rosuvastatin 5 mg and ezetimibe 10 mg
1 INDICATIONS AND USAGE ROSZET is indicated in adults: As an adjunct to diet in patients with primary non-familial hyperlipidemia to reduce low-density lipoprotein cholesterol (LDL-C). Alone or as an adjunct to other LDL-C-lowering therapies in patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C. ROSZET is a combination of rosuvastatin, an HMG CoA-reductase inhibitor (statin), and ezetimibe, a dietary cholesterol absorption inhibitor, indicated in adults: As an adjunct to diet in patients with primary non-familial hyperlipidemia to reduce low-density lipoprotein cholesterol (LDL-C). ( 1 ) Alone or as an adjunct to other LDL-C lowering therapies in patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C. ( 1 )
Althera Pharmaceuticals LLC
ROUND PINK 5
5 ROUND PINK
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16 HOW SUPPLIED/STORAGE AND HANDLING ROSZET Tablets are supplied as follows: Strength (Contents) Description Container NDC 5 mg/10 mg (rosuvastatin 5 mg and ezetimibe 10 mg) round pink biconvex tablets with “5” embossed on one side Bottle of 30 tablets and two 1 g desiccants 70661-001-30 10 mg/10 mg (rosuvastatin 10 mg and ezetimibe 10 mg) round pink biconvex tablets with “AL” embossed on one side Bottle of 30 tablets and two 1 g desiccants 70661-002-30 20 mg/10 mg (rosuvastatin 20 mg and ezetimibe 10 mg) round pink biconvex tablets with “II” embossed on one side Bottle of 30 tablets and two 1 g desiccants 70661-003-30 40 mg/10 mg (rosuvastatin 40 mg and ezetimibe 10 mg) round pink biconvex tablets with “77” embossed on one side Bottle of 30 tablets and two 1 g desiccants 70661-004-30 Store at controlled room temperature (USP), 20°C to 25 ºC (68°F to 77 ºF) [see USP Controlled Room Temperature]. Store in the original container to protect from light. Protect from moisture. Once the bottle has been opened, use the tablets within 30 days. Dispense in original container to protect from moisture.
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