ROSUVASTATIN CALCIUM- rosuvastatin calcium tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Mylan Pharmaceuticals Inc.

INN (International Name):

ROSUVASTATIN CALCIUM

Composition:

ROSUVASTATIN 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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: Rosuvastatin calcium tab

Product summary:

Rosuvastatin Calcium Tablets are available containing rosuvastatin calcium equivalent to 5 mg, 10 mg, 20 mg or 40 mg of rosuvastatin. The 5 mg tablets are beige, film-coated, round, unscored tablets debossed with M on one side of the tablet and U1 on the other side. They are available as follows: NDC 0378-2201-77 bottles of 90 tablets The 10 mg tablets are orange, film-coated, round, unscored tablets debossed with M on one side of the tablet and U2 on the other side. They are available as follows: NDC 0378-2203-77 bottles of 90 tablets The 20 mg tablets are orange, film-coated, round, unscored tablets debossed with M on one side of the tablet and U3 on the other side. They are available as follows: NDC 0378-2204-77 bottles of 90 tablets The 40 mg tablets are orange, film-coated, round, unscored tablets debossed with M on one side of the tablet and U32 on the other side. They are available as follows: NDC 0378-2232-93 bottles of 30 tablets Storage: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ROSUVASTATIN CALCIUM- ROSUVASTATIN CALCIUM TABLET, FILM COATED
MYLAN 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 tablets are an HMG-CoA reductase inhibitor
indicated for:
•
•
•
Limitations of use (1.8): Rosuvastatin calcium tablets have not been
studied in Fredrickson Type I and V dyslipidemias.
DOSAGE AND ADMINISTRATION
•
•
•
DOSAGE FORMS AND STRENGTHS
Tablets: 5 mg, 10 mg, 20 mg, and 40 mg (3)
CONTRAINDICATIONS
•
•
•
•
WARNINGS AND PRECAUTIONS
•
•
ADVERSE REACTIONS
Most frequent adverse reactions (rate ≥ 2%) are headache, myalgia,
abdominal pain, asthenia, and nausea. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT MYLAN PHARMACEUTICALS
INC. AT 1-877-446-3679 (1-877-
4-INFO-RX) 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 can be taken with or without food, at any
time of day. (2.1)
Dose range: 5-40 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 cyclos