藥品新增

<13B116> Baclofen(Gablofen®) (1000mcg/mL,20ml/V).自

新藥介紹

<13B116> Baclofen(Gablofen®) (1000mcg/mL,20ml/V).自

藥理作用/作用機轉

Inhibits the transmission of both monosynaptic and polysynaptic reflexes at the spinal cord level, possibly by hyperpolarization of primary afferent fiber terminals, with resultant relief of muscle spasticity

適應症/

劑量

Intrathecal

【Adult】

　●Spasticity: Initial:50 mcg over≧1 minute. If response is inadequate, may give 75 mcg as a 2nd screening dose 24 hrs after the 1st dose; may administer 100 mcg as a final screening dose 24 hrs after the second dose.

　　*Initial total daily continuous infusion dose via implanted pump:

　　　◎If screening dose provided positive response for 4-8 hrs: Double the screening dose that gave a positive response and administer over 24 hrs.

　　　◎If screening dose provided positive response for >8 hrs: Infuse a dose equivalent to the screening dose over 24 hrs.

　　*Initial titration after pump implantation: Do not increase dose in first 24 hrs; initial dosage adjustments may be made by increasing daily dose by 10-30% (spasticity of spinal cord origin) or by 5-15% (spasticity of cerebral origin) per 24 hrs until satisfactory response.

　　*Maintenance dose and titration: Daily dose may be increased periodically by 10-40% for spasticity of spinal cord origin or by 5-20% for spasticity of cerebral origin. Experience with doses >1,000 mcg daily is limited.

【Pediatric】

　●Spasticity:

　　*Screening dose:

　　　◎Children <4 years: Initial: 25 mcg; if response is inadequate, double the initial dose and administer 24 hrs after the 1st dose.

　　　◎Children ≧4 years and Adolescents: Initial: 25-50 mcg for 1 dose; following administration of screening dose, observe patient for 4-8 hrs. If response is inadequate, may increase screening dose in 25 mcg increments every 24 hours until a 4- 8hr positive clinical response is demonstrated or 100 mcg/dose is given.

　　*Initial total daily dose via pump:

Children and Adolescents: Double the screening dose that gave a positive response and administer over 24 hrs, then infuse a dose equivalent to the screening dose over 24 hrs.

Do not increase dose in first 24 hrs; increase daily dose by 5-15% per 24 hrs until satisfactory response is achieved; usual range: 50-100 mcg daily 

　　*Maintenance dose titration :Children and Adolescents:

　　　◎Inpatient titration: Daily dose may be increased periodically by 10-20% of dose; usual dose change is 50 mcg; maximum increment change: 100 mcg.

　　　◎Outpatient titration: Daily dose may be increased periodically by 5-10% of daily dose ; usual dose change is 25 mcg.

Usual maintenance dose: Children and Adolescents: 100-2,000 mcg daily

【Geriatric】Refer to adult dosing.

『Renal Impairment』

Mild to severe impairment: Use with caution

Hemodialysis: Avoid use

Peritoneal dialysis: Avoid use

CRRT: Avoid use

『Hepatic Impairment』

No dosage adjustment necessary

使用禁忌

Hypersensitivity to baclofen or any component of the formulation

警告/預防

Intrathecal mass, Urinary retention

不良反應

Adverse Reactions (Significant): CNS effects, Withdrawal effects

【>10%】Nausea, vomiting

【1% to 10%】Asthenia, confusion, dizziness, drowsiness, headache , hypotonia

【<1%】Hypotension, peripheral edema, pruritus, urticaria, constipation, diarrhea, sialorrhea, xerostomia, difficulty in micturition, impotence, urinary frequency, urinary incontinence, urinary retention, abnormality in thinking, agitation, chills, coma, depression, fatigue, insomnia, pain, paresthesia, seizure, speech disturbance, tremor, back pain, amblyopia, dyspnea, hypoventilation, pneumonia, accidental injury

【Frequency not defined】↑serum glucose,↑serum ALP/AST, withdrawal syndrome

懷孕用藥分級(FDA)

C /避免使用，除非有治療必要

健保規範

l 藥品說明：

l 藥品理由：

 

其他

核對用法: 脊髓腔內注射intrathecal administration only

密切監測輸注系統與幫浦警報

若出現四肢痙攣、搔癢、刺痛加劇或嗜睡、昏迷、無力等情況請回診聯絡醫師。