BRISDELLE

Brisdelle Generic Name & Formulations

Legal Class

General Description

Paroxetine (as mesylate) 7.5mg; caps.

Pharmacological Class

SSRI.

How Supplied

Caps—30

Manufacturer

Sebela Pharmaceuticals Inc.

Generic Availability

YES

Mechanism of Action

The mechanism of action of Brisdelle for the treatment of vasomotor symptoms is unknown.

Brisdelle Indications

Indications

Moderate to severe vasomotor symptoms associated with menopause.

Limitations of Use

Not indicated for treatment of any psychiatric condition.

Brisdelle Dosage and Administration

Adult

7.5mg once daily at bedtime.

Children

Not established.

Brisdelle Contraindications

Contraindications

During or within 14 days of MAOIs. Concomitant linezolid or IV methylene blue. Concomitant pimozide, thioridazine (may cause QTc prolongation). Pregnancy (Cat.X).

Brisdelle Boxed Warnings

Boxed Warning

Suicidal thoughts and behaviors.

Brisdelle Warnings/Precautions

Warnings/Precautions

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.

Brisdelle Pharmacokinetics

Absorption

Steady-state paroxetine concentrations were achieved by ~12 days. Peak concentrations were reached at a median of 6 hours (3–8 hours range).

Distribution

Paroxetine distributes throughout the body, including the central nervous system, with only 1% remaining in the plasma. Plasma protein bound: ≥93%.

Metabolism

CYP2D6.

Elimination

Renal (~64%), fecal (36%).

Brisdelle Interactions

Interactions

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, SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, meperidine, methadone, amphetamines, 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.

Brisdelle Adverse Reactions

Adverse Reactions

Headache, fatigue, nausea/vomiting; abnormal bleeding, suicidal ideation, hyponatremia, akathisia, serotonin syndrome, mania/hypomania, potential for bone fracture, sexual dysfunction.

Brisdelle Clinical Trials

See Literature

Brisdelle Note

Not Applicable

Brisdelle Patient Counseling