Medication Information
Paroxetine hydrochloride / Paroxetine controlled release (generic)
Paxil / Paxil CR (brand)

Classification: Selective serotonin reuptake inhibitor (SSRI).

Common Usage: Paroxetine is used to treat depression, obsessive-compulsive disorder (OCD), panic disorder, social anxiety disorder, generalized anxiety disorder (GAD), and post traumatic stress disorder (PTSD). The safety and efficacy of paroxetine in pediatric patients (younger than 18) has not been established.

Warnings:
Suicidality in Children and Adolescents: Antidepressants like paroxetine increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of paroxetine or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Paroxetine is not approved for pediatric patients.

Suicidality in Young Adults: Young adults (18-30) with MDD or co-morbid depression in the setting of other psychiatric illness being treated with antidepressants should be observed for clinical worsening and suicidality, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases. Patients who are started on paroxetine therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior.

Pregnancy: Epidemiological studies have shown that infants born to women who had first trimester paroxetine exposure had an increased risk of cardiovascular malformations, primarily ventricular and atrial septal defects (VSDs and ASDs). If a patient becomes pregnant while taking paroxetine, she should be advised of the potential harm to the fetus. Unless the benefits of paroxetine to the mother justify continuing treatment, consideration should be given to either discontinuuing paroxetine therapy or switching to another antidepressant.

Important Side Effects: Adverse events occurring in patients taking paroxetine include asthenia (weakness), sweating, nausea, decreased appetite, somnolence, dizziness, insomnia, tremor, nervousness, sexual dysfunction and diarrhea.

Paroxetine may be associated with activation of mania/hypomania in some patients. Paroxetine may also be associated with seizures in a small percentage of patients. The following symptoms have been associated with discontinuation of paroxetine: dizziness, sensory disturbances, agitation, anxiety, nausea and sweating. All patients should be monitored for these symptoms during discontinuation and may be advised by their doctor to taper the drug gradually.

Hyponatremia (low levels of sodium in the blood) has also rarely been reported in patients taking paroxetine, but mostly in elderly patients, those taking diuretics or who were otherwise depleted. Abnormal bleeding has also been reported in patients taking paroxetine, but it is not clear whether it is due to paroxetine or some other factor.

This is not a complete list of all known or potential adverse effects. Notify your doctor of any symptoms that have started since you began taking this medication, changing its dose, or adding or changing other medication or diet. Take care when performing any task (for example, driving or operating machinery) that requires your attention until you have experience with this drug and are confident you can perform the task safely.

Interactions with Other Medications: Serious and potentially fatal interactions have been reported in patients taking SSRIs like paroxetine in combination with monoamine oxidase inhibitors (MAOIs), such as phenelzine (Nardil), tranlcypromine (Pamate) and isocarboxazid (Marplan). Paroxetine should not be used in combination with any MAOIs or within 14 days of discontinuing treatment with an MAOI. It is not recommended for patients to take paroxetine in combination with thioridazine (Mellaril), as it may raise levels of thioridazine and potentially interfere with the rhythm of the patient's heart.

Taking paroxetine with warfarin (Coumadin) may increase bleeding times. Taking paroxetine with sumatriptan (Imitrex) may cause weakness, incoordination, and other problems. Other drug levels that may be affected by paroxetine include tricyclic antidepressants, theophylline (Dyphylline), cimetidine (Tagamet), phenobarbital (Donnatal and others), and phenytoin (Dilantin).

This is not a complete list of all known or potential drug interactions. To help prevent problems, always make sure that all prescribers know about all medications you are taking, including over-the-counter drugs, dietary herbal supplements, folk or home remedies.

Common Dosages: The recommended administration of Paxil and Paxil CR is a single daily dose with or without food, usually in the morning.

The following dosage information is intended as a general guideline only. Always follow the direction of the prescribing clinician regarding dosing.

Paxil (paroxetine)
Major depressive disorder: The usual adult dosage of paroxetine for MDD is 10 to 50 mg daily, depending on the condition being treated. The recommended initial dose is 20 mg/day. Patients not responding to 20 mg/day should have their dose increased slowly in 10 mg increments per week, up to a maximum of 50 mg/day.

Obsessive-compulsive disorder: The recommended adult dose for OCD is 40 mg/day. Patients should be started at 20 mg/day and if increases are needed, the dose can be increased in lO-mg increments each week up to a maximum of 60 mg/day.

Panic disorder: The recommended dose for adults with panic disorder is 40 mg/day, with a starting dose of 10 mg/day. If necessary, this dose can be increased in lO-mg increments each week to a maximum of 60 mg/day.

Social anxiety disorder: The recommended adult dose for social anxiety disorder is 20 mg/day.

Paxil CR (paroxetine controlled release)
(Paxil CR should be swallowed whole, not chewed or crushed.)
Major depressive disorder: The recommended initial adult dose of Paxil CR for MDD is 25 mg/day. Dose increases should occur in 12.5-mg weekly increments, up to a maximum of 62.5 mg/day.
Panic disorder: The recommended initial adult dose of Paxil CR for panic disorder is 12.5 mg/day. If necessary, the dose can be increased in l2.5-mg weekly increments to a maximum of 75 mg/day.
Social anxiety disorder: The recommended initial adult dose of Paxil CR for social anxiety disorder is 12.5 mg/day. If necessary, this dose can be increased in 12.5-mg weekly increments to a maximum of 37.5 mg/day.
Premenstrual dysphoric disorder: The recommended initial adult dose of Paxil CR for PMDD is 12.5 mg/day. Dose changes should occur at intervals of at least one week. The maximum recommended dose is 25 mg/day. Paxil CR may be administered throughout the menstrual cycle or limited to the luteal phase of the menstrual cycle, depending on physician assessment.

Identification: Paxil is available in lO-mg, yellow, scored tablets engraved with "Paxil" on one side and "10" on the other side; 20-mg, pink, scored tablets with "Paxil" engraved on one side and "20" on the other side; in 30-mg, blue tablets with "Paxil" engraved on one side and "30" on the other side; and in 40-mg, green tablets with "Paxil" engraved on one side and "40" on the other side.

Paxil is also available as enteric-coated, controlled-release tablets in three strengths. The 12.5-mg tablets are yellow and engraved "Paxil CR" on one side and "12.5" on the other. The 25-mg tablets are pink and engraved "Paxil CR" on one side and "25" on the other. The 37.5-mg tablets are blue and engraved "Paxil CR" on one side and "37.5" on the other.

Paxil is also available as an oral suspension that is orange-colored.

Storage: Store this medication at normal room temperature (between 59° and 86° F) in a tightly closed, child, light, and moisture-resistant container. If you have difficulty opening child-resistant containers, your pharmacist can provide you with a container that is easier to open. Keep it out of direct sunlight and avoid storing it in a warm and humid area ˜such as the bathroom or kitchen - to prevent deterioration. To prevent accidental poisoning, keep all medications out of the reach of children. Do not take an expired medication. Do not transfer medication from one container to another. Carefully discard discontinued medication where children cannot find it.