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:

REMEDYREPACK INC.

Designación común internacional (DCI):

ROSUVASTATIN CALCIUM

Composición:

ROSUVASTATIN 20 mg

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

Resumen del producto:

Rosuvastatin Tablets USP 5 mg are pink, oval shaped, biconvex film-coated tablets debossed with ‘I’ on one side and ‘29’ on the other side.          Bottles of 30                              NDC 57237-168-30          Bottles of 90                              NDC 57237-168-90          Bottles of 500                             NDC 57237-168-05          Bottles of 1,000                          NDC 57237-168-99           Rosuvastatin Tablets USP 10 mg are pink, round, biconvex film-coated tablets debossed with ‘I’ on one side and ‘30’ on the other side.          Bottles of 30                              NDC 57237-169-30             Bottles of 90                              NDC 57237-169-90          Bottles of 500                             NDC 57237-169-05          Bottles of 1,000                          NDC 57237-169-99 Rosuvastatin Tablets USP  20 mg are pink, round, biconvex film-coated tablets debossed with ‘I’ on one side and ‘31’ on the other side.          Bottles of 30                              NDC 57237-170-30          Bottles of 90                              NDC 57237-170-90          Bottles of 500                             NDC 57237-170-05          Bottles of 1,000                          NDC 57237-170-99        Rosuvastatin Tablets USP  40 mg are pink, oval shaped, biconvex film-coated tablets debossed with ‘I’ on one side and ‘32’ on the other side.             Bottles of 30                              NDC 57237-171-30          Bottles of 90                              NDC 57237-171-90          Bottles of 500                             NDC 57237-171-05          Bottles of 1,000                          NDC 57237-171-99 Storage Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°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
REMEDYREPACK INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ROSUVASTATIN TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ROSUVASTATIN
TABLETS.
ROSUVASTATIN TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2003
INDICATIONS AND USAGE
Rosuvastatin tablets are 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 tablets have not been studied
in Fredrickson Type I and V dyslipidemias.
DOSAGE AND ADMINISTRATION
Rosuvastatin 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
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)
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 rosuvastatin if
signs or symptoms appear. (5.1, 7.5, 7.6)
LIVER ENZYME ABNORMALITIES: Persistent elevations i