Rozuor Dosage/Direction for Use

Rosuvastatin/ezetimibe (Rozuor) is indicated in adult patients whose hypercholesterolemia is adequately controlled with separately administered monocomponent preparations of the same doses as the recommended combination.
The patient should be on an appropriate lipid-lowering diet and should continue on this diet during treatment with rosuvastatin/ezetimibe (Rozuor).
The recommended daily dose is one capsule of the given strength with or without food.
Rosuvastatin/ezetimibe (Rozuor) is not suitable for initial therapy. Treatment initiation or dose adjustment if necessary should only be done with the monocomponents and after setting the appropriate doses the switch to the fixed dose combination of the appropriate strength is possible.
Rosuvastatin/ezetimibe (Rozuor) 10 mg/10 mg and 20 mg/10 mg hard capsules are not suitable for the treatment of patients requiring 40 mg dose of rosuvastatin.
Rosuvastatin/ezetimibe (Rozuor) should be taken either ≥2 hours before or ≥4 hours after administration of a bile acid sequestrant.
Pediatric population: The safety and efficacy of rosuvastatin/ezetimibe (Rozuor) in children below the age of 18 years have not yet been established. Currently available data are described in Adverse Reactions and Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions but no recommendation on a posology can be made.
Elderly: A start dose of 5 mg rosuvastatin is recommended in patients >70 years. The combination is not suitable for initial therapy. Treatment initiation or dose adjustment if necessary should only be done with the monocomponents and after setting the appropriate doses the switch to the fixed dose combination of the appropriate strength is possible.
Dosage in patients with renal impairment: No dose adjustment is necessary in patients with mild to moderate renal impairment.
The recommended start dose is rosuvastatin 5 mg in patients with moderate renal impairment (creatinine clearance <60 ml/min). The fixed dose combination is not suitable for initial therapy. Monocomponent preparations should be used to start the treatment or to modify the dose.
The use of rosuvastatin in patients with severe renal impairment is contraindicated for all doses.
Dosage in patients with hepatic impairment: No dosage adjustment is required in patients with mild hepatic impairment (Child Pugh score 5 to 6). Treatment with Rosuvastatin/ezetimibe (Rozuor) is not recommended in patients with moderate (Child Pugh score 7 to 9) or severe (Child Pugh score >9) liver dysfunction. Rosuvastatin/ezetimibe (Rozuor) is contraindicated in patients with active liver disease.
Race: Increased systemic exposure of rosuvastatin has been seen in Asian subjects. The recommended start dose is rosuvastatin 5 mg for patients of Asian ancestry. The fixed dose combination is not suitable for initial therapy. Monocomponent preparations should be used to start the treatment or to modify the dose.
Genetic polymorphisms: Specific types of genetic polymorphisms are known that can lead to increased rosuvastatin exposure. For patients who are known to have such specific types of polymorphisms, a lower daily dose of Rosuvastatin/ezetimibe (Rozuor) is recommended.
Dosage in patients with pre-disposing factors to myopathy: The recommended start dose is rosuvastatin 5 mg in patients with predisposing factors to myopathy. The fixed dose combination is not suitable for initial therapy. Monocomponent preparations should be used to start the treatment or to modify the dose.
Concomitant therapy: Rosuvastatin is a substrate of various transporter proteins (e.g. OATP1B1 and BCRP). The risk of myopathy (including rhabdomyolysis) is increased when Rosuvastatin/ezetimibe (Rozuor) are administered concomitantly with certain medicinal products that may increase the plasma concentration of rosuvastatin due to interactions with these transporter proteins (e.g. cyclosporine and certain protease inhibitors including combinations of ritonavir with atazanavir, lopinavir, and/or tipranavir). Whenever possible, alternative medications should be considered, and, if necessary, consider temporarily discontinuing Rosuvastatin/ezetimibe (Rozuor) therapy. In situations where co-administration of these medicinal products with Rosuvastatin/ezetimibe (Rozuor) is unavoidable, the benefit and the risk of concurrent treatment and rosuvastatin dosing adjustments should be carefully considered.
Method of administration: For oral use.
Rosuvastatin/ezetimibe (Rozuor) should be taken each day once at the same time of the day with or without food. The capsule should be swallowed whole with a drink of water.