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Welchol For Oral Suspension Generic Name & Formulations
Legal Class
Rx
General Description
Colesevelam HCl 3.75g; pwd pkts; citrus flavored; contains phenylalanine 27mg/3.75g pkt.
Pharmacological Class
Bile acid sequestrant.
See Also
How Supplied
Tabs—180; Susp—30 (single-dose pkt)
Manufacturer
Generic Availability
NO
Mechanism of Action
Colesevelam HCl is a non-absorbed, lipid-lowering polymer that binds bile acids in the intestine, impeding their reabsorption.
Welchol For Oral Suspension Indications
Indications
Adjunct to diet and exercise in type 2 diabetes mellitus.
Limitations of Use
Not for treatment of type 1 diabetes or diabetic ketoacidosis.
Welchol For Oral Suspension Dosage and Administration
Adult
Take with a meal and liquid. 3 tabs twice daily or 6 tabs once daily. Susp: one 3.75g pkt once daily. Empty contents into a glass or cup, add 8oz of water, fruit juice, or diet soft drinks; stir and drink. Do not take susp in its dry form.
Children
Not established.
Administration
Take with a meal and liquid.
Nursing Considerations
Take with a meal and liquid.
Welchol For Oral Suspension Contraindications
Contraindications
History of bowel obstruction. Serum TG >500mg/dL. History of hypertriglyceridemia-induced pancreatitis.
Welchol For Oral Suspension Boxed Warnings
Not Applicable
Welchol For Oral Suspension Warnings/Precautions
Warnings/Precautions
TG levels >300mg/dL. Monitor lipids, TG, and non-HDL-C levels prior to initiation and periodically thereafter. Discontinue if acute pancreatitis occurs. Susceptibility to Vit. A, D, E, or K deficiencies. Gastroparesis, other GI motility disorders, history of major GI surgery, or risk for bowel obstruction: not recommended. Dysphagia or swallowing disorders (esp. w/tab form). Phenylketonuria (susp form). Pregnancy.
Welchol For Oral Suspension Pharmacokinetics
Elimination
Renal.
Welchol For Oral Suspension Interactions
Interactions
Monitor drugs with a narrow therapeutic index, cyclosporine, glimepiride, glipizide, olmesartan medoxomil, glyburide, levothyroxine, oral contraceptives containing ethinyl estradiol and norethindrone, phenytoin, warfarin, oral vitamin supplements; give at least 4hrs prior to colesevelam. May potentiate metformin extended-release.
Welchol For Oral Suspension Adverse Reactions
Adverse Reactions
Constipation, dyspepsia, nausea; dysphagia, pancreatitis.
Welchol For Oral Suspension Clinical Trials
See Literature
Welchol For Oral Suspension Note
Not Applicable
Welchol For Oral Suspension Patient Counseling
See Literature
Welchol For Oral Suspension Generic Name & Formulations
Legal Class
Rx
General Description
Colesevelam HCl 3.75g; pwd pkts; citrus flavored; contains phenylalanine 27mg/3.75g pkt.
Pharmacological Class
Bile acid sequestrant.
See Also
How Supplied
Tabs—180; Susp—30 (single-dose pkt)
Manufacturer
Generic Availability
NO
Mechanism of Action
Colesevelam HCl is a non-absorbed, lipid-lowering polymer that binds bile acids in the intestine, impeding their reabsorption.
Welchol For Oral Suspension Indications
Indications
Adjunct to diet and exercise: to reduce elevated LDL-C in adults with primary hyperlipidemia (Type IIa); to reduce LDL-C in boys and postmenarchal girls 10–17yrs of age with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy and lifestyle modification.
Limitations of Use
Not studied in Fredrickson Type I, III, IV, V dyslipidemias.
Welchol For Oral Suspension Dosage and Administration
Adults and Children
<10yrs or premenarchal females: not established. Take with a meal and liquid. 10–17yrs: Susp: one 3.75g pkt once daily. Empty contents into a glass or cup, add 8oz of water, fruit juice, or diet soft drinks; stir and drink. Do not take susp in its dry form. >17yrs: 3 tabs twice daily or 6 tabs once daily. With a statin: may be dosed at the same time or dosed apart.
Administration
Take with meals. Do not take susp in its dry form; must mix with water, fruit juice, or diet soft drinks before ingesting.
Nursing Considerations
Take with meals. Do not take susp in its dry form; must mix with water, fruit juice, or diet soft drinks before ingesting.
Welchol For Oral Suspension Contraindications
Contraindications
History of bowel obstruction. Serum TG >500mg/dL. History of hypertriglyceridemia-induced pancreatitis.
Welchol For Oral Suspension Boxed Warnings
Not Applicable
Welchol For Oral Suspension Warnings/Precautions
Warnings/Precautions
TG levels >300mg/dL. Monitor lipids, TG, and non-HDL-C levels prior to initiation and periodically thereafter. Discontinue if acute pancreatitis occurs. Susceptibility to Vit. A, D, E, or K deficiencies. Gastroparesis, other GI motility disorders, history of major GI surgery, or risk for bowel obstruction: not recommended. Dysphagia or swallowing disorders (esp. w/tab form). Phenylketonuria (susp form). Pregnancy.
Welchol For Oral Suspension Pharmacokinetics
Elimination
Renal.
Welchol For Oral Suspension Interactions
Interactions
Monitor drugs with a narrow therapeutic index, cyclosporine, glimepiride, glipizide, olmesartan medoxomil, glyburide, levothyroxine, oral contraceptives containing ethinyl estradiol and norethindrone, phenytoin, warfarin, oral vitamin supplements; give at least 4hrs prior to colesevelam. May potentiate metformin extended-release.
Welchol For Oral Suspension Adverse Reactions
Adverse Reactions
Constipation, dyspepsia, nausea; dysphagia, pancreatitis.
Welchol For Oral Suspension Clinical Trials
See Literature
Welchol For Oral Suspension Note
Not Applicable
Welchol For Oral Suspension Patient Counseling
See Literature
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