Label Changes for:

Pexeva (paroxetine mesylate) Tablets

July 2014

Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

including:

Anafranil (clomipramine) Capsules
Aptryxol (desvenlafaxine) extended-release Tablets
Brintellix (vortioxetine) Tablets
Celexa (citalopram hydrobromide) Tablets
Cymbalta (duloxetine hydrochloride) Capsules
Desvenlafaxine Fumarate Extended-Release Tablets
Desyrel (trazodone hydrochloride) Tablets
Effexor XR (venlafaxine hydrochloride) extended-release tablets
Fetzima (levomilnacipran) extended-release capsules
Fluoxetine Tablets
Forfivo XL (bupropion hydrochloride Extended-Release Tablets
Khedezla (desvenlafaxine base extended-release) Tablets
Lexapro (escitalopram oxalate) Tablets and Oral Solution
Luvox (fluvoxamine maleate) Tablets
Luvox CR (fluvoxamine maleate) Extended-Release Capsules
Norpramin (desipramine hydrochloride tablets USP)
Oleptro (trazodone hydrochloride) extended-release tablets
Pamelor (nortriptyline HCl) Solution (Pamelor (nortriptyline HCl) Capsules 
Paxil (paroxetine hydrochloride) tablets, oral suspension and controlled-release tablets
Pexeva (paroxetine mesylate) Tablets
Pristiq (desvenlafaxine) Extended-Release Tablets
Prozac (fluoxetine hydrochloride) Delayed Release Capsules
Prozac (fluoxetine hydrochloride) Pulvules
Remeron (mirtazapine) Tablets Remeron SolTab orally disintegrating tablets
Sinequan (doxepin hydrochloride) Capsules and Oral Concentrate
Surmontil (Trimipramine Maleate) Capsules
Symbyax (olanzapine and fluoxetine hydrochloride) Capsules
Tofranil-PM (imipramine pamoate) Capsules
Venlafaxine Hydrochloride Extended-Release Capsules
Viibryd (vilazodone hydrochloride) Tablets
Vivactil (protriptyline HCL) Tablets
Wellbutrin (bupropion hydrochloride) Wellbutrin SR and Wellbutrin XL Sustained-Release Tablets
Zoloft (sertraline hydrochloride) Tablets and Oral Concentrate

 

July 2014

WARNINGS AND PRECAUTIONS

Angle Closure Glaucoma
  • Angle-Closure Glaucoma: The pupillary dilation that occurs following the use of many antidepressant drugs may trigger and angle closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy

Information for Patients

  • Patients should be advised that taking <DRUG NAME> can cause mild pupillary dilation, which in susceptible individuals, can lead to an episode of angle-closure glaucoma.
  • Preexisting glaucoma is almost always open-angle glaucoma because angle-closure glaucoma, when diagnosed, can be treated definitively with iridectomy. Open-angle glaucoma is not a risk factor for angle-closure glaucoma. Patients may wish to be examined to determine whether they are susceptible to angle closure, and have a prophylactic procedure (e.g., iridectomy), if they are susceptible.

ADVERSE REACTIONS

  • ‚Ķangle-closure glaucoma

MEDICATION GUIDE

Visual problems

  • eye pain
  • changes in vision
  • swelling or redness in or around the eye

Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are.

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