Suicidality and Antidepressant Drugs
id: a7fceff7-821c-4480-acc9-ebcd098c11f9
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 Warnings: Clinical Worsening and Suicide Risk, Precautions: Information for Patients, and Precautions: Pediatric Use).
DESCRIPTION
id: c3981df9-6527-4703-9943-a7010790fad6
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 (-)-trans-4R-(4′-fluorophenyl)-3S-[(3′,4′-methylenedioxyphenoxy) methyl] piperidine hydrochloride anhydrous and has the empirical formula of C19H20FNO3•HCl. The molecular weight is 365.8 (anhydrous) (329.4 as free base). The structural formula of paroxetine hydrochloride is:
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 USP comply with USP Related Impurities Test 1.
CLINICAL PHARMACOLOGY
id: 164082f7-2460-4c1b-8de7-bfe5936c38f5
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1
INDICATIONS AND USAGE
id: 207be6f8-010f-4cd6-b0f0-80ede0293ba2
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
CONTRAINDICATIONS
id: 031a7e06-1914-4c9e-967d-da091d27e288
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
Concomitant use in patients taking either monoamine oxidase inhibitors (MAOIs) or thioridazine is contraindicated (see WARNINGS and PRECAUTIONS).
Concomitant use in patients taking pimozide is contraindicated (see PRECAUTIONS).
Paroxetine is contraindicated in patients with a hypersensitivity to paroxetine or any of the inactive ingredients in paroxetine.
WARNINGS
id: b153e991-ffa0-4456-adb6-ac7b56d2de05
displayName: WARNINGS SECTION
FDA Article Code: 34071-1
PRECAUTIONS
id: 46f75390-324c-400b-9ab8-c6716bd121ed
displayName: PRECAUTIONS SECTION
FDA Article Code: 42232-9
ADVERSE REACTIONS
id: 1b037175-25a0-4927-96e4-ba57f40b210c
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
DRUG ABUSE AND DEPENDENCE
id: 18982732-5df5-4fc6-9832-9b602c9a9240
displayName: DRUG ABUSE AND DEPENDENCE SECTION
FDA Article Code: 42227-9
OVERDOSAGE
id: 9b3591dc-65c5-4148-85bb-c835d21920af
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5
DOSAGE AND ADMINISTRATION
id: 92baac1a-9bb8-4f24-9d56-e3d7d9415e41
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
HOW SUPPLIED
id: ffe8407e-2c2a-4da4-93e0-0a511ed5ea06
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Paroxetine tablets USP are supplied as white to off-white, oval, film-coated tablets as follows:
10 mg scored tablets imprinted “APO” with a partial bisect on one side and “097” on the other side.
20 mg scored tablets imprinted “APO” with a partial bisect score on one side and “083” on the other side.
30 mg unscored tablets imprinted “APO” on one side and “084” on the other side.
40 mg unscored tablets imprinted “APO” on one side and “101” on the other side.
They are supplied by State of Florida DOH Central Pharmacy as follows:
|
NDC
|
Strength
|
Quantity/Form
|
Color
|
Source Prod. Code
|
| 53808-0748-1 |
10 mg |
30 Tablets in a Blister Pack |
WHITE |
60505-0097 |
| 53808-0750-1 |
20 mg |
30 Tablets in a Blister Pack |
WHITE |
60505-0083 |
| 53808-0753-1 |
30 mg |
30 Tablets in a Blister Pack |
WHITE |
60505-0084 |
| 53808-0754-1 |
40 mg |
30 Tablets in a Blister Pack |
WHITE |
60505-0101 |
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Dispense in a tight, light-resistant container [see USP].
MEDICATION GUIDE
id: ba0f06f9-a3c8-4b8e-b942-940070f51e4b
displayName: SPL MEDGUIDE SECTION
FDA Article Code: 42231-1
10mg Label
id: c01e8381-7019-430f-a05e-c34f1da8da83
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
20mg Label
id: f052ee70-f053-474c-b962-c3b02254de94
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
30mg Label
id: 2836778a-24bc-4c31-b592-2580b62a40ec
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
40mg Label
id: 0102db70-b8e9-4d3a-a689-8b786b53952d
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
