Home > Medical Reference > Complementary Medicine

Paroxetine


Special Alerts

Antidepressant Use in Pediatric Patients - October 15, 2004

In March 2004, the Food and Drug Administration (FDA) issued a Public Health Advisory concerning the use of antidepressant medications in which they called attention to reports of both suicidal ideation and suicide attempts in children taking antidepressant drugs for the treatment of major depressive disorder (MDD). In September 2004, a review of the existing data was completed by two FDA Advisory Committees. The FDA has now instructed the manufacturers of ALL antidepressants to revise the labeling for their products to include a boxed warning and expanded warning statements that alert healthcare providers to an increased risk of suicidality (suicidal thinking and behavior) in children and adolescents being treated with these agents, and to include additional information about the results of pediatric studies. The FDA also informed manufacturers that a Patient Medication Guide (MedGuide), which will be given to patients receiving the drugs advising them of the risk and precautions, is appropriate for these drug products.

The risk of suicidality for these drugs was identified in a combined analysis of short-term (up to 4 months) placebo-controlled trials of nine antidepressant drugs, including the selective serotonin reuptake inhibitors (SSRIs) and others, in children and adolescents with major depressive disorder (MDD), obsessive compulsive disorder (OCD), or other psychiatric disorders. A total of 24 trials involving over 4400 patients were included. The analysis showed a greater risk of suicidality during the first few months of treatment in those receiving antidepressants. The average risk of such events on drug was 4%, compared to a rate of 2% in groups receiving placebo. No suicides occurred in these trials. Based on this data, the FDA has determined that the following points are appropriate for inclusion in the boxed warning:

Antidepressants increase the risk of suicidal thinking and behavior (suicidality) in children and adolescents with MDD and other psychiatric disorders.

Anyone considering the use of an antidepressant in a child or adolescent for any clinical use must balance the risk of increased suicidality with the clinical need.

Patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior.

Families and caregivers should be advised to closely observe the patient and to communicate with the prescriber.

A statement regarding whether the particular drug is approved for any pediatric indication(s) and, if so, which one(s).

Among the antidepressants, only fluoxetine is approved for use in treating MDD in pediatric patients. Clomipramine, fluoxetine, fluvoxamine, and sertraline are approved for OCD in pediatric patients. None of the drugs is FDA approved for other psychiatric indications in children.

Pediatric patients being treated with antidepressants for any indication should be closely observed for clinical worsening, as well as agitation, irritability, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes (either increases or decreases). This monitoring should include daily observation by families and caregivers and frequent contact with the physician. It is also recommended that prescriptions for antidepressants be written for the smallest quantity of tablets consistent with good patient management, in order to reduce the risk of overdose.

In addition to the boxed warning and other information in professional labeling on antidepressants, MedGuides are being prepared for all of the antidepressants to provide information about the risk of suicidality in children and adolescents for patients and their families and caregivers. MedGuides are intended to be distributed by the pharmacist with each prescription or refill of a medication.

The FDA plans to work closely with the manufacturers of all approved antidepressant products to optimize the safe use of these drugs and implement the proposed labeling changes and other safety communications in a timely manner.

Additional information can be found on the FDA website at: http://www.fda.gov/medwatch/SAFETY/2004/safety04.htm#ssri, last accessed October 21, 2004.


Pronunciation

 (pa ROKS e teen)


U.S. Brand Names

 Paxil®; Paxil CR™; Pexeva™


Synonyms

 Paroxetine Hydrochloride; Paroxetine Mesylate


Generic Available

 Yes: Tablet, as hydrochloride


Canadian Brand Names

 Paxil®; Paxil CR™


Use

 Treatment of depression in adults; treatment of panic disorder with or without agoraphobia; obsessive-compulsive disorder (OCD) in adults; social anxiety disorder (social phobia); generalized anxiety disorder (GAD); post-traumatic stress disorder (PTSD)

Paxil CR™: Treatment of depression; panic disorder; premenstrual dysphoric disorder (PMDD); social anxiety disorder (social phobia)


Use - Unlabeled/Investigational

 May be useful in eating disorders, impulse control disorders, self-injurious behavior; premenstrual disorders, vasomotor symptoms of menopause; treatment of depression and obsessive-compulsive disorder (OCD) in children


Pregnancy Risk Factor

 C


Pregnancy Implications

 Teratogenic effects were not observed in animal studies. Nonteratogenic effects including respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypo- or hypertonia, hyper-reflexia, jitteriness, irritability, constant crying, and tremor have been reported in the neonate immediately following delivery after exposure late in the third trimester. Adverse effects may be due to toxic effects of SSRI or drug discontinuation. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit to the mother outweighs the possible risk to the fetus. If treatment during pregnancy is required, consider tapering therapy during the third trimester.


Lactation

 Enters breast milk/use caution (AAP rates "of concern")


Contraindications

 Hypersensitivity to paroxetine or any component of the formulation; use of MAO inhibitors or within 14 days; concurrent use with thioridazine or mesoridazine


Warnings/Precautions

 Potential for severe reaction when used with MAO inhibitors - serotonin syndrome (hyperthermia, muscular rigidity, mental status changes/agitation, autonomic instability) may occur. May precipitate a shift to mania or hypomania in patients with bipolar disorder. Monotherapy in patients with bipolar disorder should be avoided. Has a low potential to impair cognitive or motor performance - caution operating hazardous machinery or driving. Low potential for sedation or anticholinergic effects relative to cyclic antidepressants. The possibility of a suicide attempt is inherent in major depression and may persist until remission occurs. Monitor for worsening of depression or suicidality, especially during initiation of therapy or with dose increases or decreases. Worsening depression and severe abrupt suicidality that are not part of the presenting symptoms may require discontinuation or modification of drug therapy. Use caution in high-risk patients during initiation of therapy. Prescriptions should be written for the smallest quantity consistent with good patient care.

Antidepressants increase the risk of suicidal thinking and behavior in children and adolescents with MDD and other depressive disorders; consider risk prior to prescribing. Closely monitor for clinical worsening, suicidality, or unusual changes in behavior; the child's family or caregiver should be instructed to closely observe the patient and communicate condition with healthcare provider. A medication guide should be dispensed with each prescription. Paroxetine is not FDA approved for use in children.

Use caution in patients with a previous seizure disorder or condition predisposing to seizures such as brain damage, alcoholism, or concurrent therapy with other drugs which lower the seizure threshold. Use with caution in patients with hepatic or dysfunction and in elderly patients. May cause hyponatremia/SIADH. Use with caution in patients at risk of bleeding or receiving anticoagulant therapy - may cause impairment in platelet aggregation. Use with caution in patients with renal insufficiency or other concurrent illness (due to limited experience). May cause or exacerbate sexual dysfunction.

Upon discontinuation of paroxetine therapy, gradually taper dose and monitor for discontinuation symptoms (eg, dizziness, dysphoric mood, irritability, agitation, confusion, paresthesias). If intolerable symptoms occur following a decrease in dosage or upon discontinuation of therapy, then resuming the previous dose with a more gradual taper should be considered. The patient's family or caregiver should be alerted to monitor patients for the emergence of suicidality and associated behaviors such as anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia, hypomania, and mania; patients should be instructed to notify their healthcare provider if any of these symptoms or worsening depression occur.


Adverse Reactions

>10%:

Central nervous system: Headache, somnolence, dizziness, insomnia

Gastrointestinal: Nausea, xerostomia, constipation, diarrhea

Genitourinary: Ejaculatory disturbances

Neuromuscular & skeletal: Weakness

Miscellaneous: Diaphoresis

1% to 10%:

Cardiovascular: Palpitations, vasodilation, postural hypotension

Central nervous system: Nervousness, anxiety, yawning, abnormal dreams, agitation

Dermatologic: Rash

Endocrine & metabolic: Libido decreased, delayed ejaculation

Gastrointestinal: Anorexia, flatulence, vomiting, dyspepsia, taste perversion, weight gain

Genitourinary: Urinary frequency, impotence

Neuromuscular & skeletal: Tremor, paresthesia, myopathy, myalgia

Ocular: Blurred vision

Respiratory: Rhinitis

<1%: Acne, akinesia, alopecia, amenorrhea, anaphylactoid reaction, anemia, angioedema, arthritis, asthma, atrial fibrillation, bradycardia, bruxism, bundle branch block, colitis, dysphasia, EPS, ear pain, erythema multiforme, exfoliative dermatitis, eye pain, hypotension, leukopenia, mania, migraine, myasthenia, thirst

Postmarketing and/or case reports: Acute renal failure, allergic alveolitis, anaphylaxis, aplastic anemia, agranulocytosis, bone marrow aplasia, eclampsia, gastrointestinal bleeding, Guillain-Barré syndrome, hemolytic anemia, hepatic necrosis, laryngismus, neuroleptic malignant syndrome, optic neuritis, pancreatitis, pancytopenia, porphyria, priapism, pulmonary hypertension, seizure (including status epilepticus), serotonin syndrome, SIADH, thrombocytopenia, torsade de pointes, toxic epidermal necrolysis, ventricular fibrillation, ventricular tachycardia, withdrawal reactions (dizziness; sensory disturbances - eg, paresthesia such as electric shock sensations; agitation; anxiety; nausea; diaphoresis - particularly following abrupt withdrawal)


Overdosage/Toxicology

 Symptoms of overdose include somnolence, nausea, vomiting, hepatic dysfunction, drowsiness, sinus tachycardia, urinary retention, renal failure (acute), and dilated pupils. Convulsions, status epilepticus, and ventricular arrhythmias (including torsade de pointes) have been reported, as well as serotonin syndrome and manic reaction. There are no specific antidotes, following attempts at decontamination, treatment is supportive and symptomatic. Forced diuresis, dialysis, and hemoperfusion are unlikely to be beneficial.


Drug Interactions

 Substrate of CYP2D6 (major); Inhibits CYP1A2 (weak), 2B6 (moderate), 2C8/9 (weak), 2C19 (weak), 2D6 (strong), 3A4 (weak)

Amphetamines: SSRIs may increase the sensitivity to amphetamines, and amphetamines may increase the risk of serotonin syndrome

Aspirin (and other antiplatelet drugs): Concomitant use of paroxetine and NSAIDs, aspirin, or other drugs affecting coagulation has been associated with an increased risk of bleeding; monitor.

Buspirone: Combined use with SSRIs may cause serotonin syndrome

Carvedilol: Serum concentrations may be increased; monitor carefully for increased carvedilol effect (hypotension and bradycardia)

Cimetidine: Cimetidine may reduce the first-pass metabolism of paroxetine resulting in elevated paroxetine serum concentrations; consider an alternative H2 antagonist

Clozapine: May increase serum levels of clozapine; monitor for increased effect/toxicity

CYP2B6 substrates: Paroxetine may increase the levels/effects of CYP2B6 substrates. Example substrates include bupropion, promethazine, propofol, selegiline, and sertraline.

CYP2D6 inhibitors: May increase the levels/effects of paroxetine. Example inhibitors include chlorpromazine, delavirdine, fluoxetine, miconazole, pergolide, quinidine, quinine, ritonavir, and ropinirole.

CYP2D6 substrates: Paroxetine may increase the levels/effects of CYP2D6 substrates. Example substrates include amphetamines, selected beta-blockers, dextromethorphan, fluoxetine, lidocaine, mirtazapine, nefazodone, risperidone, ritonavir, thioridazine, tricyclic antidepressants, and venlafaxine.

CYP2D6 prodrug substrates: Paroxetine may decrease the levels/effects of CYP2D6 prodrug substrates. Example prodrug substrates include codeine, hydrocodone, oxycodone, and tramadol.

Cyproheptadine: May inhibit the effects of serotonin reuptake inhibitors; monitor for altered antidepressant response; cyproheptadine acts as a serotonin agonist

Dextromethorphan: Metabolism of dextromethorphan may be inhibited; visual hallucinations occurred; monitor

Haloperidol: Metabolism may be inhibited and cause extrapyramidal symptoms (EPS); monitor patients for EPS if combination is utilized

HMG-CoA reductase inhibitors: Metabolism may be inhibited by SSRIs; particularly lovastatin and simvastatin resulting in myositis and rhabdomyolysis; paroxetine appears to have weak interaction with CYP3A4, and therefore, appears to have a low risk of this interaction

Lithium: Patients receiving SSRIs and lithium have developed neurotoxicity; if combination is used; monitor for neurotoxicity

Loop diuretics: SSRIs may cause hyponatremia; additive hyponatremic effects may be seen with combined use of a loop diuretic (bumetanide, furosemide, torsemide); monitor for hyponatremia

MAO inhibitors: SSRIs should not be used with nonselective MAO inhibitors (isocarboxazid, phenelzine); fatal reactions have been reported; this combination should be avoided

Meperidine: Combined use may cause serotonin syndrome; monitor

Mesoridazine: Paroxetine may inhibit the metabolism of mesoridazine, resulting in increased plasma levels and increasing the risk of QTc interval prolongation. Concurrent use is contraindicated.

Nefazodone and trazodone: May increase the risk of serotonin syndrome with SSRIs; monitor

NSAIDs: Concomitant use of paroxetine and NSAIDs, aspirin, or other drugs affecting coagulation has been associated with an increased risk of bleeding; monitor.

Phenytoin: Metabolism of phenytoin may be inhibited, resulting in phenytoin toxicity; monitor for toxicity (ataxia, confusion, dizziness, nystagmus, involuntary muscle movement).

Procyclidine: Paroxetine increases AUC of procyclidine by 35%; this may result in increased anticholinergic effects; procyclidine dose reduction may be necessary.

Risperidone: Paroxetine, a potent CYP2D6 inhibitor, inhibits the metabolism of risperidone (CYP2D6 substrate) resulting in elevated plasma risperidone levels. The clinical implications are unclear, but clinicians should monitor for potential extrapyramidal symptoms (EPS).

Ritonavir: Combined use of paroxetine with ritonavir may cause serotonin syndrome; monitor

Selegiline: SSRIs have been reported to cause mania or hypertension when combined with selegiline; this combination is best avoided; concurrent use with SSRIs has also been reported to cause serotonin syndrome; as an MAO type B inhibitor, the risk of serotonin syndrome may be less than with nonselective MAO inhibitors

Serotonergic uptake inhibitors: Combined use with other drugs which inhibit the reuptake may cause serotonin syndrome

Sibutramine: May increase the risk of serotonin syndrome with SSRIs; avoid coadministration

Sumatriptan (and other serotonin agonists): Concurrent use may result in toxicity; weakness, hyper-reflexia, and incoordination have been observed with sumatriptan and SSRIs. In addition, concurrent use may theoretically increase the risk of serotonin syndrome; includes sumatriptan, naratriptan, rizatriptan, and zolmitriptan.

Sympathomimetics: May increase the risk of serotonin syndrome with SSRIs

Theophylline: Paroxetine may elevate serum levels of theophylline; monitor

Thioridazine: Paroxetine may inhibit the metabolism of thioridazine, resulting in increased plasma levels and increasing the risk of QTc interval prolongation. Concurrent use is contraindicated.

Tramadol: Combined use may cause serotonin syndrome; monitor

Tricyclic antidepressants: The metabolism of tricyclic antidepressants (amitriptyline, desipramine, imipramine, nortriptyline) may be inhibited by SSRIs resulting is elevated serum levels; if combination is warranted, a low dose of TCA (10-25 mg/day) should be utilized

Venlafaxine: Combined use with paroxetine may increase the risk of serotonin syndrome

Warfarin: May alter the hypoprothrombinemic response to warfarin; monitor INR

Zolpidem: At least one case of acute delirium in association with combined therapy has been reported


Ethanol/Nutrition/Herb Interactions

Ethanol: Avoid ethanol.

Food: Peak concentration is increased, but bioavailability is not significantly altered by food.

Herb/Nutraceutical: Avoid valerian, St John's wort, SAMe, kava kava.


Stability

Suspension: Store at 25°C ( 77°F)

Tablet: Store at 15°C to 30°C (59°F to 86°F)


Mechanism of Action

 Paroxetine is a selective serotonin reuptake inhibitor, chemically unrelated to tricyclic, tetracyclic, or other antidepressants; presumably, the inhibition of serotonin reuptake from brain synapse stimulated serotonin activity in the brain


Pharmacodynamics/Kinetics

Absorption: Completely absorbed following oral administration

Distribution: Vd: 8.7 L/kg (3-28 L/kg)

Protein binding: 93% to 95%

Metabolism: Extensively hepatic via CYP enzymes via oxidation and methylation; nonlinear pharmacokinetics may be seen with higher doses and longer duration of therapy. Saturation of CYP2D6 appears to account for the nonlinearity. Cmin concentrations 70% to 80% greater in the elderly compared to nonelderly patients; clearance is also decreased.

Half-life elimination: 21 hours (3-65 hours)

Time to peak, serum: Immediate release: 5.2 hours; controlled release: 6-10 hours

Excretion: As metabolites in urine and bile; 2% as unchanged drug in urine


Dosage

 Oral:

Children:

Depression (unlabeled use; not recommended by FDA): Initial: 10 mg/day and adjusted upward on an individual basis to 20 mg/day

OCD (unlabeled use): Initial: 10 mg/day and titrate up as necessary to 60 mg/day

Self-injurious behavior (unlabeled use): 20 mg/day

Social phobia (unlabeled use): 2.5-15 mg/day

Adults:

Depression:

Paxil®, Pexeva™: Initial: 20 mg once daily, preferably in the morning; increase if needed by 10 mg/day increments at intervals of at least 1 week; maximum dose: 50 mg/day

Paxil CR™: Initial: 25 mg once daily; increase if needed by 12.5 mg/day increments at intervals of at least 1 week; maximum dose: 62.5 mg/day

GAD (Paxil®): Initial: 20 mg once daily, preferably in the morning; doses of 20-50 mg/day were used in clinical trials, however, no greater benefit was seen with doses >20 mg. If dose is increased, adjust in increments of 10 mg/day at 1-week intervals.

OCD (Paxil®, Pexeva™): Initial: 20 mg once daily, preferably in the morning; increase if needed by 10 mg/day increments at intervals of at least 1 week; recommended dose: 40 mg/day; range: 20-60 mg/day; maximum dose: 60 mg/day

Panic disorder:

Paxil®, Pexeva™: Initial: 10 mg once daily, preferably in the morning; increase if needed by 10 mg/day increments at intervals of at least 1 week; recommended dose: 40 mg/day; range: 10-60 mg/day; maximum dose: 60 mg/day

Paxil CR™: Initial: 12.5 mg once daily; increase if needed by 12.5 mg/day at intervals of at least 1 week; maximum dose: 75 mg/day

PMDD (Paxil CR™): Initial: 12.5 mg once daily in the morning; may be increased to 25 mg/day; dosing changes should occur at intervals of at least 1 week. May be given daily throughout the menstrual cycle or limited to the luteal phase.

PTSD (Paxil®): Initial: 20 mg once daily, preferably in the morning; increase if needed by 10 mg/day increments at intervals of at least 1 week; range: 20-50 mg

Social anxiety disorder:

Paxil®: Initial: 20 mg once daily, preferably in the morning; recommended dose: 20 mg/day; range: 20-60 mg/day; doses >20 mg may not have additional benefit

Paxil CR™: Initial: 12.5 mg once daily, preferably in the morning; may be increased by 12.5 mg/day at intervals of at least 1 week; maximum dose: 37.5 mg/day

Vasomotor symptoms of menopause (unlabeled use, Paxil CR™): 12.5-25 mg/day

Elderly:

Paxil®, Pexeva™: Initial: 10 mg/day; increase if needed by 10 mg/day increments at intervals of at least 1 week; maximum dose: 40 mg/day

Paxil CR™; Initial: 12.5 mg/day; increase if needed by 12.5 mg/day increments at intervals of at least 1 week; maximum dose: 50 mg/day

Note: Upon discontinuation of paroxetine therapy, gradually taper dose:

Paxil®: 10 mg/day at weekly intervals; when 20 mg/day dose is reached, continue for 1 week before treatment is discontinued. Some patients may need to be titrated to 10 mg/day for 1 week before discontinuation.

Paxil CR™: Patients receiving 37.5 mg/day in clinical trials had their dose decreased by 12.5 mg/day to a dose of 25 mg/day and remained at a dose of 25 mg/day for 1 week before treatment was discontinued.

Dosage adjustment in severe renal/hepatic impairment: Adults:

Clcr<30 mL/minute: Mean plasma concentration is ~4 times that seen in normal function.

Clcr 30-60 mL/minute and hepatic dysfunction: Plasma concentration is 2 times that seen in normal function.

Paxil®, Pexeva™: Initial: 10 mg/day; increase if needed by 10 mg/day increments at intervals of at least 1 week; maximum dose: 40 mg/day

Paxil CR™: Initial: 12.5 mg/day; increase if needed by 12.5 mg/day increments at intervals of at least 1 week; maximum dose: 50 mg/day


Administration

 May be administered with or without food. Do not crush, break, or chew controlled release tablets.


Monitoring Parameters

 Mental status for depression, suicidal ideation (especially at the beginning of therapy or when doses are increased or decreased), anxiety, social functioning, mania, panic attacks; akathisia


Dietary Considerations

 May be taken with or without food.


Patient Education

 Take exactly as directed; do not increase dose or frequency or discontinue without consulting prescriber. It may take 2-3 weeks to achieve desired results. Take in the morning to reduce the incidence of insomnia (may be taken with or without food). Do not crush, break, or chew controlled release (Paxil CR™) tablets. Avoid alcohol, caffeine, and other prescription or OTC medications not approved by prescriber. Maintain adequate hydration (2-3 L/day of fluids) unless instructed to restrict fluid intake. You may experience drowsiness, dizziness, or lightheadedness (use caution when driving or engaging in tasks requiring alertness until response to drug is known); nausea, vomiting, anorexia, or dry mouth (small, frequent meals, frequent mouth care, chewing gum, or sucking lozenges may help); or orthostatic hypotension (use caution when climbing stairs or changing position from lying or sitting to standing). Report persistent insomnia or excessive daytime sedation; muscle cramping, tremors, weakness, or change in gait; chest pain, palpitations, or rapid heartbeat; vision changes or eye pain; respiratory difficulty or breathlessness; abdominal pain or blood in stool; And change in affect or thought processes, unusual agitation, abnormal dreams, worsening of condition; or suicidal ideation. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to become pregnant. Consult prescriber if breast-feeding.


Additional Information

 Paxil CR™ incorporates a degradable polymeric matrix (Geomatrix™) to control dissolution rate over a period of 4-5 hours. An enteric coating delays the start of drug release until tablets have left the stomach.


Anesthesia and Critical Care Concerns/Other Considerations

 Paroxetine has properties similar to fluvoxamine maleate. Buspirone (15-60 mg/day) may be useful in treatment of sexual dysfunction during treatment with a selective serotonin reuptake inhibitor.


Dental Health: Effects on Dental Treatment

 Key adverse event(s) related to dental treatment: Xerostomia and changes in salivation (normal salivary flow resumes upon discontinuation), postural hypotension, and abnormal taste. Problems with SSRI-induced bruxism have been reported and may preclude their use; clinicians attempting to evaluate any patient with bruxism or involuntary muscle movement, who is simultaneously being treated with an SSRI drug, should be aware of the potential association. Prolonged use may decrease or inhibit salivary flow; normal salivation resumes upon discontinuation.


Dental Health: Vasoconstrictor/Local Anesthetic Precautions

 Although caution should be used in patients taking tricyclic antidepressants, no interactions have been reported with vasoconstrictor and paroxetine, a nontricyclic antidepressant which acts to increase serotonin


Mental Health: Child/Adolescent Considerations

Depression: Paroxetine was shown to be effective and generally well tolerated in a recent randomized, double-blind, placebo-controlled parallel-design study; 275 adolescents (12-18 years of age) with major depression were randomized to receive paroxetine, imipramine, or placebo; 93 patients (mean age: 14.8 ± 1.6 years) received paroxetine at initial doses of 20 mg/day given in the morning; doses were increased if needed at week 5 to 30 mg/day (given in divided doses) and at weeks 6-8 to 40 mg/day (given in divided doses); 48% of patients remained at the initial starting dose of 20 mg/day; mean optimal daily dose: 28 ± 8.54 mg (Keller, 2001). Paroxetine was shown to be effective and well tolerated in an open label clinical trial in 45 children <14 years of age (mean: 10.7 ± 2 years) with major depression (Rey-Sanchoz, 1997). Doses were initiated at 10 mg/day and adjusted upward on an individual basis with a mean dose of 16.2 mg/day used for an average of 8.4 months. Further studies are needed.

Obsessive-compulsive disorder (OCD): Twenty OCD outpatients 8-17 years of age were treated with daily doses ranging from 10-60 mg/day for 12 weeks (Rosenberg, 1999).

Self-injurious behavior: A 15-year old autistic male with self-injurious behavior was successfully treated with 20 mg/day (Snead, 1994). Further studies are needed.

Social phobia: A small case series reported the effective use of paroxetine in 5 pediatric patients with social phobia [2 children (7 and 11 years of age) and 3 adolescents (16, 17, and 18 years of age)]; comorbid diagnoses (obsessive compulsive disorder and/or dysthymia) existed in 3 patients; doses were adjusted on an individual basis; the 7-year old was started on 2.5 mg/day and increased to 5 mg/day after 4 weeks; the 11-year old was started on 5 mg/day and the dose was titrated upwards by 5 mg/day increments every 3-4 weeks to 15 mg/day; adolescents were started on 20 mg/day (Mancini, 1999); further studies are needed.

A recent report described the SSRI discontinuation syndrome in 6 children; the syndrome was similar to that reported in adults (Diler, 2002).

Diler RS and Avci A, "Selective Serotonin Reuptake Inhibitor Discontinuation Syndrome in Children: Six Case Reports," Current Therapeutic Research , 2002, 63(3):188-97.

Keller MB, Ryan ND, Strober M, et al, "Efficacy of Paroxetine in the Treatment of Adolescent Major Depression: A Randomized, Controlled Trial," J Am Acad Child Adolesc Psychiatry , 2001, 40(7):762-72.

Mancini C, Van Ameringen M, Oakman JM, et al, "Serotonergic Agents in the Treatment of Social Phobia in Children and Adolescents: A Case Series," Depress Anxiety , 1999, 10(1):33-9.

Rey-Sanchez F and Guitierrez-Cassares JR, "Paroxetine in Children With Major Depressive Disorder: An Open Trial," J Am Acad Child Adolesc Psychiatry , 1997, 36(10):1443-7.

Rosenberg DR, Stewart CM, Fitzgerald KD, et al, "Paroxetine Open-Label Treatment of Pediatric Outpatients With Obsessive-Compulsive Disorder," J Am Acad Child Adolesc Psychiatry , 1999, 38(9):1180-5.

Snead RW, Boon F, and Presberg J, "Paroxetine for Self-Injurious Behavior," J Am Acad Child Adolesc Psychiatry , 1994, 33(6):909-10.


Dosage Forms

 Note : Available as paroxetine hydrochloride or mesylate; mg strength refers to paroxetine

Suspension, oral, as hydrochloride (Paxil®): 10 mg/5 mL (250 mL) [orange flavor]

Tablet, as hydrochloride (Paxil®): 10 mg, 20 mg, 30 mg, 40 mg

Tablet, as mesylate (Pexeva™): 10 mg, 20 mg, 30 mg, 40 mg

Tablet, controlled release, as hydrochloride (Paxil CR™): 12.5 mg, 25 mg, 37.5 mg


References

Adler LA and Angrist BM, "Paroxetine and Akathisia," Biol Psychiatry , 1995, 37(5):336-7.

Ahmad S, "Paroxetine-Induced Priapism," Arch Intern Med , 1995, 155(6):645.

"American Academy of Pediatrics Committee on Drugs. The Transfer of Drugs and Other Chemicals Into Human Milk," Pediatrics , 2001, 108(3):776-89.

Bloch M, Stager SV, Braun AR, et al, "Severe Psychiatric Symptoms Associated With Paroxetine Withdrawal," Lancet , 1995, 346(8966):57.

Boyer WF and Blumhardt CL, "The Safety Profile of Paroxetine," J Clin Psychiatry , 1992, 53(Suppl):61-6.

Dechant KL and Clissold SP, "Paroxetine: A Review of Its Pharmacodynamic and Pharmacokinetic Properties and Therapeutic Potential in Depressive Illness," Drugs , 1991, 41(2):225-53.

Diler RS and Avci A, "Selective Serotonin Reuptake Inhibitor Discontinuation Syndrome in Children: Six Case Reports," Current Therapeutic Reseach , 2002, 63(3):188-97.

Dunbar GC, "An Interim Overview of the Safety and Tolerability of Paroxetine," Acta Psychiatr Scand , 1989, 350:135-7.

Fava M, Judge R, Hoog SL, et al, "Fluoxetine Versus Sertraline and Paroxetine in Major Depressive Disorder: Changes in Weight With Long-Term Treatment," J Clin Psychiatry , 2000, 61(11):863-7.

Folkerts H, "Spontaneous Seizure After Concurrent Use of Methohexital Anesthesia for Electroconvulsive Therapy and Paroxetine: A Case Report," J Nerv Ment Dis , 1995, 183(2):115-6.

Gorman SE, Rice T, and Simmons HF, "Paroxetine Overdose," Am J Emerg Med , 1993, 11(6):682.

Greb WH, Buscher G, Dierdorf HD, et al, "Ability of Charcoal to Prevent Absorption of Paroxetine," Acta Psychiatr Scand Suppl , 1989, 350:156-7.

Grimsley SR and Jann MW, "Paroxetine, Sertraline, and Fluvoxamine: New Selective Serotonin Reuptake Inhibitors," Clin Pharm , 1992, 11(11):930-57.

Hebenstreit GF, Fellerer K, Zochling R, et al, "A Pharmacokinetic Dose Titration Study in Adult and Elderly Depressed Patients," Acta Psychiatr Scand Suppl , 1989, 350:81-4.

Horrigan JP and Barnhill LJ, "Paroxetine-Pimozide Drug Interactions," J Am Acad Child Adolesc Psychiatry , 1994, 33(7):1060-1.

Jimenez-Jimenez FJ, Tejeiro J, Martinez-Junquera G, et al, "Parkinsonism Exacerbated by Paroxetine," Neurology , 1994, 44(12):2406.

Keller MB, Ryan ND, Strober M, et al, "Efficacy of Paroxetine in the Treatment of Adolescent Major Depression: A Randomized, Controlled Trial," J Am Acad Child Adolesc Psychiatry , 2001, 40(7):762-72.

Lundmark J, Scheel Thomsen I, Fjord-Larsen T, et al, "Paroxetine: Pharmacokinetic and Antidepressant Effect in the Elderly," Acta Psychiatr Scand Suppl , 1989, 350:76-80.

Malek-Ahmadi P and Allen SA, "Paroxetine-Molindone Interaction," J Clin Psychiatry , 1995, 56(2):82-3.

Mancini C, Van Ameringen M, Oakman JM, et al, "Serotonergic Agents in the Treatment of Social Phobia in Children and Adolescents: A Case Series," Depress Anxiety , 1999, 10(1):33-9.

Markel H, Lee A, Holmes RD, et al, "LSD Flashback Syndrome Exacerbated by Selective Serotonin Reuptake Inhibitor Antidepressants in Adolescents," J Pediatr , 1994, 125(5 Pt 1):817-9.

McKenzie LJ and Risch SC, "Fibrocystic Breast Disease Following Treatment With Selective Serotonin Reuptake Inhibitors," Am J Psychiatry , 1995, 152(3):471.

Mokhlesi B, Leikin JB, Murray P, et al, "Adult Toxicology in Critical Care: Part II: Specific Poisonings," Chest , 2003, 123(3):897-922.

Myers LB, Dean BS, and Krenzelok EP, "A Pediatric Focus: Paroxetine (Paxil®) Overdose," Clin Toxicol , 1995, 33(5):551.

Myers LB, Dean BS, and Krenzelok EP, "Paroxetine (Paxil®): Overdose Assessment of a New Selective Serotonin Reuptake Inhibitor," Vet Hum Toxicol , 1994, 36:370.

Nemeroff CB, "The Clinical Pharmacology and Use of Paroxetine, A New Selective Serotonin Reuptake Inhibitor," Pharmacotherapy , 1994, 14(2):127-38.

Norden MJ, "Buspirone Treatment of Sexual Dysfunction Associated With Selective Serotonin Re-Uptake Inhibitors," Depression , 1994, 2:109-12.

Reeves RR and Bullen JA, "Serotonin Syndrome Produced by Paroxetine and Low-Dose Trazodone," Psychosomatics , 1995, 36(2):159-60.

Rey-Sanchez F and Guitierrez-Cassares JR, "Paroxetine in Children With Major Depressive Disorder: An Open Trial," J Am Acad Child Adolesc Psychiatry , 1997, 36(10):1443-7.

Roose SP, Glassman AH, Attia E, et al, "Comparative Efficacy of Selective Serotonin Reuptake Inhibitors and Tricyclics in the Treatment of Melancholia," Am J Psychiatry , 1994, 151(12):1735-9.

Roose SP, Laghrissi-Thode F, Kennedy JS, et al, "Comparison of Paroxetine and Nortriptyline in Depressed Patients With Ischemic Heart Disease," JAMA , 1998, 279(4):287-91.

Rosenberg DR, Stewart CM, Fitzgerald KD, et al, "Paroxetine Open-Label Treatment of Pediatric Outpatients With Obsessive-Compulsive Disorder," J Am Acad Child Adolesc Psychiatry , 1999, 38(9):1180-5.

Schone W and Ludwig M, "A Double-Blind Study of Paroxetine Compared With Fluoxetine in Geriatric Patients With Major Depression," J Clin Psychopharmacol , 1993, 13(6 Suppl 2):34-9.

Skop BP, Finkelstein JA, Mareth TR, et al, "The Serotonin Syndrome Associated With Paroxetine, an Over-the-Counter Cold Remedy, and Vascular Disease," Am J Emerg Med , 1994, 12(6):642-4.

Snead RW, Boon F, and Presberg J, "Paroxetine for Self-Injurious Behavior," J Am Acad Child Adolesc Psychiatry , 1994, 33(6):909-10.

Spina E, Avenoso A, Facciola G, et al, "Relationship Between Plasma Risperidone and 9-hydroxyrisperidone Concentrations and Clinical Response in Patients With Schizophrenia," Psychopharmacology (Berl) , 2001, 153(2):238-43.

Stearns V, Beebe KL, Iyengar M, et al, "Paroxetine Controlled Release in the Treatment of Menopausal Hot Flashes: A Randomized Controlled Trial," JAMA , 2003, 289(21):2827-34.

Stiskal JA, Kulin N, Koren G, et al, "Neonatal Paroxetine Withdrawal Syndrome," Arch Dis Child Fetal Neonatal Ed , 2001, 84(2):F134-5.


International Brand Names

 Allenopar® (AT); Aropax® (AR, AU, BE, BR, LU, MX, NZ, ZA); Aroxat® (CL); Aroxetin® (DE); Bectam® (CL); Casbol® (ES); Cebrilin® (BR); Daparox® (IT); Deprozel® (HR); Deroxat® (CH, FR); Deroxat EuroPharma DK® (DK); Divarius® (FR); Ennos® (AT, DE, IT); Euphix® (DE); Euplix® (DE, SE); Eutimil® (IT); Frosinor® (ES); Meloxat® (IE); Meplar® (AR); Motivan® (ES); Neurotrox® (AR); Optipar® (FI); Oxet® (DE); Oxetine® (DK); Paluxetil® (AT); Pamoxet® (AR); Parexat® (CH); Parocetan® (AT); ParoLich® (DE); Paroxat® (AT, DE, HU); Paroxedura® (DE); Paroxetin 1A Farma® (DK); Paroxetin 1A Pharma® (DE); Paroxetina Bexal® (ES); Paroxetin AbZ® (DE); Paroxetina Generis® (PT); Paroxetina® (IT); Paroxetin AL® (DE); Paroxetin Alpharma® (SE); Paroxetina Merck® (ES, PT); Paroxetina Mundogen® (ES); Paroxetin Arcana® (AT); Paroxetin AZU® (DE); Paroxetin beta® (DE); Paroxetin Biochemie® (DK); Paroxetin-biomo® (DE); Paroxetine® (GB); Paroxetin Gea® (DK, SE); Paroxetin Heumann® (DE); Paroxetin Holsten® (DE); Paroxetin-Isis® (DE); Paroxetin Lindo® (DE); Paroxetin-Mepha® (CH); Paroxetin-neuraxpharm® (DE); Paroxetin NM® (DK); Paroxetin "NM"® (DK); Paroxetin® (NO); Paroxetin ratiopharm® (AT, DE, DK, SE); Paroxetin Sandoz® (DE); Paroxetin Scand Pharma® (SE); Paroxetin Stada® (DE); Paroxetin TAD® (DE); Paroxetin UNP® (DK); Paroxetin von ct® (DE); Parox® (IE); Paxan® (CO); Paxetil® (PT); Paxil® (AR, CA, CR, DO, EC, GT, HN, MX, PA, RU, SV); Paxil CR™ (CA); Paxxet® (IL); Pondera® (BR); Psicoasten® (AR); Rexetin® (HU, PL); Seretran® (CL); Sereupin® (IT); Serodur® (DK); Seroxat® (AT, BE, CO, CZ, DE, DK, ES, FI, GB, HR, HU, ID, IE, IL, IT, KW, LU, NL, NO, PL, PT, SE, SG, SI, TH, TR, YU); Serroxat® (RO); Tagonis® (DE); Tiarix® (AR); Xet® (IN)


A.D.A.M., Inc. is accredited by URAC, also known as the American Accreditation HealthCare Commission (www.urac.org). URAC's accreditation program is the first of its kind, requiring compliance with 53 standards of quality and accountability, verified by independent audit. A.D.A.M. is among the first to achieve this important distinction for online health information and services. Learn more about A.D.A.M.'s editorial process . A.D.A.M. is also a founding member of Hi-Ethics (www.hiethics.com) and subscribes to the principles of the Health on the Net Foundation (www.hon.ch).

The information provided herein should not be used during any medical emergency or for the diagnosis or treatment of any medical condition. A licensed medical professional should be consulted for diagnosis and treatment of any and all medical conditions. Call 911 for all medical emergencies. Links to other sites are provided for information only -- they do not constitute endorsements of those other sites. © 1997-2007 A.D.A.M., Inc. Any duplication or distribution of the information contained herein is strictly prohibited.
adam.com