Pristiq

Pristiq Dosage/Direction for Use

desvenlafaxine

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma
Full Prescribing Info
Dosage/Direction for Use
Major Depressive Disorder: Recommended Usual and Maintenance Dose: 50 mg once daily, with or without food. Based on clinical judgment, if dose increases are indicated for individual patients, they should occur gradually and at intervals of not less than 7 days.
It is generally agreed that acute episodes of major depressive disorder require several months or longer of sustained pharmacologic therapy. Pristiq has been shown to be effective during long-term (up to 9 months) treatment (see Pharmacology under Actions). Patients should continue on the same dose at which they responded. They should be periodically reassessed to determine the need for continued treatment.
Vasomotor Symptoms Associated with Menopause: Recommended Dose: 100 mg once daily, with or without food. It is recommended to start at 50 mg/day for up to 7 days, to allow patients to adjust to the medicine before increasing to 100 mg/day. Patients should be periodically reassessed to determine the need to continue treatment.
When discontinuing therapy, gradual dose reduction should be considered to minimize discontinuation symptoms (see Precautions).
Hepatic Impairment: No dosage adjustment is necessary for patients with hepatic impairment (see Pharmacokinetics under Actions).
Renal Impairment: Major Depressive Disorder: The recommended starting dose in patients with severe renal impairment (24-hr CrCl <30 mL/min) or ESRD is 50 mg every other day. Because of individual variability in clearance in these patients, individualization of dosage may be desirable. Supplemental doses should not be given to patients after dialysis (see Pharmacokinetics under Actions).
Vasomotor Symptoms Associated with Menopause: The recommended dose in patients with severe renal impairment (24-hr CrCl <30 mL/min) or ESRD is 100 mg every other day. Supplemental doses should not be given to patients after dialysis. It is recommended to titrate from 50 mg every other day for up to 7 days, to 100 mg every other day to allow patients to adjust to the medicine. Because of individual variability in clearance in these patients, individualization of dosage may be desirable (see Pharmacokinetics under Actions).
Elderly: No dosage adjustment is required solely on the basis of age; however, possible reduced renal clearance of desvenlafaxine should be considered when determining dose (see Pharmacokinetics under Actions and Precautions).
Major Depressive Disorder: Of the 3292 patients in pre-marketing clinical trials with desvenlafaxine, 5% of patients were ≥65 years. No overall differences in safety or efficacy were observed between these patients and younger patients, but greater sensitivity of some older patients cannot be ruled out.
Vasomotor Symptoms Associated with Menopause: Of the 1432 patients in pre-marketing vasomotor symptoms clinical trials, 2.5% were ≥65 years and 6.7% were ≥60 years. No overall differences in safety or efficacy were observed between older patients (≥60 years) and younger patients.
Pediatric Patients: Safety and effectiveness in patients <18 years have not been established.
Discontinuation of Pristiq: Symptoms associated with discontinuation of desvenlafaxine, other SNRIs and SSRIs have been reported. 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 (see Precautions and Adverse Reactions).
Administration: For oral administration.
It is recommended that Pristiq be taken at approximately the same time each day. Tablets must be swallowed whole with fluid and not divided, crushed, chewed or dissolved.
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