Generic Name and Formulations:
Paroxetine (as mesylate) 7.5mg; caps.
Sebela Pharmaceuticals Inc.
Indications for BRISDELLE:
Moderate-to-severe vasomotor symptoms associated with menopause.
Limitations Of use:
Not indicated for treatment of any psychiatric condition.
7.5mg once daily at bedtime.
During or within 14 days of MAOIs. Concomitant linezolid or IV methylene blue. Concomitant pimozide, thioridazine (may cause QTc prolongation). Pregnancy (Cat.X).
Suicidal thoughts and behaviors.
Increased risk of suicidal thinking and behavior in children and young adults when used to treat depressive or other psychiatric disorders; monitor all patients for clinical worsening or unusual changes; consider discontinuing if occurs. Monitor for serotonin syndrome; discontinue if occurs. Risk of hyponatremia. Volume-depleted. Screen for risk of bipolar disorder prior to initiating therapy; monitor for mania/hypomania. History of seizures or with conditions that lower the seizure threshold; evaluate and consider discontinuing if occurs. Discontinue if akathisia occurs. Angle-closure glaucoma. Elderly. Nursing mothers: not recommended.
See Contraindications. Concomitant other paroxetine-containing products: not recommended. Do not start MAOIs until at least 2 weeks after discontinuing paroxetine. Increased risk of serotonin syndrome with other serotonergic drugs (eg, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John's Wort) or with drugs that impair serotonin metabolism (eg, MAOIs, linezolid, IV methylene blue). Avoid concomitant tamoxifen. May affect, or be affected by, drugs metabolized by CYP2D6, including nortriptyline, amitriptyline, imipramine, desipramine, fluoxetine, phenothiazines, risperidone, atomoxetine, digoxin, Class 1C antiarrhythmics (eg, propafenone, flecainide, encainide), quinidine. May potentiate protein-bound drugs (eg, warfarin) and theophylline; monitor. Potentiated by cimetidine; monitor. Antagonized by phenobarbital, phenytoin, fosamprenavir/ritonavir; monitor. Increased risk of bleeding with NSAIDs, aspirin, warfarin, or others that affect coagulation. Risk of hyponatremia with diuretics.
Headache, fatigue, nausea/vomiting; abnormal bleeding, suicidal ideation, angle-closure glaucoma, hyponatremia, akathisia, serotonin syndrome, mania/hypomania, potential for bone fracture.