PAROXETINE

PAROXETINE- paroxetine mesylate capsule
Solco Healthcare LLC

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS

Antidepressants, including selective serotonin reuptake inhibitors (SSRIs), have been shown to increase the risk of suicidal thoughts and behavior in pediatric and young adult patients when used to treat major depressive disorder and other psychiatric disorders. Because Paroxetine is an SSRI, monitor patients closely for worsening and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber [see Warnings and Precautions ( 5.1)].

1 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.

2 DOSAGE AND ADMINISTRATION

2.1 Dosage Information

The recommended dosage of Paroxetine Capsules for the treatment of moderate to severe VMS is 7.5 mg once daily, at bedtime, with or without food.

2.2 Use of Paroxetine Capsules Before or After a Monoamine Oxidase Inhibitor (MAOI)

Wait at least 14 days after discontinuation of an MAOI before initiating therapy with Paroxetine Capsules. Conversely, allow at least 14 days after stopping Paroxetine Capsules before starting an MAOI [see Contraindications ( 4.1), Warnings and Precautions ( 5.2) and Drug Interactions ( 7.3)].

3 DOSAGE FORMS AND STRENGTHS

Paroxetine capsules are available as 7.5 mg white opaque capsules printed with “544” in black ink on the cap and “7.5 mg” in black ink on the body. Each capsule contains 9.69 mg paroxetine mesylate equivalent to 7.5 mg paroxetine base.

4 CONTRAINDICATIONS

4.1 Monoamine Oxidase Inhibitors

Concomitant use of an MAOI with Paroxetine Capsules or within 14 days of stopping treatment with Paroxetine Capsules is contraindicated because of an increased risk of serotonin syndrome. The use of Paroxetine Capsules within 14 days of stopping an MAOI is also contraindicated [see Dosage and Administration ( 2.2), Warnings and Precautions ( 5.2) and Drug Interactions ( 7.3)].

Starting Paroxetine Capsules in a patient who is being treated with linezolid or intravenous methylene blue, both of which inhibit monoamine oxidase, is also contraindicated because of an increased risk of serotonin syndrome [see Dosage and Administration ( 2.2), Warnings and Precautions ( 5.2) and Drug Interactions ( 7.3)].

4.2 Thioridazine

Concomitant use of Paroxetine Capsules with thioridazine is contraindicated, because thioridazine prolongs the QT interval, and paroxetine can increase thioridazine levels [see Drug Interactions ( 7.1)].

4.3 Pimozide

Concomitant use of Paroxetine Capsules with pimozide is contraindicated because pimozide prolongs the QT interval, and paroxetine increases pimozide levels [see Drug Interactions ( 7.1)].

4.4 Hypersensitivity to any Ingredient in Paroxetine Capsules

Paroxetine Capsules are contraindicated in patients with a history of hypersensitivity to paroxetine or any of the other ingredients in Paroxetine Capsules.

4.5 Pregnancy

Menopausal VMS does not occur during pregnancy and Paroxetine Capsules may cause fetal harm [see Use in Specific Populations ( 8.1)].

5 WARNINGS AND PRECAUTIONS

5.1 Suicidal Thoughts and Behaviors

Paroxetine Capsules are not approved for any psychiatric condition.

Antidepressants, including those that contain an SSRI, increase the risk of suicidal thinking and behavior (suicidality) in pediatric and young adult patients when used to treat major depressive disorder (MDD) and other psychiatric disorders. There is limited information regarding suicidality in women who use Paroxetine Capsules for treatment of VMS. The Paroxetine Capsules trials excluded women with a presence or history of previous psychiatric disorders.

Consider discontinuing Paroxetine Capsules in patients with worsening depression or those who experience 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.

All patients being treated with Paroxetine Capsules should be observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of treatment.

Anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania have been reported in patients being treated with antidepressants for MDD as well as for other psychiatric and nonpsychiatric indications. 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.

Families and caregivers of patients being treated with Paroxetine Capsules 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.

5.2 Serotonin Syndrome

The development of a potentially life-threatening serotonin syndrome has been reported with SSRIs, including paroxetine, alone but particularly with concomitant use of serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, and St. John’s Wort), and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat depression and others such as linezolid and intravenous methylene blue).

Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Monitor patients for the emergence of serotonin syndrome.

The concomitant use of Paroxetine Capsules with MAOIs is contraindicated. Do not start Paroxetine Capsules in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue. All reports with methylene blue that provided information on the route of administration involved intravenous administration in the dose range of 1 mg/kg to 8 mg/kg. No reports involved the administration of methylene blue by other routes (such as oral tablets or local tissue injection) or at lower doses. There may be circumstances when it is necessary to initiate treatment with an MAOI such as linezolid or intravenous methylene blue in a patient taking Paroxetine Capsules. Paroxetine Capsules should be discontinued before initiating treatment with the MAOI [see Contraindications ( 4.1) and Dosage and Administration ( 2.2)].

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 Contraindications ( 4.1) Drug Interactions ( 7.3)].

Discontinue Paroxetine Capsules and any concomitant serotonergic agents immediately if the above events occur and initiate supportive symptomatic treatment.

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