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Drug DescriptionSide Effects & Drug InteractionsWarnings & Precautions
Clinical PharmacologyOverdosage & ContraindicationsIndications & DosagePatient Info

Effexor XR

[venlafaxine hydrochloride]


Patient Info
Information for Patients

Physicians are advised to discuss the following issues with patients for whom they prescribe Effexor XR (venlafaxine hydrochloride) extended-release capsules:

Interference with Cognitive and Motor Performance

Text Continues Below



Clinical studies were performed to examine the effects of venlafaxine on behavioral performance of healthy individuals. The results revealed no clinically significant impairment of psychomotor, cognitive, or complex behavior performance. However, since any psychoactive drug may impair judgment, thinking, or motor skills, patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that venlafaxine therapy does not adversely affect their ability to engage in such activities.

Concomitant Medication

Patients should be advised to inform their physicians if they are taking, or plan to take, any prescription or over-the-counter drugs, including herbal preparations, since there is a potential for interactions. Alcohol Although venlafaxine has not been shown to increase the impairment of mental and motor skills caused by alcohol, patients should be advised to avoid alcohol while taking venlafaxine. Allergic Reactions Patients should be advised to notify their physician if they develop a rash, hives, or a related allergic phenomenon.

Pregnancy

Patients should be advised to notify their physician if they become pregnant or intend to become pregnant.

Nursing Patients should be advised to notify their physician if they are breast-feeding an infant.

Laboratory Tests

There are no specific laboratory tests recommended.

Drug Interactions

As with all drugs, the potential for interaction by a variety of mechanisms is a possibility.

Alcohol

A single dose of ethanol (0.5 g/ kg) had no effect on the pharmacokinetics of venlafaxine or O-desmethylvenlafaxine (ODV) when venlafaxine was administered at 150 mg/ day in 15 healthy male subjects. Additionally, administration of venlafaxine in a stable regimen did not exaggerate
the psychomotor and psychometric effects induced by ethanol in these same subjects when they were not receiving venlafaxine. Cimetidine Concomitant administration of cimetidine and venlafaxine in a steady-state study for both drugs resulted in inhibition of first-pass metabolism of venlafaxine in 18 healthy subjects. The oral clearance of venlafaxine was reduced by about 43%, and the exposure (AUC) and maximum concentration (Cmax) of the drug were increased by about 60%.

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