• The mechanism of action of ZOLOFT^® is presumed to be linked to its inhibition of CNS neuronal reuptake of serotonin (5-HT)¹
• Studies at clinically relevant doses in man have demonstrated that ZOLOFT^® blocks the uptake of serotonin into human platelets¹
  
  
  

SSRI mode of action: In this figure, the serotonin reuptake inhibitor (SRI) portion of the SSRI molecule is shown inserted into the serotonin reuptake pump (the serotonin transporter, or SERT), blocking it and causing an antidepressant effect.²

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ZOLOFT^® demonstrated significant efficacy in treating depressive symptoms in patients with MDD.¹

Significant improvements of depressive symptoms with ZOLOFT^® vs placebo at Week 8, as measured by 17-item Hamilton Rating Scale for Depression (HAM-D₁₇) total score*¹

Adapted from Reimherr FW, et al. 1990.

* A double-blind, randomized, placebo-and active-controlled, parallel-group study of the efficacy and safety of ZOLOFT^® 50-200 mg/day (n=149), amitriptyline 50-150 mg/day (n=149), and placebo (n=150) in patient with DSM-III-defined major depression. After a 7- to 14-day washout period, patients were required to have a HAM-D₁₇ total score ≥18 with a <25% decrease from screening, and a higher score on the Raskin Depression Scale than on the Covi Anxiety Scale. The mean baseline HAM-D₁₇ total score was 23.29 for ZOLOFT® and 23.25 for placebo. Primary efficacy analyses included a change from baseline in HAM-D17 total score.¹ Amitriptyline data not shown.¹

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ZOLOFT^® demonstrated greater therapeutic response in clinical practice than in the clinical research setting.²

ZOLOFT^® demonstrated significantly better outcomes in clinical practice than in controlled studies^‡2

Comparison of outcomes in clinical practice and clinical research setting²

Adapted from Lydiard RB, et al. 1999.

‡ Results from a comparison of a large-scale, open-label, 8-week study of ZOLOFT^® 50-200 mg/day in adult patients 21-65 years old with DSM-III-R defined MDD and a HAM-D₁₇ score ≥18 (n=1482) vs pooled results of 2 double-blind, placebo-controlled studies (n=280). The mean baseline HAM-D₁₇ total score was 21.8 in the clinical practice population and 22.6 in the clinical research population. Overall response was assessed with HAM-D₁₇ and CGI-I scores. Response was defined as ≥50% reduction from baseline in the HAM-D₁₇ total score and achieving a CGI-I score of 1-2 at study endpoint. Remission was defined as HAM-D₁₇ total score ≤7 and CGI-I score of 1 or 2 at study endpoint.²

ZOLOFT^® demonstrated a significant reduction in OCD symptoms.³

ZOLOFT^® provided significant reductions in OCD symptoms as early as Week 3, as measured by the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) ‡³

Change from baseline in Y-BOCS scores over 12 weeks³

Adapted from Kronig MH, et al. 1999.

‡ A double-blind, randomized, placebo-controlled study of the efficacy and safety of ZOLOFT^® 50-200 mg/day (n=85) and placebo (n=79) in outpatients with moderate-to-severe OCD with a duration of illness ≥1 year. Patients had a Y-BOCS score ≥20, a National Institute of Mental Health (NIMH) Global Obsessive Compulsive Scale score ≥7, and a Clinical Global Impression (CGI) Severity Scale ≥4. The mean baseline Y-BOCS score was 25.21 for ZOLOFT^® and 25.05 for placebo. Primary assessments included a change from baseline in Y-BOCS score.³

Late life depression

ZOLOFT^® versus Fluoxetine.⁴

In a study of outpatients aged 60 years or older with MDD, ZOLOFT^® was found to be equally effective as fluoxetine for treating depressive symptoms.⁴

Effects of comorbidity and polypharmacy on ZOLOFT^® use in elderly patients with MDD.⁵

Results from an observational study of elderly depressed outpatients indicate no significant differences in adverse events with or without concurrent medications and confirm the effectiveness and safety profile of ZOLOFT^® in routine clinical practice.⁵

ZOLOFT^® can also be used to treat a broad range of other anxiety disorders⁶:

• Social anxiety disorder (SAD)
• Panic disorder (PD)
• Post-traumatic stress disorder (PTSD)

ZOLOFT^® is well tolerated in patients with acute myocardial infarctions (MI)¹ and unstable angina.²

In MDD patients with recent myocardial infarction (MI) or unstable angina, no significant changes in cardiac function were observed with ZOLOFT^® over 16 weeks vs placebo.²ᵟ

Cardiac safety profile at baseline and after 16 weeks²

BP: Blood pressure, NS: Not significant; QTC: corrected QT interval

Adapted from Glassman AH, et al. 2002.

ᵟ A 24-week, double-blind, randomized, placebo-controlled study of the safety and efficacy of ZOLOFT^® 50-200 mg/day (n=186) and placebo (n=183) in DSM-IV-defined MDD patients hospitalized for a recent diagnoses (within 30 days) of MI or unstable angina. The primary outcome measure was change from baseline in left ventricular ejection fraction (LVEF).²

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In the cardiovascular safety study with ZOLOFT^® in which no significant changes in cardiac function were observed vs placebo, ZOLOFT^® was well tolerated despite a high level of concomitant cardiovascular medication use.²**

Frequency of concomitant cardiovascular medication use²

Adapted from Glassman AH, et al. 2002

**A 24-week, double-blind, randomized, placebo-controlled study of the safety and efficacy of ZOLOFT® 50-200 mg/day (n=186) and placebo (n=183) in DSM-IV-defined MDD patients hospitalized for a recent diagnoses (within 30 days) of MI or unstable angina. The primary outcome measure was change from baseline in left ventricular ejection fraction (LVEF).²

ZOLOFT^® is well tolerated across all indications.¹

In placebo-controlled studies,ZOLOFT^® demonstrated low incidences of adverse events.¹

Adverse events with ≥5% incidence and greater than placebo²

Adapted from ZOLOFT^® US Prescribing Information (revised December 2016)

Available at:

https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019839S74S86S87_20990S35S44S45lbl.pdf

(Accessed on 30 Sep 2021)

ZOLOFT^® drug interaction profile³

ZOLOFT^® is neither a strong substrate nor a strong inhibitor of cytochrome P450 enzyme isoforms.³

 

ZOLOFT^® flexible, once-daily dosing across a number of indications.¹

Start with 50 mg once daily¹

MDD: Major Depression Disorder, PMDD: Pre-menstrual Dysphoric Disorder

Start with 25 mg once daily¹

*Monitor 50 mg/day by week 2.

SAD: Social Anxiety Disorder, PTSD: Post-Traumatic Stress Disorder, PD: Panic Disorder

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Note: Please refer to the full prescribing information before prescribing

ZOLOFT^®

Content: Sertraline hydrochloride.

Indication: Symptomatic treatment of depression including depression accompanied by anxiety in patients with or without a history of mania, obsessive compulsive disorder (OCD), panic disorder with or without agoraphobia, posttraumatic stress disorder (PTSD), social phobia (social anxiety disorder), and premenstrual dysphoric disorder (PMDD).

Dosage: Patients with depression and obsessive compulsive disorder (OCD) 50 mg/day is recommended. Maximum dose: 200mg/day. Patients with Panic disorder, Posttraumatic stress disorder (PTSD) and social phobia 25mg/day is recommended and may be increased to 50 mg a day after one week. Maximum dose: 200mg/day. Patients with premenstrual dysphoric disorder (PMDD) 50mg /day is recommended either throughout the menstrual cycle or limited to the luteal phase of the menstrual cycle. Dose could be increased up to 150 mg/day at 50mg increments per one menstrual cycle, or 100 mg a day during luteal phase.

Administration: Take with or without food, either in the morning or evening.

Contraindications: Hypersensitivity to sertraline. Concomitant use with monoamine oxidase inhibitors (MAOIs) or pimozide.

Special precautions: Increased risk of serotonin syndrome or neuroleptic malignant syndrome with concomitant use of other serotonergic drugs with sertraline (e.g. amphetamines, triptans, fentanyl and its analogues, tramadol, dextromethorphan, tapentadol, meperidine, methadone, and pentazocine), monoamine oxidase inhibitors (MAOIs), antipsychotics, and other dopamine antagonists. Co-administration with other serotonergic drugs such as tryptophan, fenfluramine, fentanyl, 5-HT agonists or St. John’s wort should be avoided. Should not be used in combination with an MAOI or within 14 days of discontinuing treatment with an MAOI. Sertraline should be used with caution in patients with risk factors for QTc prolongation/ Torsades de pointes. Care should be taken when switching from serotonin re-uptake inhibitors (SSRIs), antidepressants or anti-obsessional drugs. Activation of mania/hypomania has been reported. There are potential risk of seizures in concomitant use with anti-obsessional drugs. Sertraline should be avoided in patients with unstable epilepsy. Physicians should monitor and observe closely for clinical worsening and suicidality especially in children, adolescents and young adults from 18 to 24 years old. Caution is advised in patients with history of bleeding disorders or concomitant use with drugs affecting platelet function. Sertraline should be discontinued in patients with symptomatic hyponatremia. There is an increased risk of bone fracture. Caution should be taken for patients with hepatic and renal insufficiency. And physicians should monitor glycemic controls in diabetic patients. Also, caution should be taken for patients with history of glaucoma or angle-closure glaucoma. False positive test results may be expected following discontinuation. Sertraline may affect ability to drive or operate machinery. Caution should be taken in pregnant or lactating women, and children and adolescents below 18 years old. Adverse reactions: Insomnia, somnolence, dizziness, headache, diarrhea, nausea, ejaculation disorder, fatigue. Decreased or increased appetite, depressive symptoms, anxiety, agitation, bruxism, nightmares, decreased libido, hypertonia, tremor, paraesthesia, visual impairment, tinnitus, palpitations, hot flush, yawning, vomiting, abdominal pain, constipation, dyspepsia, dry mouth, rash, hyperhidrosis, arthralgia, sexual dysfunction , irregular menstruation, chest pain, malaise, pyrexia, asthenia, and increased weight.

Drug Interactions: Interaction with monoamine oxidase inhibitors (MAOs). Increased plasma level of pimozide. Prolongation of QTc interval and/or ventricular arrhythmias with some antipsychotics and antibiotics. Not recommended with alcohol. Increased tremor with lithium. Reduced plasma level with phenytoin. Interaction with Sumatriptan. Interaction with other serotonergic drugs and plasma protein bound drugs. Significant increase in prothrombin time with warfarin. Changes in pharmacokinetic parameters with diazepam, tolbutamide. Decreased clearance with cimetidine. Interaction with TCAs and class 1c antiarrhythmics such as propafenone and flecainide. Interaction with Desipramine.

Presentation and Packing: Film Coated tablet 50mg x 30’s.

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