ROSUVASTATIN CALCIUM tablet, film coated

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

H. J. Harkins Company Inc.

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

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

Produktu pārskats:

Rosuvastatin calcium tablets are supplied as: Bottle of 30 tablets NDC 76519-1153-03 Storage Store at 20ºC to 25ºC (68ºF to 77ºF) [see USP Controlled Room Temperature]. Protect from moisture.

Autorizācija statuss:

Abbreviated New Drug Application

Lietošanas instrukcija

H. J. Harkins Company Inc.
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MEDICATION GUIDE
Rosuvastatin Calcium Tablets
(roe SOO” va STAT’ in KAL” see um)
Read this Patient Information carefully before you start taking
rosuvastatin calcium tablets and each time
you get a refill. If you have any questions about rosuvastatin calcium
tablets, ask your doctor. Only your
doctor can determine if rosuvastatin calcium tablets are right for
you.
What are rosuvastatin calcium tablets?
Rosuvastatin calcium tablets are prescription medicines that contains
a cholesterol-lowering medicine
called rosuvastatin calcium. Most of the cholesterol in your blood is
made in the liver. Rosuvastatin
calcium tablets works by reducing cholesterol in two ways:
rosuvastatin blocks an enzyme in the liver
causing the liver to make less cholesterol, and rosuvastatin increases
the uptake and breakdown by the
liver of cholesterol already in the blood.
Rosuvastatin calcium tablets are used along with diet to:
• lower the level of your “bad” cholesterol (LDL)
• increase the level of your “good” cholesterol (HDL)
• lower the level of fat in your blood (triglycerides)
Rosuvastatin calcium tablets are used to treat:
• adults who cannot control their cholesterol levels by diet and
exercise alone
It is not known if rosuvastatin calcium tablets are safe and effective
in people who have Fredrickson Type
I and V dyslipidemias.
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.
Who should not take rosuvastatin calcium tablets?
Do not take rosuvastatin calcium tablets if you:
• are allergic to rosuvastatin calcium or any of the ingredients in
rosuvastatin calcium tablets. See the end
of this leaflet for a complete list of ingredients in rosuvastatin
calcium tablets.
• have liver problems.
• are pregnant or think you may be pregnant, or are planning to
become pr

Produkta apraksts

ROSUVASTATIN CALCIUM- ROSUVASTATIN CALCIUM TABLET, FILM COATED
H. J. HARKINS COMPANY INC.
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1153 ROSUVASTATIN CALCIUM 40MG
INDICATIONS & 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.
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.
DOSAGE AND ADMINISTRATION
2.1 General Dosing Information
The dose range for rosuvastatin calcium tablet in adults is 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 therapy or switching from another HMG CoA
reductase inhibitor therapy,
the appropriate rosuvastatin calcium tabl