EFEXOR XR CAPSULE 75 MG [SIN11435P]

Product Info

EFEXOR XR CAPSULE 75 MG

[SIN11435P]

INDICATIONS
Efexor XR is indicated for the treatment of depression, including depression with associated anxiety, in hospitalized patients.

Treatment of anxiety or GAD, including long-term treatment.

The effectiveness of Efexor XR in long-term use for GAD has been evaluated for up to 6 months in controlled clinical trials.

For prevention of relapse of an episode of depression or for prevention of the recurrence of new depressive episodes.

Efexor XR is indicated for the treatment of SAD, also known as social phobia, as defined in DSM-IV.

SAD (DSM-IV) is characterized by a marked and persistent fear of 1 or more social or performance situations in which the person is exposed to unfamiliar people or to possible scrutiny by others. Exposure to the feared situation almost invariably provokes anxiety, which may approach the intensity of a panic attack. The feared situations are avoided or endured with intense anxiety or distress. The avoidance, anxious anticipation, or distress in the feared situation(s) interferes significantly with the person’s normal routine, occupational or academic functioning, or social activities or relationships, or there is a marked distress about having the phobias. Lesser degrees of performance anxiety or shyness generally do not require psychopharmacological treatment.

Efexor XR is indicated for the treatment of panic disorder, including prevention of relapse.

DOSAGE AND ADMINISTRATION
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 dissolved, or it may be administered by carefully opening the capsule and sprinkling the entire contents on a spoonful of applesauce. 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.

Depression
The recommended dose for Efexor XR is 75 mg/day given once daily.

When required, the venlafaxine dosage can be increased in increments of 75 mg/day, at intervals of no less than 4 days. The venlafaxine dose can be titrated up to 225 mg/day in moderately depressed patients and 375 mg/day for severely depressed patients.

Extended-release venlafaxine dosage increases can be made at intervals of approximately 2 weeks or more, but not less than 4 days.

Usually, the dosage for prevention of relapse or for the prevention of recurrence of a new episode is similar to that used during initial treatment. Patients should be regularly reassessed in order to evaluate the benefit of long-term therapy.

Generalized Anxiety Disorder
The recommended dose for Efexor XR is 75 mg/day given once daily.

When required, the venlafaxine dosage can be increased in increments of 75 mg/day, up to a maximum dose of 225 mg/day, at intervals of no less than 4 days.

Extended-release venlafaxine dosage increases can be made at intervals of approximately 2 weeks or more, but not less than 4 days. Patients should be regularly reassessed in order to evaluate the benefit of long-term therapy.

Social Anxiety Disorder (Social Phobia)
For most patients with SAD (social phobia), the recommended starting dose for Efexor XR is 75 mg/day, administered in a single dose. In clinical trials establishing the efficacy of Efexor XR in outpatients with SAD, the initial dose of Efexor XR was 75 mg/day and the maximum dose was 225 mg/day. Although a dose-response relationship for effectiveness in patients with SAD was not clearly established in fixed-dose studies, certain patients not responding to the initial 75 mg/day dose 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.

In SAD, continuing therapeutic benefit has been established for periods of up to 6 months. The need for continuing medication in patients with SAD who improve with Efexor XR treatment should be periodically assessed.

Panic Disorder
The recommended dose is 75 mg of Efexor XR once daily. Treatment should be started with a dose of 37.5 mg/day of Efexor XR for the first 4 to 7 days, after which the dose should be increased to 75 mg once daily.

Patient not responding to the 75 mg/day dose may benefit from dose increases to a maximum of 225 mg/day although there is no direct clinical trial evidence of any significant increase in efficacy with increased dose. Dosage increases can be made in increments of 75 mg/day at intervals of approximately 2 weeks or more, but not less than 4 days.

Discontinuing Efexor XR
Gradual dose tapering is recommended when discontinuing venlafaxine therapy (see sections SPECIAL WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). 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.

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 10–70 mL/min.

The total daily dose of venlafaxine should be reduced by 50% in hemodialysis patients. Administration must be withheld until the dialysis session is completed.

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 Children
There is insufficient experience with the use of venlafaxine in patients younger than 18 years of age (see sections PEDIATRIC USE and ADVERSE REACTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Use in Elderly Patients
No specific dose adjustments of venlafaxine are recommended based on patient age.

CONTRAINDICATIONS
Hypersensitivity to venlafaxine or any excipients in the formulation.

Concomitant use of venlafaxine and any monoamine oxidase inhibitor (MAOI).

Venlafaxine must not be initiated for at least 14 days after discontinuation of treatment with an MAOI; a shorter interval may be justified in the case of a reversible MAOI (see prescribing information of the reversible MAOI). Venlafaxine must be discontinued for at least 7 days before starting treatment with any MAOI (see section DRUG INTERACTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).