默克公司４月８日宣布，美国ＦＤＡ已经批准了该公司新药ＦＯＳＡＭＡＸ ＰＬＵＳ Ｄ的上市申请。ＦＯＳＡＭＡＸ ＰＬＵＳ Ｄ为骨质疏松治疗药物，含有７０ｍｇ福善美（ＦＯＳＡＭＡＸ，阿仑膦酸钠）和２８００ ＩＵ维生素Ｄ３，每周只需服用一次。福善美主要于绝经后患有骨质疏松症的妇女，能够降低髋部和脊柱骨折的发生率，是目前唯一一个和一周用量的维生素Ｄ３配伍的双磷酸化合物类药物。

【原产地英文商品名】FOSAMAX PLUS D(ALENDRONATE SODIUM/CHOLECALCIFEROL))70 MG/5600IU X 4Tabs
【原产地英文药品名】ALENDRONATE SODIUM/CHOLECALCIFEROL))70 MG/5600IU
【中文参考药品译名】阿仑膦酸钠/维生素D3 70毫克/5600单位
【生产厂家中文参考译名】默克制药
【生产厂家英文名】MERCK
【中文参考商品译名】
·阿仑膦酸钠/维生素D3 70毫克/5600单位 4片/盒
·阿仑膦酸钠/维生素D3 70毫克/2800单位 4片/盒
·阿仑膦酸钠/维生素D3 70毫克/2800单位 20片/盒

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How Do I Know FOSAMAX or FOSAMAX PLUS D is Working?
You will not feel it working, but you and your doctor can monitor your progress with a bone mineral density test prescribed by your doctor. Ninety-six percent of patients, on either a once-daily or once-weekly schedule, increased or maintained bone mass.

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How Long Do I Take FOSAMAX or FOSAMAX PLUS D?
Only your doctor can determine how long you should keep taking FOSAMAX or FOSAMAX PLUS D. The effects will continue as long as you continue treatment. For most patients, that means your bone density will be maintained or increased and your bones will be less likely to fracture.

If you experience side effects, call your doctor right away.

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Selected Cautionary Information About FOSAMAX and FOSAMAX PLUS D
You should not use FOSAMAX or FOSAMAX PLUS D if you have certain disorders of the esophagus (the tube connecting the mouth with the stomach), are not able to stand or sit upright for 30 minutes, have severe kidney disease, low blood calcium, or are allergic to FOSAMAX or FOSAMAX PLUS D. Before use, talk to your doctor if you have or have had stomach or digestive problems or problems with swallowing. You should tell your doctor about all medicines you are taking, including prescription and nonprescription medicines, vitamins, and herbal supplements. In addition, for FOSAMAX PLUS D, you should talk to your doctor if you have conditions that may cause an overproduction of vitamin D (eg, sarcoidosis, leukemia, lymphoma).

Stop taking FOSAMAX or FOSAMAX PLUS D and call your doctor right away if you develop new or worsening heartburn, difficult or painful swallowing, or chest pain because these may be signs of serious upper digestive problems, which can include irritation, inflammation, or ulceration of the esophagus. (See the Patient Product Information for more details.) If you develop severe bone, joint, and/or muscle pain at any time, contact your doctor. FOSAMAX AND FOSAMAX PLUS D may cause jawbone problems in some people. Jawbone problems may include infection, and delayed healing after teeth are pulled. Digestive side effects in studies were generally mild and included stomach pain, indigestion/heartburn, or nausea.

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How to Take FOSAMAX 35-mg or 70-mg Once-Weekly Tablets, FOSAMAX 70-mg Once-Weekly Oral Solution, and FOSAMAX PLUS D 70-mg/2,800 IU Once-Weekly Tablets
Choose a day of the week that best fits your schedule. Take 1 FOSAMAX or FOSAMAX PLUS D dose on your chosen day, every week.

Tablets: Swallow 1 FOSAMAX or FOSAMAX PLUS D tablet with 6 to 8 ounces of plain water first thing in the morning before you have anything to eat or drink.

OR

Oral Solution: Drink 1 entire bottle of solution followed by at least 2 ounces (a quarter of a cup) of plain water.

Begin the day’s activities, but don’t lie down, eat, drink, or take other medications for at least 30 minutes. If you want to lie down after 30 minutes, you must eat breakfast first.

If you miss a dose, take only 1 dose of FOSAMAX or FOSAMAX PLUS D on the morning after you remember. Do not take 2 doses on the same day.

Continue your usual schedule of 1 dose once a week on your chosen day.

How to Take FOSAMAX 5-mg or 10-mg Tablets Once-Daily
Take FOSAMAX with 6 to 8 oz of plain water first thing in the morning before you have anything to eat or drink. Begin the day’s activities, but don’t lie down, eat, drink, or take other medications for at least 30 minutes. If you want to lie down after 30 minutes, you must eat breakfast first.

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How to Take FOSAMAX 5-mg or 10-mg Tablets Once-Daily
Take FOSAMAX with 6 to 8 oz of plain water first thing in the morning before you have anything to eat or drink. Begin the day’s activities, but don’t lie down, eat, drink, or take other medications for at least 30 minutes. If you want to lie down after 30 minutes, you must eat breakfast first.

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Selected Cautionary Information About FOSAMAX and FOSAMAX PLUS D
You should not use FOSAMAX or FOSAMAX PLUS D if you have certain disorders of the esophagus (the tube connecting the mouth with the stomach), are not able to stand or sit upright for 30 minutes, have severe kidney disease, low blood calcium, or are allergic to FOSAMAX. Before use, talk to your doctor if you have stomach or digestive problems. You should tell your doctor about all medicines you are taking, including prescription and nonprescription medicines, vitamins, and herbal supplements.

In addition, for FOSAMAX PLUS D, you should talk to your doctor if you have conditions that may cause an overproduction of vitamin D (eg, sarcoidosis, leukemia, and lymphoma).