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Roschlotin

Roschlotin

rosuvastatin

Manufacturer:

Curis Lifesciences

Distributor:

Philgen

Marketer:

Philgen
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
Indications/Uses
Primary hypercholesterolemia (type IIa including heterozygous familial hypercholesterolemia) or mixed dyslipidemia (type IIb) as an adjunct to diet when response to diet & other non-pharmacological treatments (eg, exercise, wt reduction) is inadequate in adults, adolescents & childn ≥10 yr. Homozygous familial hypercholesterolemia as an adjunct to diet & other lipid lowering treatments (eg, LDL apheresis) or if such treatments are not appropriate. Prevention of major CV events in patients who are estimated to have high risk for 1st CV event, as an adjunct to correction of other risk factors.
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Dosage/Direction for Use
Individualized dose. Treatment of hypercholesterolemia Statin naïve patient or patient switched from another HMG-CoA reductase inhibitor Initially 5 or 10 mg once daily, adjust dose to the next dose level after 4 wk, if necessary. Prevention of CV event Initially 20 mg daily.
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Overdosage
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Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Myopathy. Concomitant ciclosporin. Active liver disease including unexplained, persistent elevations of serum transaminases & any serum transaminase elevation exceeding 3 times ULN. Severe renal impairment (CrCl <30 mL/min). Women of childbearing potential not using appropriate contraceptive measures. Pregnancy & lactation.
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Special Precautions
Discontinue use if myopathy is diagnosed or suspected. Advise patient to promptly report any unexplained &/or persistent muscle pain, tenderness, or weakness. Increased risk of skeletal muscle effects (eg, myopathy & rhabdomyolysis) when higher doses are used concomitantly w/ cyclosporine & strong CYP3A4 inhibitors (eg, clarithromycin, itraconazole, HIV or HCV PIs). Report of rare cases of rhabdomyolysis w/ acute renal failure secondary to myoglobinuria. Carry out confirmatory test w/in 5-7 days if creatine kinase (CK) levels are significantly elevated at baseline (>5 times ULN); do not start treatment if repeat test confirms a baseline CK >5 times ULN. Persistent elevations in hepatic transaminases can occur. Check liver enzyme tests before initiating therapy & as clinically indicated thereafter.
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Use In Pregnancy & Lactation
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Adverse Reactions
DM; headache, dizziness; constipation, nausea, abdominal pain; myalgia; asthenia.
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Drug Interactions
Concomitant administration w/ certain transporter protein (including OATP1B1 & BCRP) inhibitors may result in increased rosuvastatin plasma conc & increased risk of myopathy. Increased AUC w/ ciclosporin. Exposure may be strongly increased w/ PIs. Increased risk of myopathy w/ gemfibrozil, fenofibrate, other fibrates & lipid-lowering doses (≥1 g/day) of niacin. Initiation of rosuvastatin treatment or dosage up-titration in patients treated concomitantly w/ vit K antagonists (eg, warfarin or another coumarin anticoagulant) may result in increase in INR; discontinuation or down-titration of rosuvastatin may result in decrease in INR. Reports of muscle-related events, including rhabdomyolysis, w/ fusidic acid.
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Storage
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Description
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Action
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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
Rx
Presentation/Packing
Form
Roschlotin FC tab 20 mg
Packing/Price
100's
Form
Roschlotin FC tab 40 mg
Packing/Price
100's