ZOLOFT- sertraline hydrochloride tablet, film coated

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

REMEDYREPACK INC.

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

ZOLOFT is 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) ZOLOFT is 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)]. In addition to the contraindications for all ZOLOFT formulations listed above, ZOLOFT ora

Bidhaa muhtasari:

ZOLOFT 50 mg tablets: light blue, film-coated, capsular-shaped tablets engraved on one side with "ZOLOFT" and on the other side scored and engraved with "50 mg" NDC: 70518-1913-00 PACKAGING: 30 in 1 BLISTER PACK Store ZOLOFT 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]. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Idhini hali ya:

New Drug Application

Taarifa za kipeperushi

REMEDYREPACK INC.
----------
Repackaged By / Distributed By: RemedyRepack Inc.
625 Kolter Drive, Indiana, PA 15701
[phone]
This Medication Guide has been approved by the U.S. Food and Drug
Administration
Medication Guide
ZOLOFT (ZOH-loft)
(sertraline hydrochloride)
Tablets and Oral Solution
What is the most important information I should know about ZOLOFT?
ZOLOFT 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.
•
Suicidal thoughts or actions:
•
ZOLOFT 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 ZOLOFT is 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
•
Serotonin Syndrome. This condition can be life-threatening and
symptoms may include:
•
agitation, hallucinations, coma, or other changes in
mental status
•
racing

Tabia za bidhaa

ZOLOFT- SERTRALINE HYDROCHLORIDE TABLET, FILM COATED
REMEDYREPACK INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZOLOFT SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ZOLOFT.
ZOLOFT (SERTRALINE HYDROCHLORIDE) TABLETS, FOR ORAL USE
ZOLOFT (SERTRALINE HYDROCHLORIDE) ORAL SOLUTION
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)
INDICATIONS AND USAGE
ZOLOFT is a selective serotonin reuptake inhibitor (SSRI) indicated
for the treatment of ( 1):
Major depressive disorder (MDD)
Obsessive-compulsive disorder (OCD)
Panic disorder (PD)
Post-traumatic 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 6–12)
50 mg per day (ages ≥ 13)
200 mg per day
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
dosing
50 mg per day during luteal phase
only
100 mg per day during luteal phase
only
If inadequate response to starting dosage, titrate in 25–50 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 ZOLOFT, reduce dose gradually ( 2.6, 5.4)
Oral solution: Must be diluted before administration ( 2.7)
DOSAGE FORMS AND STRENGTHS
Tablets: 25 mg, 50 mg and 100 mg ( 3)
Oral solution: 20 mg/mL ( 3)
CONTRAINDICATIONS
Concomitant use of monoamine oxidase inhibitor