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Taking thioridazine because of risk of QT prolongation [see Warnings and Precautions 5. With known hypersensitivity e. The following adverse reactions are included in more detail in other sections of the prescribing information: Hypersensitivity reactions to paroxetine [see Contraindications 4 ] Suicidal Thoughts and Behaviors [see Warnings and Precautions 5.

Incidence corrected for gender. Percentage corrected for gender. Examples selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue Pimozide and Thioridazine Clinical Impact Increased plasma concentrations of pimozide and thioridazine, drugs with a narrow therapeutic index, may increase the risk of QTc prolongation and ventricular arrhythmias.

Intervention Paroxetine is contraindicated in patients taking pimozide or thioridazine [see Contraindications 4 ]. Other Serotonergic Drugs Clinical Impact The concomitant use of serotonergic drugs with paroxetine increases the risk of serotonin syndrome. Intervention Monitor patients for signs and symptoms of serotonin syndrome, particularly during treatment initiation and dosage increases. John's Wort Drugs that Interfere with Hemostasis antiplatelet agents and anticoagulants Clinical Impact The concurrent use of an antiplatelet agent or anticoagulant with paroxetine may potentiate the risk of bleeding.

Intervention Inform patients of the increased risk of bleeding associated with the concomitant use of paroxetine and antiplatelet agents and anticoagulants. For patients taking warfarin, carefully monitor the international normalized ratio [see Warnings and Precautions 5.

Conversely, an increase in dosage of a CYP2D6 substrate may be needed if paroxetine is discontinued. Examples propafenone, flecainide, atomoxetine, desipramine, dextromethorphan, metoprolol, nebivolol, perphenazine, tolterodine, venlafaxine, risperidone. Tamoxifen Clinical Impact Concomitant use of tamoxifen with paroxetine may lead to reduced plasma concentrations of the active metabolite endoxifen and reduced efficacy of tamoxifen Intervention Consider use of an alternative antidepressant with little or no CYP2D6 inhibition [see Warnings and Precautions 5.

Intervention Any dose adjustment should be guided by clinical effect tolerability and efficacy. Clinical Considerations Unless the benefits of paroxetine to the mother justify continuing treatment, consideration should be given to either discontinuing paroxetine therapy or switching to another antidepressant [see Warnings and Precautions 5. No increase in the risk of overall congenital malformations was seen in the paroxetine-exposed infants.

The cardiac malformations in the paroxetine-exposed infants were primarily ventricular septal defects VSDs and atrial septal defects ASDs. Septal defects range in severity from those that resolve spontaneously to those which require surgery. This study showed a trend towards an increased risk for cardiovascular malformations for paroxetine risk of 1.

Of the 12 paroxetine-exposed infants with cardiovascular malformations, 9 had VSDs. In one study the OR was 2. It was not possible in this meta-analysis to determine the extent to which the observed prevalence of cardiovascular malformations might have contributed to that of overall malformations, nor was it possible to determine whether any specific types of cardiovascular malformations might have contributed to the observed prevalence of all cardiovascular malformations.

The following have been reported with paroxetine tablet overdosage: Seizures, which may be delayed, and altered mental status including coma. Absorption Paroxetine hydrochloride is completely absorbed after oral dosing of a solution of the hydrochloride salt. Paroxetine is equally bioavailable from the oral suspension and tablet.

Effect of Food The effects of food on the bioavailability of paroxetine were studied in subjects administered a single dose with and without food. Drug Interaction Studies There are clinically significant, known drug interactions between paroxetine and other drugs [see Drug Interactions 7 ].

Mutagenesis Paroxetine produced no genotoxic effects in a battery of 5 in vitro and 2 in vivo assays that included the following: Bacterial mutation assay, mouse lymphoma mutation assay, unscheduled DNA synthesis assay, and tests for cytogenetic aberrations in vivo in mouse bone marrow and in vitro in human lymphocytes and in a dominant lethal test in rats. Suicidal Thoughts and Behaviors Advise patients and caregivers to look for the emergence of suicidality, especially early during treatment and when the dosage is adjusted up or down, and instruct them to report such symptoms to the healthcare provider [see Boxed Warning and Warnings and Precautions 5.

Serotonin Syndrome Caution patients about the risk of serotonin syndrome, particularly with the concomitant use of paroxetine with other serotonergic drugs including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, St. Concomitant Medications Advise patients 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 drug-drug interactions [see Warning and Precautions 5.

Increased Risk of Bleeding Inform patients about the concomitant use of paroxetine with aspirin, NSAIDs, other antiplatelet drugs, warfarin, or other anticoagulants because the combined use has been associated with an increased risk of bleeding. Discontinuation Syndrome Advise patients not to abruptly discontinue paroxetine and to discuss any tapering regimen with their healthcare provider.

Sexual Dysfunction Advise patients that use of paroxetine may cause symptoms of sexual dysfunction in both male and female patients. Allergic Reactions Advise patients to notify their healthcare provider if they develop an allergic reaction such as rash, hives, swelling, or difficulty breathing [see Adverse Reactions 6.

Embryo-Fetal Toxicity Advise women of the potential risk to the fetus [see Warnings and Precautions 5. Nursing Advise women to notify their healthcare provider if they are breastfeeding an infant [see Use In Specific Populations 8. Medication Guide available at www. Manufactured by: Cadila Healthcare Ltd. Pennington, NJ Rev. Paroxetine tablets and other antidepressant medicines may increase suicidal thoughts and actions in some people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed.

Paroxetine tablets are not for use in children. How can I watch for and try to prevent suicidal thoughts and actions? This is very important when an antidepressant medicine is started or when the does is changed. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms. See the end of this Medication Guide for a complete list of ingredients in paroxetine tablets.

Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI or one of these medicines, including the antibiotic linezolid or intravenous methylene blue. Do not start taking an MAOI for at least 14 days after you stop treatment with paroxetine tablets. Paroxetine tablets may harm your unborn baby. Talk to your healthcare provider about the risks to your unborn baby if you take paroxetine tablets during pregnancy.

Paroxetine passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with paroxetine tablets.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Paroxetine tablets and some other medicines may affect each other causing possible serious side effects. Paroxetine tablets may affect the way other medicines work and other medicines may affect the way paroxetine tablets works.

Your healthcare provider can tell you if it is safe to take paroxetine tablets with your other medicines. Do not start or stop any other medicines during treatment with paroxetine tablets without talking to your healthcare provider first. Stopping paroxetine tablets suddenly may cause you to have serious side effects. See, "What are the possible side effects of paroxetine tablets? Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.

How should I take paroxetine tablets? Your healthcare provider may need to change the dose of paroxetine tablets until it is the right dose for you. What are possible side effects of paroxetine tablets? A potentially life-threatening problem called serotonin syndrome can happen when you take paroxetine tablets with certain other medicines. See, "Who should not take paroxetine tablets? Paroxetine tablets may cause a type of eye problem called angle-closure glaucoma in people with certain other eye conditions.

You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are. Call your healthcare provider if you have eye pain, changes in your vision, or swelling or redness in or around the eye. Taking paroxetine tablets with certain other medicines including thioridazine and pimozide may increase the risk of developing a serious heart problem called QT prolongation.

Manic episodes may happen in people with bipolar disorder who take paroxetine tablets. Suddenly stopping paroxetine tablets may cause you to have serious side effects. Your healthcare provider may want to decrease your dose slowly. Low sodium levels in your blood that may be serious and may cause death, can happen during treatment with paroxetine tablets.

Elderly people and people who take certain medicines may be at a greater risk for developing low sodium levels in your blood. Tell your healthcare provider about any unusual bleeding or bruising. Taking selective serotonin reuptake inhibitors SSRIs , including paroxetine, may cause sexual problems.

Symptoms in males may include: o Delayed ejaculation or inability to have an ejaculation o Decreased sex drive o Problems getting or keeping an erection Symptoms in females may include: o Decreased sex drive o Delayed orgasm or inability to have an orgasm Talk to your healthcare provider if you develop any changes in your sexual function or if you have any questions or concerns about sexual problems during treatment with paroxetine.

There may be treatments your healthcare provider can suggest. Call your doctor for medical advice about side effects. How should I store paroxetine tablets? Keep paroxetine tablets and all medicines out of the reach of children. General information about the safe and effective use of paroxetine tablets.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not take paroxetine tablets for a condition for which it was not prescribed. Do not give paroxetine tablets to other people, even if they have the same symptoms that you have. It may harm them. You may ask your healthcare provider or pharmacist for information about paroxetine tablets that is written for healthcare professionals.

What are the ingredients in paroxetine tablets, USP? Active ingredient: paroxetine hydrochloride, USP Inactive ingredients: dibasic calcium phosphate anhydrous, hypromellose 6 cP, lactose anhydrous, magnesium stearate, polyethylene glycol , povidone, sodium starch glycolate, talc, and titanium dioxide. Version Files Oct 29, 13 current download Sep 2, 12 download Feb 4, 11 download Dec 16, 10 download Oct 11, 9 download Sep 12, 8 download Feb 9, 7 download Sep 2, 6 download Jun 18, 5 download Feb 21, 4 download Dec 2, 3 download Apr 14, 2 download Dec 1, 1 download.

NDC 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 Starting Dose. Maximum Dose. Age Range. Increases Compared to Placebo. Decreases Compared to Placebo. Body as a Whole. Oropharynx Disorder a. Urogenital System. Ejaculatory Disturbance b,c. Other Male Genital Disorders b,d. Female Genital Disorders b,f. Obsessive Compulsive Disorder. Panic Disorder. Social Anxiety Disorder. Respiratory System. Abnormal Ejaculation a. Female Genital Disorders a.

Generalized Anxiety Disorder. Posttraumatic Stress Disorder. Female Genital Disorder a. Impotence a. Paroxetine Tablets. Clinical Impact. Pimozide and Thioridazine. Increased plasma concentrations of pimozide and thioridazine, drugs with a narrow therapeutic index, may increase the risk of QTc prolongation and ventricular arrhythmias.

Paroxetine is contraindicated in patients taking pimozide or thioridazine [see Contraindications 4 ]. Other Serotonergic Drugs. The concomitant use of serotonergic drugs with paroxetine increases the risk of serotonin syndrome. Monitor patients for signs and symptoms of serotonin syndrome, particularly during treatment initiation and dosage increases. John's Wort. Drugs that Interfere with Hemostasis antiplatelet agents and anticoagulants.

The concurrent use of an antiplatelet agent or anticoagulant with paroxetine may potentiate the risk of bleeding. Inform patients of the increased risk of bleeding associated with the concomitant use of paroxetine and antiplatelet agents and anticoagulants.

Drugs Highly Bound to Plasma Protein. Decrease the dosage of a CYP2D6 substrate if needed with concomitant paroxetine use. Concomitant use of tamoxifen with paroxetine may lead to reduced plasma concentrations of the active metabolite endoxifen and reduced efficacy of tamoxifen.

Any dose adjustment should be guided by clinical effect tolerability and efficacy. Outcome Classification. Paroxetine 20 mg. Paroxetine 40 mg. Paroxetine 60 mg. What is the most important information I should know about paroxetine tablets? Call your healthcare provider or get emergency medical help right away if you have any of the following symptoms, especially if they are new, worse, or worry you:.

What are paroxetine tablets? Symptoms may include:. The most common side effects of paroxetine tablets include:. These are not all the possible side effects of paroxetine tablets. Product Information. Inactive Ingredients. The effectiveness of paroxetine tablets in the treatment of social anxiety disorder was demonstrated in three week, multicenter, placebo-controlled studies Studies 1, 2, and 3 of adult outpatients with social anxiety disorder DSM-IV.

In these studies, the effectiveness of paroxetine tablets compared to placebo was evaluated on the basis of 1 the proportion of responders, as defined by a Clinical Global Impression CGI Improvement score of 1 very much improved or 2 much improved , and 2 change from baseline in the Liebowitz Social Anxiety Scale LSAS. Studies 1 and 2 were flexible-dose studies comparing paroxetine 20 to 50 mg daily and placebo.

Subgroup analyses generally did not indicate differences in treatment outcomes as a function of age, race, or gender. Doses of 20 mg or 40 mg of paroxetine tablets were both demonstrated to be significantly superior to placebo on the Hamilton Rating Scale for Anxiety HAM-A total score.

Study 2 was a flexible-dose study comparing paroxetine 20 mg to 50 mg daily and placebo. A third study, also flexible-dose comparing paroxetine 20 mg to 50 mg daily , did not demonstrate statistically significant superiority of paroxetine tablets over placebo on the Hamilton Rating Scale for Anxiety HAM-A total score, the primary outcome.

Subgroup analyses did not indicate differences in treatment outcomes as a function of race or gender. There were insufficient elderly patients to conduct subgroup analyses on the basis of age. Patients receiving continued paroxetine tablets experienced a significantly lower relapse rate over the subsequent 24 weeks compared to those receiving placebo. The mean duration of PTSD symptoms for the 2 studies combined was 13 years ranging from.

The 2 primary outcomes for each trial were i change from baseline to endpoint on the CAPS-2 total score 17 items , and ii proportion of responders on the CGI-I, where responders were defined as patients having a score of 1 very much improved or 2 much improved. Doses of 20 mg and 40 mg of paroxetine tablets were demonstrated to be significantly superior to placebo on change from baseline for the CAPS-2 total score and on proportion of responders on the CGI-I.

Study 2 was a week flexible-dose study comparing paroxetine 20 to 50 mg daily to placebo. Paroxetine tablets were demonstrated to be significantly superior to placebo on change from baseline for the CAPS-2 total score and on proportion of responders on the CGI-I. A third study, also a flexible-dose study comparing paroxetine 20 to 50 mg daily to placebo, demonstrated paroxetine tablets to be significantly superior to placebo on change from baseline for CAPS2 total score, but not on proportion of responders on the CGI-I.

Subgroup analyses did not indicate differences in treatment outcomes as a function of gender. There were an insufficient number of patients who were 65 years and older or were non-Caucasian to conduct subgroup analyses on the basis of age or race, respectively.

Paroxetine tablets, USP are indicated for the treatment of major depressive disorder. A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning nearly every day for at least 2 weeks ; it should include at least 4 of the following 8 symptoms: Change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation.

The effects of paroxetine tablets, USP in hospitalized depressed patients have not been adequately studied. Nevertheless, the physician who elects to use paroxetine tablets, USP for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient. The obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning. Long-term maintenance of efficacy was demonstrated in a 6-month relapse prevention trial.

Long-term maintenance of efficacy was demonstrated in a 3-month relapse prevention trial. Social anxiety disorder is characterized by a marked and persistent fear of 1 or more social or performance situations in which the person is exposed to unfamiliar people or to possible scrutiny by others. Exposure to the feared situation almost invariably provokes anxiety, which may approach the intensity of a panic attack. The feared situations are avoided or endured with intense anxiety or distress.

The avoidance, anxious anticipation, or distress in the feared situation s interferes significantly with the person's normal routine, occupational or academic functioning, or social activities or relationships, or there is marked distress about having the phobias. Lesser degrees of performance anxiety or shyness generally do not require psychopharmacological treatment.

The effectiveness of paroxetine tablets, USP in long-term treatment of social anxiety disorder, i. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. Generalized Anxiety Disorder DSM-IV is characterized by excessive anxiety and worry apprehensive expectation that is persistent for at least 6 months and which the person finds difficult to control. It must be associated with at least 3 of the following 6 symptoms: Restlessness or feeling keyed up or on edge, being easily fatigued, difficulty concentrating or mind going blank, irritability, muscle tension, sleep disturbance.

PTSD, as defined by DSM-IV, requires exposure to a traumatic event that involved actual or threatened death or serious injury, or threat to the physical integrity of self or others, and a response that involves intense fear, helplessness, or horror. A PTSD diagnosis requires that the symptoms are present for at least a month and that they cause clinically significant distress or impairment in social, occupational, or other important areas of functioning.

The use of MAOIs intended to treat psychiatric disorders with paroxetine tablets or within 14 days of stopping treatment with paroxetine tablets is contraindicated because of an increased risk of serotonin syndrome. Paroxetine tablets are contraindicated in patients with a hypersensitivity to paroxetine or any of the inactive ingredients in paroxetine tablets.

Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide. There has been a long-standing concern, however, that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment.

Pooled analyses of short-term placebo-controlled trials of antidepressant drugs SSRIs and others showed that these drugs increase the risk of suicidal thinking and behavior suicidality in children, adolescents, and young adults ages with major depressive disorder MDD and other psychiatric disorders.

Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction with antidepressants compared to placebo in adults aged 65 and older. The pooled analyses of placebo-controlled trials in children and adolescents with MDD, obsessive compulsive disorder OCD , or other psychiatric disorders included a total of 24 short-term trials of 9 antidepressant drugs in over 4, patients.

The pooled analyses of placebo-controlled trials in adults with MDD or other psychiatric disorders included a total of short-term trials median duration of 2 months of 11 antidepressant drugs in over 77, patients.

There was considerable variation in risk of suicidality among drugs, but a tendency toward an increase in the younger patients for almost all drugs studied.

There were differences in absolute risk of suicidality across the different indications, with the highest incidence in MDD. The risk differences drug vs placebo , however, were relatively stable within age strata and across indications. These risk differences drug-placebo difference in the number of cases of suicidality per 1, patients treated are provided in Table 1. No suicides occurred in any of the pediatric trials. There were suicides in the adult trials, but the number was not sufficient to reach any conclusion about drug effect on suicide.

It is unknown whether the suicidality risk extends to longer-term use, i. However, there is substantial evidence from placebo-controlled maintenance trials in adults with depression that the use of antidepressants can delay the recurrence of depression. All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, 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.

The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia psychomotor restlessness , hypomania, and mania, have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric.

Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidality, especially if these symptoms are severe, abrupt in onset, or were not part of the patient's presenting symptoms.

Families and caregivers of patients being treated with antidepressants for major depressive disorder or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients for the emergence of agitation, irritability, unusual changes in behavior, and the other symptoms described above, as well as the emergence of suicidality, and to report such symptoms immediately to health care providers.

Such monitoring should include daily observation by families and caregivers. Prescriptions for paroxetine tablets should be written for the smallest quantity of tablets consistent with good patient management, in order to reduce the risk of overdose.

A major depressive episode may be the initial presentation of bipolar disorder. Whether any of the symptoms described above represent such a conversion is unknown.

However, prior to initiating treatment with an antidepressant, patients with depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression. It should be noted that paroxetine tablets are not approved for use in treating bipolar depression.

The development of a potentially life-threatening serotonin syndrome has been reported with SNRIs and SSRIs, including paroxetine, alone but particularly 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 in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue.

Serotonin syndrome symptoms may include mental status changes e. Patients should be monitored for the emergence of serotonin syndrome. The concomitant use of paroxetine with MAOIs intended to treat psychiatric disorders is contraindicated. Paroxetine should also not be started in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue.

No reports involved the administration of methylene blue by other routes such as oral tablets or local tissue injection or at lower doses. There may be circumstances when it is necessary to initiate treatment with an MAOI such as linezolid or intravenous methylene blue in a patient taking paroxetine. If concomitant use of paroxetine with certain other serotonergic drugs, i. John's Wort is clinically warranted, be aware of a potential increased risk for serotonin syndrome, particularly during treatment initiation and dose increases.

Treatment with paroxetine and any concomitant serotonergic agents should be discontinued immediately if the above events occur and supportive symptomatic treatment should be initiated. Angle-Closure Glaucoma : The pupillary dilation that occurs following use of many antidepressant drugs including paroxetine may trigger an angle closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy.

Thioridazine administration alone produces prolongation of the QTc interval, which is associated with serious ventricular arrhythmias, such as torsade de pointes-type arrhythmias, and sudden death. This effect appears to be dose related. An in vivo study suggests that drugs which inhibit CYP2D6, such as paroxetine, will elevate plasma levels of thioridazine. Epidemiological studies have shown that infants exposed to paroxetine in the first trimester of pregnancy have an increased risk of congenital malformations, particularly cardiovascular malformations.

The findings from these studies are summarized below:. Other studies have found varying results as to whether there was an increased risk of overall, cardiovascular, or specific congenital malformations. While subject to limitations, this meta-analysis suggested an increased occurrence of cardiovascular malformations prevalence odds ratio [POR] 1.

It was not possible in this meta-analysis to determine the extent to which the observed prevalence of cardiovascular malformations might have contributed to that of overall malformations, nor was it possible to determine whether any specific types of cardiovascular malformations might have contributed to the observed prevalence of all cardiovascular malformations. If a patient becomes pregnant while taking paroxetine, she should be advised of the potential harm to the fetus. For women who intend to become pregnant or are in their first trimester of pregnancy, paroxetine should only be initiated after consideration of the other available treatment options.

These studies have revealed no evidence of teratogenic effects. However, in rats, there was an increase in pup deaths during the first 4 days of lactation when dosing occurred during the last trimester of gestation and continued throughout lactation. The no-effect dose for rat pup mortality was not determined.

The cause of these deaths is not known. Neonates exposed to paroxetine tablets and other SSRIs or serotonin and norepinephrine reuptake inhibitors SNRIs , late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding.

Such complications can arise immediately upon delivery. Reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying.

PPHN occurs in 1 — 2 per 1, live births in the general population and is associated with substantial neonatal morbidity and mortality. Other studies do not show a significant statistical association. Physicians should also note the results of a prospective longitudinal study of pregnant women with a history of major depression, who were either on antidepressants or had received antidepressants less than 12 weeks prior to their last menstrual period, and were in remission.

Women who discontinued antidepressant medication during pregnancy showed a significant increase in relapse of their major depression compared to those women who remained on antidepressant medication throughout pregnancy. When treating a pregnant woman with paroxetine, the physician should carefully consider both the potential risks of taking an SSRI, along with the established benefits of treating depression with an antidepressant. During premarketing testing, hypomania or mania occurred in approximately 1.

In a subset of patients classified as bipolar, the rate of manic episodes was 2. As with all drugs effective in the treatment of major depressive disorder, paroxetine tablets should be used cautiously in patients with a history of mania. During premarketing testing, seizures occurred in 0. Paroxetine tablets should be used cautiously in patients with a history of seizures. It should be discontinued in any patient who develops seizures.

Discontinuation of Treatment with Paroxetine Tablets:. Recent clinical trials supporting the various approved indications for paroxetine tablets employed a taper-phase regimen, rather than an abrupt discontinuation of treatment. In the majority of patients, these events were mild to moderate and were self limiting and did not require medical intervention.

During marketing of paroxetine tablets and other SSRIs and SNRIs, there have been spontaneous reports of adverse events occurring upon the discontinuation of these drugs particularly when abrupt , including the following: Dysphoric mood, irritability, agitation, dizziness, sensory disturbances e. While these events are generally self limiting, there have been reports of serious discontinuation symptoms.

Patients should be monitored for these symptoms when discontinuing treatment with paroxetine tablets. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered.

However, other studies have failed to demonstrate such a risk. It is uncertain whether the coadministration of paroxetine and tamoxifen has a significant adverse effect on the efficacy of tamoxifen. One study suggests that the risk may increase with longer duration of coadministration. 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.

The use of paroxetine or other SSRIs has been associated with the development of akathisia, which is characterized by an inner sense of restlessness and psychomotor agitation such as an inability to sit or stand still usually associated with subjective distress. This is most likely to occur within the first few weeks of treatment.

In many cases, this hyponatremia appears to be the result of the syndrome of inappropriate antidiuretic hormone secretion SIADH. Discontinuation of paroxetine should be considered in patients with symptomatic hyponatremia and appropriate medical intervention should be instituted. Signs and symptoms of hyponatremia include headache, difficulty concentrating, memory impairment, confusion, weakness, and unsteadiness, which may lead to falls. Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs, warfarin, and other anticoagulants may add to this risk.

Case reports and epidemiological studies case-control and cohort design have demonstrated an association between use of drugs that interfere with serotonin reuptake and the occurrence of gastrointestinal bleeding. Patients should be cautioned about the risk of bleeding associated with the concomitant use of paroxetine and NSAIDs, aspirin, or other drugs that affect coagulation.

Epidemiological studies on bone fracture risk following 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. The possibility of a pathological fracture, that is, a fracture produced by minimal trauma in a patient with decreased bone mineral density, should be considered in patients treated with paroxetine who present with unexplained bone pain, point tenderness, swelling, or bruising.

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. Evaluation of electrocardiograms of 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. 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.

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 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. 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. 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. 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.

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

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. As with other serotonin reuptake inhibitors, an 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.

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, amphetamines, or St. Preliminary data suggest that there may be a pharmacodynamic interaction that causes an increased bleeding diathesis in the face of unaltered prothrombin time between paroxetine and warfarin.

There have been rare postmarketing reports of serotonin syndrome with the use of an SSRI and a triptan. If concomitant use of paroxetine with a triptan is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases see WARNINGS — Serotonin Syndrome.

The metabolism and pharmacokinetics of paroxetine may be affected by the induction or inhibition of drug-metabolizing enzymes. Cimetidine inhibits many cytochrome P oxidative enzymes.

Therefore, when these drugs are administered concurrently, dosage adjustment of paroxetine tablets after the mg starting dose should be guided by clinical effect. Phenobarbital induces many cytochrome P oxidative enzymes. The effect of paroxetine on phenobarbital pharmacokinetics was not studied. Since paroxetine tablets exhibits nonlinear pharmacokinetics, the results of this study may not address the case where the 2 drugs are both being chronically dosed.

No initial dosage adjustment of paroxetine tablets is considered necessary when coadministered with phenobarbital; any subsequent adjustment should be guided by clinical effect. Since both drugs exhibit nonlinear pharmacokinetics, the above studies may not address the case where the 2 drugs are both being chronically dosed. Many drugs, including most drugs effective in the treatment of major depressive disorder paroxetine, other SSRIs and many tricyclics , are metabolized by the cytochrome P isozyme CYP2D6.

Like other agents that are metabolized by CYP2D6, paroxetine may significantly inhibit the activity of this isozyme. Concomitant use of paroxetine with risperidone, a CYP2D6 substrate has also been evaluated. The effect of paroxetine on the pharmacokinetics of atomoxetine has been evaluated when both drugs were at steady state.

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