Novastin10mg

Simvastatin 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. Simvastatin is a widely prescribed medicine and is regarded as safe for long-term use. It can be taken with or without food, taking it with food may reduce chances of nausea. Taking it regularly in the evening helps to maximize its effects. 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 headache, abdominal pain, constipation, and nausea. 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. Simvastatin is a lipid-lowering medication (statin). It works by blocking an enzyme (HMG-CoA-reductase) that is required in the body to make cholesterol. It thus lowers "bad" cholesterol (LDL) and triglycerides, raising the level of "good" cholesterol (HDL).

• High cholesterol • Prevention of heart attack and stroke

Simvastatin, an antilipemic agent is a competitive inhibitor of HMG-CoA reductase, the enzyme that catalyses the early and rate-limiting step in cholesterol biosynthesis reduces total cholesterol, LDL-cholesterol and triglycerides and increases HDL-cholesterol levels.

Adult Dose: Oral Hyperlipidaemias, Hypercholesterolemia Adult: Initially, 10-20 mg once daily. Patients w/ high CV risk or require a large reduction in cholesterol: Initially, 40 mg once daily. May adjust dose at intervals of at least 4 wk to max 80 mg once daily. All doses to be taken in the evening. Patients w/ homozygous familial hypercholesterolaemia: 40 mg once daily in the evening or 80 mg/day in 3 divided doses of 20 mg, 20 mg and an evening dose of 40 mg. Cardiovascular risk reduction Adult: High-risk patients (e.g. patients w/ DM or atherosclerotic CV disease): 20-40 mg once daily. Moderate-risk patients: 10 mg once daily. Dosage Modifications Coadministration with dronedarone, verapamil, or diltiazem: Do not exceed 10 mg/day Coadministration with amiodarone, amlodipine, or ranolazine: Do not exceed 20 mg/day Lipid determinations should be performed after 4 weeks of therapy and periodically thereafter 80 mg/day should be used only for individuals who have been taking simvastatin 80 mg chronically (eg, >12 months) without evidence of myopathy or rhabdomyolysis Patients tolerating 80 mg who need to be initiated on an interacting drug that is contraindicated or associated with a maximum dose for simvastatin should be switched to an alternative statin with less potential for drug-drug interactions Patients unable to achieve their LDL-C goal utilizing 40 mg/day should not be titrated to 80 mg (increased risk for myopathy) but should instead be placed on alternative LDL-C-lowering treatment that provides greater LDL-C lowering Child Dose: Child Heterozygous familial hypercholesterolaemia: 10-17 yr Initially, 10 mg once daily May increase at intervals of 4 wk to max 40 mg/day. All doses to be taken in the evening. Hypercholesterolemia <10 years: Safety and efficacy not established Renal Dose: Renal impairment: Mild to moderate: No dosage adjustment needed. Severe: Initially, 5 mg once daily w/ close monitoring.

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. Simvastatin may be taken with or without food, but it is better to take it at a fixed time.

If you miss a dose of Simvastatin, 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 double the dose

Common: • Abdominal pain • Constipation • Headache • Upper respiratory tract infection

[SAFE] Simvastatin does not usually affect your ability to drive. It should be taken in the evening after dinner and before sleeping. It should be taken in addition to regular exercise and low-fat diet to lower levels of fat in the blood. 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 Simvastatin may cause an increase in your blood sugar level. Do not take Simvastatin if you are pregnant, planning a pregnancy or breastfeeding.

Acute liver disease or unexplained persistent elevations of serum transaminases. Patients of Chinese descent should not take simvastatin 80 mg/day w/ lipid-modifying dose of niacin-containing products (≥1 g). Simvastatin 80 mg should not be started in new patients and to those taking lower doses. Concurrent use w/ potent CYP3A4 inhibitors e.g. itraconazole, ketoconazole, posaconazole, clarithromycin, erythromycin, telithromycin, nefazodone, HIV protease inhibitors (e.g. nelfinavir), boceprivir, telaprevir., gemfibrozil, ciclosporin, danazol, grapefruit juice. Pregnancy and lactation.

May increase bleeding risk w/ anticoagulants. Reduced serum levels w/ bosentan, efavirenz and rifampicin. Increased risk of myopathy and rhabdomyolysis w/ colchicine, amiodarone, verapamil and diltiazem. Increased risk of myopathy w/ amlodipine, fusidic acid. Potential reduction of cytotoxic effect of rituximab. Increased hepatotoxicity w/ ezetimibe. Potentially Fatal: Concurrent use w/ itraconazole, ketoconazole, posaconazole, clarithromycin, erythromycin, telithromycin, nefazodone, niacin, HIV protease inhibitors (e.g. nelfinavir), boceprivir, telaprevir, gemfibrozil, ciclosporin and danazol may increase the risk of myopathy, rhabdomyolysis and acute renal failure.

[UNSAFE] It is unsafe to consume alcohol with Simvastatin.

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

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

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