It is recommended that Efexor XR be taken with food. Each capsule must be swallowed whole with fluid. Do not divide, crush, chew, or dissolve.
This drug/food mixture should be swallowed immediately without chewing and should be followed with a glass of water to ensure complete swallowing of the pellets.
Efexor XR should be administered once daily, at approximately the same time either in the morning or in the evening.
With the exception of patients with social anxiety disorder (see as follows), patients not responding to the 75 mg/day dose may benefit from dose increases in increments of up to 75 mg/day to a maximum of 225 mg/day. Extended-release venlafaxine dosage increases can be made at intervals of 2 weeks or more, but not less than 4 days.
Depression: The usual recommended starting dose for the treatment of depression for Efexor XR is 75 mg, given once daily.
When required, the venlafaxine extended-release dosage can be increased in increments of up to 75 mg/day, at intervals of not less than 4 days. The venlafaxine extended-release dose can be titrated up to 225 mg/day in moderately depressed patients and 375 mg/day for severely depressed patients.
Antidepressant activity with the 75 mg dose was observed after 2 weeks of treatment.
Generalized Anxiety Disorder: Patients not responding to the initial 75 mg/day dose may benefit from dose increases. The dosage may be stepped up (e.g., by 37.5 mg increments) to a maximum of 150 or in some cases 225 mg/day. Extended-release venlafaxine dosage increases can be made at intervals of approximately 2 weeks or more, but not less than 4 days.
Anxiolytic activity with the 75 mg dose was observed after 1 week of treatment.
Social Anxiety Disorder (Social Phobia): The recommended dose is 75 mg/day, administered in a single dose. There is no evidence that higher doses confer any additional benefit.
Panic Disorder: It is recommended that initial single doses of 37.5 mg/day of Efexor XR be used for 7 days. In clinical trials establishing the efficacy of Efexor XR in outpatients with panic disorder, initial doses of 37.5 mg/day for 7 days were followed by doses of 75 mg/day and subsequent weekly dose increases of 75 mg/day to a maximum dose 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 7 days.
Switching Patients from Efexor Tablets: Patients who are currently being treated with Efexor may be switched to Efexor XR at the nearest equivalent dose (mg/day). However, individual dosage adjustments may be necessary.
Use in Patients with Renal Impairment: The total daily dose of venlafaxine should be reduced by 25%-50% in patients with renal impairment with a glomerular filtration rate (GFR) of 10-70 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. Reduction 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 Children and Adolescents: There is insufficient experience with the use of venlafaxine in patients younger than 18 years of age (see Use in Children and Adolescents under Precautions and Adverse Reactions).
Use in Elderly Patients: No specific dose adjustments of venlafaxine are recommended based on patient age. As with any drug, however, caution should be exercised in treating the elderly. When individualising the dosage, extra care should be taken when increasing the dose.
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 pharmacologic therapy.
Patients with anxiety often suffer over many years and such patients usually require long-term treatment.
Usually, the dosage for prevention of relapse or for prevention of recurrence of a new episode is similar to that used during initial treatment. Patients should be regularly re-assessed in order to evaluate the benefit of long-term therapy.
Efexor XR was shown to be efficacious during long-term treatment (up to 12 months in depression and up to 6 months in anxiety).
Discontinuing Efexor XR: Gradual dose tapering is recommended when discontinuing venlafaxine therapy (see Precautions and Adverse Reactions). 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.
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