A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Welchol Indications, Dosage, Storage, Stability - Colesevelam
Welchol Indications, Dosage, Storage, Stability - Colesevelam
INDICATIONS
AND USES
WelChol™, administered alone or in combination with an HMG-CoA reductase inhibitor,
is indicated as adjunctive therapy to diet and exercise for the reduction of
elevated LDL cholesterol in patients with primary hypercholesterolemia (Fredrickson
Type IIa).
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.
Prior to initiating therapy with WelChol™, secondary causes of hypercholesterolemia
(i.e., poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome,
dysproteinemias, obstructive liver disease, other drug therapy, alcoholism)
should be excluded, and a lipid profile obtained to assess total-C, HDL-C, and
TG. For individuals with TG less than 400 mg/dL, LDL-C can be estimated using
the following equation. 3
LDL-C = Total-C - [(TG/5) + HDL-C]
Periodic determination of serum cholesterol levels in patients as outlined
in the National Cholesterol Education Program (NCEP) guidelines should be done
to confirm a favorable initial and long-term response. The NCEP treatment guidelines
are presented in Table 3.
Table 3: NCEP Guideline
|
|
LDL-C |
|
PATIENT ASSESSMENT
CRITERIA
|
INITIATION
LEVEL |
MINIMUM
GOAL |
|
Without CHD and with
fewer than two risk factors
|
≥ 190 mg/dL |
< 160 mg/dL |
|
Without CHD and with
two or more risk factors
|
≥ 160 mg/dL |
< 130 mg/dL |
|
With CHD
|
≥ 130 mg/dL |
≤ 100 mg/dL |
- CHD = Coronary Heart Disease
- 1. Other risk factors for CHD include the following: age (males >45 years,
females >55 years or premature menopause without estrogen replacement therapy);
family history of premature CHD; current cigarette smoking; hypertension;
confirmed HDL-C, <35mg/dL (<0.01 mmol/L); and diabetes mellitus. Subtract
risk factor if HDL-C >60 mg/dL (>1.6 mmol/L).
- 2. In CHD patients with LDL-C levels of 100-129 mg/dL, the physician should
exercise clinical judgment in deciding whether to initiate drug treatment.
DOSAGE AND ADMINISTRATION
Monotherapy
The 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.
Combination Therapy
Welchol™, at doses of 4 to 6 tablets per day, has been shown to be safe and
effective when dosed at the same time (i.e., co-administered) as an HMG-CoA
reductase inhibitor or when the two drugs are dosed apart. [ CLINICAL PHARMACOLOGY
, Clinical Trials ]
WelChol™ should be taken with a liquid. For maximal therapeutic effect in combination
with an HMG-CoA reductase inhibitor, the recommended dose of WelChol™ is 3 tablets
taken twice per day with meals or 6 tablets taken once per day with a meal.
HOW SUPPLIED
WelChol™ is supplied as an off-white, solid tablet imprinted with the word
"Sankyo" over "C01," containing 625 mg colesevelam, magnesium stearate, microcrystalline
cellulose, silicon dioxide, HPMC (hydroxypropyl methylcellulose), and acetylated
monoglyceride.
WelChol™ Tablets are available as follows:
Bottles of 180-NDC 65597-701-18
Storage
Store at room temperature (25 °C). Brief exposure to 40 °C does not adversely
affect the product. [See USP controlled room temperature.] Protect from moisture.
REFERENCES
- Grundy SM, Ahrens EH, Salen G. Interruption of the enterohepatic circulation
of bile acids in man: comparative effects of cholestyramine and ileal exclusion
on cholesterol metabolism. J Lab Clin Med 1971; 78: 94-121.
- Shepherd J, Packard CJ, Bicker S, Veitch LTD, Gemmell MH. Cholestyramine
promotes receptor-mediated low-density-lipoprotein catabolism. N Engl J Med
1980; 302: 1219-22.
- Friedewald WT, Levy RI, Fredrickson DS: Estimation of the concentration
of LDL cholesterol in plasma without use of a preparative ultracentifuge.
Clin. Chem. 1972; 18(6): 499.
Marketed for:
Sankyo Pharma Inc.
New York, New York 10017
by:
Sankyo Parke Davis
Parsippany, New Jersey 07054
Licensed From: GelTex Pharmaceuticals, Inc.
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