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藥碼

JIN04

藥名

Tolvaptan 錠劑 15 mg

英文商品名

事審 Jinarc 錠劑 15 mg

中文商品名

佳腎康錠 15mg

螢幕名

事審 Jinarc 錠劑 15 mg 綠

劑型

Tab

規格

Tolvaptan 15mg/tab

成分

藥理分類

Diuretics, Miscellaneous

健保碼

BC27341100

ATC碼

C03XA01

藥品圖片

外觀圖片

適應症

Slow the progression of kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD)

藥理

Vasopressin Antagonist

藥動學

Distribution: Vd ~3 L/kg
Protein binding: >98%
Metabolism: Almost exclusively via CYP3A4 (none are pharmacodynamically active)
Bioavailability: 56% (range: 42% to 80%)
Time to peak, plasma: 2 to 4 hours
Excretion: Feces: 59% (19% as unchanged drug); Urine: 40% (<1% as unchanged drug)
Half-life elimination: 3 hours

禁忌症

1. Hypersensitivity (eg, anaphylactic shock, generalized rash) to tolvaptan or any component of the formulation
2. Concurrent use with strong CYP3A inhibitors
3. Use in patients unable to sense or appropriately respond to thirst

懷孕分類

C
Adverse events were observed in animal reproduction studies.

哺乳分類

Breastfeeding is not recommended by the manufacturer.

副作用

Fatigue, Dizziness, Increased thirst, Nausea, Xerostomia, Diarrhea, Polyuria

劑量和給藥方法

Initial: 60 mg/day in divided doses (given as 45 mg upon wakening and 15 mg 8 hours later)

Titrate: 90 mg/day in divided doses (given as 60 mg upon wakening and 30 mg 8 hours later) to 120 mg/day in divided doses (given as 90 mg upon wakening and 30 mg 8 hours later), at least 7 days between titrations

Maintain urine osmolality of <300 mOsm/kg if possible; If the maximum dose is not tolerated, administration of a lower dose with the goal of achieving urine osmolarity of 250 to 300 mOsm/kg is reasonable

小兒調整劑量

腎功能調整劑量

CrCl >10 mL/minute: No dosage adjustment necessary.
CrCl <10 mL/minute: Use not recommended (has not been studied); contraindicated in anuria.

肝功能調整劑量

Permanently discontinue therapy
:1. ALT or AST >3 times ULN; ALT or AST >5 times ULN for >2 weeks; ALT or AST >8 times ULN at any time
2. Persistent symptoms of hepatic injury
3. Total bilirubin >2 times ULN
4. INR >1.5

Interrupt therapy, promptly evaluate hepatic function within 48 to 72 hours:
ALT or AST increased or signs/symptoms of hepatoxicity: Continue testing as necessary; if laboratory abnormalities stabilize or resolve, treatment may be reinitiated with increased monitoring

安定性

藥袋資訊

臨床用途

延緩自體顯性多囊性腎臟病之囊泡的生長及腎功能的惡化

主要副作用

肝臟損傷、疲倦、食慾不振、噁心嘔吐、發燒、皮疹、搔癢、暗色尿液或黃疸

泡製方法

儲存方式

請置於 15-30℃ 乾燥處儲存

注意事項

其他說明

藥局 Y5 | 藥庫口D12 | <以盒給藥>

藥品外觀

顏色

形狀

剝痕

標記1

OTSUKA,15

標記2

其他

健保藥價

11144

自費價

13372.8

仿單

資料庫

健保給付規定