Paroxetine Hydrochloride (4 brand names, 4 dosage forms, 1 route)
Available dosage forms: TABLET, TABLET, EXTENDED RELEASE, SUSPENSION, CAPSULE.
Routes of administration: ORAL.
Brand Names
- PAROXETINE
- PAROXETINE HYDROCHLORIDE
- PAXIL
- PAXIL CR
Boxed Warning
Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [see Warnings and Precautions ( 5.1)] . Paroxetine tablets are not approved for use in pediatric patients [see Use in Specific Populations ( 8.4)] .
Indications and Usage
Paroxetine tablets are indicated in adults for the treatment of: Major depressive disorder (MDD) Obsessive compulsive disorder (OCD) Panic disorder (PD) Social anxiety disorder (SAD) Generalized anxiety disorder (GAD) Posttraumatic stress disorder (PTSD)
Contraindications
Paroxetine tablets are contraindicated in patients: Taking, or within 14 days of stopping, MAOIs (including the MAOIs linezolid and intravenous methylene blue) because of an increased risk of serotonin syndrome [see Warnings and Precautions ( 5.2), Drug Interactions ( 7)]. Taking thioridazine because of risk of QT prolongation [see Warnings and Precautions ( 5.3), Drug Interactions ( 7)] Taking pimozide because of risk of QT prolongation [see Warnings and Precautions ( 5.3), Drug Interactions ( 7)]. With known hypersensitivity (e.g., anaphylaxis, angioedema, Stevens-Johnson syndrome) to paroxetine or any of the inactive ingredients in paroxetine tablets [see Adverse Reactions ( 6.1), ( 6.2)] .
Adverse Reactions
The following adverse reactions are included in more detail in other sections of the prescribing information: Hypersensitivity reactions to paroxetine [see Contraindications ( 4)] Suicidal Thoughts and Behaviors [see Warnings and Precautions ( 5.1)] Serotonin Syndrome [see Warnings and Precautions ( 5.2)] Embryofetal Toxicity [see Warnings and Precautions ( 5.4)] Increased Risk of Bleeding [see Warnings and Precautions ( 5.5 )] Activation of Mania/Hypomania [see Warnings and Precautions ( 5.6)] Discontinuation Syndrome [see Warnings and Precautions ( 5.7)] Seizures [see Warnings and Precautions ( 5.8)] Angle-closure Glaucoma [see Warnings and Precautions ( 5.9)] Hyponatremia [see Warnings and Precautions ( 5.10)] Bone Fracture [see Warnings and Precautions ( 5.12)] Sexual Dysfunction [see Warnings and Precautions ( 5.13)]
Drug Interactions
Table 9 presents clinically significant drug interactions with paroxetine tablets. Table 9: Clinically Significant Drug Interactions with Paroxetine Tablets Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact The concomitant use of SSRIs, including paroxetine tablets, and MAOIs increases the risk of serotonin syndrome. Intervention Paroxetine tablets are contraindicated in patients taking MAOIs, including MAOIs such as linezolid or intravenous methylene blue [see Dosage and Administration ( 2.5), Contraindications ( 4), Warnings and Precautions ( 5.2)] . Examples selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue Pimozide and Thioridazine Clinical Impact Increased plasma concentrations of pimozide and thioridazine, drugs with a narrow therapeutic index, may increase the risk of QTc prolongation and ventricular arrhythmias. Intervention Paroxetine tablets are contraindicated in patients taking pimozide or thioridazine [see Contraindications ( 4)]. Other Serotonergic Drugs Clinical Impact The concomitant use of serotonergic drugs with paroxetine tablets increases the risk of serotonin syndrome. Intervention Monitor patients for signs and symptoms of serotonin syndrome, particularly during treatment initiation and dosage increases. If serotonin syndrome occurs, consider discontinuation of paroxetine tablets and/or concomitant serotonergic drugs [see Warnings and Precautions ( 5.2)] . Examples other SSRIs, SNRIs, triptans, tricyclic antidepressants, opioids, lithium, tryptophan, buspirone, amphetamines, and St. John’s Wort. Drugs that Interfere with Hemostasis (antiplatelet agents and anticoagulants) Clinical Impact The concurrent use of an antiplatelet agent or anticoagulant with paroxetine tablets may potentiate the risk of bleeding. Intervention Inform patients of the increased risk of bleeding associated with the concomitant use of paroxetine Tablets and antiplatelet agents and anticoagulants. For patients taking warfarin, carefully m
Mechanism of Action
The mechanism of action of paroxetine tablets in the treatment of MDD, SAD, OCD, PD, GAD, and PTSD is unknown, but is presumed to be linked to potentiation of serotonergic activity in the central nervous system resulting from inhibition of neuronal reuptake of serotonin (5-hydroxy-tryptamine, 5-HT).
Overdosage
The following have been reported with paroxetine tablet overdosage: Seizures, which may be delayed, and altered mental status including coma. Cardiovascular toxicity, which may be delayed, including QRS and QTc interval prolongation. Hypertension most commonly seen, but rarely can see hypotension alone or with co-ingestants including alcohol. Serotonin syndrome (patients with a multiple drug overdosage with other proserotonergic drugs may have a higher risk). Gastrointestinal decontamination with activated charcoal should be considered in patients who present early after a paroxetine overdose. Consider contacting a poison center (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations.