Paroxetine (Page 7 of 19)

Use in Patients with Concomitant Illness:

Clinical experience with paroxetine tablets in patients with certain concomitant systemic illness is limited. Caution is advisable in using paroxetine tablets in patients with diseases or conditions that could affect metabolism or hemodynamic responses.

As with other SSRIs, mydriasis has been infrequently reported in premarketing studies with paroxetine tablets. A few cases of acute angle closure glaucoma associated with paroxetine therapy have been reported in the literature. As mydriasis can cause acute angle closure in patients with narrow angle glaucoma, caution should be used when paroxetine tablets are prescribed for patients with narrow angle glaucoma.

Paroxetine tablets have not been evaluated or used to any appreciable extent in patients with a recent history of myocardial infarction or unstable heart disease. Patients with these diagnoses were excluded from clinical studies during the product’s premarket testing. Evaluation of electrocardiograms of 682 patients who received paroxetine tablets in double-blind, placebo-controlled trials, however, did not indicate that paroxetine tablets are associated with the development of significant ECG abnormalities. Similarly, paroxetine tablets do not cause any clinically important changes in heart rate or blood pressure.

Increased plasma concentrations of paroxetine occur in patients with severe renal impairment (creatinine clearance < 30 mL/min.) or severe hepatic impairment. A lower starting dose should be used in such patients (see ). DOSAGE AND ADMINISTRATION

Information for Patients:

Paroxetine should not be chewed or crushed, and should be swallowed whole.

Patients should be cautioned about the risk of serotonin syndrome with the concomitant use of paroxetine and triptans, tramadol, or other serotonergic agents.

Patients should be advised that taking paroxetine tablets can cause mild pupillary dilation, which in susceptible individuals, can lead to an episode of angle closure glaucoma. Pre-existing glaucoma is almost always open-angle glaucoma because angle closure glaucoma, when diagnosed, can be treated definitively with iridectomy. Open-angle glaucoma is not a risk factor for angle closure glaucoma. Patients may wish to be examined to determine whether they are susceptible to angle closure, and have a prophylactic procedure (e.g., iridectomy), if they are susceptible.

Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with paroxetine tablets and should counsel them in its appropriate use. A patient Medication Guide about “Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions” is available for paroxetine tablets. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document.

Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking paroxetine.

Clinical Worsening and Suicide Risk:

Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down. Families and caregivers of patients should be advised to look for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt. Such symptoms should be reported to the patient’s prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient’s presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate a need for very close monitoring and possibly changes in the medication.

Drugs That Interfere with Hemostasis (e.g.,NSAIDs, Aspirin and Warfarin):

Patients should be cautioned about the concomitant use of paroxetine and NSAIDs, aspirin, warfarin, or other drugs that affect coagulation since combined use of psychotropic drugs that interfere with serotonin reuptake and these agents has been associated with an increased risk of bleeding.

Interference with Cognitive and Motor Performance:

Any psychoactive drug may impair judgment, thinking, or motor skills. Although in controlled studies paroxetine tablets have not been shown to impair psychomotor performance, patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that therapy with paroxetine tablets does not affect their ability to engage in such activities.

Completing Course of Therapy:

While patients may notice improvement with treatment with paroxetine tablets in 1 to 4 weeks, they should be advised to continue therapy as directed.

Concomitant Medication:

Patients should be advised to inform their physician if they are taking, or plan to take, any prescription or over-the-counter drugs, since there is a potential for interactions.

Alcohol:

Although paroxetine tablets have not been shown to increase the impairment of mental and motor skills caused by alcohol, patients should be advised to avoid alcohol while taking paroxetine tablets.

Pregnancy:

Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during therapy (see ). WARNINGS — : Usage in Pregnancy and TeratogenicNonteratogenic Effects

Nursing:

Patients should be advised to notify their physician if they are breastfeeding an infant (see ). PRECAUTIONS — Nursing Mothers

Laboratory Tests:

There are no specific laboratory tests recommended.

Drug Interactions

Tryptophan:

As with other serotonin reuptake inhibitors, and interaction between paroxetine and tryptophan may occur when they are coadministered. Adverse experiences, consisting primarily of headache, nausea, sweating, and dizziness, have been reported when tryptophan was administered to patients taking paroxetine tablets. Consequently, concomitant use of paroxetine tablets with tryptophan is not recommended (see — ). WARNINGS Serotonin Syndrome

Monoamine Oxidase Inhibitors:

See and CONTRAINDICATIONS. WARNINGS

Pimozide:

In a controlled study of healthy volunteers, after paroxetine tablets were titrated to 60 mg daily, co-administration of a single dose of 2 mg pimozide was associated with mean increases in pimozide AUC of 151% and C of 62%, compared to pimozide administered alone. The increase in pimozide AUC and C is due to the CYP2D6 inhibitory properties of paroxetine. Due to the narrow therapeutic index of pimozide and its known ability to prolong the QT interval, concomitant use of pimozide and paroxetine tablets is contraindicated (see ). max max CONTRAINDICATIONS

Serotonergic Drugs:

Based on the mechanism of action of SNRIs and SSRIs, including paroxetine hydrochloride, and the potential for serotonin syndrome, caution is advised when paroxetine is coadministered with other drugs that may affect the serotonergic neurotransmitter systems, such as triptans, lithium, fentanyl, tramadol, or St. John’s Wort (see — ). WARNINGS Serotonin Syndrome

The concomitant use of paroxetine with MAOIs (including linezolid and intravenous methylene blue) is contraindicated (see ). The concomitant use of paroxetine with other SSRIs, SNRIs or tryptophan is not recommended (see — ). CONTRAINDICATIONS PRECAUTIONS Drug Interactions Tryptophan

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