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Colestipol: Drug information

Colestipol: Drug information
(For additional information see "Colestipol: Patient drug information" and see "Colestipol: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Colestid;
  • Colestid Flavored
Brand Names: Canada
  • Colestid
Pharmacologic Category
  • Antilipemic Agent, Bile Acid Sequestrant
Dosing: Adult
Primary hypercholesterolemia

Primary hypercholesterolemia: Note: May be considered in patients with fasting triglyceride level ≤300 mg/dL who do not meet cholesterol treatment goals with dietary modification and other lipid lowering therapies (eg, maximally tolerated statin and ezetimibe) (Ref). Oral:

Granules: Initial: 5 g once or twice daily; increase by 5 g per day at 1- to 2-month intervals. In patients with preexisting constipation, initiate at 5 g once daily for 5 to 7 days, then increase to 5 g twice daily. Maintenance: 5 to 30 g/day administered once daily or in divided doses.

Tablets: Initial: 2 g once or twice daily; increase by 2 g once or twice daily at 1- to 2-month intervals. Maintenance: 2 to 16 g/day administered once daily or in divided doses.

Pruritus with primary biliary cholangitis

Pruritus with primary biliary cholangitis (off-label use): Oral: Granules: Initial: 5 g once daily; increase as needed, up to 30 g/day (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment is unlikely because not absorbed from the gastrointestinal tract.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment is unlikely because not absorbed from the gastrointestinal tract.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Colestipol: Pediatric drug information")

Dyslipidemia

Dyslipidemia: Limited data available: Note: Bile acid sequestrant therapy should not be used in pediatric patients with hypertriglyceridemia. Statins are recommended as the primary agent for management of hypercholesterolemia, particularly those in high-risk categories. Multivitamin supplementation recommended due to potential folic acid and cholecalciferol malabsorption (Ref).

Fixed dosing: Children ≥8 years and Adolescents: Oral: Reported range: 2 to 12 g/day; in one trial, both the 10 g once daily and 5 g twice daily were shown to produce significant lowering of serum cholesterol (Ref); doses <10 g suggested to maximize tolerability (Ref).

Weight-directed dosing: Children ≥3 years and Adolescents: Very limited data available: 125 to 250 mg/kg/day has been used in patients 3 to 24 years of age (mean age: 13.7 years) with familial hypercholesterolemia (Ref). Note: Although colestipol has been used in patients down to 3 years of age, experts recommend the initiation of drug therapy for management of hypercholesterolemia in pediatric patients who are older (eg ≥10 years) (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment is unlikely because not absorbed from the gastrointestinal tract.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment is unlikely because not absorbed from the gastrointestinal tract.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

Frequency not defined.

Cardiovascular: Angina, chest pain, peripheral edema, tachycardia

Central nervous system: Dizziness, fatigue, headache (including migraine and sinus headache), insomnia

Dermatologic: Dermatitis, skin rash, urticaria

Gastrointestinal: Abdominal cramps, abdominal pain, anorexia, bloating, constipation, cholecystitis, cholelithiasis, diarrhea, dyspepsia, dysphagia, esophageal obstruction, flatulence, heartburn, hemorrhoidal bleeding, nausea, peptic ulcer, vomiting

Hepatic: Increased serum alkaline phosphatase, increased serum ALT, increased serum AST

Neuromuscular & skeletal: Arthralgia, arthritis, back pain, myalgia, weakness

Respiratory: Dyspnea

Contraindications

Hypersensitivity to colestipol or any component of the formulation

Canadian labeling: Additional contraindications (not in US labeling): Complete biliary obstruction; phenylketonurics (Colestid Orange Granules only)

Warnings/Precautions

Concerns related to adverse effects:

• Acidosis: Chronic use may lead to development of hyperchloremic acidosis.

• Bleeding: Chronic use may be associated with bleeding problems due to hypoprothrombinemia from vitamin K deficiency; may be prevented with use of vitamin K therapy.

• Constipation: May produce or exacerbate constipation; fecal impaction may occur; initiate therapy at a reduced dose and increase gradually in patients with a history of constipation. Encourage increased fluid and fiber intake; a stool softener may also be indicated. Hemorrhoids may be worsened.

• Hypothyroidism: There is a theoretical risk of developing hypothyroidism, particularly in patients with limited thyroid reserve. Use with caution.

Disease-related concerns:

• Hypertriglyceridemia: Bile acid sequestrants can increase serum triglyceride concentrations. The American College of Cardiology/American Heart Association recommends avoiding use in patients with fasting triglyceride levels ≥300 mg/dL (ACC/AHA [Grundy 2018]).

Dosage form specific issues:

• Granules: Colestipol granules should never be taken in dry form; may cause esophageal spasm and/or respiratory distress.

• Phenylalanine: Some products may contain phenylalanine.

Other warnings/precautions:

• Hyperlipidemia: Secondary causes of hyperlipidemia should be ruled out prior to therapy initiation.

• Patients susceptible to fat-soluble vitamin and folic acid deficiencies: Use with caution in patients susceptible to fat-soluble vitamin deficiencies. Absorption of fat-soluble vitamins A, D, E, and K and folic acid may be decreased; patients should take vitamins ≥4 hours before colestipol.

Warnings: Additional Pediatric Considerations

May raise serum triglyceride concentrations; in a trial of combination therapy of colestipol and pravastatin in children and adolescents (>8 years of age), the serum triglycerides increased by 12% from baseline (McCrindle 2002).

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Granules, Oral, as hydrochloride:

Colestid: 5 g/5 g scoop (300 g, 500 g) [contains aspartame; unflavored flavor]

Colestid Flavored: 5 g/7.5 g scoop (450 g) [contains aspartame; orange flavor]

Generic: 5 g/5 g scoop (500 g)

Packet, Oral, as hydrochloride:

Colestid: 5 g (30 ea [DSC], 90 ea) [unflavored flavor]

Colestid Flavored: 5 g (60 ea) [contains aspartame; orange flavor]

Generic: 5 g (30 ea, 90 ea)

Tablet, Oral, as hydrochloride:

Colestid: 1 g

Generic: 1 g

Generic Equivalent Available: US

Yes

Pricing: US

Granules (Colestid Flavored Oral)

5 g (per gram): $0.87

Granules (Colestid Oral)

5 g (per gram): $1.01

Granules (Colestipol HCl Oral)

5 g (per gram): $0.47

Pack (Colestid Flavored Oral)

5 g (per each): $9.33

Pack (Colestid Oral)

5 g (per each): $8.51

Pack (Colestipol HCl Oral)

5 g (per each): $3.93

Tablets (Colestid Oral)

1 g (per each): $2.67

Tablets (Colestipol HCl Oral)

1 g (per each): $1.24 - $1.26

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Granules, Oral, as hydrochloride:

Colestid: 5 g (5 g) [contains aspartame]

Packet, Oral, as hydrochloride:

Colestid: 5 g ([DSC])

Tablet, Oral, as hydrochloride:

Colestid: 1 g

Administration: Adult

Other drugs should be administered at least 1 hour before or 4 hours after colestipol.

Granules: Do not administer in dry form (to avoid esophageal distress or accidental inhalation). After mixing and administration of granules, rinse glass with a small amount of liquid and ingest to ensure all medication is taken.

Tablets: Administer tablets 1 at a time, swallowed whole, with plenty of liquid. Do not cut, crush, or chew tablets.

Administration: Pediatric

Oral: Other drugs should be administered at least 1 hour before or 4 hours after colestipol.

Granules: Do not administer in dry form (to avoid GI distress or accidental inhalation). Dry granules should be added to at least 90 mL of liquid and stirred until completely mixed; may be mixed with any beverage or added to soups, cereal, or pulpy fruits (eg, fruit cocktail, crushed pineapple, peaches, pears). After administration, rinse glass with a small amount of liquid to ensure all medication is consumed.

Tablets: Administer tablets one at a time; swallow whole with plenty of liquid. Do not cut, crush, or chew tablets.

Use: Labeled Indications

Primary hypercholesterolemia: Adjunctive therapy to diet in patients with primary hypercholesterolemia

Use: Off-Label: Adult

Pruritus with primary biliary cholangitis

Medication Safety Issues
Sound-alike/look-alike issues:

Colestipol may be confused with calcitriol

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Amiodarone: Bile Acid Sequestrants may decrease the bioavailability of Amiodarone. Management: Consider alternatives to this combination due to the risk of subtherapeutic amiodarone serum concentrations. If amiodarone is coadministered with colesevelam, administer amiodarone at least 4 hours before colesevelam. Risk D: Consider therapy modification

Cardiac Glycosides: Bile Acid Sequestrants may decrease the absorption of Cardiac Glycosides. Risk C: Monitor therapy

Chenodiol: Bile Acid Sequestrants may decrease the serum concentration of Chenodiol. Management: Administration of chenodiol 5 hours or more after bile acid sequestrants may reduce the magnitude of this interaction. Monitor for decreased therapeutic effects of chenodiol in patients receiving bile acid sequestrants. Risk D: Consider therapy modification

Cholic Acid: Bile Acid Sequestrants may decrease the absorption of Cholic Acid. Management: Administer cholic acid at least 1 hour before or 4 to 6 hours after administration of any bile acid-binding products to minimize the potential for a significant interaction. Risk D: Consider therapy modification

Corticosteroids (Oral): Bile Acid Sequestrants may decrease the absorption of Corticosteroids (Oral). Risk C: Monitor therapy

Deferasirox: Bile Acid Sequestrants may decrease the serum concentration of Deferasirox. Management: Avoid combination when possible; if the combination must be used, consider a 50% increase in initial deferasirox dose, with monitoring of serum ferritin concentrations and clinical responses to guide further dosing. Risk D: Consider therapy modification

Ethinyl Estradiol-Containing Products: Bile Acid Sequestrants may decrease the serum concentration of Ethinyl Estradiol-Containing Products. Management: Administer ethinyl estradiol-containing products 4 hours prior to the administration of a bile acid sequestrant. Risk D: Consider therapy modification

Ezetimibe: Bile Acid Sequestrants may decrease the absorption of Ezetimibe. Management: Administer ezetimibe at least 2 hours before or 4 hours after any bile acid sequestrant. Risk D: Consider therapy modification

Fibric Acid Derivatives: Bile Acid Sequestrants may decrease the absorption of Fibric Acid Derivatives. Management: Separate doses by at least 2 hours to minimize this interaction; fenofibric acid labeling recommends administration one hour prior to or 4-6 hours after a bile acid sequestrant. Risk D: Consider therapy modification

Leflunomide: Bile Acid Sequestrants may decrease serum concentrations of the active metabolite(s) of Leflunomide. Management: Unless using this combination to intentionally enhance leflunomide elimination, consider an alternative to the bile acid sequestrants when possible. Separating drug administration is not likely to be effective at avoiding this interaction. Risk D: Consider therapy modification

Lomitapide: Bile Acid Sequestrants may decrease the absorption of Lomitapide. Management: Administer lomitapide at least 4 hours before or after administration of a bile acid sequestrant. Risk D: Consider therapy modification

Loop Diuretics: Bile Acid Sequestrants may decrease the absorption of Loop Diuretics. Risk C: Monitor therapy

Maralixibat: Bile Acid Sequestrants may decrease the serum concentration of Maralixibat. Management: Bile acid sequestrants should be administered either at least 4 hours before, or 4 hours after, maralixibat. Risk D: Consider therapy modification

Methotrexate: Bile Acid Sequestrants may decrease the absorption of Methotrexate. Risk C: Monitor therapy

Multivitamins/Fluoride (with ADE): Bile Acid Sequestrants may decrease the serum concentration of Multivitamins/Fluoride (with ADE). Management: Avoid concomitant administration of multivitamins and bile acid sequestrants (eg, cholestyramine). Separate administration of these agents by several hours to minimize the risk of an interaction. Risk D: Consider therapy modification

Multivitamins/Minerals (with ADEK, Folate, Iron): Bile Acid Sequestrants may decrease the serum concentration of Multivitamins/Minerals (with ADEK, Folate, Iron). Specifically, bile acid sequestrants may impair the absorption of fat-soluble vitamins. Management: Avoid concomitant administration of multivitamins and bile acid sequestrants (eg, cholestyramine). Separate administration of these agents by several hours to minimize the risk of an interaction. Risk D: Consider therapy modification

Multivitamins/Minerals (with AE, No Iron): Bile Acid Sequestrants may decrease the serum concentration of Multivitamins/Minerals (with AE, No Iron). Management: Avoid concomitant administration of multivitamins and bile acid sequestrants (e.g., cholestyramine). Separate administration of these agents by several hours to minimize the risk of an interaction. Risk D: Consider therapy modification

Mycophenolate: Bile Acid Sequestrants may decrease the serum concentration of Mycophenolate. Risk X: Avoid combination

Niacin: Bile Acid Sequestrants may decrease the absorption of Niacin. Management: Consider separating the administration times of niacin and bile acid sequestrants by a few hours in order to reduce the potential for decreased efficacy of these agents. Risk D: Consider therapy modification

Nonsteroidal Anti-Inflammatory Agents: Bile Acid Sequestrants may decrease the absorption of Nonsteroidal Anti-Inflammatory Agents. Risk C: Monitor therapy

Obeticholic Acid: Bile Acid Sequestrants may decrease the serum concentration of Obeticholic Acid. Management: Administer obeticholic acid at least 4 hours before or at least 4 hours after the administration of bile acid sequestrants. Risk D: Consider therapy modification

Odevixibat: Bile Acid Sequestrants may decrease the serum concentration of Odevixibat. Management: Bile acid sequestrants should be administered either at least 4 hours before, or 4 hours after, odevixibat. Risk D: Consider therapy modification

Pravastatin: Bile Acid Sequestrants may decrease the serum concentration of Pravastatin. Management: Administer pravastatin at least 1 hour before or 4 hours after administration of bile-acid resins (eg, cholestyramine, colestipol, colesevelam) to minimize the risk for any significant interaction. Risk D: Consider therapy modification

Propranolol: Bile Acid Sequestrants may decrease the serum concentration of Propranolol. Risk C: Monitor therapy

Raloxifene: Bile Acid Sequestrants may decrease the absorption of Raloxifene. Management: Consider separating the doses of raloxifene and bile acid sequestrants by at least 4 hours. Risk D: Consider therapy modification

Taurursodiol: Bile Acid Sequestrants may decrease the absorption of Taurursodiol. Risk X: Avoid combination

Teriflunomide: Bile Acid Sequestrants may decrease the serum concentration of Teriflunomide. Management: Unless using this combination to intentionally enhance teriflunomide elimination, consider an alternative to the bile acid sequestrants when possible. Separating drug administration is unlikely to be effective at avoiding the interaction. Risk D: Consider therapy modification

Tetracyclines: Bile Acid Sequestrants may decrease the absorption of Tetracyclines. Risk C: Monitor therapy

Thiazide and Thiazide-Like Diuretics: Bile Acid Sequestrants may decrease the absorption of Thiazide and Thiazide-Like Diuretics. The diuretic response is likewise decreased. Management: Consider separating administraton of bile acid sequestrants and thiazide diuretics by at least 4 hours. Monitor for decreased therapeutic effects of thiazide diuretics if coadministered with a bile acid sequestrant. Risk D: Consider therapy modification

Thyroid Products: Bile Acid Sequestrants may decrease the serum concentration of Thyroid Products. Management: Administer oral thyroid products at least 4 hours prior to or one hour after bile acid sequestrants, or monitor for decreased serum concentrations and clinical effects of oral thyroid products during coadministration. Risk D: Consider therapy modification

Ursodiol: Bile Acid Sequestrants may decrease the serum concentration of Ursodiol. Management: Administer ursodiol 1 hour before or at least 4 to 5 hours after bile acid sequestrants to minimize the potential for any significant interaction. Monitor for decreased therapeutic effects of ursodiol in patients receiving bile acid sequestrants. Risk D: Consider therapy modification

Vitamin D Analogs: Bile Acid Sequestrants may decrease the serum concentration of Vitamin D Analogs. More specifically, bile acid sequestrants may impair absorption of Vitamin D Analogs. Management: Avoid concomitant administration of vitamin D analogs and bile acid sequestrants (eg, cholestyramine). Separate administration of these agents by several hours to minimize the potential risk of interaction. Monitor plasma calcium concentrations. Risk D: Consider therapy modification

Pregnancy Considerations

Lipid concentrations increase during pregnancy as required for normal fetal development. When increases are greater than expected, supervised dietary intervention should be initiated. Bile acid sequestrants are recommended when treatment is needed (Avis 2009; Jacobson 2015).

Colestipol is not absorbed systemically (<0.17%), but may interfere with maternal vitamin absorption; therefore, regular prenatal supplementation may not be adequate.

Breastfeeding Considerations

Due to lack of systemic absorption (<0.17%), colestipol is not expected to be present in breast milk.

When treatment for hypercholesterolemia in breastfeeding women is needed, therapy with bile acid sequestrants may be considered (Jacobson 2015; NICE 2008). However, because use may interfere with maternal vitamin absorption, the manufacturer recommends caution be used if administered to breastfeeding women.

Dietary Considerations

Some products may contain phenylalanine.

Monitoring Parameters

Lipid profile (fasting or nonfasting) before initiating treatment. Fasting lipid profile should be rechecked 4 to 12 weeks after starting therapy and every 3 to 12 months thereafter (AHA/ACC [Grundy 2018])

Mechanism of Action

Binds with bile acids to form an insoluble complex that is eliminated in feces; it thereby increases the fecal loss of bile acid-bound low density lipoprotein cholesterol

Pharmacokinetics (Adult Data Unless Noted)

Onset of action: Lowering of serum cholesterol: ~1 month; LDL-C reduction: ~19%

Absorption: None

Excretion: Feces

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Colestid;
  • (AU) Australia: Colestid;
  • (BE) Belgium: Colestid;
  • (CH) Switzerland: Colestid | Colestid orange;
  • (CZ) Czech Republic: Colestid;
  • (DE) Germany: Cholestabyl | Colestid;
  • (EC) Ecuador: Colestid;
  • (EE) Estonia: Colestid | Lestid;
  • (ES) Spain: Colestid;
  • (FI) Finland: Lestid;
  • (FR) France: Colestid;
  • (GB) United Kingdom: Colestid;
  • (HU) Hungary: Colestid;
  • (ID) Indonesia: Colestid;
  • (IE) Ireland: Colestid;
  • (IL) Israel: Colestid;
  • (KW) Kuwait: Colestid;
  • (LT) Lithuania: Colestid;
  • (LU) Luxembourg: Colestid;
  • (LV) Latvia: Colestid;
  • (NL) Netherlands: Colestid;
  • (NO) Norway: Colestid | Lestid;
  • (NZ) New Zealand: Colestid;
  • (PL) Poland: Colestid;
  • (PR) Puerto Rico: Colestid;
  • (PT) Portugal: Colestid;
  • (SA) Saudi Arabia: Colestid;
  • (SE) Sweden: Lestid;
  • (SI) Slovenia: Colestid;
  • (SK) Slovakia: Colestid;
  • (VE) Venezuela, Bolivarian Republic of: Colestid
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  4. Colestid granules (colestipol hydrochloride) [product monograph]. Kirkland, Quebec, Canada: Pfizer Canada ULC; January 2020.
  5. Colestid orange granules (colestipol hydrochloride) [product monograph]. Kirkland, Quebec, Canada: Pfizer Canada ULC; January 2020.
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