ColciGel（colchicinum 4X  中文药名：秋水仙碱）透皮凝胶治疗与预防成人发作痛风
批准日期：2015年5月 公司：Gensco Laboratories,LLC
ColciGel®（colchicinum4X）透皮凝胶  为外用治疗
美国首次批准
适应症和用法
ColciGel®（colchicinum4X）透皮凝胶是表示一种生物碱：
治疗与痛风发作成人的预防。
ColciGel®（colchicinum4X）不是镇痛药，不应被用于从其他原因治疗疼痛。
剂型和规格
ColciGel®是Colchicinum4X透皮凝胶基质。凝胶是粘性的和不透明的外观。 ColciGel®是在15毫升密封胶产生每柱塞顶（泵）的每个手动按压凝胶0.25毫升的容器内。
禁忌
创伤皮肤，提出申请的面积的继发性细菌感染和已知过敏的任何组件
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产地国家：美国
原产地英文商品名:
ColciGel transdermal gel 2x15mL (1.01 fl oz) /Bottles
原产地英文药品名:
colchicinum4X
中文参考商品译名:
ColciGel透皮凝胶 2x15mL（1.01液体盎司）/瓶
中文参考药品译名:
秋水仙碱
生产厂家中文参考译名:
Gensco Laboratories,LLC
生产厂家英文名:
Gensco Laboratories,LLC

ColciGel®（colchicinum4X） transdermal gel
Generic Name and Formulations:
Colchicinum 4X; per gram; 0.25mL per each pump depression; transdermal gel.

Company:
Gensco Laboratories
Indications for COLCIGEL:
Treatment and prophylaxis of acute gout flares.

Adult:
One dose = 0.25mL/pump. Each application = 1–4 doses. Treatment: Apply 2–4 pumps (0.5mL–1mL) at first sign of gout flare, then 2–4 pumps (0.5mL–1mL) as needed up to every hour; max 16 pumps (4 applications) in a 24-hour period; may be given during prophylaxis at max 2 pumps at first sign of flare, then 2 pumps hourly up to 3 doses as needed. Wait 12 hours, then resume prophylactic dose. Prophylaxis: >16yrs: Apply 1–3 pumps (0.25mL–0.75mL) twice daily; max 6 pumps (1.5mL) in a 24-hour period. Dose modification in renal or hepatic impairment: see full labeling.

Children:
Not recommended.

Contraindications:
Traumatized skin. Secondary bacterial infection of affected area. Concomitant P-glycoprotein or strong CYP3A4 inhibitors (except fosamprenavir) in severe renal or hepatic impairment (life-threatening toxicity was reported with oral colchicine).

Warnings/Precautions:
Avoid eyes. Discontinue if irritation, sensitivity, infection, or toxicity is suspected or occurs. Increased risk of neuromuscular toxicity in renal impairment or elderly patients. Renal or hepatic impairment. Undergoing dialysis (treatment): not recommended; (prophylaxis): monitor closely. Pregnancy (Cat.C). Nursing mothers.

Interactions:
See Contraindications. Concomitant P-glycoprotein and/or CYP3A4 inhibitors; monitor for colchicine toxicity. Concomitant statins, gemfibrozil, fibrates, and cyclosporine may potentiate myopathy.

Pharmacological Class:
Antiinflammatory (alkaloid).

Adverse Reactions:
Skin irritation at site of application; possible blood dyscrasias, overdosage (may be fatal).

Generic Availability:
NO

How Supplied:
Gel—30mL (2 X 15mL bottles)
http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=dd7806d9-50cf-486b-97ce-afeaef02d699