ROSUVASTATIN CALCIUM tablet, film coated

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

NuCare Pharmaceuticals,Inc.

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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

Dettagli prodotto:

Rosuvastatin Calcium Tablets 10 mg are available as Pink, round shaped, biconvex, film coated tablets debossed with R10 on one side and plain on other side. NDC 68071-4764-9 BOTTLES OF 90 Storage Store at controlled room temperature, 20-25ºC (68-77ºF) [see USP Controlled Room Temperature]. Protect from moisture.

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

ROSUVASTATIN CALCIUM- ROSUVASTATIN CALCIUM TABLET, FILM COATED
NUCARE PHARMACEUTICALS,INC.
----------
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 a 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 tablet 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)
Preganancy ( 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 rosuvastatin calcium tablets if signs or
sympto