Varostin

Varostin

rosuvastatin

Manufacturer:

Sapphire Lifesciences

Distributor:

ECE Pharma

Marketer:

Nelpa Lifesciences
Concise Prescribing Info
Contents
Rosuvastatin Ca
Indications/Uses
Adjunct to diet when response to diet & other non-pharmacological treatments (eg, exercise, wt reduction) is inadequate in adults, adolescent & childn ≥10 yr w/ primary hypercholesterolemia (type II A including heterozygous familial hypercholesterolemia) or mixed dyslipidemia (type II B). Adjunct to diet & other lipid-lowering treatments (eg, LDL apheresis) or if such treatment is inappropriate in HoFH. Prevention of major CV events in patients estimated to have a high risk for a 1st CV event as adjunct to correction of other risk factors.
Dosage/Direction for Use
Atherosclerosis Adult 5-40 mg once daily. Heterozygous familial hypercholesterolemia Adult 5-40 mg once daily. Childn 10-17 yr 5-20 mg daily, 8-9 yr 5-10 mg daily. HoFH Adult Initially 20 mg once daily, may be adjusted as needed. Childn 7-17 yr 20 mg once daily.
Administration
Should be taken with 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. Concomitant use w/ cyclosporin. Severe renal impairment (CrCl <30 mL/min). Women of childbearing potential not using appropriate contraception. Pregnancy & lactation.
Special Precautions
Discontinue use if ILD is suspected to have developed. Proteinuria. Skeletal muscle effects eg, myalgia, myopathy & rarely rhabdomyolysis. Increased risk of DM. Consider renal function assessment during routine follow-up of patients treated w/ 40 mg. Do not measure CK following strenuous exercise or in presence of plausible alternative cause of CK increase. Asian patients. Not recommended in concomitant use w/ PIs. Not to be taken by patients w/ galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
Adverse Reactions
Headache, myalgia, abdominal pain, asthenia & nausea.
MIMS Class
Dyslipidaemic Agents
ATC Classification
C10AA07 - rosuvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
Presentation/Packing
Form
Varostin FC tab 10 mg
Packing/Price
30's
Form
Varostin FC tab 20 mg
Packing/Price
30's
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