英文药名：AMLODIPINE OD(Amlodipine Besilate TABLETS)

中文药名：苯磺酸氨氯地平口腔崩解片

生产厂家：日本住友

アムロジピンOD錠2.5mg「YD」／アムロジピンOD錠５mg「YD」／アムロジピンOD錠10mg「YD」

商標名
AMLODIPINE OD TABLETS
一般名
アムロジピンベシル酸塩(Amlodipine Besilate)
化学名
3-Ethyl 5-methyl (4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate monobenzenesulfonate
分子式
Ｃ２０Ｈ２５ＣｌＮ２Ｏ５・Ｃ６Ｈ６Ｏ３Ｓ
分子量
５６７．０５
構造式

性状
它是一种白色至黄白色结晶粉末。
它易溶于甲醇，微溶于乙醇（99.5），微溶于水。
显示无旋光（1→100）的甲醇溶液。
融点：約１９８℃（分解）
取扱い上の注意
アムロジピンOD錠2.5mg「YD」
(1) 保管方法
1)
使用期限内であっても、開封後はなるべく速やかに使用して下さい。
2)
本剤は吸湿性が強いので、アルミピロー開封後は湿気、光を避けて保存し、服用直前までＰＴＰシートから取り出さないで下さい。
3)
やむを得ずＰＴＰシート又は瓶から取り出して保管する場合、湿気、光を避けて保存して下さい。
4)
瓶の開封後は湿気、光を避けて保存して下さい。
(2) 安定性試験
最終包装製品を用いた加速試験(40℃、相対湿度75％、６ヶ月)の結果、アムロジピンOD錠2.5mg「YD」は通常の市場流通下において３年間安定であることが推測された。4)
アムロジピンOD錠５mg「YD」
(1) 保管方法
1)
使用期限内であっても、開封後はなるべく速やかに使用して下さい。
2)
本剤は吸湿性が強いので、アルミピロー開封後は湿気、光を避けて保存し、服用直前までＰＴＰシートから取り出さないで下さい。
3)
やむを得ずＰＴＰシート又は瓶から取り出して保管する場合、湿気、光を避けて保存して下さい。
4)
瓶の開封後は湿気、光を避けて保存して下さい。
(2) 安定性試験
最終包装製品を用いた加速試験(40℃、相対湿度75％、６ヶ月)の結果、アムロジピンOD錠５mg「YD」は通常の市場流通下において３年間安定であることが推測された。5)
アムロジピンOD錠10mg「YD」
(1) 保管方法
1)
使用期限内であっても、開封後はなるべく速やかに使用して下さい。
2)
本剤は吸湿性が強いので、アルミピロー開封後は湿気、光を避けて保存し、服用直前までＰＴＰシートから取り出さないで下さい。
3)
やむを得ずＰＴＰシートから取り出して保管する場合、湿気、光を避けて保存して下さい。
(2) 安定性試験
最終包装製品を用いた加速試験(40℃、相対湿度75％、６ヶ月)の結果、アムロジピンOD錠10mg「YD」は通常の市場流通下において３年間安定であることが推測された。6)
効能・効果
氨氯地平2.5mg的口腔崩解片“YD”，口腔崩解片氨氯地平5毫克片剂“YD”
○高血圧症
通常口服给药，每日一次2.5〜5毫克氨氯地平与成人。
该剂量可以适当地调整根据症状，但可增至一次10mg的1天到效果。
通常情况下，儿童6岁以上的，每日一次口服氨氯地平2.5mg的。
另外，也将根据年龄，体重和症状调整。
○心绞痛
通常口服给药，每日一次与成人氨氯地平5毫克。
此外，适当地增加或减少取决病情。
氨氯地平10mg的口腔崩解片“YD”
○高血圧症
通常口服给药，每日一次2.5〜5毫克氨氯地平与成人。
该剂量可以适当地调整根据症状，但可增至一次10mg的1天到效果不充分。
○心绞痛
通常口服给药，每日一次与成人氨氯地平5毫克。
此外，适当地增加或减少取决于病情。
注意事项
因为影响是缓慢的，这种药物不能指望在不稳定型心绞痛，需要紧急治疗的效果。
包装
アムロジピンOD錠2.5mg「YD」

ＰＴＰ：１００錠、５００錠
バラ：５００錠

アムロジピンOD錠５mg「YD」
ＰＴＰ：１００錠、５００錠
バラ：５００錠

アムロジピンOD錠10mg「YD」
ＰＴＰ：１００錠

AMLODIPINE OD TABLETS 2.5mg 5mg 10mg "TOWA"（アムロジピンOD錠「トーワ」）
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse effects (risks) as well as efficacies (benefits). It is important to minimize adverse effects and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.
Brand name : AMLODIPINE OD TABLETS 5mg "TOWA"
　Active ingredient: Amlodipine besilate
　Dosage form: pale yellow tablet with split line, diameter: 8.5 mm, thickness: 3.5 mm
　Print on wrapping: Tw513, アムロジピンOD5mg「トーワ」,5mg, 口腔内崩壊錠 (orally disintegrating tablet), 高血圧または狭心症の薬 (medicine for hypertension and angina pectoris)
Effects of this medicine
This medicine dilates smooth muscles of coronary vessels and peripheral vessels by reducing influx of calcium into cells, and consequently lowers blood pressure as well as prevents episode of angina pectoris.
It is usually used for the treatment of hypertension and angina pectoris.
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: hypotension, hepatic or renal dysfunction.
•If you are pregnant, possible 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>>
•For hypertension: In general, for adults, take 0.5 to 1 tablet (2.5-5 mg of amlodipine) at a time, once daily. The dosage may be adjusted according to the symptoms, however, if the effect is insufficient, the dosage may be increased up to 2 tablets (10 mg), once daily. In general, for children aged 6 years and older, take 0.5 tablet (2.5 mg) at a time, once daily. The dosage may be adjusted according to the age, body weight and symptoms, however, the maximum daily dose is 1 tablet (5 mg).
For angina pectoris: In general, for adults, take 1 tablet (5 mg of amlodipine) at a time, once daily. The dosage may be adjusted according to the symptoms.
Strictly follow the instructions in any case.
•This medicine is orally disintegrating tablet. Take this medicine in either of the following ways:
(1) Take this medicine with water or warm water as you do an ordinary tablet.
(2) Soak the tablet with saliva on your tongue and crush it lightly with your tongue, then swallow it with saliva. However, never take the tablet without water when you are in a lying position.
•If you are a patient with hypertension and miss a dose, it is all right if you skip the missed dose. Follow your regular dosing schedule from the next day. If you are a patient with angina pectoris and miss a dose, take a dose as soon as you remember. However, if it is almost time for the next dose (approx. 8 hours), skip the missed dose and follow your regular dosing schedule. You should never take two doses at one time.
•If you accidentally take more than your prescribed dose, 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
•This medicine may cause dizziness or lightheadedness due to decreasing of blood pressure. Pay close attention when you work at heights, drive a car or operate dangerous machinery.
•Grapefruit juice may intensify the antihypertensive action of this medicine. Do not take this medicine concomitantly with grapefruit juice.
Possible adverse effects of this medicine
The most commonly reported adverse reactions include rash, itch, hives, photosensitivity, erythema multiforme, vasculitis, angioedema, edema, gingival overgrowth, glow (feeling hot, flash), palpitation, dizziness, lightheadedness, headache and headache dull. 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 effects indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
•general malaise, yellowing in skin or white of eye, loss of appetite [hepatic dysfunction, jaundice]
•nasal bleeding, bleeding tendency, fever, throat pain [thrombocytopenia, leukopenia]
•shortness of breath, dizziness, faint [atrioventricular block]
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.
•Discard the remainder. Do not store them. Ask the pharmacist how to discard them.
•Take split tablet as soon as possible. If you store this medicine from necessity after splitting, store away from moisture and light.