WelChol (colesevelam hydrochloride)DESCRIPTIONWelChol contains colesevelam hydrochloride a lipid-lowering agent intended for oral administration. Colesevelam is a high capacity bile acid binding molecule.Type of medication:Part of group of medications called bile acid binders or resinsCLINICAL PHARMACOLOGYColesevelam binds bile acids. Cholesterol is the sole precursor of bile acids. During digestion, bile acids are secreted into the intestine. A major portion of bile acids are then absorbed from the intestinal tract and returned to the liver via the enterohepatic circulation. Colesevelam binds bile acids in the intestine, impeding their reabsorption. The bile acid pool becomes depleted. This causes an increased demand for cholesterol in the liver cells, resulting in the dual effect of increasing transcription and activity of the cholesterol biosynthesis. These effects result in increased clearance of LDL cholesterol from the blood, resulting in decreased serum LDL cholesterol levels.INDICATIONSWelChol is indicated as adjunctive therapy to diet and exercise for the reduction of elevated LDL cholesterol in patients with hypercholesterolemia . Therapy with lipid lowering agents should be a component of multiple risk-factor intervention in patients at significant increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Lipid altering agents should be used in addition to a diet restricted in saturated fat and cholesterol and when the response to diet and other non-pharmacological means has been inadequate.DOSAGEThe recommended starting dose of WelChol™ is 3 tablets taken twice per day with meals or 6 tablets once per day with a meal. The WelChol™ dose can be increased to 7 tablets, depending upon the desired therapeutic effect. WelChol™ should be taken with a liquid.SIDE EFFECTSThe most common adverse reactions are confined to the gastrointestinal tract. To achieve minimal gastrointestinal disturbance with an optimal LDL cholesterol lowering effect, a gradual increase of dosage is recommended. Constipation is the major single complaint and at times is severe. Most instances of constipation are mild, transient, and controlled with standard treatment. Increased fluid intake and inclusion of additional dietary fiber should be the first step; a stool softener may be added if needed. Some patients require decreased dosage or discontinuation of therapy. Hemorrhoids may be aggravated. Other, less frequent gastrointestinal complaints consist of abdominal pain and cramping, intestinal gas (bloating and flatulence), indigestion, heartburn, diarrhea, loose stools, nausea and vomiting.Use in PregnancySince Colesevelam is not absorbed systemically, it is not expected to cause fetal harm when administered during pregnancy in recommended dosages.Nursing MothersCaution should be exercised when Colesevelam is administered to a nursing mother. The possible lack of proper vitamin absorption may have an effect on nursing infantsCONTRAINDICATIONSWelChol™ is contraindicated in individuals with bowel obstruction and in individuals who have shown hypersensitivity to any of the components of WelChol™. |
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