Sertraline Hydrochloride
Sertraline Hydrochloride Tablets USP
FULL PRESCRIBING INFORMATION: CONTENTS*
- Suicidality and Antidepressant Drugs
- SERTRALINE HYDROCHLORIDE DESCRIPTION
- CLINICAL PHARMACOLOGY
- SERTRALINE HYDROCHLORIDE INDICATIONS AND USAGE
- SERTRALINE HYDROCHLORIDE CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
- SERTRALINE HYDROCHLORIDE ADVERSE REACTIONS
- DRUG ABUSE AND DEPENDENCE
- OVERDOSAGE
- SERTRALINE HYDROCHLORIDE DOSAGE AND ADMINISTRATION
- HOW SUPPLIED
- Medication Guide
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 25 mg (100 Tablet Bottle)
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 50 mg (100 Tablet Bottle)
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 100 mg (100 Tablet Bottle)
FULL PRESCRIBING INFORMATION
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 is 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.)
SERTRALINE HYDROCHLORIDE DESCRIPTION
17172
CLINICAL PHARMACOLOGY
Pharmacodynamics
In vitro In vitro 121A1B2
Pharmacokinetics
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maxmax
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in vitro in vivo
maxmin
In vitro 3 PRECAUTIONS
Pediatric Pharmacokinetics
maxmaxmaxmax DOSAGE AND ADMINISTRATION
PRECAUTIONS DOSAGE AND ADMINISTRATION
PRECAUTIONS
Clinical Trials
Analyses for gender effects on outcome did not suggest any differential responsiveness on the basis of sex.
SERTRALINE HYDROCHLORIDE INDICATIONS AND USAGE
Major Depressive Disorder
Clinical Trials CLINICAL PHARMACOLOGY
Clinical Trials CLINICAL PHARMACOLOGY
Obsessive-Compulsive Disorder
Clinical Trials CLINICAL PHARMACOLOGY
Clinical Trials CLINICAL PHARMACOLOGY DOSAGE AND ADMINISTRATION
Panic Disorder
Clinical Trials CLINICAL PHARMACOLOGY
Clinical Trials CLINICAL PHARMACOLOGY DOSAGE AND ADMINISTRATION
Posttraumatic Stress Disorder (PTSD)
Clinical Trials CLINICAL PHARMACOLOGY
DOSAGE AND ADMINISTRATION
Premenstrual Dysphoric Disorder (PMDD)
Clinical Trials CLINICAL PHARMACOLOGY
DOSAGE AND ADMINISTRATION
Social Anxiety Disorder
Clinical Trials CLINICAL PHARMACOLOGY
Clinical Trials CLINICAL PHARMACOLOGY
SERTRALINE HYDROCHLORIDE CONTRAINDICATIONS
The use of MAOIs intended to treat psychiatric disorders with sertraline hydrochloride tablets or within 14 days of stopping treatment with sertraline hydrochloride tablets is contraindicated because of an increased risk of serotonin syndrome. The use of sertraline hydrochloride tablets within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated (see
WARNINGS
and
DOSAGE AND ADMINISTRATION
).
Starting sertraline hydrochloride tablets in a patient who is being treated with MAOIs such as linezolid or intravenous methylene 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 hydrochloride tablets are contraindicated in patients with a hypersensitivity to sertraline or any of the inactive ingredients in sertraline hydrochloride tablets.
WARNINGS
Clinical Worsening and Suicide Risk
| 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 |
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.
PRECAUTIONS and DOSAGE AND ADMINISTRATION—Discontinuation of Treatment with Sertraline Hydrochloride Tablets
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.
Screening Patients for Bipolar Disorder
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.
PRECAUTIONS
General
Discontinuation of Treatment with Sertraline Hydrochloride
DOSAGE AND ADMINISTRATION
Abnormal Bleeding
max CLINICAL PHARMACOLOGY DOSAGE AND ADMINISTRATION
CLINICAL PHARMACOLOGY
Information for Patients
Hyponatremia
Geriatric Use
Information for Patients
Laboratory Tests
Drug Interactions
max
max
max CONTRAINDICATIONS
CONTRAINDICATIONS, WARNINGS, DOSAGE AND ADMINISTRATION.
in vivomax
Drugs Metabolized by P450 2D6
Tricyclic Antidepressant Drugs Effective in the Treatment of Major Depressive Disorder (TCAs) PRECAUTIONS
CONTRAINDICATIONS, WARNINGS DOSAGE AND ADMINISTRATION
WARNINGS - Serotonin Syndrome
Tricyclic Antidepressant Drugs Effective in the Treatment of Major Depressive Disorder (TCAs)
Drugs Metabolized by P450 2D6 PRECAUTIONS
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in vivoin vitro
2
Pregnancy
22222 in utero
Pregnancy-Nonteratogenic Effects
WARNINGS: Serotonin Syndrome
DOSAGE AND ADMINISTRATION
Labor and Delivery
Nursing Mothers
Pediatric Use
Clinical Trials CLINICAL PHARMACOLOGY BOX WARNING WARNINGS-Clinical Worsening and Suicide Risk
Pharmacokinetics CLINICAL PHARMACOLOGY
ADVERSE REACTIONS
WARNINGS – Clinical Worsening and Suicide Risk
Geriatric Use
ADVERSE REACTIONS
PRECAUTIONS, Hyponatremia
SERTRALINE HYDROCHLORIDE ADVERSE REACTIONS
Incidence in Placebo-Controlled Trials
| Percentage of Patients Reporting Event | ||||||||
|---|---|---|---|---|---|---|---|---|
| Major Depressive Disorder/Other* |
OCD | Panic Disorder | PTSD | |||||
| Body System/Adverse Event |
Sertraline Hydrochloride (N=861) |
Placebo (N=853) |
Sertraline Hydrochloride (N=533) |
Placebo (N=373) |
Sertraline Hydrochloride (N=430) |
Placebo (N=275) |
Sertraline Hydrochloride (N=374) |
Placebo (N=376) |
|
(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). * Major depressive disorder and other premarketing controlled trials. (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. |
||||||||
|
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. & Periph. Nerv. 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 |
| |
PMDD Daily Dosing
|
PMDD Luteal Phase
Dosing(2) |
Social Anxiety Disorder
|
|
||||
|
Body System/Adverse
Event |
Sertraline
Hydrochloride (N=121) |
Placebo
(N=122) |
Sertraline
Hydrochloride (N=136) |
Placebo
(N=127) |
Sertraline
Hydrochloride (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. & Periph. Nerv. 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 |
||
| Body System/Adverse Event** | Sertraline Hydrochloride (N=2799) |
Placebo (N=2394) |
|---|---|---|
|
(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. |
||
|
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
| Adverse Event | Major Depressive Disorder/Other*, OCD, Panic Disorder, PTSD, 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) |
|---|---|---|---|---|---|---|---|---|
|
(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. |
||||||||
| 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% |
– |
– |
– |
– |
– |
– |
| Adverse Event | Sertraline Hydrochloride |
Placebo |
|---|---|---|
|
* 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) |
||
| Ejaculation failure*
(primarily delayed ejaculation) |
14% |
1% |
| Decreased libido**
|
6% |
1% |
PRECAUTIONS
Autonomic Nervous System Disorders–Frequent: Infrequent:Rare:
Body as a Whole–General Disorders–Rare:
Cardiovascular–Frequent: InfrequentRare:
Central and Peripheral Nervous System Disorders–Frequent: Infrequent:Rare:
Disorders of Skin and Appendages–lnfrequent: Rare:
Endocrine Disorders–Rare:
Gastrointestinal Disorders–Frequent: Infrequent:Rare:
General–Frequent: Infrequent:Rare:
Hearing and Vestibular Disorders–Rare:
Hematopoietic and Lymphatic–Rare:
Liver and Biliary System Disorders–Rare:
Metabolic and Nutritional Disorders–Infrequent: Rare:
Musculoskeletal System Disorders–Frequent: Infrequent:
Psychiatric Disorders–Frequent: Infrequent:Rare:
Reproductive–Infrequent: Rare:
Respiratory System Disorders–Frequent: Infrequent:Rare:
Special Senses–Frequent: Infrequent:Rare:
Urinary System Disorders–Infrequent: Rare:
DRUG ABUSE AND DEPENDENCE
Controlled Substance Class
Physical and Psychological Dependence
OVERDOSAGE
Human Experience
Overdose Management
Physicians’ Desk Reference® ®
SERTRALINE HYDROCHLORIDE DOSAGE AND ADMINISTRATION
Initial Treatment
Dosage for Adults
Clinical Trials CLINICAL PHARMACOLOGY
Dosage for Pediatric Population (Children and Adolescents)
Maintenance/Continuation/Extended Treatment
Clinical Trials CLINICAL PHARMACOLOGY
Clinical Trials CLINICAL PHARMACOLOGY
Clinical Trials CLINICAL PHARMACOLOGY
Clinical Trials CLINICAL PHARMACOLOGY
CONTRAINDICATIONS
CONTRAINDICATIONS
WARNINGS
WARNINGS
Special Populations
CLINICAL PHARMACOLOGY PRECAUTIONS
PRECAUTIONS
Discontinuation of Treatment with Sertraline Hydrochloride Tablets
PRECAUTIONS
HOW SUPPLIED
Sertraline hydrochloride tablets USP are supplied as:
25 mg Tablets:
50 mg Tablets:
100 mg Tablets:
Store at
Aurobindo Pharma USA, Inc.
Aurobindo Pharma Limited
Medication Guide
Sertraline Hydrochloride Tablets USP
What is the most important information I should know about sertraline hydrochloride tablets?
1. Suicidal thoughts or actions:
- Sertraline hydrochloride 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 hydrochloride tablets are started or when the dose is changed.
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 hydrochloride 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: ®®
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.
8. Low salt (sodium) levels in the blood.
- headache
- weakness or feeling unsteady
- confusion, problems concentrating or thinking or memory problems
Do not stop sertraline hydrochloride tablets without first talking to your healthcare provider.
- 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 hydrochloride tablets?
also
- Major Depressive Disorder (MDD)
- Obsessive Compulsive Disorder (OCD)
- Panic Disorder
- Posttraumatic Stress Disorder (PTSD)
- Social Anxiety Disorder
- Premenstrual Dysphoric Disorder (PMDD)
Who should not take sertraline hydrochloride tablets?
- are allergic to sertraline or any of the ingredients in sertraline hydrochloride tablets. See the end of this Medication Guide for a complete list of ingredients in sertraline hydrochloride tablets.
- take the antipsychotic medicine pimozide (Orap®) because this can cause serious heart problems.
- 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 hydrochloride tablets unless directed to do so by your physician.
- Do not start sertraline hydrochloride tablets if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your physician.
People who take sertraline hydrochloride 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 hydrochloride tablets?
- Are taking certain drugs such as:
- Medicines used to treat migraine headaches such as:
- triptans
- 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
- Medicines used to treat migraine headaches such as:
- 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 hydrochloride tablets will harm your unborn baby. Talk to your healthcare provider about the benefits and risks of treating depression during pregnancy.
- are breastfeeding or plan to breastfeed. Some sertraline hydrochloride may pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking sertraline hydrochloride tablets.
Tell your healthcare provider about all the medicines that you take,
| If you take sertraline hydrochloride tablets, you should not take any other medicines that contain sertraline (sertraline hydrochloride etc.). |
How should I take sertraline hydrochloride tablets?
- Take sertraline hydrochloride tablets exactly as prescribed. Your healthcare provider may need to change the dose of sertraline hydrochloride tablets until it is the right dose for you.
- Sertraline hydrochloride tablets may be taken with or without food.
- If you miss a dose of sertraline hydrochloride 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 hydrochloride tablets at the same time.
- If you take too much sertraline hydrochloride, call your healthcare provider or poison control center right away, or get emergency treatment.
What should I avoid while taking sertraline hydrochloride tablets?
What are the possible side effects of sertraline hydrochloride tablets?
- See “What is the most important information I should know about sertraline hydrochloride tablets?”
- Feeling anxious or trouble sleeping
- 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
- 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 hydrochloride tablets.
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 hydrochloride tablets?
- Store sertraline hydrochloride tablets at room temperature 20° to 25°C (68° to 77°F).
- Keep sertraline hydrochloride tablets bottle closed tightly.
Keep sertraline hydrochloride tablets and all medicines out of the reach of children.
General information about sertraline hydrochloride tablets
What are the ingredients in sertraline hydrochloride tablets?
Active ingredient:
Inactive ingredients:
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Aurobindo Pharma USA, Inc.
Aurobindo Pharma Limited
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 25 mg (100 Tablet Bottle)
NDC 65862-011-01
Sertraline Hydrochloride Tablets USP
25 mg*
PHARMACIST: PLEASE DISPENSE WITH
MEDICATION GUIDE PROVIDED SEPARATELY
Rx only 100 Tablets
AUROBINDO
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 50 mg (100 Tablet Bottle)
NDC 65862-012-01
Sertraline Hydrochloride Tablets USP
50 mg*
PHARMACIST: PLEASE DISPENSE WITH
MEDICATION GUIDE PROVIDED SEPARATELY
Rx only 100 Tablets
AUROBINDO
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 100 mg (100 Tablet Bottle)
NDC 65862-013-01
Sertraline Hydrochloride Tablets USP
100 mg*
PHARMACIST: PLEASE DISPENSE WITH
MEDICATION GUIDE PROVIDED SEPARATELY
Rx only 100 Tablets
AUROBINDO
Sertraline HydrochlorideSertraline Hydrochloride TABLET, FILM COATED
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Sertraline HydrochlorideSertraline Hydrochloride TABLET, FILM COATED
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Sertraline HydrochlorideSertraline Hydrochloride TABLET, FILM COATED
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PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
