Treatment of primary hypercholesterolaemia and mixed dyslipidaemia as an adjunct to diet when response to diet and other non-pharmacological measures is inadequate. It is also used for reduction of cardiovascular risk in appropriate patients.
Adult: The usual starting dose is 5–10 mg once daily, with or without food. The dose may be adjusted according to LDL-C response, treatment goal and individual cardiovascular risk.
The dose range is generally 5–40 mg once daily. The 40 mg dose should be reserved for selected patients requiring intensive LDL-C reduction and requires appropriate clinical assessment and monitoring.
Dose adjustment may be necessary in patients with renal impairment, patients receiving interacting medicines, and certain populations at increased risk of adverse effects.
Each tablet contains:
Rosuvastatin Calcium USP equivalent to Rosuvastatin ........ 10 mg.
Rosuvastatin is a lipid-lowering agent belonging to the class of medicines known as HMG-CoA reductase inhibitors (statins).
Rosuvastatin selectively and competitively inhibits HMG-CoA reductase, the rate-limiting enzyme involved in cholesterol synthesis. Its principal site of action is the liver.
Rosuvastatin increases the number of hepatic LDL receptors, thereby enhancing uptake and catabolism of LDL and reducing hepatic synthesis of VLDL. This results in reductions in LDL-C, total cholesterol and triglycerides, with an increase in HDL-C.
Peak plasma concentrations are reached approximately 3–5 hours after oral administration. Absolute bioavailability is approximately 20%. Rosuvastatin undergoes limited metabolism and is primarily eliminated unchanged in the faeces. Its plasma elimination half-life is approximately 19 hours.
Contraindicated in patients with hypersensitivity to rosuvastatin or any component of the product, active liver disease, unexplained persistent elevations of serum transaminases, and during pregnancy and breastfeeding.
Additional contraindications and restrictions may apply depending on dose and concomitant medications.
Use with caution in patients with risk factors for myopathy or rhabdomyolysis, renal impairment, liver disease, excessive alcohol consumption, hypothyroidism, or a history of muscular toxicity with another statin or fibrate.
Liver enzymes and creatine kinase should be assessed when clinically indicated. Patients should be advised to report unexplained muscle pain, tenderness or weakness.
Adverse effects may include headache, dizziness, constipation, nausea, abdominal pain, myalgia and asthenia.
Elevations of liver transaminases and creatine kinase may occur. Myopathy and rhabdomyolysis are rare but potentially serious adverse reactions.
There is no specific treatment for rosuvastatin overdose. Treatment should be symptomatic and supportive with monitoring of relevant organ functions.
Clinically important interactions may occur with medicines that increase rosuvastatin exposure or increase the risk of myopathy, including certain antivirals, ciclosporin, gemfibrozil and other lipid-lowering therapies. Antacids may reduce rosuvastatin plasma concentrations when administered simulta...
Appropriate dose adjustment or avoidance may be required depending on the interacting medicine.
Store below 30*C in cool and dry place. Protect from light and moisture. Keep out or reach and sight of children.
3 x 10’s, 10 x 10 ‘s Alu-Alu Blister