what are the contraindications of simvastatin

Precautions

Simvastatin Side Effects

• In Summary. More frequently reported side effects include: eczema and increased creatine phosphokinase in blood specimen.
• For the Consumer. Along with its needed effects, simvastatin may cause some unwanted effects. ...
• For Healthcare Professionals. ...
• Frequently asked questions. ...

What are the bad side effects of simvastatin?

Signs of an overdose on this drug include: Trouble breathing due to allergic reaction Passing out Jaundice, indicating liver damage Dark urine and muscle pain, indicating rhabdomyolysis and kidney damage Seizures

What happens if I overdose on simvastatin?

Simvastatin Overdose If you take too much simvastatin, call your local Poison Control Center or seek emergency medical attention right away. Other Requirements Store simvastatin at room temperature between 41°F to 86°F (5°C to 30°C). Protect from moisture and light. Keep simvastatin and all medicines out of the reach of children. Contributors

Can You overdose on simvastatin?

YES: Lemon water is well known to hydrate you and clean your liver and kidney and also lower cholesterol no harm taking with Simvastatin and mind that gra...

Does lemon interact with simvastatin?

What are 3 contraindications of statins?

having a history of liver disease. regularly drinking large quantities of alcohol. having a history of muscle-related side effects when taking a statin or fibrate (another type of medicine for high cholesterol) having a family history of myopathy or rhabdomyolysis.

What are the most common side effects of simvastatin?

The more common side effects that can occur with simvastatin include:headache.nausea.stomach pain.constipation.muscle pain or weakness.joint pain.upper respiratory infections.

What drugs are contraindicated with statins?

Certain drugs can interact with atorvastatin (Lipitor) and increase its side effects. These include fibrates, niacin supplements, cyclosporine, clarithromycin, itraconazole, HIV protease inhibitors, oral contraceptives containing norethindrone or ethinyl estradiol, digoxin, rifampin, and colchicine.

What is the contraindications for Zocor?

ZOCOR is contraindicated in patients with active liver disease which may include unexplained persistent elevations in hepatic transaminase levels [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS].

What can I take instead of statins to lower cholesterol?

7 cholesterol-lowering alternatives to statinsFibrates. Mostly used for lowering triglyceride levels in patients whose levels are very high and could cause pancreatitis. ... Plant stanols and sterols. ... Cholestyramine and other bile acid-binding resins. ... Niacin. ... Policosanol. ... Red yeast rice extract (RYRE) ... Natural products.

When Should statins be stopped in elderly?

Do not start a statin in patients ages ≥ 75 years who do not have known vascular disease or type 2 diabetes; start or continue a statin in all patients ages 75 to 84 with type 2 diabetes to prevent cardiovascular events and mortality; and start or continue a statin in patients ages > 75 years who have known vascular ...

Can you take statins with blood pressure medication?

Heart Disease Risk Can Be Lowered by Combining Statins with Blood Pressure Drugs. Researchers say prescribing statins along with blood pressure medications improves the survival odds for people with hypertension.

Can you take blood pressure medicine and cholesterol medicine at the same time?

Taking daily doses of two blood pressure drugs (fixed dose candesartan and hydrochlorothiazide) along with a cholesterol-lowering drug (low-dose rosuvastatin), proved to be the most effective, cutting first-time strokes by 44 percent among patients at intermediate risk for heart disease.

What is the most common side effect of statins?

Myalgia is the most common side effect of statin use, with documented rates from 1-10%. Rhabdomyolysis is the most serious adverse effect from statin use, though it occurs quite rarely (less than 0.1%). The most common risk factors for statin-related myopathy include hypothyroidism, polypharmacy and alcohol abuse.

What drugs does simvastatin interact with?

Some products that may interact with this drug include: "blood thinners" (such as warfarin), cyclosporine, danazol, daptomycin, gemfibrozil. Other medications can affect the removal of simvastatin from your body, which may affect how simvastatin works.

Is simvastatin a high risk medication?

[06-08-2011] The U.S. Food and Drug Administration (FDA) is recommending limiting the use of the highest approved dose of the cholesterol-lowering medication, simvastatin (80 mg) because of increased risk of muscle damage.

Which cholesterol drug is safest?

Still, all in all, the statins are the safest and best tolerated of all cholesterol-lowering medications. Although most patients respond well to statin therapy, some don't.

Which statin has the least side effects?

According to a research review people who take simvastatin (Zocor) or pravastatin (Pravachol) may experience fewer side effects.

What are the side effects of simvastatin 20 mg tablets?

Call your doctor right away if you get a headache, stomach pain, vomiting, dark-colored urine, loss of appetite, weight loss, general feeling of tiredness or weakness, light-colored stools, upper right stomach pain, or yellow eyes or skin.

What cholesterol medicine has the least side effects?

Fortunately, most side effects are mild and disappear promptly when the statin is stopped. In some cases, the problems will resolve simply by reducing the dose or switching to another statin, but care is required. Still, all in all, the statins are the safest and best tolerated of all cholesterol-lowering medications.

Can you just stop taking simvastatin?

Do not suddenly stop taking your prescribed medication without talking with your doctor first. If you have side effects from the medication, your doctor might adjust your dosage or recommend a different statin or other combination of medications.

Before Taking This Medicine

You should not take this medicine if you are allergic to simvastatin, if you are pregnant or breast-feeding, or if you have active liver disease.Th...

How Should I Take Simvastatin?

Take simvastatin exactly as prescribed. Follow all directions on your prescription label. Never take this medicine in larger amounts, or for longer...

What Happens If I Miss A Dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to...

What Should I Avoid While Taking Simvastatin?

Grapefruit and grapefruit juice may interact with simvastatin and lead to unwanted side effects. Avoid the use of grapefruit products while taking...

Simvastatin Dosing Information

Usual Adult Dose for Prevention of Cardiovascular Disease:Usual dosage range: 5 to 40 mg orally once a day in the eveningPatients with coronary hea...

What Other Drugs Will Affect Simvastatin?

Many drugs can interact with simvastatin. Not all possible interactions are listed here. Tell your doctor about all your medications and any you st...

What is simvastatin used for?

Simvastatin is used to control elevated cholesterol, or hypercholesterolemia. It is recommended to be used only after other measures such as diet, exercise, and weight reduction have not improved cholesterol levels.

When did the TGA stop prescribing simvastatin?

6 December 2011. The TGA is advising health professionals to limit the prescribing of high dose (80 mg/day) simvastatin and to be aware of new contraindications and precautions for the use of simvastatin with other medicines.

Is simvastatin contraindicated with colchicine?

Concomitant administration of simvastatin with the following medicines is now contraindicated: nefazodone. Specific precautions (such as lower recommended simvastatin doses) now exist for patients taking the following medicines: colchicine. For detailed precautions on interactions with other medicines, and the recommended course of action, ...

Can you report simvastatin to TGA?

Patients and health professionals are encouraged to report adverse reactions associated with simvastatin to the TGA. Your report will contribute to our monitoring of this medicine. The TGA cannot give personal advice about an individual's medical condition.

What are the adverse reactions to simvastatin?

The following additional adverse reactions have been identified during postapproval use of Simvastatin: pruritus, alopecia, a variety of skin changes (e.g., nodules, discoloration, dryness of skin/mucous membranes, changes to hair/nails), dizziness, muscle cramps , myalgia, pancreatitis, paresthesia, peripheral neuropathy, vomiting, anemia, erectile dysfunction, interstitial lung disease, rhabdomyolysis, hepatitis/jaundice, fatal and non-fatal hepatic failure, and depression.

What is the color of simvastatin?

Simvastatin tablets, USP 40 mg are light pink to pink, oval, biconvex, film-coated tablets with the logo “B303” debossed on one side and “40” on the other side. Simvastatin tablets, USP 80 mg are pink to dark pink, capsule-shaped, film-coated tablets with the logo “B304” debossed on one side and “80” on the other side.

Can simvastatin cause myopathy?

Cases of myopathy/rhabdomyolysis have been observed with Simvastatin coadministered with lipid-modifying doses (≥1 g/day niacin) of niacin-containing products. The risk of myopathy is greater in Chinese patients. In a clinical trial (median follow-up 3.9 years) involving patients at high risk of cardiovascular disease and with well-controlled LDL-C levels on Simvastatin 40 mg/day with or without ezetimibe 10 mg/day, there was no incremental benefit on cardiovascular outcomes with the addition of lipid-modifying doses (≥1 g/day) of niacin. Coadministration of Simvastatin tablets with lipid-modifying doses (≥1 g/day) of niacin is not recommended in Chinese patients. It is unknown if this risk applies to other Asian patients [ See Warnings and Precautions (5.1) and Use in Specific Populations (8.8) .]

Is simvastatin a CYP3A4 inhibitor?

Strong CYP3A4 inhibitors: Simvastatin, like several other inhibitors of HMG-CoA reductase, is a substrate of CYP3A4. Simvastatin is metabolized by CYP3A4 but has no CYP3A4 inhibitory activity; therefore it is not expected to affect the plasma concentrations of other drugs metabolized by CYP3A4.

Does simvastatin cause muscle pain?

Simvastatin occasionally causes myopathy manifested as muscle pain, tenderness or weakness with creatine kinase (CK) above ten times the upper limit of normal (ULN). Myopathy sometimes takes the form of rhabdomyolysis with or without acute renal failure secondary to myoglobinuria, and rare fatalities have occurred. The risk of myopathy is increased by elevated plasma levels of Simvastatin and Simvastatin acid. Predisposing factors for myopathy include advanced age (≥65 years), female gender, uncontrolled hypothyroidism, and renal impairment. Chinese patients may be at increased risk for myopathy [ see Use in Specific Populations ( 8.8 )].

Can you take simvastatin with diet?

In patients with coronary heart disease (CHD) or at high risk of CHD, Simvastatin can be started simultaneously with diet.

Can Simvastatin be switched to an alternative?

If, however, a patient who is currently tolerating the 80-mg dose of Simvastatin needs to be initiated on an interacting drug that is contraindicated or is associated with a dose cap for Simvastatin , that patient should be switched to an alternative statin with less potential for the drug-drug interaction.

What is simvastatin?

Simvastatin belongs to a group of drugs called HMG CoA reductase inhibitors, or "statins."

How old do you have to be to take simvastatin?

Simvastatin is used in adults and children who are at least 10 years old.

Can simvastatin cause birth defects?

Simvastatin can harm an unborn baby or cause birth defects. Do not use if you are pregnant or planning to become pregnant. Grapefruit and grapefruit juice may interact with simvastatin and lead to potentially dangerous effects. Do not consume grapefruit products while taking this medication.

What are the side effects of a syringe?

headache; constipation, nausea, stomach pain; or. cold symptoms such as stuffy nose, sneezing, sore throat. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Can you take simvastatin with meals?

Simvastatin is usually taken at bedtime or with an evening meal. If you take simvastatin more than once daily, take it with meals. Your doctor may occasionally change your dose to make sure you get the best results. While using simvastatin, you may need frequent blood tests at your doctor's office.

Can you take simvastatin in larger amounts?

Take simvastatin exactly as prescribed. Follow all directions on your prescription label. Never take this medicine in larger amounts, or for longer than prescribed. Taking too much of this medication may cause serious or life-threatening side effects.

Can you take simvastatin for longer than prescribed?

Never take simvastatin in larger amounts, or for longer than recommended by your doctor. Follow your doctor's dosing instructions very carefully. Taking too much of this medication may cause serious or life-threatening side effects.

How many mg is simvastatin?

Simvastatin is approved for oral administration and is available in 5-mg, 10-mg, 20-mg, 40-mg, and 80-mg tablets. A suspension dosage form is also available for those with difficulty swallowing. Recommended Dosages*.

What is a simvastatin?

Simvastatin - StatPearls - NCBI Bookshelf. Simvastatin is an oral HMG-CoA reductase inhibitor indicated as an adjunct to diet . It is a semi-synthetic derivative of lovastatin, the first FDA-approved statin. Simvastatin helps lower cholesterol production and reduce dyslipidemia associated complications. High concentrations of LDL cholesterol can ...

Which drug inhibits HMG reductase?

Lovastatin and simvastatin--inhibitor s of HMG CoA reductase and cholesterol biosynthesis. [Cardiology. 1990]

Does simvastatin reduce cholesterol?

Using acetyl-CoA as a substrate, mevalonic acid is formed, and subsequent reactions lead to the formation of cholesterol. Simvastatin acts on the rate-limiting step and serves as an HMG -CoA reductase inhibitor, consequently leading to decreased concentrations of cholesterol.

Is simvastatin a reductase inhibitor?

Indications. Simvastatin is an oral HMG-CoA reductase inhibitor indicated as an adjunct to diet. It is a semi-synthetic derivative of lovastatin, the first FDA-approved statin. Simvastatin helps lower cholesterol production and reduce dyslipidemia associated complications.

Is simvastatin a HMG?

Simvastatin is an oral HMG-CoA reductase inhibitor indicated as an adjunct to diet. It is a semi-synthetic derivative of lovastatin, the first FDA-approved statin. Simvastatin helps lower cholesterol production and reduce dyslipidemia-associated complications. High concentrations of LDL cholesterol can lead to artery damage, potentially leading to cardiac complications and stroke. However, there are several more effective statins with more favorable adverse effect profiles. This activity outlines the indications, mechanism of action, methods of administration, significant adverse effects, contraindications, and monitoring, of simvastatin, so providers can direct patient therapy in treating hyperlipidemia as part of the interprofessional team.

Is simvastatin contraindicated for pregnant women?

Patients with contraindications to simvastatin pharmacotherapy include those with active liver disease, including those who have elevated hepatic enzymes, pregnancy, and women who may become pregnant or who are breastfeeding . Concomitant use with certain medications (see above) is also a contraindication with simvastatin, and drug profiles should undergo a careful review prior to initiation.

Which drugs are associated with increased risk of serious myopathy?

Fibrates/or Nicotinic Acid, Erythromycin, Clarithromycin: May also be associated with an increased risk of serious myopathy. Itraconazole and Ketoconazole: Increase risk of myopathy with simvastatin. Warfarin: Anticoagulant effects of warfarin increased by simvastatin.

Is simvastatin contraindicated?

If there is active hepatic disease or persistent raised liver aminotransaminases, then administration of simvastatin is contraindicated.

Is simvastatin a reductase inhibitor?

Simvastatin is a potent inhibitor of HMG-CoA reductase. Inhibition of HMG-CoA reductase is the basis for an assay in pharmacokinetic studies of the b-hydroxy acid metabolites (active inhibitors) and, following base hydrolysis, active plus latent inhibitors (total inhibitors) in plasma following administration of simvastatin.

Where to report simvastatin side effects?

Report side effects from the use of simvastatin-containing medicines to the FDA MedWatch program, using the information in the "Contact Us" box at the bottom of this page.

Where to report adverse events involving simvastatin?

Report adverse events involving simvastatin-containing medicines to the FDA MedWatch program using the information in the "Contact Us" box at the bottom of this page .

How much does simvastatin lower LDL?

The 80-mg dose lowers the LDL cholesterol by an additional 6% over simvastatin 40 mg. It is estimated that approximately 2.1 million patients in the U.S. were prescribed a product containing 80-mg simvastatin in year 2010.

Why is simvastatin 80 mg safe?

Food and Drug Administration (FDA) is recommending limiting the use of the highest approved dose of the cholesterol-lowering medication, simvastatin (80 mg) because of increased risk of muscle damage. Simvastatin 80 mg should be used only in patients who have been taking this dose for 12 months ...

When did the FDA review simvastatin?

In March 2010, FDA announced it was reviewing the safety of simvastatin in the Agency's Ongoing safety review of high-dose Zocor (simvastatin) and increased risk of muscle injury

Is simvastatin a dosing restriction?

FDA has revised the drug labels for simvastatin and Vytorin to include the new dosing restriction for the 80-mg dose. The labels for simvastatin, Vytorin, and Simcor were also revised to include new dosing recommendations when these drugs are used with certain medicines that interact with simvastatin to increase the level of simvastatin in the body.

Can you take simvastatin 80 mg?

Simvastatin 80 mg should be used only in patients who have been taking this dose for 12 months or more without evidence of muscle injury (myopathy). Simvastatin 80 mg should not be started in new patients, including patients already taking lower doses of the drug. In addition to these new limitations, FDA is requiring changes to ...

How to prevent statin side effects?

Try coenzyme Q10 supplements. Coenzyme Q10 supplements may help prevent statin side effects in some people, though more studies are needed to determine any benefits of taking it. Talk to your doctor first to make sure the supplement won't interact with any of your other medications.

What drugs interact with statins?

Some drugs that may interact with statins and increase your risk of side effects include: Amiodarone (Cordarone, Pacerone), a medication for irregular heart rhythms. Gemfibrozil (Lopid), another variety of cholesterol drug.

Can statins cause heart attacks?

Having too much cholesterol in your blood increases your risk of heart attacks and strokes. Statins block a substance your liver needs to make cholesterol. This causes your liver to remove cholesterol from your blood. If you think you're experiencing side effects from statins, don't just stop taking the pills.

Does statin help with heart attack?

Sign up now. Statin side effects: Weigh the benefits and risks. Statins are effective at lowering cholesterol and protecting against a heart attack and stroke, although they may lead to side effects for some people. By Mayo Clinic Staff.

Can statins cause liver damage?

While statins are highly effective and safe for most people, they have been linked to muscle pain, digestive problems and mental fuzziness in some people who take them and may rarely cause liver damage.

Do statins increase blood sugar?

Statins prevent heart attacks in people with diabetes, so the relevance of the mild increase in sugar values with statins observed in some people is unclear. The benefit of taking statins likely outweighs the small risk to have the blood sugar level go up. Talk to your doctor if you have concerns.

Can statins cause diabetes?

It's possible your blood sugar ( blood glucose) level may increase when you take a statin, which may lead to developing type 2 diabetes. The risk is small but important enough that the Food and Drug Administration (FDA) has issued a warning on statin labels regarding blood glucose levels and diabetes.

What is simvastatin used for?

Statin drugs are used together with diet and exercise to reduce blood levels of low-density lipoprotein (LDL) cholesterol ("bad cholesterol").

Is Simvastatin a generic?

Simvastatin is sold as a single-ingredient generic medication and under the brand-name Zocor. It is also sold in combination with ezetimibe as Vytorin, and niacin as Simcor. To report any serious adverse events associated with the use of this drug, please contact the FDA MedWatch program using the contact information at the bottom of this sheet.

Indications and Usage For Simvastatin

Dosage and Administration

Dosage Forms and Strengths

Contraindications

Warnings and Precautions

Adverse Reactions

Drug Interactions

Use in Specific Populations

• Simvastatin tablets are contraindicated in the following conditions: • Concomitant use of strong CYP3A4 inhibitors (select azole anti-fungals, macrolide antibiotics, anti-viral medications, and nefazodone) [see Drug Interactions ( 7.1)]. • Concomitant use of cyclosporine, danazol or gemfibrozil [see Drug Interactions ( 7.1)]. • Acute liver failure ...

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Overdosage

Simvastatin Description