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Uses

Major Depressive Disorder

Management of major depressive disorder.

Efficacy of extended-release capsules in hospital settings not established.

Generalized Anxiety Disorder

Management of generalized anxiety disorder.

Social Phobia

Management of social phobia (social anxiety disorder).

Panic Disorder

Management of panic disorder with or without agoraphobia.

Obesity

Not indicated for the management of exogenous obesity† (either alone or in combination with weight loss agents such as phentermine), although weight loss reported in some patients receiving the drug for other disorders.

Vasomotor Symptoms

Management of vasomotor symptoms† in women with breast cancer and in postmenopausal women; improved both frequency and severity of vasomotor symptoms (hot flushes [flashes]).

Dosage and Administration

General

• Allow at least 2 weeks to elapse between discontinuance of an MAO inhibitor and initiation of venlafaxine and at least 1 week to elapse between discontinuance of venlafaxine and initiation of an MAO inhibitor.
• Monitor for possible worsening of depression, suicidality, or unusual changes in behavior, especially at the beginning of therapy or during periods of dosage adjustments. (See Risk of Suicidality and Overdosage under Cautions.)
• Avoid abrupt discontinuance. To avoid withdrawal reactions, taper dosage gradually. (See Risk of Suicidality and Overdosage and also see Withdrawal of Therapy under Cautions.)
• Consider cautiously tapering dosage during third trimester of pregnancy prior to delivery. (See Pregnancy under Cautions.)
• Sustained therapy may be required; use lowest effective dosage and periodically reassess need for continued therapy.

Administration

Oral Administration

Administer orally with food.

Administer conventional tablets twice or 3 times daily with food.

Administer extended-release capsules as a single daily dose with food at approximately the same time each day (morning or evening). Swallow extended-release capsules whole with fluid; do not divide, crush, chew, or place in water.

Alternatively, open capsule(s) and sprinkle on a small amount of applesauce; swallow immediately without chewing. After administration, the patient should drink a glass of water to ensure that the pellets are completely swallowed.

Dosage

Available as venlafaxine hydrochloride; dosage expressed in terms of venlafaxine.

Adults

Major Depressive Disorder

Oral

Initially, 75 mg daily administered in 2 or 3 divided doses as conventional tablets or as a single daily dose when using the extended-release capsules. Alternatively, an initial dosage of 37.5 mg daily as extended-release capsules for the first 4–7 days (followed by an increase to 75 mg daily) may be considered for some patients. If no improvement, dosage may be increased by increments of up to 75 mg daily at intervals of not less than 4 days up to a maximum dosage of 375 mg daily (usually administered in 3 divided doses) as conventional tablets or 225 mg daily as extended-release capsules.

No additional benefit demonstrated from dosages >225 mg daily as conventional tablets in clinical studies in moderately depressed outpatients, but patients with more severe depression responded to higher dosages (mean dosage of 350 mg daily).

If desired, conventional tablets may be switched to the extended-release capsules at the nearest equivalent daily venlafaxine dosage (e.g., change 37.5 mg administered twice daily as conventional tablets to 75-mg extended-release capsule administered once daily). Individualize dosage adjustments as necessary.

Optimum duration not established; may require several months of therapy or longer. Antidepressant efficacy demonstrated for up to 6 months with venlafaxine extended-release capsules and for up to 1 year with conventional tablets.

Periodically reassess need for continued therapy and appropriateness of dosage.

Generalized Anxiety Disorder

Oral

Initially, 75 mg once daily as extended-release capsules. In some patients, it may be desirable to initiate therapy with a dosage of 37.5 mg daily given for the first 4–7 days, followed by an increase to 75 mg daily. If no improvement, dosage may be increased in increments of up to 75 mg daily (up to a maximum dosage of 225 mg daily as extended-release capsules) at intervals of not less than 4 days.

Optimum duration not established; efficacy demonstrated in a 6-month clinical trial. Periodically reassess need for continued therapy.

Social Phobia

Oral

Initially, 75 mg once daily as extended-release capsules. In some patients, it may be desirable to initiate therapy with a dosage of 37.5 mg daily given for the first 4–7 days, followed by an increase to 75 mg daily. If no improvement, dosage may be increased in increments of up to 75 mg daily (up to a maximum dosage of 225 mg daily as extended-release capsules) at intervals of not less than 4 days.

Optimum duration not established; long-term efficacy (>12 weeks) not demonstrated. Periodically reassess need for continued therapy.

Panic Disorder

Oral

Initially, 37.5 mg once daily as extended-release capsules for 7 days. If no improvement, dosage may be increased in increments of up to 75 mg daily at intervals of not less than 7 days. In clinical trials, 37.5 mg once daily was given initially for 7 days, then 75 mg once daily for 7 days; thereafter, dosage was increased in increments of 75 mg daily every 7 days if necessary. Certain patients not responding to 75 mg once daily may benefit from dosage increases up to a maximum of approximately 225 mg daily.

Optimum duration not established; longer-term efficacy (>12 weeks) in prolonging time to relapse in responding patients demonstrated in a controlled trial. Periodically reassess need for continued therapy.

Vasomotor Symptoms

Oral

Optimum dosage for vasomotor symptoms† in women with breast cancer and in postmenopausal women not established. Initially, some clinicians recommend 37.5 mg once daily as extended-release capsules; may increase as necessary to 75 mg once daily. 75 mg once daily as extended-release capsules appeared optimal in one study. Further dosage increases may not provide additional benefit but are potentially more toxic.†

Prescribing Limits

Adults

Major Depressive Disorder

Oral

Maximum 375 mg daily (generally in 3 equally divided doses) as conventional tablets or 225 mg daily as extended-release capsules.

Generalized Anxiety Disorder

Oral

Maximum 225 mg daily as extended-release capsules.

Social Phobia

Oral

Maximum 225 mg daily as extended-release capsules.

Panic Disorder

Oral

Maximum 225 mg daily as extended-release capsules.

Special Populations

Dosage in Hepatic Impairment

Oral

Extended-release capsules: Reduce initial dosage by 50% in patients with moderate hepatic impairment.

Conventional tablets: Reduce total daily dosage by 50% in patients with moderate hepatic impairment.

In patients with cirrhosis, may be desirable to individualize dosages. May be necessary to reduce dosage of conventional tablets by >50%.

Dosage in Renal Impairment

Oral

When using conventional tablets or extended-release capsules, reduce total daily dosage by 25–50% in patients with mild-to-moderate renal impairment and by 50% in those undergoing hemodialysis. Withhold dosages until the dialysis period is complete (4 hours).