Sertraline Hydrochloride Tablets
Revised: August 2007
Rx only

/Sertraline Hydrochloride Tablets
Revised: August 2007
Rx only
Sertraline Hydrochloride Tablets
Revised: August 2007
Rx only
2018-09-06T09:12:40+00:00

Prescription Drug Name:

Sertraline Hydrochloride Tablets
Revised: August 2007
Rx only

ID:

B1BB1367-2E16-CDC8-0E5E-F125D6876BEF

Code:

34391-3

Suicidality and Antidepressant Drugs


id: 55EC2621-C6F6-3161-74D7-24F92FB3C04E
displayName: BOXED WARNING SECTION
FDA Article Code: 34066-1

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of sertraline hydrochloride tablets or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Sertraline hydrochloride tablets are not approved for use in pediatric patients except for patients with obsessive compulsive disorder (OCD). (See Warnings: Clinical Worsening and Suicide Risk, Precautions: Information for Patients, and Precautions: Pediatric Use)

DESCRIPTION


id: 7088AC36-BF0A-F153-ECCF-08D5D69C2FFE
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Sertraline hydrochloride tablets are a selective serotonin reuptake inhibitor (SSRI) for oral administration. It has a molecular weight of 342.7. Sertraline hydrochloride has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The molecular formula C17H17NCl2•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.Sertraline hydrochloride tablets are supplied for oral administration as tablets containing sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: corn starch, D&C yellow no. 10 aluminum lake (in 25 mg), FD&C blue no. 2 aluminum lake (in 25 mg and 50 mg), FD&C yellow no. 6 aluminum lake (in 25 mg), hypromellose, iron oxide yellow (in 100 mg), magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate and titanium dioxide.

INDICATIONS AND USAGE


id: 4630D5B3-E8CE-0327-91CB-4C9A7E36755F
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

Major Depressive Disorder–Sertraline hydrochloride tablets are indicated for the treatment of major depressive disorder in adults.The efficacy of sertraline hydrochloride tablets in the treatment of a major depressive episode was established in six to eight week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III category of major depressive disorder (seeClinical Trials under CLINICAL PHARMACOLOGY).A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation.The antidepressant action of sertraline hydrochloride tablets in hospitalized depressed patients has not been adequately studied.The efficacy of sertraline hydrochloride tablets in maintaining an antidepressant response for up to 44 weeks following 8 weeks of open-label acute treatment (52 weeks total) was demonstrated in a placebo-controlled trial. The usefulness of the drug in patients receiving sertraline hydrochloride tablets for extended periods should be reevaluated periodically (seeClinical Trials under CLINICAL PHARMACOLOGY).

CONTRAINDICATIONS


id: 8E739EE4-EB16-C584-D720-AFF6E9C355DB
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

Concomitant use in patients taking monoamine oxidase inhibitors (MAOIs) is contraindicated (seeWARNINGS). Concomitant use in patients taking pimozide is contraindicated (seePRECAUTIONS).Sertraline hydrochloride tablets are contraindicated in patients with a hypersensitivity to sertraline or any of the inactive ingredients in sertraline hydrochloride tablets.

WARNINGS


id: A12C8AEE-4691-907B-6B0A-1C9597A38BD4
displayName: WARNINGS SECTION
FDA Article Code: 34071-1

Cases of serious sometimes fatal reactions have been reported in patients receiving sertraline hydrochloride, a selective serotonin reuptake inhibitor (SSRI), in combination with a monoamine oxidase inhibitor (MAOI). Symptoms of a drug interaction between an SSRI and an MAOI include: hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, mental status changes that include confusion, irritability, and extreme agitation progressing to delirium and coma. These reactions have also been reported in patients who have recently discontinued an SSRI and have been started on an MAOI. Some cases presented with features resembling neuroleptic malignant syndrome. Therefore, sertraline hydrochloride should not be used in combination with an MAOI, or within 14 days of discontinuing treatment with an MAOI. Similarly, at least 14 days should be allowed after stopping sertraline hydrochloride before starting an MAOI.

ADVERSE REACTIONS


id: 0A398202-7EF6-89E4-DD3B-C1F11213F086
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4

During its premarketing assessment, multiple doses of sertraline hydrochloride were administered to over 4000 adult subjects as of February 18, 2000. The conditions and duration of exposure to sertraline hydrochloride varied greatly, and included (in overlapping categories) clinical pharmacology studies, open and double-blind studies, uncontrolled and controlled studies, inpatient and outpatient studies, fixed-dose and titration studies, and studies for multiple indications, including major depressive disorder.Untoward events associated with this exposure were recorded by clinical investigators using terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse events without first grouping similar types of untoward events into a smaller number of standardized event categories.In the tabulations that follow, a World Health Organization dictionary of terminology has been used to classify reported adverse events. The frequencies presented, therefore, represent the proportion of the over 4000 adult individuals exposed to multiple doses of sertraline hydrochloride who experienced a treatment-emergent adverse event of the type cited on at least one occasion while receiving sertraline hydrochloride. An event was considered treatment-emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation. It is important to emphasize that events reported during therapy were not necessarily caused by it.The prescriber should be aware that the figures in the tables and tabulations cannot be used to predict the incidence of side effects in the course of usual medical practice where patient characteristics and other factors differ from those that 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 nondrug factors to the side effect incidence rate in the population studied.Incidence in Placebo-Controlled Trials–Table 2 enumerates the most common treatment-emergent adverse events associated with the use of sertraline hydrochloride (incidence of at least 5% for sertraline hydrochloride and at least twice that for placebo within at least one of the indications) for the treatment of adult patients with major depressive disorder/other*, in placebo-controlled clinical trials. Most patients in major depressive disorder/other* studies received doses of 50 to 200 mg/day.

TABLE 2 MOST COMMON TREATMENT-EMERGENT ADVERSE EVENTS: INCIDENCE IN PLACEBO-CONTROLLED CLINICAL TRIALS
Percentage of Patients Reporting Event
Major Depressive Disorder/Other*
Body System/Adverse Event Sertraline hydrochloride Placebo
(N=861) (N=853)
(1)Primarily ejaculatory delay. Denominator used was for male patients only (N=271 Sertraline hydrochloride major depressive disorder/other*; N=271 placebo major depressive disorder/other*).
*Major depressive disorder and other premarketing controlled trials.
Autonomic Nervous System Disorders
Ejaculation Failure(1) 7 <1
Mouth Dry 16 9
Sweating Increased 8 3
Centr. & Periph. Nerv. System Disorders
Somnolence 13 6
Tremor 11 3
Dizziness 12 7
General
Fatigue 11 8
Pain 1 2
Malaise <1 1
Gastrointestinal Disorders
Abdominal Pain 2 2
Anorexia 3 2
Constipation 8 6
Diarrhea/Loose Stools 18 9
Dyspepsia 6 3
Nausea 26 12
Psychiatric Disorders
Agitation 6 4
Insomnia 16 9
Libido Decreased 1 <1
Associated with Discontinuation in Placebo-Controlled Clinical Trials Table 3 lists the adverse events associated with discontinuation of sertraline hydrochloride treatment (incidence at least twice that for placebo and at least 1% for sertraline hydrochloride in clinical trials) in major depressive disorder/other*.
TABLE 3 MOST COMMON ADVERSE EVENTS ASSOCIATED WITH DISCONTINUATION IN PLACEBO-CONTROLLED CLINICAL TRIALS
Adverse Event Major Depressive Disorder/ Other*
(N=861)
(1) Primarily ejaculatory delay. Denominator used was for male patients only (N=271 major depressive disorder/other*).
*   Major depressive disorder and other premarketing controlled trials.
Abdominal Pain
Agitation 1%
Anxiety
Diarrhea/Loose Stools 2%
Dizziness
Dry Mouth 1%
Dyspepsia
Ejaculation Failure(1) 1%
Fatigue
Headache 2%
Hot Flushes
Insomnia 1%
Nausea 4%
Nervousness
Palpitation
Somnolence 1%
Tremor 2%

DRUG ABUSE AND DEPENDENCE


id: 41B00BA8-EC03-22C8-953B-FC0749424BF5
displayName: DRUG ABUSE & DEPENDENCE SECTION
FDA Article Code: 42227-9

Controlled Substance Class– sertraline hydrochloride is not a controlled substance.Physical and Psychological Dependence–In a placebo-controlled, double-blind, randomized study of the comparative abuse liability of sertraline hydrochloride, alprazolam, and d-amphetamine in humans, sertraline hydrochloride did not produce the positive subjective effects indicative of abuse potential, such as euphoria or drug liking, that were observed with the other two drugs. Premarketing clinical experience with sertraline hydrochloride did not reveal any tendency for a withdrawal syndrome or any drug-seeking behavior. In animal studies sertraline hydrochloride does not demonstrate stimulant or barbiturate-like (depressant) abuse potential. As with any CNS active drug, however, physicians should carefully evaluate patients for history of drug abuse and follow such patients closely, observing them for signs of sertraline hydrochloride misuse or abuse (e.g., development of tolerance, incrementation of dose, drug-seeking behavior).

OVERDOSAGE


id: 0C4CA360-9746-2FB1-178E-9091F5A3834A
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5

Human Experience– Of 1,027 cases of overdose involving sertraline hydrochloride worldwide, alone or with other drugs, there were 72 deaths (circa 1999).Among 634 overdoses in which sertraline hydrochloride was the only drug ingested, 8 resulted in fatal outcome, 75 completely recovered, and 27 patients experienced sequelae after overdosage to include alopecia, decreased libido, diarrhea, ejaculation disorder, fatigue, insomnia, somnolence and serotonin syndrome. The remaining 524 cases had an unknown outcome. The most common signs and symptoms associated with non-fatal sertraline hydrochloride overdosage were somnolence, vomiting, tachycardia, nausea, dizziness, agitation and tremor.The largest known ingestion was 13.5 grams in a patient who took sertraline hydrochloride alone and subsequently recovered. However, another patient who took 2.5 grams of sertraline hydrochloride alone experienced a fatal outcome.Other important adverse events reported with sertraline hydrochloride overdose (single or multiple drugs) include bradycardia, bundle branch block, coma, convulsions, delirium, hallucinations, hypertension, hypotension, manic reaction, pancreatitis, QT-interval prolongation, serotonin syndrome, stupor and syncope.Overdose Management–Treatment should consist of those general measures employed in the management of overdosage with any antidepressant.Ensure an adequate airway, oxygenation and ventilation. Monitor cardiac rhythm and vital signs. General supportive and symptomatic measures are also recommended. Induction of emesis is not recommended. Gastric lavage with a large-bore orogastric tube with appropriate airway protection, if needed, may be indicated if performed soon after ingestion, or in symptomatic patients.Activated charcoal should be administered. Due to large volume of distribution of this drug, forced diuresis, dialysis, hemoperfusion and exchange transfusion are unlikely to be of benefit. No specific antidotes for sertraline are known.In managing overdosage, consider the possibility of multiple drug involvement. The physician should consider contacting a poison control center on the treatment of any overdose. Telephone numbers for certified poison control centers are listed in the Physicians’ Desk Reference® (PDR®).

HOW SUPPLIED


id: 838C876C-6167-4A96-E0E0-7170B1C361BF
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Sertraline hydrochloride tablets are supplied in capsule-shaped tablets containing sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline, are packaged in bottles.Sertraline hydrochloride 25 mg Tablets: green film coated tablets debossed WPI on one side and on the other side debossed 32 to the left of the score line and 38 to the right of the score line.Bottles of 30 and 90Sertraline hydrochloride 50 mg Tablets: blue film coated tablets debossed WPI on one side and on the other side 32 debossed to the left of the score line and 39 to the right of the score line.Bottles of 30, 90 and 1000Sertraline hydrochloride 100 mg Tablets: yellow film coated tablets debossed WPI on one side and on the other side 32 to the left of the score line and 40 to the right of the score line.Bottles of 30, 90 and 1000