Pristiq Extended-release

Pristiq扩展释放制造商

• PD-RX Pharmaceuticals，Inc。
  

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  pristiq扩展释放|PD-RX Pharmaceuticals，Inc。

  

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  2。1Initial Treatment of Major Depressive Disorder

  Pristiq的建议剂量每天每天一次，有或没有食物。

  In clinical studies, doses of 50-400 mg/day were shown to be effective, although no additional benefit was demonstrated at doses greater than 50 mg/day and adverse events and discontinuations were more frequent at higher doses.

  停用治疗时，建议尽可能减少逐渐减少剂量以最大程度地减少停用症状[请参阅剂量和给药（2.4）以及警告和预防措施（5.9）]。

  pristiq应在每天大约同一时间进行。必须用液体吞咽平板电脑，并且不会分裂，压碎，咀嚼或溶解。

  2.2特殊人口三个月的孕妇

  Neonates exposed to SNRIs or SSRIs late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding [see Use in Specific Populations (8.1)]. When treating pregnant women with PRISTIQ during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. The physician may consider tapering PRISTIQ in the third trimester.

  Patients with renal impairment

  轻度肾脏损伤患者无需调整剂量（24 −小时CRCL = 50-80 mL/min）。

  The recommended dose in patients with moderate renal impairment (24‑hr CrCl = 30‑50 mL/min) is 50 mg per day. The recommended dose in patients with severe renal impairment (24-hr CrCl < 30 mL/min) or end-stage renal disease (ESRD) is 50 mg every other day. Supplemental doses should not be given to patients after dialysis. The doses should not be escalated in patients with moderate or severe renal impairment, or ESRD [see Warnings and Precautions (5.10), Use in Specific Populations (8.6) and Clinical Pharmacology (12.6)].

  肝损伤的患者

  肝损伤患者的建议剂量为50 mg/天。不建议使用剂量升级以上/天以上[参见临床药理学（12.6）]。

  老年患者

  No dosage adjustment is required solely on the basis of age; however, the possibility of reduced renal clearance of PRISTIQ should be considered when determining the dose [see Use in Specific Populations (8.5) and Clinical Pharmacology (12.6)].

  2。3Maintenance/Continuation/Extended Treatment

  人们普遍认为，重度抑郁症的急性发作需要持续的药物治疗几个月或更长时间。但是，尚未研究Pristiq以50 mg/天的长期疗效，在短期，对照研究中有效。应定期重新评估患者，以确定继续治疗的需求。

  2。4Discontinuing PRISTIQ

  症状与PRISTI中止有关Q, other SNRIs and SSRIs have been reported [see Warnings and Precautions (5.9)]. 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.

  2.5将患者从其他抗抑郁药切换为pristiq

  在将患者从包括文拉法辛在内的其他抗抑郁药切换到pristiq时，已经报告了停用症状。Tapering of the initial antidepressant may be necessary to minimize discontinuation symptoms [see Contraindications (4.2)].

  2。6Switching Patients To or From a Monoamine Oxidase Inhibitor (MAOI)

  At least 14 days must elapse between discontinuation of an MAOI and initiation of therapy with PRISTIQ. In addition, at least 7 days must be allowed after stopping PRISTIQ before starting an MAOI [see Contraindications (4.2)].

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• Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
  

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  pristiq扩展释放|Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc

  

  ---

  2。1Initial Treatment of Major Depressive Disorder

  Pristiq的建议剂量每天每天一次，有或没有食物。

  In clinical studies, doses of 50-400 mg/day were shown to be effective, although no additional benefit was demonstrated at doses greater than 50 mg/day and adverse events and discontinuations were more frequent at higher doses.

  停用治疗时，建议尽可能减少逐渐减少剂量以最大程度地减少停用症状[请参阅剂量和给药（2.4）以及警告和预防措施（5.9）]。

  pristiq应在每天大约同一时间进行。必须用液体吞咽平板电脑，并且不会分裂，压碎，咀嚼或溶解。

  2.2特殊人口三个月的孕妇

  Neonates exposed to SNRIs or SSRIs late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding [see Use in Specific Populations (8.1)]. When treating pregnant women with PRISTIQ during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. The physician may consider tapering PRISTIQ in the third trimester.

  Patients with renal impairment

  轻度肾脏损伤患者无需调整剂量（24 −小时CRCL = 50-80 mL/min）。

  The recommended dose in patients with moderate renal impairment (24‑hr CrCl = 30‑50 mL/min) is 50 mg per day. The recommended dose in patients with severe renal impairment (24-hr CrCl < 30 mL/min) or end-stage renal disease (ESRD) is 50 mg every other day. Supplemental doses should not be given to patients after dialysis. The doses should not be escalated in patients with moderate or severe renal impairment, or ESRD [see Warnings and Precautions (5.10), Use in Specific Populations (8.6) and Clinical Pharmacology (12.6)].

  肝损伤的患者

  肝损伤患者的建议剂量为50 mg/天。不建议使用剂量升级以上/天以上[参见临床药理学（12.6）]。

  老年患者

  No dosage adjustment is required solely on the basis of age; however, the possibility of reduced renal clearance of PRISTIQ should be considered when determining the dose [see Use in Specific Populations (8.5) and Clinical Pharmacology (12.6)].

  2。3Maintenance/Continuation/Extended Treatment

  人们普遍认为，重度抑郁症的急性发作需要持续的药物治疗几个月或更长时间。但是，尚未研究Pristiq以50 mg/天的长期疗效，在短期，对照研究中有效。应定期重新评估患者，以确定继续治疗的需求。

  2。4Discontinuing PRISTIQ

  症状与PRISTI中止有关Q, other SNRIs and SSRIs have been reported [see Warnings and Precautions (5.9)]. 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.

  2.5将患者从其他抗抑郁药切换为pristiq

  在将患者从包括文拉法辛在内的其他抗抑郁药切换到pristiq时，已经报告了停用症状。Tapering of the initial antidepressant may be necessary to minimize discontinuation symptoms [see Contraindications (4.2)].

  2。6Switching Patients To or From a Monoamine Oxidase Inhibitor (MAOI)

  At least 14 days must elapse between discontinuation of an MAOI and initiation of therapy with PRISTIQ. In addition, at least 7 days must be allowed after stopping PRISTIQ before starting an MAOI [see Contraindications (4.2)].

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• 医师Care，Inc。
  

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  pristiq扩展释放|医师Care，Inc。

  

  ---

  2。1Initial Treatment of Major Depressive Disorder

  Pristiq的建议剂量每天每天一次，有或没有食物。

  In clinical studies, doses of 50-400 mg/day were shown to be effective, although no additional benefit was demonstrated at doses greater than 50 mg/day and adverse events and discontinuations were more frequent at higher doses.

  停用治疗时，建议尽可能减少逐渐减少剂量以最大程度地减少停用症状[请参阅剂量和给药（2.4）以及警告和预防措施（5.9）]。

  pristiq应在每天大约同一时间进行。必须用液体吞咽平板电脑，并且不会分裂，压碎，咀嚼或溶解。

  2.2特殊人口三个月的孕妇

  Neonates exposed to SNRIs or SSRIs late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding [see Use in Specific Populations (8.1)]. When treating pregnant women with PRISTIQ during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. The physician may consider tapering PRISTIQ in the third trimester.

  Patients with renal impairment

  No dosage adjustment is necessary in patients with mild renal impairment (24-hr CrCl = 50-80 mL/min).

  The recommended dose in patients with moderate renal impairment (24-hr CrCl = 30-50 mL/min) is 50 mg per day. The recommended dose in patients with severe renal impairment (24-hr CrCl < 30 mL/min) or end-stage renal disease (ESRD) is 50 mg every other day. Supplemental doses should not be given to patients after dialysis. The doses should not be escalated in patients with moderate or severe renal impairment, or ESRD [see Warnings and Precautions (5.10), Use in Specific Populations (8.6) and Clinical Pharmacology (12.6)].

  肝损伤的患者

  肝损伤患者的建议剂量为50 mg/天。不建议使用剂量升级以上/天以上[参见临床药理学（12.6）]。

  老年患者

  No dosage adjustment is required solely on the basis of age; however, the possibility of reduced renal clearance of PRISTIQ should be considered when determining the dose [see Use in Specific Populations (8.5) and Clinical Pharmacology (12.6)].

  2。3Maintenance/Continuation/Extended Treatment

  人们普遍认为，重度抑郁症的急性发作需要持续的药物治疗几个月或更长时间。但是，尚未研究Pristiq以50 mg/天的长期疗效，在短期，对照研究中有效。应定期重新评估患者，以确定继续治疗的需求。

  2。4Discontinuing PRISTIQ

  症状与PRISTI中止有关Q, other SNRIs and SSRIs have been reported [see Warnings and Precautions (5.9)]. 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.

  2.5将患者从其他抗抑郁药切换为pristiq

  在将患者从包括文拉法辛在内的其他抗抑郁药切换到pristiq时，已经报告了停用症状。Tapering of the initial antidepressant may be necessary to minimize discontinuation symptoms [see Contraindications (4.2)].

  2。6Switching Patients To or From a Monoamine Oxidase Inhibitor (MAOI)

  At least 14 days must elapse between discontinuation of an MAOI and initiation of therapy with PRISTIQ. In addition, at least 7 days must be allowed after stopping PRISTIQ before starting an MAOI [see Contraindications (4.2)].

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• 红衣主教健康
  

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  pristiq扩展释放|红衣主教健康

  

  ---

  2.1通用说明

  Pristiq的建议剂量每天每天一次，有或没有食物。50毫克剂量既是起始剂量，又是治疗剂量。pristiq应在每天大约同一时间进行。必须用液体吞咽平板电脑，并且不会分裂，压碎，咀嚼或溶解。

  In clinical studies, doses of 10 mg to 400 mg per day were studied. In clinical studies, doses of 50 mg to 400 mg per day were shown to be effective, although no additional benefit was demonstrated at doses greater than 50 mg per day and adverse reactions and discontinuations were more frequent at higher doses.

  The 25 mg per day dose is intended for a gradual reduction in dose when discontinuing treatment. When discontinuing therapy, gradual dose reduction is recommended whenever possible to minimize discontinuation symptoms [see Dosage and Administration (2.4) and Warnings and Precautions (5.9)].

  2。2Special Populations

  Patients with renal impairment

  The maximum recommended dose in patients with moderate renal impairment (24-hr creatinine clearance [CrCl] = 30 to 50 mL/min, Cockcroft-Gault [C-G]) is 50 mg per day. The maximum recommended dose in patients with severe renal impairment (24-hr CrCl less than 30 mL/min, C-G) or end-stage renal disease (ESRD) is 25 mg every day or 50 mg every other day. Supplemental doses should not be given to patients after dialysis [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

  肝损伤的患者

  中度至重度肝损伤患者的建议剂量为每天50毫克。不建议每天升级高于100 mg的剂量[见临床药理学（12.3）]。

  2。3Maintenance/Continuation/Extended Treatment

  人们普遍认为，重度抑郁症的急性发作需要持续的药物治疗几个月或更长时间。Longer-term efficacy of PRISTIQ (50–400 mg) was established in two maintenance trials [see Clinical Studies (14)]. Patients should be periodically reassessed to determine the need for continued treatment.

  2。4Discontinuing PRISTIQ

  症状与PRISTI中止有关Q, other SNRIs and SSRIs have been reported [see Warnings and Precautions (5.9)]. 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. The 25 mg dose is available for discontinuing therapy.

  2.5将患者从其他抗抑郁药切换为pristiq

  在将患者从包括文拉法辛在内的其他抗抑郁药切换到pristiq时，已经报告了停用症状。初始抗抑郁药的逐渐减少以最大程度地减少停用症状。

  2。6Switching Patients To or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders

  At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with PRISTIQ. Conversely, at least 7 days should be allowed after stopping PRISTIQ before starting an MAOI intended to treat psychiatric disorders [see Contraindications (4.2)].

  Use of PRISTIQ with other MAOIs such as Linezolid or Methylene Blue

  Do not start PRISTIQ 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 (4.2)].

  In some cases, a patient already receiving PRISTIQ 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, PRISTIQ should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for 7 days or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with PRISTIQ may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue [see Warnings and Precautions (5.2)].

  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 PRISTIQ is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use [see Warnings and Precautions (5.2)].

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• 辉瑞公司的子公司Wyeth Pharmaceuticals Inc.
  

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  pristiq扩展释放|辉瑞公司的子公司Wyeth Pharmaceuticals Inc.

  

  ---

  2.1通用说明

  Pristiq的建议剂量每天每天一次，有或没有食物。50毫克剂量既是起始剂量，又是治疗剂量。pristiq应在每天大约同一时间进行。必须用液体吞咽平板电脑，并且不会分裂，压碎，咀嚼或溶解。

  In clinical studies, doses of 10 mg to 400 mg per day were studied. In clinical studies, doses of 50 mg to 400 mg per day were shown to be effective, although no additional benefit was demonstrated at doses greater than 50 mg per day and adverse reactions and discontinuations were more frequent at higher doses.

  The 25 mg per day dose is intended for a gradual reduction in dose when discontinuing treatment. When discontinuing therapy, gradual dose reduction is recommended whenever possible to minimize discontinuation symptoms [see Dosage and Administration (2.4) and Warnings and Precautions (5.9)].

  2。2Special Populations

  Patients with renal impairment

  The maximum recommended dose in patients with moderate renal impairment (24-hr creatinine clearance [CrCl] = 30 to 50 mL/min, Cockcroft-Gault [C-G]) is 50 mg per day. The maximum recommended dose in patients with severe renal impairment (24-hr CrCl less than 30 mL/min, C-G) or end-stage renal disease (ESRD) is 25 mg every day or 50 mg every other day. Supplemental doses should not be given to patients after dialysis [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

  肝损伤的患者

  中度至重度肝损伤患者的建议剂量为每天50毫克。不建议每天升级高于100 mg的剂量[见临床药理学（12.3）]。

  2。3Maintenance/Continuation/Extended Treatment

  人们普遍认为，重度抑郁症的急性发作需要持续的药物治疗几个月或更长时间。Longer-term efficacy of PRISTIQ (50–400 mg) was established in two maintenance trials [see Clinical Studies (14)]. Patients should be periodically reassessed to determine the need for continued treatment.

  2。4Discontinuing PRISTIQ

  症状与PRISTI中止有关Q, other SNRIs and SSRIs have been reported [see Warnings and Precautions (5.9)]. 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. The 25 mg dose is available for discontinuing therapy.

  2.5将患者从其他抗抑郁药切换为pristiq

  在将患者从包括文拉法辛在内的其他抗抑郁药切换到pristiq时，已经报告了停用症状。初始抗抑郁药的逐渐减少以最大程度地减少停用症状。

  2。6Switching Patients To or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders

  At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with PRISTIQ. Conversely, at least 7 days should be allowed after stopping PRISTIQ before starting an MAOI intended to treat psychiatric disorders [see Contraindications (4.2)].

  Use of PRISTIQ with other MAOIs such as Linezolid or Methylene Blue

  Do not start PRISTIQ 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 (4.2)].

  In some cases, a patient already receiving PRISTIQ 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, PRISTIQ should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for 7 days or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with PRISTIQ may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue [see Warnings and Precautions (5.2)].

  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 PRISTIQ is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use [see Warnings and Precautions (5.2)].

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