ROSUVASTATIN tablet, film coated

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Quality Care Products, LLC

INN (Jina la Kimataifa):

ROSUVASTATIN CALCIUM

Tungo:

ROSUVASTATIN 10 mg

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

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 tablets are contraindicated in the following conditions: •Patients with a known h

Bidhaa muhtasari:

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. 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. 55700-574-30 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. 55700-575-30 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. Storage Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Protect from moisture.

Idhini hali ya:

Abbreviated New Drug Application

Tabia za bidhaa

ROSUVASTATIN- ROSUVASTATIN TABLET, FILM COATED
QUALITY CARE PRODUCTS, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
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 tablet 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 tablets have 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 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
Tab let s: 5 m g, 10 m g, 20 m g, a nd 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,
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