Paroxetine: Difference between revisions

Paroxetine
	Black Box Warning
	Adult Indications & Dosage
	Pediatric Indications & Dosage
	Contraindications
	Warnings & Precautions
	Adverse Reactions
	Drug Interactions
	Use in Specific Populations
	Administration & Monitoring
	Overdosage
	Pharmacology
	Clinical Studies
	How Supplied
	Images
	Patient Counseling Information
	Precautions with Alcohol
	Brand Names
	Look-Alike Names

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Revision as of 16:37, 7 November 2014

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];

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Black Box Warning

Suicidality and Antidepressant Drugs

See full prescribing information for complete Boxed Warning.

Suicidality and Antidepressant Drugs:

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of paroxetine tablets or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24, there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Paroxetine tablets are not approved for use in pediatric patients. (See WARNINGS: Clinical Worsening and Suicide Risk, PRECAUTIONS: Information for Patients, and PRECAUTIONS: Pediatric Use.)

Overview

Paroxetine is an antidepressive agent that is FDA approved for the treatment of major depressive disorder, obsessive compulsive disorder, panic disorder, social anxiety disorder, generalized anxiety disorder. There is a Black Box Warning for this drug as shown here. Common adverse reactions include palpitations, vasodilatation, diaphoresis, constipation, diarrhea, loss of appetite, nausea, xerostomia, asthenia, dizziness, headache, insomnia, somnolence, tremor, blurred vision, abnormal ejaculation, erectile dysfunction, orgasm disorder, reduced libido, yawning.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Major Depressive Disorder

Dosing Information

Dosage

Obsessive Compulsive Disorder

Dosing Information

Dosage

Panic Disorder

Dosing Information

Dosage

Social Anxiety Disorder

Dosing Information

Dosage

Generalized Anxiety Disorder

Dosing Information

Dosage

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1

Developed by:

Class of Recommendation:

Strength of Evidence:

Dosing Information

Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Paroxetine in adult patients.

Non–Guideline-Supported Use

Condition1

Dosing Information

Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Paroxetine in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1

Dosing Information

Dosage

Condition2

There is limited information regarding FDA-Labeled Use of Paroxetine in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1

Developed by:

Class of Recommendation:

Strength of Evidence:

Dosing Information

Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Paroxetine in pediatric patients.

Non–Guideline-Supported Use

Condition1

Dosing Information

Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Paroxetine in pediatric patients.

Contraindications

Condition1

Warnings

Suicidality and Antidepressant Drugs

See full prescribing information for complete Boxed Warning.

Suicidality and Antidepressant Drugs:

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of paroxetine tablets or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24, there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Paroxetine tablets are not approved for use in pediatric patients. (See WARNINGS: Clinical Worsening and Suicide Risk, PRECAUTIONS: Information for Patients, and PRECAUTIONS: Pediatric Use.)

Description

Precautions

Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Paroxetine in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Paroxetine in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

Drug

Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

Pregnancy Category

Pregnancy Category (AUS):

Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Paroxetine in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Paroxetine during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Paroxetine with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Paroxetine with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Paroxetine with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Paroxetine with respect to specific gender populations.

Race

There is no FDA guidance on the use of Paroxetine with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Paroxetine in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Paroxetine in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Paroxetine in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Paroxetine in patients who are immunocompromised.

Administration and Monitoring

Administration

Oral

Intravenous

Monitoring

There is limited information regarding Monitoring of Paroxetine in the drug label.

Description

IV Compatibility

There is limited information regarding IV Compatibility of Paroxetine in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

Description

Management

Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Paroxetine in the drug label.

Pharmacology

There is limited information regarding Paroxetine Pharmacology in the drug label.

Mechanism of Action

Structure

File:Paroxetine01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Paroxetine in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Paroxetine in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Paroxetine in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Paroxetine in the drug label.

How Supplied

Storage

There is limited information regarding Paroxetine Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Paroxetine |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Paroxetine |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Paroxetine in the drug label.

Precautions with Alcohol

Alcohol-Paroxetine interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

®^[1]

Look-Alike Drug Names

A® — B®^[2]

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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[1] Empty citation (help)

[www.ismp.org-2] "http://www.ismp.org". External link in |title= (help)

[1]

[2]

@@ Line 6: / Line 6: @@
 |indicationType=treatment
 |indication=major depressive disorder, obsessive compulsive disorder, panic disorder, social anxiety disorder, generalized anxiety disorder
+|hasBlackBoxWarning=Yes
 |adverseReactions=palpitations, vasodilatation, diaphoresis, constipation, diarrhea, loss of appetite, nausea, xerostomia, asthenia, dizziness, headache, insomnia, somnolence, tremor, blurred vision, abnormal ejaculation, erectile dysfunction, orgasm disorder, reduced libido, yawning
-|blackBoxWarningTitle=Title
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-* Content
+*Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of paroxetine tablets or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24, there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide.  Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Paroxetine tablets are not approved for use in pediatric patients. (See WARNINGS: Clinical Worsening and Suicide Risk, PRECAUTIONS: Information for Patients, and PRECAUTIONS: Pediatric Use.)
 <!--Adult Indications and Dosage-->
 <!--FDA-Labeled Indications and Dosage (Adult)-->
-|fdaLIADAdult======Condition1=====
+|fdaLIADAdult======Major Depressive Disorder=====
 * Dosing Information
@@ Line 21: / Line 22: @@
 :* Dosage
-=====Condition2=====
+=====Obsessive Compulsive Disorder=====
 * Dosing Information
@@ Line 27: / Line 28: @@
 :* Dosage
-=====Condition3=====
+=====Panic Disorder=====
 * Dosing Information
@@ Line 33: / Line 34: @@
 :* Dosage
-=====Condition4=====
+=====Social Anxiety Disorder=====
+* Dosing Information
+:* Dosage
+====Generalized Anxiety Disorder====
 * Dosing Information