Paroxetine Capsules
Name: Paroxetine Capsules
- Paroxetine Capsules used to treat
- Paroxetine Capsules dosage
- Paroxetine Capsules drug
- Paroxetine Capsules effects of
Indications and usage
Paroxetine Capsules are indicated for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause.
Limitation of Use:
Paroxetine Capsules are not indicated for the treatment of any psychiatric condition. Paroxetine Capsules contain a lower dose of paroxetine than that used to treat depression, obsessive compulsive disorder, panic disorder, generalized anxiety disorder, social anxiety disorder, and post-traumatic stress disorder. The safety and efficacy of this lower dose of paroxetine in Paroxetine Capsules have not been established for any psychiatric condition. Patients who require paroxetine for treatment of a psychiatric condition should discontinue Paroxetine Capsules and initiate a paroxetine-containing medication that is indicated for such use.
Drug interactions
No drug-drug interaction studies have been conducted with Paroxetine Capsules.
Potential for Paroxetine Capsules to Affect Other Drugs
Paroxetine is a strong CYP2D6 inhibitor. Clinical drug interaction studies have been performed with substrates of CYP2D6 and show that paroxetine can inhibit the metabolism of drugs metabolized by CYP2D6 [see Clinical Pharmacology (12.3)]. Table 2 contains examples of drugs with a metabolism that may be affected by co-administration with Paroxetine Capsules.
| Concomitant Drug Name | Effect of Paroxetine on Other Drugs | Clinical Recommendations |
|---|---|---|
| Thioridazine | Increased plasma concentrations of thioridazine Potential QTc prolongation | Concomitant use of thioridazine and Paroxetine Capsules is contraindicated. |
| Pimozide | Increased plasma concentrations of pimozide. Potential QTc prolongation | Concomitant use of pimozide and Paroxetine Capsules is contraindicated. |
| Tamoxifen | Reduced plasma concentrations of active tamoxifen metabolite | Consider avoiding concomitant use of tamoxifen and Paroxetine Capsules. |
| Tricyclic Antidepressant (TCA) (e.g., Desipramine) | Increased plasma concentrations and elimination half-life | Plasma TCA concentrations may need to be monitored and the dose of TCA may need to be reduced if a TCA is co-administered with Paroxetine Capsules. Monitor tolerability. |
| Risperidone | Increased plasma concentrations of risperidone | A lower dosage of risperidone may be necessary (see the Full Prescribing Information for risperidone). Monitor tolerability. |
| Atomoxetine | Increased exposure of atomoxetine | A lower dosage of atomoxetine may be necessary (see Full Prescribing Information for atomoxetine). Monitor tolerability. |
| Drugs Highly Bound to Plasma Protein (e.g., Warfarin) | Increased free plasma concentrations | The dosage of warfarin may need to be reduced. Monitor tolerability and the International Normalized Ratio. |
| Digoxin | Decreased plasma concentrations of digoxin | Dosage of digoxin may need to be increased. Monitor digoxin concentrations and clinical effect. |
| Theophylline | Increased plasma concentrations of theophylline | Dosage of theophylline may need to be decreased. Monitor theophylline concentrations and tolerability. |
Use caution if co-administering Paroxetine Capsules with other drugs that are metabolized by CYP2D6, including nortriptyline, amitriptyline, imipramine, desipramine, fluoxetine, phenothiazines, risperidone, and Type 1C antiarrhythmics (e.g., propafenone, flecainide, and encainide).
Potential for Other Drugs to Affect Paroxetine Capsules
The metabolism and pharmacokinetics of paroxetine may be affected by the induction and inhibition of drug metabolizing enzymes such as CYP2D6. Table 3 contains a list of drugs that may affect the pharmacokinetics of Paroxetine Capsules when administered concomitantly [see Clinical Pharmacology (12.3)].
| Concomitant Drug Name | Effect of Concomitant Drug on Paroxetine | Clinical Recommendations |
|---|---|---|
| Phenobarbital | Decreased paroxetine exposure | |
| Phenytoin | Decreased paroxetine exposure | No dose adjustment for Paroxetine Capsules. Monitor clinical effect of Paroxetine Capsules. |
| Fosamprenavir/ Ritonavir | Decreased plasma concentration of paroxetine | |
| Cimetidine | Increased plasma concentration of paroxetine |
Use caution if co-administering Paroxetine Capsules with other drugs that inhibit CYP2D6 (e.g., quinidine).
Other Potentially Significant Drug Interactions
Monoamine Oxidase Inhibitors (MAOIs)
Serious adverse reactions such as serotonin syndrome have been reported in patients receiving a concomitant SSRI and MAOI, in patients started on an SSRI who recently received an MAOI and in patients started on an MAOI who recently received an SSRI. Therefore, concomitant use of MAOIs with Paroxetine Capsules or use of Paroxetine Capsules and an MAOI within 14 days of each other is contraindicated [see Dosage and Administration (2.2), Contraindications (4.1) and Warnings and Precautions (5.2)].
Serotonergic Drugs
If concomitant use of Paroxetine Capsules with other serotonergic drugs (e.g., triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, and St. John’s Wort) is clinically warranted, consider the increased risk of serotonin syndrome and carefully observe the patient, particularly during treatment initiation [see Warnings and Precautions (5.2)].
An interaction between paroxetine and tryptophan may occur when they are co-administered. Adverse experiences, consisting primarily of headache, nausea, sweating, and dizziness, have been reported when tryptophan was administered to patients taking paroxetine. Consequently, concomitant use of Paroxetine Capsules with tryptophan is not recommended.
If concomitant use of Paroxetine Capsules with a serotonergic drug is warranted, carefully observe the patient, particularly during treatment initiation. There have been postmarketing reports of serotonin syndrome with the use of an SSRI and a triptan.
Paroxetine Capsules contain paroxetine, which is also the active ingredient in other drugs. The concomitant use of Paroxetine Capsules with other paroxetine products is not recommended [see Indications and Usage (1)].
Drugs that Interfere with Hemostasis (e.g., NSAIDs, Aspirin, and Warfarin)
Altered anticoagulant effects, including increased bleeding, have been reported when SSRIs are co-administered with NSAIDs, aspirin, and warfarin or other drugs that affect coagulation. There may be a pharmacodynamic interaction between paroxetine and warfarin that causes an increased bleeding diathesis despite unaltered prothrombin time. Carefully monitor patients receiving warfarin therapy when Paroxetine Capsules are initiated or discontinued [see Warnings and Precautions (5.4)].