美国FDA核准度洛西汀用于广泛性焦虑症的维持治疗 美国食品药物管理局(FDA)的核准盐酸度洛西汀(商品名本品为缓释胶囊,礼来制药公司)扩增一项适应症,用于广泛性焦虑症(广义焦虑症,性别与发展)的维持治疗。之前,仅限急性治疗使用选择性血清素 - 正肾上腺素再吸收抑制剂。 广泛性焦虑症特征是经常且随时有焦虑,夸大忧虑和紧张,在美国影响约700万人。若不治疗,症状会逐渐恶化,对病患的工作能力,家庭,与社会状态会有负面影响。
美国本品为药物主任詹姆斯M内斯医师在该药厂的新闻稿中表示,因为广泛性焦虑症可能是慢性疾病,医师和病患的重点在于找到对急性期和维持期都有效的治疗选项。
【藉由此次新增之核准,度洛西汀对此往往令人衰弱之状况的维持治疗提供了新选择】 美国FDA的核准是根据429名病患使用度洛西汀进行初步治疗26周,剂量范围为每天60 - 120mg的双盲研究资料,结果显示,相较于换成安慰剂组,继续使用度洛西汀26周的病患,广泛性焦虑症复发比率显著下降(15%,相较于46.4%)。 研究中最常报告之治疗中突现的副作用,包括恶心,头痛,口干,腹泻,头昏眼花,便秘,疲劳与排汗增加。 度洛西汀缓释胶囊原本获核准用于重郁症的急性和维持治疗,以及糖尿病周边神经疼痛和纤维肌痛的处置。
Why is Duloxetine hydrochloride prescribed? Cymbalta is used to treat major depression—a disorder marked by continuing, serious, and overwhelming feelings of depression that interfere with daily functioning. Symptoms may include major changes in appetite or sleep habits; lack of interest in social or work life; feelings of sadness, guilt, or worthlessness; fatigue; difficulty concentrating or making decisions; and suicidal thoughts or attempted suicide.
Cymbalta is also used to treat diabetic peripheral neuropathy, a painful nerve disorder associated with diabetes that affects the hands, legs, and feet.
Cymbalta is thought to work by correcting an imbalance of two brain chemicals known to influence mood—serotonin and norepinephrine. It belongs to a class of antidepressants called selective serotonin and norepinephrine reuptake inhibitors (SNRIs).
Most important fact about Duloxetine hydrochloride Serious, sometimes fatal reactions can occur if Cymbalta is taken with antidepressants known as MAO inhibitors, including the antidepressants phenelzine and tranylcypromine. Never combine Cymbalta with one of these drugs, and wait at least 14 days after stopping an MAO inhibitor before starting treatment with Cymbalta. Likewise, after stopping therapy with Cymbalta, allow at least 5 days before starting treatment with an MAO inhibitor.
How should you take Duloxetine hydrochloride? Take Cymbalta at about the same time each day. Swallow the capsule whole; do not chew it or break it open. Cymbalta may be taken with or without food.
It may take several weeks before the drug begins to work. Continue taking Cymbalta even if you begin to feel better. Do not stop taking Duloxetine hydrochloride without your doctor's approval. Abruptly stopping treatment may cause severe side effects.
If you miss a dose... Take the forgotten dose as soon as you remember. However, if it is almost time for your next dose, skip the one you missed and return to your regular schedule. Do not take two doses at once. Storage instructions... Store at room temperature. What side effects may occur? Side effects cannot be anticipated. If any develop or change in intensity, tell your doctor as soon as possible. Only your doctor can determine if it is safe to continue using Cymbalta.
Side effects may include: Appetite changes, constipation, diarrhea, dizziness, dry mouth, fatigue, headache, insomnia, nausea, sexual difficulties, sleepiness, sweating, tremor, urinary difficulties, vomiting, weakness Why should Duloxetine hydrochloride not be prescribed? You will not be able to use Cymbalta if it causes an allergic reaction. In addition, you should not take Cymbalta if you have uncontrolled narrow-angle glaucoma, a disease that causes increased pressure in the eyes.
Never combine Cymbalta with an MAO inhibitor (see "Most important fact about Duloxetine hydrochloride").
Do not take the drug thioridazine with Cymbalta, as it could cause fatal heartbeat irregularities.
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