SERTRALINE tablet, film coated

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Nunua Sasa

Shusha Taarifa za kipeperushi (PIL)
05-10-2023
Shusha Tabia za bidhaa (SPC)
05-10-2023

Viambatanisho vya kazi:

SERTRALINE HYDROCHLORIDE (UNII: UTI8907Y6X) (SERTRALINE - UNII:QUC7NX6WMB)

Inapatikana kutoka:

Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14) ]: • Major depressive disorder (MDD) • Obsessive-compulsive disorder (OCD) • Panic disorder (PD) • Posttraumatic stress disorder (PTSD) • Social anxiety disorder (SAD) • Premenstrual dysphoric disorder (PMDD) Sertraline hydrochloride tablets are contraindicated in patients: - Taking, or within 14 days of stopping, MAOIs, (including the MAOIs linezolid and intravenous methylene blue) because of an increased risk of serotonin syndrome [See Warnings and Precautions (5.2), Drug Interactions (7.1) ]. - Taking pimozide [See Drug Interactions (7.1) ]. - With known hypersensitivity to sertraline (e.g., anaphylaxis, angioedema) [See Adverse Reactions (6.1, 6.2) ]. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers should encourage patients to enroll by calling the National Pregnancy

Bidhaa muhtasari:

Sertraline Hydrochloride Tablets USP, 25 mg are available as light green, film coated, elliptical shaped tablets, scored on one side of tablet and debossed with "757" on the other side, packaged in bottles of 30 (NDC 23155-757-03), 90 (NDC 23155-757-09) and 500 tablets (NDC 23155-757-05). Sertraline Hydrochloride Tablets USP, 50 mg are available as light blue, film coated, elliptical shaped tablets, scored on one side of tablet and debossed with "758" on the other side, packaged in bottles of 30 (NDC 23155-758-03), 90 (NDC 23155-758-09), 500 tablets (NDC 23155-758-05), and 5000 tablets (NDC 23155-758-69). Sertraline Hydrochloride Tablets USP, 100 mg are available as light yellow, film coated, elliptical shaped tablets, scored on one side of tablet and debossed with "759" on the other side, packaged in bottles of 30 (NDC 23155-759-03), 90 (NDC 23155-759-09) and 500 tablets (NDC 23155-759-05). Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Idhini hali ya:

Abbreviated New Drug Application

Taarifa za kipeperushi

                                SERTRALINE- SERTRALINE TABLET, FILM COATED
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
----------
Dispense with Medication Guide available at:
www.avetpharma.com/product.
Medication Guide
Sertraline Hydrochloride Tablets, USP
(ser' tra leen hye'' droe klor' ide)
What is the most important information I should know about sertraline
hydrochloride tablets?
Sertraline hydrochloride tablets and other antidepressant medicines
may cause serious side effects. Call
your healthcare provider right away if you have any of the following
symptoms, or call 911 if there is an
emergency.
1. Suicidal thoughts or actions:
•
Sertraline hydrochloride tablets and other antidepressant medicines
may increase suicidal thoughts
or actions in some people 24 years of age and younger, especially
within the first few months of
treatment or when the dose is changed.
•
Depression or other serious mental illnesses are the most important
causes of suicidal thoughts or
actions.
•
Watch for these changes and call your healthcare provider right away
if you notice new or sudden
changes in mood, behavior, actions, thoughts, or feelings, especially
if severe.
•
Pay particular attention to such changes when sertraline hydrochloride
tablets are started or
when the dose is changed.
•
Keep all follow-up visits with your healthcare provider and call
between visits if you are
worried about symptoms.
Call your healthcare provider right away if you have any of the
following symptoms, or call 911 if an
emergency, especially if they are new, worse, or worry you:
•
attempts to commit suicide
•
acting aggressive or violent
•
new or worse depression
•
feeling agitated, restless, angry or irritable
•
an increase in activity or talking more than what is normal for you
•
acting on dangerous impulses
•
thoughts about suicide or dying
•
new or worse anxiety or panic attacks
•
trouble sleeping
•
other unusual changes in behavior or mood
2. Serotonin Syndrome. This condition can be life-threatening and
symptoms may include:

                                
                                Soma hati kamili
                                
                            

Tabia za bidhaa

                                SERTRALINE- SERTRALINE TABLET, FILM COATED
HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SERTRALINE
HYDROCHLORIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
SERTRALINE HYDROCHLORIDE TABLETS.
SERTRALINE HYDROCHLORIDE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1991
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
• Antidepressants increased the risk of suicidal thoughts and
behaviors in pediatric and young adult
patients (5.1)
• Closely monitor for clinical worsening and emergence of suicidal
thoughts and behaviors (5.1)
RECENT MAJOR CHANGES
Warnings and Precautions (5.2, 5.3) 08/2023
INDICATIONS AND USAGE
Sertraline hydrochloride tablets are a selective serotonin reuptake
inhibitor (SSRI) indicated for the
treatment of (1):
• Major depressive disorder (MDD)
• Obsessive-compulsive disorder (OCD)
• Panic disorder (PD)
• Posttraumatic stress disorder (PTSD)
• Social anxiety disorder (SAD)
• Premenstrual dysphoric disorder (PMDD)
DOSAGE AND ADMINISTRATION
INDICATION
STARTING DOSAGE
MAXIMUM DOSAGE
MDD (2.1)
50 mg per day
200 mg per day
OCD (2.1)
25 mg per day (ages 6 to 12)
200 mg per day
50 mg per day (ages ≥ 13)
PD, PTSD, SAD (2.1)
25 mg per day
200 mg per day
PMDD (2.2) continuous dosing
50 mg per day
150 mg per day
PMDD (2.2) intermittent dosing50 mg per day during luteal phase
only100 mg per day during luteal phase only
• If inadequate response to starting dosage, titrate in 25 to 50 mg
per day increments once weekly in
MDD,OCD, PD,PTSD,and SAD (2.1)
• See Full Prescribing Information for titration in PMDD (2.2)
• Hepatic impairment:
Mild: Recommended starting and maximum dosage is half recommended
dosage (2.4)
Moderate or severe: Not recommended (2.4)
• When discontinuing sertraline hydrochloride, reduce dose gradually
(2.6, 5.4)
DOSAGE FORMS AND STRENGTHS
Tablets: 25 mg, 50 mg
                                
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