"The U.S. Food and Drug Administration today approved Osphena (ospemifene) to treat women experiencing moderate to severe dyspareunia (pain during sexual intercourse), a symptom of vulvar and vaginal atrophy due to menopause.
Limitation of Use
BRISDELLE is not indicated for the treatment of any psychiatric condition. BRISDELLE contains a lower dose of paroxetine than that used to treat depression, obsessive compulsive disorder, panic disorder, generalized anxiety disorder, social anxiety disorder, and post-traumatic stress disorder. The safety and efficacy of this lower dose of paroxetine in BRISDELLE have not been established for any psychiatric condition. Patients who require paroxetine for treatment of a psychiatric condition should discontinue BRISDELLE and initiate a paroxetine-containing medication that is indicated for such use.
DOSAGE AND ADMINISTRATION
The recommended dosage of BRISDELLE for the treatment of moderate to severe VMS is 7.5 mg once daily, at bedtime, with or without food.
Use of BRISDELLE Before or After a Monoamine Oxidase Inhibitor (MAOI)
Wait at least 14 days after discontinuation of an MAOI before initiating therapy with BRISDELLE. Conversely, allow at least 14 days after stopping BRISDELLE before starting an MAOI [see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS].
Dosage Forms And Strengths
BRISDELLE is available as 7.5 mg pink capsules printed with black edible ink with “NOVEN” and “7.5 mg” on the capsule. Each capsule contains 9.69 mg paroxetine mesylate equivalent to 7.5 mg paroxetine base.
Storage And Handling
BRISDELLE is available as 7.5 mg pink capsules printed with black edible ink with “NOVEN” and “7.5 mg” on each capsule.
NDC 68968-9075-3, blister packs of 30
Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). Protect from light and humidity.
Distributed by: Noven Therapeutics, LLC, Miami, FL 33186. Revised 06/2013
Last reviewed on RxList: 7/12/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Brisdelle Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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