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MEGEST ORAL SUSP. 40MG/ML(120ML)
藥品許可證：衛署藥製字第046991號 中文名：麥格斯口服懸液劑 健保局藥理類別： 100000 抗癌藥物 學名： Megestrol Acetate 類別：PHR 劑量：ML 藥理作用： 1. 本品是一種合成的黃體素藥物，會影響腦下垂體，產生抗黃體化作用，具有抗腫瘤的特性機轉未明，主要用來治療子宮內膜癌。 2. 本品可改善癌症及AIDS患者產生的惡性體質，可增加患者的食慾，增加體重。 適應症： 後天免疫缺乏症候群患者的厭食症，惡病體質或原因不明的體重明顯減輕。 用法用量：成人起始建議劑量為160-200mg，最高劑量不超過400mg/天。 藥動力學： Absorption：C max is 10 to 56 ng/mL; T max is 1 to 3 h for tablets. C max is approximately 753 ng/mL, and T max is approximately 5 h for suspension. Metabolism：The megestrol acetate metabolites are negligible. Elimination：The major route for elimination is urine; minor routes are feces and respiratory, as CO2 . The t ½ is 13 to 104.9 h (mean, 34.2 h) for tablets. 副作用：陰道出血、乳房壓痛、頭痛、食慾增加、體重增加、腹痛、噁心、嘔吐、深部靜脈栓塞、過敏。 交互作用： Dofetilide Elevated dofetilide plasma concentrations may occur. Do not use concurrently. Indinavir Coadministration results in a significant decrease in C max and AUC of indinavir. 禁忌：對megestrol acetate或配方中任何成份過敏的患者。 已知或懷疑懷孕的婦女。 注意事項： 1.使用本品治療體重減輕之前，必須先找出可治療的體重減輕原因。這些原因包括可能的惡性並、全身性感染、影響吸收的腸胃道疾患、內分泌疾病及腎臟或精神病。 2.有血栓性栓塞疾病病史的患者應謹慎使用。 3.報告指出糖尿病惡化，胰島素需求量增加與麥格斯口服懸液劑有關。 藥品保存方式： 藥品應置於攝氏 15 ~ 25 度乾燥處所；如發生變質或過期，不可再食用。 Acetate 麥格斯口服劑 Megest (Megestrol Acetate)
主成分 ： 每毫升含有40毫克megestrol acetate。 * 適應症：後天免疫缺乏症候群患者的厭食症、及後天免疫缺乏症候群患者及癌症患者之惡病體質或引起的體重明顯減輕。 作用機轉 ：Megest® (Megestrol Acetate)的機轉尚未十分清楚，目前臨床上的應用主要是與糖皮質激素的活性有關，並可通過刺激中樞神經系統神經 Y刺激食慾，部分通過下調致炎細胞因數的合成和釋放而發揮作用。依賴其抗發炎、免疫調節作用及抑制血管新生作用。 用法用量 ：本藥須由醫師處方使用。 |
麥格斯 Megest (Megestrol Acetate)
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The New England Journal of Stupid
網路資訊 張貼者： Jerry Liu 2008年10月6日 星期一 Megestrol Acetate in Patients with Cachexia.. 惡病質 (Cachexia) 一個你不會想看到圖片的疾病，經常發生在癌症與感染HIV病患.. 除了精神疾病之外，癌症引起的惡病質 (簡稱為CACS) 一般被認為與某種發炎反應有關.. 一講到發炎反應，我知道下面一句話要接的一定是腫瘤壞死因子 (TNF-alpha)，IL-1與IL-6..每次都是這些東西.. 與飢餓不同的地方在於，癌症引起的失養症使得肌肉與脂肪同時減少，而飢餓只會使得你的脂肪變少.. 癌症病患發生這樣的問題，被認為是預後較差的因子之一，代表的是疾病可能正在惡化中.. 目前為止，這類病患的處理方法還是放在改善食慾方面，以藥物增加食慾是個可行的方法 (也是年輕女性最討厭的藥物).. 這類藥物可以分為三大類: 1. 類固醇: 果然是美國仙丹，成千上百種疾病都會用到類固醇這個東西..確實，在臨床研究中發現癌症病患使用類固醇可以增加食慾，讓自己覺得比較好一點，但並不會使體重增加.. 一般常用的藥物為Dexamethasone 4 mg/day..短期效果較為明顯，長期之後就沒甚麼太大差別.. 2. 黃體激素類藥物: 最常使用的就是今天要提到的老梗"Megestrol acetate"..它的好處在於沒有類固醇那一大堆副作用與不良反應.. 常用的劑量為160~800 mg/day，使用超過1280 mg/day以上效果並不會更好.. 在臨床研究中以口服錠劑的經驗比較多，但目前較常使用的液體劑型有順應性比較好的好處..因為是我我也不想吞一堆藥阿.. 但是要注意的是，這個藥物有可能引發靜脈栓塞，甚至是肺栓塞，尤其是在接受化學治療的癌症病患.. 必須千萬千萬地小心.. 在科考藍 (Cochrane，左邊的中文是大陸同胞精心翻出來有些怪怪的名詞) 中，相較於安慰劑，Megestrol acetate可以顯著增加癌症病患的 - 食慾 (RR, 3.03 [1.83-5.01]) - 體重 (RR, 3.56 [1.27-5.85]) 目前看來算是最有效且證據最充足的藥物.. Adapted from Cochrane Database Syst Rev 2005;(2):CD004310. 3. 抗組織胺藥物: 尤其以Cyproheptadine為主，這類的抗組織胺藥物有一個副作用就是刺激食慾，一般常用的劑量為8 mg TID使用，在臨床研究發現，這個藥物可以刺激食慾，但並無法阻止或是減緩體重減輕.. 但相對的，其副作用就是比較輕微的，包括嗜睡，口乾舌燥等等.. 其他還有一堆正在研究中的藥物或是食品，被用來刺激食慾的，包括: - 大麻 (Cannabinoids): 但是目前的研究結果並無法證實它是有效的 - 魚油 (EPA): 被認為可以抑制發炎反應，間接促進食慾，許多研究已經使用這個東西治療CACS，但受限於這些研究的樣本數目與設計，還屬於僅供參考，姑且一試的階段.. - Pentoxifylline: 同樣也是因為抗發炎作用而受到矚目，但在臨床研究中看起來是沒有促進食慾效果的.. 其他還有很多坊間怪招，獨門秘方的..但沒有一個被證實是有效的.. 沒有生病的拼命在減肥，生病的了拼命在增肥..昏倒.. |
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美雅祥錠 160 毫克 (Megejohn tablets 160mg)
成份：美雅祥錠 160 毫克 (Megejohn tablets 160mg) 每錠中含 160 毫克之醋酸甲地羥孕酮 (Megestrol acetate)。 ● 作用特性：醋酸甲地羥孕酮 (Megestrol acetate) 為一種合成類固醇，具有類黃體素作用。目前仍不清楚 Megestrol acetate 作用於乳癌的抗腫瘤機轉，但已知這種藥物會競爭黃體素、雄激素及糖皮質素的受器，因而影響腦下腺的功能。Megestrol acetate 的生物特性與黃體脂酮 (progesterone) 的生物特性類似。相較於黃體脂酮，醋酸甲地羥孕酮 (Megestrol acetate) 是由口服方式產生藥效。醋酸甲地羥孕酮 (Megestrol acetate) 在以口服方式投藥後可以快速被吸收。主要經由氫氧化作用 (hydroxylation) 和 glucoronidation 作用後，分泌至尿液中排泄。部份藥劑會排泄至糞便中。血漿半衰期最少 15 小時。 ● 適應症：再發性或轉移性子宮內膜癌的輔助療法。 【禁忌】：依文獻記載Megejohn 不可用於曾對 Megestrol acetate 或其錠劑中其它成份有過敏反應的病人身上，Megejohn 也不能用來作為懷孕的診斷測試。 【警告】：依文獻記載Megejohn 不予建議使用在妊娠的最初四個月內。雖說黃體酮藥物曾被使用在妊娠的最初三個月內，以來預防習慣性流產，但實際上從沒有足夠的證據，顯示其有效性。況且，對大多數婦女而言，流產的原因常係卵的缺陷所造成的，此種情況並不能由黃體酮藥物的使用得到改善。此外，黃體酮藥物具有子宮鬆弛作用，反而會不當延遲缺陷卵受精後的自然流產。因此不建議在妊娠最初四個月內使用黃體酮藥物。有一些臨床報告指出，在妊娠最初三個月內服用黃體酮藥物可能會造成男女性別之胎兒其生殖器的異常。於一般情況之下，大約每一千名男嬰中約有五到八位會尿道下裂的先天性缺陷，但如暴露在黃體酮藥物下則這些男嬰產生尿道下裂的危險性將加倍。於女嬰中截至目前，仍然沒有足夠的資料來決定這方面的危險性；但由於此類藥物的確會導致一些女嬰的外生殖器產生輕度雄性化，再加上男嬰尿道下裂危險性增加的事實，因此須提醒婦女在妊娠最初三個月內應避免使用這類藥物。倘若婦女在妊娠最初四個月內曾服用 Megejohn 或其在服用 Megejohn 期中同時懷孕，則此婦女應被告知以上所述黃體酮藥物可能會對胎兒造成傷害的事實。任何抗癌治療時，都必須接受密切的例行評估，具有血栓靜脈炎病史的病人使用 Megejohn 時必須謹慎，當服用 Megejohn 一段時日後突然停藥時，必須小心觀察有無腎上腺皮質素分泌不全的臨床症狀。關於 Megejohn 的致癌性、基因突變性以及受孕能力損害方面，動物實驗顯示；當母狗於服用 Megestrol acetate 達七年後發現有良性及惡性乳房腫瘤發生率增加的現象，但同類似的實驗在老鼠及猴子身上則沒有相同的結果，母狗乳房腫瘤發生率的增加與人體之間的關聯性，尚待釐清，但在評估給與 Megejohn 治療的利益與危險時，此點應列入考量，此外，以高劑量 Megestrol acetate 對老鼠進行生育能力以及基因突變的實驗中發現其對某些雄鼠胎兒有可逆性的雌性化現象。由於 Megejohn 對新生嬰兒可能具有潛在性的不利影響，因此於接受 Megejohn 抗癌治療期間應停止授乳。Megejohn 使用於兒童的安全性與有效性尚未確立。 【不良反應】：依文獻記載1. 體重增加：體重增加是服用 Megejohn 常見的副作用，此副作用乃導因於食慾的增加而非與體液的滯留一定有關。2.血栓性栓塞現象：血栓性栓塞症包括血栓性靜脈炎以及肺栓塞，皆曾有病例被報導過。3. 腎上腺功能失全：臨床上曾有極少數病例於突然停用 Megejohn 後不久發生腎上腺功能失全現象的報導。4. 其他不良反應：噁心、嘔吐、水腫、戒斷性子宮突然出血、呼吸困難、高血糖症、高血壓、頭髮脫落、乳癌病況突然加劇併隨高血鈣症、手腕部坑道症侯群、以及皮疹……等，皆曾被報導過但咸信發生頻率甚小。 【用藥過量】：依文獻記載單獨一次投與超大型劑量 Megestrol acetate 達每公斤體重 5 公克於老鼠身上也未見於任何急性毒症狀。於人體中即使每日服用高達 1600 毫克，也沒有任何毒性反應的表現，Megestrol acetate 尚未被測試其滲透能力，然而，由於此藥屬低溶解度，因此假定此藥過量時，將無法使用透析方法解毒。 【用法用量】：本藥須由醫師處方使用。 乳癌和子宮內膜癌：每天投藥 160mg，分 1-4 劑服用。 為能充分確定美雅祥錠 (Megejohn) 發揮效力，至少應持續治療兩個月。 在某些個案中，較低劑量亦足夠。 【用藥過量之徵兆與醫治方式】：在每天投與醋酸甲地羥孕酮 (Megestrol acetate) 達 800mg 劑量的研究中，並未指出有嚴重副作用產生。 【貯存方式和有效期限】：應貯存於攝氏25度以下之密封包裝中，並且保持乾燥。如此藥物於包裝上有效期限到期前均可使用。 【包裝】：2-1,000 粒 塑膠瓶裝；鋁箔盒裝。 在緊密的容器中，貯存於防潮、25℃ 以下之環境，兒童伸手不及處。 |
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通用名稱：醋酸甲地孕酮片
英文名稱：Megestrol Acetate Tablets 藥理毒理： 本品為孕激素對垂體促性腺激素的釋放有一定的抑制作用，但比左炔諾孕酮和炔諾酮為弱。不具有雌激素和雄激素樣活性，但有明顯抗雌激素作用。與雌激素合用，抑制排卵。動物致畸試驗表明對家兔具有死胎率增加和致畸作用。 藥代動力學：口服後生物半衰期明顯比左炔諾孕酮為短，大部分代謝產物以葡萄糖醛酸酯形式排出. 適應症：治療月經不調、功能性子宮出血、子宮內膜異位癥；晚期乳腺癌和子宮內膜腺癌；亦可用於短效複方口服避孕片的孕激素成分. 用法用量 口服： 1）治療閉經（雌激素水平足夠時），一次4mg，一日2-3次，連服2-3日，停藥2周內即有撤退性出血； 2）治療功能性子宮出血，一日4mg-8mg，共20天，開始自月經第5天服或同於1）； 3）治療子宮內膜異位癥，一次4mg-8mg，一日1-2次，自月經第5天服，連服3-6個月； 4）乳腺癌，一次40mg，一日4次，一日量160mg，連續2個月； 5）子宮內膜癌，一次10-80mg，一日4次，一日量40-320mg,或一次160mg，每日一次. 任何疑問，請遵醫囑！ 不良反應： ①主要為惡心，頭暈，倦怠； ②突破性出血； ③孕期服用有比較明確的增加女性後代男性化的作用. 禁 忌：嚴重肝，腎功能不全者，乳房腫塊者，孕婦禁用. 注意事項： 1）有子宮肌瘤，血栓病史及高血壓、糖尿病、哮喘病、癲癇、偏頭痛、精神抑郁患者慎用。 2）長期用藥註意檢查肝功能、乳房檢查. 孕婦及哺乳期婦女用藥 禁用. 貯 藏：遮光，密封保存 規 格：160mg/20mg/40mg 英文藥名: Megace (Megesterol Acetate Tablets) 中文藥名: 醋酸甲地孕酮片 生產廠家: Bristol Meyers Squibb |
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Megestrol Acetate
Megestrol acetate (abbreviated as MGA or MA, and sold mainly under the brand names Megace and Megace ES), also known as 17α-acetoxy-6-dehydro-6-methylprogesterone, is a steroidal progestin and progesterone derivative (specifically, a 17-hydroxylated progesterone) with predominantly progestational and antigonadotropic effects. Though sometimes referred to simply as megestrol, it is important to clarify that megestrol acetate is not the same as megestrol, which is a closely related but different compound. Uses Megestrol acetate is used mainly as an appetite stimulant in a variety of conditions and as an antineoplastic agent in the treatment of breast, endometrial, and prostate cancers. When given in relatively high doses, it can substantially increase appetite in most individuals, even those with advanced cancer, and is often used to boost appetite and induce weight gain in patients with cancer or HIV/AIDS-associated cachexia. It is also used as a contraceptive in combination with an estrogen at relatively low doses. In addition to its use in humans, megestrol acetate has been used extensively in veterinary medicine in the treatment of medical conditions in cats and dogs. Dosage Megestrol acetate is available as 5 mg, 20 mg and 40 mg tablets and in oral suspensions of 125 mg/ml and 40 mg/ml. It is used at a dose of 5 mg in combination with an estrogen for contraception. Appetite stimulation is achieved with doses ranging from 400 mg to 800 mg a day. Doses used to treat cancer usually range from 40 mg to 320 mg. Pharmacology Megestrol acetate acts predominantly as a potent agonist of the progesterone receptor (PR) to exert its effects. Megestrol acetate has powerful antigonadotropic effects in humans at sufficient doses, capable of decreasing circulating androgen and estrogen concentrations to castrate levels in both sexes. It can also decrease sex hormone receptors in certain parts of the body; as an example, one study in men with benign prostatic hyperplasia who were treated with 120–160 mg megestrol acetate per day for 3 to 11 days found average decreases in AR quantity of 73% and 86% in the cytoplasm and nucleus of prostatic cells, respectively. The antigonadotropic effects of megestrol acetate are the result of strong activation of the PR, which suppresses the secretion of the gonadotropins—peptide hormones responsible for signaling the body to produce not only progesterone but also the androgens and the estrogens—from the pituitary gland as a form of negative feedback inhibition, and hence downregulates the hypothalamic-pituitary-gonadal (HPG) axis, resulting in decreased levels of the sex hormones. It is the antiandrogenic and antiestrogenic effects of megestrol acetate mediated by suppression of the HPG axis that are mainly responsible for its beneficial effects against androgen and estrogen-sensitive cancers, respectively. Megestrol acetate is a high-affinity antagonist/weak partial agonist of the AR, where it binds with very similar but slightly less affinity relative to the PR (about 75% of the affinity according to one assay). Despite its weak intrinsic activity at the AR, at clinical doses in humans, megestrol acetate appears to behave, for all intents and purposes, purely as an antiandrogen. No androgenic side effects have been observed with the use of megestrol acetate in patients of either sex at dosages up to as high as 1,600 mg per day (which is the highest that has been used). Furthermore, it produces detectable androgenic effects in animals only at a dose that is the equivalent of approximately 200 times that typically used for the treatment of prostate cancer in men. Unlike the case of the AR, megestrol acetate has no significant affinity for the ER. As such, it does not possess the capacity to directly activate the ER. Furthermore, unlike antiandrogens such as cyproterone acetate and flutamide, there is relatively little risk of indirectly mediated estrogenic side effects (e.g., gynecomastia) with megestrol acetate. This is because megestrol acetate strongly suppresses both androgen and estrogen levels at the same time. Megestrol acetate is an agonist of the glucocorticoid receptor (GR), with similar but less affinity in comparison to the PR and the AR (about 37% and 50% of the affinity, respectively, according to one assay). One study found that, in the dose range tested, it possesses about 50% of the eosinopenic and hyperglycemic activity (markers of glucocorticoid activity) of an equal amount of medroxyprogesterone acetate, and about 25% that of cortisol. Accordingly, manifestations of its glucocorticoid properties, including symptoms of Cushing's syndrome, steroid diabetes, and adrenal insufficiency, have been reported with the use of megestrol acetate in the medical literature, albeit sporadically. Megestrol acetate is frequently used as an appetite stimulant. The direct mechanism of appetite enhancement is unclear, but it is known that megestrol acetate induces a variety of downstream changes to cause the effect, including stimulation of the release of neuropeptide Y in the hypothalamus, modulation of calcium channels in the ventromedial hypothalamus, and inhibition of the secretion of proinflammatory cytokines including IL-1α, IL-1β, IL-6, and TNF-α, all of which have been implicated in facilitation of appetite. Side effects The most common side effect of megestrol acetate is weight gain. Other side effects may include nausea, vomiting, nightmares, impotence, edema, breakthrough bleeding, and shortness of breath. Rare and more severe side effects may include thrombophlebitis and pulmonary embolism. It may also cause glucocorticoid-related adverse effects such as adrenal insufficiency in some individuals and/or cases (especially if the medication is suddenly discontinued following prolonged use). Contraindications Megestrol acetate should not be used in pregnancy under any circumstance as it crosses the placenta and malignantly affects the fetus. |
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Megestrol Acetate Oral Suspension Side Effects
Last reviewed on RxList 11/20/2015 Megestrol acetate oral suspension contains a form of the female hormone progesterone and is used to treat anorexia, wasting (cachexia), or an unexplained, significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (AIDS). Megestrol acetate oral suspension is available in generic form. Common side effects of megestrol acetate oral suspension include diarrhea, weight gain, changes in appetite, nausea, stomach upset, rash, impotence, touble sleeping (insomnia), mood swings, sweating, breakthrough menstrual bleeding or other changes in menstrual periods, decreased sexual ability/desire, high blood pressure, fever, and gas. The recommended adult initial dosage of megestrol acetate oral suspension is 800 mg/day (20 mL/day). Megestrol acetate oral suspension may interact with other drugs. Tell your doctor all medications and supplements you use. Megestrol acetate should not be used during pregnancy. It may cause fetal harm. Because of the potential for adverse effects on a nursing baby, breastfeeding should be discontinued if megestrol acetate oral suspension is required. Our megestrol acetate oral suspension Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Megestrol Acetate Oral Suspension FDA Prescribing Information: Side Effects (Adverse Reactions) SIDE EFFECTS Clinical Adverse Events: Adverse events which occurred in at least 5% of patients in any arm of the two clinical efficacy trials and the open trial are listed below by treatment group. All patients listed had at least one post baseline visit during the 12 study weeks. These adverse events should be considered by the physician when prescribing megestrol acetate oral suspension. Adverse events which occurred in 1 to 3% of all patients enrolled in the two clinical efficacy trials with at least one follow-up visit during the first 12 weeks of the study are listed below by body system. Adverse events occurring less than 1% are not included. There were no significant differences between incidence of these events in patients treated with megestrol acetate and patients treated with placebo. Body as a Whole - abdominal pain, chest pain, infection, moniliasis and sarcoma Cardiovascular System - cardiomyopathy and palpitation Digestive System - constipation, dry mouth, hepatomegaly, increased salivation and oral moniliasis Hemic and Lymphatic System - leukopenia Metabolic and Nutritional - LDH increased, edema and peripheral edema Nervous System - paresthesia, confusion, convulsion, depression, neuropathy, hypesthesia and abnormal thinking Respiratory System - dyspnea, cough, pharyngitis and lung disorder Skin and Appendages - alopecia, herpes, pruritus, vesiculobullous rash, sweating and skin disorder Special Senses - amblyopia Urogenital System - albuminuria, urinary incontinence, urinary tract infection and gynecomastia Postmarketing - Postmarketing reports associated with megestrol acetate oral suspension included throm-boembolic phenomena including thrombophlebitis and pulmonary embolism and glucose intolerance (see WARNINGS and PRECAUTIONS sections). Read the entire FDA prescribing information for Megestrol Acetate Oral Suspension (Megestrol Acetate Oral Suspension) |
