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英文药名：ALENDRONATE Tablets（Alendronate sodium hydrate）
中文药名：阿仑膦酸钠片/水合物
生产厂家：三和科学研究所
アレンドロン酸錠３５ｍｇ
治疗类别名称
骨质疏松症治疗剂
商標名
ALENDRONATE
一般名
アレンドロン酸ナトリウム水和物
（Alendronate Sodium Hydrate）
分子式
C4H12NNaO7P2・3H2O
分子量
325.12
構造式
化学名
Monosodium trihydrogen 4-amino-1-hydroxybutane-1,1-diyldiphosphonate trihydrate
性状
它是一种白色结晶粉末。
微溶于水，并在乙醇（99.5）几乎不溶。
易溶于0.1mol/L的柠檬酸三钠的试剂。
熔点：约252℃（分解，但在干燥后）。
操作注意事项
<稳定性试验>
使用效果的最终包装产品（40℃，相对湿度75％，6个月）·35毫克“阿仑片”正常的市场猜测是三年稳定。
药效药理
骨质疏松症的药物。由破骨细胞抑制骨吸收来抑制骨量的减少。由骨吸收抑制作用通过保持骨的质量，以维持骨强度保持松质骨的骨小梁的连续性。它示出了用于羟基磷灰石的亲和性高，通过抑制磷酸钙的羟基磷灰石晶体的形成过程中，为了防止异位骨化的发展。
适应病症
骨质疏松
用法用量
每周一次，每次35毫克（早晨服用）
包装规格
PTP20片（10片×2片板），50片（25张×2片板）
制造厂商
三和科学研究所/协和药业
Brand name : ALENDRONATE Tablets 35mg
Active ingredient: Alendronate sodium hydrate
Dosage form: white tablet, major axis: 10.3mm, minor axis: 5.6mm, thickness: 3.7mm
Print on wrapping: アレンドロン酸錠35mg
Effects of this medicine
This medicine is taken up by osteoclasts in bones, to reduce bone resorption and increase bone mass by suppressing the osteoclast activities, and consequently make bones resistant to fractures.
It is usually used for the treatment of osteoporosis.
Before using this medicine, be sure to tell your doctor and pharmacist
•If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines.
If you have difficulty in swallowing food or medicine.
If you are unable to sit up for at least 30 minutes.
If you are a patient with hypocalcemia.
•If you are pregnant or breastfeeding.
•If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)
Dosing schedule (How to take this medicine)
•Your dosing schedule prescribed by your doctor is <<to be written by a healthcare professional>>
•In general, for adults, take 1 tablet (35mg of alendronate) at a time, with about 180mL of water, once weekly, first thing in the morning (before a meal). Strictly follow the instructions.
•You fix on the day of the week to take, please take on the morning of the same day of the week every week.
•Never take the medicine with other than water (e.g. mineral water of high calcium and magnesium content, tea, coffee, juice, milk, etc.). Never chew the medicine or dissolve it in a mouth.
•You should not drink and eat anything (except for water), and not take other medicine for 30 minutes after taking this medicine. You should not lay down for 30 minutes, and keep your body sitting up until you finish the first meal in a day. Do not take the medicine at bedtime or before rising.
•If you miss a dose, take 1 tablet on the next morning of the notice day (the dosage regimen is same as usual). And continue your regular dosing schedule (Morning on the specified day of the week) for next time. You should never take two doses at one time.
•If you accidentally take a dose for two days in a row or take double doses, you should do cessation of the medicine at the next scheduled day, you take a dose according to schedule after the next scheduled day. If you feel unusual, consult with your doctor or pharmacist.
•Do not stop taking this medicine unless your doctor instructs you to do so.
Precautions while taking this medicine
•Keep the mouth clean.
•If you receive the dental treatment such as tooth extraction or implants, tell the dentist or oral surgeon about your taking this medicine.
•Try to ingest calcium through food.
•If you take supplements (e.g. calcium, vitamin D), check with your doctor or pharmacist in advance.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include nausea, constipation, diarrhea, gastric pain, gastritis, gastric discomfort, loss of appetite, anemia and headache. If any of these symptoms occur, consult with your doctor or pharmacist.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
•difficulty in swallowing, swallowing pain, chest (back side of the bone) pain [esophageal disorder, intraoral disorder]
•epigastric pain, abdominal pain, abdominal discomfort [gastric disorder, duodenal disorder]
•fever, mucosal redness/erosion, erythema [toxic epidermal necrolysis, Stevens-Johnson syndrome]
•jaw pain/swelling/numbness, loose tooth, swelling of the gum [jaw bone necrosis, jaw osteomyelitis]
•the pain of the thigh or an inguinal region [atypical subtrochanteric and diaphyseal femoral fractures]
The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.
Storage conditions and other information
•Keep out of the reach of children. Store away from direct sunlight, heat and moisture.
•Do not store the remainder and consult your pharmacy or medical institution how to discard it.
SANWA KAGAKU KENKYUSHO CO/Kyowa Pharmaceutical Industry Co.LTD.Internal
Published: 1/2014
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.
http://www.info.pmda.go.jp/go/pack/3999018F2044_1_05/
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