Rosuzet Dosage/Direction for Use

General: The patient should be on an appropriate lipid-lowering diet and should continue on this diet during treatment with Ezetimibe + Rosuvastatin (ROSUZET). The dosage should be individualized according to the baseline LDL-C level, the recommended goal of therapy, and the patient's response. Ezetimibe + Rosuvastatin (ROSUZET) can be administered as a single dose at any time of the day, with or without food.
Adults: Primary Hypercholesterolemia: The usual start dose is 10/10 mg once daily. A 10/5 mg start dose is available for special populations if needed. For patients with severe hypercholesterolemia (including heterozygous familial hypercholesterolaemia) or those with aggressive lipid targets, a start dose of 10/20 mg may be considered. Not all strengths are available locally.
Homozygous Familial Hypercholesterolemia: For patients with homozygous familial hypercholesterolemia a start dose of 10/20 mg once a day is recommended. Not all strengths are available locally.
Use in Pediatric Patients: Treatment with Ezetimibe + Rosuvastatin (ROSUZET) is not recommended.
Use in the Elderly: No dosage adjustment is required for elderly patients.
Use in Patients with Renal Insufficiency: No dosage adjustment is required for patients with mild to moderate renal impairment. For patients with severe renal impairment (CLcr<30 mL/min/1.73 m²) not on hemodialysis, the dose of Ezetimibe + Rosuvastatin (ROSUZET) should be started at 10/5 mg once daily and not exceed 10/10 mg once daily [see PHARMACOLOGY: Pharmacokinetics under Actions].
Use in Patients with Hepatic Insufficiency: No dosage adjustment is required for patients with mild hepatic impairment (Child-Pugh score 5 to 6). Treatment with Ezetimibe + Rosuvastatin (ROSUZET) is not recommended in patients with moderate (Child-Pugh score 7 to 9) or severe (Child-Pugh score >9) liver dysfunction [see PHARMACOLOGY: Pharmacokinetics under Actions].
Coadministration with Bile Acid Sequestrants: Dosing of Ezetimibe + Rosuvastatin (ROSUZET) should occur either ≥ 2 hours before or ≥ 4 hours after administration of a bile acid sequestrant.
Concomitant Therapy: Rosuvastatin is a substrate of various transporter proteins (e.g. OATP1 B1 and BCRP). The risk of myopathy (including, rhabdomyolysis) is increased when Ezetimibe + Rosuvastatin (ROSUZET) is administered concomitantly with certain medicinal products that may increase the plasma concentration of rosuvastatin due to interactions with these transporter proteins (e.g. ciclosporin and certain protease inhibitors including combinations of ritonavir with atazanavir, lopinavir, and/or tipranavir. It is recommended that prescribers consult the relevant product information when considering administration of such products together with Ezetimibe + Rosuvastatin (ROSUZET). Whenever possible, alternative medications should be considered, and if necessary, consider temporarily discontinuing Ezetimibe + Rosuvastatin (ROSUZET) therapy. In situations where co-administration of these "medicinal products with Ezetimibe + Rosuvastatin (ROSUZET) is unavoidable, the benefit and the risk of concurrent treatment and Ezetimibe + Rosuvastatin (ROSUZET) dosing adjustments should be carefully considered [see PRECAUTIONS and INTERACTIONS].
Race: A 10/5 mg starting dose of Ezetimibe + Rosuvastatin (ROSUZET) should be considered for Asian patients. Increased plasma concentration of rosuvastatin has been seen in Asian subjects [see Race under PRECAUTIONS and PHARMACOLOGY: Pharmacokinetics under Actions]. The increased systemic exposure should be taken into consideration when treating Asian patients whose hypercholesterolaemia is not adequately controlled at doses up to 10/20 mg/day.
Genetic polymorphisms: Genotypes of SLCO1 B1 (OATP1 B1) c.521CC and ABCG2 (BCRP) c.421 AA have been shown to be associated with an increase in rosuvastatin exposure (AUC) compared to SLCO1 B1 c.521 TT and ABCG2 c.421 CC. For patients known to have the c.521 CC or c.421 AA genotype, a maximum once daily dose of 10/20 mg of Ezetimibe + Rosuvastatin (ROSUZET) is recommended (see Rosuvastatin under INTERACTIONS and PHARMACOLOGY: Pharmacokinetics under Actions).