red yeast rice

Pronunciation:	RED YEAST RICE
Brand:	Cholestin

What is the most important information I should know about red yeast rice?

Red yeast rice has not been approved by the FDA to treat any disease, and it should not be substituted for prescription medications.

Red yeast rice has not been evaluated by the FDA for safety, effectiveness, or purity. All potential risks and/or advantages of red yeast rice may not be known. Additionally, there are no regulated manufacturing standards in place for these compounds. Some marketed herbal supplements have been found to be contaminated with toxic metals or other drugs. Herbal/health supplements should be purchased from a reliable source to minimize the risk of contamination.

Some cholesterol-lowering medications can cause a condition that results in the breakdown of skeletal muscle tissue. This condition can lead to kidney failure. Call a doctor at once if you have unexplained muscle pain or tenderness, muscle weakness, fever or flu symptoms, and dark colored urine.

Avoid drinking alcohol while using red yeast rice. Alcohol may increase your risk of liver damage.

What is red yeast rice?

Red yeast rice is a product of yeast that is grown on rice. It is marketed as Cholestin, Monascus, Zhi Tai, hong qu, red koji, red rice, Xue Zhi Kang, and others.

Red yeast rice has been used with diet, exercise, and medical care to lower cholesterol and triglyceride levels. It may reduce levels of "bad" cholesterol (low-density lipoprotein, or LDL) and triglycerides in the blood, and may also increase levels of "good" cholesterol (high-density lipoprotein, or HDL).

Red yeast rice has not been approved by the FDA to treat any disease, and it should not be substituted for prescription medications.

Red yeast rice may also have uses other than those listed in this medication guide.

What should I discuss with my healthcare provider before taking red yeast rice?

Do not take red yeast rice if you are allergic to it, or if you have a history of liver disease.

Before taking red yeast rice, talk to your doctor, pharmacist, herbalist, or other healthcare provider. You may not be able to use this product if you have:

asthma;
kidney disease;
a serious infection, disease, or medical condition;
if you are pregnant;
if you have recently had surgery or an organ transplant; or
if you drink more than 2 alcoholic beverages per day.

If you have any of these conditions, it may be dangerous for you to use red yeast rice.

Do not take red yeast rice without telling your doctor if you are pregnant or plan to become pregnant during treatment. Red yeast rice may be harmful to an unborn baby.

It is not known whether red yeast rice passes into breast milk or if it could harm a nursing baby. Do not use this product without telling your doctor if you are breast-feeding a baby.

Do not give any herbal/health supplement to a child without the advice of a doctor.

How should I take red yeast rice?

When considering the use of herbal supplements, seek the advice of your doctor. You may also consider consulting a practitioner who is trained in the use of herbal/health supplements.

If you choose to take red yeast rice, use it as directed on the package or as directed by your doctor, pharmacist, or other healthcare provider. Do not use more of this product than is recommended on the label.

Red yeast rice is available in a capsule formulation.

Other forms of red yeast rice may also be available, such as tablets, teas, tinctures, and topical forms. Do not use many different forms of red yeast rice together at the same time, unless you healthcare provider instructs you to. Using different forms together may increase your risk of an overdose of red yeast rice.

Red yeast rice should be taken with food to reduce stomach upset.

Store red yeast rice in a sealed container as directed on the product label, away from moisture, heat, and light.

What happens if I miss a dose?

No information is available about missing a dose of red yeast rice. Consult your doctor, pharmacist, or healthcare provider for instructions if you miss a dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this product.

Symptoms of a red yeast rice overdose may include stomach pain or upset.

What should I avoid while taking red yeast rice?

Avoid drinking alcohol while using red yeast rice. Alcohol may increase your risk of liver damage.

Grapefruit and grapefruit juice may interact with red yeast rice and lead to potentially dangerous effects. Discuss the use of grapefruit products with your healthcare provider. Do not increase or decrease the amount of grapefruit products in your diet without first talking to your healthcare provider.

What are the possible side effects of red yeast rice?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using red yeast rice and call your doctor at once if you have any of these serious side effects:

muscle pain, tenderness, or weakness with fever or flu symptoms and dark colored urine; or
urinating less than usual or not at all.

Less serious side effects may be more likely to occur, such as:

upset stomach;
heartburn;
gas, bloating;
mild headache; or
dizziness.

Side effects other than those listed here may also occur. Talk to your doctor, pharmacist, or healthcare provider about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect red yeast rice?

Do not take red yeast rice without the advice of a doctor if you are using any of the following medications:

cyclosporine (Sandimmune, Neoral, Gengraf);
antibiotics such as azithromycin (Zithromax), clarithromycin (Biaxin), erythromycin (E-Mycin, E.E.S., Ery-Tab, Erythrocin), itraconazole (Sporanox), or ketoconazole (Nizoral);
other cholesterol-lowering medications, such as atorvastatin (Lipitor), cerivastatin (Baycol), clofibrate (Atromid-S), gemfibrozil (Lopid), fenofibrate (Tricor), fluvastatin (Lescol), lovastatin (Mevacor), pravastatin (Pravachol), or simvastatin (Zocor);
niacin (Niacor, Nicobid, Niaspan, Nicolar, Nicotinex, Slo-Niacin, others);
itraconazole (Sporanox) or ketoconazole (Nizoral);
danazol (Danazol, Danocrine);
nefazodone (Serzone); or
HIV medication such as nevirapine (Viramune), delavirdine (Rescriptor), efavirenz (Sustiva), indinavir (Crixivan), ritonavir (Norvir), saquinavir (Invirase), or nelfinavir (Viracept).

If you are using any of these drugs, you may not be able to use red yeast rice, or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect red yeast rice. Tell your healthcare provider about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your healthcare provider.

Where can I get more information?

Your doctor, pharmacist, or healthcare provider may have more information about red yeast rice.

Consultation with a licensed healthcare professional is advisable before using any herbal/health supplement. Additionally, consultation with a practitioner trained in the uses of herbal/health supplements may be beneficial and coordination of treatment among all healthcare providers involved may be advantageous. Remember, keep this and all other prescription drug products, over-the-counter drug products, and herbal/health supplements out of the reach of children.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2003 Cerner Multum, Inc. Version: 4.03. Revision date: 2/14/07.

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