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仿單摘錄表（腎功能／肝功能／兒科）

劑量資料摘錄自所列來源原文，請以最新仿單與臨床判斷為準。除法律另有規定或作者有故意、重大過失外，作者對前述損害不負責任；本條款不排除使用者依法不得預先拋棄之權利。閱讀免責聲明

資料來源：Data provided by the U.S. Food and Drug Administration（https://open.fda.gov），openFDA drug label API｜授權：CC0 1.0 Universal（另有標示者除外；部分資料可能涉及第三方權利，third party rights may apply）｜openFDA terms
The drug labeling provided in this API may not be the labeling on currently distributed products or identical to the labeling that is approved.The drug labeling and other information has been reformatted to make it easier to read but its content has neither been altered nor verified by FDA. （openFDA drug label disclaimer）
Do not rely on openFDA to make decisions regarding medical care.本資訊不作為臨床診斷或處方決策依據。

Source: National Library of Medicine (DailyMed)（https://dailymed.nlm.nih.gov）
本表文字摘錄自美國仿單（US labeling），不是我國核准之仿單，且未經 FDA 驗證（not verified by FDA）。

共 11 筆摘錄。

查無符合的摘錄條目。請換一個藥名或成分，或改選「全部類型」。

• metformin

  AI 已核對（說明）

  由 AI 逐字比對來源仿單，非作者本人審閱。

  美國 FDA 仿單（US label） 腎功能 成人・口服緩釋錠

  適用範圍

  成人・口服緩釋錠

  成分

  METFORMIN HYDROCHLORIDE

  商品名

  Metformin

  給藥途徑

  ORAL

  劑型

  TABLET, EXTENDED RELEASE

  調整類型

  腎功能

  來源

  US FDA label (SPL): Metformin, REMEDYREPACK INC.

  章節

  2.4 Recommended Dosage in Patients With Renal Impairment

  仿單版本

  2026-09-09

  擷取日期

  2026-10-20

  Set ID

  05999192-ebc6-4198-bd1e-f46abbfb4f8a

  2.4 Recommended Dosage in Patients With Renal Impairment • Assess renal function prior to initiation of metformin hydrochloride extended-release tablets and periodically thereafter. • Metformin hydrochloride extended-release tablets are contraindicated in patients with an estimated glomerular filtration rate (eGFR) below 30 mL/minute/1.73 m 2 . • Initiation of metformin hydrochloride extended-release tablets in patients with an eGFR between 30 to 45 mL/minute/1.73 m 2 is not recommended. • In patients taking metformin hydrochloride extended-release tablets whose eGFR later falls below 45 mL/min/1.73 m 2 , assess the benefit risk of continuing therapy. • Discontinue metformin hydrochloride extended-release tablets if the patient’s eGFR later falls below 30 mL/minute/1.73 m 2 [see Warnings and Precautions (5.1) ].

  相關段落（同一份仿單的整段原文）

  2.5 Discontinuation for Iodinated Contrast Imaging Procedures Discontinue metformin hydrochloride extended-release tablets at the time of, or prior to, an iodinated contrast imaging procedure in patients with an eGFR between 30 and 60 mL/min/1.73 m 2 ; in patients with a history of liver disease, alcoholism, or heart failure; or in patients who will be administered intra-arterial iodinated contrast. Re-evaluate eGFR 48 hours after the imaging procedure; restart metformin hydrochloride extended-release tablets if renal function is stable.

  引用段落請見原仿單：DailyMed 原仿單（新分頁）

  在 DailyMed 開啟原始仿單（新分頁）

• metformin

  AI 已核對（說明）

  由 AI 逐字比對來源仿單，非作者本人審閱。

  美國 FDA 仿單（US label） 腎功能 口服錠（速放）

  適用範圍

  口服錠（速放）

  成分

  METFORMIN HYDROCHLORIDE

  商品名

  METFORMIN HYDROCHLORIDE

  給藥途徑

  ORAL

  劑型

  TABLET, FILM COATED

  調整類型

  腎功能

  來源

  US FDA label (SPL): METFORMIN HYDROCHLORIDE, Quallent Pharmaceuticals Health LLC

  章節

  2.3 Recommendations for Use in Renal Impairment

  仿單版本

  2026-08-12

  擷取日期

  2026-10-20

  Set ID

  25be863d-490c-47f6-9ad3-c828dc43fbf0

  2.3 Recommendations for Use in Renal Impairment Assess renal function prior to initiation of metformin hydrochloride tablets and periodically thereafter. Metformin hydrochloride tablets are contraindicated in patients with an estimated glomerular filtration rate (eGFR) below 30 mL/minute/1.73 m 2 . Initiation of metformin hydrochloride tablets in patients with an eGFR between 30 mL/minute/1.73 m 2 to 45 mL/minute/1.73 m 2 is not recommended. In patients taking metformin hydrochloride tablets whose eGFR later falls below 45 mL/min/1.73 m 2 , assess the benefit risk of continuing therapy. Discontinue metformin hydrochloride tablets if the patient's eGFR later falls below 30 mL/minute/1.73 m 2 [see Warnings and Precautions ( 5.1 )] .

  相關段落（同一份仿單的整段原文）

  2.4 Discontinuation for Iodinated Contrast Imaging Procedures Discontinue metformin hydrochloride tablets at the time of, or prior to, an iodinated contrast imaging procedure in patients with an eGFR between 30 mL/min/1.73 m 2 and 60 mL/min/1.73 m 2 ; in patients with a history of liver disease, alcoholism, or heart failure; or in patients who will be administered intra-arterial iodinated contrast. Re-evaluate eGFR 48 hours after the imaging procedure; restart metformin hydrochloride tablets if renal function is stable.

  引用段落請見原仿單：DailyMed 原仿單（新分頁）

  在 DailyMed 開啟原始仿單（新分頁）

• enoxaparin

  AI 已核對（說明）

  由 AI 逐字比對來源仿單，非作者本人審閱。

  美國 FDA 仿單（US label） 腎功能 成人・皮下／靜脈注射

  適用範圍

  成人・皮下／靜脈注射

  成分

  ENOXAPARIN SODIUM

  商品名

  Lovenox

  給藥途徑

  SUBCUTANEOUS, INTRAVENOUS

  劑型

  INJECTION

  調整類型

  腎功能

  來源

  US FDA label (SPL): Lovenox, Sanofi-Aventis U.S. LLC

  章節

  2.3 Dose Reduction for Patients with Severe Renal Impairment

  仿單版本

  2026-05-28

  擷取日期

  2026-10-20

  Set ID

  5017a927-2a24-4f27-89f9-27c805bf7d59

  2.3 Dose Reduction for Patients with Severe Renal Impairment The recommended prophylaxis and treatment dosage regimens for patients with severe renal impairment (creatinine clearance <30 mL/min) are described in Table 1 [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3) ] .

  Table 1: Dosage Regimens for Patients with Severe Renal Impairment (creatinine clearance <30 mL/minute)

  Indication	Dosage Regimen
  Prophylaxis in abdominal surgery	30 mg administered subcutaneously once daily
  Prophylaxis in hip or knee replacement surgery	30 mg administered subcutaneously once daily
  Prophylaxis in medical patients during acute illness	30 mg administered subcutaneously once daily
  Inpatient treatment of acute deep vein thrombosis with or without pulmonary embolism, when administered in conjunction with warfarin sodium	1 mg/kg administered subcutaneously once daily
  Outpatient treatment of acute deep vein thrombosis without pulmonary embolism, when administered in conjunction with warfarin sodium	1 mg/kg administered subcutaneously once daily
  Prophylaxis of ischemic complications of unstable angina and non–Q-wave myocardial infarction, when concurrently administered with aspirin	1 mg/kg administered subcutaneously once daily
  Treatment of acute ST-segment elevation myocardial infarction in patients <75 years of age, when administered in conjunction with aspirin	30 mg single intravenous bolus plus a 1 mg/kg subcutaneous dose followed by 1 mg/kg administered subcutaneously once daily
  Treatment of acute ST-segment elevation myocardial infarction in geriatric patients ≥75 years of age, when administered in conjunction with aspirin	1 mg/kg administered subcutaneously once daily (no initial bolus)

  純文字原文

  Table 1: Dosage Regimens for Patients with Severe Renal Impairment (creatinine clearance <30 mL/minute) Indication Dosage Regimen Prophylaxis in abdominal surgery 30 mg administered subcutaneously once daily Prophylaxis in hip or knee replacement surgery 30 mg administered subcutaneously once daily Prophylaxis in medical patients during acute illness 30 mg administered subcutaneously once daily Inpatient treatment of acute deep vein thrombosis with or without pulmonary embolism, when administered in conjunction with warfarin sodium 1 mg/kg administered subcutaneously once daily Outpatient treatment of acute deep vein thrombosis without pulmonary embolism, when administered in conjunction with warfarin sodium 1 mg/kg administered subcutaneously once daily Prophylaxis of ischemic complications of unstable angina and non–Q-wave myocardial infarction, when concurrently administered with aspirin 1 mg/kg administered subcutaneously once daily Treatment of acute ST-segment elevation myocardial infarction in patients <75 years of age, when administered in conjunction with aspirin 30 mg single intravenous bolus plus a 1 mg/kg subcutaneous dose followed by 1 mg/kg administered subcutaneously once daily Treatment of acute ST-segment elevation myocardial infarction in geriatric patients ≥75 years of age, when administered in conjunction with aspirin 1 mg/kg administered subcutaneously once daily (no initial bolus)

  Although no dose adjustment is recommended in patients with creatinine clearance 30 to 50 mL/min and creatinine clearance 50 to 80 mL/min, observe these patients frequently for signs and symptoms of bleeding.

  另見原仿單（本站未摘錄）

  • 2.2 Adult Dosage

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• gabapentin

  AI 已核對（說明）

  由 AI 逐字比對來源仿單，非作者本人審閱。

  美國 FDA 仿單（US label） 腎功能 十二歲以上・口服錠

  適用範圍

  十二歲以上・口服錠

  成分

  GABAPENTIN

  商品名

  GABARONE

  給藥途徑

  ORAL

  劑型

  TABLET

  調整類型

  腎功能

  來源

  US FDA label (SPL): GABARONE, INA Pharmaceutics Inc.

  章節

  2.3 Dosage Adjustment in Patients with Renal Impairment

  仿單版本

  2026-01-07

  擷取日期

  2026-10-20

  Set ID

  0f350a4b-f294-4b98-b69f-3cc789e930ba

  2.3 Dosage Adjustment in Patients with Renal Impairment Dosage adjustment in patients 12 years of age and older with renal impairment or undergoing hemodialysis is recommended, as follows (see dosing recommendations above for effective doses in each indication):

  TABLE 1. GABARONE Tablets Dosage Based on Renal Function

  TID = Three times a day; BID = Two times a day; QD = Single daily dose
  aFor patients with creatinine clearance <15 mL/min, reduce daily dose in proportion to creatinine clearance (e.g., patients with a creatinine clearance of 7.5 mL/min should receive one-half the daily dose that patients with a creatinine clearance of 15 mL/min receive).
  bPatients on hemodialysis should receive maintenance doses based on estimates of creatinine clearance as indicated in the upper portion of the table and a supplemental post-hemodialysis dose administered after each 4 hours of hemodialysis as indicated in the lower portion of the table.
  Renal Function Creatinine Clearance (mL/min)	Total Daily Dose Range (mg/day)	Dose Regimen (mg)
  ≥60	900 to 3600	300 TID	400 TID	600 TID	800 TID	1200 TID
  >30 to 59	400 to 1400	200 BID	300 BID	400 BID	500 BID	700 BID
  >15 to 29	200 to 700	200 QD	300 QD	400 QD	500 QD	700 QD
  15 a	100 to 300	100 QD	125 QD	150 QD	200 QD	300 QD
  		Post-Hemodialysis Supplemental Dose (mg) b
  Hemodialysis		125 b	150 b	200 b	250 b	350 b

  純文字原文

  TABLE 1. GABARONE Tablets Dosage Based on Renal Function TID = Three times a day; BID = Two times a day; QD = Single daily dose a For patients with creatinine clearance <15 mL/min, reduce daily dose in proportion to creatinine clearance (e.g., patients with a creatinine clearance of 7.5 mL/min should receive one-half the daily dose that patients with a creatinine clearance of 15 mL/min receive). b Patients on hemodialysis should receive maintenance doses based on estimates of creatinine clearance as indicated in the upper portion of the table and a supplemental post-hemodialysis dose administered after each 4 hours of hemodialysis as indicated in the lower portion of the table. Renal Function Creatinine Clearance (mL/min) Total Daily Dose Range (mg/day) Dose Regimen (mg) ≥60 900 to 3600 300 TID 400 TID 600 TID 800 TID 1200 TID >30 to 59 400 to 1400 200 BID 300 BID 400 BID 500 BID 700 BID >15 to 29 200 to 700 200 QD 300 QD 400 QD 500 QD 700 QD 15 a 100 to 300 100 QD 125 QD 150 QD 200 QD 300 QD Post-Hemodialysis Supplemental Dose (mg) b Hemodialysis 125 b 150 b 200 b 250 b 350 b

  Creatinine clearance (CLCr) is difficult to measure in outpatients. In patients with stable renal function, creatinine clearance can be reasonably well estimated using the equation of Cockcroft and Gault:

  CLCr	=	[140 – age (years)] x weight (kg)	(x 0.85 for female patients)
  		72 x serum creatinine (mg/dL)

  純文字原文

  CLCr = [140 – age (years)] x weight (kg) (x 0.85 for female patients) 72 x serum creatinine (mg/dL)

  The use of GABARONE in patients less than 12 years of age with compromised renal function has not been studied.

  在 DailyMed 開啟原始仿單（新分頁）

• levetiracetam

  AI 已核對（說明）

  由 AI 逐字比對來源仿單，非作者本人審閱。

  美國 FDA 仿單（US label） 腎功能 成人・口服

  適用範圍

  成人・口服

  成分

  LEVETIRACETAM

  商品名

  Keppra

  給藥途徑

  ORAL

  劑型

  SOLUTION; TABLET, FILM COATED

  調整類型

  腎功能

  來源

  US FDA label (SPL): Keppra, UCB, Inc.

  章節

  2.5 Dosage Adjustments in Adult Patients with Renal Impairment

  仿單版本

  2026-01-28

  擷取日期

  2026-10-20

  Set ID

  3ca9df05-a506-4ec8-a4fe-320f1219ab21

  2.5 Dosage Adjustments in Adult Patients with Renal Impairment KEPPRA dosing must be individualized according to the patient's renal function status. Recommended dosage adjustments for adults are shown in Table 1. In order to calculate the dose recommended for patients with renal impairment, creatinine clearance adjusted for body surface area must be calculated. To do this an estimate of the patient's creatinine clearance (CLcr) in mL/min must first be calculated using the following formula:

  CLcr=

  [140-age (years)] × weight (kg) ---------------------------------------- 72 × serum creatinine (mg/dL)

  (× 0.85 for female patients)

  純文字原文

  CLcr= [140-age (years)] × weight (kg) ---------------------------------------- 72 × serum creatinine (mg/dL) (× 0.85 for female patients)

  Then CLcr is adjusted for body surface area (BSA) as follows:

  CLcr (mL/min/1.73m 2)=

  CLcr (mL/min) ------------------------------ BSA subject (m 2)

  × 1.73

  純文字原文

  CLcr (mL/min/1.73m 2 )= CLcr (mL/min) ------------------------------ BSA subject (m 2 ) × 1.73

  Table 1: Dosing Adjustment Regimen for Adult Patients with Renal Impairment

  Group	Creatinine Clearance (mL/min/1.73m 2)	Dosage (mg)	Frequency
  Normal	> 80	500 to 1,500	Every 12 hours
  Mild	50 – 80	500 to 1,000	Every 12 hours
  Moderate	30 – 50	250 to 750	Every 12 hours
  Severe	< 30	250 to 500	Every 12 hours
  ESRD patients using dialysis	----	500 to 1,000 Following dialysis, a 250 to 500 mg supplemental dose is recommended.	Every 24 hours

  純文字原文

  Table 1: Dosing Adjustment Regimen for Adult Patients with Renal Impairment Group Creatinine Clearance (mL/min/1.73m 2 ) Dosage (mg) Frequency Normal > 80 500 to 1,500 Every 12 hours Mild 50 – 80 500 to 1,000 Every 12 hours Moderate 30 – 50 250 to 750 Every 12 hours Severe < 30 250 to 500 Every 12 hours ESRD patients using dialysis ---- 500 to 1,000 Following dialysis, a 250 to 500 mg supplemental dose is recommended. Every 24 hours

  在 DailyMed 開啟原始仿單（新分頁）

• vancomycin

  AI 已核對（說明）

  由 AI 逐字比對來源仿單，非作者本人審閱。

  美國 FDA 仿單（US label） 腎功能 限靜脈注射（IV）

  適用範圍

  限靜脈注射（IV）

  成分

  VANCOMYCIN HYDROCHLORIDE

  商品名

  Vancomycin Hydrochloride

  給藥途徑

  INTRAVENOUS, ORAL

  劑型

  INJECTION, POWDER, FOR SOLUTION

  調整類型

  腎功能

  來源

  US FDA label (SPL): Vancomycin Hydrochloride, Avenacy, LLC

  章節

  2.4 Intravenous Dosage in Patients with Renal Impairment

  仿單版本

  2026-07-31

  擷取日期

  2026-10-20

  Set ID

  c757e65b-ca6f-4c00-afe2-025962b43d31

  2.4 Intravenous Dosage in Patients with Renal Impairment Dosage adjustment must be made in adult and pediatric patients with renal impairment. The initial dose should be no less than 15 mg/kg, in adult patients with any degree of renal impairment. In premature infants and the elderly, greater dosage reductions than expected may be necessary because of decreased renal function. Measure trough vancomycin serum concentrations to guide therapy, especially in seriously ill patients with changing renal function. For functionally anephric patients, an initial dose of 15 mg/kg of body weight should be given to achieve prompt therapeutic serum concentration. A dose of 1.9 mg/kg/24 hr should be given after the initial dose of 15 mg/kg.

  相關段落（同一份仿單的整段原文）

  2.1 Important Administration Instructions for Intravenous Use To reduce the risk of infusion related adverse reactions, administer diluted Vancomycin Hydrochloride for Injection by intravenous infusion over 60 minutes or greater [see Warnings and Precautions ( 5.5 ) and Adverse Reactions ( 6.1 )] . Diluted Vancomycin Hydrochloride for Injection concentrations of no more than 5 mg/mL are recommended in adults [see Dosage and Administration ( 2.2 )]. See also age-specific recommendations [see Dosage and Administration ( 2.2 , 2.3 )] . In selected patients in need of fluid restriction, a concentration up to 10 mg/mL may be used. Infusion related events may occur, however, at any rate or concentration [see Warnings and Precautions ( 5.5 )]. Other drugs should not be added to the diluted Vancomycin Hydrochloride for Injection [see Dosage and Administration ( 2.7 )] . Administer diluted Vancomycin Hydrochloride for Injection prior to intravenous anesthetic agents to reduce the risk of infusion related adverse reactions [see Warnings and Precautions ( 5.5 )]. Administer diluted Vancomycin Hydrochloride for Injection by a secure intravenous route of administration to avoid local irritation and phlebitis reactions [see Warnings and Precautions ( 5.6 )] .

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• piperacillin and tazobactam

  AI 已核對（說明）

  由 AI 逐字比對來源仿單，非作者本人審閱。

  美國 FDA 仿單（US label） 腎功能 成人・靜脈注射

  適用範圍

  成人・靜脈注射

  成分

  TAZOBACTAM SODIUM + PIPERACILLIN SODIUM複方

  商品名

  Piperacillin and Tazobactam and Sodium Chloride

  給藥途徑

  INTRAVENOUS

  劑型

  INJECTION, SOLUTION

  調整類型

  腎功能

  來源

  US FDA label (SPL): Piperacillin and Tazobactam and Sodium Chloride, B. Braun Medical Inc.

  章節

  2.4 Recommended Dosage in Adult Patients With Renal Impairment

  仿單版本

  2026-05-08

  擷取日期

  2026-10-20

  Set ID

  a63ca653-27d4-45fe-a744-77e0efe45220

  2.4 Recommended Dosage in Adult Patients With Renal Impairment In adult patients with renal impairment (creatinine clearance ≤ 40 mL/min) and dialysis patients (hemodialysis and CAPD), the intravenous dose of Piperacillin and Tazobactam for Injection and Sodium Chloride Injection should be reduced based on the degree of renal impairment. The recommended daily dosage of Piperacillin and Tazobactam for Injection and Sodium Chloride Injection for patients with renal impairment administered by intravenous infusion over 30 minutes is described in Table 1.

  Table 1: Recommended Dosage of Piperacillin and Tazobactam in Patients with Normal Renal Function and Renal Impairment (As total grams piperacillin and tazobactam)Administer Piperacillin and Tazobactam for Injection and Sodium Chloride Injection by intravenous infusion over 30 minutes.
  Creatinine clearance, mL/min	All Indications (except nosocomial pneumonia)	Nosocomial Pneumonia
  Greater than 40 mL/min	3.375 g every 6 hours	4.5 g every 6 hours
  20 to 40 mL/minCreatinine clearance for patients not receiving hemodialysis	2.25 g every 6 hours	3.375 g every 6 hours
  Less than 20 mL/min	2.25 g every 8 hours	2.25 g every 6 hours
  Hemodialysis0.75 g (0.67 g piperacillin and 0.08 g tazobactam) should be administered following each hemodialysis session on hemodialysis days	2.25 g every 12 hours	2.25 g every 8 hours
  CAPD	2.25 g every 12 hours	2.25 g every 8 hours

  純文字原文

  Table 1: Recommended Dosage of Piperacillin and Tazobactam in Patients with Normal Renal Function and Renal Impairment (As total grams piperacillin and tazobactam) Administer Piperacillin and Tazobactam for Injection and Sodium Chloride Injection by intravenous infusion over 30 minutes. Creatinine clearance, mL/min All Indications (except nosocomial pneumonia) Nosocomial Pneumonia Greater than 40 mL/min 3.375 g every 6 hours 4.5 g every 6 hours 20 to 40 mL/min Creatinine clearance for patients not receiving hemodialysis 2.25 g every 6 hours 3.375 g every 6 hours Less than 20 mL/min 2.25 g every 8 hours 2.25 g every 6 hours Hemodialysis 0.75 g (0.67 g piperacillin and 0.08 g tazobactam) should be administered following each hemodialysis session on hemodialysis days 2.25 g every 12 hours 2.25 g every 8 hours CAPD 2.25 g every 12 hours 2.25 g every 8 hours

  For patients on hemodialysis, the maximum dose is 2.25 g every 12 hours for all indications other than nosocomial pneumonia and 2.25 g every 8 hours for nosocomial pneumonia. Since hemodialysis removes 30% to 40% of the administered dose, an additional dose of 0.75 g piperacillin and tazobactam for injection should be administered following each dialysis period on hemodialysis days. No additional dosage of Piperacillin and Tazobactam for Injection and Sodium Chloride Injection is necessary for CAPD patients.

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• amoxicillin

  AI 已核對（說明）

  由 AI 逐字比對來源仿單，非作者本人審閱。

  美國 FDA 仿單（US label） 兒科 未滿三個月嬰兒・口服膠囊

  適用範圍

  未滿三個月嬰兒・口服膠囊

  成分

  AMOXICILLIN

  商品名

  Amoxicillin

  給藥途徑

  ORAL

  劑型

  CAPSULE

  調整類型

  兒科

  來源

  US FDA label (SPL): Amoxicillin, REMEDYREPACK INC.

  章節

  2.3 Dosage in Pediatric Patients Aged Less than 12 Weeks (3 months)

  仿單版本

  2026-08-20

  擷取日期

  2026-10-20

  Set ID

  3a4afd36-dffa-44a1-9d09-e93cf66053bf

  2.3 Dosage in Pediatric Patients Aged Less than 12 Weeks (3 months) It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin capsules is 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function. Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic, or evidence of bacterial eradication has been obtained.

  在 DailyMed 開啟原始仿單（新分頁）

• acetaminophen

  AI 已核對（說明）

  由 AI 逐字比對來源仿單，非作者本人審閱。

  美國 FDA 仿單（US label） 兒科 兒童・靜脈注射

  適用範圍

  兒童・靜脈注射

  成分

  ACETAMINOPHEN

  商品名

  Acetaminophen

  給藥途徑

  INTRAVENOUS

  劑型

  INJECTION, SOLUTION

  調整類型

  兒科

  來源

  US FDA label (SPL): Acetaminophen, Camber Pharmaceuticals, Inc.

  章節

  2.3 Recommended Dosage: Children

  仿單版本

  2026-04-23

  擷取日期

  2026-10-20

  Set ID

  1c8fef8f-2ff5-4bea-bccb-90c2c8544c21

  2.3 Recommended Dosage: Children Children 2 to 12 years of age: the recommended dosage of acetaminophen injection is 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours, with a maximum single dose of acetaminophen injection of 15 mg/kg, a minimum dosing interval of 4 hours, and a maximum daily dose of acetaminophen of 75 mg/kg per day. Table 2. Dosing for Children

  Age group	Dose given every 4 hours	Dose given every 6 hours	Maximum single dose	Maximum total daily dose of acetaminophen (by all routes)
  Children 2 to 12 years of age	12.5 mg/kg	15 mg/kg	15 mg/kg (up to 750 mg)	75 mg/kg in 24 hours (up to 3750 mg)

  純文字原文

  Age group Dose given every 4 hours Dose given every 6 hours Maximum single dose Maximum total daily dose of acetaminophen (by all routes) Children 2 to 12 years of age 12.5 mg/kg 15 mg/kg 15 mg/kg (up to 750 mg) 75 mg/kg in 24 hours (up to 3750 mg)

  相關段落（同一份仿單的整段原文）

  2.1 General Dosing Information Acetaminophen injection may be given as a single or repeated dose for the treatment of acute pain or fever. No dose adjustment is required when converting between oral acetaminophen and acetaminophen injection dosing in adults and adolescents who weigh 50 kg and above. Calculated maximum daily dose of acetaminophen is based on all routes of administration (i.e., intravenous, oral, and rectal) and all products containing acetaminophen. Exceeding the maximum mg/kg daily dose of acetaminophen as described in Tables 1 to 3 may result in hepatic injury, including the risk of liver failure and death. To avoid the risk of overdose, ensure that the total amount of acetaminophen from all routes and from all sources does not exceed the maximum recommended dose.

  2.5 Instructions for Intravenous Administration For adult and adolescent patients weighing ≥ 50 kg requiring 1000 mg doses of acetaminophen injection, administer the dose by inserting a vented intravenous set through the septum of the 100 mL vial. Acetaminophen injection may be administered without further dilution. Examine the container contents before dose preparation or administering. DO NOT USE if particulate matter or discoloration is observed. Administer the contents of the container intravenously over 15 minutes. Use aseptic technique when preparing acetaminophen injection for intravenous infusion. Do not add other medications to the acetaminophen injection vial or infusion device. For doses less than 1000 mg, the appropriate dose must be withdrawn from the container and placed into a separate container prior to administration. Using aseptic technique, withdraw the appropriate dose (650 mg or weight-based) from an intact sealed acetaminophen injection container and place the measured dose in a separate empty, sterile container (e.g., glass bottle, plastic intravenous container, or syringe) for intravenous infusion to avoid the inadvertent delivery and administration of the total volume of the commercially available container. The entire 100 mL container of acetaminophen injection is not intended for use in patients weighing less than 50 kg. Acetaminophen injection is supplied in a single-dose container and the unused portion must be discarded. Place small volume pediatric doses up to 60 mL in volume in a syringe and administer over 15 minutes using a syringe pump. Monitor the end of the infusion in order to prevent the possibility of an air embolism, especially in cases where the acetaminophen infusion is the primary infusion. Once the container seal has been penetrated, or the contents transferred to another container, administer the dose of acetaminophen injection within 6 hours. Do not add other medications to the acetaminophen injection solution. Diazepam and chlorpromazine hydrochloride are physically incompatible with acetaminophen injection, therefore do not administer simultaneously.

  另見原仿單（本站未摘錄）

  • 2.2 Recommended Dosage: Adults and Adolescents
  • 2.4 Recommended Dosage For Treatment of Fever in Neonates and Infants

  在 DailyMed 開啟原始仿單（新分頁）

• sitagliptin

  AI 已核對（說明）

  由 AI 逐字比對來源仿單，非作者本人審閱。

  美國 FDA 仿單（US label） 腎功能 成人・口服錠

  適用範圍

  成人・口服錠

  成分

  SITAGLIPTIN PHOSPHATE

  商品名

  JANUVIA

  給藥途徑

  ORAL

  劑型

  TABLET, FILM COATED

  調整類型

  腎功能

  來源

  US FDA label (SPL): JANUVIA, A-S Medication Solutions

  章節

  2.2 Recommendations for Use in Renal Impairment

  仿單版本

  2026-07-08

  擷取日期

  2026-10-20

  Set ID

  194c3718-5eb5-4cf5-85d0-2bb1ed8293b8

  2.2 Recommendations for Use in Renal Impairment Assess renal function prior to initiation of JANUVIA and periodically thereafter. For patients with an estimated glomerular filtration rate [eGFR] greater than or equal to 45 mL/min/1.73 m 2 to less than 90 mL/min/1.73 m 2 , no dosage adjustment for JANUVIA is required. For patients with moderate renal impairment (eGFR greater than or equal to 30 mL/min/1.73 m 2 to less than 45 mL/min/1.73 m 2 ), the dose of JANUVIA is 50 mg once daily. For patients with severe renal impairment (eGFR less than 30 mL/min/1.73 m 2 ) or with end-stage renal disease (ESRD) requiring hemodialysis or peritoneal dialysis, the dose of JANUVIA is 25 mg once daily. JANUVIA may be administered without regard to the timing of dialysis.

  相關段落（同一份仿單的整段原文）

  2.1 Recommended Dosing The recommended dose of JANUVIA is 100 mg once daily. JANUVIA can be taken with or without food.

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• apixaban

  AI 已核對（說明）

  由 AI 逐字比對來源仿單，非作者本人審閱。

  美國 FDA 仿單（US label） 肝功能 成人・口服錠

  適用範圍

  成人・口服錠

  成分

  APIXABAN

  商品名

  ELIQUIS

  給藥途徑

  ORAL

  劑型

  TABLET, FILM COATED

  調整類型

  肝功能

  來源

  US FDA label (SPL): ELIQUIS, Cardinal Health 107, LLC

  章節

  8.7 Hepatic Impairment

  仿單版本

  2026-04-24

  擷取日期

  2026-10-20

  Set ID

  a454cd24-0c6d-46e8-b1e4-197388606175

  8.7 Hepatic Impairment No dose adjustment is required in patients with mild hepatic impairment (Child-Pugh class A). Because patients with moderate hepatic impairment (Child-Pugh class B) may have intrinsic coagulation abnormalities and there is limited clinical experience with ELIQUIS in these patients, dosing recommendations cannot be provided [see Clinical Pharmacology (12.2) ] . ELIQUIS is not recommended in patients with severe hepatic impairment (Child-Pugh class C) [see Clinical Pharmacology (12.2) ] . ELIQUIS has not been studied in pediatric patients with hepatic impairment.

  引用段落請見原仿單：DailyMed 原仿單（新分頁）

  在 DailyMed 開啟原始仿單（新分頁）