中文药名：氨氯地平口腔果冻
英文药名：AMLODIPINE ORAL JELLY 5mg
主料：苯磺酸氨氯地平
成分：氨氯地平斯汀
重量：60g
病状：降压
生产厂家：东和制药有限公司
http://www.info.pmda.go.jp/go/pack/2171022Q1054_1_04/
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 ORAL JELLY 5mg "TOWA"
Active ingredient: Amlodipine besilate
Dosage form: white to pale yellow jelly
Print on wrapping: アムロジピン内用ゼリー5mg「トーワ」, 5mg/包 (2g), 高血圧または狭心症のお薬です (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 2.5 to 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 sachets (10 mg), once daily. In general, for children aged 6 years and older, take 2.5 mg of amlodipine 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 sachet (5 mg).
For angina pectoris: In general, for adults, take 1 sachet (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 should be used only for oral intake.
•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]
•bradycardia, dizziness, shortness of breath [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.
•If you carry around this medicine, make sure not to fold the package.
•Take this medicine as soon as possible after you open the package and discard the remainder. Do not store them. Ask the pharmacist how to discard them.
アムロジピン内用ゼリー2.5mg「トーワ」／アムロジピン内用ゼリー5mg「トーワ」
欧文商標名
AMLODIPINE ORAL JELLY 2.5mg “TOWA”
一般名：アムロジピンベシル酸塩（Amlodipine Besilate)
別 名：ベシル酸アムロジピン
化学名：3-Ethyl 5-methyl (4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate monobenzenesulfonate
構造式：
分子式：C20H25ClN2O5・C6H6O3S
分子量：567.05
性 状：白色～帯黄白色の結晶性の粉末である。メタノールに溶けやすく、エタノール（99.5）にやや溶けにくく、水に溶けにくい。メタノール溶液（１→100）は旋光性を示さない。
融 点：約198℃（分解）
取扱い上の注意
安定性試験
最終包装製品を用いた長期保存試験（25℃、相対湿度60％、２年）及び加速試験（40℃、相対湿度75％、６ヵ月）の結果、アムロジピン内用ゼリー2.5mg「トーワ」及びアムロジピン内用ゼリー５mg「トーワ」は通常の市場流通下においてそれぞれ３年間安定であることが推測された3)4)。
包装
アムロジピン内用ゼリー2.5mg「トーワ」：１g×50包
アムロジピン内用ゼリー５mg「トーワ」 ：２g×50包
