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SERTRALINE Hydrochloride Tablets, Oral Solution (GREENSTONE LLC)

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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.

SERTRALINE Hydrochloride Tablets, Oral Solution (GREENSTONE LLC) 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

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

  • Major depressive disorder...
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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 sertraline hydrochloride dosage in...

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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

Sertraline hydrochloride is contraindicated in patients:

  • Taking, or within 14 days of stopping, MAOIs, (including the MAOIs linezolid and intravenous methylene blue) because of an...
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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...

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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 sertraline hydrochloride...

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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

Sertraline hydrochloride is not a controlled substance.

...
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10 OVERDOSAGE

Human Experience

The most common signs and symptoms associated with non-fatal sertraline hydrochloride overdosage were...

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11 DESCRIPTION

Sertraline hydrochloride is 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-naphthalenamine...

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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 sertraline hydrochloride was established in the following trials:

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

    14.1...

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16 HOW SUPPLIED/STORAGE AND HANDLING

Sertraline hydrochloride 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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17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Suicidal...

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Medication Guide
SERTRALINE HYDROCHLORIDE
Tablets and Oral Solution
This Medication Guide has been approved by the U.S. Food and...
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This product's label may have been updated. For current full prescribing information, please visit www.greenstonellc.com.

...

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