英文药名:JZOLOFT OD Tablets(Sertraline hydrochloride)
中文药名:盐酸舍曲林口腔崩解片
生产厂家:辉瑞制药
ジェイゾロフト錠25mg/ジェイゾロフト錠50mg/ジェイゾロフト錠100mg/ ジェイゾロフトOD錠25mg/ジェイゾロフトOD錠50mg/ ジェイゾロフトOD錠100mg
治疗类别名称 选择性五羟色胺再摄取抑制剂 商標名 JZOLOFT Tablets JZOLOFT OD Tablets 一般名 塩酸セルトラリン(sertraline hydrochloride) 化学名 (+)-(1S,4S)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthylamine monohydrochloride 分子式 C17H17Cl2N・HCl 分子量 342.69 構造式
性状 舍曲林盐酸盐是一种白色结晶粉末。甲醇,乙醇(95)或N,易溶微微N-二甲基乙酰胺,微溶于水。 熔点 约230〜236℃ 分配系数 7×102(pH值为7,辛醇/水系统) 适应病症 抑郁症,惊恐障碍,创伤后应激障碍 用法用量 成人:1天初始剂量25mg,逐渐增加1天为100mg,口服给药每天一次。该剂量应调整为不超过年龄,每日100mg症状的范围内为宜。 药效药理 舍曲林盐酸盐是抑制的有效的和选择性血清素再摄取机制存在于脑的血清素神经的药物,被认为是通过在大脑中突触间隙增加血清素浓度,以提高持续血清素神经传递。 1. 抗抑郁作用 (1) 它缩短不动时间在小鼠强迫游泳试验。 (2) 它抑制在逃避行为在大鼠强迫游泳试验的减少(水轮机旋转速度) (3) 它抑制嗅球分离的大鼠的运动活性的增强。 (4) 它允许通过应激负荷恢复正常大鼠自发性动力减少。 2. 抗焦虑作用 它抑制大理石小鼠大理石埋藏测试埋藏行为。 3. 自发动量降低效果由5-HT 2C受体激动剂。 它是由间 - 氯苯基哌嗪的给药,以减少自发活动的大鼠的降低(M-CPP)。 4. 作用机序 (1) 在用大鼠脑突触体的实验中,这种药物(IC 50)的血清素摄取的50%抑制浓度为0.058μmol/ L,血清素这种药物的摄取抑制效果进行比较,去甲肾上腺素或多巴胺摄取的抑制作用约20倍的选择性是方式(体外) (2) 在试验使用大鼠或牛脑膜制剂,但这种药物显示了血清素再摄取位点,肾上腺素能受体(α1,α2,β),多巴胺受体,毒蕈碱受体,组胺受体具有高亲和性(H1),血清素受体(5-HT1A,5-HT1B,5-HT1D,5-HT),苯二氮受体结合亲和力较低(体外)27,35)。小鼠大脑的进一步去甲肾上腺素能神经系统,不影响所造成的多巴胺神经系统和乙酰胆碱神经系统的激活行为和症状。 包装规格 *片为 25毫克:100、140、500片(PTP),500粒(瓶) 50毫克:100、140、500片(PTP),500粒(瓶) 100毫克 100片(PTP)
*口腔崩解片为 25毫克100片(PTP) 50毫克100片(PTP) 100毫克100片(PTP)
制造和销售 辉瑞公司日本 JZOLOFT OD Tablets(Sertraline hydrochloride) JZOLOFT OD Tablets 50mg(ジェイゾロフトOD錠50mg) Brand name : JZOLOFT OD Tablets 50mg Active ingredient: Sertraline hydrochloride Dosage form: white tablet, diameter: 10 mm, thickness: 4.7 mm Print on wrapping: JZOLOFT OD 50mg, ジェイゾロフト OD, 50, ジェイゾロフト OD 50mg, PT ZOD50, 50 OD JZOLOFT OD Tablets 50mg(ジェイゾロフトOD錠50mg) Brand name : JZOLOFT OD Tablets 50mg Active ingredient: Sertraline hydrochloride Dosage form: white tablet, diameter: 10 mm, thickness: 4.7 mm Print on wrapping: JZOLOFT OD 50mg, ジェイゾロフト OD, 50, ジェイゾロフト OD 50mg, PT ZOD50, 50 OD JZOLOFT OD Tablets 100mg(ジェイゾロフトOD錠100mg) Brand name : JZOLOFT OD Tablets 100mg Active ingredient: Sertraline hydrochloride Dosage form: white tablet, diameter: 13 mm, thickness: 6.0 mm Print on wrapping: JZOLOFT OD 100mg, ジェイゾロフト OD, 100, ジェイゾロフト OD 100mg, PT ZOD100, 100 OD Effects of this medicine This medicine has the effects such as antidepressant or antipanic disorder by selectively inhibiting the reuptake of serotonin in the brain to increase continuous nerve transmission with increased serotonin level at the synaptic cleft. It is usually used to treat depression/depressed state, panic disorder and post-traumatic stress disorder (PTSD). 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: liver dysfunction, manic-depressive illness, suicidal thoughts/suicide attempt or its history, predisposition of organic brain disorder or schizophrenia, highly impulsive comorbid disorders, convulsive disorders such as epilepsy or its history, QT prolonged or its history, bradycardia, hypokalemia, bleeding tendency or suspected hemorrhagic disorders, glaucoma or its history. •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, start with 25 mg of sertraline at a time, once a day and gradually increase the dosage up to 1 tablet (100 mg) at a time, once a day. The dosage may be adjusted up to 1 tablet (100 mg) per day according to the diseases, age or symptoms. This preparation contains 100 mg of sertraline in a tablet. Strictly follow the instructions. •You can take this medicine without water. Wet the tablet with saliva on tongue and crush it lightly, and then swallow it with saliva. You can take it with water like regular tablets. •If you miss a dose and remember it within one day, take the missed dose as soon as possible. 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. Sudden discontinuation of the medicine may cause adverse symptoms (anxiety, restlessness, excitement, dizziness, headache). Precautions while taking this medicine •This medicine may cause sleepiness and dizziness, pay attention when you operate dangerous machinery such as driving a car. •Avoid alcohol during medication, since alcohol may intensify medicinal or medical effects. •Avoid taking health food containing St. John's wort (a kind of herb) with the medicine, since it may enhance serotonin action. •This medicine may cause worsening symptoms of the disease, suicidal thoughts/suicide attempt and harming others, but these causal relationships are unknown. If any of these signs occur, consult with your doctor/pharmacist without stopping your medication. Family members should receive information about the following risks from your doctor: change in patient's behavior such as suicide, tendency to excite, acting aggressive and change in mental or physical condition due to slight irritation, and worsening of the underlying disease such as depression. After fully understanding these risks, family members should observe whether your condition have changed or not. If family members noticed any of these conditions, contact the doctor. In addition, if you yourself notice any of them, inform your family members. Possible adverse reactions to this medicine The most commonly reported adverse reactions include nausea, somnolence, dry mouth, headache, diarrhea and dizziness. 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. •anxiety, restlessness/excitement/confusion, sweat [serotonin syndrome] •akinetic mutism, muscle stiffness, swallowing difficulty [neuroleptic malignant syndrome] •muscle spasmodically contracting, complete loss of consciousness [convulsion, coma] •general malaise, loss of appetite, yellowing of the skin and the white of eyes [liver dysfunction] •increase body weight in a short duration without edema, convulsion, conscious disorder [syndrome of inappropriate antidiuretic hormone secretion (SIADH)] 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 reach of children. Store away from direct sunlight, heat and moisture. •Discard the remainder. Do not store them. If you dispose of unused medicines, ask the pharmacist and the medical institution how to discard them. Pfizer Pharmaceuticals Inc.Internal Revised: 3/2015 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/1179046F1028_2_13/
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