Lumsiva tablets

Lumsiva

  • Active Ingredient: Simvastatin
  • 40 mg, 20 mg, 10 mg
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What is Lumsiva?

The active ingredient of Lumsiva brand is simvastatin. Simvastatin is in a group of drugs called HMG CoA reductase inhibitors, or "statins." Simvastatin reduces levels of "bad" cholesterol (low-density lipoprotein, or LDL) and triglycerides in the blood, while increasing levels of "good" cholesterol (high-density lipoprotein, or HDL). Simvastatin USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets USP for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of Simvastatin and the following inactive ingredients: ascorbic acid, butylated hydroxy anisole, citric acid anhydrous, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, isopropyl alcohol, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinised starch, and titanium dioxide.

Used for

Lumsiva is used to treat diseases such as: Cardiovascular Risk Reduction, High Cholesterol, High Cholesterol, Familial Heterozygous, High Cholesterol, Familial Homozygous, Hyperlipoproteinemia, Hyperlipoproteinemia Type IIa, Elevated LDL, Hyperlipoproteinemia Type IIb, Elevated LDL VLDL, Hyperlipoproteinemia Type III, Elevated beta-VLDL IDL, Hyperlipoproteinemia Type IV, Elevated VLDL, Prevention of Cardiovascular Disease.

Side Effect

Possible side effects of Lumsiva include: runny nose; bloody or cloudy urine; inability to have or keep an erection; difficulty with moving; difficult, burning, or painful urination; weakness in the arms, hands, legs, or feet; sweating; pains in the stomach, side, or abdomen, possibly radiating to the back.

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COMMON BRAND(S): Zocor

GENERIC NAME(S): Lumsiva

OTHER NAME(S): Lumsiva Tablet

Lumsiva 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. It belongs to a group of drugs known as "statins." It works by reducing the amount of cholesterol made by the liver. Lowering "bad" cholesterol and triglycerides and raising "good" cholesterol decreases the risk of heart disease and helps prevent strokes and heart attacks.

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.

Are There Alternatives to Lumsiva?

  • Increases the liver's ability to collect and get rid of LDL cholesterol ("bad cholesterol")
  • Increases HDL cholesterol ("good cholesterol")
  • Decreases triglycerides.

Before taking this medicine

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

The following drugs can increase your risk of serious muscle problems if you take them together with Lumsiva. These drugs should not be used while you are taking this medicine:

an antibiotic--clarithromycin, erythromycin, telithromycin;

antifungal medication--itraconazole, ketoconazole, posaconazole, voriconazole;

hepatitis C medications--boceprevir, telaprevir; or

HIV/AIDS medication--atazanavir, cobicistat (Stribild, Tybost), darunavir, fosamprenavir, indinavir, nelfinavir, ritonavir, saquinavir, tipranavir.

Before you start taking Lumsiva, tell your doctor if you are already using any of these other medicines:

heart medication--amiodarone, amlodipine, diltiazem, dronedarone, ranolazine, verapamil.

To make sure Lumsiva is safe for you, tell your doctor if you have:

history of liver disease;

history of kidney disease;

a thyroid disorder; or

if you drink more than 2 alcoholic beverages daily.

Lumsiva can cause a condition that results in the breakdown of skeletal muscle tissue, potentially leading to kidney failure. This condition may be more likely to occur in older adults and in people who have kidney disease or poorly controlled hypothyroidism (underactive thyroid).

FDA pregnancy category X. This medicine can harm an unborn baby or cause birth defects. Do not take Lumsiva if you are pregnant. Stop taking this medication and tell your doctor right away if you become pregnant. Use effective birth control to avoid pregnancy while you are taking this medicine.

What other drugs will affect Lumsiva?

Many drugs can interact with Lumsiva. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment, especially:

This list is not complete and many other drugs can interact with Lumsiva. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

Serious side effects

It happens rarely, but less than 1 in 1,000 people taking Lumsiva may have a serious side effect.

Stop taking Lumsiva and call a doctor if you get:

  • muscle pain, tenderness, weakness or cramps - these can be signs of muscle breakdown and kidney damage
  • yellow skin or the whites of your eyes turn yellow, or if you have pale poo and dark pee - this can be a sign of liver problems
  • a skin rash with pink-red blotches, especially on the palms of the hands or soles of the feet
  • severe stomach pain - this can be a sign of pancreas problems
  • a cough, feeling short of breath, and weight loss - this can be a sign of lung disease

Do not exceed 10 mg Lumsiva daily with:

(Note: These drugs are contraindicated with Simcor as Simcor is only available with 20 mg or 40 mg of Lumsiva.)

Do not exceed 20 mg Lumsiva daily with:

  • Amiodarone
  • Verapamil

What Are Side Effects Associated with Using Lumsiva?

Common side effects of Lumsiva include:

Less common side effects of Lumsiva include:

Postmarketing side effects of Lumsiva reported include:

  • Erectile dysfunction
  • Interstitial lung disease
  • Rare reports of cognitive impairment (e.g., memory loss, forgetfulness, amnesia, memory impairment, confusion) associated with statin use

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

What should I discuss with my healthcare provider before taking Lumsiva (Flolipid, Zocor)?

You should not take Lumsiva if you are allergic to it, or if:

  • you have active liver disease; or
  • you are pregnant or breast-feeding.

Some medicines can cause unwanted or dangerous effects when used with Lumsiva. Your doctor may change your treatment plan if you also use medicine such as:

Tell your doctor if you have ever had:

  • liver disease;
  • kidney disease;
  • diabetes;
  • a thyroid disorder;
  • if you are of Asian descent; or
  • if you drink more than 2 alcoholic beverages daily.

Lumsiva can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. This condition may be more likely to occur in older adults and in people who have kidney disease or poorly controlled hypothyroidism (underactive thyroid).

Do not use Lumsiva if you are pregnant. It could harm the unborn baby or cause birth defects. Use effective birth control to prevent pregnancy while you are using this medicine. Stop taking Lumsiva and tell your doctor right away if you become pregnant.

It is not safe to breast-feed a baby while you are using this medicine.

If side effects occur, or if you do not respond well to Lumsiva, alternatives to the medication are available. A number of other medicines used for treating high cholesterol include other statins (the class of drugs that Lumsiva belongs to), fibrates, bile acid sequestrants, nicotinic acid, and cholesterol absorption inhibitors. You may have better results with one of these alternatives.

Q: What effects does Zocor have on the liver? I had hepatitis B 30 years ago. I understand that vitamin C supplements should be limited. Is that also correct? Also, is coQ10 reduced in the liver? This is important for the heart, correct?

A: Zocor (Lumsiva) can increase liver enzymes occasionally. Doctors usually watch this by doing blood tests periodically. Studies show that it is usually well-tolerated and taken by many patients. Please keep up with doctor's appointments so that liver function can be continuously monitored. Studies suggest that vitamin C is a excreted through the urine since it is water-soluble. Many medications are metabolized in the liver and therefore, with the history of hepatitis, it is important to monitor liver function frequently. Coenzyme Q10 is sometimes taken to combat the side effects of statins (medications like Zocor) such as muscle pain. Controlling high cholesterol is very important in promoting heart health. Please consult your physician prior to starting any new medications.

Q: My ankles and legs have been swelling frequently since starting Zocor. Can the medication cause this?

A: Zocor (Lumsiva) is classified as a HMG-CoA reductase inhibitor antilipemic agent, commonly referred to as a "statin". Zocor works in the body to lower LDL or bad cholesterol, lower triglycerides and increase HDL or good cholesterol. Zocor is used for the treatment of high cholesterol and other uses. Some of the most common side effects of Zocor include: upper respiratory infection, abdominal pain, headache, constipation, and nausea. Zocor may also cause muscle aches, tenderness, or weakness, and these may be signs of a serious medical condition, and should be reported promptly to a health care provider. According to medical references, edema (swelling) is a possible side effect reported by studied patients taking Zocor. Edema is reported at an incidence of 3% versus 2% reported in patients taking a placebo. If you think that you are experiencing a side effect from your Zocor, the recommendation is made to talk to your physician. Your physician can provide further guidance in regards to your swelling. Swelling in the lower extremities can also be signs and symptoms of various medical conditions. Your physician can rule out any other cause for the swelling. Jen Marsico, RPh

See also:

Lumsiva may pass into breast milk and could harm a nursing baby. Do not breast-feed while you are taking this medicine.

Q: Can Zocor elevate triglyceride levels? I do know that it is meant to lower cholesterol levels but since I have been taking it my triglycerides continue to become more elevated with each blood test.

A: There have been isolated cases where Zocor has increased triglycerides levels, however this is not typical. This should be addressed with your provider, as he or she may want to test you to make sure that Zocor (Lumsiva) is not affecting your liver in a non-productive way. Please visit us here for more information on Zocor: //www.everydayhealth.com/drugs/zocor Matt Curley, Pharm D. MSCIS

Strong CYP3A4 Inhibitors

These drugs block your body from breaking down Lumsiva. This can lead to very high levels of the drug in your body. It can also increase side effects, including rhabdomyolysis.

These drugs should not be used with Lumsiva. If treatment with these drugs is required, the use of Lumsiva must be on hold during the course of treatment. Examples of these drugs include:

  • ketoconazole
  • itraconazole
  • voriconazole
  • posaconazole
  • erythromycin
  • clarithromycin
  • telithromycin
  • cyclosporine
  • danazol
  • nefazodone
  • boceprevir
  • telaprevir
  • ritonavir
  • tipranavir
  • indinavir
  • fosamprenavir
  • darunavir
  • atazanavir
  • nelfinavir
  • cobicistat

How it works

Lumsiva belongs to the drug class known as HMG-CoA reductase inhibitors, also called statins. A class of drugs is a group of medications that work in a similar way. These drugs are often used to treat similar conditions.

Statins work to reduce the body’s cholesterol production. They also reduce the amount of cholesterol and triglycerides moving through the body. High cholesterol and triglycerides are associated with increased risk of:

Statins are usually used in combination with lifestyle changes, such as changes to diet and exercise.

Lumsiva oral tablet doesn’t drowsiness, but it can cause other side effects.

How are doctors sure that statins really are safe and beneficial?

Statins have been studied more than nearly any other drug that people take. In fact, more than 170,000 people who take statins have been studied in detail and for extended periods of time. We certainly know the benefits of statins.

We also understand the risks of statins. In some instances, after doctors have prescribed a drug for 10 years or more, it is taken off the market because of unforeseen, adverse side effects. We’ve been prescribing statins since the 1990s for patients at high risk for stroke and heart disease. With statins, the side effects actually are well known. But how can we put that in perspective?

Any focus on statin side effects needs to be counterbalanced by the fact that statins reduce people’s risk of dying from heart attack, heart disease, or stroke. Data from the 2008 JUPITER Trial suggest a 54 percent heart attack risk reduction and a 48 percent stroke risk reduction in people at risk for heart disease who used statins as preventive medicine. The data are not speculative; rather, they reflect statins’ real potential to save lives and avoid illness.

There are many varieties of brand name and generic statins available. All statins work in more or less the same way to lower bad cholesterol (LDL cholesterol) in patients at high risk for cardiac events.

Below are a few of the common brand names you may recognize, along with their generic counterparts:

  • Lipitor (atorvastatin)
  • Crestor (rosuvastatin)
  • Mevacor (lovastatin)
  • Lescol (fluvastatin)
  • Pravachol (pravastatin)
  • Zocor (Lumsiva)
  • Livalo (pitavastatin)
  • Vytorin (Lumsiva/ezetimibe)

home drugs a-z list Lumsiva(Oral Suspension) side effects drug center

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Lumsiva oral suspension is an HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet to: reduce the risk of total mortality by reducing CHD deaths and reduce the risk of non-fatal myocardial infarction, stroke, and the need for revascularization procedures in patients at high risk of coronary events; reduce elevated total-C, LDL-C, Apo B, TG and increase HDL-C in patients with primary hyperlipidemia (heterozygous familial and nonfamilial) and mixed dyslipidemia; reduce elevated TG in patients with hypertriglyceridemia and reduce TG and VLDL-C in patients with primary dysbetalipoproteinemia; reduce total-C and LDL-C in adult patients with homozygous familial hypercholesterolemia; and reduce elevated total-C, LDL-C, and Apo B in boys and postmenarchal girls, 10 to 17 years of age with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy. Common side effects of Lumsiva include

The dose range of Lumsiva is 5 to 40 mg/day. Lumsiva may interact with azole antifungals, macrolide antibiotics, HIV protease inhibitors, boceprevir, telaprevir, nefazodone, cobicistat-containing products, gemfibrozil, cyclosporine, danazol, verapamil, diltiazem, dronedarone, amiodarone, amlodipine, ranolazine, lomitapide, colchicine, niacin, and grapefruit juice. Tell your doctor all medications and supplements you use. Lumsiva oral is not recommended for use during pregnancy; it may harm a fetus. Women taking Lumsiva oral should discuss contraception with their doctor. It is unknown if Lumsiva oral passes into breast milk. Because of the potential for undesirable side effects in a nursing infant, breastfeeding while taking Lumsiva oral is not recommended.

Our Lumsiva oral suspension Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

Q: I have a scratched cornea and dry eye. I've been suffering for the past five weeks with this, ever since my doctor increased my dosage of Zocor. Can this be causing my dry and painful eye?

A: Dry and painful eyes are not reported side effects for Zocor (Lumsiva). You should contact your health care provider about your eye pain to determine the cause and possible treatment options. For more information regarding Zocor (Lumsiva), go to //www.everydayhealth.com/drugs/zocor. Beth Isaac, PharmD


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