Colesevelam Hcl
625 mg · Tablet, Film Coated
- Prescription only
- Bile Acid Sequestrant
- Active substance
- Colesevelam Hcl
- Made by
- PD-Rx Pharmaceuticals, Inc.
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
This information is not included in the verified source. Open the official leaflet
How it works
From the US prescribing label for the same active substance (Colesevelam). It describes the substance, not this exact product.
Primary Hyperlipidemia Colesevelam hydrochloride, the active pharmaceutical ingredient in colesevelam hydrochloride, is a non-absorbed, lipid-lowering polymer that binds bile acids in the intestine, impeding their reabsorption.
As the bile acid pool becomes depleted, the hepatic enzyme, cholesterol 7-α-hydroxylase, is upregulated, which increases the conversion of cholesterol to bile acids.
Colesevelam hydrochloride is not metabolized systemically and does not interfere with systemic drug-metabolizing enzymes such as cytochrome P-450.
In 16 healthy volunteers, an average of 0.05% of administered radioactivity from a single 14 C-labeled colesevelam hydrochloride dose was excreted in the urine.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2025-09-27
Safety of the active substance
From the US prescribing label for the same active substance (Colesevelam). It describes the substance, not this exact product.
- Colesevelam hydrochloride is contraindicated in patients with: Serum TG concentrations > 500 mg/dL [see Warnings and Precautions ( 5.1 )] History of hypertriglyceridemia-induced pancreatitis [see Warnings and Precautions ( 5.1 )] A history of bowel obstruction [see Warnings and Precautions ( 5.2 )] Patients with serum triglyceride levels >500 mg/dL ( 4 ).
- Patients with a history of hypertriglyceridemia-induced pancreatitis ( 4 ).
- Patients with a history of bowel obstruction ( 4 ).
Quoted from the US prescribing label for the same active substance. Your own pack’s leaflet is the authority for your product. DailyMed
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
European UnionNo exact match for this strength and form
Spain1 matching products
Details
| Made by | PD-Rx Pharmaceuticals, Inc. |
|---|---|
| Active substance | Colesevelam Hcl |
| Used in | Digestion, stomach, diabetes and nutrition |
| Strength | 625 mg |
| Form | Tablet, Film Coated |
| Route | Oral |
| Packs | 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC |
| NDC | 72789-476 |
Source: NDC Directory · 2026-09-13 · not reviewed by a clinician
Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).
Other strengths and forms
4 products are sold under this name. Grouped by form; a number on a strength means several companies make it.
- Tablet, Film Coated4 products
625 mg4
625 mg · 4 companies
- A-S Medication Solutions
- Ascend Laboratories, LLC
- Bryant Ranch Prepack
- PD-Rx Pharmaceuticals, Inc. · this page
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.