Simvastatin + Ezetimibe

By Medically reviewed by hellodoktor

Generic Name: Simvastatin + Ezetimibe Brand Name(s): Simvastatin + Ezetimibe.

Uses

What is Simvastatin + Ezetimibe used for?

Simvastatin + Ezetimibe is used along with a proper diet to help lower “bad” cholesterol and fats (such as LDL, triglycerides) and raise “good” cholesterol (HDL) in the blood. Ezetimibe works by reducing the amount of cholesterol your body absorbs from your diet. Simvastatin belongs to a group of drugs known as “statins.” It works by reducing the amount of cholesterol made by the liver.

In addition to eating a proper diet (such as a low-cholesterol/low-fat diet), other lifestyle changes that may help this medication work better include exercising, losing weight if overweight, and stopping smoking. Consult your doctor for more details.

Lowering “bad” cholesterol and triglycerides and raising “good” cholesterol decreases the risk of heart disease and helps prevent strokes and heart attacks.

How should I take Simvastatin + Ezetimibe?

Take this medication by mouth with or without food as directed by your doctor, usually once daily in the evening.

Dosage is based on your medical condition, response to treatment, age, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Chinese patients taking niacin may require lower doses of simvastatin. Ask your doctor for more details.

The usual maximum dose for the simvastatin in this medication is 40 milligrams a day. If you have been instructed by your doctor to take more than 40 milligrams of simvastatin, continue on that same dose. However, promptly talk with him or her about the risks and benefits of your higher dose.

Do not increase your dose or take this medication more often than prescribed. Your condition will not improve any faster, and the risk of serious side effects may be increased.

Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor instructs you otherwise. Grapefruit can increase the amount of this medication in your bloodstream. Consult your doctor or pharmacist for more details.

If you also take certain other drugs to lower your cholesterol (bile acid-binding resins such as cholestyramine or colestipol), take this product at least 2 hours before or at least 4 hours after taking these medications. These medications can react with this product, preventing its full absorption.

Take this medication regularly in order to get the most benefit from it. Remember to take it at the same time each day. It is important to continue taking this medication even if you feel well. Most people with high cholesterol or triglycerides do not feel sick.

It is very important to continue to follow your doctor’s advice about diet and exercise. It may take up to 4 weeks before you get the full benefit of this drug.

How do I store Simvastatin + Ezetimibe?

Simvastatin + Ezetimibe is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Simvastatin + Ezetimibe in the bathroom or the freezer. There may be different brands of Simvastatin + Ezetimibe that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Simvastatin + Ezetimibe down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Simvastatin + Ezetimibe?

Before taking this product, tell your doctor or pharmacist if you are allergic to ezetimibe or simvastatin; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, alcohol use.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Limit alcoholic beverages. Daily use of alcohol may increase your risk for liver problems, especially when combined with this product. Ask your doctor or pharmacist for more information.

Older adults may be more sensitive to the side effects of this medication, especially muscle problems.

This medication must not be used during pregnancy. Simvastatin may harm an unborn baby. Therefore, it is important to prevent pregnancy while taking this medication. Consult your doctor for more details and to discuss the use of reliable forms of birth control (such as condoms, birth control pills) while taking this medication. If you become pregnant or think you may be pregnant, tell your doctor right away.

It is unknown if this medication passes into breast milk. However, similar drugs pass into breast milk. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Simvastatin + Ezetimibe during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Simvastatin + Ezetimibe. Simvastatin + Ezetimibe is pregnancy risk category X according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Simvastatin + Ezetimibe?

A very small number of people taking simvastatin may have mild memory problems or confusion. If these rare effects occur, talk to your doctor.

Rarely, statins may cause or worsen diabetes. Talk to your doctor about the benefits and risks.

This drug may rarely cause muscle problems (which can rarely lead to very serious conditions called rhabdomyolysis and autoimmune myopathy). Tell your doctor right away if you develop any of these symptoms during treatment and if these symptoms persist after your doctor stops this drug: muscle pain/tenderness/weakness (especially with fever or unusual tiredness), signs of kidney problems (such as change in the amount of urine).

This medication may rarely cause liver problems. If you notice any of the following rare but serious side effects, tell your doctor right away: yellowing eyes/skin, dark urine, severe stomach/abdominal pain, persistent nausea/vomiting.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Simvastatin + Ezetimibe?

Some products that may interact with this drug include: “blood thinners” (such as warfarin), cyclosporine, danazol, gemfibrozil.

Other medications can affect the removal of simvastatin from your body, which may affect how simvastatin works. Examples include certain azole antifungals (such as itraconazole, ketoconazole, posaconazole, voriconazole), boceprevir, cobicistat, colchicine, delavirdine, macrolide antibiotics (such as clarithromycin, erythromycin), nefazodone, HIV protease inhibitors (such as nelfinavir, ritonavir), telaprevir, telithromycin, among others.

Do not take any red yeast rice products while you are taking ezetimibe/simvastatin because some red yeast rice products may also contain a statin called lovastatin. Taking ezetimibe/simvastatin and red yeast rice products together can increase your risk of serious muscle and liver problems.

Simvastatin + Ezetimibe may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Simvastatin + Ezetimibe?

Simvastatin + Ezetimibe may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Simvastatin + Ezetimibe?

Simvastatin + Ezetimibe may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Simvastatin + Ezetimibe.

What is the dose of Simvastatin + Ezetimibe for an adult?

Usual Adult Dose for Hyperlipidemia

Initial dose: 10 mg ezetimibe-10 mg simvastatin or 10 mg ezetimibe-20 mg simvastatin orally once a day in the evening.

The dosage range is 10 mg-10 mg to 10 mg-40 mg per day. Initiation of therapy with 10 mg-10 mg per day may be considered for patients requiring less aggressive LDL-C reductions. Patients who require a larger reduction in LDL-C (greater than 55%) may be started at 10 mg-40 mg per day in the absence of moderate to severe renal impairment (estimated glomerular filtration rate less than 60 mL/min/1.73 m2). After initiation or titration, lipid levels may be analyzed after 2 or more weeks and dosage adjusted, if needed.

Due to the increased risk of myopathy, including rhabdomyolysis, particularly during the first year of

treatment, use of the 10/80-mg dose of ezetimibe-simvastatin should be restricted to patients who have been taking the 10/80 mg dose chronically (e.g., for 12 months or more) without evidence of muscle toxicity

Patients should be placed on a standard cholesterol-lowering diet before receiving ezetimibe-simvastatin and should continue on this diet during treatment with ezetimibe-simvastatin. The dosage should be individualized according to the baseline LDL-C level, the recommended goal of therapy, and patient response.

Use:

As an adjunct to diet to reduce elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and non-high-density lipoprotein cholesterol (non-HDL-C), and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary (heterozygous familial and nonfamilial) hyperlipidemia or mixed hyperlipidemia.

Usual Adult Dose for Homozygous Familial Hypercholesterolemia

10 mg ezetimibe-40 mg simvastatin orally once a day in the evening.

Restricted dosing for 10/80 mg ezetimibe-simvastatin should be used as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) in these patients or if such treatments are unavailable.

Use:

As an adjunct to diet to reduce elevated total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH), as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable.

Renal Dose Adjustments

CrCl 60 mL/min or greater: No dosage adjustment recommended

CrCl less than 60 mL/min with chronic kidney disease: Dose should be 10 mg ezetimibe-20 mg simvastatin orally once a day in the evening. Doses higher than this should be used with caution and close monitoring.

Liver Dose Adjustments

No dosage adjustment is recommended in patients with mild hepatic impairment.

Ezetimibe-simvastatin is contraindicated in patients with active liver disease or unexplained persistent elevations in serum transaminases. The use of ezetimibe-simvastatin is not recommended in patients with moderate to severe hepatic impairment due to the unknown effects of increased exposure to ezetimibe in such patients.

Dose Adjustments

The dose of simvastatin should not exceed 10 mg daily in patients receiving concomitant therapy with verapamil or diltiazem. The dose of simvastatin should not exceed 20 mg daily in patients receiving concomitant therapy with amiodarone, amlodipine or ranolazine.

Due to the increased risk of myopathy, including rhabdomyolysis, associated with the 10 mg/80 mg dose of ezetimibe/simvastatin, patients unable to achieve their LDL-C goal utilizing the 10 mg/40 mg dose of ezetimibe/simvastatin should not be titrated to the 10 mg/80 mg dose, but should be placed on alternative LDL-C lowering treatment that provides greater LDL-C lowering.

Patients who are currently tolerating the 10/80-mg dose who need to be initiated on an interacting drug that is contraindicated or is associated with a dose cap for simvastatin should be switched to an alternative statin or statin-based regimen with less potential for the drug-drug interaction.

Caution should be used when treating Chinese patients with ezetimibe-simvastatin doses exceeding 10/20 mg/day coadministered with lipid modifying doses (1 g/day or greater niacin) of niacin containing products due to an increased risk for myopathy in these patients.

Other Comments

Administration advice:

-Ezetimibe-simvastatin should be taken as a single daily dose in the evening, without regard to meals.

Monitoring:

Hepatic: Baseline liver function tests, measured periodically thereafter as clinically indicated; signs and symptoms of serious hepatic injury

Musculoskeletal: Signs and symptoms of myopathy; CK levels

General:

-Grapefruit juice should be avoided during ezetimibe-simvastatin therapy.

Patient advice:

-All patients starting therapy with ezetimibe-simvastatin, or whose dose is being increased, should be advised of the risk of myopathy and told to report any unexplained muscle pain, tenderness, or weakness.

What is the dose of Simvastatin + Ezetimibe for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Simvastatin + Ezetimibe available?

Simvastatin + Ezetimibe is available in the following dosage forms and strengths:

  • Oral tablet.

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Simvastatin + Ezetimibe, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Sources

Review Date: April 26, 2018 | Last Modified: September 12, 2019

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