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Fentora(芬太尼口腔片)

——FDA批准Fentora用于特定癌症患者以治疗癌痛

2006-09-27 22:43:53  作者:新特药房  来源:中国新特药网天津分站  浏览次数:228  文字大小:【】【】【

 

Fentora

Generic name: Fentanyl buccal

What is Fentora?

Fentora is used to manage breakthrough cancer pain (sudden painful episodes) in patients who are opioid-tolerant.

What is the most important information I should know about Fentora?

Fentora has high potential for abuse, and should only be used to treat opioid-tolerant patients who experience persistent cancer pain. Fentora is not recommended for temporary or post-operative pain, such as pain from a medical or dental procedure.

Fentora comes in two different products, tablets and lozenges. Take Fentora exactly as indicated by your doctor and never switch or substitute these products without your doctor's approval.

Keep Fentora out of the reach of children. This drug contains medicine in amounts that could be fatal to children and babies.

Who should not take Fentora?

Fentora should not be taken to control temporary pain from injuries, surgery, and headaches, including migraines.

Do not take Fentora if you are not opioid-tolerant; it may cause life-threatening breathing problems. Also, you should not take Fentora if you are allergic to it or to any of its ingredients.

What should I tell my doctor before I take the first dose of Fentora?

Tell your doctor about all prescription, over-the-counter, and herbal medications you are taking before beginning treatment with Fentora. Also, talk to your doctor about your complete medical history, especially if you are not opioid-tolerant, if you are taking medications knows as monoamine oxidase inhibitors (MAOIs), or if you are pregnant, plan to become pregnant, or are breastfeeding.

What is the usual dosage?

The information below is based on the dosage guidelines your doctor uses. Depending on your condition and medical history, your doctor may prescribe a different regimen. Do not change the dosage or stop taking your medication without your doctor's approval.

Adults: The usual starting dose is 100 micrograms (mcg). Use 1 dose of Fentora for an episode of breakthrough cancer pain. If your breakthrough cancer pain is not relieved after 30 minutes, use only 1 more dose of Fentora at this time. Wait at least 4 more hours before using Fentora again for another episode of breakthrough cancer pain.

How should I take Fentora?


The Fentora tablet should be placed between the cheek and gum and left to disintegrate for 14-25 minutes. After 30 minutes, any remaining pieces of the tablet could be swallowed with a glass of water. Do not split, suck, chew, or swallow Fentora tablets; this will result in a lower concentration in the body.

What should I avoid while taking Fentora?

Do not split, suck, chew, or swallow Fentora tablets. Also, do not take Fentora if you are pregnant, planning to become pregnant, or are breast-feeding. This drug may cause harm to your unborn child, and my cause breathing problems in your nursing baby. Do not drive, operate heavy machinery, or do other dangerous activities until you know how Fentora affects you. Fentora can make you sleepy. Ask your doctor when it is okay to do these activities. Do not drink alcohol while using Fentora. It can increase your chance of getting dangerous side effects.

What are possible food and drug interactions associated with Fentora?

If Fentora is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Fentora with the following: amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, or verapamil.

What are the possible side effects of Fentora?

Side effects cannot be anticipated. If any develop or change in intensity, tell your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking this drug.

Side effects may include: dizziness, drowsiness, headache, nausea, sleepiness, vomiting

Can I receive Fentora if I am pregnant or breastfeeding?


Do not take Fentora if you are pregnant, planning to become pregnant, or are breastfeeding. This drug may pass into your breast milk causing breathing problems in your baby.

What should I do if I miss a dose of Fentora?


Fentora is not a regularly scheduled medicine. It should only be used for breakthrough cancer pain. Remember to continue taking your regularly used around-the-clock opioid medicine and take Fentora only when you experience an episode of breakthrough pain.

How should I store Fentora?


Store Fentora at room temperature until ready to use. Always keep Fentora out of reach of children and in a secure place to protect from theft. If a child accidentally takes Fentora, get emergency help right away.

FDA批准Cephalon抗癌药物Fentora上市

近日,FDA宣布,已批准了Cephalon公司的新药Fentora (芬太尼口腔片)用于某些特定的癌症患者以治疗癌痛。

Fentora为一种靶向作用于中枢神经系统的药物,用于癌症患者慢性疼痛中的爆发性疼痛控制。

Cephalon公司于2005年8月向FDA提交了该药物的上市申请,2006年6月,FDA认为该药“可以通过审批”。在申请函中,Cephalon提供了Fentora在13项临床试验中获取的数据,其中一项主要的临床试验结果显示,该药可以在用药后的15分钟内缓解疼痛。

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