Manufacturer/Distributor: Opsonin Pharma Limited
Generic Name: Rosuvastatin 5 mg Tablet
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Ropitor 5 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. Ropitor 5 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.
Uses of Ropitor 5
Side effects of Ropitor 5
Common
How to use Ropitor 5
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. Ropitor 5 may be taken with or without food, but it is better to take it at a fixed time.
How Ropitor 5 works
Ropitor 5 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).
What if you forget to take Ropitor 5?
If you miss a dose of Ropitor 5, 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.
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Brief Description
Indication
Hyperlipidaemias, Primary hypercholesterolaemia (heterozygous familial hypercholesterolaemia), mixed dyslipidaemia, homozygous familial hypercholesterolaemia, Stroke prevention
Administration
May be taken with or without food.
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
Contraindication
Severe renal impairment, active liver disease, unexplained persistent elevations of serum transaminases; hypersensitivity. Pregnancy, lactation.
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.
Precaution
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
Side Effect
>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.
Interaction
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.
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