Suicidality and Antidepressant Drugs
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displayName: BOXED WARNING SECTION
FDA Article Code: 34066-1
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, USP 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, USP are not approved for use in pediatric patients. (See : , : and : .)
WARNINGS
Clinical Worsening and Suicide Risk
PRECAUTIONS
Information for Patients,
PRECAUTIONS
Pediatric Use
DESCRIPTION
id: 2e641e6f-17bd-48fa-b7cf-e4c6327d397b
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Paroxetine hydrochloride is an orally administered psychotropic drug. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)- -4 -(4′-fluorophenyl)-3 -[(3′,4′-methylenedioxyphenoxy) methyl] piperidine hydrochloride anhydrous and has the empirical formula of C H FNO •HCl . The molecular weight is 365.8 (anhydrous) (329.4 as free base). The structural formula of paroxetine hydrochloride is:
trans
R
S
19
20
3
Paroxetine hydrochloride is an odorless, off-white powder, having a melting point range of 116° to 120°C and a solubility of 5.4 mg/mL in water.
Each film-coated tablet, for oral administration, contains paroxetine hydrochloride equivalent to paroxetine as follows: 10 mg; 20 mg; 30 mg; 40 mg. Inactive ingredients consist of anhydrous lactose, hydroxypropyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, sodium starch glycolate and titanium dioxide. Paroxetine tablets comply with USP Related Impurities Test 1.
CLINICAL PHARMACOLOGY
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displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1
INDICATIONS AND USAGE
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displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
CONTRAINDICATIONS
id: 6589fd04-80d8-406e-8fc7-b14ae5128075
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
The use of MAOIs intended to treat psychiatric disorders with paroxetine tablets or within 14 days of stopping treatment with, paroxetine tablets is contraindicated because of an increased risk of serotonin syndrome. The use of paroxetine within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated (see and ).
WARNINGS
DOSAGE AND ADMINISTRATION
Starting paroxetine tablets in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome (see and
WARNINGS
DOSAGE AND ADMINISTRATION
).
Concomitant use with thioridazine is contraindicated (see and ).
WARNINGS
PRECAUTIONS
Concomitant use in patients taking pimozide is contraindicated (see ).
PRECAUTIONS
Paroxetine tablets, USP are contraindicated in patients with a hypersensitivity to paroxetine or any of the inactive ingredients in paroxetine tablets, USP.
WARNINGS
id: d6af08a9-50a6-47f7-b354-57cf530cb4d1
displayName: WARNINGS SECTION
FDA Article Code: 34071-1
PRECAUTIONS
id: 53d1a0a1-3a35-41ec-be64-de20387122c2
displayName: PRECAUTIONS SECTION
FDA Article Code: 42232-9
ADVERSE REACTIONS
id: d128069d-fbf6-4f55-8eb5-1db5198ea9d8
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
DRUG ABUSE AND DEPENDENCE
id: 0285271d-f641-4be3-8061-89d7270b7a1d
displayName: DRUG ABUSE AND DEPENDENCE SECTION
FDA Article Code: 42227-9
OVERDOSAGE
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displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5
DOSAGE AND ADMINISTRATION
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displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
HOW SUPPLIED
id: 506d9541-f3b6-4464-95fd-840cde217ea5
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
NDC:64725-0083-1 in a BOTTLE of 60 TABLET, FILM COATEDS
MEDICATION GUIDE
id: 979828c8-edf9-4f1c-915d-540d1cca0dd8
displayName: SPL MEDGUIDE SECTION
FDA Article Code: 42231-1
