藥品名稱
drug name | Modafinil 200 mg/tab (Provigil) 普衛醒錠 |
| 藥檔狀態 | 停用 |
成 份
Ingredient | Modafinil |
| 單位含量 | 200 mg/tab |
| Dosage Forms | Tablet: 200 mg |
| 顏 色 | 白色(PROVIGIL,200MG) |
| Color | |
| 形 狀 | 長橢圓形 |
| Shape | |
| 劑 型 | 口服/錠劑 |
| Dose Form | |
大 小
Size | 7*17 |
標 示
outward | PROVIGIL |
廠商名稱
Manufacturer | 香港商艾維斯有限公司台灣分公司 |
製 造 商
Manufacturer | PATHEON MANUFACTURING SERVICES LLC |
字 號
Product ID | 衛署罕藥輸字第000010號 |
藥理分類
Pharmacologic Category | Psychiatry/sympathomimetics/Simulants |
作用機轉
Mechanism of action | The exact mechanism of action is unclear, it does not appear to alter the release of dopamine or norepinephrine, it may exert its stimulant effects by decreasing GABA-mediated neurotransmission, although this theory has not yet been fully evaluated; several studies also suggest that an intact central alpha-adrenergic system is required for modafinil`s activity; the drug increases high-frequency alpha waves while decreasing both delta and theta wave activity, and these effects are consistent with generalized increases in mental alertness. |
| 用途/適應症 | 因猝睡症之日間過度睡眠 |
| Use |
Narcolepsy:
To improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy.
Obstructive sleep apnea:
To improve wakefulness in adult patients with obstructive sleep apnea (OSA)
Shift work sleep disorder:
To improve wakefulness in adult patients with shift work sleep disorder (SWSD)
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衛福部核准適用症狀
MOHW approved indications |
改善猝睡症患者的日間過度睡眠症狀。
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| 常用劑量 | 每天一次，早飯後使用1顆
(藥品劑量會因人或病情增減，請依照醫師指示服用。) |
| Dose |
Oral:
Pediatric:
ADHD (unlabeled use): 50-100 mg once daily
Adults:
ADHD (unlabeled use): 100-300 mg once daily
Narcolepsy, OSAHS: Initial: 200 mg as a single daily dose in the morning.
SWSD: Initial: 200 mg as a single dose taken ~1 hour prior to start of work shift.
(Note: Doses of 400 mg/day, given as a single dose, have been well tolerated, but there is no consistent evidence that this dose confers additional benefit.)
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懷孕分級
Pregnancy Risk Factor |
C
-
[FDA(美國食品及藥物管理局)懷孕分級說明:
A：對照試驗無法證實懷孕初期及後期使用會危害胎兒。
B：動物試驗無法證實對胎兒有害，但缺乏人類對照試驗；或動物試驗有副作用報告，但無法證實對懷孕初期及後期之胎兒有害。
C：動物實驗中對胎兒有害但缺乏孕婦對照實驗；或無動物及孕婦試驗。
D：證實對胎兒有害，但疾病對孕婦有生命威脅或較安全藥品無法使用或無效時可使用。
X：證實對胎兒有害，且使用後危害大於可能的益處。孕婦及可能懷孕婦女禁用。]
仿單：
孕婦只有在對胎兒的效益高於潛在危險時才可在懷孕期間使用此藥。
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| 禁忌症 |
凡已知對Modafinil成分過敏的病人不可使用PROVIGIL。
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| Contraindications |
Hypersensitivity to modafinil, armodafinil, or any component of the formulation
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| 常見副作用 | 頭痛、便秘、噁心、焦慮。 |
| Common adverse drug reactions | Headache, constipation, nausea, anxiety. |
| Adverse Reactions |
Cardiovascular: Chest pain (3%), hypertension (3%), palpitations (2%), tachycardia (2%), vasodilatation (2%), edema (1%)
Central nervous system: Headache (adults 34%; children 20% [Biederman 2005]; dose related), nervousness (7%), anxiety (5%; dose related), dizziness (5%), insomnia (5%), depression (2%), drowsiness (2%), paresthesia (2%), agitation (1%), chills (1%), confusion (1%), emotional lability (1%), hypertonia (1%), vertigo (1%)
Dermatologic: Diaphoresis (1%)
Endocrine & metabolic: Weight loss (children 5% [Greenhill 2006]), increased thirst (1%), increased gamma-glutamyl transferase
Gastrointestinal: Decreased appetite (children 16% [Biederman 2005]), abdominal pain (children 12% [Greenhill 2006]), nausea (11%), diarrhea (6%), dyspepsia (5%), xerostomia (4%), anorexia (4%), constipation (2%), dysgeusia (1%), flatulence (1%), oral mucosa ulcer (1%)
Genitourinary: Urine abnormality (1%)
Hematologic & oncologic: Eosinophilia (1%)
Hepatic: Abnormal hepatic function tests (2%), increased serum alkaline phosphatase
Neuromuscular & skeletal: Back pain (6%), dyskinesia (1%), hyperkinesia (1%), tremor (1%)
Ocular: Abnormal vision (1%)
Respiratory: Rhinitis (7%), pharyngitis (4%), asthma (1%), epistaxis (1%)
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監測
Monitoring |
Levels of sleepiness; blood pressure; heart rate; increased monitoring in patients with recent MI or unstable angina; development of severe skin reactions; development or exacerbation of psychiatric symptoms (eg, agitation, anxiety, depression)
When used for the treatment of ADHD, thoroughly evaluate for cardiovascular risk. Monitor heart rate, blood pressure, and consider obtaining ECG prior to initiation
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| 警語與注意事項 | 請遵照醫師或藥師指示使用。禁用於懷孕或計畫懷孕之婦女，治療期間與停藥後2個月內須採用有效避孕措施 |
| Warnings & precautions | Please follow the physician or pharmacist instructed to use. |
| 針劑溶解條件 |
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| 針劑不相容性 |
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| 針劑施打條件 |
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| 針劑保存安定性 |
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最近修改日期時間
Updated | 8/5/2019 8:42:56 AM |
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