Arvast 10/Arvast 20

Arvast 10/Arvast 20

rosuvastatin

Manufacturer:

Accord Healthcare

Distributor:

DKSH
Concise Prescribing Info
Contents
Rosuvastatin Ca
Indications/Uses
Treatment of adults, adolescents & childn ≥10 yr w/ primary hypercholesterolaemia (type IIa including heterozygous familial hypercholesterolaemia) or mixed dyslipidaemia (type IIb) as adjunct to diet when response to diet & other non-pharmacological treatments is inadequate. Homozygous familial hypercholesterolaemia as adjunct to diet & other lipid lowering treatments (eg, LDL apheresis). Prevention of major CV events.
Dosage/Direction for Use
Treatment of hypercholesterolaemia Statin naive & patient switched from another HMG CoA reductase inhibitor Initially 5 or 10 mg once daily. May adjust dose to next level after 4 wk. Max dose of 40 mg should only be considered in patients w/ severe hypercholesterolaemia at high CV risk (particularly those w/ familial hypercholesterolaemia), who do not achieve the treatment goal on 20 mg & whom routine follow-up will be performed. Prevention of CV events 20 mg once daily. Childn & adolescent w/ heterozygous familial hypercholesterolaemia Initially 5 mg daily. Usual dose range: 5-20 mg once daily. Elderly >70 yr, Asian, patient w/ predisposing factors to myopathy, moderate renal impairment (CrCl <60 mL/min) 5 mg.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Patients w/ active liver disease including unexplained, persistent elevations of serum transaminases & any serum transaminase elevation exceeding 3 x the ULN; myopathy; receiving concomitant ciclosporin; severe renal impairment (CrCl <30 mL/min). Women of childbearing potential, pregnancy & lactation.
Special Precautions
Proteinuria in higher doses particularly 40 mg. Effects on skeletal muscle eg, myalgia, myopathy & rhabdomyolysis. Patients w/ pre-disposing factors for myopathy/rhabdomyolysis: Renal impairment, hypothyroidism, personal or family history of hereditary muscular disorders, previous history of muscular toxicity w/ another H MG-CoA reductase inhibitor or fibrate, alcohol abuse, age >70 yr, situations where an increase in plasma levels may occur, concomitant use of fibrates. If creatinine kinase levels are significantly elevated at baseline (>5 x ULN) treatment should not be started. Not recommended in concomitant w/ fibric acid derivatives including gemfibrozil, ciclosporin, nicotinic acid, azole antifungals, protease inhibitors & macrolides. Do not use in any patient w/ acute, serious condition suggestive of myopathy or predisposing to the development of renal failure secondary to rhabdomyolysis (eg, sepsis, hypotension, major surgery, trauma, severe metabolic, endocrine & electrolyte disorders; or uncontrolled seizures). Patients who consume excessive quantities of alcohol &/or have a history of liver disease; secondary hypercholesterolaemia caused by hypothyroidism or nephrotic syndrome. Increased exposure in Asian patients. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Interstitial lung disease w/ long-term therapy. Patients at risk (fasting glucose 5.6-6.9 mmol/L, BMI >30 kg/m2, raised triglycerides, HTN). Childn <10 yr.
Adverse Reactions
DM, headache, dizziness, constipation, nausea, abdominal pain, myalgia, asthenia.
Drug Interactions
Increased risk of myopathy w/ transporter protein inhibitors including hepatic uptake transporter OATP1B1 & efflux transporter BCRP. Contraindicated in concomitant w/ ciclosporin. Increased exposure w/ protease inhibitors. Increased Cmax & AUC w/ gemfibrozil & other lipid-lowering products. Increased AUC w/ ezetimibe. Decreased plasma conc w/ antacid. Decreased AUC & Cmax w/ erythromycin. Increased INR w/ vit K antagonists (eg, warfarin or other coumarin anticoagulant). May increase AUC of ethinyl estradiol & norgestrel.
ATC Classification
C10AA07 - rosuvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
Presentation/Packing
Form
Arvast 20 FC tab 20 mg
Packing/Price
30's
Form
Arvast 10 FC tab 10 mg
Packing/Price
30's
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