FLUOXETINE tablet, film coated

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

FLUOXETINE HYDROCHLORIDE (UNII: I9W7N6B1KJ) (FLUOXETINE - UNII:01K63SUP8D)

Dostopno od:

PEL HEALTHCARE LLC

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

Fluoxetine is indicated for the acute and maintenance treatment of Major Depressive Disorder in adult patients and in pediatric patients aged 8 to 18 years [see Clinical Studies (14.1)]. The usefulness of the drug in adult and pediatric patients receiving fluoxetine for extended periods should periodically be re-evaluated [see Dosage and Administration (2.1)]. Fluoxetine is indicated for the acute and maintenance treatment of obsessions and compulsions in adult patients and in pediatric patients aged 7 to 17 years with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2)]. The effectiveness of fluoxetine in long-term use, i.e., for more than 13 weeks, has not been systematically evaluated in placebo-controlled trials. Therefore, the physician who elects to use fluoxetine for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient [see Dosage and Administration (2.2)]. Fluoxetine is indicated for the acute and maintenance treatment of

Povzetek izdelek:

Fluoxetine Tablets, USP are available containing fluoxetine hydrochloride, USP equivalent to 10 mg or 20 mg of fluoxetine. The 10 mg  tablets are white to off-white, film-coated, oval-shaped, functionally scored tablets, debossed with “G” bisect “W” on one side of the tablet and “1604” on the other side. They are available as follows: NDC  80426-044-01 bottles of 30 tablets NDC 80426-044-02 bottles of 100 tablets The 20 mg  tablets are white to off-white, film-coated, oval-shaped, functionally scored tablet, debossed with “G” bisect “W” on one side of the tablet and “1605” on the other side. They are available as follows: NDC 80426-045-01 bottles of 30 tablets NDC 80426-045-02 bottles of 100 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]   Protect from light.   Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

FLUOXETINE - FLUOXETINE TABLET, FILM COATED
PEL HEALTHCARE LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FLUOXETINE TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
FLUOXETINE TABLETS.
FLUOXETINE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1987
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
• INCREASED RISK OF SUICIDAL THINKING AND BEHAVIOR IN CHILDREN,
ADOLESCENTS, AND YOUNG
ADULTS TAKING ANTIDEPRESSANTS (5.1).
• MONITOR FOR WORSENING AND EMERGENCE OF SUICIDAL THOUGHTS AND
BEHAVIORS (5.1).
_WHEN USING FLUOXETINE AND OLANZAPINE IN COMBINATION, ALSO REFER TO
BOXED WARNING_
_SECTION OF THE PACKAGE INSERT FOR SYMBYAX ._
RECENT MAJOR CHANGES
Warnings and Precautions, Serotonin Syndrome (5.2) 07/2023
Warning and Precaution (5.7) 07/2023
INDICATIONS AND USAGE
Fluoxetine is a selective serotonin reuptake inhibitor indicated for:
• Acute and maintenance treatment of Major Depressive Disorder (MDD)
in adult and pediatric patients
aged 8 to 18 years (1.1)
• Acute and maintenance treatment of Obsessive Compulsive Disorder
(OCD) in adults and pediatric
patients aged 7 to 17 years (1.2)
• Acute and maintenance treatment of Bulimia Nervosa in adult
patients (1.3)
• Acute treatment of Panic Disorder, with or without agoraphobia, in
adult patients (1.4)
DOSAGE AND ADMINISTRATION
INDICATION
ADULT
PEDIATRIC
MDD (2.1)
20 mg/day in am (initial dose)
10 mg/day to 20 mg/day (initial
dose)
OCD (2.2)
20 mg/day in am (initial dose)
10 mg/day (initial dose)
Bulimia Nervosa (2.3)
60 mg/day in am
Panic Disorder (2.4)
10 mg/day (initial dose)
• A lower or less frequent dosage should be used in patients with
hepatic impairment, the elderly, and for
patients with concurrent disease or on multiple concomitant
medications (2.7)
DOSAGE FORMS AND STRENGTHS
Tablets: 10 mg, 20 mg (3)
CONTRAINDICATIONS
Serotonin Syndrome and MAOIs: Do not use MAOIs intended to treat
psychiatric disorders