Sertraline Hydrochloride description, usages, side effects, indications, overdosage, supplying and lots more!

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Sertraline Hydrochloride

Aurobindo Pharma Limited

Sertraline Hydrochloride Oral Concentrate


FULL PRESCRIBING INFORMATION: CONTENTS*




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•

Sertraline Hydrochloride


PRECAUTIONS, Information for Patients DOSAGE AND ADMINISTRATION

CLINICAL PHARMACOLOGY

Pharmacodynamics


In vitro In vitro 121A1B2

Pharmacokinetics

Systemic Bioavailability


maxmax

maxmax

max

Metabolism


in vitro in vivo

,maxmin

Protein Binding


In vitro 3 PRECAUTIONS

Pediatric Pharmacokinetics


maxmaxmaxmax DOSAGE AND ADMINISTRATION

Age


Liver Disease


PRECAUTIONS DOSAGE AND ADMINISTRATION

Renal Disease


PRECAUTIONS

Clinical Trials

Major Depressive Disorder




































































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


WARNINGSPRECAUTIONS



WARNINGS

Clinical Worsening and Suicide Risk




 
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





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 DOSAGE AND ADMINISTRATION — Discontinuation of Treatment with 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.

Screening Patients for Bipolar Disorder




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

Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-like Reactions

The development of a potentially life-threatening serotonin syndrome or Neuroleptic Malignant Syndrome (NMS)-like reactions have been reported with SNRIs and SSRIs alone, including sertraline hydrochloride treatment, but particularly with concomitant use of serotonergic drugs (including triptans and fentanyl) with drugs which impair metabolism of serotonin (including MAOIs), or with antipsychotics or other dopamine antagonists. Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Serotonin syndrome, in its most severe form can resemble neuroleptic malignant syndrome, which includes hyperthermia, muscle rigidity, autonomic instability with possible rapid fluctuation of vital signs, and mental status changes. Patients should be monitored for the emergence of serotonin syndrome or NMS-like signs and symptoms.

The concomitant use of sertraline hydrochloride with MAOIs intended to treat depression is contraindicated.

If concomitant treatment of sertraline hydrochloride with a 5-hydroxytryptamine receptor agonist (triptan) is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases.

The concomitant use of sertraline hydrochloride with serotonin precursors (such as tryptophan) is not recommended.

Treatment with sertraline hydrochloride and any concomitant serotonergic or antidopaminergic agents, including antipsychotics, should be discontinued immediately if the above events occur and supportive symptomatic treatment should be initiated.

Coadministration of sertraline hydrochloride with other drugs which enhance the effects of serotonergic neurotransmission, such as tryptophan, fenfluramine, fentanyl, 5-HT agonists, or the herbal medicine St. John’s Wort (hypericum perforatum) should be undertaken with caution and avoided whenever possible due to the potential for pharmacodynamic interaction.

PRECAUTIONS

General

Activation of Mania/Hypomania


Weight Loss


Seizure


Discontinuation of Treatment with Sertraline Hydrochloride




DOSAGE AND ADMINISTRATION

Abnormal Bleeding




Weak Uricosuric Effect


Use in Patients with Concomitant Illness








max CLINICAL PHARMACOLOGY DOSAGE AND ADMINISTRATION

CLINICAL PHARMACOLOGY

Interference with Cognitive and Motor Performance


Information for Patients

Hyponatremia


Geriatric Use

Platelet Function


Information for Patients




Clinical Worsening and Suicide Risk




















Laboratory Tests


False-positive urine immunoassay screening tests for benzodiazepines have been reported in patients taking sertraline. This is due to lack of specificity of the screening tests. False-positive test results may be expected for several days following discontinuation of sertraline therapy. Confirmatory tests, such as gas chromatography/mass spectrometry, will distinguish sertraline from benzodiazepines.

Drug Interactions

Potential Effects of Coadministration of Drugs Highly Bound to Plasma Proteins




Cimetidine


max

CNS Active Drugs


max





max CONTRAINDICATIONS








Monoamine Oxidase Inhibitors


CONTRAINDICATIONS and WARNINGS.

Drugs Metabolized by P450 3A4


in vivomax

Drugs Metabolized by P450 2D6


Tricyclic Antidepressant Drugs Effective in the Treatment of Major Depressive Disorder PRECAUTIONS

Serotonergic Drugs


WARNINGS-Serotonin Syndrome PRECAUTIONS - Drug Interactions

Triptans


WARNINGS - Serotonin Syndrome

Sumatriptan


Tricyclic Antidepressant Drugs Effective in the Treatment of Major Depressive Disorder (TCAs)


Drugs Metabolized by P450 2D6 PRECAUTIONS

Hypoglycemic Drugs


Atenolol


Digoxin


Microsomal Enzyme Induction


Drugs That Interfere With Hemostasis (Non-selective NSAIDs, Aspirin, Warfarin, etc.)


Electroconvulsive Therapy


Alcohol


Carcinogenesis


2222

Mutagenesis


in vivoin vitro

Impairment of Fertility


2

Pregnancy



22222 in utero

Pregnancy-Nonteratogenic Effects


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.  These findings are based on post marketing reports.  Such complications can arise immediately upon delivery.  Reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying.  These features are consistent with either a direct toxic effect of SSRIs and SNRIs or, possibly, a drug discontinuation syndrome.  It should be noted that, in some cases, the clinical picture is consistent with serotonin syndrome (see WARNINGS).

Infants exposed to SSRIs in late pregnancy may have an increased risk for persistent pulmonary hypertension of the newborn (PPHN). PPHN occurs in 1 to 2 per 1,000 live births in the general population and is associated with substantial neonatal morbidity and mortality. In a retrospective case-control study of 377 women whose infants were born with PPHN and 836 women whose infants were born healthy, the risk for developing PPHN was approximately six-fold higher for infants exposed to SSRIs after the 20th week of gestation compared to infants who had not been exposed to antidepressants during pregnancy. There is currently no corroborative evidence regarding the risk for PPHN following exposure to SSRIs in pregnancy; this is the first study that has investigated the potential risk. The study did not include enough cases with exposure to individual SSRIs to determine if all SSRIs posed similar levels of PPHN risk.

When treating a pregnant woman with sertraline hydrochloride during the third trimester, the physician should carefully consider both the potential risks and benefits of treatment (see DOSAGE AND ADMINISTRATION). Physicians should note that in a prospective longitudinal study of 201 women with a history of major depression who were euthymic in the context of antidepressant therapy at the beginning of pregnancy, women who discontinued antidepressant medication during pregnancy were more likely to experience a relapse of major depression than women who continued antidepressant medication.

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



TABLE 2 MOST COMMON TREATMENT-EMERGENT ADVERSE EVENTS: INCIDENCE IN PLACEBO-CONTROLLED CLINICAL 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
ydrochloride
(N=533)		 Placebo
(N=373)		 Sertraline
ydrochloride
(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
  
  
TABLE 3 TREATMENT-EMERGENT ADVERSE EVENTS: INCIDENCE IN PLACEBO-CONTROLLED CLINICAL TRIALS Percentage of Patients Reporting Event Major Depressive Disorder/Other*, OCD, Panic Disorder, PTSD, PMDD and Social Anxiety Disorder combined
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


TABLE 4 MOST COMMON ADVERSE EVENTS 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%
 –
 –
 –
 –
 –
 –

Male and Female Sexual Dysfunction with SSRIs





TABLE 5
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%





Other Adverse Events in Pediatric Patients


Other Events Observed During the Premarketing Evaluation of Sertraline Hydrochloride






PRECAUTIONS 

Autonomic Nervous System Disorders–Frequent:Infrequent:Rare:

Body as a Whole–General Disorders–Rare:

Cardiovascular–Frequent:Infrequent:Rare:

Central and Peripheral Nervous System Disorders–Frequent:Infrequent:Rare:

Disorders of Skin and Appendages–Infrequent: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 DisordersInfrequent:Rare:

Laboratory Tests



Other Events Observed During the Post marketing Evaluation of Sertraline Hydrochloride


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

Major Depressive Disorder and Obsessive-Compulsive Disorder



Panic Disorder, Posttraumatic Stress Disorder and Social Anxiety Disorder
 




Premenstrual Dysphoric Disorder
 


Clinical Trials CLINICAL PHARMACOLOGY



Dosage for Pediatric Population (Children and Adolescents)







Maintenance/Continuation/Extended Treatment

Major Depressive Disorder


Clinical Trials CLINICAL PHARMACOLOGY



Clinical Trials CLINICAL PHARMACOLOGY



Clinical Trials CLINICAL PHARMACOLOGY



Clinical Trials CLINICAL PHARMACOLOGY



Switching Patients to or from a Monoamine Oxidase Inhibitor


CONTRAINDICATIONSWARNINGS

Special Populations

Dosage for Hepatically Impaired Patients


CLINICAL PHARMACOLOGY PRECAUTIONS

Treatment of Pregnant Women During the Third Trimester


PRECAUTIONS

The physician may consider tapering sertraline hydrochloride in the third trimester.

Discontinuation of Treatment with Sertraline Hydrochloride


PRECAUTIONS

Sertraline Hydrochloride Oral Concentrate




HOW SUPPLIED


Sertraline Hydrochloride Oral Concentrate



Store at


Aurobindo Pharma USA, Inc.




Aurobindo Pharma Limited


PATIENT INSTRUCTIONS

USING YOUR SERTRALINE HYDROCHLORIDE DISPENSING SYRINGE AND BOTTLE
Use this product as indicated below, unless directed otherwise by your Physician.
IMPORTANT: Please read these instructions before using Sertraline hydrochloride oral concentrate.

  • Push the plastic screw-cap on the bottle down while turning it counter clockwise. Remove the unscrewed cap (see Figure 1).
  • Hold the pull tab of the seal and remove (see Figure 2).
  • Insert the adaptor into the mouth of the bottle and push down until it is completely seated in the neck of the bottle (leave adaptor inserted in the bottle after use) (see Figure 3).
  • Remove the secure tip from orifice of the dispensing syringe (see Figure 4).
  • Insert the dispensing syringe into the adaptor fixed to the bottle neck (see Figure 5).
  • After inserting the syringe into the adaptor, make the bottle upside down and pull the plunger up to the level (see markings on side) that equals the dosage prescribed by your physician (see Figure 6).
  • Turn the bottle to original position and remove the dispensing syringe from the bottle (see Figure 7) and then empty the entire contents of the dispensing syringe and mix with 4 oz (1/2 cup) of water, ginger ale, lemon/lime soda, lemonade or orange juice ONLY. Do not mix sertraline hydrochloride oral concentrate with anything other than the liquids listed. The dose should be taken immediately after mixing. Do not mix in advance. At times, a slight haze may appear after mixing; this is normal.
  • Replace the plastic cap on the bottle by screwing it clockwise; rinse the empty dispensing syringe with water. And close the orifice of the dispensing syringe by fixing the secure tip (see Figure 8).

 
Sertraline Hydrochloride

Manufactured for:
Aurobindo Pharma USA, Inc.
2400 Route 130 North
Dayton, NJ 08810

Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 072, India

Revised: 07/2012

Medication Guide


Sertraline Hydrochloride Oral Concentrate



What is the most important information I should know about sertraline hydrochloride oral concentrate?



1.   Suicidal thoughts or actions:
  • Sertraline hydrochloride oral concentrate 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 oral concentrate 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 hydrochloride oral concentrate may be associated with these serious side effects:
2.   Serotonin Syndrome or Neuroleptic Malignant Syndrome like reactions. 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 oral concentrate 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 is sertraline hydrochloride oral concentrate?

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 oral concentrate?

  • are allergic to sertraline or any of the ingredients in sertraline hydrochloride oral concentrate. See the end of this Medication Guide for a complete list of ingredients in sertraline hydrochloride oral concentrate.
  • 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 hydrochloride oral concentrate) 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 hydrochloride oral concentrate.
    • Do not start sertraline hydrochloride oral concentrate if you stopped taking an MAOI in the last 2 weeks.

People who take sertraline hydrochloride oral concentrate 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 oral concentrate?

  • 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
  • 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 oral concentrate 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 oral concentrate.

Tell your healthcare provider about all the medicines that you take,


   If you take sertraline hydrochloride oral concentrate, you should not take any other medicines that contain sertraline (sertraline hydrochloride etc.).

How should I take sertraline hydrochloride oral concentrate?
  • Take sertraline hydrochloride oral concentrate exactly as prescribed. Your healthcare provider may need to change the dose of sertraline hydrochloride oral concentrate until it is the right dose for you.
  • Sertraline hydrochloride oral concentrate must be diluted before use:
    • Follow the instructions carefully
    • When diluting sertraline hydrochloride oral concentrate, use ONLY water, ginger ale, lemon/lime soda, lemonade, or orange juice.
  • If you miss a dose of sertraline hydrochloride oral concentrate, 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 oral concentrate at the same time.
  • If you take too much sertraline hydrochloride oral concentrate, call your healthcare provider or poison control center right away, or get emergency treatment.

What should I avoid while taking sertraline hydrochloride oral concentrate?



What are the possible side effects of sertraline hydrochloride oral concentrate?

  • See “What is the most important information I should know about sertraline hydrochloride oral concentrate?”
  • 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 oral concentrate.



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 oral concentrate? 
  • Store sertraline hydrochloride oral concentrate at room temperature 20° to 25°C (68° to 77°F).
  • Keep sertraline hydrochloride oral concentrate bottle closed tightly.

Keep sertraline hydrochloride oral concentrate and all medicines out of the reach of children.

General information about sertraline hydrochloride oral concentrate







What are the ingredients in sertraline hydrochloride oral concentrate?

Active ingredient:

Inactive ingredients:



®
®
®
®


Aurobindo Pharma USA, Inc.




Aurobindo Pharma Limited


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg/mL (60 mL Bottle)


Rx only                          NDC 65862-224-20
Sertraline Hydrochloride
Oral Concentrate
20 mg/mL*


PHARMACIST: PLEASE DISPENSE WITH
MEDICATION GUIDE PROVIDED SEPARATELY
60 mL
AUROBINDO

Sertraline Hydrochloride

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg/mL Carton Label


Rx only                             NDC 65862-224-20
Sertraline
Hydrochloride
Oral Concentrate
20 mg/mL*



PHARMACIST: PLEASE DISPENSE WITH
MEDICATION GUIDE PROVIDED SEPARATELY
60 mL
AUROBINDO


Sertraline Hydrochloride

Sertraline Hydrochloride

Sertraline Hydrochloride SOLUTION, CONCENTRATE

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:65862-224
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
SERTRALINE HYDROCHLORIDE SERTRALINE 20 mg

Inactive Ingredients

Ingredient Name Strength
ALCOHOL
propylene glycol
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 60 in 1 BOTTLE
2 60 in 1 BOTTLE, PLASTIC
3 NDC:65862-224-20 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078861 2008-10-31


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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