Paroxetine (Page 10 of 19)

Geriatric Use:

SSRIs and SNRIs, including paroxetine, have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse event (see ). PRECAUTIONS, Hyponatremia

In worldwide premarketing clinical trials with paroxetine tablets, 17% of patients treated with paroxetine tablets (approximately 700) were 65 years of age or older. Pharmacokinetic studies revealed a decreased clearance in the elderly, and a lower starting dose is recommended; there were, however, no overall differences in the adverse event profile between elderly and younger patients, and effectiveness was similar in younger and older patients (see and ). CLINICAL PHARMACOLOGYDOSAGE AND ADMINISTRATION

ADVERSE REACTIONS

Associated with Discontinuation of Treatment:

Twenty percent (1,199/6,145) of patients treated with paroxetine tablets in worldwide clinical trials in major depressive disorder and 16.1% (84/522), 11.8% (64/542), 9.4% (44/469), and 10.7% (79/735), and 11.7% (79/676) of patients treated with paroxetine tablets in worldwide trials in social anxiety disorder, OCD, panic disorder, and GAD, respectively, discontinued treatment due to an adverse event. The most common events (≥1%) associated with discontinuation and considered to be drug related (i.e., those events associated with dropout at a rate approximately twice or greater for paroxetine tablets compared to placebo) included the following:

Major Depressive Disorder OCD Panic Disorder Social Anxiety Disorder Generalized Anxiety Disorder
Paroxetine Tablets Placebo Paroxetine Tablets Placebo Paroxetine Tablets Placebo Paroxetine Tablets Placebo Paroxetine Tablets Placebo

Where numbers are not provided the incidence of the adverse events in patients treated with paroxetine tablets were not >1% or were not greater than or equal to 2 times the incidence of placebo.

*
Incidence corrected for gender.
CNS
Somnolence 2.3% 0.7% 1.9% 0.3% 3.4% 0.3% 2.0% 0.2%
Insomnia 1.7% 0% 1.3% 0.3% 3.1% 0%
Agitation 1.1% 0.5%
Tremor 1.1% 0.3% 1.7% 0%
Anxiety 1.1% 0%
Dizziness 1.5% 0% 1.9% 0% 1.0% 0.2%
Gastrointestinal
Constipation 1.1% 0%
Nausea 3.2% 1.1% 1.9% 0% 3.2% 1.2% 4.0% 0.3% 2.0% 0.2%
Diarrhea 1.0% 0.3%
Dry Mouth 1.0% 0.3%
Vomiting 1.0% 0.3% 1.0% 0%
Flatulence 1.0% 0.3%
Other
Asthenia 1.6% 0.4% 1.9% 0.4% 2.5% 0.6% 1.8% 0.2%
Abnormal
ejaculation * 1.6% 0% 2.1% 0% 4.9% 0.6% 2.5% 0.5%
Sweating 1.0% 0.3% 1.1% 0% 1.1% 0.2%
Impotence * 1.5% 0%
Libido Decreased 1.0% 0%

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