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:

Preferred Pharmaceuticals, Inc.

INN (International Name):

ROSUVASTATIN CALCIUM

Composition:

ROSUVASTATIN 40 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 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:    Risk Summary Rosuvastatin is contraindicated for use in pre

Product summary:

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 20                              NDC 68788-6823-2          Bottles of 30                              NDC 68788-6823-3          Bottles of 60                              NDC 68788-6823-6          Bottles of 90                              NDC 68788-6823-9  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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ROSUVASTATIN CALCIUM- ROSUVASTATIN CALCIUM TABLET, FILM COATED
PREFERRED 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 tablets are an HMG Co-A reductase inhibitor indicated
for:
•
•
•
Limitations of use (1.8): Rosuvastatin 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 RISING HEALTH, LLC AT
1-833-395-6928 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 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/ritonavir, or simeprevi