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 ?
Clinical trials show that colesevelam reduces LDL levels by 12%-16% in hyperlipidemic patients while lowering gly-cosylated hemoglobin by 0.
In the studies, adding colesevelam to patients' diabetes treatment dropped their hemoglobin [A.
Key Words: bile acid sequestrant, dyslipidemia, cholesterol, lipid-lowering, low density lipoprotein cholesterol (LDL-C), combination drug therapy, colesevelam HCl.
Results: Colesevelam markedly reduced the circulating cholesterol concentration and decreased plaque area by 81 % compared with controls (P<0.
Colesevelam hydrochloride therapy in patients with type 2 diabetes mellitus treated with metformin: Glucose and lipid effects.
The first is that fecal cholesterol elimination increased two-fold in response to colesevelam therapy.
The Company believes that 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.
Drugs with a known interaction with colesevelam (cyclosporine, glimepiride, glipizide, glyburide, levothyroxine, olmesartan medoxomil, oral contraceptives[ethinyl estradiol, norethindrone], and metformin extended release[ER]) should be administered at least 4 hours prior to Welchol.
31) The introduction of new agents such as the recently launched colesevelam hydrochloride may provide more acceptable alternatives to traditional resins.
109 Impax and Daiichi Sankyo, Genzyme, reach colesevelam settlement.
8 g colesevelam, then levothyroxine with 500 mg lanthanum carbonate.