Efexor XR Dosage/Direction for Use

The recommended starting dose of venlafaxine extended-release capsules is 75 mg given once daily.
Patients not responding to the initial 75 mg/day dose may benefit from dose increases to a maximum of 225 mg/day. While the recommended dose for moderately depressed patients is up to 225 mg/day for immediate-release venlafaxine, more severely depressed patients in one study responded to a mean dose of 350 mg/day (range of 150 to 375 mg/day).
Extended-release venlafaxine dosage increases can be made at intervals of approximately 2 weeks or more, but not less than 4 days.
Patients treated with venlafaxine immediate-release tablets may be switched to venlafaxine extended-release capsules at the nearest equivalent daily dosage. For example, venlafaxine immediate-release tablets 37.5 mg twice daily may be switched to venlafaxine extended-release capsules 75 mg once daily. Individual dosage adjustments may be necessary.
Gradual dose tapering is recommended when discontinuing venlafaxine therapy (See Precautions and Adverse Reactions).
Tapering over at least a two-week period is recommended if venlafaxine has been used for more than 6 weeks. In clinical trials with venlafaxine extended-release capsules, tapering was achieved by reducing the daily dose by 75 mg at 1-week intervals. However, the time period required for tapering and the amount of dose reduction may depend on the dose, duration of therapy, and the individual patient. In some patients, discontinuation may need to occur very gradually over periods of months or longer.
It is recommended that venlafaxine extended-release capsules be taken with food, at approximately the same time each day. Capsules must be swallowed whole with fluid and not divided, crushed, chewed, or placed in water.
Panic Disorder: It is recommended that initial single doses of 37.5 mg/day of venlafaxine extended-release capsules be used for 4 to 7 days. In clinical trials establishing the efficacy of Efexor XR in outpatients with panic disorder, initial doses of 37.5 mg/day for 4 to 7 days were followed by doses of 75 mg/day, with maximum doses of 225 mg/day. Although a dose-response relationship for effectiveness in patients with panic disorder was not clearly established in fixed-dose studies, certain patients not responding to 75 mg/day may benefit from dose increases to a maximum of approximately 225 mg/day. Dose increases should be in increments of up to 75 mg/day, as needed, and should be made at intervals of not less than 4 days.
Use in Patients with Renal Impairment: The total daily dose of venlafaxine should be reduced by 25% to 50% in patients with renal impairment with a glomerular filtration rate (GFR) of 10 to 70 mL/min.
The total daily dose of venlafaxine should be reduced by 50% in hemodialysis patients.
Because of individual variability in clearance in these patients, individualization of dosage may be desirable.
Use in Patients with Hepatic Impairment: The total daily dose of venlafaxine should be reduced by 50% in patients with mild to moderate hepatic impairment. Reductions of more than 50% may be appropriate for some patients.
Because of individual variability in clearance in these patients, individualization of dosage may be desirable.
Use in Elderly Patients: No specific dose adjustments of venlafaxine are recommended based on patient age. However, as with any therapy, caution should be exercised in treating the elderly (e.g. due to the possibility of renal impairment. See also dosage recommendations for renal impairment). The lowest effective dose should always be used, and patients should be carefully monitored when an increase in the dose is required.
Use in Children and Adolescents: There is insufficient experience with the use of venlafaxine in patients younger than 18 years of age (see Adverse Reactions). Efficacy in patients less than 18 years of age has not been established. Therefore, venlafaxine is not recommended for use in patients less than 18 years of age.
In pediatric clinical trials, the adverse reaction, suicidal ideation, was observed. There were also increased reports of hostility and, especially in major depressive disorder, self-harm.
As with adults, decreased appetite, weight loss, increased blood pressure, and increased serum cholesterol have been observed in children and adolescents (ages 6 to 17 years; see Adverse Reactions). Regular measurement of weight and blood pressure is recommended if venlafaxine is used in children and adolescents. Discontinuation of venlafaxine treatment should be considered in children and adolescents who experience a sustained increase in blood pressure. Measurement of serum cholesterol levels should be considered during long-term treatment of children and adolescent (see Adverse Reactions). Safety in children younger than 6 years of age has not been evaluated.
Maintenance/Continuation/Extended Treatment: The physician should periodically re-evaluate the usefulness of long-term Efexor XR treatment for the individual patient. It is generally agreed that acute episodes of major depression require several months or longer of sustained pharmacological therapy. Venlafaxine has been shown to be efficacious during long-term (up to 12 months) treatment.
Discontinuing Efexor XR: Discontinuation effects are well known to occur with the abrupt withdrawal of other antidepressants. While the discontinuation effects of Efexor XR has not been systematically evaluated in controlled clinical trials, a retrospective survey of events occurring during taper or following discontinuation of Efexor XR revealed the following events that occurred with an incidence of at least 3% and at least twice the placebo incidence: dizziness, dry mouth, insomnia, nausea, nervousness and sweating.
In addition, a retrospective survey of events occurring during taper or following discontinuation of Efexor XR tablets revealed the following events that occurred at an incidence of at least 5% and at least twice the placebo incidence: fatigue, headache, nausea, dizziness, sleep disturbance and nervousness. Diarrhea and one hypomanic episode was also reported.
In post-marketing experience, symptoms reported following discontinuation, dose reduction or tapering of venlafaxine at various doses have also included confusion, paresthesia, sweating, vertigo and vomiting. It is therefore recommended that when discontinuing Efexor XR after more than one week's therapy, the dose should be gradually reduced over at least one week and the patient monitored in order to minimize the risk of discontinuation symptoms.
Dose tapering is recommended when discontinuing venlafaxine therapy. Tapering over at least a two-week period is recommended if venlafaxine has been used for more than 6 weeks. The period required for tapering may depend on the dose, duration of therapy and the individual patient.