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paroxetine

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Overview

What is BRISDELLE?

BRISDELLE (paroxetine) is an orally administered selective serotonin reuptake inhibitor (SSRI) for the treatment of moderate to severe VMS associated with menopause. It is identified chemically as (-)- -4R- (4’-fluorophenyl) - 3S - [(3’, 4’-methylenedioxyphenoxy) methyl] piperidine mesylate and has the empirical formula of C H FNO •CH SO H. The molecular weight is 425.5 (329.4 as free base). The structural formula is:

The mesylate salt of paroxetine is an odorless, off-white powder, having a melting point range of 147° to 150°C and a solubility of more than 1 g/mL in water.

Each pink capsule contains 9.69 mg paroxetine mesylate equivalent to 7.5 mg paroxetine base.

Inactive ingredients consist of: 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.



What does BRISDELLE look like?



What are the available doses of BRISDELLE?

Capsules: 7.5 mg ( )

What should I talk to my health care provider before I take BRISDELLE?

How should I use BRISDELLE?

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

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.

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.


What interacts with BRISDELLE?

Sorry No Records found


What are the warnings of BRISDELLE?

Sorry No Records found


What are the precautions of BRISDELLE?

Sorry No Records found


What are the side effects of BRISDELLE?

Sorry No records found


What should I look out for while using BRISDELLE?

Concurrent use with monoamine oxidase inhibitors (MAOI) or use within 14 days of MAOI use ( , , , )

Use with thioridazine ( , )

Use with pimozide ( , )

Hypersensitivity to any ingredient in BRISDELLE ( )

Pregnancy ( , )

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 .


What might happen if I take too much BRISDELLE?


How should I store and handle BRISDELLE?

Storage and HandlingStore at 20ºC-25ºC (68ºF-77ºF); excursions permitted to 15ºC- 30ºC (59ºF -86ºF) [See USP Controlled Room Temperature].Storage and HandlingStore at 20ºC-25ºC (68ºF-77ºF); excursions permitted to 15ºC- 30ºC (59ºF -86ºF) [See USP Controlled Room Temperature].BRISDELLE is available as 7.5 mg pink capsules printed with black edible ink with “BRISDELLE” and “7.5 mg” on each capsule.NDC 54766-907-53, blister packs of 30BRISDELLE is available as 7.5 mg pink capsules printed with black edible ink with “BRISDELLE” and “7.5 mg” on each capsule.NDC 54766-907-53, blister packs of 30


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Nonclinical studies have shown that paroxetine is an SSRI. BRISDELLE is not an estrogen, and its mechanism of action for the treatment of VMS is unknown.

Non-Clinical Toxicology
Concurrent use with monoamine oxidase inhibitors (MAOI) or use within 14 days of MAOI use ( , , , )

Use with thioridazine ( , )

Use with pimozide ( , )

Hypersensitivity to any ingredient in BRISDELLE ( )

Pregnancy ( , )

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 .

As with other drugs, the potential for interaction by a variety of mechanisms (e.g., pharmacodynamic, pharmacokinetic inhibition or enhancement, etc.) is a possibility (see ).

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. There is limited information regarding suicidality in women who use BRISDELLE for treatment of VMS. The BRISDELLE trials excluded women with a presence or history of previous psychiatric disorders.

Consider discontinuing BRISDELLE in patients with worsening depression or those who experience emergent suicidality or symptoms that might be precursors to worsening depression or suicidality, especially if these symptoms are severe, abrupt in onset, or were not part of the patient’s presenting symptoms.

All patients being treated with BRISDELLE should be observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of treatment.

Anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania have been reported in patients being treated with antidepressants for MDD as well as for other psychiatric and nonpsychiatric indications. Although a causal link between the emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal impulses has not been established, there is concern that such symptoms may represent precursors to emerging suicidality.

Families and caregivers of patients being treated with BRISDELLE should be alerted about the need to monitor patients for the emergence of agitation, irritability, unusual changes in behavior, and the other symptoms described above, as well as the emergence of suicidality, and to report such symptoms immediately to healthcare providers.

The following serious adverse reactions are discussed elsewhere in labeling:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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