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Paroxetine

State of Florida DOH Central Pharmacy


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Suicidality in Children and Adolescents


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 paroxetine tablets or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Paroxetine is not approved for use in pediatric patients. (See WARNINGS: Clinical Worsening and Suicide Risk, PRECAUTIONS: Information for Patients, and PRECAUTIONS: Pediatric Use.)

PAROXETINE DESCRIPTION


transRS192032
Paroxetine



CLINICAL PHARMACOLOGY


Pharmacodynamics


In vitroIn vitro1221211


Pharmacokinetics



Absorption and Distribution


maxmaxmin½maxmin0-24

max



in vitro

Metabolism and Excretion


min

PRECAUTIONS

Other Clinical Pharmacology Information

Specific Populations


Renal and Liver Disease:max

DOSAGE AND ADMINISTRATION

Elderly Patients:minmin DOSAGE AND ADMINISTRATION

Drug-Drug Interactions


In vitro PRECAUTIONS—Drug Interactions

Clinical Trials

Major Depressive Disorder





Obsessive Compulsive Disorder






Outcome Classification (%) on CGI-Global Improvement Item for Completers in Study 1
Outcome
Classification 		Placebo
(n = 74) 		Paroxetine
20 mg
(n = 75) 		Paroxetine
40 mg
(n = 66) 		Paroxetine
60 mg
(n = 66)
Worse
    14%
      7%
      7%
      3%
No Change
    44%
      35%
      22%
      19%
Minimally Improved
    24%
      33%
      29%
      34%
Much Improved
    11%
      18%
      22%
      24%
Very Much Improved
    7%
       7%
      20%
      20%





Panic Disorder















Generalized Anxiety Disorder











PAROXETINE INDICATIONS AND USAGE

Major Depressive Disorder




CLINICAL PHARMACOLOGY—Clinical Trials



CLINICAL PHARMACOLOGY—Clinical Trials

Obsessive Compulsive Disorder




CLINICAL PHARMACOLOGY—Clinical Trials



CLINICAL PHARMACOLOGY—Clinical Trials DOSAGE AND ADMINISTRATION

Panic Disorder




CLINICAL PHARMACOLOGY—Clinical Trials



CLINICAL PHARMACOLOGY—Clinical Trials

Generalized Anxiety Disorder




CLINICAL PHARMACOLOGY—Clinical Trials



CLINICAL PHARMACOLOGY—Clinical Trials DOSAGE AND ADMINISTRATION

PAROXETINE CONTRAINDICATIONS

 

WARNINGS  PRECAUTIONS

PRECAUTIONS


WARNINGS

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 to 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.


Table 1
Age Range Drug-Placebo Difference in
Number of Cases of Suicidality
per 1,000 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 Paroxetine Tablets ), for a description of the risks of discontinuation of paroxetine.

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 healthcare providers. Such monitoring should include daily observation by families and caregivers. Prescriptions for paroxetine 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



Potential for Interaction With Monoamine Oxidase Inhibitors


In patients receiving another serotonin reuptake inhibitor drug in combination with a monoamine oxidase inhibitor (MAOI), there have been reports of serious, sometimes fatal, reactions including hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, and mental status changes that include extreme agitation progressing to delirium and coma. These reactions have also been reported in patients who have recently discontinued that drug and have been started on an MAOI. Some cases presented with features resembling neuroleptic malignant syndrome. While there are no human data showing such an interaction with paroxetine, limited animal data on the effects of combined use of paroxetine and MAOIs suggest that these drugs may act synergistically to elevate blood pressure and evoke behavioral excitation. Therefore, it is recommended that paroxetine not be used in combination with an MAOI (including linezolid, an antibiotic which is a reversible non-selective MAOI), or within 14 days of discontinuing treatment with an MAOI (see CONTRAINDICATIONS ). At least 2 weeks should be allowed after stopping paroxetine before starting an MAOI. 

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 treatment with paroxetine, but particularly with concomitant use of serotonergic drugs (including triptans) 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 paroxetine with MAOIs intended to treat depression is contraindicated.

If concomitant treatment of paroxetine 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 paroxetine with serotonin precursors (such as tryptophan) is not recommended.

Treatment with paroxetine 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.

Potential Interaction With Thioridazine


Thioridazine administration alone produces prolongation of the QTc interval, which is associated with serious ventricular arrhythmias, such as torsade de pointes–type arrhythmias, and sudden death. This effect appears to be dose related.
 
An in vivo study suggests that drugs which inhibit CYP2D6, such as paroxetine, will elevate plasma levels of thioridazine. Therefore, it is recommended that paroxetine not be used in combination with thioridazine (see CONTRAINDICATIONS and PRECAUTIONS).

Usage in Pregnancy

 

Teratogenic Effects


PRECAUTIONS—Discontinuation of Treatment With Paroxetine Tablets




Animal Findings


22

Nonteratogenic Effects


WARNINGS—Potential for Interaction With Monoamine Oxidase Inhibitors

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.

There have also been postmarketing reports of premature births in pregnant women exposed to paroxetine or other SSRIs.


DOSAGE AND ADMINISTRATION

PRECAUTIONS

General

Activation of Mania/Hypomania



Seizures



Discontinuation of Treatment With Paroxetine Tablets








DOSAGE AND ADMINISTRATION

PRECAUTIONS—Pediatric Use

Akathisia



Hyponatremia


Geriatric Use

Signs and symptoms of hyponatremia include headache, difficulty concentrating, memory impairment, confusion, weakness, and unsteadiness, which may lead to falls. Signs and symptoms associated with more severe and/or acute cases have included hallucination, syncope, seizure, coma, respiratory arrest, and death.

Abnormal Bleeding



Use in Patients With Concomitant Illness








DOSAGE AND ADMINISTRATION

Information for Patients





Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with paroxetineand should counsel them in its appropriate use. A patient Medication Guide about “Antidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidal Thoughts or Actions” is available for paroxetine. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document.

Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking paroxetine.

Clinical Worsening and Suicide Risk



Drugs That Interfere With Hemostasis (e.g., NSAIDs, Aspirin, and Warfarin)



Interference With Cognitive and Motor Performance



Completing Course of Therapy



Concomitant Medication



Alcohol



Pregnancy


WARNINGS—Usage in Pregnancy: Teratogenic and Nonteratogenic Effects

Nursing


PRECAUTIONS—Nursing Mothers

Laboratory Tests

There are no specific laboratory tests recommended.


Drug Interactions

Tryptophan


WARNINGS–Serotonin Syndrome

Monoamine Oxidase Inhibitors


CONTRAINDICATIONS WARNINGS

Pimozide


maxmax CONTRAINDICATIONS

Serotonergic Drugs


WARNINGS—Serotonin Syndrome CONTRAINDICATIONS PRECAUTIONS—Drug Interactions, Tryptophan

Thioridazine


CONTRAINDICATIONS WARNINGS

Warfarin


Drugs That Interfere With Hemostasis

Triptans


WARNINGS–Serotonin Syndrome

Drugs Affecting Hepatic Metabolism



Cimetidine


450

Phenobarbital


450½

Phenytoin


½ ADVERSE REACTIONS—Postmarketing Reports

Drugs Metabolized by CYP2D6


450max½max





CONTRAINDICATIONS WARNINGS



450 PRECAUTIONS—Tricyclic Antidepressants

Drugs Metabolized by Cytochrome CYP3A4


in vivoin vitroin vitroiin vivo

Tricyclic Antidepressants (TCAs)


PRECAUTIONS—Drugs Metabolized by Cytochrome CYP2D6

Drugs Highly Bound to Plasma Protein



Drugs That Interfere With Hemostasis (e.g., NSAIDs, Aspirin, and Warfarin)



Alcohol



Lithium



Digoxin



Diazepam



Procyclidine


0-24maxmin

Beta-Blockers


ADVERSE REACTIONS—Postmarketing Reports

Theophylline



Fosamprenavir/Ritonavir



Electroconvulsive Therapy (ECT)



Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis


2

Mutagenesis


in vitroin vivoin vivoin vitro

Impairment of Fertility


22

Pregnancy

See WARNINGS—Usage in Pregnancy: Teratogenic and Nonteratogenic Effects .


Labor and Delivery

The effect of paroxetine on labor and delivery in humans is unknown.


Nursing Mothers



Pediatric Use


BOX WARNING and WARNINGS—Clinical Worsening and Suicide Risk



Discontinuation of Treatment With Paroxetine Tablets

Geriatric Use


PRECAUTIONS, Hyponatremia)

CLINICAL PHARMACOLOGY DOSAGE AND ADMINISTRATION

PAROXETINE ADVERSE REACTIONS

Associated With Discontinuation of Treatment



 
 
Major
Depressive Disorder		 OCD Panic Disorder Generalized
Anxiety Disorder
Paroxetine Placebo Paroxetine Placebo Paroxetine Placebo Paroxetine Placebo
Where numbers are not provided the incidence of the adverse events in patients treated with paroxetine was not >1% or was
not greater than or equal to 2 times the incidence of placebo.
1. Incidence corrected for gender.
CNS
 
  
  
  
  
  
  
  
Somnolence
    2.3%
  0.7%
     —
 
     1.9%
  0.3%
    2%
  0.2%
Insomnia
     —
   —
    1.7%
    0%
    1.3%
  0.3%
 
  
Agitation
    1.1%
  0.5%
     —
 
  
  
  
  
Tremor
    1.1%
  0.3%
     —
 
  
  
  
  
Anxiety
     —
   —
     —
 
  
  
  
  
Dizziness
     —
   —
    1.5%
    0%
 
  
     1%
  0.2%
Gastrointestinal
 
  
  
  
  
  
  
  
Constipation
     —
 
     1.1%
    0%
 
  
  
  
Nausea
    3.2%
  1.1%
    1.9%
    0%
    3.2%
  1.2%
    2%
  0.2%
Diarrhea
     1%
  0.3%
     —
 
  
  
  
  
Dry mouth
     1%
  0.3%
     —
 
  
  
  
  
Vomiting
     1%
  0.3%
     —
 
  
  
  
  
Flatulence
 
  
  
  
  
  
  
  
Other 
 
  
  
  
  
  
  
  
Asthenia
    1.6%
  0.4%
    1.9%
  0.4%
 
  
     1.8%
  0.2%
Abnormal ejaculation1
     1.6%
    0%
     2.1%
    0%
 
  
      2.5%
   0.5%
Sweating
     1%
  0.3%
     —
 
  
  
     1.1%
  0.2%
Impotence1
      —
 
     1.5%
   0%
 
  
  
  
Libido Decreased
 
  
  
  
  
  
  
  

Commonly Observed Adverse Events

Major Depressive Disorder



Obsessive Compulsive Disorder



Panic Disorder



Generalized Anxiety Disorder



Incidence in Controlled Clinical Trials



Major Depressive Disorder




Table 2.  Treatment-Emergent Adverse Experience Incidence Placebo-Controlled Clinical Trials for Major DepressiveDisorder1

Body System
Preferred Term		 Paroxetine
(n = 421)		 Placebo 
(n = 421)
Body as a Whole
 Headache
Asthenia
     18%
    15%
    17%
   6%
Cardiovascular
Palpitation
Vasodilation
     3%
    3%
    1%
   1%
Dermatologic
 Sweating
Rash
     11%
    2%
    2%
   1%
Gastrointestinal
 Nausea
Dry Mouth
Constipation
Diarrhea
Decreased Appetite
Flatulence
Oropharynx Disorder2
Dyspepsia
     26%
    18%
    14%
    12%
    6%
    4%
    2%
    2%
    9%
   12%
   9%
   8%
   2%
   2%
   0%
   1%
Musculoskeletal
 Myopathy
Myalgia
Myasthenia
     2%
    2%
    1%
    1%
   1%
   0%
Nervous System
 Somnolence
Dizziness
Insomnia
Tremor
Nervousness
Anxiety
Paresthesia
Libido Decreased
Drugged Feeling
Confusion
     23%
    13%
    13%
    8%
    5%
    5%
    4%
    3%
    2%
    1%
    9%
   6%
   6%
   2%
   3%
   3%
   2%
   0%
   1%
   0%
Respiration
Yawn
     4%
    0%
Special Senses
 Blurred Vision
Taste Perversion
     4%
    2%
    1%
   0%
Urogenital System
 Ejaculatory Disturbance3,4
Other Male Genital Disorders3,5
Urinary Frequency
Urination Disorder6
Female Genital Disorders3,7
    13%
    10%
    3%
    3%
    2%
    0%
   0%
   1%
   0%
   0%

  • Events reported by at least 1% of patients treated with paroxetine are included, except the following events which had an incidence on placebo ≥ paroxetine: Abdominal pain, agitation, back pain, chest pain, CNS stimulation, fever, increased appetite, myoclonus, pharyngitis, postural hypotension, respiratory disorder includes mostly “cold symptoms” or “URI”), trauma, and vomiting.

    2.    Includes mostly “lump in throat” and “tightness in throat.”

    3.    Percentage corrected for gender.

    4.    Mostly “ejaculatory delay.”

    5.    Includes “anorgasmia,” “erectile difficulties,” “delayed ejaculation/orgasm,” and “sexual dysfunction,” and “impotence.”

    6.    Includes mostly “difficulty with micturition” and “urinary hesitancy.”

    7.    Includes mostly “anorgasmia” and “difficulty reaching climax/orgasm.” 

Obsessive Compulsive Disorder and Panic Disorder



Table 3. Treatment-Emergent Adverse Experience Incidence in Placebo-Controlled Clinical Trials for Obsessive Compulsive Disorder, and Panic Disorder1




Body System



Preferred Term		 Obsessive Compulsive
Disorder		 Panic Disorder
Paroxetine
(n = 542)		 Placebo
(n = 265)		 Paroxetine 
(n = 469)		 Placebo
(n = 324)
Body as a Whole
 
 
 
 
 Asthenia
       22%
     14%
     14%
     5%
Abdominal Pain
       —
     —
     4%
     3%
Chest Pain
       3%
     2%
     —
     —
Back Pain
       —
     —
     3%
     2%
Chills
       2%
     1%
     2%
     1%
Trauma
       —
     —
     —
     —
Cardiovascular
 Vasodilation
       4%
     1%
     —
     —
Palpitation
       2%
     0%
     —
     —
Dermatologic
 Sweating
       9%
     3%
     14%
     6%
Rash
      3%
     2%
     —
     —
Gastrointestinal
 Nausea
      23%
     10%
     23%
     17%
Dry Mouth
      18%
     9%
     18%
     11%
Constipation
      16%
     6%
     8%
     5%
Diarrhea
      10%
     10%
     12%
     7%
Decreased Appetite
       9%
     3%
      7%
      3%
Dyspepsia
      —
     —
     —
     —
Flatulence
      —
     —
     —
     —
Increased Appetite
      4%
     3%
    2%
    1%
Vomiting
      —
    —
    —
    —
Musculoskeletal
Myalgia
      —
     —
     —
     —
Nervous System
Insomnia
      24%
    13%
    18%
    10%
Somnolence
      24%
    7%
    19%
    11%
Dizziness
      12%
    6%
    14%
    10%
Tremor
      11%
    1%
    9%
    1%
Nervousness
      9%
    8%
    —
    —
Libido Decreased
      7%
    4%
    9%
    1%
Agitation
      —
    —
    5%
    4%
Anxiety
      —
    —
    5%
    4%
Abnormal Dreams
      4%
    1%
     —
     —
Concentration
Impaired 		      3%
    2%
      —
     —
Depersonalization
      3%
    0%
    —
    —
Myoclonus
      3%
    0%
    3%
    2%
Amnesia
      2%
    1%
    —
    —
Respiratory System
 Rhinitis
      —
    —
    3%
    0%
Pharyngitis
      —
    —
    —
    —
Yawn
      —
    —
    —
    —
Special Senses
 
 Abnormal Vision
      4%
    2%
    —
    —
Taste Perversion
      2%
    0%
    —
    —
Urogenital System
 Abnormal
Ejaculation2 		     23%
     1%
    21%
     1%
Dysmenorrhea
      —
    —
    —
    —
Female Genital
Disorder2
      3%
    0%
    9%
    1%
Impotence2
      8%
    1%
    5%
    0%
Urinary Frequency
      3%
    1%
    2%
    0%
Urination Impaired
      3%
    0%
    —
    —
Urinary Tract
Infection
       2%
    1%
    2%
    1%

  • Events reported by at least 2% of OCD and panic disorder in patients treated with paroxetine are included, except the following events which had an incidence on placebo ≥ paroxetine: [OCD]: Abdominal pain, agitation, anxiety, back pain, cough increased, depression, headache, hyperkinesia, infection, paresthesia, pharyngitis, respiratory disorder, rhinitis, and sinusitis. [panic disorder]: Abnormal dreams, abnormal vision, chest pain, cough increased, depersonalization, depression, dysmenorrhea, dyspepsia, flu syndrome, headache, infection, myalgia, nervousness, palpitation, paresthesia, pharyngitis, rash, respiratory disorder, sinusitis, taste perversion, trauma, urination impaired, and vasodilation.
  • Percentage corrected for gender.

Generalized Anxiety Disorder




Table 4. Treatment-Emergent Adverse Experience Incidence in Placebo-Controlled Clinical Trials for Generalized Anxiety Disorder1


Body System

Preferred Term		 Generalized Anxiety
Disorder
Paroxetine
(n = 735)		 Placebo 
(n = 529)
Body as a Whole
Asthenia
    14%
     6%
Headache
    17%
     14%
Infection
    6%
     3%
Abdominal Pain
 
 
Trauma
 
 
Cardiovascular
Vasodilation
    3%
     1%
Dermatologic
Sweating
    6%
     2%
Gastrointestinal
Nausea
    20%
     5%
Dry Mouth
    11%
     5%
Constipation
    10%
     2%
Diarrhea
    9%
     7%
Decreased Appetite
    5%
     1%
Vomiting
    3%
     2%   
Dyspepsia
    —
     —
Nervous System
Insomnia
     11%
     8%
Somnolence
    15%
     5%
Dizziness
    6%
     5%
Tremor
    5%
     1%
Nervousness
    4%
     3%
Libido Decreased
    9%
     2%
Abnormal Dreams
 
  
Respiratory System
Respiratory Disorder
    7%
     5%
Sinusitis
    4%
     3%
Yawn
    4%
     —
Special Senses
Abnormal Vision
    2%
     1%
Urogenital System
Abnormal Ejaculation2
    25%
     2%
Female Genital Disorder2
    4%
     1%
Impotence2
    4%
     3%

  • Events reported by at least 2% of GAD in patients treated with paroxetine are included, except the following events which
    had an incidence on placebo ≥ paroxetine [GAD]: Abdominal pain, back pain, trauma, dyspepsia, myalgia, and pharyngitis.

Dose Dependency of Adverse Events




Table 5. Treatment-Emergent Adverse Experience Incidence in a Dose-Comparison Trial in the Treatment of Major Depressive Disorder*

Body System/Preferred Term		 Placebo Paroxetine
n = 51  10 mg    
n = 102		  20 mg  
n = 104		  30 mg     
n = 101		  40 mg   
n = 102
*  Rule for including adverse events in table: Incidence at least 5% for 1 of paroxetine
   groups and ≥ twice the placebo incidence for at least 1 paroxetine group.
Body as a Whole





Asthenia
    0%
     2.9%
     10.6%
     13.9%
    12.7%
Dermatology





Sweating
    2%
     1%
     6.7%
     8.9%
    11.8%
Gastrointestinal





Constipation
     5.9%
     4.9%
     7.7%
     9.9%
     12.7%
Decreased Appetite
     2%
     2%
     5.8%
     4%
     4.9%
Diarrhea
     7.8%
     9.8%
     19.2%
     7.9%
     14.7%
Dry Mouth
     2%
     10.8%
     18.3%
     15.8%
     20.6%
Nausea
     13.7%
     14.7%
     26.9%
     34.7%
     36.3%
Nervous System





Anxiety
     0%
     2%
     5.8%
    5.9%
     5.9%
Dizziness
     3.9%
     6.9%
     6.7%
     8.9%
     12.7%
Nervousness
     0%
     5.9%
     5.8%
     4.0%
     2.9%
Paresthesia
     0%
     2.9%
     1%
     5%
     5.9%
Somnolence
     7.8%
     12.7%
     18.3%
     20.8%
     21.6%
Tremor
     0%
     0%
     7.7%
     7.9%
     14.7%
Special Senses





Blurred Vision
     2%
     2.9%
     2.9%
     2%
    7.8%
Urogenital System





Abnormal Ejaculation
     0%
     5.8%
     6.5%
     10.6%
     13%
Impotence
     0%
     1.9%
     4.3%
     6.4%
     1.9%
Male Genital Disorders
     0%
     3.8%
     8.7%
     6.4%
     3.7%






Adaptation to Certain Adverse Events



Male and Female Sexual Dysfunction With SSRIs






Table 6. Incidence of Sexual Adverse Events in Controlled Clinical Trials
 
 Paroxetine Placebo
n (males)
    1446
    1042
Decreased Libido
     6-15%
     0-5%
Ejaculatory Disturbance
     13-28%
     0-2%
Impotence
     2-9%
     0-3%
n (females)
    1822
    1340
Decreased Libido
     0-9%
     0-2%
Orgasmic Disturbance
     2-9%
     0-1%






Weight and Vital Sign Changes



ECG Changes



Liver Function Tests



Hallucinations



Other Events Observed During the Premarketing Evaluation of Paroxetine






PRECAUTIONS

Body as a Whole


Infrequent:rare:

Cardiovascular System


Frequent:infrequent:rare:

Digestive System


Infrequent:rare:

Endocrine System


Rare:

Hemic and Lymphatic Systems


Infrequent:rare:

Metabolic and Nutritional


Frequent:infrequent:rare:

Musculoskeletal System


Frequent:infrequent:rare:

Nervous System


Frequent:infrequent:rare:

Respiratory System


Infrequent: rare:

Skin and Appendages


Frequent:infrequent:rare:

Special Senses


Frequent:infrequent:rare:

Urogenital System


Infrequent:rare:

Postmarketing Reports

Voluntary reports of adverse events in patients taking paroxetine that have been received since market introduction and not listed above that may have no causal relationship with the drug include acute pancreatitis, elevated liver function tests (the most severe cases were deaths due to liver necrosis, and grossly elevated transaminases associated with severe liver dysfunction), Guillain-Barré syndrome, toxic epidermal necrolysis, priapism, syndrome of inappropriate ADH secretion, symptoms suggestive of prolactinemia and galactorrhea; extrapyramidal symptoms which have included akathisia, bradykinesia, cogwheel rigidity, dystonia, hypertonia, oculogyric crisis which has been associated with concomitant use of pimozide; tremor and trismus; status epilepticus, acute renal failure, pulmonary hypertension, allergic alveolitis, anaphylaxis, eclampsia, laryngismus, optic neuritis, porphyria, ventricular fibrillation, ventricular tachycardia (including torsade de pointes), thrombocytopenia, hemolytic anemia, events related to impaired hematopoiesis (including aplastic anemia, pancytopenia, bone marrow aplasia, and agranulocytosis), and vasculitic syndromes (such as Henoch-Schönlein purpura). There has been a case report of an elevated phenytoin level after 4 weeks of paroxetine and phenytoin coadministration. There has been a case report of severe hypotension when paroxetine was added to chronic metoprolol treatment.

DRUG ABUSE AND DEPENDENCE

Controlled Substance Class


Physical and Psychologic Dependence

Paroxetine has not been systematically studied in animals or humans for its potential for abuse, tolerance or physical dependence. While the clinical trials did not reveal any tendency for any drug-seeking behavior, these observations were not systematic and it is not possible to predict on the basis of this limited experience the extent to which a CNS-active drug will be misused, diverted, and/or abused once marketed. Consequently, patients should be evaluated carefully for history of drug abuse, and such patients should be observed closely for signs of misuse or abuse of paroxetine (e.g., development of tolerance, incrementations of dose, drug-seeking behavior).


OVERDOSAGE

Human Experience





Overdosage Management








PRECAUTIONS—Drugs Metabolized by Cytochrome CYP2D6

Physicians' Desk Reference

PAROXETINE DOSAGE AND ADMINISTRATION

Major Depressive Disorder

Usual Initial Dosage



Maintenance Therapy





Obsessive Compulsive Disorder

Usual Initial Dosage



Maintenance Therapy


CLINICAL PHARMACOLOGY—Clinical Trials

Panic Disorder

Usual Initial Dosage



Maintenance Therapy


CLINICAL PHARMACOLOGY—Clinical Trials

Generalized Anxiety Disorder

Usual Initial Dosage



Maintenance Therapy


CLINICAL PHARMACOLOGY—Clinical Trials

Special Populations

Treatment of Pregnant Women During the Third Trimester


WARNINGS

Dosage for Elderly or Debilitated Patients, and Patients With Severe Renal or Hepatic Impairment



Switching Patients to or From a Monoamine Oxidase Inhibitor



Discontinuation of Treatment With Paroxetine Tablets


PRECAUTIONS

HOW SUPPLIED


Paroxetine Tablets USP, 10 mg

Paroxetine Tablets USP, 20 mg

Paroxetine Tablets USP, 30 mg

Paroxetine Tablets USP, 40 mg

They are supplied by State of Florida DOH Central Pharmacy as follows:

NDC Strength Quantity/Form Color Source Prod. Code
53808-0749-1 20 mg 30 Tablets in a Blister Pack PINK 65862-155
53808-0752-1 30 mg 30 Tablets in a Blister Pack BLUE 65862-156
53808-0756-1 40 mg 30 Tablets in a Blister Pack PINK 65862-157

Store at


Aurobindo Pharma USA, Inc.




Aurobindo Pharma Limited

This Product was Repackaged By:

State of Florida DOH Central Pharmacy
104-2 Hamilton Park Drive
Tallahassee, FL 32304
United States

MEDICATION GUIDE


Antidepressant Medicines, Depression and Other Serious Mental Illnesses,
and Suicidal Thoughts or Actions
Talk to your, or your family member’s, healthcare provider about:
  • all risks and benefits of treatment with antidepressant medicines
  • all treatment choices for depression or other serious mental illness

What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions?

  • Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.
  • Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions.
  • How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?

  • Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.
  • Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.
  • Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms

Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you:

  • thoughts about suicide or dying
  • attempts to commit suicide
  • new or worse depression
  • new or worse anxiety
  • feeling very agitated or restless
  • panic attacks
  • trouble sleeping (insomnia)
  • new or worse irritability
  • acting aggressive, being angry, or violent
  • acting on dangerous impulses
  • an extreme increase in activity and talking (mania)
  • other unusual changes in behavior or mood

What else do I need to know about antidepressant medicines?

  • Never stop an antidepressant medicine without first talking to a healthcare provider. Stopping an antidepressant medicine suddenly can cause other symptoms.
  • Antidepressants are medicines used to treat depression and other illnesses. It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants.
  • Antidepressant medicines have other side effects. Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member.
  • Antidepressant medicines can interact with other medicines. Know all of the medicines that you or your family member takes. Keep a list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider.
  • Not all antidepressant medicines prescribed for children are FDA approved for use in children. Talk to your child’s healthcare provider for more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This Medication Guide has been approved by the U.S. Food and Drug Administration for all antidepressants.

20mg Label

Paroxetine

30mg Label

Paroxetine

40mg Label

Paroxetine

Paroxetine

PAROXETINE HYDROCHLORIDE TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:53808-0749(NDC:65862-155)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
PAROXETINE HYDROCHLORIDE PAROXETINE 20 mg

Inactive Ingredients

Ingredient Name Strength
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
lactose monohydrate
SODIUM STARCH GLYCOLATE TYPE A POTATO
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
MAGNESIUM STEARATE
hypromellose
titanium dioxide
polyethylene glycol
polysorbate 80
D&C RED NO. 30

Product Characteristics

Color Size Imprint Code Shape
pink (PINK) 4 mm 56;C CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:53808-0749-1 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078406 2009-07-01


Paroxetine

PAROXETINE HYDROCHLORIDE TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:53808-0752(NDC:65862-156)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
PAROXETINE HYDROCHLORIDE PAROXETINE 30 mg

Inactive Ingredients

Ingredient Name Strength
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
lactose monohydrate
SODIUM STARCH GLYCOLATE TYPE A POTATO
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
MAGNESIUM STEARATE
hypromellose
titanium dioxide
polyethylene glycol
polysorbate 80
FD&C BLUE NO. 2

Product Characteristics

Color Size Imprint Code Shape
blue (BLUE) 4 mm F;12 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:53808-0752-1 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078406 2009-07-01


Paroxetine

PAROXETINE HYDROCHLORIDE TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:53808-0756(NDC:65862-157)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
PAROXETINE HYDROCHLORIDE PAROXETINE 40 mg

Inactive Ingredients

Ingredient Name Strength
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
lactose monohydrate
SODIUM STARCH GLYCOLATE TYPE A POTATO
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
MAGNESIUM STEARATE
hypromellose
titanium dioxide
polyethylene glycol
polysorbate 80
D&C RED NO. 30

Product Characteristics

Color Size Imprint Code Shape
pink (PINK) 5 mm A59 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:53808-0756-1 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078406 2009-07-01


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