Pregabalin【C】

Neurologic Drugs : Antiepileptics
OLYRI1 “Lyrica capsule75 mg/cap
OLYGA1 “Lygaba capsule 75 mg/cap

適應症:帶狀泡疹後神經痛。成人局部癲癇的輔助治療。纖維肌痛(fibromyalgia)。糖尿病周邊神經病變引起的神經性疼痛。脊髓損傷所引起的神經性疼痛。

Usual dose:

Neuropathic pain: Initial, 50 mg three times a day, and may be increased to 100 mg three times a day. MAX:300 mg/day.

Fibromyalgia: Initial, 75 mg twice daily, may increase to 150 mg twice daily within 1 week determined by tolerability and efficacy to a MAX of 225 mg twice daily (MAX:450 mg/day)

Neuropathic pain – Spinal cord injury: Initial, 75mg twice daily; may increase to 150 mg twice daily within 1 week based on efficacy and tolerability; may further increase to 300 mg orally twice daily for insufficient pain relief after 2 to 3 weeks of treatment. (MAX:600mg/day)

Partial seizure; Adjunct: Initial, <75 mg twice a day OR 50 mg three times daily (150 mg/day) and increased to a MAX 600 mg/day in divided doses (either two or three times daily).

Postherpetic neuralgia: Initial, 75 mg two times a day OR 50 mg orally three times a day(150 mg/day); may be increased to 300 mg/day. Maintenance dose, 75 to 150 mg twice a day OR 50-100 mg three times a day (150-300 mg/day), MAX:600 mg/day.

Restless legs syndrome: 300 mg once daily, given 1 to 3 hours before bedtime.(non-FDA use).

Dose Adjustments

Renal impairment: renal impairment: CrCl of 30 to 60 mL/min, 75 to 300 mg/day in 2 to 3 divided doses; CrCl of 15 to 30 mL/min, 25 to 150 mg/day given once daily or in 2 divided doses; CrCl less than 15 mL/min, 25 to 75 mg once daily.

Discontinuation of therapy: taper the dose gradually over a minimum of 1 week.

Contraindication: Huntington’s chorea

Adverse effect:

Common: peripheral edema, increased appetite, weight gain, constipation, xerostomia, asthenia, ataxia, dizziness, headache, incoordination, somnolence, tremor, blurred vision, diplopia , disturbance in thinking, euphoria, nasopharyngitis , fatigue.

Serious: jaundice, hypersensitivity reaction, increased creatine kinase level, suicidal thoughts, angioedema.

健保使用規範:(101/2/1、102/2/1、105/1/1)

1.使用於帶狀疱疹皮膚病灶後神經痛,並符合下列條件:

(1)經使用其他止痛劑或非類固醇抗發炎劑(NSAIDs)藥品治療後仍無法控制疼痛或有嚴重副作用者。(97/12/1、98/4/1)

(2)每日最大劑量為600mg。

2.使用於纖維肌痛(fibromyalgia)

(1)需符合American College of Rheumatology (ACR)及臨床試驗實證纖維肌痛診斷標準:

Ⅰ.WPI(wide spread pain index)≧7、Symptom severity (SS)≧5且pain rating scale≧6分或WPI 3-6、SS scale≧9且pain rating scale≧6分。

Ⅱ.症狀持續超過三個月。

Ⅲ.應排除其他疾病因素,並於病歷詳載。

(2)限風濕免疫科、神經內科、復健科及疼痛專科醫師使用,不得併用同適應症之它類藥品。

(3)如使用3個月後pain rating scale未減少2分以上應停藥。

(4)病歷每3個月應記載一次評估結果,每日最大劑量為450mg。

3.使用於糖尿病併發周邊神經病變並具有臨床神經疼痛 (neuropathic pain),且符合以下條件(105/1/1):

(1)經神經科專科醫師診斷或經神經傳導(NCV) 檢查證實之多發性神經病變(polyneuropathy)。

(2)Pain rating scale≧4分。

(3)不得併用同類適應症之藥品。

(4)使用後應每3個月評估一次,並於病歷中記載評估結果,倘Pain rating scale較前一次評估之數值未改善或未持續改善,應予停止使用。

(5)每日最大劑量為300 mg。

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