colesevelam


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Related to colesevelam: bromocriptine, colesevelam hydrochloride

colesevelam

 [ko″lĕ-sev´ĕ-lam]
a polymer that binds bile acids in the intestine and prevents them from being reabsorbed, resulting in decreased serum levels of total cholesterol, LDL cholesterol (LDL-C), and apolipoprotein B and increased levels of HDL cholesterol (HDL-C); administered orally as the hydrochloride salt as adjunctive therapy to reduce elevated LDL-C levels in patients with primary hypercholesterolemia.

colesevelam

(koe-le-sev-e-lam) ,

Lodalis

(trade name),

Welchol

(trade name)

Classification

Therapeutic: lipid lowering agents
Pharmacologic: bile acid sequestrants
Pregnancy Category: B

Indications

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.

Action

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

Therapeutic effects

Decreased cholesterol and blood glucose.

Pharmacokinetics

Absorption: Not absorbed; action is primarily local in the GI tract.
Distribution: Unknown.
Metabolism and Excretion: Unknown.
Half-life: Unknown.

Time/action profile (cholesterol-lowering effect)

ROUTEONSETPEAKDURATION
PO24–48 hr2 wkunknown

Contraindications/Precautions

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; Obstetric / Lactation / Pediatric: Pregnancy, lactation, or children <10 yr (safety not established).

Adverse Reactions/Side Effects

Gastrointestinal

  • constipation
  • dyspepsia

Interactions

Drug-Drug interaction

May ↓ absorption of glyburide, glimepiride, glipizide, levothyroxine, olmesartan, phenytoin, cyclosporine, warfarin, and estrogen-containing oral contraceptives (give ≥4 hr before colesevelam).May ↑ levels of metformin extended-release

Route/Dosage

Hyperlipidemia

Oral (Adults) 3 tablets twice daily or 6 tablets once daily.
Oral (Adults and Children 10–17 yr) Suspension—one 3.75-g packet once daily or one 1.875-g packet twice daily.

Type 2 Diabetes

Oral (Adults) 3 tablets twice daily or 6 tablets once daily; Suspension—one 3.75-g packet once daily or one 1.875-g packet twice daily.

Availability

Tablets: 625 mg
Granules for oral suspension: 1.875 g/packet (contains 13.5 mg phenylalanine), 3.75 g/packet (contains 27 mg phenylalanine)

Nursing implications

Nursing assessment

  • Hypercholesterolemia: Obtain a diet history, especially in regard to fat consumption.
  • Type 2 Diabetes: Observe patient for signs and symptoms of hypoglycemic reactions (sweating, hunger, weakness, dizziness, tremor, tachycardia, anxiety).
  • Lab Test Considerations: Monitor serum total cholesterol, LDL, and triglyceride levels before initiating, 4–6 wk after starting, and periodically during therapy.
    • Monitor serum glucose and glycosylated hemoglobin periodically during therapy in patients with diabetes.

Potential Nursing Diagnoses

Constipation (Side Effects)
Noncompliance (Patient/Family Teaching)

Implementation

  • Patients stabilized on a diabetic regimen who are exposed to stress, fever, trauma, infection, or surgery may require administration of insulin.
  • Oral: Administer once or twice daily with meals. Colesevelam should be taken with a liquid. For oral suspension, empty the entire contents of one packet into a glass or cup. Add 1/2 to 1 cup (4 to 8 ounces) of water, fruit juice, or a diet soft drink; do not take in dry form to avoid espophgeal distress.

Patient/Family Teaching

  • Instruct patient to take medication as directed; do not skip doses or double up on missed doses.
  • 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. Advise patients taking oral vitamin supplementation or oral contraceptives to take their vitamins at least 4 hr prior to colesevelam.
  • 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.
  • 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.
    • Insulin is the recommended method of controlling blood sugar during pregnancy. Counsel female patients to use a form of contraception other than oral contraceptives and to notify health care professional promptly if pregnancy is planned or suspected.
    • Advise patient to carry a form of sugar (sugar packets, candy) and identification describing disease process and medication regimen at all times.

Evaluation/Desired Outcomes

  • Decrease in serum total choesterol, LDL cholesterol, apolipoprotein, and blood glucose levels.
  • Control of blood glucose levels without the appearance of hypoglycemic or hyperglycemic episodes.

colesevelam

/co·le·sev·e·lam/ (ko″lĕ-sev´ĕ-lam) a bile acid–binding polymer that decreases serum levels of total cholesterol, LDL cholesterol, and apolipoprotein B and increases levels of HDL cholesterol; used as the hydrochloride salt in the treatment of primary hypercholesterolemia.

colesevelam

[ko′lesev′elam]
a polymer that binds bile acids in the intestine and prevents them from being reabsorbed, resulting in decreased serum levels of total cholesterol, low-density lipoprotein cholesterol (LDL-C), and apolipoprotein B and increased levels of high-density lipoprotein cholesterol. It is administered orally as the hydrochloride salt. It is an adjunctive therapy to reduce elevated LDL-C levels in patients with primary hypercholesterolemia.
References in periodicals archive ?
Colesevelam and colestipol: novel medication resins in the gastrointestinal tract.
Colesevelam is a bile acid sequestrant that lowers HbAlc, fasting plasma glucose, and low-density lipoprotein cholesterol (Fonseca, Handelsman, & Staels, 2010).
The next step is to use add-on therapy with another agent such as niacin (Niaspan), ezetimibe (Zetia), or colesevelam (Welchol) to get those cholesterol levels down to goal.
Colesevelam (Welchol), a bile acid sequestrant, is the only agent approved by the Food and Drug Administration for both treatment of dyslipidemia and improving glycemic control in type 2 diabetes.
memory problems (Crestor) and reduced Simvastatin energy levels (Zocor) Cholesterol Can reduce LDL by Diarrhea, absorption 18-20%; slightly headache, joint inhibitors decrease pain, nausea, Ezetimibe triglycerides; muscle aches (Zetia) slightly increase HDL; not proven to reduce heart disease or heart attacks Bile acid sequestrants Colesevelam Can reduce LDL by Nausea, (Welchol) about 15-30% heartburn, Colestipol constipation, (Colestid) stomach pain, Cholestyramine gas; may raise (Questran) triglycerides Niacin Can reduce LDL by Facial/neck (nicotinic about 20%; lowers flushing, liver acid) Niaspan triglycerides; abnormalities, (prescription) increases HDL gout, nausea, cholesterol diarrhea; may increase blood-sugar levels Source: Stanley Hazen, MD, PhD, Cleveland Clinic
According to Impax, it is the first to file an ANDA with a paragraph IV certification with respect to the colesevelam HCl 625mg tablet product and expects to be entitled to at least three months of market exclusivity prior to the launch of additional ANDA products.
26 January 2011 - US Watson Pharmaceuticals Inc (NYSE: WPI) said yesterday that its subsidiary, Watson Laboratories Inc, has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) seeking approval to market Colesevelam HCI powder for oral suspension, 1.
18) The administration of 6 tablets of colesevelam with statins has been shown to result in an approximate 10-16% further reduction in LDL-C levels, favorable effects upon HDL-C levels, and mild to moderate elevations in triglyceride levels.
Colesevelam hydrochloride (HCI) is a bile acid sequestrant indicated alone or in combination with a statin, and as an adjunct to diet and exercise, for the reduction of elevated low-density lipoprotei n-cholesterol (LDL-C) in patients with primary hypercholesterolemia.
A newer, specifically engineered BAS, colesevelam HCl, is a hydrophilic polymer taken as a tablet.
Tambien se estan explorando las potencialidades terapeuticas de un nuevo grupo de polimeros no absorbibles como el colesevelam que se une a acidos biliares y a la glucosa en el intestino impidiendo su absorcion (17, 18).