available)

Granules for oral suspension: 3.75 g/packet (contains 27 mg phenylalanine)
Tablets: 625 mg

Hyperlipidemia

PO (Adults and Children 10–17 yr): 6 tablets once daily or 3 tablets twice daily or one 3.75-g packet once daily.

Type 2 Diabetes

PO (Adults ): 6 tablets once daily or 3 tablets twice daily or one 3.75-g packet once daily.

Binds bile acids in the GI tract.
Results in increased clearance of cholesterol.
Mechanism for lowering blood glucose unknown.

Therapeutic effects:

Decreased cholesterol and blood glucose.

Therapeutic Classification: lipid-lowering agents

Pharmacologic Classification: bile acid sequestrants

Absorption: Not absorbed; action is primarily local in the GI tract.

Distribution: Unknown.

Metabolism/Excretion: Unknown.

Half-Life: Unknown.

(cholesterol-lowering effect)

ROUTE	ONSET	PEAK	DURATION
PO	24–48 hr	2 wk	unknown

Instruct patient to take medication as directed; do not skip doses or double up on missed doses.
Advise patients taking oral vitamin supplementation or oral contraceptives to take their vitamins at least 4 hr prior to colesevelam, especially those taking warfarin. Colesevelam may decrease absorption of fat-soluble vitamins A, D, E, and K.
Instruct patient to consume a diet that promotes bowel regularity. Patients should be instructed to promptly discontinue colesevelam and notify health care professional if severe abdominal pain or severe constipation or symptoms of acute pancreatitis (severe abdominal pain with or without nausea and vomiting) occur.
Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking other Rx, OTC, or herbal products.
Rep: Insulin is the recommended method of controlling blood sugar during pregnancy. Counsel females of reproductive potential that colesevelam may reduce efficacy of oral contraceptives; advise patients to take oral contraceptives at least 4 hr prior to taking colesevelam or use a form of contraception other than oral contraceptives and to notify health care professional promptly if pregnancy is planned or suspected.
Hypercholesterolemia: Advise patient that this medication should be used in conjunction with diet restrictions (fat, cholesterol, carbohydrates, alcohol), exercise, and cessation of smoking.
Diabetes: Explain to patient that this medication controls hyperglycemia but does not cure diabetes. Therapy is long term.
- Review signs of hypoglycemia and hyperglycemia with patient. If hypoglycemia occurs, advise patient to drink a glass of orange juice or ingest 2–3 tsp of sugar, honey, or corn syrup dissolved in water or an appropriate number of glucose tablets and notify health care professional.
- Encourage patient to follow prescribed diet, medication, and exercise regimen to prevent hypoglycemic or hyperglycemic episodes.
- Instruct patient in proper testing of serum glucose and ketones. These tests should be closely monitored during periods of stress or illness and health care professional notified if significant changes occur.
- Advise patient to carry a form of sugar (sugar packets, candy) and identification describing disease process and medication regimen at all times.

NDC Code

0115- Amneal Pharmaceuticals of New York LLC
- 0115-1320- Colesevelam Hydrochloride
  - 0115-1320-19- 180 TABLET, COATED in 1 BOTTLE (0115-1320-19)

42291- AvKARE, Inc.
- 42291-147- Colesevelam Hydrochloride
  - 42291-147-18- 180 TABLET, COATED in 1 BOTTLE (42291-147-18)

43598- Dr.Reddys Laboratories Inc
- 43598-230- Colesevelam Hydrochloride
  - 43598-230-18- 180 TABLET in 1 BOTTLE (43598-230-18)

50090- A-S Medication Solutions
- 50090-4371- Colesevelam HCL
  - 50090-4371-0- 90 TABLET, FILM COATED in 1 BOTTLE (50090-4371-0)

51407- Golden State Medical Supply Inc
- 51407-159- Colesevelam Hydrochloride
  - 51407-159-18- 180 TABLET in 1 BOTTLE (51407-159-18)

51660- Ohm Laboratories, Inc.
- 51660-995- Colesevelam hydrochloride
  - 51660-995-30- 30 PACKET in 1 CARTON (51660-995-30) > 1 POWDER, FOR SUSPENSION in 1 PACKET

51660- Ohm Laboratories, Inc.
- 51660-996- Colesevelam hydrochloride
  - 51660-996-28- 180 TABLET, FILM COATED in 1 BOTTLE (51660-996-28)

60687- American Health Packaging
- 60687-385- Colesevelam Hydrochloride
  - 60687-385-25- 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-385-25) > 1 TABLET, COATED in 1 BLISTER PACK (60687-385-95)

65597- Daiichi Sankyo Inc.
- 65597-208- Welchol
  - 65597-208-30- 30 PACKAGE in 1 CARTON (65597-208-30) > 1 BAR, CHEWABLE in 1 PACKAGE

65597- Daiichi Sankyo Inc.
- 65597-209- Welchol
  - 65597-209-30- 30 PACKAGE in 1 CARTON (65597-209-30) > 1 BAR, CHEWABLE in 1 PACKAGE

65597- Daiichi Sankyo Inc.
- 65597-210- Welchol
  - 65597-210-30- 30 PACKAGE in 1 CARTON (65597-210-30) > 1 BAR, CHEWABLE in 1 PACKAGE

65597- Daiichi Sankyo Inc.
- 65597-701- Welchol
  - 65597-701-18- 180 TABLET, FILM COATED in 1 BOTTLE (65597-701-18)

65597- Daiichi Sankyo Inc.
- 65597-902- Welchol
  - 65597-902-30- 30 PACKET in 1 CARTON (65597-902-30) > 1 FOR SUSPENSION in 1 PACKET

67877- Ascend Laboratories, LLC
- 67877-506- Colesevelam HCL
  - 67877-506-05- 500 TABLET, FILM COATED in 1 BOTTLE (67877-506-05)

67877- Ascend Laboratories, LLC
- 67877-506- Colesevelam HCL
  - 67877-506-30- 30 TABLET, FILM COATED in 1 BOTTLE (67877-506-30)

67877- Ascend Laboratories, LLC
- 67877-506- Colesevelam HCL
  - 67877-506-51- 180 TABLET, FILM COATED in 1 BOTTLE (67877-506-51)

67877- Ascend Laboratories, LLC
- 67877-506- Colesevelam HCL
  - 67877-506-90- 90 TABLET, FILM COATED in 1 BOTTLE (67877-506-90)

67877- Ascend Laboratories, LLC
- 67877-523- Colesevelam hydrochloride
  - 67877-523-30- 30 POWDER, FOR SUSPENSION in 1 PACKET (67877-523-30)

68382- Zydus Pharmaceuticals (USA) Inc.
- 68382-619- Colesevelam
  - 68382-619-10- 1000 TABLET, FILM COATED in 1 BOTTLE (68382-619-10)

68382- Zydus Pharmaceuticals (USA) Inc.
- 68382-619- Colesevelam
  - 68382-619-28- 180 TABLET, FILM COATED in 1 BOTTLE (68382-619-28)

68382- Zydus Pharmaceuticals (USA) Inc.
- 68382-619- Colesevelam
  - 68382-619-77- 10 BLISTER PACK in 1 CARTON (68382-619-77) > 10 TABLET, FILM COATED in 1 BLISTER PACK (68382-619-30)

68462- Glenmark Pharmaceuticals Inc., USA
- 68462-433- colesevelam hydrochloride
  - 68462-433-18- 180 TABLET, FILM COATED in 1 BOTTLE (68462-433-18)

68462- Glenmark Pharmaceuticals Inc., USA
- 68462-433- colesevelam hydrochloride
  - 68462-433-90- 90 TABLET, FILM COATED in 1 BOTTLE (68462-433-90)

68462- Glenmark Pharmaceuticals Inc.,USA
- 68462-620- Colesevelam Hydrochloride
  - 68462-620-30- 30 PACKET in 1 BOX (68462-620-30) > 1 POWDER, FOR SUSPENSION in 1 PACKET

69452- Bionpharma Inc.
- 69452-158- COLESEVELAM HYDROCHLORIDE
  - 69452-158-25- 180 TABLET, FILM COATED in 1 BOTTLE (69452-158-25)

70771- Cadila Healthcare Limited
- 70771-1368- COLESEVELAM
  - 70771-1368-0- 1000 TABLET in 1 BOTTLE (70771-1368-0)

70771- Cadila Healthcare Limited
- 70771-1368- COLESEVELAM
  - 70771-1368-4- 10 BLISTER PACK in 1 CARTON (70771-1368-4) > 10 TABLET in 1 BLISTER PACK (70771-1368-2)

70771- Cadila Healthcare Limited
- 70771-1368- COLESEVELAM
  - 70771-1368-8- 180 TABLET in 1 BOTTLE (70771-1368-8)

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Indications ⬇

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