ROSUVASTATIN tablet, film coated

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Camber Pharmaceuticals, Inc.

INN (mednarodno ime):

ROSUVASTATIN CALCIUM

Sestava:

ROSUVASTATIN 5 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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 component of t

Povzetek izdelek:

Rosuvastatin Tablets USP 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. Bottle of 90 Tablets                                                                            NDC 31722-882-90 Blister pack of 100 (10×10) Unit dose tablets                               NDC 31722-882-31 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. Bottle of 90 Tablets                                                                            NDC 31722-883-90 Blister pack of 100 (10×10) Unit dose tablets                               NDC 31722-883-31 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. Bottle of 90 Tablets                                                                            NDC 31722-884-90 Blister pack of 100 (10×10) Unit dose tablets                               NDC 31722-884-31 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. Bottle of 30 Tablets                                                                            NDC 31722-885-30 Blister pack of 100 (10×10) Unit dose tablets                               NDC 31722-885-31 Storage Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Protect from moisture.

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

ROSUVASTATIN - ROSUVASTATIN TABLET, FILM COATED
CAMBER PHARMACEUTICALS, 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 ABNOR