FDA records indicate that there are no current recalls for this drug.
Zoloft(sertraline hydrochloride)
Zoloft® is an antidepressant medication classified as a selective serotonin reuptake inhibitor (SSRI), generally prescribed to adults to treat major depression and anxiety disorders and, less commonly, for vascular headaches and premature ejaculation. It is an oral medication originally brought to the market by American pharmaceutical manufacturer Pfizer and is available in 25mg, 50mg, and 100mg capsules.
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Questions & Answers
Question
Zoloft makes me more moody and more depressed. I didn’t take it for long.
副作用和不良反应
Common side effects include fatigue, insomnia, nausea, dry mouth, headache, diarrhea, dizziness, weight gain, and sexual dysfunction (difficulty achieving arousal, erection and/or orgasm).
As with all antidepressants, Zoloft carries the FDA’s black box warning due to an increased risk of suicidal thoughts/ideation and actions, especially in children and young adults.(fda.gov)
The use of Zoloft during the first trimester of pregnancy is associated with increased risks of the following birth defects: omphalocele (abdominal wall defects), anal atresia (malformation of the anus/rectum), limb reduction, and septal (heart) defects.(ncbi.nlm.nih.gov)
Like many other antidepressant medications, the discontinuation of regular use of Zoloft can cause numerous unpleasant withdrawal side effects, including flu-like symptoms (nausea, vomiting, sweating, headaches, diarrhea), sleep disturbances (insomnia, nightmares, fatigue), sensory/movement disturbances (vertigo, dizziness, “zap” like electrical sensations in the brain or nerve paths), and mood disturbances (anxiety, dysphoria, agitation). Most cases of these withdrawal symptoms are mild and resolve themselves after 1-4 weeks.
Possible Adverse Interactions
Zoloft should not be taken with, or immediately after stopping use of, monoamine oxidase inhibitors (MAOIs), another class of commonly used antidepressants, as this can cause serotonin syndrome or serotonin toxicity, a condition that can be fatal.
It is also contraindicated for use with the antipsychotic medication pimozide (Orap) due to the risk of serious heart problems. The concentrated form also contains an alcohol solution, so it is recommended not to take it with Antabuse, a medication used to treat alcoholism. Grapefruit and grapefruit juice should also be avoided, as it can increase the levels of Zoloft in the body.
Legal Issues
Pfizer has over 1,000 lawsuits pending against them regarding the use of Zoloft causing birth defects in pregnancy. In June 2015, a jury in Philadelphia, PA sided with the defendant (Pfizer) in a case wherein the plaintiffs alleged that Pfizer did not sufficiently warn patients of the potential for birth defects, finding that the drug’s label adequately warned physicians to weigh and discuss the benefits and risks of use before prescribing it (Robinson v. Wolters Kluwer Health Inc. and Pfizer, Inc.). This is the second such judgment in favor of Pfizer regarding birth defects and use of Zoloft in as many trials.(bloomberg.com)
Zoloft was also the subject of a consumer fraud class action lawsuit that was filed in 2013 in California. The case, Plumlee vs. Pfizer Inc., centered on claims by plaintiff Laura Plumlee that she had taken the drug as prescribed for 3 years with absolutely no effect. The suit alleged that Pfizer deliberately omitted from labeling that there had been studies conducted that found Zoloft to be no more effective than a placebo, and that their marketing and advertising regarding its effectiveness was misleading. The plaintiff’s first claim was dismissed in March 2014, not due to the argument of effectiveness or lack thereof, but due to time-barring. Plumlee had last used Zoloft in 2008, but did not file the lawsuit until 2013. She was given the opportunity to amend her claim and re-file, but the suit was ultimately dismissed with prejudice in September 2014.
FDA Safety Alerts
July, 2006
Food and Drug Administration Labeling Changes indicate several changes but this specific Alert was issued warning of increased risk of Neonatal Persistent Pulmonary Hypertension in mothers taking the drug(fda.gov).
December 14, 2011
The FDA warns of pregnancy risks in SSRI’s in general, including Zoloft.(fda.gov).
July 26, 2011
FDA警告服用抗生素线唑胺(Zyvox)和某些精神病血清素药物(包括Zoloft)的患者中的严重CNS反应。(fda.gov)
Manufacturer Warnings
An undated warning letter from Pfizer alerts healthcare providers to the warnings and label changes regarding detrimental interactions of Zoloft with pimozide (Orap) and MAOIs(fda.gov).
FDA Labeling Changes
September 2014
A labeling adjustment was made to the drug interactions to remove previous additions of QT prolongation, Torsades de Pointes, and ventricular tachycardia – all types of cardiac arrhythmia (irregular heart rhythm)(fda.gov).
February 2013
Diabetes mellitus (scientific name for both Type 1 and Type 2 diabetes) was added to the list of events observed during the post-marketing evaluation of Zoloft.(fda.gov)
December 2012
Contraindications and warnings were added regarding the types of drugs or substances that will interact with use of Zoloft and possibly cause serotonin syndrome, expanding upon the warnings issued in January 2009(fda.gov).
2011年8月
Information was added to the packaging label to advise caution when co-administering Zoloft with drugs that may enhance serotonergic neurotransmission (transmission/absorption of serotonin) due to possibility for interaction. In addition, a precaution was added regarding laboratory testing: patients using Zoloft were reported to have received false positives on urine immunoassay screening tests for benzodiazepines(a class of frequently abused anti-anxiety medications) such as clonazepam(fda.gov).
2009年1月
发布关于t的潜力的一个警告he potentially fatal complication serotonin syndrome, also known as serotonin storm or serotonin toxicity, or a similar condition called neuroleptic malignant syndrome. Both of these conditions can occur when Zoloft is taken in combination with MAOIs (such as selegiline or phenelzine), or other drugs that alter the neurotransmission of serotonin(fda.gov).
March 2008
Precautions were added to the label making changes to the following subjects: abnormal bleeding as a potential side effect, and interactions with drugs that interfere with the clotting and flow of blood (Non-selective NSAIDs, aspirin, warfarin, etc.)(fda.gov).
Uses
Zoloft® is an antidepressant medication classified as a selective serotonin reuptake inhibitor (SSRI), generally prescribed to adults to treat major depression and anxiety disorders and, less commonly, for vascular headaches and premature ejaculation. It is an oral medication originally brought to the market by American pharmaceutical manufacturer Pfizer and is available in 25mg, 50mg, and 100mg capsules.
History
Sertraline was the result of many levels of experimentation by Pfizer chemists, beginning in the early 1970’s with the invention of multiple psychoactive compounds that were based on the structures of some of the earliest available antipsychotic medications. These experiments would eventually result in the development of many neurotransmitter reuptake inhibitors, the most potent and selective of which would go on to be tested in vivo (on living organisms, including human trials) and dubbed sertraline. None of the scientists responsible for its creation were anticipating the production of an SSRI type of antidepressant, so the discovery is considered a happy accident.
Zoloft was approved by the FDA on the recommendation of the Psychopharmacological Drugs Advisory Committee in 1991. It was also made available in the United Kingdom the previous year, and in Australia in 1994. It was only approved for prescription to adults over the age of 18 until 2002, when the FDA approved its use in children over age 6 to treat severe cases of obsessive-compulsive disorder. In 2005, the FDA issued a black box warning for all antidepressants, including sertraline, concerning suicidal thoughts and behaviors in children; this warning was amended in 2007 to include the possibility of suicidal tendencies in young adults aged 18 to 24.
左洛复过期的专利在美国在2006年llowing for the availability of sertraline in its generic form. Other brand names for sertraline include Lustral and Asentra. In 2013, it was the most prescribed antidepressant and second-most prescribed psychiatric medication in the United States.(psychentral.com)
Other Information
怎么运行的
作为一个SSRI, inhibitin左洛复被认为工作g the passage of serotonin between two nerve cells, allowing for the serotonin to stay in the synapse (gap) between the cells, thereby increasing its availability to bind with the proteins in the receiving cell. This increase in available serotonin is believed to positively affect mood and manage depression.
Sources
Zoloft Manufacturers
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Stat RX USA LLC
Zoloft | Stat Rx Usa Llc
Initial Treatment成人剂量Major Depressive Disorder and Obsessive-Compulsive DisorderZoloft治疗应每天以50 mg的剂量给药。
Panic Disorder, Posttraumatic Stress Disorder and Social Anxiety DisorderZOLOFT treatment should be initiated with a dose of 25 mg once daily. After one week, the dose should be increased to 50 mg once daily.
尽管尚未建立针对重度抑郁症,强迫症,恐慌症,PTSD或社交焦虑症之间的剂量和作用之间的关系,但在临床试验中,患者的剂量为50-200 mg/天,这证明了Zoloft对Zoloft for Zoloft的有效性这些适应症的处理。因此,建议每天服用一次50毫克,作为初始治疗剂量。对50 mg剂量反应的患者可能会从剂量增加到最多200 mg/天的剂量增加。考虑到Zoloft的24小时消除半衰期,不应以少于1周的时间进行剂量变化。
Premenstrual Dysphoric DisorderZOLOFT treatment should be initiated with a dose of 50 mg/day, either daily throughout the menstrual cycle or limited to the luteal phase of the menstrual cycle, depending on physician assessment.
尽管尚未建立PMDD剂量和作用之间的关系,但在每个新月经周期开始时,患者的剂量为50-150 mg/天,剂量增加(请参阅临床药理学下的临床试验)。在整个月经周期中每天给药时,每天给药时,未反应50 mg/天剂量的患者可能会受益于150毫克/天的剂量增加(以50 mg的增量/月经周期)受益,或者在100 mg/day的剂量时,或在剂量/天的时间/天。月经周期。如果已经建立了100 mg/天的剂量,则使用黄体期给药,则在每个黄体剂量期开始时应使用50 mg/天的滴定步骤三天。
ZOLOFT should be administered once daily, either in the morning or evening.
Dosage for Pediatric Population (Children and Adolescents)Obsessive-Compulsive DisorderZOLOFT treatment should be initiated with a dose of 25 mg once daily in children (ages 6–12) and at a dose of 50 mg once daily in adolescents (ages 13–17).
While a relationship between dose and effect has not been established for OCD, patients were dosed in a range of 25–200 mg/day in the clinical trials demonstrating the effectiveness of ZOLOFT for pediatric patients (6–17 years) with OCD. Patients not responding to an initial dose of 25 or 50 mg/day may benefit from dose increases up to a maximum of 200 mg/day. For children with OCD, their generally lower body weights compared to adults should be taken into consideration in advancing the dose, in order to avoid excess dosing. Given the 24 hour elimination half-life of ZOLOFT, dose changes should not occur at intervals of less than 1 week.
ZOLOFT should be administered once daily, either in the morning or evening.
维护/延续/扩展治疗Major Depressive DisorderIt is generally agreed that acute episodes of major depressive disorder require several months or longer of sustained pharmacologic therapy beyond response to the acute episode. Systematic evaluation of ZOLOFT has demonstrated that its antidepressant efficacy is maintained for periods of up to 44 weeks following 8 weeks of initial treatment at a dose of 50–200 mg/day (mean dose of 70 mg/day) (see Clinical Trials under CLINICAL PHARMACOLOGY). It is not known whether the dose of ZOLOFT needed for maintenance treatment is identical to the dose needed to achieve an initial response. Patients should be periodically reassessed to determine the need for maintenance treatment.
Posttraumatic Stress Disorder普遍认为,PTSD需要几个月或更长时间的持续药理治疗,而不是对初始治疗的反应。对Zoloft的系统评估表明,在24周治疗后,其在PTSD中的功效在50-200 mg/天的治疗后保持了28周(请参阅临床药理学下的临床试验)。尚不清楚维持治疗所需的Zoloft剂量是否与实现初始反应所需的剂量相同。应定期重新评估患者,以确定需要进行维持治疗。
Social Anxiety DisorderSocial anxiety disorder is a chronic condition that may require several months or longer of sustained pharmacological therapy beyond response to initial treatment. Systematic evaluation of ZOLOFT has demonstrated that its efficacy in social anxiety disorder is maintained for periods of up to 24 weeks following 20 weeks of treatment at a dose of 50–200 mg/day (see Clinical Trials under CLINICAL PHARMACOLOGY). Dosage adjustments should be made to maintain patients on the lowest effective dose and patients should be periodically reassessed to determine the need for long-term treatment.
强迫症和恐慌症It is generally agreed that OCD and Panic Disorder require several months or longer of sustained pharmacological therapy beyond response to initial treatment. Systematic evaluation of continuing ZOLOFT for periods of up to 28 weeks in patients with OCD and Panic Disorder who have responded while taking ZOLOFT during initial treatment phases of 24 to 52 weeks of treatment at a dose range of 50–200 mg/day has demonstrated a benefit of such maintenance treatment (see Clinical Trials under CLINICAL PHARMACOLOGY). It is not known whether the dose of ZOLOFT needed for maintenance treatment is identical to the dose needed to achieve an initial response. Nevertheless, patients should be periodically reassessed to determine the need for maintenance treatment.
Premenstrual Dysphoric DisorderZoloft在长期使用中的有效性,即对于超过3个月经周期,在对照试验中尚未系统地评估。但是,由于女性通常报告症状会随着年龄的增长而恶化,直到更年期开始时,考虑到继续反应的患者是合理的。剂量调整可能包括剂量方案之间的变化(例如,在月经周期的黄体阶段,每天在月经周期中每天)可能需要定期将患者维持最低的剂量,并应定期重新确定患者的患者以确定患者。需要继续治疗。
切换患者往返单胺氧化酶抑制剂At least 14 days should elapse between discontinuation of an MAOI and initiation of therapy with ZOLOFT. In addition, at least 14 days should be allowed after stopping ZOLOFT before starting an MAOI (see CONTRAINDICATIONS and WARNINGS).
Special PopulationsDosage for Hepatically Impaired PatientsThe use of sertraline in patients with liver disease should be approached with caution. The effects of sertraline in patients with moderate and severe hepatic impairment have not been studied. If sertraline is administered to patients with liver impairment, a lower or less frequent dose should be used (see CLINICAL PHARMACOLOGY and PRECAUTIONS).
Treatment of Pregnant Women During the Third TrimesterNeonates exposed to ZOLOFT and other SSRIs or SNRIs, late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding (see PRECAUTIONS). When treating pregnant women with ZOLOFT during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. The physician may consider tapering ZOLOFT in the third trimester.
和左洛复中止治疗Symptoms associated with discontinuation of ZOLOFT and other SSRIs and SNRIs, have been reported (see PRECAUTIONS). Patients should be monitored for these symptoms when discontinuing treatment. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate.
ZOLOFT Oral ConcentrateZoloft口服浓缩物含有20 mg/ml的舍曲林(作为盐酸盐)作为活性成分和12%的酒精。Zoloft口服浓缩液必须在使用前稀释。在服用之前,请使用提供的滴管来清除所需量的Zoloft口服浓缩液,并与4盎司(1/2杯)水,姜汁啤酒,柠檬/柠檬汽水,柠檬水,柠檬水或橙汁混合。不要将Zoloft口服浓缩液与列出的液体之外的任何东西混合。混合后应立即服用剂量。不要提前混合。有时,混合后可能会出现轻微的阴霾。这是正常的。请注意,由于滴管分配器含有干燥的天然橡胶,因此应谨慎对待乳胶敏感性。
Zoloft口服浓缩物因浓缩物的酒精含量而被Antabuse(Disulfiram)禁用。
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Pd-rx Pharmaceuticals, Inc.
Zoloft | Pd-rx Pharmaceuticals, Inc.
Initial Treatment Dosage for Adults Major Depressive Disorder and Obsessive-Compulsive DisorderZoloft治疗应每天以50 mg的剂量给药。
Panic Disorder, Posttraumatic Stress Disorder and Social Anxiety DisorderZOLOFT treatment should be initiated with a dose of 25 mg once daily. After one week, the dose should be increased to 50 mg once daily.
尽管尚未建立针对重度抑郁症,强迫症,恐慌症,PTSD或社交焦虑症之间的剂量和作用之间的关系,但在临床试验中,患者的剂量为50-200 mg/天,这证明了Zoloft对Zoloft for Zoloft的有效性这些适应症的处理。因此,建议每天服用一次50毫克,作为初始治疗剂量。对50 mg剂量反应的患者可能会从剂量增加到最多200 mg/天的剂量增加。考虑到Zoloft的24小时消除半衰期,不应以少于1周的时间进行剂量变化。
Premenstrual Dysphoric DisorderZOLOFT treatment should be initiated with a dose of 50 mg/day, either daily throughout the menstrual cycle or limited to the luteal phase of the menstrual cycle, depending on physician assessment.
尽管尚未建立PMDD剂量和作用之间的关系,但在每个新月经周期开始时,患者的剂量为50-150 mg/天,剂量增加(请参阅临床药理学下的临床试验)。在整个月经周期中每天给药时,每天给药时,未反应50 mg/天剂量的患者可能会受益于150毫克/天的剂量增加(以50 mg的增量/月经周期)受益,或者在100 mg/day的剂量时,或在剂量/天的时间/天。月经周期。如果已经建立了100 mg/天的剂量,则使用黄体期给药,则在每个黄体剂量期开始时应使用50 mg/天的滴定步骤三天。
ZOLOFT should be administered once daily, either in the morning or evening.
小儿种群(儿童和青少年)强迫症的剂量ZOLOFT treatment should be initiated with a dose of 25 mg once daily in children (ages 6–12) and at a dose of 50 mg once daily in adolescents (ages 13–17).
While a relationship between dose and effect has not been established for OCD, patients were dosed in a range of 25–200 mg/day in the clinical trials demonstrating the effectiveness of ZOLOFT for pediatric patients (6–17 years) with OCD. Patients not responding to an initial dose of 25 or 50 mg/day may benefit from dose increases up to a maximum of 200 mg/day. For children with OCD, their generally lower body weights compared to adults should be taken into consideration in advancing the dose, in order to avoid excess dosing. Given the 24 hour elimination half-life of ZOLOFT, dose changes should not occur at intervals of less than 1 week.
ZOLOFT should be administered once daily, either in the morning or evening.
维护/延续/扩展治疗重大抑郁症It is generally agreed that acute episodes of major depressive disorder require several months or longer of sustained pharmacologic therapy beyond response to the acute episode. Systematic evaluation of ZOLOFT has demonstrated that its antidepressant efficacy is maintained for periods of up to 44 weeks following 8 weeks of initial treatment at a dose of 50–200 mg/day (mean dose of 70 mg/day) (see Clinical Trials under CLINICAL PHARMACOLOGY). It is not known whether the dose of ZOLOFT needed for maintenance treatment is identical to the dose needed to achieve an initial response. Patients should be periodically reassessed to determine the need for maintenance treatment.
Posttraumatic Stress Disorder普遍认为,PTSD需要几个月或更长时间的持续药理治疗,而不是对初始治疗的反应。对Zoloft的系统评估表明,在24周治疗后,其在PTSD中的功效在50-200 mg/天的治疗后保持了28周(请参阅临床药理学下的临床试验)。尚不清楚维持治疗所需的Zoloft剂量是否与实现初始反应所需的剂量相同。应定期重新评估患者,以确定需要进行维持治疗。
Social Anxiety DisorderSocial anxiety disorder is a chronic condition that may require several months or longer of sustained pharmacological therapy beyond response to initial treatment. Systematic evaluation of ZOLOFT has demonstrated that its efficacy in social anxiety disorder is maintained for periods of up to 24 weeks following 20 weeks of treatment at a dose of 50–200 mg/day (see Clinical Trials under CLINICAL PHARMACOLOGY). Dosage adjustments should be made to maintain patients on the lowest effective dose and patients should be periodically reassessed to determine the need for long-term treatment.
强迫症和恐慌症It is generally agreed that OCD and Panic Disorder require several months or longer of sustained pharmacological therapy beyond response to initial treatment. Systematic evaluation of continuing ZOLOFT for periods of up to 28 weeks in patients with OCD and Panic Disorder who have responded while taking ZOLOFT during initial treatment phases of 24 to 52 weeks of treatment at a dose range of 50–200 mg/day has demonstrated a benefit of such maintenance treatment (see Clinical Trials under CLINICAL PHARMACOLOGY). It is not known whether the dose of ZOLOFT needed for maintenance treatment is identical to the dose needed to achieve an initial response. Nevertheless, patients should be periodically reassessed to determine the need for maintenance treatment.
Premenstrual Dysphoric DisorderZoloft在长期使用中的有效性,即对于超过3个月经周期,在对照试验中尚未系统地评估。但是,由于女性通常报告症状会随着年龄的增长而恶化,直到更年期开始时,考虑到继续反应的患者是合理的。剂量调整可能包括剂量方案之间的变化(例如,在月经周期的黄体阶段,每天在月经周期中每天)可能需要定期将患者维持最低的剂量,并应定期重新确定患者的患者以确定患者。需要继续治疗。
切换患者往返单胺氧化酶抑制剂At least 14 days should elapse between discontinuation of an MAOI and initiation of therapy with ZOLOFT. In addition, at least 14 days should be allowed after stopping ZOLOFT before starting an MAOI (see CONTRAINDICATIONS and WARNINGS).
特殊人群剂量用于肝损害患者The use of sertraline in patients with liver disease should be approached with caution. The effects of sertraline in patients with moderate and severe hepatic impairment have not been studied. If sertraline is administered to patients with liver impairment, a lower or less frequent dose should be used (see CLINICAL PHARMACOLOGY and PRECAUTIONS).
Treatment of Pregnant Women During the Third TrimesterNeonates exposed to ZOLOFT and other SSRIs or SNRIs, late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding (see PRECAUTIONS). When treating pregnant women with ZOLOFT during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. The physician may consider tapering ZOLOFT in the third trimester.
和左洛复中止治疗Symptoms associated with discontinuation of ZOLOFT and other SSRIs and SNRIs, have been reported (see PRECAUTIONS). Patients should be monitored for these symptoms when discontinuing treatment. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate.
ZOLOFT Oral ConcentrateZoloft口服浓缩物含有20 mg/ml的舍曲林(作为盐酸盐)作为活性成分和12%的酒精。Zoloft口服浓缩液必须在使用前稀释。在服用之前,请使用提供的滴管来清除所需量的Zoloft口服浓缩液,并与4盎司(1/2杯)水,姜汁啤酒,柠檬/柠檬汽水,柠檬水,柠檬水或橙汁混合。不要将Zoloft口服浓缩液与列出的液体之外的任何东西混合。混合后应立即服用剂量。不要提前混合。有时,混合后可能会出现轻微的阴霾。这是正常的。请注意,由于滴管分配器含有干燥的天然橡胶,因此应谨慎对待乳胶敏感性。
Zoloft口服浓缩物因浓缩物的酒精含量而被Antabuse(Disulfiram)禁用。
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Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
Zoloft | Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
Initial Treatment成人剂量Major Depressive Disorder and Obsessive-Compulsive DisorderZoloft治疗应每天以50 mg的剂量给药。
Panic Disorder, Posttraumatic Stress Disorder and Social Anxiety DisorderZOLOFT treatment should be initiated with a dose of 25 mg once daily. After one week, the dose should be increased to 50 mg once daily.
尽管尚未建立针对重度抑郁症,强迫症,恐慌症,PTSD或社交焦虑症之间的剂量和作用之间的关系,但在临床试验中,患者的剂量为50-200 mg/天,这证明了Zoloft对Zoloft for Zoloft的有效性这些适应症的处理。因此,建议每天服用一次50毫克,作为初始治疗剂量。对50 mg剂量反应的患者可能会从剂量增加到最多200 mg/天的剂量增加。考虑到Zoloft的24小时消除半衰期,不应以少于1周的时间进行剂量变化。
Premenstrual Dysphoric DisorderZOLOFT treatment should be initiated with a dose of 50 mg/day, either daily throughout the menstrual cycle or limited to the luteal phase of the menstrual cycle, depending on physician assessment.
尽管尚未建立PMDD剂量和作用之间的关系,但在每个新月经周期开始时,患者的剂量为50-150 mg/天,剂量增加(请参阅临床药理学下的临床试验)。在整个月经周期中每天给药时,每天给药时,未反应50 mg/天剂量的患者可能会受益于150毫克/天的剂量增加(以50 mg的增量/月经周期)受益,或者在100 mg/day的剂量时,或在剂量/天的时间/天。月经周期。如果已经建立了100 mg/天的剂量,则使用黄体期给药,则在每个黄体剂量期开始时应使用50 mg/天的滴定步骤三天。
ZOLOFT should be administered once daily, either in the morning or evening.
Dosage for Pediatric Population (Children and Adolescents)Obsessive-Compulsive DisorderZOLOFT treatment should be initiated with a dose of 25 mg once daily in children (ages 6–12) and at a dose of 50 mg once daily in adolescents (ages 13–17).
While a relationship between dose and effect has not been established for OCD, patients were dosed in a range of 25–200 mg/day in the clinical trials demonstrating the effectiveness of ZOLOFT for pediatric patients (6–17 years) with OCD. Patients not responding to an initial dose of 25 or 50 mg/day may benefit from dose increases up to a maximum of 200 mg/day. For children with OCD, their generally lower body weights compared to adults should be taken into consideration in advancing the dose, in order to avoid excess dosing. Given the 24 hour elimination half-life of ZOLOFT, dose changes should not occur at intervals of less than 1 week.
ZOLOFT should be administered once daily, either in the morning or evening.
维护/延续/扩展治疗Major Depressive DisorderIt is generally agreed that acute episodes of major depressive disorder require several months or longer of sustained pharmacologic therapy beyond response to the acute episode. Systematic evaluation of ZOLOFT has demonstrated that its antidepressant efficacy is maintained for periods of up to 44 weeks following 8 weeks of initial treatment at a dose of 50–200 mg/day (mean dose of 70 mg/day) (see Clinical Trials under CLINICAL PHARMACOLOGY). It is not known whether the dose of ZOLOFT needed for maintenance treatment is identical to the dose needed to achieve an initial response. Patients should be periodically reassessed to determine the need for maintenance treatment.
Posttraumatic Stress Disorder普遍认为,PTSD需要几个月或更长时间的持续药理治疗,而不是对初始治疗的反应。对Zoloft的系统评估表明,在24周治疗后,其在PTSD中的功效在50-200 mg/天的治疗后保持了28周(请参阅临床药理学下的临床试验)。尚不清楚维持治疗所需的Zoloft剂量是否与实现初始反应所需的剂量相同。应定期重新评估患者,以确定需要进行维持治疗。
Social Anxiety DisorderSocial anxiety disorder is a chronic condition that may require several months or longer of sustained pharmacological therapy beyond response to initial treatment. Systematic evaluation of ZOLOFT has demonstrated that its efficacy in social anxiety disorder is maintained for periods of up to 24 weeks following 20 weeks of treatment at a dose of 50–200 mg/day (see Clinical Trials under CLINICAL PHARMACOLOGY). Dosage adjustments should be made to maintain patients on the lowest effective dose and patients should be periodically reassessed to determine the need for long-term treatment.
强迫症和恐慌症It is generally agreed that OCD and Panic Disorder require several months or longer of sustained pharmacological therapy beyond response to initial treatment. Systematic evaluation of continuing ZOLOFT for periods of up to 28 weeks in patients with OCD and Panic Disorder who have responded while taking ZOLOFT during initial treatment phases of 24 to 52 weeks of treatment at a dose range of 50–200 mg/day has demonstrated a benefit of such maintenance treatment (see Clinical Trials under CLINICAL PHARMACOLOGY). It is not known whether the dose of ZOLOFT needed for maintenance treatment is identical to the dose needed to achieve an initial response. Nevertheless, patients should be periodically reassessed to determine the need for maintenance treatment.
Premenstrual Dysphoric DisorderZoloft在长期使用中的有效性,即对于超过3个月经周期,在对照试验中尚未系统地评估。但是,由于女性通常报告症状会随着年龄的增长而恶化,直到更年期开始时,考虑到继续反应的患者是合理的。剂量调整可能包括剂量方案之间的变化(例如,在月经周期的黄体阶段,每天在月经周期中每天)可能需要定期将患者维持最低的剂量,并应定期重新确定患者的患者以确定患者。需要继续治疗。
切换患者往返单胺氧化酶抑制剂At least 14 days should elapse between discontinuation of an MAOI and initiation of therapy with ZOLOFT. In addition, at least 14 days should be allowed after stopping ZOLOFT before starting an MAOI (see CONTRAINDICATIONS and WARNINGS).
Special PopulationsDosage for Hepatically Impaired PatientsThe use of sertraline in patients with liver disease should be approached with caution. The effects of sertraline in patients with moderate and severe hepatic impairment have not been studied. If sertraline is administered to patients with liver impairment, a lower or less frequent dose should be used (see CLINICAL PHARMACOLOGY and PRECAUTIONS).
Treatment of Pregnant Women During the Third TrimesterNeonates exposed to ZOLOFT and other SSRIs or SNRIs, late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding (see PRECAUTIONS). When treating pregnant women with ZOLOFT during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. The physician may consider tapering ZOLOFT in the third trimester.
和左洛复中止治疗Symptoms associated with discontinuation of ZOLOFT and other SSRIs and SNRIs, have been reported (see PRECAUTIONS). Patients should be monitored for these symptoms when discontinuing treatment. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate.
ZOLOFT Oral ConcentrateZoloft口服浓缩物含有20 mg/ml的舍曲林(作为盐酸盐)作为活性成分和12%的酒精。Zoloft口服浓缩液必须在使用前稀释。在服用之前,请使用提供的滴管来清除所需量的Zoloft口服浓缩液,并与4盎司(1/2杯)水,姜汁啤酒,柠檬/柠檬汽水,柠檬水,柠檬水或橙汁混合。不要将Zoloft口服浓缩液与列出的液体之外的任何东西混合。混合后应立即服用剂量。不要提前混合。有时,混合后可能会出现轻微的阴霾。这是正常的。请注意,由于滴管分配器含有干燥的天然橡胶,因此应谨慎对待乳胶敏感性。
Zoloft口服浓缩物因浓缩物的酒精含量而被Antabuse(Disulfiram)禁用。
-
Cardinal Health
Zoloft | Cardinal Health
Initial Treatment Dosage for Adults Major Depressive Disorder and Obsessive-Compulsive DisorderZoloft治疗应每天以50 mg的剂量给药。
Panic Disorder, Posttraumatic Stress Disorder and Social Anxiety DisorderZOLOFT treatment should be initiated with a dose of 25 mg once daily. After one week, the dose should be increased to 50 mg once daily.
尽管尚未建立针对重度抑郁症,强迫症,恐慌症,PTSD或社交焦虑症之间的剂量和作用之间的关系,但在临床试验中,患者的剂量为50-200 mg/天,这证明了Zoloft对Zoloft for Zoloft的有效性这些适应症的处理。因此,建议每天服用一次50毫克,作为初始治疗剂量。对50 mg剂量反应的患者可能会从剂量增加到最多200 mg/天的剂量增加。考虑到Zoloft的24小时消除半衰期,不应以少于1周的时间进行剂量变化。
Premenstrual Dysphoric DisorderZOLOFT treatment should be initiated with a dose of 50 mg/day, either daily throughout the menstrual cycle or limited to the luteal phase of the menstrual cycle, depending on physician assessment.
尽管尚未建立PMDD剂量和作用之间的关系,但在每个新月经周期开始时,患者的剂量为50-150 mg/天,剂量增加(请参阅临床药理学下的临床试验)。在整个月经周期中每天给药时,每天给药时,未反应50 mg/天剂量的患者可能会受益于150毫克/天的剂量增加(以50 mg的增量/月经周期)受益,或者在100 mg/day的剂量时,或在剂量/天的时间/天。月经周期。如果已经建立了100 mg/天的剂量,则使用黄体期给药,则在每个黄体剂量期开始时应使用50 mg/天的滴定步骤三天。
ZOLOFT should be administered once daily, either in the morning or evening.
小儿种群(儿童和青少年)强迫症的剂量ZOLOFT treatment should be initiated with a dose of 25 mg once daily in children (ages 6–12) and at a dose of 50 mg once daily in adolescents (ages 13–17).
While a relationship between dose and effect has not been established for OCD, patients were dosed in a range of 25–200 mg/day in the clinical trials demonstrating the effectiveness of ZOLOFT for pediatric patients (6–17 years) with OCD. Patients not responding to an initial dose of 25 or 50 mg/day may benefit from dose increases up to a maximum of 200 mg/day. For children with OCD, their generally lower body weights compared to adults should be taken into consideration in advancing the dose, in order to avoid excess dosing. Given the 24 hour elimination half-life of ZOLOFT, dose changes should not occur at intervals of less than 1 week.
ZOLOFT should be administered once daily, either in the morning or evening.
维护/延续/扩展治疗重大抑郁症It is generally agreed that acute episodes of major depressive disorder require several months or longer of sustained pharmacologic therapy beyond response to the acute episode. Systematic evaluation of ZOLOFT has demonstrated that its antidepressant efficacy is maintained for periods of up to 44 weeks following 8 weeks of initial treatment at a dose of 50–200 mg/day (mean dose of 70 mg/day) (see Clinical Trials under CLINICAL PHARMACOLOGY). It is not known whether the dose of ZOLOFT needed for maintenance treatment is identical to the dose needed to achieve an initial response. Patients should be periodically reassessed to determine the need for maintenance treatment.
Posttraumatic Stress Disorder普遍认为,PTSD需要几个月或更长时间的持续药理治疗,而不是对初始治疗的反应。对Zoloft的系统评估表明,在24周治疗后,其在PTSD中的功效在50-200 mg/天的治疗后保持了28周(请参阅临床药理学下的临床试验)。尚不清楚维持治疗所需的Zoloft剂量是否与实现初始反应所需的剂量相同。应定期重新评估患者,以确定需要进行维持治疗。
Social Anxiety DisorderSocial anxiety disorder is a chronic condition that may require several months or longer of sustained pharmacological therapy beyond response to initial treatment. Systematic evaluation of ZOLOFT has demonstrated that its efficacy in social anxiety disorder is maintained for periods of up to 24 weeks following 20 weeks of treatment at a dose of 50–200 mg/day (see Clinical Trials under CLINICAL PHARMACOLOGY). Dosage adjustments should be made to maintain patients on the lowest effective dose and patients should be periodically reassessed to determine the need for long-term treatment.
强迫症和恐慌症It is generally agreed that OCD and Panic Disorder require several months or longer of sustained pharmacological therapy beyond response to initial treatment. Systematic evaluation of continuing ZOLOFT for periods of up to 28 weeks in patients with OCD and Panic Disorder who have responded while taking ZOLOFT during initial treatment phases of 24 to 52 weeks of treatment at a dose range of 50–200 mg/day has demonstrated a benefit of such maintenance treatment (see Clinical Trials under CLINICAL PHARMACOLOGY). It is not known whether the dose of ZOLOFT needed for maintenance treatment is identical to the dose needed to achieve an initial response. Nevertheless, patients should be periodically reassessed to determine the need for maintenance treatment.
Premenstrual Dysphoric DisorderZoloft在长期使用中的有效性,即对于超过3个月经周期,在对照试验中尚未系统地评估。但是,由于女性通常报告症状会随着年龄的增长而恶化,直到更年期开始时,考虑到继续反应的患者是合理的。剂量调整可能包括剂量方案之间的变化(例如,在月经周期的黄体阶段,每天在月经周期中每天)可能需要定期将患者维持最低的剂量,并应定期重新确定患者的患者以确定患者。需要继续治疗。
切换患者往返单胺氧化酶抑制剂At least 14 days should elapse between discontinuation of an MAOI and initiation of therapy with ZOLOFT. In addition, at least 14 days should be allowed after stopping ZOLOFT before starting an MAOI (see CONTRAINDICATIONS and WARNINGS).
特殊人群剂量用于肝损害患者The use of sertraline in patients with liver disease should be approached with caution. The effects of sertraline in patients with moderate and severe hepatic impairment have not been studied. If sertraline is administered to patients with liver impairment, a lower or less frequent dose should be used (see CLINICAL PHARMACOLOGY and PRECAUTIONS).
Treatment of Pregnant Women During the Third TrimesterNeonates exposed to ZOLOFT and other SSRIs or SNRIs, late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding (see PRECAUTIONS). When treating pregnant women with ZOLOFT during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. The physician may consider tapering ZOLOFT in the third trimester.
和左洛复中止治疗Symptoms associated with discontinuation of ZOLOFT and other SSRIs and SNRIs, have been reported (see PRECAUTIONS). Patients should be monitored for these symptoms when discontinuing treatment. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate.
ZOLOFT Oral ConcentrateZoloft口服浓缩物含有20 mg/ml的舍曲林(作为盐酸盐)作为活性成分和12%的酒精。Zoloft口服浓缩液必须在使用前稀释。在服用之前,请使用提供的滴管来清除所需量的Zoloft口服浓缩液,并与4盎司(1/2杯)水,姜汁啤酒,柠檬/柠檬汽水,柠檬水,柠檬水或橙汁混合。不要将Zoloft口服浓缩液与列出的液体之外的任何东西混合。混合后应立即服用剂量。不要提前混合。有时,混合后可能会出现轻微的阴霾。这是正常的。请注意,由于滴管分配器含有干燥的天然橡胶,因此应谨慎对待乳胶敏感性。
Zoloft口服浓缩物因浓缩物的酒精含量而被Antabuse(Disulfiram)禁用。
-
Remedyrepack Inc.
Zoloft | Remedyrepack Inc.
Zoloft治疗应每天以50 mg的剂量给药。
ZOLOFT treatment should be initiated with a dose of 25 mg once daily. After one week, the dose should be increased to 50 mg once daily.
尽管尚未建立针对重度抑郁症,强迫症,恐慌症,PTSD或社交焦虑症之间的剂量和作用之间的关系,但在临床试验中,患者的剂量为50-200 mg/天,这证明了Zoloft对Zoloft for Zoloft的有效性这些适应症的处理。因此,建议每天服用一次50毫克,作为初始治疗剂量。对50 mg剂量反应的患者可能会从剂量增加到最多200 mg/天的剂量增加。考虑到Zoloft的24小时消除半衰期,不应以少于1周的时间进行剂量变化。
ZOLOFT treatment should be initiated with a dose of 50 mg/day, either daily throughout the menstrual cycle or limited to the luteal phase of the menstrual cycle, depending on physician assessment.
尽管尚未建立PMDD剂量和作用之间的关系,但在每个新月经周期开始时,患者的剂量为50-150 mg/天,剂量增加(请参阅临床药理学下的临床试验)。在整个月经周期中每天给药时,每天给药时,未反应50 mg/天剂量的患者可能会受益于150毫克/天的剂量增加(以50 mg的增量/月经周期)受益,或者在100 mg/day的剂量时,或在剂量/天的时间/天。月经周期。如果已经建立了100 mg/天的剂量,则使用黄体期给药,则在每个黄体剂量期开始时应使用50 mg/天的滴定步骤三天。
ZOLOFT should be administered once daily, either in the morning or evening.
ZOLOFT treatment should be initiated with a dose of 25 mg once daily in children (ages 6–12) and at a dose of 50 mg once daily in adolescents (ages 13–17).
While a relationship between dose and effect has not been established for OCD, patients were dosed in a range of 25–200 mg/day in the clinical trials demonstrating the effectiveness of ZOLOFT for pediatric patients (6–17 years) with OCD. Patients not responding to an initial dose of 25 or 50 mg/day may benefit from dose increases up to a maximum of 200 mg/day. For children with OCD, their generally lower body weights compared to adults should be taken into consideration in advancing the dose, in order to avoid excess dosing. Given the 24 hour elimination half-life of ZOLOFT, dose changes should not occur at intervals of less than 1 week.
ZOLOFT should be administered once daily, either in the morning or evening.
It is generally agreed that acute episodes of major depressive disorder require several months or longer of sustained pharmacologic therapy beyond response to the acute episode. Systematic evaluation of ZOLOFT has demonstrated that its antidepressant efficacy is maintained for periods of up to 44 weeks following 8 weeks of initial treatment at a dose of 50–200 mg/day (mean dose of 70 mg/day) (see Clinical Trials under CLINICAL PHARMACOLOGY). It is not known whether the dose of ZOLOFT needed for maintenance treatment is identical to the dose needed to achieve an initial response. Patients should be periodically reassessed to determine the need for maintenance treatment.
普遍认为,PTSD需要几个月或更长时间的持续药理治疗,而不是对初始治疗的反应。对Zoloft的系统评估表明,在24周治疗后,其在PTSD中的功效在50-200 mg/天的治疗后保持了28周(请参阅临床药理学下的临床试验)。尚不清楚维持治疗所需的Zoloft剂量是否与实现初始反应所需的剂量相同。应定期重新评估患者,以确定需要进行维持治疗。
Social anxiety disorder is a chronic condition that may require several months or longer of sustained pharmacological therapy beyond response to initial treatment. Systematic evaluation of ZOLOFT has demonstrated that its efficacy in social anxiety disorder is maintained for periods of up to 24 weeks following 20 weeks of treatment at a dose of 50–200 mg/day (see Clinical Trials under CLINICAL PHARMACOLOGY). Dosage adjustments should be made to maintain patients on the lowest effective dose and patients should be periodically reassessed to determine the need for long-term treatment.
It is generally agreed that OCD and Panic Disorder require several months or longer of sustained pharmacological therapy beyond response to initial treatment. Systematic evaluation of continuing ZOLOFT for periods of up to 28 weeks in patients with OCD and Panic Disorder who have responded while taking ZOLOFT during initial treatment phases of 24 to 52 weeks of treatment at a dose range of 50–200 mg/day has demonstrated a benefit of such maintenance treatment (see Clinical Trials under CLINICAL PHARMACOLOGY). It is not known whether the dose of ZOLOFT needed for maintenance treatment is identical to the dose needed to achieve an initial response. Nevertheless, patients should be periodically reassessed to determine the need for maintenance treatment.
Zoloft在长期使用中的有效性,即对于超过3个月经周期,在对照试验中尚未系统地评估。但是,由于女性通常报告症状会随着年龄的增长而恶化,直到更年期开始时,考虑到继续反应的患者是合理的。剂量调整可能包括剂量方案之间的变化(例如,在月经周期的黄体阶段,每天在月经周期中每天)可能需要定期将患者维持最低的剂量,并应定期重新确定患者的患者以确定患者。需要继续治疗。
至少14天应该在旨在治疗精神疾病的MAOI的停用与Zoloft治疗的开始之间。相反,在启动旨在治疗精神疾病的MAOI之前停止Zoloft后,至少应允许14天(请参阅禁忌症)。
Do not start ZOLOFT in a patient who is being treated with linezolid or intravenous methylene blue because there is increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered (see CONTRAINDICATIONS).
In some cases, a patient already receiving ZOLOFT therapy may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, ZOLOFT should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for 2 weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with ZOLOFT may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue (see WARNINGS).
The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with ZOLOFT is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use (see WARNINGS).
The use of sertraline in patients with liver disease should be approached with caution. The effects of sertraline in patients with moderate and severe hepatic impairment have not been studied. If sertraline is administered to patients with liver impairment, a lower or less frequent dose should be used (see CLINICAL PHARMACOLOGY and PRECAUTIONS).
Neonates exposed to ZOLOFT and other SSRIs or SNRIs, late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding (see PRECAUTIONS). When treating pregnant women with ZOLOFT during the third trimester, the physician should carefully consider the potential risks and benefits of treatment.
Symptoms associated with discontinuation of ZOLOFT and other SSRIs and SNRIs, have been reported (see PRECAUTIONS). Patients should be monitored for these symptoms when discontinuing treatment. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate.
Zoloft口服浓缩物含有20 mg/ml的舍曲林(作为盐酸盐)作为活性成分和12%的酒精。Zoloft口服浓缩液必须在使用前稀释。在服用之前,请使用提供的滴管来清除所需量的Zoloft口服浓缩液,并与4盎司(1/2杯)水,姜汁啤酒,柠檬/柠檬汽水,柠檬水,柠檬水或橙汁混合。不要将Zoloft口服浓缩液与列出的液体之外的任何东西混合。混合后应立即服用剂量。不要提前混合。有时,混合后可能会出现轻微的阴霾。这是正常的。请注意,由于滴管分配器含有干燥的天然橡胶,因此应谨慎对待乳胶敏感性。
Zoloft口服浓缩物因浓缩物的酒精含量而被Antabuse(Disulfiram)禁用。
-
Aphena Pharma Solutions - 田纳西州有限责任公司
Zoloft | Aphena Pharma Solutions - Tennessee, Llc
Initial Treatment Dosage for Adults Major Depressive Disorder and Obsessive-Compulsive DisorderZoloft治疗应每天以50 mg的剂量给药。
Panic Disorder, Posttraumatic Stress Disorder and Social Anxiety DisorderZOLOFT treatment should be initiated with a dose of 25 mg once daily. After one week, the dose should be increased to 50 mg once daily.
尽管尚未建立针对重度抑郁症,强迫症,恐慌症,PTSD或社交焦虑症之间的剂量和作用之间的关系,但在临床试验中,患者的剂量为50-200 mg/天,这证明了Zoloft对Zoloft for Zoloft的有效性这些适应症的处理。因此,建议每天服用一次50毫克,作为初始治疗剂量。对50 mg剂量反应的患者可能会从剂量增加到最多200 mg/天的剂量增加。考虑到Zoloft的24小时消除半衰期,不应以少于1周的时间进行剂量变化。
Premenstrual Dysphoric DisorderZOLOFT treatment should be initiated with a dose of 50 mg/day, either daily throughout the menstrual cycle or limited to the luteal phase of the menstrual cycle, depending on physician assessment.
尽管尚未建立PMDD剂量和作用之间的关系,但在每个新月经周期开始时,患者的剂量为50-150 mg/天,剂量增加(请参阅临床药理学下的临床试验)。在整个月经周期中每天给药时,每天给药时,未反应50 mg/天剂量的患者可能会受益于150毫克/天的剂量增加(以50 mg的增量/月经周期)受益,或者在100 mg/day的剂量时,或在剂量/天的时间/天。月经周期。如果已经建立了100 mg/天的剂量,则使用黄体期给药,则在每个黄体剂量期开始时应使用50 mg/天的滴定步骤三天。
ZOLOFT should be administered once daily, either in the morning or evening.
小儿种群(儿童和青少年)强迫症的剂量ZOLOFT treatment should be initiated with a dose of 25 mg once daily in children (ages 6–12) and at a dose of 50 mg once daily in adolescents (ages 13–17).
While a relationship between dose and effect has not been established for OCD, patients were dosed in a range of 25–200 mg/day in the clinical trials demonstrating the effectiveness of ZOLOFT for pediatric patients (6–17 years) with OCD. Patients not responding to an initial dose of 25 or 50 mg/day may benefit from dose increases up to a maximum of 200 mg/day. For children with OCD, their generally lower body weights compared to adults should be taken into consideration in advancing the dose, in order to avoid excess dosing. Given the 24 hour elimination half-life of ZOLOFT, dose changes should not occur at intervals of less than 1 week.
ZOLOFT should be administered once daily, either in the morning or evening.
维护/延续/扩展治疗重大抑郁症It is generally agreed that acute episodes of major depressive disorder require several months or longer of sustained pharmacologic therapy beyond response to the acute episode. Systematic evaluation of ZOLOFT has demonstrated that its antidepressant efficacy is maintained for periods of up to 44 weeks following 8 weeks of initial treatment at a dose of 50–200 mg/day (mean dose of 70 mg/day) (see Clinical Trials under CLINICAL PHARMACOLOGY). It is not known whether the dose of ZOLOFT needed for maintenance treatment is identical to the dose needed to achieve an initial response. Patients should be periodically reassessed to determine the need for maintenance treatment.
Posttraumatic Stress Disorder普遍认为,PTSD需要几个月或更长时间的持续药理治疗,而不是对初始治疗的反应。对Zoloft的系统评估表明,在24周治疗后,其在PTSD中的功效在50-200 mg/天的治疗后保持了28周(请参阅临床药理学下的临床试验)。尚不清楚维持治疗所需的Zoloft剂量是否与实现初始反应所需的剂量相同。应定期重新评估患者,以确定需要进行维持治疗。
Social Anxiety DisorderSocial anxiety disorder is a chronic condition that may require several months or longer of sustained pharmacological therapy beyond response to initial treatment. Systematic evaluation of ZOLOFT has demonstrated that its efficacy in social anxiety disorder is maintained for periods of up to 24 weeks following 20 weeks of treatment at a dose of 50–200 mg/day (see Clinical Trials under CLINICAL PHARMACOLOGY). Dosage adjustments should be made to maintain patients on the lowest effective dose and patients should be periodically reassessed to determine the need for long-term treatment.
强迫症和恐慌症It is generally agreed that OCD and Panic Disorder require several months or longer of sustained pharmacological therapy beyond response to initial treatment. Systematic evaluation of continuing ZOLOFT for periods of up to 28 weeks in patients with OCD and Panic Disorder who have responded while taking ZOLOFT during initial treatment phases of 24 to 52 weeks of treatment at a dose range of 50–200 mg/day has demonstrated a benefit of such maintenance treatment (see Clinical Trials under CLINICAL PHARMACOLOGY). It is not known whether the dose of ZOLOFT needed for maintenance treatment is identical to the dose needed to achieve an initial response. Nevertheless, patients should be periodically reassessed to determine the need for maintenance treatment.
Premenstrual Dysphoric DisorderZoloft在长期使用中的有效性,即对于超过3个月经周期,在对照试验中尚未系统地评估。但是,由于女性通常报告症状会随着年龄的增长而恶化,直到更年期开始时,考虑到继续反应的患者是合理的。剂量调整可能包括剂量方案之间的变化(例如,在月经周期的黄体阶段,每天在月经周期中每天)可能需要定期将患者维持最低的剂量,并应定期重新确定患者的患者以确定患者。需要继续治疗。
Switching a Patient To or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders至少14天应该在旨在治疗精神疾病的MAOI的停用与Zoloft治疗的开始之间。相反,在启动旨在治疗精神疾病的MAOI之前停止Zoloft后,至少应允许14天(请参阅禁忌症)。
Use of ZOLOFT With Other MAOIs Such as Linezolid or Methylene BlueDo not start ZOLOFT in a patient who is being treated with linezolid or intravenous methylene blue because there is increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered (see CONTRAINDICATIONS).
In some cases, a patient already receiving ZOLOFT therapy may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, ZOLOFT should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for 2 weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with ZOLOFT may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue (see WARNINGS).
The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with ZOLOFT is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use (see WARNINGS).
特殊人群剂量用于肝损害患者The use of sertraline in patients with liver disease should be approached with caution. The effects of sertraline in patients with moderate and severe hepatic impairment have not been studied. If sertraline is administered to patients with liver impairment, a lower or less frequent dose should be used (see CLINICAL PHARMACOLOGY and PRECAUTIONS).
Treatment of Pregnant Women During the Third TrimesterNeonates exposed to ZOLOFT and other SSRIs or SNRIs, late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding (see PRECAUTIONS). When treating pregnant women with ZOLOFT during the third trimester, the physician should carefully consider the potential risks and benefits of treatment.
Zoloft停止治疗Symptoms associated with discontinuation of ZOLOFT and other SSRIs and SNRIs, have been reported (see PRECAUTIONS). Patients should be monitored for these symptoms when discontinuing treatment. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate.
ZOLOFT Oral ConcentrateZoloft口服浓缩物含有20 mg/ml的舍曲林(作为盐酸盐)作为活性成分和12%的酒精。Zoloft口服浓缩液必须在使用前稀释。在服用之前,请使用提供的滴管来清除所需量的Zoloft口服浓缩液,并与4盎司(1/2杯)水,姜汁啤酒,柠檬/柠檬汽水,柠檬水,柠檬水或橙汁混合。不要将Zoloft口服浓缩液与列出的液体之外的任何东西混合。混合后应立即服用剂量。不要提前混合。有时,混合后可能会出现轻微的阴霾。这是正常的。请注意,由于滴管分配器含有干燥的天然橡胶,因此应谨慎对待乳胶敏感性。
Zoloft口服浓缩物因浓缩物的酒精含量而被Antabuse(Disulfiram)禁用。
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Roerig
Zoloft | Roerig
Initial Treatment Dosage for Adults Major Depressive Disorder and Obsessive-Compulsive DisorderZoloft治疗应每天以50 mg的剂量给药。
Panic Disorder, Posttraumatic Stress Disorder and Social Anxiety DisorderZOLOFT treatment should be initiated with a dose of 25 mg once daily. After one week, the dose should be increased to 50 mg once daily.
尽管尚未建立针对重度抑郁症,强迫症,恐慌症,PTSD或社交焦虑症之间的剂量和作用之间的关系,但在临床试验中,患者的剂量为50-200 mg/天,这证明了Zoloft对Zoloft for Zoloft的有效性这些适应症的处理。因此,建议每天服用一次50毫克,作为初始治疗剂量。对50 mg剂量反应的患者可能会从剂量增加到最多200 mg/天的剂量增加。考虑到Zoloft的24小时消除半衰期,不应以少于1周的时间进行剂量变化。
Premenstrual Dysphoric DisorderZOLOFT treatment should be initiated with a dose of 50 mg/day, either daily throughout the menstrual cycle or limited to the luteal phase of the menstrual cycle, depending on physician assessment.
尽管尚未建立PMDD剂量和作用之间的关系,但在每个新月经周期开始时,患者的剂量为50-150 mg/天,剂量增加(请参阅临床药理学下的临床试验)。在整个月经周期中每天给药时,每天给药时,未反应50 mg/天剂量的患者可能会受益于150毫克/天的剂量增加(以50 mg的增量/月经周期)受益,或者在100 mg/day的剂量时,或在剂量/天的时间/天。月经周期。如果已经建立了100 mg/天的剂量,则使用黄体期给药,则在每个黄体剂量期开始时应使用50 mg/天的滴定步骤三天。
ZOLOFT should be administered once daily, either in the morning or evening.
小儿种群(儿童和青少年)强迫症的剂量ZOLOFT treatment should be initiated with a dose of 25 mg once daily in children (ages 6–12) and at a dose of 50 mg once daily in adolescents (ages 13–17).
While a relationship between dose and effect has not been established for OCD, patients were dosed in a range of 25–200 mg/day in the clinical trials demonstrating the effectiveness of ZOLOFT for pediatric patients (6–17 years) with OCD. Patients not responding to an initial dose of 25 or 50 mg/day may benefit from dose increases up to a maximum of 200 mg/day. For children with OCD, their generally lower body weights compared to adults should be taken into consideration in advancing the dose, in order to avoid excess dosing. Given the 24 hour elimination half-life of ZOLOFT, dose changes should not occur at intervals of less than 1 week.
ZOLOFT should be administered once daily, either in the morning or evening.
维护/延续/扩展治疗重大抑郁症It is generally agreed that acute episodes of major depressive disorder require several months or longer of sustained pharmacologic therapy beyond response to the acute episode. Systematic evaluation of ZOLOFT has demonstrated that its antidepressant efficacy is maintained for periods of up to 44 weeks following 8 weeks of initial treatment at a dose of 50–200 mg/day (mean dose of 70 mg/day) (see Clinical Trials under CLINICAL PHARMACOLOGY). It is not known whether the dose of ZOLOFT needed for maintenance treatment is identical to the dose needed to achieve an initial response. Patients should be periodically reassessed to determine the need for maintenance treatment.
Posttraumatic Stress Disorder普遍认为,PTSD需要几个月或更长时间的持续药理治疗,而不是对初始治疗的反应。对Zoloft的系统评估表明,在24周治疗后,其在PTSD中的功效在50-200 mg/天的治疗后保持了28周(请参阅临床药理学下的临床试验)。尚不清楚维持治疗所需的Zoloft剂量是否与实现初始反应所需的剂量相同。应定期重新评估患者,以确定需要进行维持治疗。
Social Anxiety DisorderSocial anxiety disorder is a chronic condition that may require several months or longer of sustained pharmacological therapy beyond response to initial treatment. Systematic evaluation of ZOLOFT has demonstrated that its efficacy in social anxiety disorder is maintained for periods of up to 24 weeks following 20 weeks of treatment at a dose of 50–200 mg/day (see Clinical Trials under CLINICAL PHARMACOLOGY). Dosage adjustments should be made to maintain patients on the lowest effective dose and patients should be periodically reassessed to determine the need for long-term treatment.
强迫症和恐慌症It is generally agreed that OCD and Panic Disorder require several months or longer of sustained pharmacological therapy beyond response to initial treatment. Systematic evaluation of continuing ZOLOFT for periods of up to 28 weeks in patients with OCD and Panic Disorder who have responded while taking ZOLOFT during initial treatment phases of 24 to 52 weeks of treatment at a dose range of 50–200 mg/day has demonstrated a benefit of such maintenance treatment (see Clinical Trials under CLINICAL PHARMACOLOGY). It is not known whether the dose of ZOLOFT needed for maintenance treatment is identical to the dose needed to achieve an initial response. Nevertheless, patients should be periodically reassessed to determine the need for maintenance treatment.
Premenstrual Dysphoric DisorderZoloft在长期使用中的有效性,即对于超过3个月经周期,在对照试验中尚未系统地评估。但是,由于女性通常报告症状会随着年龄的增长而恶化,直到更年期开始时,考虑到继续反应的患者是合理的。剂量调整可能包括剂量方案之间的变化(例如,在月经周期的黄体阶段,每天在月经周期中每天)可能需要定期将患者维持最低的剂量,并应定期重新确定患者的患者以确定患者。需要继续治疗。
Switching a Patient To or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders至少14天应该在旨在治疗精神疾病的MAOI的停用与Zoloft治疗的开始之间。相反,在启动旨在治疗精神疾病的MAOI之前停止Zoloft后,至少应允许14天(请参阅禁忌症)。
Use of ZOLOFT With Other MAOIs Such as Linezolid or Methylene BlueDo not start ZOLOFT in a patient who is being treated with linezolid or intravenous methylene blue because there is increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered (see CONTRAINDICATIONS).
In some cases, a patient already receiving ZOLOFT therapy may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, ZOLOFT should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for 2 weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with ZOLOFT may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue (see WARNINGS).
The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with ZOLOFT is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use (see WARNINGS).
特殊人群剂量用于肝损害患者The use of sertraline in patients with liver disease should be approached with caution. The effects of sertraline in patients with moderate and severe hepatic impairment have not been studied. If sertraline is administered to patients with liver impairment, a lower or less frequent dose should be used (see CLINICAL PHARMACOLOGY and PRECAUTIONS).
Treatment of Pregnant Women During the Third TrimesterNeonates exposed to ZOLOFT and other SSRIs or SNRIs, late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding (see PRECAUTIONS). When treating pregnant women with ZOLOFT during the third trimester, the physician should carefully consider the potential risks and benefits of treatment.
Zoloft停止治疗Symptoms associated with discontinuation of ZOLOFT and other SSRIs and SNRIs, have been reported (see PRECAUTIONS). Patients should be monitored for these symptoms when discontinuing treatment. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate.
ZOLOFT Oral ConcentrateZoloft口服浓缩物含有20 mg/ml的舍曲林(作为盐酸盐)作为活性成分和12%的酒精。Zoloft口服浓缩液必须在使用前稀释。在服用之前,请使用提供的滴管来清除所需量的Zoloft口服浓缩液,并与4盎司(1/2杯)水,姜汁啤酒,柠檬/柠檬汽水,柠檬水,柠檬水或橙汁混合。不要将Zoloft口服浓缩液与列出的液体之外的任何东西混合。混合后应立即服用剂量。不要提前混合。有时,混合后可能会出现轻微的阴霾。这是正常的。请注意,由于滴管分配器含有干燥的天然橡胶,因此应谨慎对待乳胶敏感性。
Zoloft口服浓缩物因浓缩物的酒精含量而被Antabuse(Disulfiram)禁用。
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