藥碼
AKU01
藥名
RIF/INH/EMB 150/75/275 mg
英文商品名
Akurit-3 三合一 錠劑
中文商品名
立剋核膜衣錠
螢幕名
Akurit-3 三合一 錠劑
劑型
Tab
規格
Film coated tablet: Rifampin 150mg+ Isoniazid 75mg+ Ethambutol HCl 275mg/ tab
成分
藥理分類
Antituberculosis Agents
健保碼
BC25519100
ATC碼
適應症
結核病 Treatment of tuberculosis infection
藥理
Antitubercular Agent
AkuriT-3 is a three drug fixed dose combination of anti-TB drugs, including rifampin 150 mg, Isoniazid 75 mg and Ethambutol 275 mg.
AkuriT-3 is a three drug fixed dose combination of anti-TB drugs, including rifampin 150 mg, Isoniazid 75 mg and Ethambutol 275 mg.
藥動學
Rifampin:
1. Duration: ≤24 hours
2. Absorption: Well absorbed; food may delay or slightly reduce peak
3. Distribution: Highly lipophilic, crosses blood-brain barrier well; Vd ~1.1 L/kg; Protein binding: 80%
4. Metabolism: Hepatic; undergoes enterohepatic recirculation
5. Half-life elimination: (Infants and Children 6 months to <5 years) ~1 to 4 hours; (Adults) ~2-3 hours
6. Time to peak, serum: 1-2 hours
7. Excretion: Feces (60% to 65%) and urine (~30%) as unchanged drug
Isoniazid:
1. Absorption: Rapid and complete; food reduces rate and extent of absorption
2. Distribution: All body tissues and fluids including CSF; Protein binding: 10-15%
3. Metabolism: Hepatic to acetylisoniazid with decay rate determined genetically by acetylation phenotype; undergoes further hydrolysis to isonicotinic acid and acetylhydrazine
4. Half-life: May be prolonged in patients with impaired hepatic function or severe renal impairment; (Fast acetylators) 30-100 minutes; (Slow acetylators) 2-5 hours
5. Time to peak, serum: 1-2 hours
6. Excretion: Urine (75% to 95% as unchanged drug and metabolites); small amounts excreted in feces and saliva
Ethambutol:
1. Absorption: ~80%
2. Distribution: Widely throughout body; Protein binding: 20-30%
3. Metabolism: Hepatic (20%) to inactive metabolite
4. Half-life elimination: 2.5-3.6 hours; (ESRD) 7-15 hours
5. Time to peak, serum: 2-4 hours
6. Excretion: Urine (~50% as unchanged drug, 8% to 15% as metabolites); feces (~20% as unchanged drug)
1. Duration: ≤24 hours
2. Absorption: Well absorbed; food may delay or slightly reduce peak
3. Distribution: Highly lipophilic, crosses blood-brain barrier well; Vd ~1.1 L/kg; Protein binding: 80%
4. Metabolism: Hepatic; undergoes enterohepatic recirculation
5. Half-life elimination: (Infants and Children 6 months to <5 years) ~1 to 4 hours; (Adults) ~2-3 hours
6. Time to peak, serum: 1-2 hours
7. Excretion: Feces (60% to 65%) and urine (~30%) as unchanged drug
Isoniazid:
1. Absorption: Rapid and complete; food reduces rate and extent of absorption
2. Distribution: All body tissues and fluids including CSF; Protein binding: 10-15%
3. Metabolism: Hepatic to acetylisoniazid with decay rate determined genetically by acetylation phenotype; undergoes further hydrolysis to isonicotinic acid and acetylhydrazine
4. Half-life: May be prolonged in patients with impaired hepatic function or severe renal impairment; (Fast acetylators) 30-100 minutes; (Slow acetylators) 2-5 hours
5. Time to peak, serum: 1-2 hours
6. Excretion: Urine (75% to 95% as unchanged drug and metabolites); small amounts excreted in feces and saliva
Ethambutol:
1. Absorption: ~80%
2. Distribution: Widely throughout body; Protein binding: 20-30%
3. Metabolism: Hepatic (20%) to inactive metabolite
4. Half-life elimination: 2.5-3.6 hours; (ESRD) 7-15 hours
5. Time to peak, serum: 2-4 hours
6. Excretion: Urine (~50% as unchanged drug, 8% to 15% as metabolites); feces (~20% as unchanged drug)
禁忌症
1. Hypersensitivity to ethambutol to Rifampin, Isoniazid or Ethambutol.
2. Concomitant use with atazanavir, darunavir, saquinavir, tipranavir, rilpivirine or elvitegravir/cobicistat.
3. Previous isoniazid-associated hepatic injury.
4. Severe adverse reactions to isoniazid, such as fever, chills, and arthritis; optic neuritis.
2. Concomitant use with atazanavir, darunavir, saquinavir, tipranavir, rilpivirine or elvitegravir/cobicistat.
3. Previous isoniazid-associated hepatic injury.
4. Severe adverse reactions to isoniazid, such as fever, chills, and arthritis; optic neuritis.
懷孕分類
C
哺乳分類
Avoided
副作用
| Drug | Rifampin | Isoniazid | Ethambutol | |
|---|---|---|---|---|
| Significant |
1. Clostridioides difficile infection 2. Hematologic effects (Decreased hemoglobin, disorder of hemostatic components of blood, disseminated intravascular coagulation, eosinophilia, hemolysis, hemolytic anemia, hemorrhage, leukopenia, thrombocytopenia) 3. Hepatotoxicity 4. Hypersensitivity reactions (urticaria, angioedema, anaphylaxis, flu-like symptoms) 5. Pulmonary toxicity |
Increased serum transaminases |
1. Hepatotoxicity 2. Optic neuritis (changes in vision, color blindness, visual defects) |
|
| Adverse reactions | Cardiovascular | Decreased blood pressure, edema, shock | Vasculitis | Myocarditis, pericarditis |
| Endocrine | Adrenocortical insufficiency, increased uric acid | Gynecomastia, hyperglycemia, metabolic acidosis, pellagra, pyridoxine deficiency | Acute gout attack, hyperuricemia | |
| Gastrointestinal | Abdominal cramps, diarrhea, discomfort, flatulence, nausea, staining of tooth, vomiting | Epigastric distress, nausea, pancreatitis, vomiting | Abdominal pain, anorexia, gastric distress, nausea, vomiting | |
| Genitourinary | Hematuria | Bilirubinuria | - | |
| Nervous system | Ataxia, behavioral changes, cerebral hemorrhage, confusion, dizziness, fatigue, headache, lack of concentration, myasthenia, numbness, psychosis, sore mouth | Brain disease, memory impairment, paresthesia, peripheral neuropathy, psychosis, seizure | Confusion, dizziness, headache, malaise, peripheral neuritis | |
| Neuromuscular | Limb pain, myopathy | Lupus-like syndrome, rheumatic disease | Arthralgia | |
| Ophthalmic | Conjunctivitis | Optic atrophy, optic neuritis | Color blindness, decreased visual acuity, optic neuritis, scotoma, visual disturbance | |
| Dermatologic | - | Skin rash, toxic epidermal necrolysis | Dermatitis, erythema multiforme, pruritus, skin rash | |
| Hematologic | - | Agranulocytosis, anemia, eosinophilia, lymphadenopathy, thrombocytopenia | Eosinophilia, leukopenia, lymphadenopathy, neutropenia, thrombocytopenia | |
| Renal | Acute interstitial nephritis, acute renal injury, increased blood urea nitrogen, renal insufficiency, renal tubular necrosis | - | Nephritis | |
| Respiratory | Dyspnea, flu-like symptoms | - | Pneumonitis, pulmonary infiltrates | |
| Hepatic | - | Hepatitis, hyperbilirubinemia, jaundice, hepatotoxicity | Abnormal hepatic function tests, hepatitis, hepatotoxicity | |
| Miscellaneous | fever | |||
劑量和給藥方法
Dosage:
1. Body Weight 30-37kg: 2 tab PO QD
2. Body Weight 38-54kg: 3 tab PO QD
3. Body Weight 55-70kg: 4 tab PO QD
4. Body Weight ＞70kg: 5 tab PO QD
Administration:
Take 1 hour before meal or 2 hours after meal
1. Body Weight 30-37kg: 2 tab PO QD
2. Body Weight 38-54kg: 3 tab PO QD
3. Body Weight 55-70kg: 4 tab PO QD
4. Body Weight ＞70kg: 5 tab PO QD
Administration:
Take 1 hour before meal or 2 hours after meal
小兒調整劑量
腎功能調整劑量
肝功能調整劑量
There are no dosage adjustments provided in the manufacturer's labeling; use with caution.
安定性
藥袋資訊
臨床用途
抗結核劑
主要副作用
噁心、嘔吐、肝功能異常、過敏、視力減退
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 Y4 | 藥庫 口A12
藥品外觀
顏色
16
形狀
04
剝痕
標記1
RHE
標記2
其他
健保藥價
8.2
自費價
10.91
仿單
資料庫
健保給付規定