Sertraline Hydrochloride Tablets

40-9094

Revised – July 2008

Rx only

/Sertraline Hydrochloride Tablets

40-9094

Revised – July 2008

Rx only

Sertraline Hydrochloride Tablets

40-9094

Revised – July 2008

Rx only

2018-09-06T09:12:40+00:00

Prescription Drug Name:

Sertraline Hydrochloride Tablets

40-9094

Revised – July 2008

Rx only

ID:

26BD97A0-0B1F-D7B8-27C0-6104C79FFBC1

Code:

34391-3

BOXED WARNING


id: C2B5D5EF-E226-6C40-D066-AF8B6661FF4F
displayName: BOXED WARNING SECTION
FDA Article Code: 34066-1

Suicidality and Antidepressant Drugs 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 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 the treatment of major depressive disorder in pediatric patients. (See Warnings: Clinical Worsening and Suicide Risk, Precautions: Information for Patients, and Precautions: Pediatric Use).

DESCRIPTION


id: AD26653C-F542-433D-40BD-FD53E16A39F4
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Sertraline hydrochloride is 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 is supplied for oral administration as scored tablets equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium starch glycolate, titanium dioxide, and triacetin. The 50 mg tablet also contains: FD & C Yellow #6 Aluminum Lake. The 100 mg tablet also contains: D & C Red #27 Phloxine Aluminum Lake, FD&C Blue #1 Brilliant Blue FCF Aluminum Lake, and FD&C Red #40 Allura Red AC Aluminum Lake.

INDICATIONS AND USAGE


id: 87385860-F969-4BBA-6BDE-05E576D6D5B2
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 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 (see Clinical 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 in hospitalized depressed patients has not been adequately studied. The efficacy of sertraline hydrochloride 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 for extended periods should be reevaluated periodically (see Clinical Trials under CLINICAL PHARMACOLOGY).

CONTRAINDICATIONS


id: C268DF5C-139D-1764-2706-5A7793684132
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

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

ADVERSE REACTIONS


id: 2D4AB9EC-EF3F-F83D-36CC-AD7EFC1EA5AA
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 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 1 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) 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

(N=861)

Placebo


(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
Central & Peripheral
Nervous 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

DRUG ABUSE AND DEPENDENCE


id: 2934D3B2-5FE1-AF6F-6BED-1EA22250123F
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: F841C7F3-18BE-3359-BD63-62909F80476F
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: 184036BA-FDC1-ACDF-8078-C6C11F425CA8
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Sertraline hydrochloride tablets are available as follows: 25 mg – Each white to off-white, capsule-shaped, film coated tablet imprinted with and 721 on one side and bisect on the other side contains sertraline hydrochloride equivalent to 25 mg sertraline.  Tablets are supplied in bottles of 30 (NDC 0228-2721-03) and 90 (NDC 0228-2721-09) with a child-resistant closure, and 500 (NDC 0228-2721-50) without a child-resistant closure. 50 mg – Each orange, capsule-shaped, film coated tablet imprinted with and 722 on one side and bisect on the other side contains sertraline hydrochloride equivalent to 50 mg sertraline.  Tablets are supplied in bottles of 30 (NDC 0228-2722-03) and 90 (NDC 0228-2722-09) with a child-resistant closure, and 3000 (NDC 0228-2722-90) without a child-resistant closure. 100 mg – Each pink, capsule-shaped, film coated tablet imprinted with and 723 on one side and bisect on the other side contains sertraline hydrochloride equivalent to 100 mg sertraline.  Tablets are supplied in bottles of 30 (NDC 0228-2723-03) and 90 (NDC 0228-2723-09) with a child-resistant closure, and 1000 (NDC 0228-2723-96) without a child-resistant closure. Dispense in a tight, light-resistant container as defined in the USP. Store at 25º C (77º F); excursions permitted to 15º-30º C (59º-86º F) [see USP Controlled Room Temperature]. Manufactured by Actavis Elizabeth LLC 200 Elmora Avenue Elizabeth, NJ 07207 USA 40-9094 Revised – July 2008