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‑naphthalenamine hydrochloride. The empirical formula C 17 H 17 NCl 2 •HCl is represented by the following structural formula: Sertraline hydrochloride is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. ZOLOFT tablets for oral...

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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 a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of: • Major depressive disorder (MDD) • Obsessive-compulsive disorder (OCD) • Panic disorder (PD) • Posttraumatic stress d...

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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 tablets : light blue film-coated, engraved on one side with “ZOLOFT” and on the other side scored and engraved with “50 mg” 100 mg tablets : light yellow film-coated, engraved on one side with “ZOLOFT” and on the other side scored and engraved with “100 mg” Oral solution : a clear, colorless solution with a menthol scent containing sertraline hydrochloride equi...

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Indication Starting Dosage Maximum Dosage MDD 50 mg per day 200 mg per day OCD 25 mg per day (ages 6-12) 50 mg per day (ages ≥ 13) 200 mg per day PD, PTSD, SAD 25 mg per day 200 mg per day PMDD continuous dosing 50 mg per day 150 mg per day PMDD 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 • See Full Prescribing Infor...

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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 , Drug Interactions ] . • Taking pimozide [See Drug Interactions ] . • 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 or...

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The following have been reported with sertraline tablet overdosage: • Seizures, which may be delayed, and altered mental status including coma. • Cardiovascular toxicity, which may be delayed, including QRS and QTc interval prolongation. Hypertension most commonly seen, but rarely can see hypotension alone or with co-ingestants including alcohol. • Serotonin syndrome (patients with a multiple drug overdosage with other proserotonergic drugs may have a higher risk). Gastrointestinal decontamination ...

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• Serotonin Syndrome: Increased risk when co-administered with other serotonergic agents, but also when taken alone. If it occurs, discontinue ZOLOFT and serotonergic agents and initiate supportive treatment. • Increased Risk of Bleeding: Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), other antiplatelet drugs, warfarin, and other anticoagulants may increase this risk. • Activation of Mania/Hypomania: Screen patients for bipolar disorder. • Seizures: Use with caution in pa...

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• Protein-bound drugs: Monitor for adverse reactions and reduce dosage of ZOLOFT or other protein-bound drugs (e.g., warfarin) as warranted. ( 7.1 , 12.3 ) • CYP2D6 substrates: Reduce dosage of drugs metabolized by CYP2D6. ( 7.1 , 12.3 ) 7.1 Clinically Significant Drug Interactions Table 5 includes clinically significant drug interactions with ZOLOFT [See Clinical Pharmacology ] . Table 5. Clinically-Significant Drug Interactions with ZOLOFT Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact: The ...

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8.1 Pregnancy 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 Registry for Antidepressants at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/research/pregnancyregistry/antidepressants . Risk Summary Based on data from published observational studies, exposure to SSRIs, particularly i...

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