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Rosuvastatin Teva New
/ Teva Israel LTD, Israel

Drug summary

Statin. Rosuvastatin 5 mg, 10 mg, 20 mg, 40 mg.
FC tabs 30 X 5/10/20/40 mg
The recommended start dose is 5 mg or 10 mg 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. Dose adjustment to the next dose level can be made after 4 weeks.
Adlts with: Primary hypercholesterolaemia (type IIa including heterozygous familial hypercholesterolaemia) or mixed dyslipidaemia (type IIb) as an adjunct to diet when response to diet and other nonpharmacological treatments (e.g. exercise, weight reduction) is inadequate.Homozygous familial hypercholesterolaemia as an adjunct to diet and other lipid lowering treatments (e.g. LDL apheresis) or if such treatments are not appropriate.
C/I: hypersensitivity
- in patients with active liver disease including unexplained, persistent elevations of serum transaminases and any serum transaminase elevation exceeding 3 times the upper limit of normal (ULN).
- in patients with severe renal impairment (creatinine clearance <30 ml/min).
- in patients with myopathy.
- in patients receiving concomitant combination of sofosbuvir/velpatasvir/voxilaprevir
- in patients receiving concomitant ciclosporin.
- pregnancy and lactation
40 mg in pts with pre-disposing factors for myopathy/rhabdomyolysis:
- moderate renal impairment (creatinine clearance < 60 ml/min)
- hypothyroidism
- personal or family history of hereditary muscular disorders
- previous history of muscular toxicity with another HMG-CoA reductase inhibitor or fibrate
- alcohol abuse
- situations where an increase in plasma levels may occur
- Asian patients
- concomitant use of fibrates.

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Active Ingredient

Rosuvastatin 5 mg, 10 mg, 20 mg, 40 mg

Status in Israel

Presentation and Status in Health Basket

Presentation	Basket	Yarpa	Pharmasoft
Film Coated Tablets 30 x 5 mg
Film Coated Tablets 30 x 10 mg
Film Coated Tablets 30 x 20 mg
Film Coated Tablets 30 x 40 mg

Dosage

Please refer to the license holder for further details.

Indications

Treatment of adult with:
• Primary hypercholesterolaemia (type IIa including heterozygous familial hypercholesterolaemia) or mixed dyslipidaemia (type IIb) as an adjunct to diet when response to diet and other nonpharmacological treatments (e.g. exercise, weight reduction) is inadequate.
• Homozygous familial hypercholesterolaemia as an adjunct to diet and other lipid lowering treatments (e.g. LDL apheresis) or if such treatments are not appropriate.

Contra-Indications

Please refer to the license holder for further details.

Special Precautions

Please refer to the license holder for further details.

Side Effects

Please refer to the license holder for further details.

Drug interactions

Please refer to the license holder for further details.

Pregnancy and Lactation

Please refer to the license holder for further details.

Overdose

Please refer to the license holder for further details.

Manufacturer

Teva Israel Ltd

Licence holder

Teva Israel LTD, Israel