Thuốc Duragesic Mat (Transdermal)

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Thuốc Duragesic Mat (Transdermal)
Thuốc Duragesic Mat (Transdermal)

Hovevn Health chia sẻ các bài viết về: Thuốc Dur Duric Mat (Transdermal), tác dụng phụ – liều lượng, Mat Duragesic Mat (Transdermal) điều trị bệnh gì. Các vấn đề lưu ý khác. Vui lòng tham khảo các chi tiết dưới đây.

Tên chung: fentanyl (Tuyến xuyên da)

FEN-ta-nil

Holevn.org xem xét y tế. Cập nhật lần cuối vào ngày 27 tháng 6 năm 2019.

Tuyến xuyên da (Bản vá, Phát hành mở rộng)

Nghiện, lạm dụng và lạm dụng; Chiến lược đánh giá và giảm thiểu rủi ro (REMS); Suy hô hấp đe dọa tính mạng; Tiếp xúc vô tình; Hội chứng rút Opioid sơ sinh; Tương tác Cytochrom P450 3A4; Nguy cơ tăng hấp thu Fentanyl khi sử dụng nhiệt bên ngoài; và Rủi ro từ việc sử dụng đồng thời các loại thuốc Benzodiazepin hoặc thuốc ức chế thần kinh trung ương khácFentanyl khiến người dùng gặp rủi ro nghiện, lạm dụng và lạm dụng, có thể dẫn đến quá liều và tử vong. Đánh giá rủi ro của bệnh nhân trước khi kê đơn và theo dõi thường xuyên các hành vi hoặc điều kiện này. Để đảm bảo rằng lợi ích của thuốc giảm đau opioid vượt xa nguy cơ nghiện, lạm dụng và lạm dụng, Cục Quản lý Thực phẩm và Dược phẩm (FDA) đã yêu cầu Chiến lược Đánh giá và Giảm thiểu Rủi ro (REMS) cho các sản phẩm này. Suy hô hấp nguy hiểm, đe dọa tính mạng hoặc gây tử vong có thể xảy ra. Theo dõi chặt chẽ, đặc biệt là khi bắt đầu hoặc sau khi tăng liều. Tiếp xúc với fentanyl, đặc biệt ở trẻ em, có thể dẫn đến quá liều fentanyl. Sử dụng fentanyl khi mang thai có thể dẫn đến hội chứng cai nghiện opioid ở trẻ sơ sinh, có thể đe dọa đến tính mạng nếu không được công nhận và điều trị. Nếu việc sử dụng opioid là cần thiết trong một thời gian dài ở phụ nữ mang thai, khuyên bệnh nhân về nguy cơ mắc hội chứng cai nghiện opioid ở trẻ sơ sinh và đảm bảo sẽ có phương pháp điều trị thích hợp. Sử dụng đồng thời với thuốc ức chế CYP3A4 (hoặc ngừng sử dụng thuốc gây cảm ứng CYP3A4) Quá liều gây tử vong của fentanyl. Tiếp xúc với trang web ứng dụng fentanyl và khu vực xung quanh với các nguồn nhiệt trực tiếp bên ngoài đã dẫn đến quá liều gây tử vong của fentanyl. Cảnh báo bệnh nhân để tránh tiếp xúc với trang web ứng dụng fentanyl và khu vực xung quanh với các nguồn nhiệt bên ngoài trực tiếp. Sử dụng đồng thời opioid với các thuốc benzodiazepin hoặc thuốc ức chế thần kinh trung ương khác, bao gồm cả rượu, có thể dẫn đến an thần sâu sắc, ức chế hô hấp, hôn mê và tử vong. Dự trữ đồng thời kê đơn để sử dụng ở những bệnh nhân mà các lựa chọn điều trị thay thế là không đủ; giới hạn liều lượng và thời lượng đến mức tối thiểu cần thiết; và theo dõi bệnh nhân về các dấu hiệu và triệu chứng của suy hô hấp và an thần.

Tuyến xuyên da (Bản vá, Hỗ trợ thiết bị)

Cảnh báo: Suy hô hấp đe dọa tính mạng; Ionsys NHỚ; Nghiện, lạm dụng và lạm dụng; Tương tác Cytochrom P450 3A4; và Rủi ro từ việc sử dụng đồng thời với Benzodiazepin hoặc các thuốc ức chế thần kinh trung ương khác Có thể xảy ra trầm cảm, đe dọa đến tính mạng hoặc gây tử vong cho hô hấp. Giám sát chặt chẽ, đặc biệt là khi bắt đầu. Chỉ có bệnh nhân nên kích hoạt hệ thống xuyên da.Fentanyl iontophoretic chỉ dành cho bệnh nhân trong bệnh viện. Ngừng sử dụng hệ thống xuyên da fentanyl iontophoretic trước khi bệnh nhân rời khỏi bệnh viện. Các cơ sở chăm sóc sức khỏe phân phối hệ thống xuyên da fentanyl iontophoretic phải được chứng nhận trong chương trình này và tuân thủ các yêu cầu của REMS. Hệ thống xuyên da iontophoretic khiến người dùng có nguy cơ nghiện, lạm dụng và lạm dụng, có thể dẫn đến quá liều và tử vong. Đánh giá nguy cơ của bệnh nhân trước khi kê đơn và theo dõi thường xuyên các hành vi và điều kiện này. Sử dụng đồng thời với các thuốc ức chế CYP3A4 (hoặc ngừng sử dụng thuốc gây cảm ứng CYP3A4) có thể dẫn đến quá liều gây tử vong cho fentanyl. có thể dẫn đến an thần sâu sắc, suy hô hấp, hôn mê và tử vong. Dự trữ đồng thời kê đơn để sử dụng ở những bệnh nhân mà các lựa chọn điều trị thay thế là không đủ; giới hạn liều lượng và thời lượng đến mức tối thiểu cần thiết; và theo dõi bệnh nhân về các dấu hiệu và triệu chứng của suy hô hấp và an thần.

Tên thương hiệu thường được sử dụng

Tại Hoa Kỳ

  • Duragesic
  • Ionsys

Ở Canada

  • Thảm Duragesic

Các dạng bào chế có sẵn:

  • Bản vá, phát hành mở rộng
  • Bản vá, hỗ trợ thiết bị

Lớp trị liệu: Giảm đau

Lớp hóa học: Opioid

Sử dụng cho Duragesic Mat

Miếng dán da Fentanyl được sử dụng để điều trị đau dữ dội, bao gồm đau cấp tính sau phẫu thuật. Ionsys® được áp dụng bởi nhà cung cấp dịch vụ chăm sóc sức khỏe của bạn trong môi trường bệnh viện sau khi phẫu thuật để kiểm soát cơn đau cấp tính trong thời gian ngắn. Duragesic® được sử dụng để giảm đau đủ nghiêm trọng để yêu cầu giảm đau suốt ngày trong một thời gian dài. Fentanyl là một thuốc giảm đau gây nghiện mạnh (thuốc giảm đau). Nó hoạt động trên hệ thống thần kinh trung ương (CNS) để giảm đau.

Không nên sử dụng miếng dán da Duragesic® nếu bạn cần dùng thuốc giảm đau chỉ trong một thời gian ngắn, chẳng hạn như sau phẫu thuật nha khoa hoặc phẫu thuật cắt amidan. Không sử dụng miếng dán cho đau nhẹ hoặc đau chỉ xảy ra một lần trong một thời gian.

Khi một loại thuốc gây nghiện được sử dụng trong một thời gian dài, nó có thể trở thành thói quen, gây ra sự phụ thuộc về tinh thần hoặc thể chất. Tuy nhiên, những người bị đau liên tục không nên để nỗi sợ phụ thuộc ngăn họ sử dụng ma túy để giảm đau. Sự phụ thuộc tinh thần (nghiện) không có khả năng xảy ra khi ma túy được sử dụng cho mục đích này. Sự phụ thuộc về thể chất có thể dẫn đến tác dụng phụ khi rút thuốc nếu ngừng điều trị đột ngột. Tuy nhiên, tác dụng phụ nghiêm trọng khi cai thuốc thường có thể được ngăn chặn bằng cách giảm dần liều trong một khoảng thời gian trước khi ngừng điều trị hoàn toàn.

Thuốc này chỉ có sẵn trong một chương trình phân phối hạn chế được gọi là chương trình giảm đau Opioid REMS (Chiến lược đánh giá và giảm thiểu rủi ro).

Trước khi sử dụng Duragesic Mat

Khi quyết định sử dụng thuốc, rủi ro của việc dùng thuốc phải được cân nhắc với lợi ích mà nó sẽ làm. Đây là một quyết định mà bạn và bác sĩ của bạn sẽ đưa ra. Đối với thuốc này, cần xem xét những điều sau đây:

Dị ứng

Hãy cho bác sĩ của bạn nếu bạn đã từng có bất kỳ phản ứng bất thường hoặc dị ứng với thuốc này hoặc bất kỳ loại thuốc khác. Cũng nói với chuyên gia chăm sóc sức khỏe của bạn nếu bạn có bất kỳ loại dị ứng nào khác, chẳng hạn như thực phẩm, thuốc nhuộm, chất bảo quản hoặc động vật. Đối với các sản phẩm không kê đơn, đọc nhãn hoặc thành phần gói cẩn thận.

Nhi khoa

Các nghiên cứu phù hợp được thực hiện cho đến nay đã không chứng minh được các vấn đề cụ thể ở trẻ em sẽ hạn chế tính hữu ích của miếng dán Duragesic® ở trẻ em từ 2 tuổi trở lên. Tuy nhiên, bệnh nhân nhi phải dung nạp opioid trước khi sử dụng miếng dán fentanyl . An toàn và hiệu quả chưa được thiết lập ở trẻ em dưới 2 tuổi.

Các nghiên cứu phù hợp đã không được thực hiện về mối quan hệ của tuổi tác với tác động của miếng dán Ionsys® trong dân số nhi khoa. An toàn và hiệu quả chưa được thành lập.

Lão

Các nghiên cứu phù hợp được thực hiện cho đến nay đã không chứng minh được các vấn đề cụ thể về lão khoa sẽ hạn chế tính hữu ích của miếng dán da fentanyl ở người cao tuổi. Tuy nhiên, bệnh nhân cao tuổi có nhiều khả năng bị buồn ngủ và các vấn đề về phổi, thận, gan hoặc tim liên quan đến tuổi, có thể cần thận trọng và điều chỉnh liều cho bệnh nhân dùng miếng dán da fentanyl.

Cho con bú

Không có nghiên cứu đầy đủ ở phụ nữ để xác định nguy cơ trẻ sơ sinh khi sử dụng thuốc này trong thời gian cho con bú. Cân nhắc lợi ích tiềm năng chống lại các rủi ro tiềm ẩn trước khi dùng thuốc này trong khi cho con bú.

Tương tác với thuốc

Mặc dù một số loại thuốc không nên được sử dụng cùng nhau, trong các trường hợp khác, hai loại thuốc khác nhau có thể được sử dụng cùng nhau ngay cả khi có thể xảy ra tương tác. Trong những trường hợp này, bác sĩ của bạn có thể muốn thay đổi liều, hoặc các biện pháp phòng ngừa khác có thể là cần thiết. Khi bạn đang dùng thuốc này, điều đặc biệt quan trọng là chuyên gia chăm sóc sức khỏe của bạn phải biết nếu bạn đang sử dụng bất kỳ loại thuốc nào được liệt kê dưới đây. Các tương tác sau đây đã được chọn trên cơ sở ý nghĩa tiềm năng của chúng và không nhất thiết phải bao gồm tất cả.

Sử dụng thuốc này với bất kỳ loại thuốc sau đây không được khuyến khích. Bác sĩ có thể quyết định không điều trị cho bạn bằng thuốc này hoặc thay đổi một số loại thuốc khác mà bạn dùng.

  • Mifepristone
  • Nalmefene
  • Naltrexone
  • Safinamid

Fentanyl can cause serious unwanted effects or a fatal overdose if taken by children, pets, or adults who are not used to strong narcotic pain medicines. Make sure you store the medicine in a safe and secure place to prevent others from getting it.

    To dispose of the Duragesic® patch, fold the patch in half with the sticky side inside. If the patch has not been used, take it out of the pouch and remove the liner that covers the sticky side of the patch before folding it in half. Ask your pharmacist about the best way to dispose of patches you do not use. Do not flush the pouch or the protective liner down the toilet. Put them in a trash can.

    Your healthcare provider will dispose of the Ionsys® patch after removing it.

    Drop off any unused narcotic medicine at a drug take-back location right away. If you do not have a drug take-back location near you, flush any unused narcotic medicine down the toilet. Check your local drug store and clinics for take-back locations. You can also check the DEA web site for locations. Here is the link to the FDA safe disposal of medicines website: www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/ensuringsafeuseofmedicine/safedisposalofmedicines/ucm186187.htm

    Precautions while using Duragesic Mat

    It is very important that your doctor check your or your child’s progress while using this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may needed to check for unwanted effects.

    Do not touch the sticky side of the patch or the gel. Fentanyl can be quickly absorbed through the eyes and mouth and can be extremely dangerous. If you do touch the sticky side of the patch or gel, let your nurse or doctor know right away and rinse the area with large amounts of water. Do not use soaps or other cleansers.

    Check with your doctor at regular times while using fentanyl. Be sure to report any side effects.

    After you have been using this medicine for awhile, “breakthrough” pain may occur more often than usual, and it may not be relieved by your regular dose of medicine. If this occurs, do not increase the amount of fentanyl skin patch or other narcotic that you are using without first checking with your doctor.

    This medicine will add to the effects of alcohol and other CNS depressants. CNS depressants are medicines that slow down the nervous system, which may cause drowsiness or make you less alert. Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds, sedatives, tranquilizers, or sleeping medicine, other prescription pain medicine or narcotics, benzodiazepines, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. This effect may last for a few days after you stop using this medicine. Check with your doctor before taking any of the medicines listed while you are using this medicine.

    The Ionsys® patch must be removed before a procedure called a magnetic resonance imaging (MRI) scan. It may cause skin burns if left in place during the procedure.

    The Ionsys® patch may cause serious skin reactions. Call you doctor right away if you have blistering, lesions, a rash, redness, or swelling of the skin, especially at the site of application.

    Fentanyl may cause some people to become drowsy, dizzy, or lightheaded, or to feel a false sense of well-being. Do not drive or do anything else that could be dangerous until you know how this medicine affects you. These effects usually go away after a few days of treatment, when your body gets used to the medicine. However, check with your doctor if drowsiness that is severe enough to interfere with your activities continues for more than a few days.

    Dizziness, lightheadedness, or even fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem. Also, lying down for a while may relieve dizziness or lightheadedness.

    Nausea or vomiting may occur, especially during the first several days of treatment. Lying down for a while may relieve these effects. However, if they are especially bothersome or if they continue for more than a few days, check with your doctor. You may be able to take another medicine to help prevent these problems.

    Using narcotics for a long time may cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.

    Heat can cause the fentanyl in the patch to be absorbed into your body faster. This may increase the chance of serious side effects or an overdose. While you are using this medicine, do not use a heating pad, electric blanket, heat or tanning lamps, sauna, a sunlamp, or a heated water bed, and do not sunbathe, or take long baths or showers in hot water. Also, check with your doctor if you get a fever.

  • Be careful not to tear the patch or make any holes in it. Damage to a patch may allow fentanyl to pass into your skin too quickly. This can cause an overdose.
  • Apply the patch to a dry, flat skin area on your upper arm, chest, or back. Choose a place where the skin is not very oily and is free of scars, cuts, burns, or irritation. Do not apply this medicine to areas that have received radiation treatment.
  • The patch will stay in place better if it is applied to an area with little or no hair. If you need to apply the patch to a hairy area, you may first clip the hair with scissors, but do not shave it off.
  • If you need to clean the area before applying the medicine, use only plain water. Do not use soaps, other cleansers, lotions, or anything that contains oils or alcohol. Be sure that the skin is completely dry before applying the medicine.
  • Remove the liner covering the sticky side of the skin patch. Then press the patch firmly in place, using the palm of your hand, for a minimum of 30 seconds. Make sure that the entire adhesive surface is attached to your skin, especially around the edges.
  • If the patch becomes loose, tape the edges with first aid tape.
  • If the patch falls off after applying it, throw it away and apply a new patch in a different area.
  • If you need to apply more than 1 patch at a time, place the patches far enough apart so that the edges do not touch or overlap each other.
  • Wash your hands with a lot of clear water after applying the medicine. Do not use soap or other cleansers.
  • Remove the patch after 3 days (72 hours), or as directed by your doctor. Choose a different place on your skin to apply the next patch. If possible, use a place on the other side of your body. Wait at least 3 days before using the first area again.
  • In young children or persons with decreased mental alertness, the Duragesic® patch should be put on the upper back to decrease the chance that the patch will be removed and placed in the mouth.

    After a Duragesic® patch is applied, fentanyl passes into the skin a little at a time. A certain amount of the medicine must build up in the skin before it is absorbed into the body. Up to a full day (24 hours) may pass before the first dose begins to work. Your doctor may need to adjust the dose during the first few weeks before finding the amount that works best for you. Even if you feel that the medicine is not working, do not increase the amount of fentanyl skin patch that you apply. Instead, check first with your doctor.

    You will probably need to take a faster-acting narcotic by mouth to relieve pain during the first few days of using fentanyl skin patch. You may also need another narcotic while your dose of fentanyl is being adjusted, and to relieve any “breakthrough” pain that occurs later on. Be sure you do not take more of the other narcotic, and do not take it more often than directed. Taking 2 narcotics together can increase the chance of serious side effects.

    Grapefruit and grapefruit juice may increase the effects of fentanyl skin patch by increasing the amount of the medicine in your body. You should not consume grapefruit products while you are using this medicine.

    Dosing

    The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

    The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

    • For transdermal dosage form (Duragesic® skin patch):
      • For relief of chronic pain:
        • Adults and children 2 years of age and older—Your doctor will decide which dose of the patch you need based on your present daily narcotic dose. The patch is applied to the skin and left in place for 3 days (72 hours). Your doctor may adjust your dose as needed.
        • Children younger than 2 years of age—Use and dose must be determined by your doctor.
    • For transdermal dosage form (Ionsys® skin patch):
      • For short-term relief of acute pain after surgery:
        • Adults—Your doctor will decide which dose of the patch you need based on your present daily narcotic dose. The patch is applied by your healthcare provider to your upper outer arm or chest. Your doctor will show you how to adjust your dose as needed while in the hospital.

    Missed dose

    If you forget to wear or change a patch, put one on as soon as you can. If it is almost time to put on your next patch, wait until then to apply a new patch and skip the one you missed. Do not apply extra patches to make up for a missed dose.

    Remove the Duragesic® patch 3 days (72 hours) after applying it.

    Your healthcare provider will remove the Ionsys® patch before you leave the hospital. The Ionsys® patch is not for use at home.

    Storage

    Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

    Keep out of the reach of children.

    Do not keep outdated medicine or medicine no longer needed.

    Ask your healthcare professional how you should dispose of any medicine you do not use.

    Fentanyl can cause serious unwanted effects or a fatal overdose if taken by children, pets, or adults who are not used to strong narcotic pain medicines. Make sure you store the medicine in a safe and secure place to prevent others from getting it.

    To dispose of the Duragesic® patch, fold the patch in half with the sticky side inside. If the patch has not been used, take it out of the pouch and remove the liner that covers the sticky side of the patch before folding it in half. Ask your pharmacist about the best way to dispose of patches you do not use. Do not flush the pouch or the protective liner down the toilet. Put them in a trash can.

    Your healthcare provider will dispose of the Ionsys® patch after removing it.

    Drop off any unused narcotic medicine at a drug take-back location right away. If you do not have a drug take-back location near you, flush any unused narcotic medicine down the toilet. Check your local drug store and clinics for take-back locations. You can also check the DEA web site for locations. Here is the link to the FDA safe disposal of medicines website: www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/ensuringsafeuseofmedicine/safedisposalofmedicines/ucm186187.htm

    Precautions while using Duragesic Mat

    It is very important that your doctor check your or your child’s progress while using this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may needed to check for unwanted effects.

    Do not touch the sticky side of the patch or the gel. Fentanyl can be quickly absorbed through the eyes and mouth and can be extremely dangerous. If you do touch the sticky side of the patch or gel, let your nurse or doctor know right away and rinse the area with large amounts of water. Do not use soaps or other cleansers.

    Check with your doctor at regular times while using fentanyl. Be sure to report any side effects.

    After you have been using this medicine for awhile, “breakthrough” pain may occur more often than usual, and it may not be relieved by your regular dose of medicine. If this occurs, do not increase the amount of fentanyl skin patch or other narcotic that you are using without first checking with your doctor.

    This medicine will add to the effects of alcohol and other CNS depressants. CNS depressants are medicines that slow down the nervous system, which may cause drowsiness or make you less alert. Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds, sedatives, tranquilizers, or sleeping medicine, other prescription pain medicine or narcotics, benzodiazepines, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. This effect may last for a few days after you stop using this medicine. Check with your doctor before taking any of the medicines listed while you are using this medicine.

    The Ionsys® patch must be removed before a procedure called a magnetic resonance imaging (MRI) scan. It may cause skin burns if left in place during the procedure.

    The Ionsys® patch may cause serious skin reactions. Call you doctor right away if you have blistering, lesions, a rash, redness, or swelling of the skin, especially at the site of application.

    Fentanyl may cause some people to become drowsy, dizzy, or lightheaded, or to feel a false sense of well-being. Do not drive or do anything else that could be dangerous until you know how this medicine affects you. These effects usually go away after a few days of treatment, when your body gets used to the medicine. However, check with your doctor if drowsiness that is severe enough to interfere with your activities continues for more than a few days.

    Dizziness, lightheadedness, or even fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem. Also, lying down for a while may relieve dizziness or lightheadedness.

    Nausea or vomiting may occur, especially during the first several days of treatment. Lying down for a while may relieve these effects. However, if they are especially bothersome or if they continue for more than a few days, check with your doctor. You may be able to take another medicine to help prevent these problems.

    Using narcotics for a long time may cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.

    Heat can cause the fentanyl in the patch to be absorbed into your body faster. This may increase the chance of serious side effects or an overdose. While you are using this medicine, do not use a heating pad, electric blanket, heat or tanning lamps, sauna, a sunlamp, or a heated water bed, and do not sunbathe, or take long baths or showers in hot water. Also, check with your doctor if you get a fever.

    Be careful about letting other people come in contact with your patch. The patch could stick to someone else, such as when you hug them or if someone helps you put the patch on. If any medicine gets on another person, wash it off right away with clear water.

    Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are using this medicine. Serious side effects can occur if your medical doctor or dentist gives you certain other medicines without knowing that you are using fentanyl.

    You may bathe, shower, or swim while wearing a fentanyl skin patch. However, be careful to wash and dry the area around the patch gently. Rubbing may cause the patch to get loose or come off. If this does occur, throw away the patch and apply a new one in a different place. Make sure the area is completely dry before applying the new patch.

    If you have been using this medicine regularly for several weeks or more, do not suddenly stop using it without first checking with your doctor. You may be directed to gradually reduce the amount you are using before stopping treatment completely to lessen the chance of withdrawal side effects.

    Using too much fentanyl skin patch, or taking too much of another narcotic with fentanyl skin patch, may cause an overdose. If this occurs, get emergency help right away. An overdose can cause severe breathing problems (breathing may even stop), unconsciousness, and death. Serious signs of an overdose include: very slow breathing (fewer than 8 breaths a minute) and drowsiness that is so severe that you are not able to answer when spoken to, or, if asleep, cannot be awakened. Other signs of an overdose may include: cold, clammy skin, low blood pressure, pinpoint pupils of the eyes, and slow heartbeat. It may be best to have a family member or a friend check on you several times a day when you start using a narcotic regularly, and whenever your dose is increased, so that he or she can get help for you if you cannot do so yourself.

    This medicine may cause sleep-related breathing problems (eg, sleep apnea, sleep-related hypoxemia). Your doctor may decrease your dose if you have sleep apnea (stop breathing for short periods during sleep) while using this medicine.

    Do not use a fentanyl patch if you have taken a monoamine oxidase (MAO) inhibitor in the past 2 weeks. Some examples of MAO inhibitors are isocarboxazid (Marplan®), phenelzine (Nardil®), selegiline (Eldepryl®), and tranylcypromine (Parnate®). If you use the 2 medicines close together it may cause serious side effects like confusion, agitation, restlessness, stomach or intestinal symptoms, a sudden high temperature, an extremely high blood pressure, or severe convulsions.

    Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.

    Using this medicine while you are pregnant may cause serious unwanted effects, including neonatal opioid withdrawal syndrome in your newborn baby. Tell your doctor right away if you think you are pregnant or if you plan to become pregnant while using this medicine.

    Using too much of this medicine may cause reduced infertility (unable to have children). Talk with your doctor before using this medicine if you plan to have children.

    Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

    Duragesic Mat side effects

    Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

    Check with your doctor immediately if any of the following side effects occur:

    Less common

    • Anxiety
    • bloating or swelling of the face, arms, hands, lower legs, or feet
    • burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
    • confusion
    • decrease in urine volume
    • difficulty in breathing or swallowing
    • difficulty in passing urine (dribbling)
    • fast, irregular, pounding, or racing heartbeat or pulse
    • painful urination
    • rapid weight gain
    • seeing, hearing, or feeling things that are not there
    • skin itching, rash, or redness
    • swelling of the face, throat, or tongue
    • tremor
    • unusual weight gain or loss
    • upper stomach pain

    Rare

    • Bluish color of the fingernails, lips, skin, palms, or nail beds
    • burning, itching, redness, skin rash, swelling, or soreness at the application site
    • confusion about identity, place, and time
    • false or unusual sense of well-being
    • irregular, fast or slow, or shallow breathing

    Incidence not known

    • Agitation
    • blurred vision
    • chest pain or discomfort
    • cough
    • darkening of the skin
    • diarrhea
    • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
    • fever
    • headache
    • hives
    • lightheadedness, dizziness, or fainting
    • loss of appetite
    • mental depression
    • nausea
    • nervousness
    • overactive reflexes
    • poor coordination
    • pounding in the ears
    • restlessness
    • severe constipation
    • severe vomiting
    • shivering
    • sweating
    • talking or acting with excitement you cannot control
    • tightness in the chest
    • unusual tiredness or weakness
    • vomiting

    Get emergency help immediately if any of the following symptoms of overdose occur:

    Symptoms of overdose

    • Cold, clammy skin
    • drowsiness that is so severe you are not able to answer when spoken to or, if asleep, cannot be awakened
    • pinpoint (small) pupils in the eyes
    • seizures
    • slow heartbeat
    • very slow or troubled breathing

    Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

    More common

    • Constipation
    • feeling cold
    • sleepiness or unusual drowsiness
    • trouble sleeping

    Less common

    • Dry mouth
    • feeling of constant movement of self or surroundings
    • feeling of crawling, tingling, or burning of the skin
    • lack or loss of strength
    • memory loss
    • sensation of spinning
    • unusual dreams

    Rare

    • Abnormal ejaculation
    • decreased interest in sexual intercourse
    • decreased sexual performance or desire
    • inability to have or keep an erection
    • loss in sexual ability, desire, drive, or performance
    • muscle twitching

    Incidence not known

    • Belching
    • heartburn
    • indigestion
    • stomach discomfort or upset

    Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

    Seek emergency medical attention or call 115

    Further information

    The content of Holevn is solely for the purpose of providing information about Thuốc Duragesic Mat (Transdermal)  and is not intended to be a substitute for professional medical advice, diagnosis or treatment. Please contact your nearest doctor or clinic, hospital for advice. We do not accept liability if the patient arbitrarily uses the drug without following a doctor’s prescription.

    Reference from: https://www.drugs.com/cons/duragesic-mat.html

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Interactions with food/tobacco/alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Ethanol
  • Grapefruit Juice

Other medical problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Alcohol abuse, or history of or
  • Brain tumor, history of or
  • Breathing problems (eg, asthma, apnea, low oxygen levels, sleep apnea) or
  • Chronic obstructive pulmonary disease (COPD) or
  • Cor pulmonale (serious heart condition) or
  • Gallbladder disease (eg, gallstones) or
  • Depression, history of or
  • Drug dependence, including narcotic or illicit drug abuse or dependence, history of or
  • Head injury, history of or
  • Mental health problems, history of or
  • Weakened physical condition—Use with caution. May increase risk for more serious side effects.
  • Bradyarrhythmia (slow heart rhythm) or
  • Hypotension (low blood pressure) or
  • Pancreatitis (swelling of the pancreas), acute or
  • Seizures, history of—Use with caution. May make these conditions worse.
  • Kidney disease or
  • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
  • Lung or breathing problems (eg, asthma, respiratory depression), severe or
  • Stomach or bowel blockage (eg, paralytic ileus), known or suspected—Should not be used in patients with these conditions.

Proper use of Duragesic Mat

This section provides information on the proper use of a number of products that contain fentanyl. It may not be specific to Duragesic Mat. Please read with care.

Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. This is especially important for elderly patients, who may be more sensitive to the effects of pain medicines. If too much of this medicine is used for a long time, it may become habit-forming (causing mental or physical dependence) or cause an overdose.

The fentanyl skin patch is only used for opioid-tolerant patients. A patient is opioid-tolerant if oral narcotics have already been used for severe pain. Check with your doctor if you have questions about this.

It is very important that you understand the rules of the Opioid Analgesic REMS program to prevent addiction, abuse, and misuse of fentanyl. This medicine should also come with a Medication Guide and patient instructions. Read and follow these instructions carefully. Read it again each time you refill your prescription in case there is new information. Ask your doctor if you have any questions.

You will receive the Ionsys® patch while you are in a hospital. A nurse or other trained health professional will give you this medicine after surgery. You will be taught how to use this medicine in the hospital, but the patch will be removed by your healthcare provider before you leave the hospital. Do not leave the hospital with the patch on your skin.

To use the Duragesic® patch:

  • Use this medicine exactly as directed by your doctor. It will work only if it has been applied correctly.
  • This medicine should only be used on skin that is not irritated or injured. Do not put the patch in your mouth, chew it, or swallow it.
  • Fentanyl skin patches are packaged in sealed pouches. Do not remove the patch from the sealed pouch until you are ready to apply it.
  • When handling the skin patch, be careful not to touch the adhesive (sticky) surface with your hand. The adhesive part of the system contains some fentanyl, which can be absorbed into your body too fast through the skin of your hand. If any of the medicine does get on your hand, rinse the area right away with a lot of clear water. Do not use soap or other cleansers.
  • Be careful not to tear the patch or make any holes in it. Damage to a patch may allow fentanyl to pass into your skin too quickly. This can cause an overdose.
  • Apply the patch to a dry, flat skin area on your upper arm, chest, or back. Choose a place where the skin is not very oily and is free of scars, cuts, burns, or irritation. Do not apply this medicine to areas that have received radiation treatment.
  • The patch will stay in place better if it is applied to an area with little or no hair. If you need to apply the patch to a hairy area, you may first clip the hair with scissors, but do not shave it off.
  • If you need to clean the area before applying the medicine, use only plain water. Do not use soaps, other cleansers, lotions, or anything that contains oils or alcohol. Be sure that the skin is completely dry before applying the medicine.
  • Remove the liner covering the sticky side of the skin patch. Then press the patch firmly in place, using the palm of your hand, for a minimum of 30 seconds. Make sure that the entire adhesive surface is attached to your skin, especially around the edges.
  • If the patch becomes loose, tape the edges with first aid tape.
  • If the patch falls off after applying it, throw it away and apply a new patch in a different area.
  • If you need to apply more than 1 patch at a time, place the patches far enough apart so that the edges do not touch or overlap each other.
  • Wash your hands with a lot of clear water after applying the medicine. Do not use soap or other cleansers.
  • Remove the patch after 3 days (72 hours), or as directed by your doctor. Choose a different place on your skin to apply the next patch. If possible, use a place on the other side of your body. Wait at least 3 days before using the first area again.

In young children or persons with decreased mental alertness, the Duragesic® patch should be put on the upper back to decrease the chance that the patch will be removed and placed in the mouth.

After a Duragesic® patch is applied, fentanyl passes into the skin a little at a time. A certain amount of the medicine must build up in the skin before it is absorbed into the body. Up to a full day (24 hours) may pass before the first dose begins to work. Your doctor may need to adjust the dose during the first few weeks before finding the amount that works best for you. Even if you feel that the medicine is not working, do not increase the amount of fentanyl skin patch that you apply. Instead, check first with your doctor.

You will probably need to take a faster-acting narcotic by mouth to relieve pain during the first few days of using fentanyl skin patch. You may also need another narcotic while your dose of fentanyl is being adjusted, and to relieve any “breakthrough” pain that occurs later on. Be sure you do not take more of the other narcotic, and do not take it more often than directed. Taking 2 narcotics together can increase the chance of serious side effects.

Grapefruit and grapefruit juice may increase the effects of fentanyl skin patch by increasing the amount of the medicine in your body. You should not consume grapefruit products while you are using this medicine.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For transdermal dosage form (Duragesic® skin patch):
    • For relief of chronic pain:
      • Adults and children 2 years of age and older—Your doctor will decide which dose of the patch you need based on your present daily narcotic dose. The patch is applied to the skin and left in place for 3 days (72 hours). Your doctor may adjust your dose as needed.
      • Children younger than 2 years of age—Use and dose must be determined by your doctor.
  • For transdermal dosage form (Ionsys® skin patch):
    • For short-term relief of acute pain after surgery:
      • Adults—Your doctor will decide which dose of the patch you need based on your present daily narcotic dose. The patch is applied by your healthcare provider to your upper outer arm or chest. Your doctor will show you how to adjust your dose as needed while in the hospital.

Missed dose

If you forget to wear or change a patch, put one on as soon as you can. If it is almost time to put on your next patch, wait until then to apply a new patch and skip the one you missed. Do not apply extra patches to make up for a missed dose.

Remove the Duragesic® patch 3 days (72 hours) after applying it.

Your healthcare provider will remove the Ionsys® patch before you leave the hospital. The Ionsys® patch is not for use at home.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Fentanyl can cause serious unwanted effects or a fatal overdose if taken by children, pets, or adults who are not used to strong narcotic pain medicines. Make sure you store the medicine in a safe and secure place to prevent others from getting it.

To dispose of the Duragesic® patch, fold the patch in half with the sticky side inside. If the patch has not been used, take it out of the pouch and remove the liner that covers the sticky side of the patch before folding it in half. Ask your pharmacist about the best way to dispose of patches you do not use. Do not flush the pouch or the protective liner down the toilet. Put them in a trash can.

Your healthcare provider will dispose of the Ionsys® patch after removing it.

Drop off any unused narcotic medicine at a drug take-back location right away. If you do not have a drug take-back location near you, flush any unused narcotic medicine down the toilet. Check your local drug store and clinics for take-back locations. You can also check the DEA web site for locations. Here is the link to the FDA safe disposal of medicines website: www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/ensuringsafeuseofmedicine/safedisposalofmedicines/ucm186187.htm

Precautions while using Duragesic Mat

It is very important that your doctor check your or your child’s progress while using this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may needed to check for unwanted effects.

Do not touch the sticky side of the patch or the gel. Fentanyl can be quickly absorbed through the eyes and mouth and can be extremely dangerous. If you do touch the sticky side of the patch or gel, let your nurse or doctor know right away and rinse the area with large amounts of water. Do not use soaps or other cleansers.

Check with your doctor at regular times while using fentanyl. Be sure to report any side effects.

After you have been using this medicine for awhile, “breakthrough” pain may occur more often than usual, and it may not be relieved by your regular dose of medicine. If this occurs, do not increase the amount of fentanyl skin patch or other narcotic that you are using without first checking with your doctor.

This medicine will add to the effects of alcohol and other CNS depressants. CNS depressants are medicines that slow down the nervous system, which may cause drowsiness or make you less alert. Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds, sedatives, tranquilizers, or sleeping medicine, other prescription pain medicine or narcotics, benzodiazepines, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. This effect may last for a few days after you stop using this medicine. Check with your doctor before taking any of the medicines listed while you are using this medicine.

The Ionsys® patch must be removed before a procedure called a magnetic resonance imaging (MRI) scan. It may cause skin burns if left in place during the procedure.

The Ionsys® patch may cause serious skin reactions. Call you doctor right away if you have blistering, lesions, a rash, redness, or swelling of the skin, especially at the site of application.

Fentanyl may cause some people to become drowsy, dizzy, or lightheaded, or to feel a false sense of well-being. Do not drive or do anything else that could be dangerous until you know how this medicine affects you. These effects usually go away after a few days of treatment, when your body gets used to the medicine. However, check with your doctor if drowsiness that is severe enough to interfere with your activities continues for more than a few days.

Dizziness, lightheadedness, or even fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem. Also, lying down for a while may relieve dizziness or lightheadedness.

Nausea or vomiting may occur, especially during the first several days of treatment. Lying down for a while may relieve these effects. However, if they are especially bothersome or if they continue for more than a few days, check with your doctor. You may be able to take another medicine to help prevent these problems.

Using narcotics for a long time may cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.

Heat can cause the fentanyl in the patch to be absorbed into your body faster. This may increase the chance of serious side effects or an overdose. While you are using this medicine, do not use a heating pad, electric blanket, heat or tanning lamps, sauna, a sunlamp, or a heated water bed, and do not sunbathe, or take long baths or showers in hot water. Also, check with your doctor if you get a fever.

Be careful about letting other people come in contact with your patch. The patch could stick to someone else, such as when you hug them or if someone helps you put the patch on. If any medicine gets on another person, wash it off right away with clear water.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are using this medicine. Serious side effects can occur if your medical doctor or dentist gives you certain other medicines without knowing that you are using fentanyl.

You may bathe, shower, or swim while wearing a fentanyl skin patch. However, be careful to wash and dry the area around the patch gently. Rubbing may cause the patch to get loose or come off. If this does occur, throw away the patch and apply a new one in a different place. Make sure the area is completely dry before applying the new patch.

If you have been using this medicine regularly for several weeks or more, do not suddenly stop using it without first checking with your doctor. You may be directed to gradually reduce the amount you are using before stopping treatment completely to lessen the chance of withdrawal side effects.

Using too much fentanyl skin patch, or taking too much of another narcotic with fentanyl skin patch, may cause an overdose. If this occurs, get emergency help right away. An overdose can cause severe breathing problems (breathing may even stop), unconsciousness, and death. Serious signs of an overdose include: very slow breathing (fewer than 8 breaths a minute) and drowsiness that is so severe that you are not able to answer when spoken to, or, if asleep, cannot be awakened. Other signs of an overdose may include: cold, clammy skin, low blood pressure, pinpoint pupils of the eyes, and slow heartbeat. It may be best to have a family member or a friend check on you several times a day when you start using a narcotic regularly, and whenever your dose is increased, so that he or she can get help for you if you cannot do so yourself.

This medicine may cause sleep-related breathing problems (eg, sleep apnea, sleep-related hypoxemia). Your doctor may decrease your dose if you have sleep apnea (stop breathing for short periods during sleep) while using this medicine.

Do not use a fentanyl patch if you have taken a monoamine oxidase (MAO) inhibitor in the past 2 weeks. Some examples of MAO inhibitors are isocarboxazid (Marplan®), phenelzine (Nardil®), selegiline (Eldepryl®), and tranylcypromine (Parnate®). If you use the 2 medicines close together it may cause serious side effects like confusion, agitation, restlessness, stomach or intestinal symptoms, a sudden high temperature, an extremely high blood pressure, or severe convulsions.

Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.

Using this medicine while you are pregnant may cause serious unwanted effects, including neonatal opioid withdrawal syndrome in your newborn baby. Tell your doctor right away if you think you are pregnant or if you plan to become pregnant while using this medicine.

Using too much of this medicine may cause reduced infertility (unable to have children). Talk with your doctor before using this medicine if you plan to have children.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Duragesic Mat side effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

  • Anxiety
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
  • confusion
  • decrease in urine volume
  • difficulty in breathing or swallowing
  • difficulty in passing urine (dribbling)
  • fast, irregular, pounding, or racing heartbeat or pulse
  • painful urination
  • rapid weight gain
  • seeing, hearing, or feeling things that are not there
  • skin itching, rash, or redness
  • swelling of the face, throat, or tongue
  • tremor
  • unusual weight gain or loss
  • upper stomach pain

Rare

  • Bluish color of the fingernails, lips, skin, palms, or nail beds
  • burning, itching, redness, skin rash, swelling, or soreness at the application site
  • confusion about identity, place, and time
  • false or unusual sense of well-being
  • irregular, fast or slow, or shallow breathing

Incidence not known

  • Agitation
  • blurred vision
  • chest pain or discomfort
  • cough
  • darkening of the skin
  • diarrhea
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • fever
  • headache
  • hives
  • lightheadedness, dizziness, or fainting
  • loss of appetite
  • mental depression
  • nausea
  • nervousness
  • overactive reflexes
  • poor coordination
  • pounding in the ears
  • restlessness
  • severe constipation
  • severe vomiting
  • shivering
  • sweating
  • talking or acting with excitement you cannot control
  • tightness in the chest
  • unusual tiredness or weakness
  • vomiting

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

  • Cold, clammy skin
  • drowsiness that is so severe you are not able to answer when spoken to or, if asleep, cannot be awakened
  • pinpoint (small) pupils in the eyes
  • seizures
  • slow heartbeat
  • very slow or troubled breathing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  • Constipation
  • feeling cold
  • sleepiness or unusual drowsiness
  • trouble sleeping

Less common

  • Dry mouth
  • feeling of constant movement of self or surroundings
  • feeling of crawling, tingling, or burning of the skin
  • lack or loss of strength
  • memory loss
  • sensation of spinning
  • unusual dreams

Rare

  • Abnormal ejaculation
  • decreased interest in sexual intercourse
  • decreased sexual performance or desire
  • inability to have or keep an erection
  • loss in sexual ability, desire, drive, or performance
  • muscle twitching

Incidence not known

  • Belching
  • heartburn
  • indigestion
  • stomach discomfort or upset

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Seek emergency medical attention or call 115

Further information

The content of Holevn is solely for the purpose of providing information about Thuốc Duragesic Mat (Transdermal)  and is not intended to be a substitute for professional medical advice, diagnosis or treatment. Please contact your nearest doctor or clinic, hospital for advice. We do not accept liability if the patient arbitrarily uses the drug without following a doctor’s prescription.

Reference from: https://www.drugs.com/cons/duragesic-mat.html

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