COLESTID Tablet (2019)

Βιβλιογραφική αναφορά

Συγγραφείς

Pharmacia and Upjohn Company LLC

Λέξεις κλειδιά

0009-0450

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1. Description

The active ingredient in COLESTID Tablets is micronized colestipol hydrochloride, which is a lipid lowering agent for oral use. Colestipol is an insoluble, high molecular weight basic anion-exchange copolymer ...

2. Clinical Pharmacology

Cholesterol is the major, and probably the sole precursor of bile acids. During normal digestion, bile acids are secreted via the bile from the liver and gall bladder into the intestines. Bile acids emulsify ...

3. Indications and Usage

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 Tablets are indicated as adjunctive ...

4. Contraindications

COLESTID Tablets are contraindicated in those individuals who have shown hypersensitivity to any of their components.

6. Precautions

Prior to initiating therapy with COLESTID Tablets, secondary causes of hypercholesterolemia (e.g., poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive ...

6.2. Information for Patients

COLESTID Tablets may be larger than pills you have taken before. If you have had swallowing problems or choking with food, liquids or other tablets or capsules in the past, you should discuss this with ...

6.4. Drug Interactions

Since colestipol hydrochloride is an anion exchange resin, it may have a strong affinity for anions other than the bile acids. <em>In vitro</em> studies have indicated that colestipol hydrochloride binds ...

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

In studies conducted in rats in which cholestyramine resin (a bile acid sequestering agent similar to colestipol hydrochloride) was used as a tool to investigate the role of various intestinal factors, ...

6.7. Pregnancy

Since colestipol hydrochloride is essentially not absorbed systemically (less than 0.17% of the dose), it is not expected to cause fetal harm when administered during pregnancy in recommended dosages. ...

6.9. Nursing Mothers

Caution should be exercised when COLESTID Tablets are administered to a nursing mother. The possible lack of proper vitamin absorption described in the Pregnancy section may have an effect on nursing infants. ...

6.10. Pediatric Use

Safety and effectiveness in the pediatric population have not been established.

7. Adverse Reactions

Gastrointestinal The most common adverse reactions are confined to the gastrointestinal tract. To achieve minimal GI disturbance with an optimal LDL-C lowering effect, a gradual increase of dosage starting ...

9. Overdosage

Overdosage of COLESTID Tablets 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, ...

10. Dosage and Administration

For adults, COLESTID Tablets are recommended in doses of 2 to 16 grams/day given once or in divided doses. The starting dose should be 2 grams once or twice daily. Dosage increases of 2 grams, once or ...

11. How Supplied

COLESTID Tablets are yellow, elliptical, imprinted U, and are supplied as follows: Bottles of 120 NDC 0009-0450-03 Each tablet contains 1 gram of micronized colestipol hydrochloride.

12. Storage and Handling

Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].

14. References

Summary of the Second Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel II). <em> ...