Desvenlafaxine | Pristiq
PRISTIQ, a selective serotonin and norepinephrine reuptake inhibitor (SNRI), is indicated for the treatment of major depressive disorder [MDD]
- Recommended dose: 50 mg once daily with or without food (2.1).
- There was no evidence that doses greater than 50 mg/day confer any additional benefit (2.1).
- When discontinuing treatment, gradual dose reduction is recommended whenever possible (2.1 and 5.9).
- Tablets should be taken whole; do not divide, crush, chew, or dissolve (2.1).
- Renal Impairment: The recommended dose in patients with moderate renal impairment is 50 mg/day. The recommended dose in patients with severe renal impairment and end-stage renal disease (ESRD) is 50 mg every other day. The dose should not be escalated in patients with moderate or severe renal impairment or ESRD (2.2).
- Hepatic Impairment: Dose escalation above 100 mg/day is not recommended (2.2).
- PRISTIQ tablets are available as 50 and 100 mg tablets (3).
- Each tablet contains 76 mg or 152 mg of desvenlafaxine succinate equivalent to 50 mg or 100 mg of desvenlafaxine (3).
- Initial Dosage for Adults: Usual starting dosage is 50 mg two or three times daily. Depending upon tolerance, dosage may be increased to 100 mg two or three times daily by the end of the first week. (Initial dosage of 300 mg daily may be given, but notable sedation may occur in some patients during the first few days of therapy at this level.) Increases above 300 mg daily should be made only if 300 mg daily has been ineffective during a trial period of at least two weeks. When effective dosage is established, the drug may be given in a single dose (not to exceed 300 mg) at bedtime.
- Elderly Patients: In general, lower dosages are recommended for these patients. Recommended starting dosage of amoxapine is 25 mg two or three times daily. If no intolerance is observed, dosage may be increased by the end of the first week to 50 mg two or three times daily. Although 100 to 150 mg daily may be adequate for many elderly patients, some may require higher dosage. Careful increases up to 300 mg daily are indicated in such cases. Once an effective dosage is established, amoxapine may conveniently be given in a single bedtime dose, not to exceed 300 mg.
- Maintenance: Recommended maintenance dosage of amoxapine is the lowest dose that will maintain remission. If symptoms reappear, dosage should be increased to the earlier level until they are controlled. For maintenance therapy at dosages of 300 mg or less, a single dose at bedtime is recommended.
—–INDICATIONS AND USAGE—–
- See description above.
—–DOSAGE AND ADMINISTRATION—–
- See description above.
—–CONTRAINDICATIONS—–
- Hypersensitivity to desvenlafaxine succinate, venlafaxine hydrochloride or any excipients in the PRISTIQ formulation (4.1).
- Do not use with an MAOI or within 14 days of stopping an MAOI. Allow 7 days after stopping PRISTIQ before starting an MAOI (4.2)
—–WARNINGS & PRECAUTIONS—–
- Clinical Worsening/Suicide Risk: Monitor for clinical worsening and suicide risk (5.1).
- Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-like Reactions: Serotonin syndrome or NMS-like reactions have been reported with SSRIs and SNRIs. Discontinue PRISTIQ and initiate supportive treatment (5.2).
- Elevated Blood Pressure: Has occurred with PRISTIQ. Hypertension should be controlled before initiating treatment. Monitor blood pressure regularly during treatment (5.3).
- Abnormal Bleeding: PRISTIQ may increase the risk of bleeding events. Patients should be cautioned about the risk of bleeding associated with the concomitant use of PRISTIQ and NSAIDs, aspirin, or other drugs that affect coagulation (5.4).
- Narrow-angle Glaucoma: Mydriasis has occurred with PRISTIQ. Patients with raised intraocular pressure or those at risk of angle-closure glaucoma should be monitored (5.5).
- Activation of Mania/Hypomania: Has occurred. Use cautiously in patients with Bipolar Disorder. Caution patients about the risk of activation of mania/hypomania (5.6).
- Cardiovascular/Cerebrovascular Disease: Use cautiously in patients with cardiovascular or cerebrovascular disease (5.7).
- Cholesterol and Triglyceride Elevation: Have occurred. Use cautiously in patients with lipid metabolism disorders. Consider monitoring serum cholesterol and triglyceride (5.8).
- Discontinuation Symptoms: Have occurred. Taper the dose when possible and monitor for discontinuation symptoms (5.9).
- Renal Impairment: Reduces the clearance of PRISTIQ. Dosage adjustment is necessary in severe and ESRD. In moderate renal impairment, the dose should not exceed 50 mg/day (5.10).
- Seizure: Can occur. Use cautiously in patients with seizure disorder (5.11).
- Hyponatremia: Can occur in association with SIADH (5.12).
- Drugs Containing Desvenlafaxine or Venlafaxine: Should not be used concomitantly with PRISTIQ (5.13).
- Interstitial Lung Disease and Eosinophilic Pneumonia: Can occur (5.14).
—–ADVERSE REACTIONS—–
- Adverse reactions in patients in short-term fixed-dose studies (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).
—–USE IN SPECIFIC POPULATIONS—–
- Dosage adjustment is recommended in patients with severe renal impairment and end-stage renal disease. The dose should not be escalated in moderate to severe impairment or in ESRD (2.2, 8.6 and 12.6).
- There is an increased incidence of orthostatic hypotension in PRISTIQ treated patients ≥ 65 years (6.1 and 8.5).
- For elderly patients, the possibility of reduced renal clearance of desvenlafaxine should be considered when determining dose (2.2).
- Only administer PRISTIQ to pregnant or breastfeeding women if the expected benefits outweigh the possible risks (8.1 and 8.3).
