Indications
Rostatin Tablet is used for:
Hyperlipidaemias, Primary hypercholesterolaemia (heterozygous familial hypercholesterolaemia), mixed dyslipidaemia, homozygous familial hypercholesterolaemia, Stroke prevention
Adult Dose
Oral
Hypercholesterolemia, Hypertriglyceridemia, hyperlipidemia, mixed dyslipidemiaProphylaxis of cardiovascular events in high-risk patients
Adult: Initially, 5 or 10 mg once daily, may increase dose at 4-wkly intervals to 20 mg daily if necessary.
Max: 40 mg once daily.
Active liver disease: Use is contraindicated
Child Dose
Oral
Child
Heterozygous familial hypercholesterolaemia: >10 yr Initially, 5 mg once daily, may be adjusted at intervals of at least 4 wk.
Max: 20 mg once daily.
Renal Dose
Renal impairment
Severe (CrCl <30 mL/min/1.73m²) and not on hemodialysis: Decrease starting dose to 5 mg PO qDay; not to exceed 10 mg PO qDay
CrCl>30mL/min/1.73m²: Dose adjustment not necessary
Administration
May be taken with or without food.
Contra Indications
Severe renal impairment, active liver disease, unexplained persistent elevations of serum transaminases; hypersensitivity. Pregnancy, lactation.
Precautions
Patients w/ predisposing factors for myopathy (e.g. untreated hypothyroidism, renal impairment), history of chronic liver disease and alcoholism. Monitoring Parameters Monitor creatine kinase (CK) periodically and LFT. Discontinue treatment if there is significant or persistent increase in CK levels, serum aminotransferase levels or evidence of myopathy.
Lactation
Contraindicated
Pregnancy-Lactation
Pregnancy
Contraindicated
Because HMG-CoA reductase inhibitors decrease cholesterol synthesis and possibly synthesis of other biologically active substances derived from cholesterol (eg, cell membranes), rosuvastatin may cause fetal harm when administered to pregnant women
Lactation
Contraindicated
Limited data indicate that rosuvastatin is present in human milk; because statins have the potential for serious adverse reactions in nursing infants, women who require rosuvastatin treatment should not breastfeed their infants
Interactions
May increase serum levels of warfarin and oral contraceptives. May increase serum levels w/ itraconazole, HIV protease inhibitors. May decrease serum levels w/ erythromycin and antacids. May increase risk of myopathy w/ fenofibrate, niacin.
Potentially Fatal: Increased risk of rhabdomyolysis w/ gemfibrozil and ciclosporin.
Side Effects
Side effects of Rosuvastatin :
>10%
Myalgia (3-13%)
1-10%
Arthralgia (10%), Diabetes mellitus, new onset (3%), Pharyngitis (9%), Headache (6%), Asthenia (up to 5%), Dizziness (4%), CPK increased (3%), Nausea (3%), Abdominal pain (2%), ALT increased (2%), Constipation (2%), Flulike illness (2%), UTI (2%)
<1%
Jaundice, Myopathy, Rhabdomyolysis
Potentially Fatal: Rhabdomyolysis with acute renal failure.
Mode of Action
Rosuvastatin is a selective and competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme in cholesterol synthesis. It increases the number of hepatic LDL receptors on the cell surface, enhancing uptake and catabolism of LDL. It also decreases apolipoprotein B, triglycerides and increases HDL.
Note
Rostatin 5mg Tablet generic name is Rosuvastatin. Rostatin 5mg Tablet is manufactured by Drug International Ltd.Rostatin is availble in all over Bangladesh.
Mes BD drug index information on Rostatin Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.