rosuvastatin calcium tablet film coated
1 INDICATIONS AND USAGE Pediatric use information for patients 7 to 17 years of age is approved for AstraZeneca’s CRESTOR (rosuvastatin calcium) tablets. However, due to AstraZeneca’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. Rosuvastatin calcium tablets are an HMG-CoA reductase inhibitor indicated for: • adult patients with hypertriglyceridemia as an adjunct to diet ( 1.3 ) • adult patients with primary dysbetalipoproteinemia (Type III hyperlipoproteinemia) as an adjunct to diet ( 1.4 ) • adult patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C, total-C, and ApoB ( 1.5 ) Limitations of use ( 1.8 ): Rosuvastatin calcium tablets have not been studied in Fredrickson Type I and V dyslipidemias. 1.3 Hypertriglyceridemia Rosuvastatin calcium tablets are indicated as adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia. 1.4 primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia) Rosuvastatin calcium tablets are indicated as an adjunct to diet for the treatment of adult patients with primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia). 1.5 Adult Patients with homozygous familial hypercholesterolemia Rosuvastatin calcium tablets are indicated as adjunctive therapy to other lipid-lowering treatments (e.g., LDL apheresis) or alone if such treatments are unavailable to reduce LDL-C, Total-C, and ApoB in adult patients with homozygous familial hypercholesterolemia. 1.8 Limitations of Use Rosuvastatin calcium tablets have not been studied in Fredrickson Type I and V dyslipidemias.
mylan pharmaceuticals inc.
ROUND BROWN M U2
M U2 ROUND BROWN
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rosuvastatin calcium tablet film coated
mylan pharmaceuticals inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING Rosuvastatin Calcium Tablets are available containing rosuvastatin calcium equivalent to 5 mg, 10 mg, 20 mg or 40 mg of rosuvastatin. The 5 mg tablets are beige, film-coated, round, unscored tablets debossed with M on one side of the tablet and U1 on the other side. They are available as follows: NDC 0378-2201-77 bottles of 90 tablets The 10 mg tablets are orange, film-coated, round, unscored tablets debossed with M on one side of the tablet and U2 on the other side. They are available as follows: NDC 0378-2203-77 bottles of 90 tablets The 20 mg tablets are orange, film-coated, round, unscored tablets debossed with M on one side of the tablet and U3 on the other side. They are available as follows: NDC 0378-2204-77 bottles of 90 tablets The 40 mg tablets are orange, film-coated, round, unscored tablets debossed with M on one side of the tablet and U32 on the other side. They are available as follows: NDC 0378-2232-93 bottles of 30 tablets Storage: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
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