藥品異動通知2024.01.08

藥理作用/作用機轉

適應症/

劑量

PO

【Adult】

　●Hypercholesterolemia: 1 # QD.

【Pediatric】Safety and efficacy not established.

【Geriatric】Refer to adult dosing.

『Renal Impairment: Adult』

GFR 15 to 59 mL/minute/1.73 m2: 1 mg QD; maximum: 2 mg QD

『Hepatic Impairment: Adult』

Moderate to severe impairment (Child-Pugh class B or C): Use of ezetimibe not recommended.

使用禁忌

Hypersensitivity to pitavastatin/ezetimibe or any component of the formulation; active liver disease or decompensated cirrhosis; coadministration with cyclosporine.

警告/預防

Hepatotoxicity, DM, Myopathy/Rhabdomyolysis,

不良反應

【>10%】Constipation , diarrhea, Back pain, myalgia, Increased serum transaminases, Arthralgia, Sinusitis, upper respiratory tract infection

【Frequency not defined】Influenza, headache, nasopharyngitis, erythema multiforme, abdominal pain, cholecystitis, cholelithiasis, nausea, pancreatitis, thrombocytopenia, autoimmune hepatitis, cholestatic hepatitis , hepatocellular hepatitis, anaphylaxis, angioedema, depression, dizziness, headache, paresthesia, increased creatine phosphokinase in blood specimen, myalgia, myopathy, rhabdomyolysis, night blindness, photophobia, vision color changes, visual field loss.

懷孕用藥分級(FDA)

X / 致畸胎性

健保規範

• 藥品說明：

• 藥品理由：

比照24A119

其他

禁止用於孕婦及授乳中的母親。

本品不得與 gemfibrozil 併用。