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ZOLOFT®(sertraline HCl)

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Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

ZOLOFT® Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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WARNING: SUICIDAL THOUGHTS AND BEHAVIORS

Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adult patients in short-term studies. Closely monitor all...

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1 INDICATIONS AND USAGE

ZOLOFT is indicated for the treatment of the following [See Clinical Studies (14)]:

  • Major depressive disorder (MDD)
  • Obsessive-...
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2 DOSAGE AND ADMINISTRATION

2.1 Dosage in Patients with MDD, OCD, PD, PTSD, and SAD

The recommended initial dosage and maximum ZOLOFT dosage in patients with MDD, OCD...

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3 DOSAGE FORMS AND STRENGTHS

25 mg tablets: light green film-coated, engraved on one side with "ZOLOFT" and on the other side scored and engraved with "25 mg"

50 mg...

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4 CONTRAINDICATIONS

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...
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5 WARNINGS AND PRECAUTIONS

5.1 Suicidal Thoughts and Behaviors in Pediatric and Young Adult Patients

In pooled analyses of placebo-controlled trials of antidepressant...

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6 ADVERSE REACTIONS

The following adverse reactions are described in more detail in other sections of the prescribing information:

  • Hypersensitivity reactions to sertraline [See...
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7 DRUG INTERACTIONS

7.1 Clinically Significant Drug Interactions

Table 5 includes clinically significant drug interactions with ZOLOFT [See...

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Overall, available...

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9 DRUG ABUSE AND DEPENDENCE

9.1 Controlled Substance

ZOLOFT contains sertraline, which is not a controlled substance.

...
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10 OVERDOSAGE

Human Experience

The most common signs and symptoms associated with non-fatal ZOLOFT overdosage were somnolence, vomiting,...

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11 DESCRIPTION

ZOLOFT contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Sertraline potentiates serotonergic activity in the central nervous system through inhibition of neuronal reuptake...

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13 NONCLINICALTOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

...

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14 CLINICAL STUDIES

Efficacy of ZOLOFT was established in the following trials:

  • MDD: two short-term trials and one maintenance trials in adults [See

    14.1 Major Depressive Disorder...

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16 HOW SUPPLIED/STORAGE AND HANDLING

ZOLOFT 25 mg tablets: light green, film-coated, capsular-shaped tablets engraved on one side with "ZOLOFT" and on the other side scored and engraved with "25 mg"

...
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  This Medication Guide has been approved by the U.S. Food and Drug Administration
Medication Guide
ZOLOFT (ZOH-loft)
(sertraline...
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This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com.

...

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