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WELCHOL FOR ORAL SUSPENSION
Diabetes
Hyperlipoproteinemias
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Drug Name:

WELCHOL FOR ORAL SUSPENSION Rx

Generic Name and Formulations:
Colesevelam HCl 3.75g; pwd pkts; citrus flavored; contains phenylalanine 27mg/3.75g pkt.

Company:
Daiichi Sankyo

Therapeutic Use:

Indications for WELCHOL FOR ORAL SUSPENSION:

Adjunct to diet and exercise in type 2 diabetes mellitus. Limitations of use: not for the treatment of type 1 diabetes or diabetic ketoacidosis. Not studied in type 2 diabetes in combination with DPP-4 inhibitors.

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 4–8oz of water, fruit juice, or diet soft drinks; stir and drink. Do not take susp in its dry form.

Children:

Not studied.

Contraindications:

History of bowel obstruction. Serum TG>500mg/dL. History of hypertriglyceridemia-induced pancreatitis.

Warnings/Precautions:

TG levels >300mg/dL. Monitor lipids, TG, and non-HDL-C levels prior to therapy and periodically thereafter. 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). Pregnancy (Cat.B). Nursing mothers.

Interactions:

Monitor drugs with a narrow therapeutic index, cyclosporine, glimepiride, glipizide, olmesartan medoxomil, glyburide, levothyroxine, oral contraceptives containing ethinyl estradiol and norethindrone, phenytoin, warfarin; give at least 4hrs prior to colesevelam. May potentiate metformin extended-release.

See Also:

WELCHOL

Pharmacological Class:

Bile acid sequestrant.

Adverse Reactions:

Constipation, dyspepsia, nausea; dysphagia, pancreatitis.

Elimination:

Renal.

Generic Availability:

NO

How Supplied:

Tabs—180; Susp—30 (single-dose pkt)

Indications for WELCHOL FOR ORAL SUSPENSION:

Adjunct to diet and exercise: to reduce elevated LDL-C in adults with primary hyperlipidemia (Type IIa), alone or with a statin, when response to nondrug therapy is inadequate; to reduce LDL-C in boys and postmenarchal girls 10–17yrs of age with heterozygous familial hypercholesterolemia, alone or with a statin after failing an adequate trial of diet therapy. Limitations of use: not studied in Fredrickson Type I, III, IV, V dyslipidemias, children <10yrs, or premenarchal girls.

Adults and Children:

<10yrs: not established. Take with a meal and liquid. ≥10yrs: Susp: one 3.75g pkt once daily. Empty contents into a glass or cup, add 4–8oz 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.

Contraindications:

History of bowel obstruction. Serum TG>500mg/dL. History of hypertriglyceridemia-induced pancreatitis.

Warnings/Precautions:

TG levels >300mg/dL. Monitor lipids, TG, and non-HDL-C levels prior to therapy and periodically thereafter. 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). Pregnancy (Cat.B). Nursing mothers.

Interactions:

Monitor drugs with a narrow therapeutic index, cyclosporine, glimepiride, glipizide, olmesartan medoxomil, glyburide, levothyroxine, oral contraceptives containing ethinyl estradiol and norethindrone, phenytoin, warfarin; give at least 4hrs prior to colesevelam. May potentiate metformin extended-release.

See Also:

WELCHOL

Pharmacological Class:

Bile acid sequestrant.

Adverse Reactions:

Constipation, dyspepsia, nausea; dysphagia, pancreatitis.

Elimination:

Renal.

Generic Availability:

NO

How Supplied:

Tabs—180; Susp—30 (single-dose pkt)

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