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PRISTIQ(desvenlafaxine) Extended-Release Tablets
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HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use PRISTIQ safely and effectively. See full prescribing information for PRISTIQ.
PRISTIQ ® (desvenlafaxine) Extended-Release Tablets, for oral use
Initial U.S. Approval: 2008
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
See full prescribing information for complete boxed warning.
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•Increased risk of suicidal thinking and behavior in children, adolescents and young adults taking antidepressants (5.1).
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•Monitor for worsening and emergence of suicidal thoughts and behaviors (5.1).
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•PRISTIQ is not approved for use in pediatric patients (8.4).
RECENT MAJOR CHANGES
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Dosage and Administration, General Instruction for Use (2.1)
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04/2014
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Dosage and Administration, Special populations (2.2)
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07/2014
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Dosage and Administration, Discontinuing PRISTIQ (2.4)
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04/2014
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Warnings and Precautions, Angle Closure Glaucoma(5.5)
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05/2014
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INDICATIONS AND USAGE
PRISTIQ, is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of major depressive disorder (MDD) (1).
DOSAGE AND ADMINISTRATION
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•Recommended dose: 50 mg once daily with or without food ( 2.1).
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•There was no evidence that doses greater than 50 mg per day confer any additional benefit ( 2.1).
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•The 25 mg per day dose is intended for a gradual reduction in dose when discontinuing treatment or dosing in severe renal and end-stage renal disease patients ( 2.1).
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•Discontinuation: Reduce dose gradually whenever possible ( 2.1).
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•Take tablets whole; do not divide, crush, chew, or dissolve ( 2.1).
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•Moderate renal impairment: Maximum dose 50 mg per day ( 2.2).
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•Severe renal impairment and end-stage renal disease: Maximum dose 25 mg per day or 50 mg every other day ( 2.2).
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•Moderate to severe hepatic impairment: Maximum dose 100 mg per day ( 2.2).
DOSAGE FORMS AND STRENGTHS
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•PRISTIQ extended-release tablets: 25 mg, 50 mg and 100 mg ( 3).
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•Each tablet contains 38 mg, 76 mg or 152 mg of desvenlafaxine succinate equivalent to 25 mg, 50 mg or 100 mg of desvenlafaxine, respectively ( 3).
CONTRAINDICATIONS
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•Hypersensitivity to desvenlafaxine succinate, venlafaxine hydrochloride or any excipients in the PRISTIQ formulation (4.1).
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•Serotonin syndrome and MAOIs: Do not use MAOIs intended to treat psychiatric disorders with PRISTIQ or within 7 days of stopping treatment with PRISTIQ. Do not use PRISTIQ within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start PRISTIQ in a patient who is being treated with linezolid or intravenous methylene blue (4.2).
WARNINGS AND PRECAUTIONS
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•Clinical Worsening/Suicide Risk: Monitor for clinical worsening and suicide risk ( 5.1).
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•Serotonin Syndrome: Serotonin syndrome has been reported with SSRIs and SNRIs, including with PRISTIQ, both when taken alone, but especially when co-administered with other serotonergic agents (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John's Wort). If such symptoms occur, discontinue PRISTIQ and initiate supportive treatment. If concomitant use of PRISTIQ with other serotonergic drugs is clinically warranted, patients should be made aware of a potential increased risk for serotonin syndrome, particularly during treatment initiation and dose increases ( 5.2).
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•Elevated Blood Pressure: Control hypertension before initiating treatment. Monitor blood pressure regularly during treatment ( 5.3).
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•Abnormal Bleeding: PRISTIQ may increase risk of bleeding events. Caution patients about risk of bleedingassociated with concomitant use of PRISTIQ and NSAIDs, aspirin, or other drugs that affect coagulation ( 5.4).
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•Angle Closure Glaucoma: Angle closure glaucoma has occurred in patients with untreated anatomically narrow angles treated with antidepressants. ( 5.5)
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•Activation of Mania/Hypomania: Use cautiously in patients with Bipolar Disorder. Caution patients about risk of activation of mania/hypomania ( 5.6).
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•Discontinuation Syndrome: Taper dose when possible and monitor for discontinuation symptoms ( 5.7).
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•Seizure: Can occur. Use cautiously in patients with seizure disorder ( 5.8).
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•Hyponatremia: Can occur in association with SIADH ( 5.9).
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•Interstitial Lung Disease and Eosinophilic Pneumonia: Can occur ( 5.10).
Most common adverse reactions (incidence ≥5% and twice the rate of placebo in the 50 or 100 mg dose groups) were: nausea, dizziness, insomnia, hyperhidrosis, constipation, somnolence, decreased appetite, anxiety, and specific male sexual function disorders (6.1).
To report SUSPECTED ADVERSE REACTIONS, contact Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc., at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
USE IN SPECIFIC POPULATIONS
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•Pregnancy: Based on animal data, may cause fetal harm ( 8.1).
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•Nursing Mothers: Discontinue drug or nursing taking into consideration importance of drug to mother ( 8.3).
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•Geriatric Use: There is an increased incidence of orthostatic hypotension in desvenlafaxine treated patients ≥ 65 years ( 6.1 and 8.5).
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 11/2016
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
PRISTIQ, a serotonin and norepinephrine reuptake inhibitor (SNRI), is indicated for the treatment of major depressive disorder (MDD) [see Clinical Studies (14) and Dosage and Administration (2.1)]. The efficacy of PRISTIQ has been established in four short-term (8-week, placebo-controlled studies) and two maintenance studies in adult outpatients who met DSM-IV criteria for major depressive disorder.
Close
2 DOSAGE AND ADMINISTRATION
2.1 GENERAL INSTRUCTION FOR USE
The recommended dose for PRISTIQ is 50 mg once daily, with or without food. The 50 mg dose is both a starting dose and the therapeutic dose. PRISTIQ should be taken at approximately the same time each day. Tablets must be swallowed whole with fluid and not divided, crushed, chewed, or dissolved.
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)].
2.2 Special 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)].
Patients with hepatic impairment
The recommended dose in patients with moderate to severe hepatic impairment is 50 mg per day. Dose escalation above 100 mg per day is not recommended [see Clinical Pharmacology (12.3)].
2.3 Maintenance/Continuation/Extended Treatment
It is generally agreed that acute episodes of major depressive disorder require several months or longer of sustained pharmacologic therapy. 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.
2.4 Discontinuing PRISTIQ
Symptoms associated with discontinuation of PRISTIQ, 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 Switching Patients From Other Antidepressants to PRISTIQ
Discontinuation symptoms have been reported when switching patients from other antidepressants, including venlafaxine, to PRISTIQ. Tapering of the initial antidepressant may be necessary to minimize discontinuation symptoms.
2.6 Switching 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
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