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Dosing

Welchol for Oral Suspension offers mixing options for your patients

Welchol® PacketsWelchol® Packets

*Phenylketonurics: Welchol for Oral Suspension contains 27 mg phenylalanine per 3.75 g dose.

The Welchol for Oral Suspension dosing option gives your patients1:

  • Customization with a variety of mixing options (water, fruit juice, or diet soft drinks)
  • Dosing flexibility to be taken with any meal of the day (preferably the same meal daily)
  • Flexible dosing
  • Taste—Welchol for Oral Suspension is sugar-free and citrus-flavored

To avoid esophageal distress, Welchol for Oral Suspension should not be taken in its dry form. Due to tablet size, Welchol for Oral Suspension is recommended for, but not limited to, use in the pediatric population as well as in any patient who has difficulty swallowing tablets.

Welchol® Oral Suspension Preparation Welchol® Oral Suspension Preparation

Dosage in type 2 diabetes

  • The recommended dose of Welchol for Oral Suspension is 1 packet once a day
  • Welchol for Oral Suspension should be taken with a meal

Dosage in primary hyperlipidemia

  • The recommended dose of Welchol for Oral Suspension is 1 packet once a day
  • Welchol for Oral Suspension should be taken with a meal
  • Welchol for Oral Suspension can be dosed at the same time as an HMG-CoA reductase inhibitor (statin) or the two drugs can be dosed apart
  • After initiation of Welchol, lipid levels should be analyzed within 4 to 6 weeks
  • Welchol for Oral Suspension is recommended for, but not limited to, the pediatric population and for any patient who has difficulty swallowing tablets. Dose adjustments are not required when Welchol is administered to children 10-17 years of age
  • Welchol has not been studied in children younger than 10 years of age or in pre-menarchal girls

Dosage form and strength

  • Each 3.75 g oral suspension packet contains a single dose

Contraindications:
Welchol is contraindicated in patients with:

  • A history of bowel obstruction
  • Serum TG concentrations >500 mg/dL
  • A history of hypertriglyceridemia-induced pancreatitis
Please see Important Safety Information about Welchol below.

Welchol Tablets
A1C and LDL-C efficacy without systemic absorption for your adult patients with T2DM and primary hyperlipidemia

Welchol® 625mg TabletsWelchol® 625mg Tablets

The Welchol Tablet dosing option gives your patients1:

  • Dosing flexibility to be taken with any meal of the day (preferably the same meal daily)
  • Adjustability with a once- or twice-daily* dosing regimen

*Twice-daily dosing only applies to Welchol Tablets.

Dosage in primary hyperlipidemia and T2DM

  • The recommended dose of Welchol Tablets in adults, whether used as monotherapy or in combination with an HMG-CoA reductase inhibitor (statin), is 6 tablets once daily or 3 tablets twice daily
  • Welchol Tablets should be taken with a meal and liquid
  • Welchol for Oral Suspension is available as an alternative—3.75 g dose that mixes with 4-8 ounces of water, fruit juice, or diet soft drinks and should be taken with a meal
  • Welchol can be dosed at the same time as an HMG-CoA reductase inhibitor (statin) or the two drugs can be dosed apart
  • After initiation of Welchol, lipid levels should be analyzed within 4 to 6 weeks

Dosage form and strength
Due to tablet size, Welchol for Oral Suspension is recommended for, but not limited to, use in the pediatric population as well as in any patient who has difficulty swallowing tablets.

  • 625 mg tablets are off-white, oval, film-coated, and imprinted with "Sankyo" and "C01" on one side

Contraindications
Welchol is contraindicated in patients with:

  • A history of bowel obstruction
  • Serum TG concentrations >500 mg/dL
  • A history of hypertriglyceridemia-induced pancreatitis
Please see Important Safety Information about Welchol below.

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Important Safery Information

Indications

Welchol is indicated as an adjunct to diet and exercise to :

  • reduce elevated low-density lipoprotein cholesterol (LDL-C) in patients with primary hyperlipidemia (Fredrickson Type IIa) as monotherapy or in combination with an hydroxymethyl-glutaryl-coenzyme A (HMG CoA) reductase inhibitor (statin)
  • reduce LDL-C levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia, as monotherapy or in combination with a statin after failing an adequate trial of diet therapy
  • improve glycemic control in adults with type 2 diabetes mellitus
Important Limitations of Use
  • Welchol should not be used for the treatment of type 1 diabetes or for the treatment of diabetic ketoacidosis
  • Welchol has not been studied in type 2 diabetes in combination with a dipeptidyl peptidase-4 inhibitor
  • Welchol has not been studied in Fredrickson Type I, III, IV, and V dyslipidemias
  • Welchol has not been studied in children younger than 10 years of age or in premenarchal girls

IMPORTANT SAFETY INFORMATION ABOUT WELCHOL (colesevelam HCI)

Contraindications

Welchol is contraindicated in:

  • individuals with a history of bowel obstruction
  • those with serum triglyceride (TG) concentrations of >500 mg/dL, or
  • those with a history of hypertriglyceridemia-induced pancreatitis.
Warnings and Precautions

The effect of Welchol on cardiovascular morbidity and mortality has not been determined.

Welchol can increase serum TG concentrations particularly when used in combination with pioglitazone, sulfonylureas, or insulin. Caution should be exercised when treating patients with TG levels >300 mg/dL.

Welchol may decrease the absorption of fat-soluble vitamins A, D, E, and K. Patients on vitamin supplements should take their vitamins at least 4 hours prior to Welchol. Caution should be exercised when treating patients with a susceptibility to vitamin K or fat-soluble vitamin deficiencies.

Caution should also be exercised when treating patients with gastroparesis, gastrointestinal motility disorders, a history of major gastrointestinal tract surgery, and when treating patients with dysphagia and swallowing disorders.

Welchol interacts with some drugs. 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. Drugs that have not been tested for interaction with colesevelam, especially those with a narrow therapeutic index, should also be administered at least 4 hours prior to Welchol. Alternatively, the physician should monitor drug levels of the co-administered drug.

To avoid esophageal distress, Welchol for Oral Suspension should not be taken in its dry form.

Due to tablet size, Welchol for Oral Suspension is recommended for, but not limited to, use in the pediatric population as well as in any patient who has difficulty swallowing tablets.

Phenylketonurics: Welchol for Oral Suspension contains 27 mg phenylalanine per 3.75 gram dose.

Adverse Reactions

In clinical trials, the adverse reactions observed in ≥2% of patients, and more commonly with Welchol than placebo, regardless of investigator assessment of causality seen in:

  • Adult patients with Primary Hyperlipidemia were: constipation, dyspepsia, nausea, accidental injury, asthenia, pharyngitis, flu syndrome, rhinitis, and myalgia
  • Pediatric patients with heFH primary hyperlipidemia were: nasopharyngitis, headache, fatigue, creatine phosphokinase increase, rhinitis, and vomiting
  • Adult patients with Type 2 Diabetes were: constipation, hypoglycemia, dyspepsia, nausea, hypertension, and back pain

Post-marketing experience: Due to the voluntary nature of these reports it is not possible to reliably estimate frequency or establish a causal relationship:

  • Increased seizure activity or decreased phenytoin levels have been reported in patients receiving phenytoin concomitantly with Welchol
  • Reduced International Normalized Ratio (INR) has been reported in patients receiving warfarin concomitantly with Welchol
  • Elevated thyroid-stimulating hormone (TSH) has been reported in patients receiving thyroid hormone replacement therapy
  • Dysphagia has been reported with both tablet and oral suspension formulations
Pregnancy

Welchol is Pregnancy Category B.

Please click here for Full Prescribing Information about Welchol.

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