简介:
部份中文洛索洛芬钠处方资料(仅供参考)
商品名称:LOXONIN TABLETS
英文名称:Loxoprofen Sodium Hydrate
中文名称:洛索洛芬钠片
生产厂家:第一三共制药
药品简介
Loxonin(Loxoprofen Sodium Hydrate)洛索洛芬是一种前药型非甾体抗炎药,用于膝骨性关节炎、肌痛或创伤引起的肿胀和疼痛患者在1-4周内有所改善。
ロキソニン錠60mg/ロキソニン細粒10%
药效分类
镇痛、抗炎、退烧药
批准日期:2009年9月
商標名
LOXONIN TABLETS
1. 一般名
ロキソプロフェンナトリウム水和物(Loxoprofen Sodium Hydrate)
2. 化学名
Monosodium 2-{4-[(2-oxocyclopentyl)methyl]phenyl}propanoate dihydrate
3. 分子式
C15H17NaO3・2H2O
4. 分子量
304.31
5. 構造式
6. 性状
白色—带黄白色的结晶或结晶性的粉末。
甲醇中非常容易溶解,而且容易溶于乙醇(95),所以几乎不溶于乙酸乙酯。
水溶液(1→20)显示不了机光性。
7.分配系数
(参照分配系数的表)
分配系数的表
有機溶媒 |
水相のpH |
分配係数K |
1-オクタノール |
日局、第1液(pH1.2) |
190 |
1-オクタノール |
日局、第2液(pH6.8) |
0.82 |
クロロホルム |
日局、第1液(pH1.2) |
87 |
クロロホルム |
日局、第2液(pH6.8) |
0.95 |
处理上的注意
60毫克的罗基索宁曾在药片表面出现因色素引起的红色斑点
药效药理
聚氯乙烯水和物具有良好的镇痛、抗炎症、解热作用,但是特别是镇痛作用非常强。本药剂还会起到专业药物的作用,它会在从消化管吸收之后转换成活性代谢物。
1.镇痛作用
(1)透明苯酚水及物在randall- selitto法(炎症足加压法)的试验中,ed50值为0.13mg/kg,相对于布洛芬、萘普待因、印度甲申,高出10 ~ 20倍的镇痛作用。
(2)老鼠发炎疼痛止痛法(lutto经口)中,异丙芬钠水和物的id50值为0.76mg/kg,具有和萘普待因、印度甲酸等相同的效力。
(3)慢性关节疼痛止痛法(lutto经口)中,roxsopfon钠水和物的ed50值为0.53mg/kg,具有最强的镇痛作用,同时还具有印度metsin、ketif芬、萘普待因生4 ~ 6倍的效力。这种药的镇痛作用是末梢性的。
2.抗炎症作用
对于克罗基丙酮显流酶(rate)、阿兹巴特关节炎等急速慢性炎症,它与布洛芬、萘普待因相似。
3.热解毒
丙酮丙芬钠对因酵母而产生的发热现象,与石墨烯、萘普待因其燃烧的过程几乎等比,同时还比印度甲申热3倍。
4.作用机制
本剂的作用机制是前列腺素合成抑制作用,它的作用在于胞嘧啶。ロキソプロフェンナトリウム水合物在口服时,胃粘膜刺激作用较弱的未变化身体消化管比此后迅速被吸收,抑制前列腺素生物合成作用的强烈活性代谢物trans-oh身体(srs)配位被转换成作用。
适应症
1.下列疾病及症状的消炎·镇痛
关节囊性关节炎、变形性关节炎、腰痛、肩关节周围炎、颈肩腕症候群、牙痛2.手术后外伤及拔牙后的镇痛·消炎
3.下列疾病的清热镇痛
急性上呼吸道炎(包括急性支气管炎和急性上呼吸道炎)
用法与用量
1.下列疾病及症状的消炎·镇痛
关节囊性关节炎、变形性关节炎、腰痛、肩关节周围炎、颈肩腕症候群、牙痛
通常成年人每天服用60毫克钙(无水化合物),每天服用3次。进行整顿的情况下,一次需要花费60 ~ 120mg。另外,根据年龄、症状适当增减。另外,应避免在肚子饿时服用药物。
2.手术后外伤及拔牙后的镇痛·消炎
通常成年人每天服用60毫克钙(无水化合物),每天服用3次。进行整顿的情况下,一次需要花费60 ~ 120mg。另外,根据年龄、症状适当增减。如果你饿了,最好不要服用药物
3.下列疾病的清热镇痛
急性上呼吸道炎(包括急性支气管炎和急性上呼吸道炎)
通常情况下,成人食用1次60mg。另外,根据年龄、症状适当增减。但原则上一天进行两次,一天最大限度为180mg。另外,应避免在肚子饿时服用药物。
包装
片剂
60mg
(PTP)100片(10片×10)1000片(10片×100)3150片(21片×150)(罐:玫瑰:加入干燥剂)1000片

细粒10%
(瓶)100g
(罐:
含干燥剂)500g
制造销售元
第一三共制药
注:以上中文处方资料不够完整,使用者以原处方资料附件。
完整说明书附件:
http://www.info.pmda.go.jp/go/pack/1149019C1149_1_09/
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 : LOXONIN TABLETS 60mg
Active ingredient: Loxoprofen sodium hydrate
Dosage form: tablet (faintly reddish), (φ: 9.1mm, thickness: 3.3mm)
Print on wrapping: Loxonin, 157, ロキソニン, ロキソニン60mg
Effects of this medicine
This medicine suppresses prostaglandin synthesis that causes inflammation, and acts to ease swelling/pain induced by inflammation as well as to bring down fever.
It is usually used to treat rheumatoid arthritis and osteoarthritis. It is also used to reduce pain and inflammation after surgery, wounds and tooth removal, as well as to bring down fever or ease pain induced by acute inflammation of upper respiratory tract.
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: peptic ulcer, blood disease, liver/kidney/heart disorders, aspirin asthma.
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>>
For the use in reducing inflammation and pain induced by rheumatoid arthritis, osteoarthritis, lumbar pain, frozen shoulder, neck-shoulder-arm syndrome, tooth pain, as well as after surgery/wounds/tooth removal: In general, for adults, take 1 tablet (60mg of the active ingredient) at a time, 3 times a day. If taken as on-demand use, take 1 to 2 tablets (60 to 120mg) at a time.
For the use in reducing fever or pain induced by acute inflammation of upper respiratory tract: In general, for adults, take 1 tablet (60mg of the active ingredient) at a time, as needed. Usually up to twice a day. Do not exceed 3 tablets (180mg) a day.
The dose may be adjusted according to your disease, age and symptoms. Avoid taking the medicine on an empty stomach. Strictly follow the instructions.
If you miss a dose, take the missed dose as soon as possible. If it is almost time for the next dose, skip the missed dose and continue 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
Possible adverse effects of this medicine
The most commonly reported adverse reactions include gastric discomfort, stomachache, nausea/vomiting, loss of appetite, edema/swelling, rash, hives, drowsiness, fever, and itch. 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.
pale face, breathing difficulty, cold sweat[shock, anaphylactoid symptoms]
nose/gums bleeding, bruising on the limbs[agranulocytosis, hemolytic anemia, leukopenia, thrombocytopenia]
redness/swelling/rash/blister of skin/mucous membrane, fever, general fatigue[toxic epidermal necrosis, oculomucocutaneous syndrome]
decreased urine output, swelling, loss of appetite[acute renal failure, nephrotic syndrome, interstitial nephritis]
breathing difficulty, general swelling[congestive heart failure]
fever, cough, breathing difficulty[interstitial pneumonia]
blood vomiting, blood in stool[digestive tract bleeding]
pain in the pit of the stomach, stomachache[digestive tract perforation]
general fatigue, nausea, yellowing of the skin/white of eyes[liver dysfunction, jaundice]
breathlessness, wheezing[asthma]
fever, headache, nausea[aseptic meningitis]
sore muscle, feeling of weakness[rhabdomyolysis]
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 the reach of children. Store away from light, heat and moisture.
Discard the remainder. Do not store them.
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