Sertraline Tablets, USP, 25mg, 50mg and 100 mg

/Sertraline Tablets, USP, 25mg, 50mg and 100 mg
Sertraline Tablets, USP, 25mg, 50mg and 100 mg2018-09-06T09:12:40+00:00

Prescription Drug Name:

Sertraline Tablets, USP, 25mg, 50mg and 100 mg

ID:

c5bbefe1-3d7f-4687-a8f4-b11782d014c0

Code:

34391-3

BOXED WARNING


id: 7bf6b871-09b9-4379-9a9b-6bdb989e8471
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: 51f9c85b-5d41-4a24-9fb1-3934c58c8d91
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, USP has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C17H17NCl2•HCl is represented by the following structural formula: Sertraline hydrochloride, USP is a white crystalline powder that is slightly soluble in water and isopropyl alcohol and sparingly soluble in ethanol. Sertraline tablets, USP are supplied for oral administration as scored tablets containing sertraline hydrochloride equivalent to 25 mg, 50 mg and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, opadry green (titanium dioxide, hypromellose 3cP, hypromellose 6cP, Macrogol/Peg 400, Polysorbate 80, D&C Yellow # 10 Aluminum Lake, and FD&C Blue # 2/Indigo Carmine Aluminum Lake for 25mg tablet), opadry light blue (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400,  FD&C Blue # 2/Indigo Carmine Aluminum Lake and Polysorbate 80 for 50 mg tablet), opadry yellow (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, Polysorbate 80, Iron Oxide Yellow, Iron oxide Red for 100mg tablet) and sodium starch glycolate.

INDICATIONS AND USAGE


id: 118b56c1-b520-4664-a9b3-89a83db3fc9b
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

Major Depressive Disorder– Sertraline hydrochloride is 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). Obsessive-Compulsive Disorder– Sertraline hydrochloride is indicated for the treatment of obsessions and compulsions in patients with obsessive-compulsive disorder (OCD), as defined in the DSM-III-R; i.e., the obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning. The efficacy of Sertraline hydrochloride was established in 12-week trials with obsessive-compulsive outpatients having diagnoses of obsessive-compulsive disorder as defined according to DSM-III or DSM-III-R criteria (see Clinical Trials under CLINICAL PHARMACOLOGY). Obsessive-compulsive disorder is characterized by recurrent and persistent ideas, thoughts, impulses, or images (obsessions) that are ego-dystonic and/or repetitive, purposeful, and intentional behaviors (compulsions) that are recognized by the person as excessive or unreasonable. The efficacy of Sertraline hydrochloride in maintaining a response, in patients with OCD who responded during a 52-week treatment phase while taking Sertraline hydrochloride and were then observed for relapse during a period of up to 28 weeks, was demonstrated in a placebo-controlled trial (see Clinical Trials under CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use Sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Panic Disorder– Sertraline hydrochloride is indicated for the treatment of panic disorder in adults, with or without agoraphobia, as defined in DSM-IV. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks. The efficacy of Sertraline hydrochloride was established in three 10-12 week trials in adult panic disorder patients whose diagnoses corresponded to the DSM-III-R category of panic disorder (see Clinical Trials under CLINICAL PHARMACOLOGY). Panic disorder (DSM-IV) is characterized by recurrent unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart, or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded, or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes. The efficacy of Sertraline hydrochloride in maintaining a response, in adult patients with panic disorder who responded during a 52-week treatment phase while taking Sertraline hydrochloride and were then observed for relapse during a period of up to 28 weeks, was demonstrated in a placebo-controlled trial (see Clinical Trials under CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use Sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Posttraumatic Stress Disorder (PTSD)– Sertraline hydrochloride (sertraline hydrochloride) is indicated for the treatment of posttraumatic stress disorder in adults. The efficacy of Sertraline hydrochloride in the treatment of PTSD was established in two 12-week placebo-controlled trials of adult outpatients whose diagnosis met criteria for the DSM-III-R category of PTSD (see Clinical Trials under CLINICAL PHARMACOLOGY). PTSD, as defined by DSM-III-R/IV, requires exposure to a traumatic event that involved actual or threatened death or serious injury, or threat to the physical integrity of self or others, and a response which involves intense fear, helplessness, or horror. Symptoms that occur as a result of exposure to the traumatic event include reexperiencing of the event in the form of intrusive thoughts, flashbacks or dreams, and intense psychological distress and physiological reactivity on exposure to cues to the event; avoidance of situations reminiscent of the traumatic event, inability to recall details of the event, and/or numbing of general responsiveness manifested as diminished interest in significant activities, estrangement from others, restricted range of affect, or sense of foreshortened future; and symptoms of autonomic arousal including hypervigilance, exaggerated startle response, sleep disturbance, impaired concentration, and irritability or outbursts of anger. A PTSD diagnosis requires that the symptoms are present for at least a month and that they cause clinically significant distress or impairment in social, occupational, or other important areas of functioning. The efficacy of Sertraline hydrochloride in maintaining a response in adult patients with PTSD for up to 28 weeks following 24 weeks of open-label treatment was demonstrated in a placebo-controlled trial. Nevertheless, the physician who elects to use Sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Premenstrual Dysphoric Disorder (PMDD) – Sertraline hydrochloride is indicated for the treatment of premenstrual dysphoric disorder (PMDD) in adults. The efficacy of sertraline hydrochloride in the treatment of PMDD was established in 2 placebo-controlled trials of female adult outpatients treated for 3 menstrual cycles who met criteria for the DSM-IIIR/IV category of PMDD (see Clinical Trials under CLINICAL PHARMACOLOGY). The essential features of PMDD include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. Other features include decreased interest in activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. Physical symptoms associated with PMDD include breast tenderness, headache, joint and muscle pain, bloating and weight gain. These symptoms occur regularly during the luteal phase and remit within a few days following onset of menses; the disturbance markedly interferes with work or school or with usual social activities and relationships with others. In making the diagnosis, care should be taken to rule out other cyclical mood disorders that may be exacerbated by treatment with an antidepressant. The effectiveness of Sertraline hydrochloride in long-term use, that is, for more than 3 menstrual cycles, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use Sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Social Anxiety Disorder – Sertraline hydrochloride is indicated for the treatment of social anxiety disorder, also known as social phobia in adults. The efficacy of Sertraline hydrochloride in the treatment of social anxiety disorder was established in two placebo-controlled trials of adult outpatients with a diagnosis of social anxiety disorder as defined by DSM-IV criteria (see Clinical Trials under CLINICAL PHARMACOLOGY). Social anxiety disorder, as defined by DSM-IV, is characterized by marked and persistent fear of social or performance situations involving exposure to unfamiliar people or possible scrutiny by others and by fears of acting in a humiliating or embarrassing way. Exposure to the feared social situation almost always provokes anxiety and feared social or performance situations are avoided or else are endured with intense anxiety or distress. In addition, patients recognize that the fear is excessive or unreasonable and the avoidance and anticipatory anxiety of the feared situation is associated with functional impairment or marked distress. The efficacy of Sertraline hydrochloride in maintaining a response in adult patients with social anxiety disorder for up to 24 weeks following 20 weeks of Sertraline hydrochloride treatment was demonstrated in a placebo-controlled trial. Physicians who prescribe Sertraline hydrochloride for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see Clinical Trials under CLINICAL PHARMACOLOGY).

CONTRAINDICATIONS


id: 8fbb0b26-68e8-4487-9e98-558d6f1ee901
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

All Dosage Forms of Sertraline: The use of MAOIs intended to treat psychiatric disorders with Sertraline hydrochloride or within 14 days of stopping treatment with Sertraline hydrochloride is contraindicated because of an because of an increased risk if serotonin syndrome.  The use of Sertraline hydrochloride within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated (see WARNINGS and DOSAGE AND ADMINISTRATION). Starting Sertraline hydrochloride in a patient who is being treated with MAOIs such as linezolid or intravenous methyelene blue is also contraindicated because of an increased risk of serotonin syndrome (see WARNINGS and DOSAGE AND ADMINISTRATION). Concomitant use in patients taking pimozide is contraindicated (see PRECAUTIONS). Sertraline is contraindicated in patients with a hypersensitivity to sertraline or any of the inactive ingredients in sertraline hydrochloride tablets.

WARNINGS


id: 36bcedd8-2d2b-4625-9310-468668bced6f
displayName: WARNINGS SECTION
FDA Article Code: 34071-1

Clinical Worsening and Suicide Risk Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide. There has been a long-standing concern, however, that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment. Pooled analyses of short-term placebo-controlled trials of antidepressant drugs (SSRIs and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18-24) with major depressive disorder (MDD) and other psychiatric disorders. 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 with antidepressants compared to placebo in adults aged 65 and older. The pooled analyses of placebo-controlled trials in children and adolescents with MDD, obsessive compulsive disorder (OCD), or other psychiatric disorders included a total of 24 short-term trials of 9 antidepressant drugs in over 4400 patients. The pooled analyses of placebo-controlled trials in adults with MDD or other psychiatric disorders included a total of 295 short-term trials (median duration of 2 months) of 11 antidepressant drugs in over 77,000 patients. There was considerable variation in risk of suicidality among drugs, but a tendency toward an increase in the younger patients for almost all drugs studied. There were differences in absolute risk of suicidality across the different indications, with the highest incidence in MDD. The risk differences (drug vs placebo), however, were relatively stable within age strata and across indications. These risk differences (drug-placebo difference in the number of cases of suicidality per 1000 patients treated) are provided in Table 1.

Table 1
 Age Range  Drug-Placebo Difference in Number of Cases of Suicidality per 1000 Patients Treated
   Increases Compared to placebo
 <18  14 additional cases
 18-24  5 additional cases
   Decreases Compared to placebo
 25-64  1 fewer case
 >65  6 fewer cases
No suicides occurred in any of the pediatric trials. There were suicides in the adult trials, but the number was not sufficient to reach any conclusion about drug effect on suicide. It is unknown whether the suicidality risk extends to longer-term use, i.e., beyond several months. However, there is substantial evidence from placebo-controlled maintenance trials in adults with depression that the use of antidepressants can delay the recurrence of depression. All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases. The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric. Although a causal link between the emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal impulses has not been established, there is concern that such symptoms may represent precursors to emerging suicidality. Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidality, especially if these symptoms are severe, abrupt in onset, or were not part of the patient’s presenting symptoms. If the decision has been made to discontinue treatment, medication should be tapered, as rapidly as is feasible, but with recognition that abrupt discontinuation can be associated with certain symptoms (see PRECAUTIONS and DOSAGE AND ADMINISTRATION—Discontinuation of Treatment with sertraline hydrochloride, for a description of the risks of discontinuation of Sertraline hydrochloride). Families and caregivers of patients being treated with antidepressants for major depressive disorder or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients for the emergence of agitation, irritability, unusual changes in behavior, and the other symptoms described above, as well as the emergence of suicidality, and to report such symptoms immediately to health care providers. Such monitoring should include daily observation by families and caregivers. Prescriptions for Sertraline hydrochloride should be written for the smallest quantity of tablets consistent with good patient management, in order to reduce the risk of overdose. Screening Patients for Bipolar Disorder: A major depressive episode may be the initial presentation of bipolar disorder. It is generally believed (though not established in controlled trials) that treating such an episode with an antidepressant alone may increase the likelihood of precipitation of a mixed/manic episode in patients at risk for bipolar disorder. Whether any of the symptoms described above represent such a conversion is unknown. However, prior to initiating treatment with an antidepressant, patients with depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression. It should be noted that sertraline hydrochloride is not approved for use in treating bipolar depression. Serotonin Syndrome: The development of a potentially life-threatening serotonin syndrome has been reported with SNRIs and SSRIs, including Sertraline hydrochloride, alone but particularly with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John’s Wort) and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue). Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms(e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Patients should be monitored for the emergence of serotonin syndrome. The concomitant use of sertraline hydrochloride with MAOIs intended to treat psychiatric disorders is contraindicated. Sertraline hydrochloride should also not be started in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue. All reports with methylene blue that provided information on the route of administration involved intravenous administration in the dose range of 1 mg/kg to 8 mg/kg. No reports involved the administration of methylene blue by other routes (such as oral tablets or local tissue injection) or at lower doses. There may be circumstances when it is necessary to initiate treatment with a MAOI such as linezolid or intravenous methylene blue in a patient taking sertraline hydrochloride. Sertraline hydrochloride should be discontinued before initiating treatment with the MAOI (see CONTRAINDICATIONS and DOSAGE AND ADMINISTRATION). If concomitant use of sertraline hydrochloride with other serotonergic drugs including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, buspirone, tryptophan, and St. John’s Wort is clinically warranted, patients should be made aware of a potential increased risk for serotonin syndrome, particularly during treatment initiation and dose increases. Treatment with Sertraline hydrochloride and any concomitant serotonergic agents should be discontinued immediately if the above events occur and supportive symptomatic treatment should be initiated. Angle-Closure Glaucoma: The pupillary dilation that occurs following use of many antidepressant drugs including sertraline may trigger an angle closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy.

ADVERSE REACTIONS


id: 091236d1-ca4b-448c-bf80-6e7c3bccff1f
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 and PMDD. 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*, OCD, panic disorder, PTSD, PMDD and social anxiety disorder in placebo-controlled clinical trials. Most patients in major depressive disorder/other*, OCD, panic disorder, PTSD and social anxiety disorder studies received doses of 50 to 200 mg/day. Patients in the PMDD study with daily dosing throughout the menstrual cycle received doses of 50 to 150 mg/day, and in the PMDD study with dosing during the luteal phase of the menstrual cycle received doses of 50 to 100 mg/day. Table 3 enumerates treatment-emergent adverse events that occurred in 2% or more of adult patients treated with Sertraline hydrochloride and with incidence greater than placebo who participated in controlled clinical trials comparing Sertraline hydrochloride with placebo in the treatment of major depressive disorder/other*, OCD, panic disorder, PTSD, PMDD and social anxiety disorder. Table 3 provides combined data for the pool of studies that are provided separately by indication in Table 2.

TABLE 2 MOST COMMON TREATMENT-EMERGENT ADVERSE EVENTS: INCIDENCE IN PLACEBO-CONTROLLED CLINICAL TRIALS
 *Major depressive disorder and other premarketing controlled trials.
  (
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*; N=296 sertraline hydrochloride OCD; N=219 placebo OCD; N=216 sertraline hydrochloride panic disorder; N=134 placebo panic disorder; N=130 sertraline hydrochloride PTSD; N=149 placebo PTSD; No male patients in PMDD studies; N=205 sertraline hydrochloride social anxiety disorder; N=153 placebo social anxiety disorder).
  (
2
)The luteal phase and daily dosing PMDD trials were not designed for making direct comparisons between the two dosing regimens. Therefore, a comparison between the two dosing regimens of the PMDD trials of incidence rates shown in Table 2 should be avoided.
                                              
Percentage 
of 
Patients 
Reporting 
Event

   Major        
Depressive 
Disorder
/
Other
*

 OCD

 Panic 
Disorder

 PTSD

 Body 
System
/
Adverse 
Event 

 Sertraline 
(
N
=
861
)

 Placebo 
(
N
=
853
)

 Sertraline 
(
N
=
533
)

 Placebo 
(
N
=
373
)

 Sertraline 
(
N
=
430
)

 Placebo 
(
N
=
275
)

 Sertraline 
(
N
=
374
)

 Placebo 
(
N
=
376
)

 Autonomic 
Nervous 
System 
Disorders 

 Ejaculation Failure(
1
) 
 7  <1  17  2  19  1  11  1
 Mouth Dry   16  9  14  9  15  10  11  6
 Sweating Increased   8  3  6  1  5  1  4  2
 Center


Peripheral

Nervous

System 
Disorders 

 Somnolence   13  6  15  8  15  9  13  9
 Tremor   11  3  8  1  5  1  5  1
 Dizziness   12  7  17  9  10  10  8  5
 General 

               
 Fatigue   11  8  14  10  11  6  10  5
 Pain   1  2  3  1  3  3  4  6
 Malaise   <1  1  1  1  7  14  10  10
 Gastrointestinal 
Disorders 

 Abdominal Pain   2   2  5  5  6  7  6  5
 Anorexia   3   2  11  2  7  2  8  2
 Constipation   8   6  6  4  7  3  3  3
 Diarrhea/Loose Stools   18   9  24  10  20  9  24  15
 Dyspepsia   6   3  10  4  10  8  6  6
 Nausea   26   12  30  11  29  18  21  11
 Psychiatric 
Disorders 

 Agitation   6   4  6  3  6  2  5  5
 Insomnia   16   9  28  12  25  18  20  11
 Libido Decreased   1   <1  11  2  7  1  7  2
 Percentage 
of 
Patients 
Reporting 
Event

   PMDD 
Daily 
Dosing

   PMDD 
Luteal 
Phase 
Dosing

(


2


)

   Social 
Anxiety 
Disorder

 Body 
System
/
Adverse 
Event 

 Sertraline 
(
N
=
121

 Placebo 
(
N
=
122

   Sertraline 
(
N
=
136
)

 Placebo 
(
N
=
127
)

   Sertraline 
(
N
=
344
)

 Placebo 
(
N
=
268
)

 Autonomic 
Nervous 
System 
Disorders 

 Ejaculation Failure(
1
) 
 N/A  N/A    N/A  N/A    14  –
 Mouth Dry   6  3    10  3    12  4
 Sweating Increased   6  <1    3  0    11  2
 Center


Peripheral

Nervous

System 
Disorders 

 Somnolence   7  <1    2  0    9  6
 Tremor   2  0    <1  <1    9  3
 Dizziness   6  3    7  5    14  6
 General 

               
 Fatigue   16  7    10  <1    12  6
 Pain   6  <1    3  2    1  3
 Malaise   9  5    7  5    8  3
 Gastrointestinal 
Disorders 

 Abdominal Pain   7  <1    3  3    5  5
 Anorexia   3  2    5  0    6  3
 Constipation   2  3    1  2    5  3
 Diarrhea/Loose Stools   13  3    13  7    21  8
 Dyspepsia   7  2    7  3    13  5
 Nausea   23  9    13  3    22  8
 Psychiatric 
Disorders 

 Agitation   2  <1    1  0    4  2
 Insomnia   17  11    12  10    25  10
 Libido Decreased   11  2    4  2    9  3
TABLE 3 TREATMENT-EMERGENT ADVERSE EVENTS: INCIDENCE IN PLACEBO-CONTROLLED CLINICAL TRIALSPercentage of Patients Reporting Event Major Depressive Disorder/Other*, OCD, Panic Disorder, PTSD, PMDD and Social Anxiety Disorder combined
  (1) Primarily ejaculatory delay. Denominator used was for male patients only (N=1118 Sertraline hydrochloride; N=926 placebo).
 *Major depressive disorder and other premarketing controlled trials.
 **Included are events reported by at least 2% of patients taking Sertraline hydrochloride except the following events, which had an incidence on placebo greater than or equal to Sertraline hydrochloride: abdominal pain, back pain, flatulence, malaise, pain, pharyngitis, respiratory disorder, upper respiratory tract infection.
 Body System/Adverse Event**  Sertraline
(N=2799)
 Placebo
(N=2394)
 Autonomic 
Nervous 
System 
Disorders

   
 Ejaculation Failure (
1
)
 14  1
 Mouth Dry  14  8
 Sweating Increased  7  2
 Center


Periph

Nerv

System 
Disorders

   
 Somnolence  13  7
 Dizziness  12  7
 Headache  25  23
 Paresthesia  2  1
 Tremor  8  2
 Disorders 
of 
Skin 
and 
Appendages

   
 Rash  3  2
 Gastrointestinal 
Disorders

   
 Anorexia  6  2
 Constipation  6  4
 Diarrhea/Loose Stools  20  10
 Dyspepsia  8  4
 Nausea  25  11
 Vomiting  4  2
 General

   
 Fatigue  12  7
 Psychiatric 
Disorders

   
 Agitation  5  3
 Anxiety  4  3
 Insomnia  21  11
 Libido Decreased  6  2
 Nervousness  5  4
 Special 
Senses

   
 Vision Abnormal  3  2
Associated with Discontinuation in Placebo-Controlled Clinical Trials Table 4 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*, OCD, panic disorder, PTSD, PMDD, and social anxiety disorder.
TABLE 4 MOST COMMON ADVERSE EVENTS ASSOCIATED WITH DISCONTINUATION IN PLACEBO-CONTROLLED CLINICAL TRIALS
  (1)Primarily ejaculatory delay. Denominator used was for male patients only (N=271 major depressive disorder/other*; N=296 OCD; N=216 panic disorder; N=130 PTSD; No male patients in PMDD studies; N=205 social anxiety disorder).
 *Major depressive disorder and other premarketing controlled trials.
 Adverse
Event
 Major Depressive Disorder/Other*,
OCD, panic Disorder, PSTD, PMDD 
and Social Anxiety Disorder combined
(N=2799)
 Major
Depressive Disorder/
Other*
(N=861)
 

OCD
(N=533)

 

Panic Disorder
(N=430)

 

PTSD
(N=374)

 

PMDD
Daily
Dosing
(N=121)

 
PMDD
Luteal Phase Dosing
(N=136)
 
Social
Anxiety
Disorder
(N=344)
 Abdominal Pain  –  –  –  –  –  –  –  1%
 Agitation  –  1%  –  2%  –  –  –  –
 Anxiety  –  –  –  –  –  –  –  2%
 Diarrhea/ Loose Stools  2%  2%  2%  1%  –  2%  –  –
 Dizziness  –  –  1%  –  –  –  –  –
 Dry Mouth  –  1%  –  –  –  –  –  –
 Dyspepsia  –  –  –  1%  –  –  –  –
 Ejaculation Failure(
1
)
 1%  1%  1%  2%  –  N/A  N/A  2%
 Fatigue  –  –  –  –  –  –  –  2%
 Headache  1%  2%  –  –  1%  –  –  2%
 Hot Flushes  –  –  –  –  –  –  1%  –
 Insomnia  2%  1%  3%  2%  –  –  1%  3%
 Nausea  3%  4%  3%  3%  2%  2%  1%  2%
 Nervousness  –  –  –  –  –  2%  –  –
 Palpitation  –  –  –  –  –  –  1%  –
 Somnolence  1%  1%  2%  2%  –  –  –  –
 Tremor  –  2%  –  –  –  –  –  –
Male and Female Sexual Dysfunction with SSRIs Although changes in sexual desire, sexual performance and sexual satisfaction often occur as manifestations of a psychiatric disorder, they may also be a consequence of pharmacologic treatment. In particular, some evidence suggests that selective serotonin reuptake inhibitors (SSRIs) can cause such untoward sexual experiences. Reliable estimates of the incidence and severity of untoward experiences involving sexual desire, performance and satisfaction are difficult to obtain, however, in part because patients and physicians may be reluctant to discuss them. Accordingly, estimates of the incidence of untoward sexual experience and performance cited in product labeling, are likely to underestimate their actual incidence. Table 5 below displays the incidence of sexual side effects reported by at least 2% of patients taking Sertraline hydrochloride in placebo-controlled trials.
TABLE 5
  *Denominator used was for male patients only (N=1118 Sertraline hydrochloride; N=926 placebo)
  **Denominator used was for male and female patients (N=2799 Sertraline hydrochloride; N=2394 placebo)
 Adverse Event  Sertraline  Placebo
 Ejaculation failure*(primarily delayed ejaculation)  14%  1%
 Decreased libido**  6%  1%
There are no adequate and well-controlled studies examining sexual dysfunction with sertraline treatment. Priapism has been reported with all SSRIs. While it is difficult to know the precise risk of sexual dysfunction associated with the use of SSRIs, physicians should routinely inquire about such possible side effects. Other Adverse Events in Pediatric Patients–In over 600 pediatric patients treated with Sertraline hydrochloride, the overall profile of adverse events was generally similar to that seen in adult studies. However, the following adverse events, from controlled trials, not appearing in Tables 2 and 3, were reported at an incidence of at least 2% and occurred at a rate of at least twice the placebo rate (N=281 patients treated with Sertraline hydrochloride): fever, hyperkinesia, urinary incontinence, aggressive reaction, sinusitis, epistaxis and purpura. Other Events Observed During the Premarketing Evaluation of Sertraline hydrochloride–Following is a list of treatment-emergent adverse events reported during premarketing assessment of Sertraline hydrochloride in clinical trials (over 4000 adult subjects) except those already listed in the previous tables or elsewhere in labeling. 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 an event of the type cited on at least one occasion while receiving Sertraline hydrochloride. All events are included except those already listed in the previous tables or elsewhere in labeling and those reported in terms so general as to be uninformative and those for which a causal relationship to Sertraline hydrochloride treatment seemed remote. It is important to emphasize that although the events reported occurred during treatment with Sertraline hydrochloride, they were not necessarily caused by it. Events are further categorized by body system and listed in order of decreasing frequency according to the following definitions: frequent adverse events are those occurring on one or more occasions in at least 1/100 patients; infrequent adverse events are those occurring in 1/100 to 1/1000 patients; rare events are those occurring in fewer than 1/1000 patients. Events of major clinical importance are also described in the PRECAUTIONS section. Autonomic Nervous System DisordersFrequent: impotence; Infrequent: flushing, increased saliva, cold clammy skin, mydriasis; Rare: pallor, glaucoma, priapism, vasodilation. Body as a WholeGeneral DisordersRare: allergic reaction, allergy. CardiovascularFrequent: palpitations, chest pain; Infrequent: hypertension, tachycardia, postural dizziness, postural hypotension, periorbital edema, peripheral edema, hypotension, peripheral ischemia, syncope, edema, dependent edema; Rare: precordial chest pain, substernal chest pain, aggravated hypertension, myocardial infarction, cerebrovascular disorder. Central and Peripheral Nervous System DisordersFrequent: hypertonia, hypoesthesia; Infrequent: twitching, confusion, hyperkinesia, vertigo, ataxia, migraine, abnormal coordination, hyperesthesia, leg cramps, abnormal gait, nystagmus, hypokinesia; Rare: dysphonia, coma, dyskinesia, hypotonia, ptosis, choreoathetosis, hyporeflexia. Disorders of Skin and AppendagesInfrequent: pruritus, acne, urticaria, alopecia, dry skin, erythematous rash, photosensitivity reaction, maculopapular rash; Rare: follicular rash, eczema, dermatitis, contact dermatitis, bullous eruption, hypertrichosis, skin discoloration, pustular rash. Endocrine DisordersRare: exophthalmos, gynecomastia. Gastrointestinal DisordersFrequent: appetite increased; Infrequent: dysphagia, tooth caries aggravated, eructation, esophagitis, gastroenteritis; Rare: melena, glossitis, gum hyperplasia, hiccup, stomatitis, tenesmus, colitis, diverticulitis, fecal incontinence, gastritis, rectum hemorrhage, hemorrhagic peptic ulcer, proctitis, ulcerative stomatitis, tongue edema, tongue ulceration. General–Frequent: back pain, asthenia, malaise, weight increase; Infrequent: fever, rigors, generalized edema; Rare: face edema, aphthous stomatitis. Hearing and Vestibular DisordersRare: hyperacusis, labyrinthine disorder. Hematopoietic and LymphaticRare: anemia, anterior chamber eye hemorrhage. Liver and Biliary System DisordersRare: abnormal hepatic function. Metabolic and Nutritional DisordersInfrequent: thirst; Rare: hypoglycemia, hypoglycemia reaction. Musculoskeletal System DisordersFrequent: myalgia; Infrequent: arthralgia, dystonia, arthrosis, muscle cramps, muscle weakness. Psychiatric DisordersFrequent: yawning, other male sexual dysfunction, other female sexual dysfunction; Infrequent: depression, amnesia, paroniria, teeth-grinding, emotional lability, apathy, abnormal dreams, euphoria, paranoid reaction, hallucination, aggressive reaction, aggravated depression, delusions; Rare: withdrawal syndrome, suicide ideation, libido increased, somnambulism, illusion. ReproductiveInfrequent: menstrual disorder, dysmenorrhea, intermenstrual bleeding, vaginal hemorrhage, amenorrhea, leukorrhea; Rare: female breast pain, menorrhagia, balanoposthitis, breast enlargement, atrophic vaginitis, acute female mastitis. Respiratory System DisordersFrequent: rhinitis; Infrequent: coughing, dyspnea, upper respiratory tract infection, epistaxis, bronchospasm, sinusitis; Rare: hyperventilation, bradypnea, stridor, apnea, bronchitis, hemoptysis, hypoventilation, laryngismus, laryngitis. Special SensesFrequent: tinnitus; Infrequent: conjunctivitis, earache, eye pain, abnormal accommodation; Rare: xerophthalmia, photophobia, diplopia, abnormal lacrimation, scotoma, visual field defect. Urinary System DisordersInfrequent: micturition frequency, polyuria, urinary retention, dysuria, nocturia, urinary incontinence; Rare: cystitis, oliguria, pyelonephritis, hematuria, renal pain, strangury. Laboratory Tests–In man, asymptomatic elevations in serum transaminases (SGOT [or AST] and SGPT [or ALT]) have been reported infrequently (approximately 0.8%) in association with sertraline hydrochloride administration. These hepatic enzyme elevations usually occurred within the first 1 to 9 weeks of drug treatment and promptly diminished upon drug discontinuation. Sertraline hydrochloride therapy was associated with small mean increases in total cholesterol (approximately 3%) and triglycerides (approximately 5%), and a small mean decrease in serum uric acid (approximately 7%) of no apparent clinical importance. The safety profile observed with Sertraline hydrochloride treatment in patients with major depressive disorder, OCD, panic disorder, PTSD, PMDD and social anxiety disorder is similar. Other Events Observed During the Postmarketing Evaluation of Sertraline hydrochloride –Reports of adverse events temporally associated with Sertraline hydrochloride that have been received since market introduction, that are not listed above and that may have no causal relationship with the drug, include the following: acute renal failure, anaphylactoid reaction, angioedema, blindness, optic neuritis, cataract, increased coagulation times, bradycardia, AV block, atrial arrhythmias, QT-interval prolongation, ventricular tachycardia (including torsade de pointes-type arrhythmias), hypothyroidism, agranulocytosis, aplastic anemia and pancytopenia, leukopenia, thrombocytopenia, lupus-like syndrome, serum sickness, hyperglycemia, galactorrhea, hyperprolactinemia, extrapyramidal symptoms, oculogyric crisis, psychosis, pulmonary hypertension, severe skin reactions, which potentially can be fatal, such as Stevens-Johnson syndrome, vasculitis, photosensitivity and other severe cutaneous disorders, rare reports of pancreatitis, and liver events—clinical features (which in the majority of cases appeared to be reversible with discontinuation of sertraline hydrochloride) occurring in one or more patients include: elevated enzymes, increased bilirubin, hepatomegaly, hepatitis, jaundice, abdominal pain, vomiting, liver failure and death.

DRUG ABUSE AND DEPENDENCE


id: a32e16f4-bc1f-4f73-8c2a-33ee5fdae18b
displayName: DRUG ABUSE AND 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: 54cb3e07-ec06-4579-b523-ecc9036623bf
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®).

DOSAGE AND ADMINISTRATION


id: cb643a4a-876b-473d-957e-e77129a564fa
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7

Initial Treatment Dosage for Adults Major Depressive Disorder–Sertraline hydrochloride treatment should be administered at a dose of 50 mg once daily. While a relationship between dose and effect has not been established for major depressive disorder, OCD, panic disorder, PTSD or social anxiety disorder, patients were dosed in a range of 50-200 mg/day in the clinical trials demonstrating the effectiveness of Sertraline hydrochloride for the treatment of this indication. Consequently, a dose of 50 mg, administered once daily, is recommended as the initial therapeutic dose. Patients not responding to a 50 mg dose may benefit from dose increases up to a maximum of 200 mg/day. Given the 24 hour elimination half-life of sertraline hydrochloride, dose changes should not occur at intervals of less than 1 week. Premenstrual Dysphoric Disorder– Sertraline hydrochloride treatment should be initiated with a dose of 50 mg/day, either daily throughout the menstrual cycle or limited to the luteal phase of the menstrual cycle, depending on physician assessment. While a relationship between dose and effect has not been established for PMDD, patients were dosed in the range of 50-150 mg/day with dose increases at the onset of each new menstrual cycle (see Clinical Trials under CLINICAL PHARMACOLOGY). Patients not responding to a 50 mg/day dose may benefit from dose increases (at 50 mg increments/ menstrual cycle) up to 150 mg/day when dosing daily throughout the menstrual cycle, or 100 mg/day when dosing during the luteal phase of the menstrual cycle. If a 100 mg/day dose has been established with luteal phase dosing, a 50 mg/day titration step for three days should be utilized at the beginning of each luteal phase dosing period. Sertraline hydrochloride should be administered once daily, either in the morning or evening. Dosage for Pediatric Population (Children and Adolescents) Obsessive-Compulsive Disorder– Sertraline hydrochloride treatment should be initiated with a dose of 25 mg once daily in children (ages 6-12) and at a dose of 50 mg once daily in adolescents (ages 13-17). While a relationship between dose and effect has not been established for OCD, patients were dosed in a range of 25-200 mg/day in the clinical trials demonstrating the effectiveness of Sertraline hydrochloride for pediatric patients (6-17 years) with OCD. Patients not responding to an initial dose of 25 or 50 mg/day may benefit from dose increases up to a maximum of 200 mg/day. For children with OCD, their generally lower body weights compared to adults should be taken into consideration in advancing the dose, in order to avoid excess dosing. Given the 24 hour elimination half-life of Sertraline hydrochloride, dose changes should not occur at intervals of less than 1 week. Sertraline hydrochloride should be administered once daily, either in the morning or evening. Maintenance/Continuation/Extended Treatment Major Depressive Disorder–It is generally agreed that acute episodes of major depressive disorder require several months or longer of sustained pharmacologic therapy beyond response to the acute episode. Systematic evaluation of sertraline hydrochloride has demonstrated that its antidepressant efficacy is maintained for periods of up to 44 weeks following 8 weeks of initial treatment at a dose of 50-200 mg/day (mean dose of 70 mg/day) (see Clinical Trials under CLINICAL PHARMACOLOGY). It is not known whether the dose of sertraline hydrochloride needed for maintenance treatment is identical to the dose needed to achieve an initial response. Patients should be periodically reassessed to determine the need for maintenance treatment. Posttraumatic Stress Disorder–It is generally agreed that PTSD requires several months or longer of sustained pharmacological therapy beyond response to initial treatment. Systematic evaluation of Sertraline hydrochloride has demonstrated that its efficacy in PTSD is maintained for periods of up to 28 weeks following 24 weeks of treatment at a dose of 50-200 mg/day (see Clinical Trials under CLINICAL PHARMACOLOGY). It is not known whether the dose of Sertraline hydrochloride needed for maintenance treatment is identical to the dose needed to achieve an initial response. Patients should be periodically reassessed to determine the need for maintenance treatment. Social Anxiety Disorder–Social anxiety disorder is a chronic condition that may require several months or longer of sustained pharmacological therapy beyond response to initial treatment. Systematic evaluation of Sertraline hydrochloride has demonstrated that its efficacy in social anxiety disorder is maintained for periods of up to 24 weeks following 20 weeks of treatment at a dose of 50-200 mg/day (see Clinical Trials under CLINICAL PHARMACOLOGY). Dosage adjustments should be made to maintain patients on the lowest effective dose and patients should be periodically reassessed to determine the need for long-term treatment. Obsessive-Compulsive Disorder and Panic Disorder–It is generally agreed that OCD and Panic Disorder require several months or longer of sustained pharmacological therapy beyond response to initial treatment. Systematic evaluation of continuing Sertraline hydrochloride for periods of up to 28 weeks in patients with OCD and Panic Disorder who have responded while taking Sertraline hydrochloride during initial treatment phases of 24 to 52 weeks of treatment at a dose range of 50-200 mg/day has demonstrated a benefit of such maintenance treatment (see Clinical Trials under CLINICAL PHARMACOLOGY). It is not known whether the dose of Sertraline hydrochloride needed for maintenance treatment is identical to the dose needed to achieve an initial response. Nevertheless, patients should be periodically reassessed to determine the need for maintenance treatment. Premenstrual Dysphoric Disorder–The effectiveness of sertraline hydrochloride in long-term use, that is, for more than 3 menstrual cycles, has not been systematically evaluated in controlled trials. However, as women commonly report that symptoms worsen with age until relieved by the onset of menopause, it is reasonable to consider continuation of a responding patient. Dosage adjustments, which may include changes between dosage regimens (e.g., daily throughout the menstrual cycle versus during the luteal phase of the menstrual cycle), may be needed to maintain the patient on the lowest effective dosage and patients should be periodically reassessed to determine the need for continued treatment. Switching a Patient To or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders: At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with Sertraline hydrochloride. Conversely, at least 14 days should be allowed after stopping Sertraline hydrochloride before starting an MAOI intended to treat psychiatric disorders (see CONTRAINDICATIONS ). Use of Sertraline Hydrochloride With Other MAOIs Such as Linezolid or Methylene Blue: Do not start Sertraline hydrochloride in a patient who is being treated with linezolid or intravenous methylene blue because there is increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered (see CONTRAINDICATIONS). In some cases, a patient already receiving Sertraline hydrochloride therapy may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, Sertraline hydrochloride should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for 2 weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with Sertraline hydrochloride may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue (see WARNINGS). The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with Sertraline hydrochloride is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use (see WARNINGS). Special Populations Dosage for Hepatically Impaired Patients–The use of sertraline in patients with liver disease should be approached with caution. The effects of sertraline in patients with moderate and severe hepatic impairment have not been studied. If sertraline is administered to patients with liver impairment, a lower or less frequent dose should be used (see CLINICAL PHARMACOLOGY and PRECAUTIONS). Treatment of Pregnant Women During the Third Trimester–Neonates exposed to Sertraline hydrochloride and other SSRIs or SNRIs, late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding (see PRECAUTIONS). When treating pregnant women with Sertraline hydrochloride during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. Discontinuation of Treatment with Sertraline hydrochloride Symptoms associated with discontinuation of Sertraline hydrochloride and other SSRIs and SNRIs, have been reported (see PRECAUTIONS). Patients should be monitored for these symptoms when discontinuing treatment. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate.

HOW SUPPLIED


id: d814c9db-9c5a-41be-bc7c-4fd5940ca75a
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Sertraline Hydrochloride 50 mg Tablets: Light Blue film coated Modified oval biconvex tablets debossed with I on the left side of bisect and G on the right side of bisect on one side and “213″ on other

120 TABLET in a BOTTLE (53217-242-02)
30 TABLET in a BOTTLE (53217-242-30)
60 TABLET in a BOTTLE (53217-242-60)
90 TABLET in a BOTTLE (53217-242-90)
Repackaged by: Aidarex Pharmaceuticals Corona, CA 92880

MEDICATION GUIDE


id: 52f965a3-6efe-413e-9f9e-351740f64d9d
displayName: SPL MEDGUIDE SECTION
FDA Article Code: 42231-1

Sertraline Tablets, USP (SIR-trah-leen) Read the Medication Guide that comes with Sertraline hydrochloride before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment. Talk with your healthcare provider if there is something you do not understand or want to learn more about. What is the most important information I should know about Sertraline tablets? Sertraline hydrochloride and other antidepressant medicines may cause serious side effects, including: 1.    Suicidal thoughts or actions: Sertraline tablets and other antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers or young adults within the first few months of treatment or when the dose is changed.
Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions.
Watch for these changes and call your healthcare provider right away if you notice:
New or sudden changes in mood, behavior, actions, thoughts or feelings, especially if severe.
Pay particular attention to such changes when sertraline tablets is started or when the dose is changed.
Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms. Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency, especially if they are new, worse or worry you: attempts to commit suicide
acting on dangerous impulses
acting aggressive or violent
thoughts about suicide or dying
new or worse depression
new or worse anxiety or panic attacks
feeling agitated, restless, angry or irritable
trouble sleeping
an increase in activity or talking more than what is normal for you
other unusual changes in behavior or mood
Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency. Sertraline tablets may be associated with these serious side effects: 2.    Serotonin Syndrome. This condition can be life threatening and may include: agitation, hallucinations, coma or other changes in mental status
coordination problems or muscle twitching (overactive reflexes)
racing heartbeat, high or low blood pressure
sweating or fever
nausea, vomiting, or diarrhea
muscle rigidity
3. Severe allergic reactions: trouble breathing
swelling of the face, tongue, eyes or mouth
rash, itchy welts (hives) or blisters, alone or with fever or joint pain
4.      Abnormal bleeding: Sertraline tablets and other antidepressant medicines may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin (Coumadin®†, Jantoven®†), a non-steroidal anti-inflammatory drug (NSAIDs, like ibuprofen or naproxen), or aspirin. 5.      Seizures or convulsions 6.      Manic episodes: greatly increased energy
severe trouble sleeping
racing thoughts
reckless behavior
unusually grand ideas
excessive happiness or irritability
talking more or faster than usual
7.      Changes in appetite or weight. Children and adolescents should have height and weight monitored during treatment. 8.      Low salt (sodium) levels in the blood. Elderly people may be at greater risk for this. Symptoms may include: headache
weakness or feeling unsteady
confusion, problems concentrating or thinking or memory problems
9. Visual problems eye pain
changes in vision
swelling or redness in or around the eye
Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are. Do not stop sertraline tablets without first talking to your healthcare provider. Stopping sertraline tablets too quickly may cause serious symptoms including: anxiety, irritability, high or low mood, feeling restless or changes in sleep habits
headache, sweating, nausea, dizziness
electric shock-like sensations, shaking, confusion
What are sertraline tablets? Sertraline tablets are a prescription medicine used to treat depression. It is important to talk with your healthcare provider about the risks of treating depression and also the risks of not treating it. You should discuss all treatment choices with your healthcare provider. Sertraline tablets are also used to treat: Major Depressive Disorder (MDD)
Obsessive Compulsive Disorder (OCD)
Panic Disorder
Posttraumatic Stress Disorder (PTSD)
Social Anxiety Disorder
Premenstrual Dysphoric Disorder (PMDD)
Talk to your healthcare provider if you do not think that your condition is getting better with sertraline tablet treatment. Who should not take sertraline tablets? Do not take sertraline tablets if you: are allergic to sertraline or any of the ingredients in sertraline tablets. See the end of this Medication Guide for a complete list of ingredients in sertraline tablets.
take the antipsychotic medicine pimozide (Orap®†) because this can cause serious heart problems.
take Antabuse®† (disulfiram) (if you are taking the liquid form of sertraline) due to the alcohol content.
take a monoamine oxidase inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid.
Do not take an MAOI within 2 weeks of stopping sertraline tablets unless directed to do so by your physician.
Do not start sertraline tablets if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your physician.
People who take sertraline tablets close in time to an MAOI may have serious or even life-threatening side effects. Get medical help right away if you have any of these symptoms: high fever
uncontrolled muscle spasms
stiff muscles
rapid changes in heart rate or blood pressure
confusion
loss of consciousness (pass out)
What should I tell my healthcare provider before taking sertraline tablets? Ask if you are not sure. Before starting sertraline tablets, tell your healthcare provider if you: ● Are taking certain drugs such as: Medicines used to treat migraine headaches such as: ● triptants Medicines used to treat mood, anxiety, psychotic or thought disorders, such as: ● tricyclic antidepressants ● lithium ● diazepam ● SSRIs ● SNRIs ● antipsychotic drugs ● valproate Medicines used to treat seizures such as: ● phenytoin Medicines used to treat pain such as: ● tramadol Medicines used to thin your blood such as: ● warfarin Medicines used to control your heartbeat such as: ● propafenone ● flecainide ● digitoxin Medicines used to treat type II diabetes such as: ● tolbutamide Cimetidine used to treat heartburn
Over-the-counter medicines or supplements such as:
● Aspirin or other NSAIDs ● Tryptophan ● St. John’s Wort ● have liver problems ● have kidney problems. ● have heart problems ● have or had seizures or convulsions ● have bipolar disorder or mania ● have low sodium levels in your blood ● have a history of a stroke ● have high blood pressure ● have or had bleeding problems ● are pregnant or plan to become pregnant. It is not known if sertraline will harm your unborn baby. Talk to your healthcare provider about the benefits and risks of treating depression during pregnancy. ● are breast-feeding or plan to breast-feed. Some sertraline may pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking sertraline tablets. Tell your healthcare provider about all the medicines that you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Sertraline tablets and some medicines may interact with each other, may not work as well, or may cause serious side effects. Your healthcare provider or pharmacist can tell you if it is safe to take sertraline tablets with your other medicines. Do not start or stop any medicine while taking sertraline tablets without talking to your healthcare provider first.

 If 
you 
take 
sertraline 
tablets

you 
should 
not 
take 
any 
other 
medicines 
that 
contain 
sertraline 
(
sertraline 
HCl

sertraline 
hydrochloride

etc
.).

How should I take sertraline tablets? Take sertraline tablets exactly as prescribed. Your healthcare provider may need to change the dose of sertraline tablets until it is the right dose for you.
Sertraline tablets may be taken with or without food.
If you miss a dose of sertraline tablets, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of sertraline tablets at the same time.
If you take too many sertraline tablets, call your healthcare provider or poison control center right away, or get emergency treatment.
What should I avoid while taking sertraline tablets? Sertraline tablets can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly. You should not drive, operate heavy machinery, or do other dangerous activities until you know how sertraline tablets affect you. Do not drink alcohol while using sertraline tablets. What are the possible side effects of sertraline tablets? Sertraline tablets may cause serious side effects, including: See “What is the most important information I should know about sertraline tablets?”
Feeling anxious or trouble sleeping
Common possible side effects in people who take sertraline tablets include: nausea, loss of appetite, diarrhea or indigestion
change in sleep habits including increased sleepiness or insomnia
increased sweating
sexual problems including decreased libido and ejaculation failure
tremor or shaking
feeling tired or fatigued
agitation
Other side effects in children and adolescents include: abnormal increase in muscle movement or agitation
nose bleed
urinating more often
urinary incontinence
aggressive reaction
heavy menstrual periods
possible slowed growth rate and weight change. Your child’s height and weight should be monitored during treatment with sertraline tablets.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of sertraline tablets. For more information, ask your healthcare provider or pharmacist. CALL YOUR DOCTOR FOR MEDICAL ADVICE ABOUT SIDE EFFECTS. YOU MAY REPORT SIDE EFFECTS TO THE FDA AT 1-800-FDA-1088. How should I store sertraline tablets? Store sertraline tablets at room temperature between 20°C to 25°C (68°F to 77°F).
Keep sertraline tablets bottle closed tightly.
Keep sertraline tablets and all medicines out of the reach of children. General information about sertraline tablets Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use sertraline tablets for a condition for which it was not prescribed. Do not give sertraline tablets to other people, even if they have the same condition. It may harm them. This Medication Guide summarizes the most important information about sertraline tablets. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about sertraline tablets that is written for healthcare professionals. For more information about sertraline tablets call Cipla Ltd. at 1-866-604-3268 What are the ingredients in sertraline tablets? Active ingredient: sertraline hydrochloride, USP Inactive ingredients: dibasic calcium phosphate dihydrate, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, opadry green (titanium dioxide, hypromellose 3cP, hypromellose 6cP, Macrogol/Peg 400, polysorbate 80, D&C Yellow #10 Aluminum Lake, and FD&C Blue # 2/Indigo Carmine Aluminum Lake for 25 mg tablet), opadry light blue (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, FD&C Blue #2/Indigo Carmine Aluminum Lake and polysorbate 80 for 50 mg tablet), opadry yellow (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, polysorbate 80, Iron Oxide Yellow, Iron oxide Red for 100 mg tablet) and sodium starch glycolate. † The brand names mentioned in this Medication Guide are registered trademarks of their respective manufacturers. This Medication Guide has been approved by the U.S. Food and Drug Administration. Manufactured for: Cipla USA Inc., 9100 S. Dadeland Blvd., Suite 1500 Miami, FL 33156 Manufactured by: InvaGen Pharmaceuticals, Inc. (a subsidiary of Cipla Ltd.) Hauppauge, NY 11788 or Ascent Pharmaceuticals, Inc. Central Islip, NY 11722 Revised: 07/2016

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


id: 548250f5-bf66-49b3-8939-415679aad556
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

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