ROSUVASTATIN tablet, film coated

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

REMEDYREPACK INC.

DCI (Dénomination commune internationale):

ROSUVASTATIN CALCIUM

Composition:

ROSUVASTATIN 20 mg

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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 any c

Descriptif du produit:

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. NDC: 70518-0986-00 NDC: 70518-0986-01 NDC: 70518-0986-02 PACKAGING: 90 in 1 BOTTLE PLASTIC PACKAGING: 30 in 1 BOX PACKAGING: 1 in 1 POUCH Storage Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Protect from moisture. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

ROSUVASTATIN- ROSUVASTATIN 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 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 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 ABN