LUSTATIN-40 Rosuvastatin Calcium 40mg Tablet 1's
RXDRUG-DR-XY43256-1pc
Discreet Packaging
FDA-registered Products
FDA-licensed Pharmacies
Indications/Uses
Rosuvastatin is used to reduce LDL cholesterol, apolipoprotein B, and triglycerides, and to increase HDL-cholesterol in the management of hyperlipidaemias, including primary hypercholesterolaemia (type IIa), mixed dyslipidaemia (type IIb), and hypertriglyceridaemia (type IV), as well as in patients with homozygous familial hypercholesterolaemia. It is also used to reduce the progression of atherosclerosis.
Dosage/Direction for Use
Before treatment initiation the patient should be placed on a standard cholesterol-lowering diet that should continue during treatment. The dose should be individualised according to the goal of therapy and patient response, using current consensus guidelines.
Dosage in adult patients with normal renal function: Treatment of hypercholesterolaemia: The recommended start dose is 5 or 10 mg orally once daily in both statin naive or patients switched from another HMG CoA reductase inhibitor. The choice of start dose should take into account the individual patient's cholesterol level and future cardiovascular risk as well as the potential risk for adverse reactions. A dose adjustment to the next dose level can be made after 4 weeks, if necessary. In light of the increased reporting rate of adverse reactions with the 40 mg dose compared to lower doses, a final titration to the maximum dose of 40 mg should only be considered in patients with severe hypercholesterolaemia at high cardiovascular risk (in particular those with familial hypercholesterolaemia), who do not achieve their treatment goal on 20 mg, and in whom routine follow-up will be performed. Specialist supervision is recommended when the 40 mg dose is initiated.
Prevention of cardiovascular events: In the cardiovascular events risk reduction study, the dose used was 20 mg daily.
Dosage in pediatric patients: Paediatric population: Paediatric use should only be carried out by specialists.
Children and adolescents 6 to 17 years of age (Tanner Stage In children and adolescents with heterozygous familial hypercholesterolaemia the usual start dose is 5 mg daily.
In children 6 to 9 years of age with heterozygous familial hypercholesterolaemia, the usual dose range is 5-10 mg orally once daily. Safety and efficacy of doses greater than 10 mg have not been studied in this population.
In children 10 to 17 years of age with heterozygous familial hypercholesterolaemia, the usual dose range is 5-20 mg orally once daily. Safety and efficacy of doses greater than 20 mg have not been studied in this population.
Children younger than 6 years: The safety and efficacy of use in children younger than 6 years has not been studied. Therefore, Rosuvastatin is not recommended for use in children younger than 6 years.
Use in the elderly: A start dose of 5 mg is recommended in patients > 70 years. No other dose adjustment is necessary in relation to age.
Administration Instructions: Rosuvastatin may be given at any time of day, with or without food.
Dosage in adult patients with normal renal function: Treatment of hypercholesterolaemia: The recommended start dose is 5 or 10 mg orally once daily in both statin naive or patients switched from another HMG CoA reductase inhibitor. The choice of start dose should take into account the individual patient's cholesterol level and future cardiovascular risk as well as the potential risk for adverse reactions. A dose adjustment to the next dose level can be made after 4 weeks, if necessary. In light of the increased reporting rate of adverse reactions with the 40 mg dose compared to lower doses, a final titration to the maximum dose of 40 mg should only be considered in patients with severe hypercholesterolaemia at high cardiovascular risk (in particular those with familial hypercholesterolaemia), who do not achieve their treatment goal on 20 mg, and in whom routine follow-up will be performed. Specialist supervision is recommended when the 40 mg dose is initiated.
Prevention of cardiovascular events: In the cardiovascular events risk reduction study, the dose used was 20 mg daily.
Dosage in pediatric patients: Paediatric population: Paediatric use should only be carried out by specialists.
Children and adolescents 6 to 17 years of age (Tanner Stage
In children 6 to 9 years of age with heterozygous familial hypercholesterolaemia, the usual dose range is 5-10 mg orally once daily. Safety and efficacy of doses greater than 10 mg have not been studied in this population.
In children 10 to 17 years of age with heterozygous familial hypercholesterolaemia, the usual dose range is 5-20 mg orally once daily. Safety and efficacy of doses greater than 20 mg have not been studied in this population.
Children younger than 6 years: The safety and efficacy of use in children younger than 6 years has not been studied. Therefore, Rosuvastatin is not recommended for use in children younger than 6 years.
Use in the elderly: A start dose of 5 mg is recommended in patients > 70 years. No other dose adjustment is necessary in relation to age.
Administration Instructions: Rosuvastatin may be given at any time of day, with or without food.
Overdosage
In case of over dosage treatment should be symptomatic.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to any component of these products; active liver disease or unexplained persistent elevated liver function tests; pregnancy, lactation.
Warnings
Hepatic Effects: Therapy with Rosuvastatin and other statins has been associated with increases in serum aminotransferase (transaminase) concentrations. Therefore, the manufacturer recommends that liver function tests be performed before and at 12 weeks after initiation of Rosuvastatin therapy or any increase in dosage and periodically (e.g., semiannually) thereafter. Patients who develop increased serum transaminase concentrations or manifestations of liver disease should have frequent liver function tests performed thereafter until the abnormalities return to normal.
Jaundice has been reported rarely with Rosuvastatin therapy.
Musculoskeletal Effects: Myopathy has been reported occasionally (up to 0.1%) with Rosuvastatin therapy. Rhabdomyolysis with or without acute renal failure secondary to myoglobinuria has been reported rarely with statin therapy, including with Rosuvastatin. Rhabdomyolysis occurs more frequently in patients receiving Rosuvastatin 40 mg daily compared with lower dosages. However, it does not appear that the risk of rhabdomyolysis is greater with Rosuvastatin than with other statins.
Jaundice has been reported rarely with Rosuvastatin therapy.
Musculoskeletal Effects: Myopathy has been reported occasionally (up to 0.1%) with Rosuvastatin therapy. Rhabdomyolysis with or without acute renal failure secondary to myoglobinuria has been reported rarely with statin therapy, including with Rosuvastatin. Rhabdomyolysis occurs more frequently in patients receiving Rosuvastatin 40 mg daily compared with lower dosages. However, it does not appear that the risk of rhabdomyolysis is greater with Rosuvastatin than with other statins.
Special Precautions
Prior to institution of antilipemic therapy, vigorously attempt to control serum cholesterol by appropriate dietary regimens, weight reduction, exercise, and treatment of any underlying disorder that might be the cause of lipid abnormality.
Use In Pregnancy & Lactation
Lactation: Distributed into milk in animals; not known whether Rosuvastatin is distributed into milk in humans. Discontinue nursing or drug, taking into account the importance of the drug to the woman.
Adverse Reactions
The adverse reactions seen with Rosuvastatin are generally mild and transient. In controlled clinical trials, less than 4% of Rosuvastatin treated patients were withdrawn due to adverse reactions.
Tabulated list of adverse reactions: Based on data from clinical studies and extensive post-marketing experience, the following table presents the adverse reaction profile for rosuvastatin. Adverse reactions listed as follows are classified according to frequency and system organ class (SOC). The frequencies of adverse reactions are ranked according to the following convention: Common (≥ 1/100 to <1/10); Uncommon (≥ 1/1,000 to <1/100); Rare (≥ 1/10,000 to <1/1000); Very rare (<1/10,000); Not known (cannot be estimated from the available data). (See table.)
Tabulated list of adverse reactions: Based on data from clinical studies and extensive post-marketing experience, the following table presents the adverse reaction profile for rosuvastatin. Adverse reactions listed as follows are classified according to frequency and system organ class (SOC). The frequencies of adverse reactions are ranked according to the following convention: Common (≥ 1/100 to <1/10); Uncommon (≥ 1/1,000 to <1/100); Rare (≥ 1/10,000 to <1/1000); Very rare (<1/10,000); Not known (cannot be estimated from the available data). (See table.)
Drug Interactions
Antacids: Potential pharmacokinetic interaction (decreased plasma Rosuvastatin concentrations with concomitant aluminum-magnesium hydroxide antacid). Administer antacids 2 hours after Rosuvastatin.
Bile Acid Sequestrants: Potential pharmacodynamic interaction (enhanced effect on total and LDL-cholesterol) with concomitant bile acid sequestrant.
Cyclosporine: Potential pharmacokinetic interaction (clinically important increases in peak plasma Rosuvastatin concentration and AUC with concomitant cyclosporine); limit dosage of Rosuvastatin to 5 mg daily with such concomitant therapy.
Digoxin: Pharmacokinetic interaction unlikely (no change in plasma digoxin concentrations) with concomitant Rosuvastatin.
Bile Acid Sequestrants: Potential pharmacodynamic interaction (enhanced effect on total and LDL-cholesterol) with concomitant bile acid sequestrant.
Cyclosporine: Potential pharmacokinetic interaction (clinically important increases in peak plasma Rosuvastatin concentration and AUC with concomitant cyclosporine); limit dosage of Rosuvastatin to 5 mg daily with such concomitant therapy.
Digoxin: Pharmacokinetic interaction unlikely (no change in plasma digoxin concentrations) with concomitant Rosuvastatin.
Storage
Store at temperatures not exceeding 30°C. Protect from light.
Action
Pharmacology: Rosuvastatin calcium is a synthetic heptanoic acid-derivative antilipemic agent. The drug is an inhibitor of 3-hydroxymethylglutaryl-CoA (HMG-CoA) reductase (i.e., statin), which catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis. Rosuvastatin reduces total and LDL-cholesterol, apo B, and non-HDL-cholesterol concentrations and increases HDL-cholesterol concentrations in patients with homozygous and heterozygous familial hypercholesterolemia, nonfamilial forms of hypercholesterolemia, and mixed dyslipidemia. Rosuvastatin also reduces triglyceride concentrations in patients with primary hypertriglyceridemia.
Pharmacokinetics: Rosuvastatin is incompletely absorbed from the gastrointestinal tract, with an absolute bioavailability of about 20%. Peak plasma concentrations are achieved about 5 hours after an oral dose.
It is taken up extensively by the liver, its primary site of action, and undergoes limited metabolism, mainly by the cytochrome P450 isoenzyme CYP2C9. It is about 90% bound to plasma proteins.
The plasma elimination half-life of Rosuvastatin is about 19 hours. About 90% of an oral dose of Rosuvastatin appears in the faeces, including absorbed and non-absorbed drug, and the remainder is excreted in the urine; about 5% of a dose is excreted unchanged in urine.
Pharmacokinetics: Rosuvastatin is incompletely absorbed from the gastrointestinal tract, with an absolute bioavailability of about 20%. Peak plasma concentrations are achieved about 5 hours after an oral dose.
It is taken up extensively by the liver, its primary site of action, and undergoes limited metabolism, mainly by the cytochrome P450 isoenzyme CYP2C9. It is about 90% bound to plasma proteins.
The plasma elimination half-life of Rosuvastatin is about 19 hours. About 90% of an oral dose of Rosuvastatin appears in the faeces, including absorbed and non-absorbed drug, and the remainder is excreted in the urine; about 5% of a dose is excreted unchanged in urine.
MedsGo Class
Dyslipidaemic Agents
Features
Brand
Lustatin-40
Full Details
Dosage Strength
40 mg
Drug Ingredients
- Rosuvastatin
Drug Packaging
Tablet 1's
Generic Name
Rosuvastatin Calcium
Dosage Form
Tablet
Registration Number
DR-XY43256
Drug Classification
Prescription Drug (RX)
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