Rosuvastatin

Rosuvastatin belongs to a group of medicines called statins. It is used to lower cholesterol and to reduce the risk of heart disease. Cholesterol is a fatty substance that builds up in your blood vessels and causes narrowing, which may lead to a heart attack or stroke. Rosuvastatin is a widely prescribed medicine and is regarded as safe for long-term use. It can be taken with a meal or on an empty stomach. You can take it at any time of the day but try to take it at the same time each day. Most people with high cholesterol do not feel ill, but stopping your medicine may increase your cholesterol levels, making your condition worse and increasing your risk of heart disease and stroke. It is important to have your cholesterol levels checked regularly. This medicine is only one part of the treatment program which should also include a healthy diet, regular exercise, smoking cessation, moderation of alcohol intake and weight reduction. You can eat normally while taking this medicine, but try to avoid foods that are high in fat. Common side effects of this medicine include muscle pain, weakness, nausea, headache, and stomach pain. These are usually mild and disappear after a short time. Consult your doctor if they persist or if you notice any yellowing of your eyes or get repeated or unexplained muscle pains. This medicine should not be used in conditions such as liver disease. Also, pregnant women and breastfeeding mothers should not take this medicine as it may harm the developing baby. Diabetic patients should monitor their blood sugar levels while taking this medicine, as it may lead to an increase in blood sugar levels. Rosuvastatin is a lipid-lowering medication (statin). It works by blocking an enzyme (HMG-CoA-reductase) that is required by the body to make cholesterol, thereby lowering "bad" cholesterol (LDL) and triglycerides and raising "good" cholesterol (HDL).

• High cholesterol (Hypercholesterolemia) • High triglycerides (Hypertriglyceridemia) • Mixed dyslipidemia • Prevention of heart attack and stroke in high-risk patients • Heterozygous familial hypercholesterolemia (in children)

Statins (HMG-CoA Reductase Inhibitors)

Lipid-lowering Agent

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.

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.

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 30mL/min/1.73m²: Dose adjustment not necessary

Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Rosuvastatin may be taken with or without food, but it is better to take it at a fixed time.

If you miss a dose of Rosuvastatin, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular schedule. Do not take two doses within 12 hours.

Common: • Muscle pain • Weakness • Headache • Abdominal pain

[SAFE] Rosuvastatin does not usually affect your ability to drive. Rosuvastatin treats high cholesterol by lowering "bad" cholesterol (LDL) and triglycerides (fats). It should be taken in addition to regular exercise and low-fat diet. In general, Rosuvastatin is safe. It may cause diarrhea, gas or an upset stomach. If any of these happen to you, take it with food. Inform your doctor if you experience fatigue, muscle weakness or muscle pain. Your doctor may check your liver function before starting the treatment and regularly thereafter. Inform your doctor if you notice signs of liver problems such as stomach pains, unusually dark urine or yellowing of skin or eyes. Inform your doctor if you have kidney disease, liver disease or diabetes before starting treatment with this medicine. If you are diabetic, monitor your blood sugar level regularly as Rosuvastatin may cause an increase in your blood sugar level. Do not take Rosuvastatin if you are pregnant, planning a pregnancy or breastfeeding.

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

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.

[CAUTION] Caution is advised when consuming alcohol with Rosuvastatin. Please consult your doctor.

[UNSAFE] Rosuvastatin is highly unsafe to use during pregnancy. Seek your doctor's advice as studies on pregnant women and animals have shown significant harmful effects to the developing baby.

[UNSAFE] Rosuvastatin is unsafe to use during breastfeeding. Data suggests that the drug may cause toxicity to the baby.

Rosuvastatin can be used in children over 10 years for heterozygous familial hypercholesterolemia. Initial dose is 5 mg once daily, maximum 20 mg once daily. Consult a pediatrician.

Use with caution in elderly patients. Kidney and liver function may decline with age, so dose adjustment may be necessary.

[CAUTION] Rosuvastatin should be used with caution in patients with kidney disease. Dose adjustment of Rosuvastatin may be needed. Please consult your doctor. Use of Rosuvastatin is not recommended in patients with severe kidney disease. [CAUTION] Rosuvastatin should be used with caution in patients with liver disease. Dose adjustment of Rosuvastatin may be needed. Please consult your doctor. Use of Rosuvastatin is not recommended in patients with severe liver disease and active liver disease.

Overdose may cause muscle pain, muscle weakness, nausea, diarrhea, and liver problems. There is no specific antidote. Symptomatic and supportive treatment should be given in case of massive overdose.

Store below 30°C, away from light and moisture. Keep out of reach of children. Do not use after the expiry date.

Molecular Formula: C₂₂H₂₈FN₃O₆S