Stravas Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Rosuvastatin Ca

Indications/Uses

Primary hyperlipidemia IIa including heterozygous familial hypercholesterolemia or mixed dyslipidemia IIb that cannot be properly controlled by diet & non-pharmacological interventions (eg, exercise therapy & wt reduction). Adjuvant to dietary control & other lipid-lowering measures in HoFH.

Click to view Stravas detailed prescribing information

Dosage/Direction for Use

Usual starting dose: 5 mg once daily. Patient requiring more aggressive reduction of LDL-C Initially 10 mg once daily. Adjust to higher dose level after 4 wk of treatment if necessary. Max daily dose: 20 mg.

Click to view Stravas detailed prescribing information

Overdosage

View Stravas overdosage for action to be taken in the event of an overdose.

Administration

May be taken with or without food.

Contraindications

Hypersensitivity to rosuvastatin. Patients w/ active liver disease including patients w/ unexplained persistent elevation of serum transaminase & any elevation that exceeds 3x ULN; myopathy; those using cyclosporine. Severe renal impairment (CrCl <30 mL/min). Pregnancy & lactation. Women at risk of becoming pregnant w/o using appropriate contraception.

Click to view Stravas detailed prescribing information

Special Precautions

Proteinuria was observed in patients treated at high doses especially 40 mg. Skeletal muscle effects eg, myalgia, myopathy, rhabdomyolysis (rare) especially at doses >20 mg. Increases creatinine kinase. Caution in heavy alcohol consumption &/or history of liver disease. Interstitial pulmonary disease (rare). Elevated fasting serum glucose levels. Galactose intolerance, lactase deficiency or malabsorption of glucose-galactose.

Click to view Stravas detailed prescribing information

Use In Pregnancy & Lactation

Click to view Stravas detailed prescribing information

Adverse Reactions

Proteinuria, hematuria; myalgia, myopathy & rare rhabdomyolysis; dose-dependent elevation of transaminase; sexual dysfunction, interstitial pulmonary disease especially those receiving long-term treatment. Hyperglycemia, abnormal glucose tolerance, elevated glycosylated Hb level, new onset diabetes & deterioration of blood glucose control; cognitive impairment manifested as memory loss/decline, thinking confusion (mostly non-serious & reversible).

Click to view Stravas detailed prescribing information

Drug Interactions

May result in elevated plasma conc & increased risk of myopathy including rhabdomyolysis in concomitant use w/ transporter inhibitors. Higher AUC w/ cyclosporine; ezetimibe. Increase rosuvastatin exposure in concurrent use of PIs. Increased in C_max & AUC w/ gemfibrozil & other lipid-lowering products, erythromycin; increase risk of myopathy w/ fenofibrate, HMG-CoA reductase inhibitors; colchicine.

Click to view Stravas detailed prescribing information

Storage

View Stravas storage conditions for details to ensure optimal shelf-life.

Description

View Stravas description for details of the chemical structure and excipients (inactive components).

Action

View Stravas mechanism of action for pharmacodynamics and pharmacokinetics details.

MIMS Class

Dyslipidaemic Agents

ATC Classification

C10AA07 - rosuvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.

Regulatory Classification

Presentation/Packing

Form

Stravas FC tab 10 mg

Packing/Price

30's

Stravas

rosuvastatin

Manufacturer:

Zhejiang Jingxin

Distributor:

Trumed