Indicated in adults for the treatment of:

• Major depressive disorder (MDD)
• Panic disorder (PD)
• Social anxiety disorder (SAD)
• Premenstrual dysphoric disorder (PMDD)

Prior to initiating treatment with Paxil CR or another antidepressant, screen patients for a personal or family history of bipolar disorder, mania, or hypomania.

In patients with bipolar disorder, treating a depressive episode with PAXIL CR or another antidepressant may precipitate a mixed/manic episode.

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.

The recommended initial dose of PAXIL CR is 12.5 mg per day for elderly patients, patients with severe renal impairment, and patients with severe hepatic impairment.

Dosage should not exceed 50 mg per day for MDD or PD and should not exceed 37.5 mg per day for SAD.

A gradual reduction in dosage rather than abrupt cessation is recommended whenever possible.

PAXIL CR has not been systematically evaluated in patients with seizure disorders. Patients with history of seizures were excluded from clinical studies.

The pupillary dilation that occurs following use of many antidepressant drugs including PAXIL CR may trigger an angle closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy. Cases of angle-closure glaucoma associated with use of paroxetine hydrochloride tablets have been reported. Avoid use of antidepressants, including PAXIL CR, in patients with untreated anatomically narrow angles.

PAXIL CR is 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
• Taking thioridazine because of risk of QT prolongation
• Taking pimozide because of risk of QT prolongation

At least 14 days must elapse between discontinuation of a monoamine oxidase inhibitor (MAOI) antidepressant and initiation of PAXIL CR. In addition, at least 14 days must elapse after stopping PAXIL CR before starting an MAOI antidepressant.

Hyponatremia may occur as a result of treatment with SNRIs and SSRIs, including PAXIL CR. Cases with serum sodium lower than 110 mmol/L have been reported.

SSRIs and SNRIs, including PAXIL CR, have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse reaction.

Epidemiological studies on bone fracture risk during exposure to some antidepressants, including SSRIs, have reported an association between antidepressant treatment and fractures. There are multiple possible causes for this observation and it is unknown to what extent fracture risk is directly attributable to SSRI treatment.

Serotonin-norepinephrine reuptake inhibitors (SNRIs) and SSRIs, including PAXIL CR, can precipitate serotonin syndrome, a potentially life-threatening condition. The risk is increased with concomitant use of other 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, i.e., MAOIs. Serotonin syndrome can also occur when these drugs are used alone.

Drugs that interfere with serotonin reuptake inhibition, including PAXIL CR, increase the risk of bleeding events. Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDS), other antiplatelet drugs, warfarin, and other anticoagulants may add to this risk.

Some studies have shown that the efficacy of tamoxifen, as measured by the risk of breast cancer relapse/mortality, may be reduced with concomitant use of paroxetine as a result of paroxetine’s irreversible inhibition of CYP2D6 and lower blood levels of tamoxifen. When tamoxifen is used for the treatment or prevention of breast cancer, prescribers should consider using an alternative antidepressant with little or no CYP2D6 inhibition.

PAXIL CR is a CYP2D6 inhibitor. The concomitant use of PAXIL CR with a CYP2D6 substrate (e.g., propafenone, flecainide, atomoxetine, desipramine, dextromethorphan, metoprolol, nebivolol, perphenazine, tolterodine, venlafaxine, risperidone) may increase the exposure of the CYP2D6 substrate. Decrease the dosage of a CYP2D6 substrate if needed with concomitant PAXIL CR use. Conversely, an increase in dosage of a CYP2D6 substrate may be needed if PAXIL CR is discontinued.

Co-administration of fosamprenavir/ritonavir with paroxetine significantly decreased plasma levels of paroxetine.

Reports of elevated theophylline levels associated with immediate-release paroxetine treatment have been reported. While this interaction has not been formally studied, it is recommended that theophylline levels be monitored when these drugs are concurrently administered.

Some clinical studies have shown that SSRIs (including paroxetine) may affect sperm quality during SSRI  treatment, which may affect fertility in some men.

PAXIL CR can cause fetal harm when administered to a pregnant woman. Epidemiological studies have shown that infants exposed to paroxetine in the first trimester of pregnancy have an increased risk of cardiovascular malformations. Exposure to paroxetine in late pregnancy may lead to an increased risk for persistent pulmonary hypertension of the newborn (PPNH) and/or neonatal complications requiring prolonged hospitalization, respiratory support, and tube feeding.

If PAXIL CR is used during pregnancy, or if the patient becomes pregnant while taking PAXIL CR, the patient should be apprised of the potential hazard to the fetus.Like many other drugs, paroxetine is secreted in human milk.

Because of the potential for serious adverse reactions in nursing infants from PAXIL CR, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

GoToSource

• Use in patients under the age of 18. GoToSource

• Dosage should not exceed 50 mg per day for MDD or PD and should not exceed 37.5 mg per day for SAD. GoToSource

• Premature ejaculation, migraine headaches, diabetic neuropathy, fibromyalgia and neurocardiogenic syncope. GoToSource

• Autism. GoToSource

• Behavioral and psychological symptoms of dementia. GoToSource

• Irritable bowel syndrome. GoToSource

• Tinnitus. GoToSource

• Chronic pain. GoToSource

• Dysthymia. GoToSource

• Pathological gambling. GoToSource

• Eating disorders. GoToSource

• Borderline personality disorder, smoking cessation and alcoholism. GoToSource

• Use with minocycline for unipolar psychotic depression. GoToSource

Serotonin syndrome or neuroleptic malignant syndrome (potentially life-threatening drug reaction). GoToSource

Violent behavior and severe withdrawal symptoms including anxiety, agitation, irritability, homicidal ideation and aggression. GoToSource

Increased risk of cataracts. GoToSource

Increased risk of bleeding. GoToSource 

Weight gain. GoToSource

Hyponatremia (low blood sodium level). GoToSource

Exacerbation of nervous tics in patients with tourette syndrome. GoToSource

Suicidal ideation and behavior. GoToSource

Liver injury. GoToSource

Chronic angle-closure glaucoma. GoToSource

Galactorrhea (nipple discharge). GoToSource 

Idiopathic thrombocytopenic purpura (bleeding disorder). GoToSource

Hypereosinophilia (high blood eosinophil levels, a type of white blood cell). GoToSource

Granuloma annulare (skin lesion). GoToSource

Orthostatic hypotension, mild bradycardia (slow heart rate) and conduction abnormalities such as QT interval prolongation. GoToSource

Increased risk of falls. GoToSource

Visual and auditory hallucinations. GoToSource

Upper gastrointestinal bleeding. GoToSource

Retrobulbar hematoma. GoToSource

Abnormal sperm DNA fragmentation. GoToSource

Diabetes. GoToSource

Akathisia (inner restlessness). GoToSource

Increase in LDL cholesterol levels. GoToSource

Seizures. GoToSource

Bone fractures. GoToSource

Restless legs syndrome. GoToSource

Sexual dysfunction. GoToSource

Lawsuits filed for suicides, akathisia, birth defects and withdrawal symptoms.