Država: Sjedinjene Američke Države
Jezik: engleski
Izvor: NLM (National Library of Medicine)
ROSUVASTATIN CALCIUM (UNII: 83MVU38M7Q) (ROSUVASTATIN - UNII:413KH5ZJ73)
Direct_Rx
ORAL
PRESCRIPTION DRUG
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. 1.3 Hypertriglyceridemia Rosuvastatin calcium tablets are indicated as adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia. 1.4 Primary Dysbetalipoproteinemia (Type III Hyperlipoproteinemia) Rosuvastatin calcium tablets are indicated as an adjunct to diet for the treatment of adult patients with primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia). 1.5 Adult Patients with Homozygous Familial Hypercholesterolemia 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. 1.8 Limitations of Use Rosuvastatin cal
Rosuvastatin Calcium Tablets 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 Blister pack of 100 (10×10) Unit dose tablets 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 Blister pack of 100 (10×10) Unit dose tablets 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 Blister pack of 100 (10×10) Unit dose tablets 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 Blister pack of 100 (10×10) Unit dose tablets Storage Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Protect from moisture.
Abbreviated New Drug Application
ROSUVASTATIN CALCIUM- ROSUVASTATIN CALCIUM TABLET, FILM COATED DIRECT_RX ---------- ROSUVASTATIN CALCIUM 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. 1.3 Hypertriglyceridemia Rosuvastatin calcium tablets are indicated as adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia. 1.4 Primary Dysbetalipoproteinemia (Type III Hyperlipoproteinemia) Rosuvastatin calcium tablets are indicated as an adjunct to diet for the treatment of adult patients with primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia). 1.5 Adult Patients with Homozygous Familial Hypercholesterolemia 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. 1.8 Limitations of Use Rosuvastatin calcium tablets have not been studied in Fredrickson Type I and V dyslipidemias. 2.1 General Dosing Information The dose range for rosuvastatin calcium tablets in adults are 5 to 40 mg orally once daily. The usual starting dose is 10 to 20 mg once daily. The usual starting dose in adult patients with homozygous familial hypercholesterolemia is 20 mg once daily. The maximum rosuvastatin calcium tablet dose of 40 mg should be used only for those patients who have not achieved their LDL-C goal utilizing the 20 mg dose [see Warnings and Precautions (5.1)]. Rosuvastatin calcium tablets can be administered as a single dose at any time of day, with or without food. The tablet should be swallowed whole. When initiating rosuvastatin calcium tablets therapy or switching from another HMG-CoA reductase inhibitor therapy, the appropriate rosuvastatin calcium tablets starting dose should first be utilized, and only the Pročitajte cijeli dokument