Paroxetine Tablets, USP
Suicidality and Antidepressant Drugs
DESCRIPTION
CLINICAL PHARMACOLOGY
Pharmacodynamics
Pharmacokinetics
Other Clinical Pharmacology Information
Clinical Trials
| 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% |
INDICATIONS AND USAGE
CONTRAINDICATIONS
WARNINGS
Clinical Worsening and Suicide Risk
| Age Range | Drug-Placebo Difference inNumber 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 |
Screening Patients for Bipolar Disorder
Potential for Interaction With Monoamine Oxidase Inhibitors
Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-like Reactions
Potential Interaction With Thioridazine
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).
Animal Findings
Nonteratogenic Effects
PRECAUTIONS
General
Discontinuation of Treatment With Paroxetine Tablets
Hyponatremia
Information for Patients
Drugs That Interfere With Hemostasis (e.g., NSAIDs, Aspirin, and Warfarin)
Laboratory Tests
Drug Interactions
Tryptophan
Drugs Metabolized by CYP2D6
Tricyclic Antidepressants (TCAs)
Carcinogenesis, Mutagenesis, Impairment of Fertility
Pregnancy
Labor and Delivery
Nursing Mothers
Pediatric Use
Geriatric Use
ADVERSE REACTIONS
| 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 |
| 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 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 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 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% |
| 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% |
Postmarketing Reports
DRUG ABUSE AND DEPENDENCE
Controlled Substance Class
OVERDOSAGE
DOSAGE AND ADMINISTRATION
Discontinuation of Treatment With Paroxetine Tablets
HOW SUPPLIED
Medication Guide
| If you take paroxetine tablets, you should not take any other medicines that contain paroxetine, including PAXIL CR and PEXEVA® (paroxetine mesylate). |
- 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.
Relabeling and Repackaging by:
STAT Rx USA LLC
Gainesville, GA 30501
PACKAGE LABEL - PAROXETINE 10 MG TABLETS