藥碼
BOT01
藥名
Botox 自費 針 100 U/Vial
英文商品名
Botox 自費 針 100 U/Vial
中文商品名
保妥適乾粉注射劑
螢幕名
Botox 自費 針 100 U/Vial
劑型
Inj
規格
成分
藥理分類
Other Misc. Therapeutic Agents
健保碼
ATC碼
藥品圖片
外觀圖片
適應症
Axillary hyperhidrosis:
Treatment of severe primary axillary hyperhidrosis in adults not adequately managed with topical agents.
Cervical dystonia:
Treatment of cervical dystonia in patients 16 years of age to reduce the severity of abnormal head position and neck pain.
Migraine, chronic, prevention:
Prophylaxis of chronic migraine headaches ((15 days/month with headache lasting 4 hours/day) in adults.
Neurogenic detrusor overactivity:
Treatment of neurogenic detrusor overactivity in pediatric patients 5 years of age who have an inadequate response to or who are intolerant to an anticholinergic medication.
Overactive bladder:
Treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency in adults who have an inadequate response to or who are intolerant to an anticholinergic medication.
Spasticity:
Treatment of spasticity in patients 2 years of age.
Strabismus and blepharospasm associated with dystonia:
Treatment of strabismus and blepharospasm associated with dystonia, including benign essential blepharospasm or VII nerve disorders, in patients 12 years of age.
Urinary incontinence due to detrusor overactivity :
Treatment of urinary incontinence due to detrusor overactivity associated with a neurologic condition (eg, spinal cord injury, multiple sclerosis) in adults who have an inadequate response to or are intolerant of an anticholinergic medication.
藥理
Neuromuscular Blocker Agent, Toxin; Ophthalmic Agent, Toxin
OnabotulinumtoxinA (previously known as botulinum toxin type A) is a neurotoxin produced by Clostridium botulinum, spore-forming anaerobic bacillus, which appears to affect only the presynaptic membrane of the neuromuscular junction in humans, where it prevents calcium-dependent release of acetylcholine and produces a state of denervation.
藥動學
Onset of action (improvement):
Blepharospasm: ~3 to 4 days
Cervical dystonia: ~2 weeks
Spasticity: Focal and cerebral palsy related: <2 weeks
Duration:
Blepharospasm: ~3 to 4 months
Cervical dystonia: 3 to 4 months
Spasticity: ~3 to 3.5 months
Absorption:
Not expected to be present in peripheral blood at recommended doses following intramuscular (IM) injection
Time to peak:
Blepharospasm: 1 to 2 weeks
Cervical dystonia: ~6 weeks
Spasticity (focal): 4 to 6 weeks
禁忌症
Hypersensitivity to any botulinum toxin preparation or any component of the formulation; infection at the proposed injection site(s).
懷孕分類
C; OnabotulinumtoxinA has not been detected systemically in peripheral blood at recommended doses following intramuscular injection.
哺乳分類
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.
副作用
Urinary tract infection, bacteriuria, urinary retention; Headache; Dysphagia; Neck pain; Upper respiratory tract infection; Blepharoptosis, ertical deviation of eyes
劑量和給藥方法
Blepharospasm: IM
1. Initial dose: 1.25 to 2.5 units injected into the medial and lateral pretarsal orbicularis oculi of the upper lid and lateral pretarsal orbicularis oculi of lower lid.
2. Dose may be increased up to twice the previous dose if the response from the initial dose lasted ≦2 months; maximum dose per site: 5 units.
Cervical dystonia: IM
For dosing guidance, the mean dose is 236 units divided among the affected muscles in patients previously treated with botulinum toxin (maximum: ≦50 units/site).
Spasticity: IM
Individualize dose based on patient size, extent, and location of muscle involvement, degree of spasticity, local muscle weakness, and response to prior treatment.
Migraine, chronic, prevention: IM
Administer 5 units per 0.1 mL per site. Recommended total dose is 155 units once every 12 weeks.
小兒調整劑量
Blepharospasm/strabismus: Children ≧12 years: Refer to adult dosing.
Cervical dystonia: Children ≧16 years: Refer to adult dosing.
Spasticity:
Children ≧2 years: IM: 4 units/kg (total dose) divided into two injections into medial and lateral heads of the gastrocnemius of affected leg; if clinically indicated, may repeat every 2 months (maximum dose: 200 units).
In diplegia, the recommended dose is 6 units/kg (total dose) divided between affected limbs.
腎功能調整劑量
There are no dosage adjustments provided in the manufacturer's labeling.
肝功能調整劑量
There are no dosage adjustments provided in the manufacturer's labeling.
安定性
1. Store unopened vials under refrigeration at 2°C to 8°C for up to 36 months or until the expiration date on the vial.
2. Extended storage information at room temperature may be available; contact product manufacturer to obtain current recommendations.
3. After reconstitution, store in refrigerator at 2°C to 8°C and use within 24 hours (does not contain a preservative).
藥袋資訊
臨床用途
肉毒桿菌製劑
主要副作用
注射部位疼痛、肌肉無力
泡製方法
儲存方式
請置於 2-8℃ 冷藏儲存
注意事項
其他說明
門診 <冰箱>X14 | 藥庫 <冰箱>X23
藥品外觀
顏色
形狀
剝痕
標記1
標記2
其他
健保藥價
0
自費價
8379
仿單
資料庫
健保給付規定