FDA records indicate that there are no current recalls for this drug.
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问题和答案
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
目前没有可用于此药物的法律信息。
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
目前还没有生产informa的警告tion available for this drug.
FDA Labeling Changes
目前没有FDA标记可用于此药物的变化。
用途
VIIBRYD® is indicated for the treatment of major depressive disorder (MDD). The efficacy of VIIBRYD was established in two 8-week, randomized, double-blind, placebo-controlled trials in adult patients with a diagnosis of MDD[见临床研究(14)].
Major depressive disorder consists of one or more major depressive episodes. A major depressive episode (DSM-IV-TR) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least 5 of the following 9 symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, or a suicide attempt or suicidal ideation.
History
There is currently no drug history available for this drug.
其他信息
用于口服给药的VIIBRYD片剂含有多晶型αsvVilazodone盐酸盐(HCl),一种选择性血清素再摄取抑制剂和5小时1Areceptor partial agonist.
Vilazodone HCl is 2-benzofurancarboxamide, 5-[4-[4-(5-cyano-1H- 吲哚-3-基)丁基] -1-哌嗪基] - ,盐酸盐(1:1)。其分子量为477.99。结构式是:
In addition to the active ingredient, VIIBRYD Tablets contain lactose monohydrate, microcrystalline cellulose, magnesium stearate, colloidal silicon dioxide, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, FD&C Blue #1 (40 mg only), FD&C Yellow #6 (20 mg only) and FD&C Red #40 (10 mg only).
Sources
Viibryd Manufacturers
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Cardinal Health
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森林实验室,Inc。
viibryd |森林实验室,Inc。
2.1 Dosage for Treatment of Major Depressive Disorderviibryd的推荐目标剂量为每日20毫克至40毫克,食物每日一次,食物[参见临床药理学(12.3),临床研究(14)]。为了达到目标剂量,滴定石Viibryd如下:
从每日10毫克的初始剂量开始,食物7天,然后每天增加到20毫克。剂量可以在剂量增加至少7天后每日增加40毫克。If a dose is missed, it should be taken as soon as the patient remembers. If it is almost time for the next dose, the patient should skip the missed dose and take the next dose at the regular time. Two doses should not be taken at the same time.
2.2 Screen for Bipolar Disorder Prior to Starting VIIBRYD在用viibryd或另一种抗抑郁药物治疗之前,筛选患者的个人或家族史,躁狂症或hypomania [请参阅警告和预防措施(5.4)]。
2.3 Switching to or from a Monoamine Oxidase Inhibitor AntidepressantAt least 14 days must elapse between discontinuation of a monoamine oxidase inhibitor (MAOI) antidepressant and initiation of VIIBRYD. In addition, at least 14 days must elapse after stopping VIIBRYD before starting an MAOI antidepressant [see Contraindications (4), Warnings and Precautions (5.2)].
2.4用CYP3A4抑制剂或诱导剂的剂量调节接受Cyp3A4抑制剂的患者:
During concomitant use of a strong CYP3A4 inhibitor (e.g., itraconazole, clarithromycin, voriconazole), the VIIBRYD dose should not exceed 20 mg once daily. The original VIIBRYD dose level, can be resumed when the CYP3A4 inhibitor is discontinued [see Drug Interactions (7)].
患者接受CYP3A4诱导剂:
Based on clinical response, consider increasing the dosage of VIIBRYD by 2-fold, up to a maximum 80 mg once daily, over 1 to 2 weeks in patients taking strong CYP3A4 inducers (e.g., carbamazepine, phenytoin, rifampin) for greater than 14 days. If CYP3A4 inducers are discontinued, gradually reduce the VIIBRYD dosage to its original level over 1 to 2 weeks [see Drug Interactions (7)].
2.5 Discontinuing Treatment with VIIBRYDAdverse reactions may occur upon discontinuation of VIIBRYD [see Warnings and Precautions (5.5)]. A gradual reduction in dosage rather than abrupt cessation is recommended whenever possible. VIIBRYD should be down tapered from the 40 mg once daily dose to 20 mg once daily for 4 days, followed by 10 mg once daily for 3 days. Patients taking VIIBRYD 20 mg once daily should be tapered to 10 mg once daily for 7 days.
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