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Rosuvastatin information from DrugsUpdate  

See Available Brands of Rosuvastatin in India

P - Contraindicated in pregnancy
L - Contraindicated in lactation

Rosuvastatin is a member of the drug class of statins, used to treat high cholesterol and related conditions, and to prevent cardiovascular disease. Shionogi developed the product and the pharmaceutical company AstraZeneca markets it as Crestor. In India, Rosuvastatin is marketed as Rozavel by Sun pharma.

Pharmacodynamics

Pharmacokinetics

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.

Onset
1 week

Absorption
Incompletely absorbed in the GI tract. Bioavailability: about 20%. Plasma concentrations peak 5 hours after oral admin.

Distribution
Protein-binding: 90%. Extensively taken up by the liver.

Metabolism
Limited metabolism by CYP2C9.

Excretion
Faeces (90% of an oral dose); 19 hours (elimination half-life).

Rosuvastatin Indications / Rosuvastatin Uses

Information Not Available

Rosuvastatin Adverse Reactions / Rosuvastatin Side Effects

Headache, dizziness, constipation, nausea, vomiting, abdominal pain, myalgia, chest pain, peripheral oedema, depression, insomnia, rash, paraesthesia, proteinuria and asthenia.

Potentially Fatal: Rhabdomyolysis with acute renal failure.

Precautions

Monitor
It is recommended that LFTs be performed before and at 12 weeks following both the initiation of therapy and any elevation in dose, and periodically (eg, semi-annually) thereafter.

Overdosage
Symptomatic and supportive treatment should be instituted as required.

Special Precautions

Not to be used in patient with acute, serious condition suggestive of myopathy or predisposing to the development of renal failure secondary to rhabdomyolysis e.g. sepsis, hypotension, major surgery, trauma, severe metabolic, endocrine and electrolyte disorders or uncontrolled seizures. History of liver disease and alcoholism. Discontinue treatment if there is marked or persistent increase in serum aminotransferase concentrations, significant increase in creatinine phosphokinase or evidence of myopathy.

Other Drug Interactions

Increased risk of myopathy when used with gemfibrozil. May increase serum levels of warfarin and oral contraceptives. Concurrent admin with aluminium/magnesium hydroxide may lead to decreased bioavailability of rosuvastatin. Serum levels may be increased by fluconazole.

Potentially Fatal: Increased risk of serious myopathy and renal failure when used with ciclosporin.

Other Interactions

Information Not Available

Dosage

Oral
Hyperlipidaemias
Adult: Initially, 5-10 mg daily, may increase dose at 4-weekly intervals to 20 mg daily if necessary. Max: 40 mg daily. In patients receiving gemfibrozil, max: 10 mg once daily. For those receiving ciclosporin, max: 5 mg once daily.

CrCl (ml/min)    Dosage Recommendation
<60                  Initially, 5 mg/day. Max: 20 mg/day.
<30                  Avoid use.

Food(before/after)

May be taken with or without food

List of Contraindications

Rosuvastatin and Pregnancy

Contraindicated in pregnancy

Rosuvastatin and Lactation

Contraindicated in lactation

Rosuvastatin and Children

Safety and efficacy not established

Rosuvastatin and Geriatic

Information Not Available

Rosuvastatin and Other Contraindications

Severe renal impairment, active liver disease, unexplained persistent elevations of serum transaminases; hypersensitivity. Pregnancy, lactation.

Storage

Oral
Store at 20-25°C

Lab interference

Oral
Store at 20-25°C

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