RiteMed Rosuvastatin

RiteMed Rosuvastatin Dosage/Direction for Use

rosuvastatin

Manufacturer:

Lek Pharma

Distributor:

RiteMED
Full Prescribing Info
Dosage/Direction for Use
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 naive 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 (see as follows). 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 the 40 mg dose is initiated.
Pediatric population: Pediatric use should only be carried out by specialists.
Children and adolescents 10 to 17 years of age (boys Tanner Stage II and above, and girls who are at least 1 year post-menarche): In children and adolescents with hypercholesterolemia the usual start dose is 5 mg daily. The usual dose range is 5-20 mg orally once daily. Titration should be conducted according to the individual response and tolerability in pediatric patients, as recommended by the pediatric 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. Safety and efficacy of doses greater than 20 mg have not been studied in this population.
The 40 mg tablet is not suitable for use in pediatric patients.
Children younger than 10 years: Experience in children younger than 10 years is limited to a small number of children (aged between 8 and 10 years) with homozygous familial hypercholesterolemia. Therefore, rosuvastatin is not recommended for use in children younger than 10 years.
Use in the elderly: A start dose of 5 mg is recommended in patients >70 years (see Precautions). No other dose adjustment 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 Pharmacology: Pharmacokinetics under Actions and Contraindications).
Dosage 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 Pharmacology: Pharmacokinetics under Actions and Precautions). The recommended start dose is 5 mg for patients of Asian ancestry. The 40 mg dose is contraindicated in these patients.
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).
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