制造商：
梅达制药

药理分类：
阿片类镇痛药

活性成分（补）：
芬太尼（如柠檬酸）200mcg，400mcg，600mcg，800mcg，1200mcg;颊水溶性薄膜。

指示（补）：
突破疼痛，只在阿片类药物耐受的病人谁已经接受并容忍持续（不美通社）为基础持续阿片类药物治疗癌性疼痛。阿片类药物耐受的病人是那些服用口服吗啡，â•60mg/day，透皮芬太尼，â•25mcg/hr，口服羟考酮，â•30mg/day，口服酮，â•8mg/day，口服羟，â•25毫克/天，或相等剂量的另一种，â•1周阿片。

药理作用：
Onsolis是一种强效阿片类镇痛药，芬太尼口腔transmucosal形式。它有两个层次：一个粉红色的生物黏附层，其中包含的活性成分，和白色的活跃层。芬太尼的交付量是成正比的电影表面积。像其他纯阿片受体激动剂，对μ-受体在中枢神经系统产生镇痛芬太尼行为和中枢神经系统抑郁症。它也可引起瞳孔缩小，降低肠胃蠕动。

从这个产品芬太尼的吸收是一个初步快速的交货transmucosal和更长时间的吞吃毒品从胃肠道吸收相结合。如果电影是咀嚼和吞咽，它可能会导致较低的峰值低浓度和生物利用度比如果直接使用。

法律分类：
印度工业联合会

成人：
，•18yrs：不要剪片。里面放置在湿润地区的脸颊，等待前饮用的液体至少5分钟，却不能操纵电影或吃，直到电影已经解散。与200mcg膜（s）滴定，然后切换到一部影片在滴定剂量。最初200mcg，在200mcg增量滴定，最大4 × 200mcg电影或一1200mcg电影。最大一剂量/集;不超过4次/天，至少2小时分开。如果上述4个200mcg电影滴定，切换到一1200mcg电影，最大1200mcg/dose。不要转换从一微克微克芬太尼基础的其他产品。不要转乘其他芬太尼产品。不要把上面再加一个电影。可使用膜后放置30分钟再追加药物如果需要的话。

儿童：
“18yrs：不推荐。

禁忌（补）：
不适用于阿片类药物的非耐受的病人。急性或后运疼痛（包括头痛/偏头痛，牙痛，或ER）​​。

警告/注意事项：
呼吸系统疾病或抑郁症。头部受伤。颅内压增高。心动过缓。受损的肺，心血管，肾脏，或肝功能。贮存，处置得当。老人。虚弱。妊娠（Cat.C）。劳动和分娩，哺乳期妇女：不推荐。

互动（补）：
不推荐单胺氧化抑制剂后14天。 Potentiates中枢神经系统抑郁症，酒精，其他中枢神经系统抑制剂（如噻嗪，骨骼肌肉松弛剂，抗组织胺药，安眠药）。由CYP3A4抑制剂Potentiated（如大环内酯类，唑类抗真菌剂，阿瑞，蛋白酶抑制剂，奈法唑酮，维拉帕米，地尔硫卓）。 CYP3A4的诱导剂的拮抗（如巴比妥酸盐，依非韦伦，莫达非尼，奈韦拉平，抗惊厥药，吡格列酮，曲格列酮，利福布丁，利福平，圣约翰草）。

不良反应（补）：
胃肠不适，头晕，脱水，呼吸困难，嗜睡，呼吸或循环系统抑郁症，低血压，休克，嗜睡，抗胆碱作用，等等。

注释：
可通过限制分配方案。请拨打（877）4ONSOLIS或访问www.OnsolisFocus.com报名参加。注意患者和妥善处理和处置照顾者;可能是致命的儿童。

如何提供：
电影，Äî30

最后更新：
2009年11月25日

Indication(s):

Breakthrough pain, only in opioid-tolerant patients who are already receiving and are tolerant to continuous (not prn) opioid therapy for underlying persistent cancer pain. Opioid-tolerant patients are those taking oral morphine ≥60mg/day, transdermal fentanyl ≥25mcg/hr, oral oxycodone ≥30mg/day, oral hydromorphone ≥8mg/day, oral oxymorphone ≥25mg/day, or equianalgesic dose of another opioid for ≥1 week.

Pharmacology:

Onsolis is an oral transmucosal form of the potent opioid analgesic, fentanyl. It has two layers: a pink bioadhesive layer that contains the active ingredient, and a white inactive layer. The amount of fentanyl delivered is proportional to the surface area of the film. Like other pure opioid agonists, fentanyl acts on the mu-receptors in the CNS to produce analgesia and CNS depression. It also causes miosis and reduced gastrointestinal motility.

The absorption of fentanyl from this product is a combination of an initial rapid transmucosal delivery and a more prolonged absorption of swallowed drug from the GI tract. If a film is chewed and swallowed, it will likely result in lower peak concentrations and lower bioavailability than if used as directed.

Legal Classification:

CII

Adults:

≥18yrs: Do not cut film. Place on moistened area inside cheek; wait at least 5min before drinking liquids, do not manipulate film or eat until film has dissolved. Titrate with 200mcg film(s) then switch to one film at the titrated dose. Initially 200mcg; titrate in 200mcg increments, up to max 4 x 200mcg films or one 1200mcg film. Max one dose/episode; no more than 4 doses/day at least 2hrs apart. If titrating above 4 x 200mcg films, switch to one 1200mcg film; max 1200mcg/dose. Do not convert from other fentanyl products on a mcg-mcg basis. Do not interchange with other fentanyl products. Do not put one film on top of another. May use another rescue drug 30min after film placement if needed.

Children:

<18yrs: not recommended.

Contraindication(s):

Not for opioid non-tolerant patients. Acute or post-op pain (including headache/migraine, dental pain, or ER).

Warnings/Precautions:

Respiratory disorders or depression. Head injury. Increased intracranial pressure. Bradycardia. Impaired pulmonary, cardiovascular, renal, or hepatic function. Store and dispose of properly. Elderly. Debilitated. Pregnancy (Cat.C). Labor & delivery, nursing mothers: not recommended.

Interaction(s):

Not recommended within 14 days of MAOIs. Potentiates CNS depression with alcohol, other CNS depressants (eg, phenothiazines, skeletal muscle relaxants, antihistamines, hypnotics). Potentiated by CYP3A4 inhibitors (eg, macrolides, azole antifungals, aprepitant, protease inhibitors, nefazodone, verapamil, diltiazem). Antagonized by CYP3A4 inducers (eg, barbiturates, efavirenz, modafinil, nevirapine, anticonvulsants, pioglitazone, troglitazone, rifabutin, rifampin, St John's wort).

Adverse Reaction(s):

GI upset, dizziness, dehydration, dyspnea, somnolence; respiratory or circulatory depression, hypotension, shock, drowsiness, anticholinergic effects, others.

Notes:

Available by restricted distribution program. Call (877) 4ONSOLIS or visit www.OnsolisFocus.com to enroll. Caution patients and caregivers in proper handling and disposal; may be fatal to children.

How Supplied:

Films—30