ROSUVASTATIN CALCIUM- rosuvastatin calcium tablet, film coated

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Jubilant Cadista Pharmaceuticals Inc.

INN (International Nazwa):

ROSUVASTATIN CALCIUM

Skład:

ROSUVASTATIN 5 mg

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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

Podsumowanie produktu:

Rosuvastatin calcium tablets are supplied as: 5 mg: Yellow colored, round, biconvex tablet, debossed with ‘W’ on one side and ‘C’ on the other side. Bottle of 30’s with child-resistant closure            NDC 59746-428-30       Bottle of 90’s with child-resistant closure            NDC 59746-428-90       Bottle of 100’s with child-resistant closure          NDC 59746-428-01       Bottle of 1000’s                                                   NDC 59746-428-10 10 mg: Pink colored, round, biconvex tablet, debossed with ‘X’ on one side and ‘C’ on the other side. Bottle of 30’s with child-resistant closure            NDC 59746-429-30       Bottle of 90’s with child-resistant closure            NDC 59746-429-90       Bottle of 100’s with child-resistant closure          NDC 59746-429-01       Bottle of 1000’s                                                   NDC 59746-429-10 20 mg: Pink colored, round, biconvex tablet, debossed with ‘I1’ on one side and ‘C’ on the other side. Bottle of 30’s with child-resistant closure            NDC 59746-430-30       Bottle of 90’s with child-resistant closure            NDC 59746-430-90       Bottle of 100’s with child-resistant closure          NDC 59746-430-01       Bottle of 1000’s                                                   NDC 59746-430-10 40 mg: Pink colored, oval shaped, biconvex tablet, debossed with ‘I2’ on one side and ‘C’ on the other side. Bottle of 30’s with child-resistant closure            NDC 59746-431-30       Bottle of 90’s with child-resistant closure            NDC 59746-431-90       Bottle of 100’s with child-resistant closure          NDC 59746-431-01       Bottle of 1000’s                                                   NDC 59746-431-10 Storage Store at 20° to 25°C (68° to 77°F); [See USP Controlled Room Temperature]. Protect from moisture.

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

ROSUVASTATIN CALCIUM - ROSUVASTATIN CALCIUM TABLET, FILM COATED
JUBILANT CADISTA PHARMACEUTICALS INC.
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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
INDICATIONS AND USAGE
Rosuvastatin calcium 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 calcium has not been studied in
Fredrickson Type I and V dyslipidemias.
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Tablets: 5 mg, 10 mg, 20 mg, and 40 mg (3) (3)
CONTRAINDICATIONS
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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, atazanavir/ritonavir,
lopinavir/ritonavir, or simeprevir. Cases of myopathy and
rhabdomyolysis with acute renal failure secondary to
myoglobinuria have been reported. Advise patients to promptly report
to their physician unexplained and/or persistent
muscle pain, tenderness, or weakness and discontinue rosuvastatin
calcium if signs or symptoms appear. (5.1, 7.5, 7.6)
LIVER ENZYME ABNORMALITIES: Persistent elevations in hepatic
transaminases can occur. Perform liver enzyme tests
before initiating therapy and as clinically indicated thereafter.
(5.2)
ADVERSE REACTIONS
Most frequent adverse reactions (rate ≥ 2%) are headache, myalgia,
abdominal pain, asthenia, and nausea. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT JUBILANT CADISTA
PHARMACEUTICALS INC. AT 1-800-3