IPG-CITALOPRAM

1 Adverse Reaction Overview During the premarketing clinical development, 3652 patients received citalopram hydrobromide for the treatment of depression. Of these patients, 66% were females and 34% were males. The mean age of the patients was 50 years, with 70% being <60 years old (30% <40 years old, 40% 40 to 59 years old) and 30% being ≥60 years old.

Adverse events observed with citalopram hydrobromide are in general mild and transient. They usually attenuate during the first one or two weeks of treatment. 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.

9% (163/1027) of the citalopram hydrobromide -treated patients discontinued treatment due to an adverse event. 7% (33/426). 1% vs. 4% vs. 4% vs. 3% vs. 3% vs. 2% vs. 1% vs. 1% vs. 2%). Incidence of Adverse Events in Placebo-controlled Studies Table 2 enumerates the incidence of treatment emergent adverse events that occurred in 1027 depressed patients who received citalopram hydrobromide at doses ranging from 10 to 80 mg/day in placebo - controlled trials of up to 6 weeks in duration.

Events included are those occurring in 2% or more of patients treated with citalopram hydrobromide, and for which the incidence in patients treated with citalopram hydrobromide was greater than the incidence in placebo-treated patients.

Reported adverse events were classified using the standard World Health Organization (WHO)-based dictionary terminology. The prescriber should be aware that these figures cannot be used to predict the incidence of IPG-CITALOPRAM (citalopram hydrobromide) Page 18 of 49 adverse events in the course of usual medical practice where patient characteristics and other factors differ from those which prevailed in the clinical trials.

Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and non-drug factors to the adverse event incidence rate in the population studied.

1 Pregnant Women 07/2022 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES .................................................................................

2 TABLE OF CONTENTS ....................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION ......................................................................

1 Pediatrics .................................................................................................................... 2 Geriatrics ....................................................................................................................

4 2 CONTRAINDICATIONS ....................................................................................................... 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................. 5 4 DOSAGE AND ADMINISTRATION ......................................................................................

1 Dosing Considerations ............................................................................................... 2 Recommended Dose and Dosage Adjustment........................................................... 4 Administration .............................................................................................................

5 Missed Dose ............................................................................................................... 7 5 OVERDOSAGE .....................................................................................................................

8 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .............................. 9 7 WARNINGS AND PRECAUTIONS ....................................................................................... 1 Special Populations ..................................................................................................

• IPG-CITALOPRAM is contraindicated in patients who are hypersensitive to citalopram hydrobromide 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.

2 Drug Interactions Overview, 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, citalopram 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 MAO inhibitor and methylene blue, which is a MAOI).

Similarly, at least 14 days should elapse after discontinuing citalopram treatment before starting a MAOI. • Pimozide Citalopram should not be used in combination with the antipsychotic drug pimozide, as IPG-CITALOPRAM (citalopram hydrobromide) Page 5 of 49 results from a controlled study indicate that concomitant use is associated with an increased risk of QTc prolongation compared to pimozide alone.

2 Drug Interactions Overview, Drugs That Prolong the QT Interval • QT Prolongation IPG-CITALOPRAM is contraindicated in patients with known QT interval prolongation or with congenital long QT syndrome. 2 Drug Interactions Overview, Drugs That Prolong the QT Interval;