ROSUVASTATIN CALCIUM tablet, film coated

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

ROSUVASTATIN CALCIUM (UNII: 83MVU38M7Q) (ROSUVASTATIN - UNII:413KH5ZJ73)

Доступна с:

Bryant Ranch Prepack

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

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 is indicated as adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia. Rosuvastatin is indicated as an adjunct to diet for the treatment of adult patients with primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia). Rosuvastatin is 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. Rosuvastatin has not been studied in Fredrickson Type I and V dyslipidemias. Rosuvastatin is contraindicated in the following conditions: •           Patients with a known hypersensitivity to any component of this product. Hypersensitivity reactio

Обзор продуктов:

Rosuvastatin calcium tablets are supplied as: 10 mg:  Yellow, round, biconvex, coated tablets. Debossed as ‘CY’ on one side, and ‘10’ on other side. NDC: 71335-9640-4: 120 Tablets in a BOTTLE NDC: 71335-9640-5: 180 Tablets in a BOTTLE NDC: 71335-9640-6: 100 Tablets in a BOTTLE NDC: 71335-9640-1: 30 Tablets in a BOTTLE NDC: 71335-9640-2: 90 Tablets in a BOTTLE NDC: 71335-9640-3: 60 Tablets in a BOTTLE Storage Store at controlled room temperature, 20ºC to 25ºC (68ºF to 77ºF); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Protect from moisture. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

ROSUVASTATIN CALCIUM- ROSUVASTATIN CALCIUM TABLET, FILM COATED
BRYANT RANCH PREPACK
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ROSUVASTATIN CALCIUM
TABLETS SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR ROSUVASTATIN CALCIUM TABLETS.
ROSUVASTATIN CALCIUM TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2003
RECENT MAJOR CHANGES
Dosage and Administration, Use with Concomitant Therapy (2.4) 5/2020
Warning and Precautions, Skeletal Muscle Effects (5.1) 5/2020
Warning and Precautions, Immune-Mediated Necrotizing Myopathy (5.2)
9/2020
INDICATIONS AND USAGE
Rosuvastatin is an HMG Co-A 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 has not been studied in
Fredrickson Type I and V dyslipidemias.
DOSAGE AND ADMINISTRATION
• Rosuvastatin calcium tablets can be taken with or without food, at
any time of day. (2.1)
• Dose range: 5-40 mg once daily. Use 40 mg dose only for patients
not reaching LDL-C goal with 20 mg.
(2.1)
• Adult HoFH: Starting dose 20 mg/day (2.1)
DOSAGE FORMS AND STRENGTHS
Tablets: 5 mg, 10 mg, 20 mg, and 40 mg (3)
CONTRAINDICATIONS
• Known hypersensitivity to product components (4)
• Active liver disease, which may include unexplained persistent
elevations in hepatic transaminase levels
(4)
• Pregnancy (4, 8.1, 8.3)
• Lactation (4, 8.2)
WARNINGS AND PRECAUTIONS
• SKELETAL MUSCLE EFFECTS (E.G., MYOPATHY AND RHABDOMYOLYSIS): Risks
increase with use of 40
mg dose, advanced age (≥65), hypothyroidism, renal impairment, and
combination use with
cyclosporine, darolutamide, regorafenib, certain anti-viral medicines
or their combinations. Cases of
myopathy and rhabdomyolysis with acute renal fai