Robestar

Robestar Dosage/Direction for Use

rosuvastatin

Manufacturer:

Lek Pharma

Distributor:

Sandoz
Full Prescribing Info
Dosage/Direction for Use
Dosage: Before treatment initiation the patient should be placed on a standard cholesterol-lowering diet that should continue during treatment. The dose should be individualized according to the goal of therapy and patient response, using current consensus guidelines.
Rosuvastatin may be given at any time of day, with or without food.
Treatment of Hypercholesterolemia: The recommended start dose is 5 or 10 mg orally once daily in both statin naïve or patients switched from another HMG CoA reductase inhibitor. The choice of start dose should take into account the individual patient's cholesterol level and future cardiovascular risk as well as the potential risk for adverse reactions. A dose adjustment to the next dose level can be made after 4 weeks, if necessary (see Pharmacology: Pharmacodynamics under Actions).
In light of the increased reporting rate of adverse reactions with the 40 mg dose compared to lower doses (see Adverse Reactions), a final titration to the maximum dose of 40 mg should only be considered in patients with severe hypercholesterolemia at high cardiovascular risk (in particular those with familial hypercholesterolemia), who do not achieve their treatment goal on 20 mg, and in whom routine follow-up will be performed (see Precautions).
Specialist supervision is recommended when 40 mg dose is initiated.
Prevention of cardiovascular events: In the cardiovascular events risk reduction study, the dose used was 20 mg daily (see Pharmacology: Pharmacodynamics under Actions).
Pediatric Population: Pediatric use should only be carried out by specialists.
Children and adolescents 6 to 17 years of age (Tanner Stage <II-V): In children and adolescents with heterozygous familial hypercholesterolaemia, the usual start dose is 5 mg daily.
In children 6 to 9 years of age with heterozygous familial hypercholesterolaemia, the usual dose range is 5-10 mg orally once daily. Safety and efficacy of doses greater than 10 mg have not been studied in this population.
In children 10 to 17 years of age with heterozygous familial hypercholesterolaemia, the usual dose range is 5-20 mg orally once daily. Safety and efficacy of doses greater than 20 mg have not been studied in this population.
Titration should be conducted according to the individual response and tolerability in paediatric patients, as recommended by the paediatric treatment recommendations (see Precautions).
Children and adolescents should be placed on standard cholesterol-lowering diet before rosuvastatin treatment initiation; this diet should be continued during rosuvastatin treatment.
Experience in children with homozygous familial hypercholesterolaemia is limited to a small number of children aged between 8 and 17 years.
The 40 mg tablet is not suitable for use in paediatric patients.
Children younger than 6 years: The safety and efficacy of use in children younger than 6 years has not been studied. Therefore, rosuvastatin is not recommended for use in children younger than 6 years.
Use in the Elderly: A start dose of 5 mg is recommended in patients >70 years (see Precautions). No other dose adjustments is necessary in relation to age.
Dosage in Patients with Renal Insufficiency: No dose adjustment is necessary in patients with mild to moderate renal impairment.
The recommended start dose is 5 mg in patients with moderate renal impairment (creatinine clearance <60 mL/min). The 40 mg dose is contraindicated in patients with moderate renal impairment. The use of rosuvastatin in patients with severe renal impairment is contraindicated for all doses (see Contraindications and Pharmacology: Pharmacokinetics under Actions).
Dose in Patients with Hepatic Impairment: There was no increase in systemic exposure to rosuvastatin in subjects with Child-Pugh scores of 7 or below. However, increased systemic exposure has been observed in subjects with Child-Pugh scores of 8 and 9 (see Pharmacology: Pharmacokinetics under Actions). In these patients an assessment of renal function should be considered (see Precautions). There is no experience in subjects with Child-Pugh scores above 9. Rosuvastatin is contraindicated in patients with active liver disease (see Contraindications).
Race: Increased systemic exposure has been seen in Asian subjects (see Contraindications, Precautions and Pharmacology: Pharmacokinetics under Actions). The recommended start dose is 5 mg for patients of Asian ancestry. The 40 mg dose is contraindicated in these patients.
Genetic polymorphisms: Specific types of genetic polymorphisms are known that can lead to increased rosuvastatin exposure (see Pharmacology: Pharmacokinetics under Actions). For patients who are known to have such specific types of polymorphisms, a lower daily dose of rosuvastatin is recommended.
Dosage in Patients with Predisposing Factors to Myopathy: The recommended start dose is 5 mg in patients with predisposing factors to myopathy (see Precautions).
The 40 mg dose is contraindicated in some of these patients (see Contraindications).
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 rosuvastatin 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; see Precautions and Interactions). Whenever possible, alternative medications should be considered, and, if necessary, consider temporarily discontinuing rosuvastatin therapy. In situations where co-administration of these medicinal products with rosuvastatin is unavoidable, the benefit and the risk of concurrent treatment and rosuvastatin dosing adjustments should be carefully considered (see Interactions).
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