Source: FDA, National Drug Code (US) Revision Year: 2019
Since no drug is innocuous, strict attention should be paid to the indications and contraindications, particularly when selecting drugs for chronic long-term use.
COLESTID Granules and FLAVORED COLESTID Granules are indicated as adjunctive therapy to diet for the reduction of elevated serum total and low-density lipoprotein (LDL) cholesterol in patients with primary hypercholesterolemia (elevated low density lipoproteins [LDL] cholesterol) who do not respond adequately to diet. Generally, COLESTID and FLAVORED COLESTID have no clinically significant effect on serum triglycerides, but with its use triglyceride levels may be raised in some patients.
Therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Treatment should begin and continue with dietary therapy (see NCEP guidelines). A minimum of six months of intensive dietary therapy and counseling should be carried out prior to initiation of drug therapy. Shorter periods may be considered in patients with severe elevations of LDL-C or with definite CHD.
According to the NCEP guidelines, the goal of treatment is to lower LDL-C, and LDL-C is to be used to initiate and assess treatment response. Only if LDL-C levels are not available, should the Total-C be used to monitor therapy. The NCEP treatment guidelines are shown below.
| LDL-Cholesterol mg/dL (mmol/L) | |||
|---|---|---|---|
| Definite Atherosclerotic Disease* | Two or More Other Risk Factors† | Initiation Level | Goal |
| No | No | ≥190 (≥4.9) | <160 (<4.1) |
| No | Yes | ≥160 (≥4.1) | <130 (<3.4) |
| Yes | Yes or No | ≥130 (≥3.4) | ≤100 (≤2.6) |
* Coronary heart disease or peripheral vascular disease (including symptomatic carotid artery disease).
† Other risk factors for coronary heart disease (CHD) include: age (males: ≥4 5 years; females: ≥55 years or premature menopause without estrogen replacement therapy); family history of premature CHD; current cigarette smoking; hypertension; confirmed HDL-C <35 mg/dL (0.91 mmol/L); and diabetes mellitus. Subtract one risk factor if HDL-C is ≥60 mg/dL (1.6 mmol/L).
One dose (1 packet or 1 level teaspoon) of COLESTID Granules contains 5 grams of colestipol hydrochloride. One dose (1 packet or 1 level scoopful) of FLAVORED COLESTID Granules is approximately 7.5 grams powder which contains 5 grams of colestipol hydrochloride. The recommended daily adult dose is one to six packets or level scoopfuls given once or in divided doses. Treatment should be started with one dose once or twice daily with an increment of one dose/day at one- or two-month intervals. Appropriate use of lipid profiles as per NCEP guidelines including LDL-cholesterol and triglycerides is advised so that optimal, but not excessive doses are used to obtain the desired therapeutic effect on LDL-cholesterol level. If the desired therapeutic effect is not obtained at one to six doses/day with good compliance and acceptable side effects, combined therapy or alternate treatment should be considered.
To avoid accidental inhalation or esophageal distress, COLESTID and FLAVORED COLESTID should not be taken in its dry form. COLESTID and FLAVORED COLESTID should always be mixed with water or other fluids before ingesting. Patients should take other drugs at least one hour before or four hours after COLESTID or FLAVORED COLESTID to minimize possible interference with their absorption. (See PRECAUTIONS, Drug Interactions.)
COLESTID and FLAVORED COLESTID should always be mixed in a liquid such as water or the beverage of your choice. It may also be taken in soups or with cereals or pulpy fruits. COLESTID or FLAVORED COLESTID should never be taken in its dry form.
FLAVORED COLESTID is an orange-flavored product. Although it may be mixed with a variety of liquids or foods, the selection should be based on patient preference.
Rinse the glass with a small amount of additional beverage to make sure all the medication is taken.
COLESTID and FLAVORED COLESTID may be taken mixed with milk in hot or regular breakfast cereals, or even mixed in soups that have a high fluid content. It may also be added to fruits that are pulpy such as crushed pineapple, pears, peaches, or fruit cocktail.
Overdosage of COLESTID Granules or FLAVORED COLESTID Granules has not been reported. Should overdosage occur, however, the chief potential harm would be obstruction of the gastrointestinal tract. The location of such potential obstruction, the degree of obstruction and the presence or absence of normal gut motility would determine treatment.
Store at controlled room temperature 20° to 25° C (68° to 77° F) [see USP].
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