ROSUVASTATIN CALCIUM tablet, film coated

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Proficient Rx LP

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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: Risk Summary Rosuvastati

Resumen del producto:

Rosuvastatin calcium tablets are supplied as: Store at 20° to 25°C (68° to 77°F). [See USP controlled room temperature]. Protect from moisture.

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

ROSUVASTATIN CALCIUM- ROSUVASTATIN CALCIUM TABLET, FILM COATED
PROFICIENT RX LP
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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 tablets are an HMG Co‑A reductase inhibitor
indicated for:
1.
2.
3.
Limitations of use (1.8):
•
DOSAGE AND ADMINISTRATION
•
•
•
DOSAGE FORMS AND STRENGTHS
Tablets: 5 mg, 10 mg, 20 mg, and 40 mg (3)
CONTRAINDICATIONS
1.
2.
3.
4.
WARNINGS AND PRECAUTIONS
•
•
ADVERSE REACTIONS
Most frequest adverse reactions (rate ≥2%) are headache, myalgia,
abdominal pain, asthenia, and
nausea. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT BIOCON PHARMA INC. AT
1-866-924-6266
OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
•
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)
Rosuvastatin calcium tablets have not been studied in Fredrickson Type
I and V dyslipidemias.
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)
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)
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/ritona