PAROXETINE
STAT Rx USA LLC
PSS World Medical Inc.
Paroxetine Tablets, USP
FULL PRESCRIBING INFORMATION: CONTENTS*
- Suicidality and Antidepressant Drugs
- PAROXETINE DESCRIPTION
- CLINICAL PHARMACOLOGY
- PAROXETINE INDICATIONS AND USAGE
- PAROXETINE CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
- PAROXETINE ADVERSE REACTIONS
- DRUG ABUSE AND DEPENDENCE
- OVERDOSAGE
- PAROXETINE DOSAGE AND ADMINISTRATION
- HOW SUPPLIED
- Medication Guide
- PACKAGE LABEL - PAROXETINE 10 MG TABLETS
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 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
CLINICAL PHARMACOLOGY
Pharmacodynamics
In vitroIn vitro1221211
Pharmacokinetics
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in vitro
min
PRECAUTIONS: Drugs Metabolized by CYP2D6
Other Clinical Pharmacology Information
Renal and Liver Disease: max
DOSAGE AND ADMINISTRATION
Elderly Patients: minmin DOSAGE AND ADMINISTRATION
In vitro PRECAUTIONS: Drug Interactions
Clinical Trials
| 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% |
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 DOSAGE AND ADMINISTRATION
Generalized Anxiety Disorder
CLINICAL PHARMACOLOGY: Clinical Trials
CLINICAL PHARMACOLOGY: Clinical Trials DOSAGE AND ADMINISTRATION
PAROXETINE CONTRAINDICATIONS
WARNINGS
WARNINGS
WARNINGS PRECAUTIONS
PRECAUTIONS
WARNINGS
Clinical Worsening and Suicide Risk
| 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 |
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 Paroxetine 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 healthcare providers. Such monitoring should include daily observation by families and caregivers.
Screening Patients for Bipolar Disorder
Potential for Interaction With Monoamine Oxidase Inhibitors
CONTRAINDICATIONS DOSAGE AND ADMINISTRATION
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
- A study based on Swedish national registry data demonstrated that infants exposed to paroxetine during pregnancy (n = 815) had an increased risk of cardiovascular malformations (2% risk in paroxetine-exposed infants) compared to the entire registry population (1% risk), for an odds ratio (OR) of 1.8 (95% confidence interval 1.1 to 2.8). No increase in the risk of overall congenital malformations was seen in the paroxetine-exposed infants. The cardiac malformations in the paroxetine-exposed infants were primarily ventricular septal defects (VSDs) and atrial septal defects (ASDs). Septal defects range in severity from those that resolve spontaneously to those which require surgery.
- A separate retrospective cohort study from the United States (United Healthcare data) evaluated 5,956 infants of mothers dispensed antidepressants during the first trimester (n = 815 for paroxetine). This study showed a trend towards an increased risk for cardiovascular malformations for paroxetine (risk of 1.5%) compared to other antidepressants (risk of 1%), for an OR of 1.5 (95% confidence interval 0.8 to 2.9). Of the 12 paroxetine-exposed infants with cardiovascular malformations, 9 had VSDs. This study also suggested an increased risk of overall major congenital malformations including cardiovascular defects for paroxetine (4% risk) compared to other (2% risk) antidepressants (OR 1.8; 95% confidence interval 1.2 to 2.8).
- Two large case-control studies using separate databases, each with >9,000 birth defect cases and >4,000 controls, found that maternal use of paroxetine during the first trimester of pregnancy was associated with a 2- to 3-fold increased risk of right ventricular outflow tract obstructions. In one study the odds ratio was 2.5 (95% confidence interval, 1 to 6, 7 exposed infants) and in the other study the odds ratio was 3.3 (95% confidence interval, 1.3 to 8.8, 6 exposed infants).
PRECAUTIONS: Discontinuation of Treatment With Paroxetine Tablets)
Animal Findings
22
Nonteratogenic Effects
WARNINGS: Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-like Reactions
th
DOSAGE AND ADMINISTRATION
PRECAUTIONS
General
Discontinuation of Treatment With Paroxetine Tablets
DOSAGE AND ADMINISTRATION
PRECAUTIONS: Pediatric Use
Drug Interactions
Hyponatremia
PRECAUTIONS: Geriatric Use
DOSAGE AND ADMINISTRATION
Information for Patients
Drugs That Interfere With Hemostasis (e.g., NSAIDs, Aspirin, and Warfarin)
WARNINGS: Usage in Pregnancy: Teratogenic Effects and Nonteratogenic Effects
PRECAUTIONS: Nursing Mothers
Laboratory Tests
Drug Interactions
Tryptophan
WARNINGS: Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-like Reactions
CONTRAINDICATIONS WARNINGS
maxmax CONTRAINDICATIONS
WARNINGS: Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-like Reactions
CONTRAINDICATIONS PRECAUTIONS: Drug Interactions: Tryptophan
CONTRAINDICATIONS WARNINGS
PRECAUTIONS: Drugs That Interfere With Hemostasis
WARNINGS: Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-like Reactions
450
450½
½ ADVERSE REACTIONS: Postmarketing Reports
Drugs Metabolized by CYP2D6
450max½max
CONTRAINDICATIONS WARNINGS
PRECAUTIONS
450 PRECAUTIONS: Tricyclic Antidepressants (TCAs)
in vivoin vitroin vitroiin vivo
Tricyclic Antidepressants (TCAs)
PRECAUTIONS: Drugs Metabolized by Cytochrome CYP2D6
0-24maxmin
ADVERSE REACTIONS: Postmarketing Reports
Carcinogenesis, Mutagenesis, Impairment of Fertility
2
in vitroin vivoin vivoin vitro
22
Pregnancy
WARNINGS: Usage in Pregnancy: Teratogenic Effects and Nonteratogenic Effects.
Labor and Delivery
Nursing Mothers
Pediatric Use
BOX WARNING WARNINGS : Clinical Worsening and Suicide Risk
DOSAGE AND ADMINISTRATION: 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 |
||||||||
Incidence in Controlled Clinical Trials
| Body System | Preferred Term | Paroxetine (n=421) |
Placebo (n=421) |
|---|---|---|---|
| 1. 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.” |
|||
| Body as a Whole |
Headache |
18% |
17% |
| Asthenia |
15% |
6% |
|
| Cardiovascular
|
Palpitation |
3% |
1% |
| Vasodilation |
3% |
1% |
|
| Dermatologic |
Sweating |
11% |
2% |
| Rash |
2% |
1% |
|
| Gastrointestinal |
Nausea |
26% |
9% |
| Dry Mouth |
18% |
12% |
|
| Constipation |
14% |
9% |
|
| Diarrhea |
12% |
8% |
|
| Decreased Appetite |
6% |
2% |
|
| Flatulence |
4% |
2% |
|
| Oropharynx Disorder2
|
2% |
0% |
|
| Dyspepsia |
2% |
1% |
|
| Musculoskeletal |
Myopathy |
2% |
1% |
| Myalgia |
2% |
1% |
|
| Myasthenia |
1% |
0% |
|
| Nervous System |
Somnolence |
23% |
9% |
| Dizziness |
13% |
6% |
|
| Insomnia |
13% |
6% |
|
| Tremor |
8% |
2% |
|
| Nervousness |
5% |
3% |
|
| Anxiety |
5% |
3% |
|
| Paresthesia |
4% |
2% |
|
| Libido Decreased |
3% |
0% |
|
| Drugged Feeling |
2% |
1% |
|
| Confusion |
1% |
0% |
|
| Respiration
|
Yawn |
4% |
0% |
| Special Senses |
Blurred Vision |
4% |
1% |
| Taste Perversion |
2% |
0% |
|
| Urogenital System |
Ejaculatory Disturbance3,4
|
13% |
0% |
| Other Male Genital Disorders3,5
|
10% |
0% |
|
| Urinary Frequency |
3% |
1% |
|
| Urination Disorder6
|
3% |
0% |
|
| Female Genital Disorders3,7
|
2% |
0% |
|
| Body System | Preferred Term | Obsessive Compulsive Disorder |
Panic Disorder | ||
|---|---|---|---|---|---|
| Paroxetine (n = 542) |
Placebo (n = 265) |
Paroxetine (n = 469) |
Placebo (n = 324) |
||
| 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. 2. Percentage corrected for gender. |
|||||
| 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% |
|
| Body System | Preferred Term | Generalized Anxiety Disorder | |
|---|---|---|---|
| Paroxetine (n=735) |
Placebo (n=529) |
||
| 1. 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.
2. Percentage corrected for gender. |
|||
| 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% |
|
| 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% |
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% |
| 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% |
Other Events Observed During the Premarketing Evaluation of Paroxetine
PRECAUTIONS
Infrequent: rare:
Frequent: infrequent:rare:
Infrequent: rare:
Rare:
Infrequent: rare:
Frequent: infrequent:rare:
Frequent: infrequent:rare:
Frequent: infrequent:rare:
Infrequent: rare:
Frequent: infrequent:rare:
Frequent: infrequent:rare:
Infrequent: rare:
Postmarketing Reports
DRUG ABUSE AND DEPENDENCE
Controlled Substance Class
Physical and Psychologic Dependence
OVERDOSAGE
Human Experience
Overdosage Management
PRECAUTIONS: Drugs Metabolized by Cytochrome CYP2D6
Physicians' Desk Reference
PAROXETINE DOSAGE AND ADMINISTRATION
Major Depressive Disorder
Obsessive Compulsive Disorder
CLINICAL PHARMACOLOGY: Clinical Trials
Panic Disorder
CLINICAL PHARMACOLOGY: Clinical Trials
Generalized Anxiety Disorder
CLINICAL PHARMACOLOGY: Clinical Trials
Special Populations
WARNINGS: Usage in Pregnancy
Switching Patients to or From a Monoamine Oxidase Inhibitor Antidepressant
CONTRAINDICATIONS
Use of Paroxetine Tablets With Reversible MAOIs Such as Linezolid or Methylene Blue
CONTRAINDICATIONS WARNINGS
Discontinuation of Treatment With Paroxetine Tablets
PRECAUTIONS: Discontinuation of Treatment With Paroxetine Tablets
HOW SUPPLIED
Paroxetine Tablets USP, 10 mg
Store at
Aurobindo Pharma USA, Inc.
Aurobindo Pharma Limited
Relabeling and Repackaging by
Medication Guide
Paroxetine Tablets, USP
What is the most important information I should know about paroxetine tablets?
1. Suicidal thoughts or actions:
- Paroxetine 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 paroxetine 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. Paroxetine tablets 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 paroxetine 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 paroxetine tablets?
.
- Major Depressive Disorder (MDD)
- Obsessive Compulsive Disorder (OCD)
- Panic Disorder
- Generalized Anxiety Disorder (GAD)
Who should not take paroxetine tablets?
- are allergic to paroxetine or any of the ingredients in paroxetine tablets. See the end of this Medication Guide for a complete list of ingredients in paroxetine tablets.
- 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 paroxetine tablets unless directed to do so by your physician.
- Do not start paroxetine tablets if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your physician.
-
People who take paroxetine 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)
- take MELLARIL® (thioridazine). Do not take MELLARIL® together with paroxetine tablets because this can cause serious heart rhythm problems or sudden death.
- take the antipsychotic medicine pimozide (ORAP®) because this can cause serious heart problems.
What should I tell my healthcare provider before taking paroxetine tablets? Ask if you are not sure.
- are pregnant, may be pregnant, or plan to become pregnant. There is a possibility that paroxetine tablets may harm your unborn baby, including an increased risk of birth defects, particularly heart defects. Other risks may include a serious condition in which there is not enough oxygen in the baby’s blood. Your baby may also have certain other symptoms shortly after birth. Premature births have also been reported in some women who used paroxetine tablets during pregnancy.
- are breastfeeding. Paroxetine passes into your milk. Talk to your healthcare provider about the best way to feed your baby while taking paroxetine tablets.
- are taking certain drugs such as:
- triptans used to treat migraine headache
- other antidepressants (SSRIs, SNRIs, tricyclics, or lithium) or antipsychotics
- drugs that affect serotonin, such as lithium, tramadol, tryptophan, St. John’s wort
- certain drugs used to treat irregular heart beats
- certain drugs used to treat schizophrenia
- certain drugs used to treat HIV infection
- certain drugs that affect the blood, such as warfarin, aspirin, and ibuprofen
- certain drugs used to treat epilepsy
- atomoxetine
- cimetidine
- fentanyl
- metoprolol
- pimozide
- procyclidine
- tamoxifen
- 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
- have glaucoma (high pressure in the eye)
Tell your healthcare provider about all the medicines you take
| If you take paroxetine tablets, you should not take any other medicines that contain paroxetine, including PAXIL CR and PEXEVA® (paroxetine mesylate). |
How should I take paroxetine tablets?
- Take paroxetine tablets exactly as prescribed. Your healthcare provider may need to change the dose of paroxetine tablets until it is the right dose for you.
- Paroxetine tablets may be taken with or without food.
- If you miss a dose of paroxetine 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 paroxetine tablets at the same time.
- If you take too much paroxetine, call your healthcare provider or poison control center right away, or get emergency treatment.
- Do not stop taking paroxetine tablets suddenly without talking to your doctor (unless you have symptoms of a severe allergic reaction). If you need to stop taking paroxetine tablets, your healthcare provider can tell you how to safely stop taking it.
What should I avoid while taking paroxetine tablets?
What are possible side effects of paroxetine tablets?
“What is the most important information I should know about paroxetine tablets?”
- nausea
- sleepiness
- weakness
- dizziness
- feeling anxious or trouble sleeping
- sexual problems
- sweating
- shaking
- not feeling hungry
- dry mouth
- constipation
- infection
- yawning
CALL YOUR DOCTOR FOR MEDICAL ADVICE ABOUT SIDE EFFECTS. YOU MAY REPORT SIDE EFFECTS TO THE FDA AT 1-800-FDA-1088 or 1-800-332-1088.
How should I store paroxetine tablets?
- Store paroxetine tablets at room temperature between 20° to 25°C (68° to 77°F).
- Keep paroxetine tablets away from light.
- Keep bottle of paroxetine tablets closed tightly.
Keep paroxetine tablets and all medicines out of the reach of children.
General information about paroxetine tablets
What are the ingredients in paroxetine tablets?
Active ingredient:
Inactive ingredients in tablets:
Aurobindo Pharma USA, Inc.
Aurobindo Pharma Limited
Relabeling and Repackaging by:
STAT Rx USA LLC
Gainesville, GA 30501
PACKAGE LABEL - PAROXETINE 10 MG TABLETS
Paroxetine Tablets, USP 10 mg
PHARMACIST: PLEASE DISPENSE WITH
MEDICATION GUIDE PROVIDED SEPARATELY
Rx only
PAROXETINEPAROXETINE HYDROCHLORIDE TABLET, FILM COATED
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PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
