ROSUVASTATIN CALCIUM tablet, film coated

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

Direct_Rx

administration_route:

ORAL

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

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. 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 cal

leaflet_short:

Rosuvastatin Calcium Tablets are supplied as: 5 mg: Light yellow to yellow, round, bevel edged biconvex film coated tablets debossed with 'H' on one side and 'R3' on the other side. They are supplied as follows. Bottle of 90 Tablets Blister pack of 100 (10×10) Unit dose tablets 10 mg: Light pink to pink, round, bevel edged biconvex film coated tablets debossed with 'H' on one side and 'R4' on the other side. They are supplied as follows. Bottle of 90 Tablets Blister pack of 100 (10×10) Unit dose tablets 20 mg: Light pink to pink, round, bevel edged biconvex film coated tablets debossed with 'H' on one side and 'R5' on the other side. They are supplied as follows. Bottle of 90 Tablets Blister pack of 100 (10×10) Unit dose tablets 40 mg: Light pink to pink, oval, bevel edged biconvex film coated tablets debossed with 'H' on one side and 'R6' on the other side. They are supplied as follows. Bottle of 30 Tablets Blister pack of 100 (10×10) Unit dose tablets Storage Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Protect from moisture.

authorization_status:

Abbreviated New Drug Application

SPC

ROSUVASTATIN CALCIUM- ROSUVASTATIN CALCIUM TABLET, FILM COATED
DIRECT_RX
----------
ROSUVASTATIN CALCIUM
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.
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.
2.1 General Dosing Information
The dose range for rosuvastatin calcium tablets in adults are 5 to 40
mg orally once daily. The usual
starting dose is 10 to 20 mg once daily. The usual starting dose in
adult patients with homozygous
familial hypercholesterolemia is 20 mg once daily.
The maximum rosuvastatin calcium tablet dose of 40 mg should be used
only for those patients who
have not achieved their LDL-C goal utilizing the 20 mg dose [see
Warnings and Precautions (5.1)].
Rosuvastatin calcium tablets can be administered as a single dose at
any time of day, with or without
food. The tablet should be swallowed whole.
When initiating rosuvastatin calcium tablets therapy or switching from
another HMG-CoA reductase
inhibitor therapy, the appropriate rosuvastatin calcium tablets
starting dose should first be utilized, and
only the