藥碼
HYD05
藥名
Hydroxyurea 500 mg
英文商品名
Hydrea 膠囊 500 mg/Cap
中文商品名
愛治膠囊
螢幕名
Hydrea 膠囊 500 mg
劑型
Cap
規格
Hydroxyurea 500mg/Cap
成分
藥理分類
Anticancer-Others
健保碼
X000211100
ATC碼
適應症
Chronic myeloid leukemia, Resistant.
Sickle cell anemia with crisis (Moderate to Severe).
Squamous cell carcinoma of head and neck, In combination with chemoradiation therapy.
Sickle cell anemia with crisis (Moderate to Severe).
Squamous cell carcinoma of head and neck, In combination with chemoradiation therapy.
藥理
The mechanism of action of hydroxyurea is not known. As an antineoplastic agent, it is an antimetabolite hypothesized to inhibit DNA synthesis by acting as a ribonucleotide reductase inhibitor, without interfering with the synthesis of ribonucleic acid or of protein. In sickle cell anemia, it increases deformability of sickled cells by increasing hemoglobin F levels in red blood cells (RBC), decreases neutrophils, increasing the water content of RBCs, and altering the adhesion of RBCs to endothelium.
藥動學
Tmax: 1 to 4 hours.Protein binding: 75% to 80%.Vd: Equal to total body water.Metabolism: Liver: 60%.Excretion: Renal: 40% unchanged (sickle cell anemia) Renal clearance: 1.8 to 2.1 L/hr/m(2). Total body clearance: 4.3 to 5.5 L/hr/m(2). Elimination Half Life 2 to 4.5 hours.
禁忌症
Hypersensitivity to hydroxyurea or any component of the product.
懷孕分類
D
Available evidence is inconclusive or is inadequate for determining fetal risk when used in pregnant women or women of childbearing potential.
Weigh the potential benefits of drug treatment against potential risks before prescribing this drug during pregnancy.
Available evidence is inconclusive or is inadequate for determining fetal risk when used in pregnant women or women of childbearing potential.
Weigh the potential benefits of drug treatment against potential risks before prescribing this drug during pregnancy.
哺乳分類
Infant risk cannot be ruled out.
副作用
1. Common:
Decreased platelet count, Decreased reticulocyte count, Myelosuppression, Neutropenia (Pediatric, 12.6% )
2. Serious:
Dermatologic: Gangrenous disorder, Skin cancer, Skin ulcer, Ulcer of lower extremity.
Hematologic: Genetic mutation, Long-term use.
Respiratory: Parvovirus infection (3.7% )
Decreased platelet count, Decreased reticulocyte count, Myelosuppression, Neutropenia (Pediatric, 12.6% )
2. Serious:
Dermatologic: Gangrenous disorder, Skin cancer, Skin ulcer, Ulcer of lower extremity.
Hematologic: Genetic mutation, Long-term use.
Respiratory: Parvovirus infection (3.7% )
劑量和給藥方法
*Dosing weight: Actual or ideal weight, whichever is less.
*Swallow whole, do not open capsules.
Chronic myeloid leukemia, Resistant:
Initial, 15 mg/kg/day orally, and titrate based on individual tumor type, disease state, response, and risk factors.
Essential thrombocythemia:
optimal dosing and timing not yet defined
Sickle cell anemia with crisis (Moderate to Severe):
Initial, 15 mg/kg/day orally as a single daily dose; based on blood counts, may increase by 5 mg/kg/day every 12 weeks to a MAX 35 mg/kg/day.
Squamous cell carcinoma of head and neck, In combination with chemoradiation therapy Initial, 15 mg/kg/day orally, and titrate based on individual tumor type, disease state, response, and risk factors.
Concomitant medication: Prophylactic folic acid.
*Swallow whole, do not open capsules.
Initial, 15 mg/kg/day orally, and titrate based on individual tumor type, disease state, response, and risk factors.
optimal dosing and timing not yet defined
Initial, 15 mg/kg/day orally as a single daily dose; based on blood counts, may increase by 5 mg/kg/day every 12 weeks to a MAX 35 mg/kg/day.
Squamous cell carcinoma of head and neck, In combination with chemoradiation therapy Initial, 15 mg/kg/day orally, and titrate based on individual tumor type, disease state, response, and risk factors.
小兒調整劑量
1. 2 years or older:
(1) Calculate dose based on patient's actual or ideal weight, whichever is less; calculate and round dose to the nearest 50 mg or 100 mg strength (FDA dosage)
(2) Initial, 20 mg/kg orally once daily; based on blood counts, may increase by 5 mg/kg/day every 8 weeks or if a painful crisis occurs; give until mild myelosuppression (absolute neutrophil count 2,000 to 4,000/mcL) occurs
(3) Up to a MAX of 35 mg/kg/day (FDA dosage)
2. 9 to 18 months: Initial and maintenance dosage, 20 mg/kg/day orally (off-label dosage).
3. 3 years or older: 20 mg/kg/day orally on 4 consecutive days each week and increase by 5 mg/kg/day at 4-week intervals up to a MAX 40 mg/kg/day.
4. 10 years or older:
(1) Initial, 10 to 20 mg/kg/day (500 mg as a single morning dose) and increase by 5 to 10 mg/kg/day at 12-week intervals, based on hematologic response
(2) Up to a MAX 35 mg/kg/day. Mean dose was 22.8 mg/kg/day.
腎功能調整劑量
1. CrCl >60 mL/minute: No dosage adjustment (of initial dose) necessary.
2. CrCl <60 mL/minute: Reduce initial dose by 50% (to 7.5~10 mg/kg/day); titrate to response/avoidance of toxicity
3. End-stage renal disease (ESRD): Reduce initial dose by 50%( (to 7.5~10 mg/kg/day); titrate to response/avoidance of toxicity (administer after dialysis on dialysis days)
4. Chronic kidney disease: Initial 5 to 10 mg/kg/day.
The following guidelines have been used by some clinicians: Reduce initial dose to 15 mg/kg/dose once daily.
肝功能調整劑量
Adult: There are no dosage adjustments provided in the manufacturer's labeling; closely monitor for bone marrow toxicity.
Pediatric:There are no dosage adjustments provided in the manufacturer’s labeling; based on experience in adults, closely monitor for bone marrow toxicity.
Pediatric:There are no dosage adjustments provided in the manufacturer’s labeling; based on experience in adults, closely monitor for bone marrow toxicity.
安定性
Store in a tightly closed container at a controlled room temperature, 25 °C, with excursions permitted between 15 and 30°C
藥袋資訊
臨床用途
化學治療藥
主要副作用
腹瀉、嗜睡、食慾差、噁心或嘔吐等
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
門診 Y7 藥庫 口D112
藥品外觀
顏色
18
8
形狀
13
剝痕
標記1
BMS,303
標記2
其他
健保藥價
15.2
自費價
20.22
仿單
資料庫
健保給付規定