英文：LIVALO TABLETS
 
中文：匹伐他汀钙片

适合病症：用于高血脂症和家族性高胆固醇血症的治疗

药品形状：片剂

リバロ錠1mg／リバロ錠2mg／*リバロ錠4mg

商標名 LIVALO TAB 一般名 ピタバスタチンカルシウム（Pitavastatin Calcium） 化学名 (＋)-monocalcium bis{(3R,5S,6E)-7-[2-cyclopropyl-4-(4-fluorophenyl)-3-quinolyl]-3,5-dihydroxy-6-heptenoate} 構造式 分子式 C50H46CaF2N2O8 分子量 880.98 性状 白色～微黄色の粉末で、においはない。ピリジン又はテトラヒドロフランに溶けやすく、エチレングリコールにやや溶けやすく、メタノールに溶けにくく、水又はエタノール（99.5）に極めて溶けにくく、アセトニトリル又はジエチルエーテルにほとんど溶けない。希塩酸に溶ける。

包装

リバロ錠1mg　　PTP：100錠、140錠（14錠×10）、500錠、700錠（14錠×50）

リバロ錠1mg　　瓶：500錠

リバロ錠2mg　　PTP：100錠、140錠（14錠×10）、500錠、700錠（14錠×50）、1000錠

リバロ錠2mg　　瓶：500錠

*リバロ錠4mg　　PTP：100錠

販売元
興和創薬株式会社

完整处方说明：http://www.info.pmda.go.jp/go/pack/2189016F1028_1_20/

品名
英文：LIVALO TABLETS1mg
リバロ錠1mg
匹伐他汀钙片1mg   
日文：リバロ錠1mg   
中文：匹伐他汀钙片1mg
有效成分
英文：Pitavastatin Calcium
日文：ピタバスタチンカルシウム
中文：
生产厂家：第一三共株式会社
适合病症：用于高血脂症和家族性高胆固醇血症的治疗
批准上市时间：2003年9月

ピタバスタチンカルシウム錠1mg「テバ」

LivaloGeneric Name: pitavastatin (Oral route)

pi-tav-a-STAT-in

Commonly used brand name(s):

In the U.S.

Livalo
Available Dosage Forms:

Tablet
Pharmacologic Class: HMG-COA Reductase Inhibitor

Uses For Livalo
Pitavastatin is used together with a proper diet to treat high cholesterol levels and high triglyceride (fat) levels in the blood. High levels of cholesterol or triglycerides can clog blood vessels and cause medical problems. Pitavastatin may help prevent some medical problems that are caused by clogged blood vessels.

Pitavastatin belongs to the group of medicines called HMG-CoA reductase inhibitors or "statins". It works by blocking an enzyme that is needed by the body to make cholesterol. This reduces the amount of cholesterol in the blood.

This medicine is available only with your doctor's prescription.

Before Using Livalo
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of pitavastatin in the pediatric population. Safety and efficacy have not been established.

Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of pitavastatin in the elderly. However, elderly patients are more likely to have kidney problems, which may require an adjustment in the dose for patients receiving pitavastatin.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	X	Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Cyclosporine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Erythromycin
• Fenofibrate
• Gemfibrozil
• Lopinavir
• Niacin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Rifampin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse, or history of or
• Dehydration or
• Hypotension (low blood pressure) or
• Hypothyroidism (underactive thyroid), not adequately treated or
• Infection, severe or
• Myopathy (muscle pain or weakness), active or history of or
• Seizures, uncontrolled or
• Surgery, major and recent or
• Trauma (injury), major and recent—Use with caution. May increase risks for more serious side effects.

• Kidney disease—Use with caution. Effects may be increased because of slower removal of the medicine from the body.

• Kidney disease, severe and not using dialysis treatments or
• Liver disease, active—Should not be used in patients with these conditions.

Proper Use of Livalo

Use this medicine only as directed by your doctor. Do not use more or less of it, and do not use it more or less often than your doctor ordered.

Before prescribing medicine for your high cholesterol, your doctor will probably try to control it by changing your diet. The diet may be low in fats, sugars, or cholesterol. Carefully follow the diet your doctor gave you. The medicine will work better when it is used together with a modified diet and exercise.

Remember that this medicine will not cure your high cholesterol, but it does help control it. You must continue to take it as directed if you want to keep your cholesterol levels low.

You may take this medicine with or without food.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For high cholesterol:
    • Adults—At first, 2 milligrams (mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 4 mg a day.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, 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 dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Livalo

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

Do not use cyclosporine (Gengraf®, Neoral®, Sandimmune®) while you are taking this medicine. Using these medicines together may cause serious side effects.

Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness along with unusual tiredness or fever. These may be symptoms of serious muscle conditions called myopathy and rhabdomyolysis.

Do not use excessive amounts of alcohol while taking pitavastatin. This could cause side effects in the liver.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Livalo Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

• Difficulty with moving
• joint pain
• muscle aching or cramping
• muscle pains or stiffness
• pain in the arms and legs
• swollen joints

Incidence not known

• Chills
• cough
• diarrhea
• fever
• general feeling of discomfort or illness
• headache
• loss of appetite
• nausea
• runny nose
• shivering
• sore throat
• sweating
• trouble with sleeping
• unusual tiredness or weakness
• vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Back pain
• difficulty having a bowel movement (stool)

Incidence not known

• Hives or welts
• itching skin
• rash
• redness of the skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.