Paroxetine mesylate

What is Paroxetine mesylate?

• Paroxetine mesylate (BRISDELLE) is a selective serotonin reuptake inhibitor (SSRI) used for the treatment of moderate to severe vasomotor symptoms associated with menopause (VMS).

Paroxetine

What are the uses of this medicine?

• This medicine is used to reduce moderate to severe hot flashes associated with menopause.

Limitation of Use:

• BRISDELLE does not prevent or treat osteoporosis or dryness, itching or burning in and around the vagina.
• BRISDELLE is not for psychiatric problems such as depression, obsessive compulsive disorder, panic disorder, generalized anxiety disorder, social anxiety disorder, and post-traumatic stress disorder.

How does this medicine work?

• BRISDELLE is not an estrogen, and its mechanism of action for the treatment of VMS is unknown.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• take a Monoamine Oxidase Inhibitor (MAOI)
• take thioridazine
• take the antipsychotic medicine pimozide
• are allergic to paroxetine or any of the ingredients in BRISDELLE
• are pregnant

What drug interactions can this medicine cause?

• Concomitant use of thioridazine and BRISDELLE is contraindicated.
• Concomitant use of pimozide and BRISDELLE is contraindicated.
• Consider avoiding concomitant use of tamoxifen and BRISDELLE.
• Use caution if co-administering BRISDELLE with other drugs that are metabolized by CYP2D6, including nortriptyline, amitriptyline, imipramine, desipramine, fluoxetine, phenothiazines, risperidone, and Type 1C antiarrhythmics (e.g., propafenone, flecainide, and encainide).
• Use caution if co-administering BRISDELLE with other drugs that inhibit CYP2D6 (e.g., quinidine).
• concomitant use of MAOIs with BRISDELLE or use of BRISDELLE and an MAOI within 14 days of each other is contraindicated.
• Carefully monitor patients receiving warfarin therapy when BRISDELLE is initiated or discontinued.
• The concomitant use of BRISDELLE with other paroxetine products is not recommended.
• If concomitant use of BRISDELLE with other serotonergic drugs (e.g., triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, and St. John’s Wort) is clinically warranted.

Is this medicine FDA approved?

• FDA approved this drug in the year of 2013.

How should this medicine be used?

Recommended Dosage:

• 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.

Administration

• Take BRISDELLE exactly as your healthcare provider tells you to take it.
• Take BRISDELLE 1 time each day at bedtime.
• BRISDELLE may be taken with or without food.
• If you miss a dose of BRISDELLE, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of BRISDELLE at the same time.
• If you take too much BRISDELLE, call your healthcare provider or poison control center right away, or go to the nearest emergency room right away.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Capsules: 7.5 mg

This medicine is available in fallowing brand namesː

• BRISDELLE

What side effects can this medication cause?

The most common side effects of this medicine include:

• headache
• tiredness
• nausea and vomiting

BRISDELLE may cause serious side effects, including:

• Suicidal thoughts or actions
• Serotonin Syndrome
• Reduced effectiveness of tamoxifen
• Abnormal bleeding
• Visual problems
• Low salt (sodium) levels in the blood
• Bone Fractures
• Manic episodes
• Seizures or convulsions
• Restlessness
• Driving
• Sexual problems (dysfunction)

What special precautions should I follow?

• BRISDELLE can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly. You should not drive, operate heavy machinery, or do other dangerous activities until you know how BRISDELLE affects you.
• BRISDELLE is not approved for any psychiatric condition. Antidepressants, including those that contain an SSRI, increase the risk of suicidal thinking and behavior (suicidality) in pediatric and young adult patients when used to treat major depressive disorder (MDD) and other psychiatric disorders. Consider discontinuing BRISDELLE in patients with worsening depression or those who experience emergent suicidality.
• The development of a potentially life-threatening serotonin syndrome has been reported with SSRIs, including paroxetine. Discontinue BRISDELLE and initiate supportive treatment
• Efficacy of tamoxifen may be reduced when administered concomitantly with BRISDELLE.
• SSRIs, including BRISDELLE, may increase the risk of bleeding events. Caution patients about the risk of bleeding associated with the concomitant use of BRISDELLE and non-steroidal anti-inflammatory drugs (NSAIDs), aspirin, or other drugs that affect coagulation
• Angle closure glaucoma has occurred in patients who have untreated anatomically narrow angles and who are treated with antidepressants.
• Hyponatremia may occur as a result of treatment with SSRIs, including BRISDELLE. Can occur in association with syndrome of inappropriate antidiuretic hormone secretion (SIADH).
• Epidemiological studies on bone fracture risk following exposure to SSRIs have reported an association between SSRI treatment and fractures. BRISDELLE is only indicated for the treatment of moderate to severe VMS and is not approved for use in treating either depression or bipolar depression. Screen for bipolar disorder and monitor for mania/hypomania
• Use cautiously in patients with a history of seizures or with conditions that potentially lower the seizure threshold.
• Akathisia Can occur, most likely in the first few weeks of treatment.
• Use of SSRIs, including BRISDELLE, may cause symptoms of sexual dysfunction.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• Seizures
• coma
• Cardiovascular toxicity
• Hypertension
• Serotonin syndrome

Management of overedosage:

• Gastrointestinal decontamination with activated charcoal should be considered in patients who present early after a paroxetine overdose.
• Treatment should consist of those general measures employed in the management of overdosage with any SSRI.
• Ensure an adequate airway, oxygenation, and ventilation.
• Monitor cardiac rhythm and vital signs.
• General supportive and symptomatic measures are also recommended.
• Induction of emesis is not recommended.
• In managing overdosage, consider the possibility of multiple drug involvement.

Can this medicine be used in pregnancy?

• BRISDELLE is contraindicated in pregnant women because menopausal VMS does not occur during pregnancy and paroxetine can cause fetal harm.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established; BRISDELLE is not indicated in the pediatric population.

What are the active and inactive ingredients in this medicine?

• Active ingredient: paroxetine
• Inactive ingredients: dibasic calcium phosphate, sodium starch glycolate, magnesium stearate, gelatin, titanium dioxide, FD&C Yellow #6, FD&C Red #3, FD&C Red #40, shellac and black iron oxide.

Who manufactures and distributes this medicine?

• Distributed by: Sebela Pharmaceuticals Inc. 645 Hembree Parkway, Suite I

Roswell

• BRISDELLE ® is a registered trademark of Sebela International Ltd.

What should I know about storage and disposal of this medication?

• Store BRISDELLE at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep BRISDELLE out of the light.
• Keep BRISDELLE dry.
• Keep BRISDELLE and all medicines out of the reach of children.

• Dailymed label info on Paroxetine mesylate
• FDA Paroxetine mesylate

Paroxetine mesylate Resources
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The following are antidepressant subclasses and drugs

MAO Inhibitors Isocarboxazid, Phenelzine, Tranylcypromine

SNRIs Duloxetine, Levomilnacipran, Venlafaxine

SSRIs Citalopram, Escitalopram, Fluoxetine, Fluvoxamine, Paroxetine, Sertraline, Vilazodone, Vortioxetine

Tricyclics Amitriptyline, Amoxapine, Clomipramine, Desipramine, Doxepin, Imipramine, Nortriptyline, Protriptyline, Trimipramine

Miscellaneous Bupropion, Flibanserin, Mirtazapine, Nefazodone, Trazodone