SERVICE
體 重 管 理
對抗飢餓感與食物渴望
CONTRAVE 康纖芙-體重控制釋放錠 Extended Release Tablets
兩個成人一個胖 別讓肥肉太囂張
兩個成人一個胖 別讓肥肉太囂張
美食當前總是克制不了食慾和飢餓感嗎?最新通過台灣衛福部核准的CONTRAVE 康纖芙-體重控制釋放錠，經美國FDA以及歐洲EMA藥物管理局認證，能讓人減少飢餓感、降低食物渴望，進而達到體重控制的效果，是擁抱健康自信，提升生活品質的秘密武器。
Is food always unable to restrain appetite and hunger? The latest CONTRAVE-weight control release tablets approved by the Taiwan Ministry of Health and Welfare, certified by the US FDA and the European EMA Drug Administration, can reduce hunger and food cravings, thereby achieving The effect of weight control is the secret weapon to embrace healthy self-confidence and improve the quality of life.
「肥胖」也是一種慢性疾病 “Obesity” is also a chronic disease
肥胖，是一種複雜的多因子疾病，不只會造成心血管疾病、糖尿病…等慢性疾病，也是現代人的罹癌風險因子之一。包括世界肥胖聯盟(WOF)、肥胖學會(TOS)、歐洲肥胖研究協會(EASO)…等醫療專業協會，都將肥胖視為需要「慢性病治療模式」的全球健康挑戰。因此減重、變瘦，不單單只是追求好看身型的表淺問題，避免肥胖而引起其他併發症，才是現代人的一大隱憂。
Obesity is a complex multifactorial disease that not only causes chronic diseases such as cardiovascular disease and diabetes, but is also one of the risk factors for cancer in modern people. Medical professional associations, including the World Obesity Federation (WOF), recognize obesity as a global health challenge that requires a “chronic disease treatment model.” Therefore, weight loss and thinning are not only a superficial problem of pursuing a good-looking body shape, but avoiding other complications caused by obesity is a major hidden worry for modern people.
肥胖症與超過195種併發症有關，其中「心血管疾病」是肥胖者的主要死因，且在美國確診癌症的案例中，就超過40%與過重有關！2021年5月台灣疫情升溫，中央流行疫情指揮中心曾公布1名30多歲年輕女性的本土個案病逝消息，發言人表示，該案體重約90幾公斤，肥胖很可能就是影響病況的風險因素之一。
Obesity is related to more than 195 complications, among which “cardiovascular disease” is the main cause of death for obese people, and in the cases of cancer diagnosed in the United States, more than 40% are related to overweight! In May 2021, the epidemic in Taiwan heated up. The Central Epidemic Command Center announced the death of a local case of a young woman in her 30s. The spokesperson said that the case weighed about 90 kilograms, and obesity is likely to be one of the risk factors affecting the condition. one.
什麼是CONTRAVE 康纖芙-體重控制釋放錠？ What is CONTRAVE?
主要成分是:
Naltrexone 8mg
Bupropion 90mg
適應症:
CONTRAVE 作為低熱量飲食與增加體能活動之輔助療法，用於以下初始身體質量指數 (BMI) 之成人長期體重管理：
- 30 kg/m2 或超過（肥胖），或者
- 27 kg/m2 或超過（體重過重）且患有至少一項體重相關共病症（如高血壓、第二型糖尿病或血脂異常）。
用法用量:
- 目標劑量為每日口服兩次，一次兩顆 8/90 mg 錠劑
The main ingredients are:
Naltrexone 8mg
Bupropion 90mg
Indications:
CONTRAVE is indicated as an adjunct to a reduced-calorie diet and increased physical activity for long-term weight management in adults with the following initial body mass index (BMI):
30 kg/m2 or more (obese), or 27 kg/m2 or more (overweight) with at least one weight-related comorbidity (such as hypertension, type 2 diabetes, or dyslipidemia).
Dosage:
Target dose is two 8/90 mg lozenges orally twice daily
2014
2015
歐洲藥品管理局EMA通過核准
2015
2022
台灣衛服部TFDA通過核准
衛部藥輸字第028220號
CONTRAVE 用法用量 Usage amount
醫師有可能視情況調整您的劑量，請依照醫師指示服用，不應使用超過建議劑量。
- 若您不確定如何使用，請與您的醫師或藥師確認， 請勿自行調整劑量 。
- 若您已維持劑量治療 12 周後，尚未減輕基期體重的至少5%，醫師應會請您停用康纖芙。
- 請完整吞服康纖芙錠劑，不應切割、咀嚼或弄碎錠劑 。若您無法吞服完整錠劑請告知醫師。
- 康纖芙應在早上和晚上口服使用， 單次不可使用超過兩錠，每日總錠數不可超過 4 錠 。
- 康纖芙 請勿搭配高脂餐點服用 ，可能會增加癲 癇發作 風險 。
- 若您遺漏服用一劑藥物，請直接跳過遺漏的劑量，等待下一次排定的用藥時間，再重新開始平
- 常的用藥時程。請勿使用兩倍劑量以補足之前忘記的錠劑。
- 若您發生用藥過量，請立即告知醫師或盡速就醫。
Your doctor may adjust your dose according to the situation, please take it according to your doctor’s instructions, and you should not use more than the recommended dose.
- If you are not sure how to use, please check with your doctor or pharmacist, do not adjust the dose yourself.
- Your physician should ask you to stop CONTRAVE if you have not lost at least 5% of your baseline body weight after 12 weeks of treatment with your maintenance dose.
- Swallow CONTRAVE lozenges whole and the lozenges should not be cut, chewed or broken. Tell your doctor if you are unable to swallow lozenges whole.
- CONTRAVE should be taken orally in the morning and evening. Do not use more than two lozenges at a time, and the total number of lozenges per day should not exceed 4 lozenges.
- Do not take CONTRAVE with a high-fat meal as it may increase the risk of seizures.
- If you miss a dose, skip the missed dose and wait for your next scheduled dose before starting your regular dose again.
- Regular medication schedule. Do not use a double dose to make up for a forgotten lozenge.
- If you overdose, tell your doctor or seek medical attention right away.
有下列情況時請勿使用康纖芙，請在看診時務必告知醫師
- 罹患未受控制的高血壓。
- 有癲癇症或癲癇發作的病史。
- 已知有中樞 神經系統腫瘤。
- 使用其他含 bupropion 成份的產品（包括但不限於 WELLBUTRIN 、 WELLBUTRIN SR 、WELLBUTRIN XL 、 APLENZIN 和 ZYBAN ）或含 naltrexone 的藥品 包括但不限於 NOTHOLIC)。
- 有躁鬱症病史。
- 患有暴食症 (b ulimia 或心因性厭食症 anorexia nervosa) ，這會提高癲癇發作的風險。
- 長期使用類鴉片 ( 或鴉 片劑 ( 之促效劑 如 methadone) 或部分促效劑如buprenorphine)buprenorphine)，或突然戒斷鴉片劑 acute opiate withdrawal)
- 目前突然停用酒精、 benzodiazepine 類藥物、 b arbiturate 類藥物及抗癲癇藥物。
- 同時施用單胺氧化酶抑制劑 ( 。在停用 MAOI 與啟用康纖芙治療之間應相隔至少 14 天。當康纖芙與 MAOI 併用時，發生高血壓反應的風險較高。在接受 linezolid 或靜脈亞甲基藍等可逆性 MAOI 治療的病人中，也禁止啟用康纖芙。
- 已知對 bupropi on 、 n altrexone 或康纖芙的任何其他成分過敏。過去曾在使用 bupropion 時通報類全身性過敏 全身性過敏反應 (anaphylactoid/anaphylactic reactions 及史蒂芬強森症候群(Stevens Johnson syndrome)。
- 重度肝功能不全。
Do not use CONTRAVE if you have the following conditions, please make sure to tell your doctor when you visit
- Suffer from uncontrolled high blood pressure.
- Have a history of epilepsy or seizures.
- Known central nervous system tumors.
- Use other products that contain bupropion (including but not limited to WELLBUTRIN, WELLBUTRIN SR, WELLBUTRIN XL, APLENZIN, and ZYBAN) or medicines that contain naltrexone (including but not limited to NOTHOLIC).
- Has a history of bipolar disorder.
- Have binge eating disorder (bulimia or anorexia nervosa), which can increase your risk of seizures.
- Long-term use of opioids (or opiate agonists such as methadone) or partial agonists such as buprenorphine), or acute opiate withdrawal)
Alcohol, benzodiazepines, barbiturates, and antiepileptic drugs are currently discontinued abruptly. - Concomitant administration of monoamine oxidase inhibitors (at least 14 days should elapse between discontinuation of MAOI and initiation of
- CONTRAVE treatment. When CONTRAVE is used concomitantly with MAOI, the risk of hypertensive reactions is higher. In patients receiving reversible MAOI therapy such as linezolid or intravenous methylene blue In patients, enable CONTRAVE is also disabled.
- Known hypersensitivity to bupropion, naltrexone, or any other component of CONTRAVE. Anaphylactoid/anaphylactic reactions and (Stevens Johnson syndrome) have been reported in the past with the use of bupropion.
- Severe hepatic insufficiency.
康纖芙與善纖達同類品比較 Comparison of CONTRAVE and SAXENDA
| 康纖芙 CONTRAVE | 善纖達 SAXENDA | |
|---|---|---|
| 主要成分 Element | Naltrexone 8mg Bupropion 90mg | Liraglutide 3mg |
| 內含量 content | 120 tabs | 18mg |
| 觀察週數 Observation weeks | 56 | 56 |
| 平均體重下降比例 average weight loss | 8.2% | 8.0% |
| 禁忌使用 contraindicated | 肝相關問題病史 liver-related problems 癲癇病史 epilepsy 腦神經病變病史 cranial neuropathy 正在服用戒斷藥物 taking withdrawal medication 躁鬱症病史 bipolar disorder | 膽相關問題病史 Biliary related medical history 腎相關問題病史 Kidney related medical history 甲狀腺相關病史 History of thyroid disease |
康纖芙的常見問題Q&A
Q：在服用康纖芙期間我應該要避免服用什麼?
A：服藥期間請勿過量飲酒。若您平時已飲用過量酒精，請於停止飲用前告知醫療人員。若驟然停止，可能會增加癲癇發生機率 。
Q：什麼是康纖芙可能造成的副作用?
A：和所有藥物一樣，此藥物有可能導致副作用，但是並非每個人都會出現副作用。( 噁心、便秘、頭痛、嘔吐、頭暈、失眠、口乾、腹瀉)
Q：我應該如何儲存康纖芙?
A：請儲放在30C以下。請將康纖芙和其他所有藥物放置於兒童接觸不到的地方。
Q: What should I avoid while taking CONTRAVE?
A: Do not drink excessively while taking the medicine. If you drink too much alcohol on a regular basis, tell healthcare provider before you stop drinking. Stopping suddenly may increase the chance of seizures.
Q: What are the possible side effects of CONTRAVE?
A: Like all medicines, this medicine can cause side effects, but not everyone gets side effects. ( Nausea, constipation, headache, vomiting, dizziness, insomnia, dry mouth, diarrhea)
Q: How should I store CONTRAVE?
A: Please store below 30C. Keep CONTRAVE and all other medicines out of the reach of children.
注意事項與禁忌症 Precautions and Contraindications
1.若您不確定如何使用，請與您的醫師或藥師確認， 請勿自行調整劑量 。
2.懷孕或哺乳、預備懷孕的婦女勿使用。
3.如果藥物或過敏及預備懷孕者請事先徵詢醫師意見。
4.請完整吞服 康纖芙錠劑，不應切割、咀嚼 或弄碎錠劑 。若您無法吞服完整錠劑請告知醫師。
5.康纖芙應在早上和晚上口服使用， 單次不可使用超過兩錠，每日總錠數不可超過 4 錠 。
6.康纖芙 請勿搭配高脂餐點服用 ，可能會增加癲癇發作風險 。
7.若您遺漏服用一劑藥物，請直接跳過遺漏的劑量，等待下一次排定的用藥時間，再重新開始平常的用藥時程。請勿使用兩倍劑量以補足之前忘記的錠劑。
1. If you are not sure how to use it, please confirm with your physician or pharmacist, and do not adjust the dosage by yourself.
2. Women who are pregnant, breastfeeding, or planning to become pregnant should not use it.
3. If you are allergic to drugs or are planning to become pregnant, please consult your doctor in advance.
4. Please swallow CONTRAVE whole, do not cut, chew or break the lozenges. Tell your doctor if you are unable to swallow lozenges whole.
5. CONTRAVE should be taken orally in the morning and evening. Do not use more than two tablets at a time, and the total number of tablets per day should not exceed 4 tablets.
6. Do not take CONTRAVE with high-fat meals, which may increase the risk of seizures.
7. If you miss a dose of medicine, please skip the missed dose directly, wait for the next scheduled medication time, and then start the usual medication schedule again. Do not use a double dose to make up for a forgotten lozenge.
康纖芙可能引起之嚴重副作用有
- 自殺意念和行為 自殺傾向
- 發生頻率未知，請見本指引第一頁 〝關於康纖芙，我應該知道哪些重要資訊〞。
- 癲癇發作
- 發生頻率約 0.1%。 對於使用較高劑量康纖芙、本身患有特定疾病或同時服用其他藥物的病人，其發生癲癇機率較高。
- 康纖芙療程中， 請勿自行同時服用其他藥物， 若有 請務必告知醫療人員。
- 一旦發生癲癇，請立即停藥並就醫 ，並請勿自行再度服用康纖芙。
- 增加類鴉片止痛劑過量風 險
- 若您同時服用類鴉片止痛劑與康纖芙，康纖芙成分之一 naltrexone) 可能會因下列原因而導致意外用藥過量。
- Naltrexone 會阻斷類鴉片止痛劑例如海洛因、美沙酮或類鴉片止痛劑效果。請勿試圖服用大量類鴉片止痛劑 包括含有類鴉片藥物的藥物，如海洛因或處方止痛藥）去克服此阻斷作用，這將會導致嚴重傷害、昏迷或死亡。
- Naltrexone 阻斷效果於服用後隨時間緩慢下降至消失。若您過去曾使用非法藥物或 類鴉片止痛劑，使用相同的劑量可能會導致類鴉片止痛劑過量和致死。 在下述情況下，您也有可能對於低劑量類鴉片止痛劑有較高感受性。
- 若您出現下述症狀， 請立即就醫
呼吸困難、嗜睡且呼吸減慢、呼吸緩慢、感到暈眩 、 昏沉、混亂或其他異狀
突然戒斷類鴉片止痛劑
為避免類鴉片止痛劑戒斷症狀出現，使用 康纖 芙前，至少 7 至 1 0 天前 請勿使用任何類康纖芙® 持續性釋放錠(Contrave® Extended-Release Tablets)之藥品風險管理計畫書，鴉片止痛劑 ((包含非法藥物包含非法藥物、、處方藥物處方藥物(含TTramadolramadol)、含有類鴉片類藥物的咳嗽和感冒藥含有類鴉片類藥物的咳嗽和感冒藥或止瀉劑或止瀉劑或進行類鴉片止痛劑成癮治療或進行類鴉片止痛劑成癮治療((buprenorphinebuprenorphine或或methadonemethadone))。進行醫療行為或手。進行醫療行為或手術前，請務必告知醫師您在服用康纖芙。術前，請務必告知醫師您在服用康纖芙。 - 嚴重過敏反應嚴重過敏反應
- 發生頻率未知，發生頻率未知，有些人可能會發生對於有些人可能會發生對於康纖芙成分之一康纖芙成分之一((bupropionbupropion))出現嚴重過敏反應。若出現嚴重過敏反應。若您出現下列您出現下列以下任何疑似過敏反應症狀，請以下任何疑似過敏反應症狀，請停用康纖芙且立即就醫停用康纖芙且立即就醫：：
- 皮疹、搔癢、蕁麻疹、發燒、水腫、淋巴結腫大、眼周或嘴巴內出現疼痛潰瘍、嘴皮疹、搔癢、蕁麻疹、發燒、水腫、淋巴結腫大、眼周或嘴巴內出現疼痛潰瘍、嘴唇或舌頭腫脹、胸痛或呼吸困難。唇或舌頭腫脹、胸痛或呼吸困難。
- 藥物導致之紅斑性狼瘡藥物導致之紅斑性狼瘡
- 發生頻率未知，若您服藥後出現疑似紅斑性狼瘡症狀發作發生頻率未知，若您服藥後出現疑似紅斑性狼瘡症狀發作、皮疹或皮膚病變皮疹或皮膚病變(特別於接受日特別於接受日曬皮膚部位曬皮膚部位))，，請立即回診請立即回診。。
- 血壓或心跳速率上升血壓或心跳速率上升
- 有些人可能出現血壓或心跳速率升高，開始使用康纖芙前及療有些人可能出現血壓或心跳速率升高，開始使用康纖芙前及療程中應測量血壓和脈搏，且程中應測量血壓和脈搏，且應遵照一般臨床實務做法定期監測。應遵照一般臨床實務做法定期監測。
- 康纖芙成分之一康纖芙成分之一((naltrexonenaltrexone))有可能造成肝損傷或肝炎。若您出現下列若您出現下列以下任何疑似急性肝以下任何疑似急性肝損傷之前兆，請停用康纖芙且立即就醫損傷之前兆，請停用康纖芙且立即就醫：：
噁心、嘔吐、上腹部疼痛、食慾不振、疲倦、眼睛或皮膚泛黃噁心、嘔吐、上腹部疼痛、食慾不振、疲倦、眼睛或皮膚泛黃
躁症活化躁症活化
康纖芙成分之一(bupropionbupropion)可能過去患有躁鬱症病人出現躁症或重鬱症狀。可能過去患有躁鬱症病人出現躁症或重鬱症狀。 - 視力變化視力變化閉鎖型青光眼
- 康纖芙成分之一((bupropionbupropion))有可能導致部分病人出現隅角閉鎖型青光眼。有可能導致部分病人出現隅角閉鎖型青光眼。若出現眼睛疼若出現眼睛疼痛、視力變化或眼睛周圍紅腫，建議建議回診與醫師討論。
- 患有患有第二型糖尿病病人，療程前及療程中應定期監測血糖；若出現低血糖症狀，請於回診第二型糖尿病病人，療程前及療程中應定期監測血糖；若出現低血糖症狀。時告知您的醫師。
Serious side effects that may be caused by CONTRAVE are
Suicidal ideation and behavior Suicidal tendencies
The frequency of occurrence is unknown, please see “What important information should I know about CONTRAVE” on the first page of this guide.
Seizures occur approximately 0.1% of the time. Seizures were more likely to occur in patients who used higher doses of CONTRAVE, had certain medical conditions, or were taking other medications.
During the course of CONTRAVE treatment, please do not take other medicines by yourself at the same time, if you have any, please be sure to inform the medical staff.
Once seizures occur, stop taking the drug and seek medical attention immediately, and do not take CONTRAVE again on your own.
Increased risk of opioid analgesic overdose
If you take an opioid pain reliever with CONTRAVE, naltrexone, one of the ingredients in CONTRAVE, may lead to accidental overdose for the following reasons.
Naltrexone blocks the effects of opioid pain relievers such as heroin, methadone, or opioid pain relievers. Do not try to overcome this block by taking large amounts of opioid pain relievers (including medicines containing opioids such as heroin or prescription pain relievers), as this could result in serious injury, coma, or death.
The blocking effect of Naltrexone slowly decreases to disappear over time after taking it. If you have used illicit drugs or opioid pain relievers in the past, taking the same dose could result in an opioid pain reliever overdose and death. You may also have a high sensitivity to low-dose opioid pain relievers in the situations described below.
Seek medical attention immediately if you experience the following symptoms
Difficulty breathing, drowsiness and slow breathing, slow breathing, feeling dizzy, drowsy, confused, or otherwise unusual
Sudden withdrawal from opioid analgesics
In order to avoid withdrawal symptoms of opioid analgesics, do not use any drug risk management plan (Contrave® Extended-Release Tablets) at least 7 to 10 days before using CONTRAVE, opioid analgesics (including illegal Medications that contain illegal drugs, (including T Tramadol ramadol), cough and cold medicines that contain opioids, cough and cold medicines that contain opioids, or antidiarrheals, or taking opioid pain reliever addiction treatment or taking ( (buprenorphinebuprenorphine or methadonemethadone). Perform medical procedures or procedures. Before performing medical procedures or surgery, please be sure to tell your doctor that you are taking Contrave. Before surgery, please be sure to tell your doctor that you are taking CONTRAVE.
severe allergic reaction severe allergic reaction
The frequency of occurrence is unknown, and the frequency of occurrence is unknown. Some people may experience severe allergic reactions to one of the ingredients of CONTRAVE ((bupropionbupropion)). In case of severe allergic reaction. Stop using CONTRAVE and seek immediate medical attention if you experience any of the following suspected allergic reaction symptoms: rash, itching, hives, fever, edema, swollen lymph nodes , painful sores around the eyes or in the mouth, mouth rash, itching, hives, fever, edema, swollen lymph nodes, painful sores around the eyes or in the mouth, swelling of the lips or tongue, chest pain, or trouble breathing. Swollen lips or tongue, chest pain, or trouble breathing.
Drug-induced lupus erythematosus Drug-induced lupus erythematosus
The frequency of occurrence is unknown, if you develop suspected lupus erythematosus symptoms after taking the drug Parts where the skin is exposed to the sun), please return to the clinic immediately.
Elevated blood pressure or heart rate Some people may experience an increase in blood pressure or heart rate. Some people may experience an increase in blood pressure or heart rate before starting and during treatment with CONTRAVE. Blood pressure and heart rate should be measured before and during treatment with CONTRAVE. Pulse, blood pressure and pulse should be measured during the procedure and should be monitored periodically in accordance with general clinical practice. Periodic monitoring should be in accordance with general clinical practice.
liver toxicity
One of the ingredients in CONTRAVE ((naltrexonenaltrexone)) has the potential to cause liver damage or hepatitis. May cause liver damage or hepatitis. Stop using CONTRAVE and seek immediate medical attention if you develop any of the following signs of suspected acute liver injury:
Nausea, vomiting, upper abdominal pain, loss of appetite, tiredness, yellowing eyes or skin Nausea, vomiting, upper abdominal pain, loss of appetite, tiredness, yellowing eyes or skin
Mania activation Mania activation
One of the components of CONTRAVE (bupropionbupropion) may have symptoms of mania or major depression in patients with bipolar disorder in the past. People with bipolar disorder may have symptoms of mania or major depression in the past.
Vision changes Locked-in glaucoma; If you experience eye pain, vision changes, or redness around the eyes, it is recommended to return to the clinic to discuss with your doctor.
Patients with type 2 diabetes should regularly monitor blood sugar before and during the course of treatment; if symptoms of hypoglycemia occur, please monitor blood sugar regularly before and during the course of treatment; inform your doctor when you return to the clinic
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