Rx Item-Fluvastatin 20Mg Cap 100 By Teva Pharma Gen Lescol

Clinical Information
Gen. Code and Des.
21694 fluvastatin sodium ORAL CAPSULE 20 MG
GCN and Des.
30 fluvastatin sodium ORAL CAPSULE 20 MG
Strength
20MG
Dose Form
CAPSULE
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family

AHFS Class
24060800 HMG-COA REDUCTASE INHIBITORS
Active Ingredients
4440 fluvastatin sodium 93957552
Inactive Ingredients
2432 lactose 64044515
2537 povidone 9003398
2549 gelatin 9000708

FLUVASTATIN- fluvastatin sodium capsule
Teva Pharmaceuticals USA Inc

1 INDICATIONS AND USAGE

Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other non-pharmacologic measures alone has been inadequate.

1.1 Hypercholesterolemia (Heterozygous Familial and Nonfamilial) and Mixed Dyslipidemia


Fluvastatin capsules are indicated

�
as an adjunct to diet to reduce elevated total cholesterol (Total-C), low-density lipoprotein cholesterol (LDL-C), triglyceride (TG) and apolipoprotein B (Apo B) levels, and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary hypercholesterolemia and mixed dyslipidemia (Fredrickson Type IIa and IIb).
�
as an adjunct to diet to reduce Total-C, LDL-C, and Apo B levels in adolescent boys and adolescent girls who are at least one year post-menarche, 10 to 16 years of age, with heterozygous familial hypercholesterolemia and the following findings are present:
1.
LDL-C remains ? 190 mg/dL or
2.
LDL-C remains ? 160 mg/dL and:
there is a positive family history of premature cardiovascular disease or
two or more other cardiovascular disease risk factors are present

RX ITEM-Fluvastatin 20Mg Cap 100 By Teva
Item No.:RX363402 NDC No.93744201 UPC No.:300937442011 NDC No. 00093-7442-01 UPC/GTIN No. 3-00937-44201-1 MPN 744201

Fluvastatin 20Mg Cap 100 By Teva Pharma
Item No.:RX363402 NDC No.93744201 UPC No.:300937442011 NDC No. 00093-7442-01 UPC/GTIN No. 3-00937-44201-1 MPN 744201

FLUVASTATIN SODIUM ORAL C
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