ROSUVASTATIN- rosuvastatin calcium tablet, film coated

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

Rosuvastatin Calcium (UNII: 83MVU38M7Q) (Rosuvastatin - UNII:413KH5ZJ73)

Доступно од:

Apotex Corp.

INN (Међународно име):

ROSUVASTATIN CALCIUM

Састав:

ROSUVASTATIN 5 mg

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

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 tablets are indicated as adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia. Rosuvastatin tablets are indicated as an adjunct to diet for the treatment of adult patients with primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia). Rosuvastatin 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. Rosuvastatin tablets have not been studied in Fredrickson Type I and V dyslipidemias. Rosuvastatin tablets are contraindicated in the following conditions: - Patients with a known hypersensitivity to any component of t

Резиме производа:

Rosuvastatin tablets, USP are available containing 5 mg, 10 mg, 20 mg or 40 mg of rosuvastatin. 5 mg: Yellow, round, biconvex film-coated tablets. Engraved "APO" on one side, "ROS" over "5" on the other side. They are supplied as follows: Bottles of 30 (NDC 60505-4502-3) Bottles of 90 (NDC 60505-4502-9) Unit dose blisters of 100 (NDC 60505-4502-0) 10 mg: Pink, round, biconvex film-coated tablets. Engraved "APO" on one side, "ROS" over "10" on the other side. They are supplied as follows: Bottles of 30 (NDC 60505-4503-3) Bottles of 90 (NDC 60505-4503-9) Unit dose blisters of 100 (NDC 60505-4503-0) 20 mg: Pink, round, biconvex film-coated tablets. Engraved "APO" on one side, "ROS" over "20" on the other side. They are supplied as follows: Bottles of 30 (NDC 60505-4504-3) Bottles of 90 (NDC 60505-4504-9) Unit dose blisters of 100 (NDC 60505-4504-0) 40 mg: Pink, oval, biconvex film-coated tablets. Engraved "APO" on one side, "ROS40" on the other side. They are supplied as follows: Bottles of 30 (NDC 60505-4505-3) Bottles of 90 (NDC 60505-4505-9) Unit dose blisters of 100 (NDC 60505-4505-0) Storage Store at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted from 15ºC to 30ºC (59ºF to 86ºF) [see USP Controlled Room Temperature]. Protect from moisture.

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

ROSUVASTATIN- ROSUVASTATIN CALCIUM TABLET, FILM COATED
APOTEX CORP.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ROSUVASTATIN TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ROSUVASTATIN
TABLETS.
ROSUVASTATIN 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
Warnings and Precautions, Immune-Mediated Necrotizing Myopathy (5.2)
9/2020
INDICATIONS AND USAGE
Rosuvastatin tablets are 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 tablets have not been studied
in Fredrickson Type I and V dyslipidemias.
DOSAGE AND ADMINISTRATION
Rosuvastatin tablets, USP can be taken with or without food, at any
time of day. (2.1)
Dose range: 5 to 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
antiviral medicines or their combinations . Cases of myopathy and
rhabdomyolysis with acute renal failure secondary to
myoglobinuria have been reported. Advise patien