Effexor XR

[venlafaxine hydrochloride]

Discontinuing Effexor XR

When discontinuing Effexor XR after more than 1 week of therapy, it is generally recommended that the dose be tapered to minimize the risk of discontinuation symptoms. Patients who have received Effexor XR for 6 weeks or more should have their dose tapered over at least a 2-week period. In clinical trials with Effexor XR, tapering was achieved by reducing the daily dose by 75 mg at 1 week intervals. Individualization of tapering may be necessary.

Discontinuation symptoms have been systematically evaluated in patients taking venlafaxine, to include prospective analyses of clinical trials in Generalized Anxiety Disorder and retrospective surveys of trials of major depressive disorder. Abrupt discontinuation or dose reduction of venlafaxine at various doses has been found to be associated with the appearance of new symptoms, the frequency of which increased with increased dose level and with longer duration of treatment.

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Reported symptoms include

agitation,
anorexia,
anxiety,
confusion,
coordination impaired,
diarrhea,
dizziness,
dry mouth,
dysphoric mood,
fasciculation, fatigue,
headaches,
hypomania,
insomnia,
nausea,
nervousness,
nightmares,
seizures,
sensory disturbances (including shock-like electrical sensations), somnolence,
sweating,
tinnitus,
tremor,
vertigo,
vomiting.

It is therefore recommended that the dosage of Effexor XR be tapered gradually and the patient monitored. The period required for tapering may depend on the dose, duration of therapy and the individual patient. Discontinuation effects are well known to occur with
antidepressants.

Switching Patients To or From a Monoamine Oxidase Inhibitor

At least 14 days should elapse between discontinuation of an MAOI and initiation of therapy with Effexor XR. In addition, at least 7 days should be allowed after stopping Effexor XR before starting an MAOI (see CONTRAINDICATIONS and WARNINGS).

HOW SUPPLIED

Effexor XR (venlafaxine hydrochloride) extended-release capsules are available as follows:
37.5 mg, grey cap/ peach body with and "Effexor XR" on the cap and "37.5" on the body.
NDC 0008-0837-01, bottle of 100 capsules.
NDC 0008-0837-03, carton of 10 Redipak ® blister strips of 10 capsules each.
Store at controlled room temperature, 20° C to 25° C (68° F to 77° F).
75 mg, peach cap and body with and "Effexor XR" on the cap and "75" on the body.
NDC 0008-0833-01, bottle of 100 capsules.
NDC 0008-0833-03, carton of 10 Redipak blister strips of 10 capsules each.
Store at controlled room temperature, 20° C to 25° C (68° F to 77° F).

150 mg, dark orange cap and body with and "Effexor XR" on the cap and "150" on the body.
NDC 0008-0836-01, bottle of 100 capsules.
NDC 0008-0836-03, carton of 10 Redipak blister strips of 10 capsules each.
Store at controlled room temperature, 20° C to 25° C (68° F to 77° F).
The appearance of these capsules is a trademark of Wyeth Pharmaceuticals.
Wyeth Pharmaceuticals Inc. W10404C008
Philadelphia, PA 19101 ET02
Rev 12/ 03 34

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