RX ITEM-Brisdelle 7.5mg Cap 30 by Noven Therapeutics

BRISDELLE- paroxetine mesylate capsule
Sebela Pharmaceuticals Inc.

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS

Antidepressants, including selective serotonin reuptake inhibitors (SSRIs), have been shown to increase the risk of suicidal thoughts and behavior in pediatric and young adult patients when used to treat major depressive disorder and other psychiatric disorders. Because BRISDELLE is an SSRI, monitor patients closely for worsening and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber [see Warnings and Precautions ( 5.1)] .

1 INDICATIONS AND USAGE



BRISDELLE is indicated for the treatment of moderate to severe vasomotor symptoms (VMS) associated with 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.

2 DOSAGE AND ADMINISTRATION

2.1 Dosage Information
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.

2.2 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 ( 4.1), Warnings and Precautions ( 5.2) and Drug Interactions ( 7.3)] .

3 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.

Brisdelle 7.5mg Cap 30 by Noven Therapeu
NDC No. 68968-9075-03 54766-0907-53 54766-907-53 UPC/GTIN No. 3-68968-90753-4 MPN 890753 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometri

AmericanPharmaWholesale.com
Noven Therapeutics

PAROXETINE MESYLATE ORAL
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

Buy More Save More!
Want to do Research on this Med or need a large quantity? Email Details with quantity required to:[email protected]

AmericanPharmaWholesale.com
Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.