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依普黄酮胶囊OSTEN(ipriflavone)

2013-01-21 09:59:44  作者:新特药房  来源:互联网  浏览次数:89  文字大小:【】【】【
简介: 部分中文Osten处方资料(仅供参考)【中文品名】依普黄酮【药效类别】钙代谢调节药【通用药名】IPRIFLAVONE【别  名】丙氧基酮, Osten, Yambolap, FL-113, TC-80【化学名称】 4H-1-Benzopyran-4-one, ...

部分中文Osten处方资料(仅供参考)
【中文品名】依普黄酮
【药效类别】钙代谢调节药
【通用药名】IPRIFLAVONE
【别  名】丙氧基酮, Osten, Yambolap, FL-113, TC-80
【化学名称】 4H-1-Benzopyran-4-one, 7-(1-mthylethoxy)-3-phenyl-
【CA登记号】[35212-22-7]
【分 子 式】C18H16O3
【分 子 量】280.33
【开发单位】武田药品工业株式会社 (日本)
【首次上市】1990年,日本
【性  状】
白色或黄白色结晶或结晶性粉末,无臭,无味。易溶于三氯甲烷、N,N-二甲基甲酰胺,溶于乙腈、丙酮、乙酸乙酯,略溶于无水甲醇、乙酸,不溶于水。mp116~119℃。
【用  途】
抗骨质疏松药。可显著抑制骨密度、骨强度和甲状钙素的下降。还具有增加骨量、促进甲状腺钙素分泌及抑制破骨细胞数的作用。用于治疗骨质疏松症。
IPRIFLAVONE
Isoflavones are water-soluble chemicals found in many plants.
Ipriflavone is a semisynthetic version of an isoflavone found in soy.
Soy isoflavones have effects in the body somewhat similar to those of estrogen. This should be beneficial, but it is possible that soy could present some of the risks of estrogen, as well.
In 1969, a research project was initiated to manufacture a type of isoflavone that would possess the bone-stimulating effects of estrogen without any estrogen-like activity elsewhere in the body. Such a product would help prevent osteoporosis, but cause no other health risks.
Ipriflavone was the result. After 7 successful years of experiments with animals, human research was started in 1981.
Today, ipriflavone is available in over 22 countries and in most drugstores in the United States as a nonprescription dietary supplement. It is an accepted treatment for osteoporosis in Italy, Turkey, and Japan.
According to all but one study, ipriflavone combined with calcium can slow and perhaps slightly reverse bone breakdown.
It also seems to help reduce the pain of fractures caused by osteoporosis. However, since it does not appear to have any estrogenic effects anywhere else in the body, it shouldn't
increase the risk of breast or uterine cancer. On the other hand, it won't reduce the hot flashes, night sweats, mood changes, or vaginal dryness of menopause, nor prevent heart
disease.
Note: A recent, large study found that ipriflavone might reduce white blood cell count in some individuals. See Safety Issues for more information.
Sources
Ipriflavone is not an essential nutrient and is not found in food. It must be taken as a supplement.
Therapeutic Dosages
The proper dosage of ipriflavone is 200 mg 3 times daily, or 300 mg twice daily. A calcium supplement providing 1,000 mg of calcium daily should be taken as well.
Therapeutic Uses
Ipriflavone appears to be able to slow down and perhaps slightly reverse osteoporosis. It may be helpful for this purpose in ordinary postmenopausal osteoporosis, as well as in
osteoporosis caused by medications.1-22  Ipriflavone also
seems to ease the pain of fractures caused by osteoporosis.23,24,25 
Ipriflavone has also been proposed as a bodybuilding aid, but there is no meaningful evidence that it is helpful for this purpose.
What Is the Scientific Evidence for Ipriflavone?
Numerous double-blind, placebo-controlled studies involving a total of over 1,700 participants have examined the effects of ipriflavone on various forms of osteoporosis.26-37  Overall, it appears that ipriflavone can slow the progression of osteoporosis and perhaps reverse it to some extent. For example, a 2-year, double-blind study followed 198
postmenopausal women who showed evidence of bone loss.38  At the end of the study, there was a gain in bone density of 1% in the ipriflavone group and a loss of 0.7% in the placebo group.
These numbers may sound small, but they can add up to a lot of bone over time.
However, the largest and longest study of ipriflavone found no benefit.39  In this 3-year trial of 474 postmenopausal women, no differences in the extent of osteoporosis were seen between the ipriflavone and placebo groups.
How can this failure be accounted for in view of all the successful trials that came before?
Perhaps because the researchers in this study gave women only 500 mg of calcium daily. All other major studies of ipriflavone gave participants 1,000 mg of calcium daily. It's
possible that ipriflavone requires the higher dose of calcium in order to work properly.
Ipriflavone, like estrogen, probably works by fighting bone breakdown.40-43  However, there is some evidence that it may also increase new bone formation, too.44,45,46  Combining ipriflavone with estrogen may enhance anti-osteoporosis benefits.47,48  However, we do not know for sure whether such combinations increase or reduce the other
risks (or benefits) of estrogen.
Ipriflavone may also be helpful for preventing osteoporosis in women who are taking Lupron or corticosteroids, medications that accelerate bone loss.49,50,51  (However, the combined use of ipriflavone and drugs that suppress the immune system, such as corticosteroids, presents potential risks.
See Safety Issues.) Finally, for reasons that are not at all clear, ipriflavone appears to be able to reduce pain in osteoporosis-related fractures that have already occurred.52,53,54  Safety Issues About 3,000 people have used ipriflavone in clinical studies, and in all but two, no significant adverse effects were seen.55,56  However, these trials (a 3-year, double-blind trial of almost 500 women, as well as a small study) found worrisome evidence that ipriflavone can reduce levels of white blood cells called lymphocytes.57,58  For this reason, anyone taking ipriflavone for the long-term should have periodic measurements taken of white blood cell count.
In addition, ipriflavone should not be used by anyone with immune deficiencies, such as HIV, or by those who take drugs that suppress the immune system, except under physician
supervision.
There are other potential risks as well. Because ipriflavone is metabolized by the kidneys, individuals with severe kidney disease should have their ipriflavone dosage
monitored by a physician.59  Individuals with ulcers should also avoid ipriflavone.60 
Also, although ipriflavone itself does not affect tissues outside of bone, some evidence suggests that if it is combined with estrogen, estrogen's effects on the uterus are
increased.61,62  This might mean that the risk of uterine cancer would be elevated over taking estrogen alone.
It should be possible to overcome this risk by taking progesterone along with estrogen, which is standard medical practice.
However, this finding does make one wonder whether ipriflavone-estrogen combinations raise the risk of breast cancer too, an estrogen side effect that has no easy solution. At present, there is no available information on this important subject.
Additionally, ipriflavone may interfere with certain drugs by affecting the way they are processed in the liver.
For example, it may raise blood levels of the older asthma drug theophylline.63,64,65  It could also raise levels of caffeine, meaning that if you drink coffee while taking ipriflavone you might stay up longer than you expect.
Ipriflavone could also interact with tolbutamide (a drug for diabetes), phenytoin (used for epilepsy), and Coumadin (a blood thinner).66  Such interactions are potentially dangerous, especially since phenytoin and Coumadin cause osteoporosis, and some people
might be tempted to try taking ipriflavone at the same time.
Interactions You Should Know About
If you are taking:
Theophylline, tolbutamide, phenytoin (Dilantin), warfarin (Coumadin), or any other drug metabolized in the liver: Ipriflavone might change the levels of that drug in your body.
Estrogen: Ipriflavone might help it strengthen your bones even more.
However, it might also increase the risk of uterine cancer.
Drugs that suppress the immune system, such as corticosteroids, methotrexate, or cyclosporine: Do not use ipriflavone except under medical supervision.
附件:


20108519473512.pdf


---------------------------------------------------------------
产地国家: 日本
原产地英文商品名:
OSTEN 200mg/cap 100caps/bottle
原产地英文药品名:
ipriflavone
中文参考商品译名:
OSTEN 200毫克/胶囊 100胶囊/瓶
中文参考药品译名:
依普黄酮
生产厂家中文参考译名:
日本武田
生产厂家英文名:
TAKEDA

http://www.info.pmda.go.jp/go/pack/3999008F1273_1_07/

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