WELCHOL Tab（colesevelam HCI）/WELCHOL FOR ORAL SUSPENSION（colesevelam HCI）
WELCHOL Rx
Hyperlipoproteinemias Only 4 drugs may be compared at once
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Generic Name and Formulations:
Colesevelam HCl 625mg; tabs.
Company:
Daiichi Sankyo
Select therapeutic use: Diabetes
Hyperlipoproteinemias
Indications for WELCHOL:
Adjunct to diet and exercise in type 2 diabetes in combination with metformin, sulfonylureas, or insulin. 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 or TZDs.
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 recommended.
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. Risk of bowel obstruction (eg, gastroparesis, other GI motility disorders, or a history of major GI surgery). 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 FOR ORAL SUSPENSION
Pharmacological Class:
Bile acid sequestrant.
Adverse Reactions:
Constipation, dyspepsia, nausea, dysphagia; pancreatitis.
Elimination:
Renal.
Generic Availability:
NO
How Supplied:
Tabs—180; Susp 3.75g—30 (single-dose pkt)
Indications for WELCHOL:
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. Risk of bowel obstruction (eg, gastroparesis, other GI motility disorders, or a history of major GI surgery). 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.
Pharmacological Class:
Bile acid sequestrant.
Adverse Reactions:
Constipation, dyspepsia, nausea, dysphagia; pancreatitis.
Elimination:
Renal.
Generic Availability:
NO
How Supplied:
Tabs—180; Susp 3.75g—30 (single-dose pkt) |
