TEVA-ESCITALOPRAM

1 Pregnant Women 08/2022 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. 1 Pediatrics ...........................................................................................................

2 Geriatrics ........................................................................................................... 1 Dosing Considerations .......................................................................................

2 Recommended Dose and Dosage Adjustment ................................................... 4 Administration ................................................................................................... 5 Missed Dose.......................................................................................................

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1 Adverse Reaction Overview Adverse events information for escitalopram oxalate was collected from 715 patients with major depressive disorder (MDD) who were exposed to escitalopram oxalate and from 592 patients who were exposed to placebo in double-blind, placebo-controlled trials.

During clinical trials, all treatment groups were comparable with respect to gender, age and race. The mean age of patients was 41 years (18 to 76 years). Of these patients, approximately 66% were females and 34% were males. 4% (97/592) on placebo.

2%). 5% vs. 8% vs. 0% of male patients). Most Frequent Adverse Events Adverse events that occurred in escitalopram-treated patients in the course of the short-term, placebo-controlled trials with an incidence greater than, or equal to, 10% were: headache and nausea.

The incidence of headache was higher in the placebo group, which suggests that this is a non-specific symptom related to the underlying condition or treatment administration. The point prevalence of nausea increased during the first week (as expected with an SSRI) and then decreased to approach placebo levels by the end of the studies.

2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.

Adverse reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. Major Depressive Disorder Table 2 enumerates the incidence of treatment-emergent adverse events that occurred in 715 depressed patients who received escitalopram oxalate at doses ranging from 10 to 20 mg/day in placebo-controlled trials of up to 8 weeks in duration.

1 Pregnant Women 08/2022 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. 1 Pediatrics ...........................................................................................................

2 Geriatrics ........................................................................................................... 1 Dosing Considerations .......................................................................................

2 Recommended Dose and Dosage Adjustment ................................................... 4 Administration ................................................................................................... 5 Missed Dose.......................................................................................................

9 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ........................... 10 7 WARNINGS AND PRECAUTIONS ............................................................................. 1 Special Populations ..........................................................................................

1 Pregnant Women ......................................................................................... 2 Breast-feeding .............................................................................................. 3 Pediatrics......................................................................................................

4 Geriatrics ...................................................................................................... 19 8 ADVERSE REACTIONS .............................................................................................

1 Adverse Reaction Overview ............................................................................. 2 Clinical Trial Adverse Reactions ....................................................................... 1 Clinical Trial Adverse Reactions – Pediatrics.................................................

• TEVA-ESCITALOPRAM is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.

4 Drug- Drug Interactions, QT Interval Prolongation). 4 Drug-Drug Interactions, Monoamine Oxidase Inhibitors). With the co-administration of an SSRI with MAOI, there have been reports of serious, sometimes fatal reactions including hyperthermia, rigidity, myoclonus, autonomic instability with possible fluctuations of vital signs, and mental status changes, including extreme agitation progressing to delirium and coma.

Some cases presented with features resembling serotonin syndrome. Therefore, TEVA-ESCITALOPRAM should not be used in combination with a MAOI or within 14 days of discontinuing treatment with a MAOI (including linezolid, an antibiotic which is a reversible non-selective MAOI, and methylene blue, which is a MAOI).

Similarly, at least 14 days should elapse after discontinuing TEVA-ESCITALOPRAM treatment before starting a MAOI. • Pimozide TEVA-ESCITALOPRAM should not be used in combination with the antipsychotic drug pimozide, as results from a controlled study with racemic citalopram indicate that concomitant use is associated with an increased risk of QTc prolongation compared to pimozide alone.

4 Drug-Drug Interactions).