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PAXILCR
Overview
What is PAXILCR?
PAXIL CR (paroxetine hydrochloride) is an orally administered psychotropic drug with a chemical structure unrelated to other selective serotonin reuptake inhibitors or to tricyclic, tetracyclic, or other available antidepressant or antipanic agents. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)--4(4'-fluorophenyl)-3-[(3',4'-methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and has the empirical formula of CHFNO•HCl•1/2HO. The molecular weight is 374.8 (329.4 as free base). The structural formula of paroxetine hydrochloride is:
Paroxetine hydrochloride is an odorless, off-white powder, having a melting point range of 120° to 138°C and a solubility of 5.4 mg/mL in water.
Each enteric, film-coated, controlled-release tablet contains paroxetine hydrochloride equivalent to paroxetine as follows: 12.5 mg–yellow, 25 mg–pink, 37.5 mg–blue. One layer of the tablet consists of a degradable barrier layer and the other contains the active material in a hydrophilic matrix.
Inactive ingredients consist of hypromellose, polyvinylpyrrolidone, lactose monohydrate, magnesium stearate, silicon dioxide, glyceryl behenate, methacrylic acid copolymer type C, sodium lauryl sulfate, polysorbate 80, talc, triethyl citrate, titanium dioxide, polyethylene glycols, and 1 or more of the following colorants: Yellow ferric oxide, red ferric oxide, D&C Red No. 30 aluminum lake, FD&C Yellow No. 6 aluminum lake, D&C Yellow No. 10 aluminum lake, FD&C Blue No. 2 aluminum lake.
What does PAXILCR look like?
What are the available doses of PAXILCR?
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What should I talk to my health care provider before I take PAXILCR?
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How should I use PAXILCR?
PAXIL CR is indicated for the treatment of major depressive disorder.
The efficacy of PAXIL CR in the treatment of a major depressive episode was established in two 12-week controlled trials of outpatients whose diagnoses corresponded to the DSM-IV category of major depressive disorder (see CLINICAL PHARMACOLOGY: Clinical Trials).
A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed mood or loss of interest or pleasure in nearly all activities, representing a change from previous functioning, and includes the presence of at least 5 of the following 9 symptoms during the same 2-week period: Depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt, or suicidal ideation.
The antidepressant action of paroxetine in hospitalized depressed patients has not been adequately studied.
PAXIL CR has not been systematically evaluated beyond 12 weeks in controlled clinical trials; however, the effectiveness of immediate-release paroxetine hydrochloride in maintaining a response in major depressive disorder for up to 1 year has been demonstrated in a placebo-controlled trial (see CLINICAL PHARMACOLOGY: Clinical Trials). The physician who elects to use PAXIL CR for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).
What interacts with PAXILCR?
The use of MAOIs intended to treat depression with, or within 14 days of treatment with, PAXIL CR is contraindicated (see WARNINGS).
Do not start PAXIL CR in a patient who is being treated with a reversible MAOI such as linezolid or methylene blue because of an increased risk of serotonin syndrome or neuroleptic malignant syndrome (NMS)-like reactions (see WARNINGS).
Concomitant use with thioridazine is contraindicated (see WARNINGS and PRECAUTIONS).
Concomitant use in patients taking pimozide is contraindicated (see PRECAUTIONS).
PAXIL CR is contraindicated in patients with a hypersensitivity to paroxetine or to any of the inactive ingredients in PAXIL CR.
What are the warnings of PAXILCR?
Clinical Worsening and Suicide Risk
Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. 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 18-24) 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 4,400 patients. The pooled analyses of placebo-controlled trials in adults with MDD or other psychiatric disorders included a total of 295 short-term trials (median duration of 2 months) of 11 antidepressant drugs in over 77,000 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 1,000 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.e., beyond several months. 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. Although a causal link between the emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal impulses has not been established, there is concern that such symptoms may represent precursors to emerging suicidality.
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.
If the decision has been made to discontinue treatment, medication should be tapered, as rapidly as is feasible, but with recognition that abrupt discontinuation can be associated with certain symptoms (see PRECAUTIONS and DOSAGE AND ADMINISTRATION: , for a description of the risks of discontinuation of PAXIL CR).
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 healthcare providers. Such monitoring should include daily observation by families and caregivers.
| Age Range | Drug-Placebo Difference in Number of Cases of Suicidality per 1,000 Patients Treated |
| <18 | 14 additional cases |
| 18-24 | 5 additional cases |
| 25-64 | 1 fewer case |
| ≥65 | 6 fewer cases |
Screening Patients for Bipolar Disorder
A major depressive episode may be the initial presentation of bipolar disorder. It is generally believed (though not established in controlled trials) that treating such an episode with an antidepressant alone may increase the likelihood of precipitation of a mixed/manic episode in patients at risk for 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 PAXIL CR is not approved for use in treating bipolar depression.
Potential for Interaction With Monoamine Oxidase Inhibitors
In patients receiving another serotonin reuptake inhibitor drug in combination with monoamine oxidase inhibitors (MAOIs), including reversible MAOIs such as linezolid and methylene blue, there have been reports of serious, sometimes fatal, reactions including hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, and mental status changes that include extreme agitation progressing to delirium and coma. These reactions have also been reported in patients who have recently discontinued that drug and have been started on an MAOI. Some cases presented with features resembling serotonin syndrome or NMS-like reactions (see CONTRAINDICATIONS and DOSAGE AND ADMINISTRATION).
Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-like Reactions
Potential Interaction With Thioridazine
Usage in Pregnancy
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Reproduction studies were performed at doses up to 50 mg/kg/day in rats and 6 mg/kg/day in rabbits administered during organogenesis. These doses are approximately 8 (rat) and 2 (rabbit) times the maximum recommended human dose (MRHD) on an mg/m basis. 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. This effect occurred at a dose of 1 mg/kg/day or approximately one-sixth of the MRHD on an mg/m basis. The no-effect dose for rat pup mortality was not determined. The cause of these deaths is not known.
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What are the precautions of PAXILCR?
General
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During premarketing testing of immediate-release paroxetine hydrochloride, hypomania or mania occurred in approximately 1.0% of paroxetine-treated unipolar patients compared to 1.1% of active-control and 0.3% of placebo-treated unipolar patients. In a subset of patients classified as bipolar, the rate of manic episodes was 2.2% for immediate-release paroxetine and 11.6% for the combined active-control groups. Among 1,627 patients with major depressive disorder, panic disorder, social anxiety disorder, or PMDD treated with PAXIL CR in controlled clinical studies, there were no reports of mania or hypomania. As with all drugs effective in the treatment of major depressive disorder, PAXIL CR should be used cautiously in patients with a history of mania.
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During premarketing testing of immediate-release paroxetine hydrochloride, seizures occurred in 0.1% of paroxetine-treated patients, a rate similar to that associated with other drugs effective in the treatment of major depressive disorder. Among 1,627 patients who received PAXIL CR in controlled clinical trials in major depressive disorder, panic disorder, social anxiety disorder, or PMDD, 1 patient (0.1%) experienced a seizure. PAXIL CR should be used cautiously in patients with a history of seizures. It should be discontinued in any patient who develops seizures.
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Some studies have shown that the efficacy of tamoxifen, as measured by the risk of breast cancer relapse/mortality, may be reduced when co-prescribed with paroxetine as a result of paroxetine’s irreversible inhibition of CYP2D6 (see Drug Interactions). 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.
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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.
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SSRIs and SNRIs, including paroxetine, may increase the risk of bleeding events. 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. Bleeding events related to SSRIs and SNRIs use have ranged from ecchymoses, hematomas, epistaxis, and petechiae to life-threatening hemorrhages. 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.
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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.
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Information for Patients
PAXIL CR should not be chewed or crushed, and should be swallowed whole.
Patients should be cautioned about the risk of serotonin syndrome with the concomitant use of PAXIL CR and triptans, tramadol, or other serotonergic agents.
Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with PAXIL CR and should counsel them in its appropriate use. A patient Medication Guide is available for PAXIL CR. 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 PAXIL CR.
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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. Such symptoms should be reported to the patient’s prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient’s presenting symptoms. 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.
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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.
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Any psychoactive drug may impair judgment, thinking, or motor skills. Although in controlled studies immediate-release paroxetine hydrochloride has 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 PAXIL CR does not affect their ability to engage in such activities.
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While patients may notice improvement with use of PAXIL CR in 1 to 4 weeks, they should be advised to continue therapy as directed.
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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.
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Although immediate-release paroxetine hydrochloride has not been shown to increase the impairment of mental and motor skills caused by alcohol, patients should be advised to avoid alcohol while taking PAXIL CR.
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Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during therapy (see WARNINGS: Usage in Pregnancy: and).
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Patients should be advised to notify their physician if they are breastfeeding an infant (see PRECAUTIONS: Nursing Mothers).
Laboratory Tests
There are no specific laboratory tests recommended.
Drug Interactions
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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 immediate-release paroxetine. Consequently, concomitant use of PAXIL CR with tryptophan is not recommended (see WARNINGS: Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-like Reactions).
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See CONTRAINDICATIONS and WARNINGS.
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In a controlled study of healthy volunteers, after immediate-release paroxetine hydrochloride was titrated to 60 mg daily, co-administration of a single dose of 2 mg pimozide was associated with mean increases in pimozide AUC of 151% and C of 62%, compared to pimozide administered alone. The increase in pimozide AUC and C is due to the CYP2D6 inhibitory properties of paroxetine. Due to the narrow therapeutic index of pimozide and its known ability to prolong the QT interval, concomitant use of pimozide and PAXIL CR is contraindicated (see CONTRAINDICATIONS).
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Based on the mechanism of action of SNRIs and SSRIs, including paroxetine hydrochloride, and the potential for serotonin syndrome, caution is advised when PAXIL CR is coadministered with other drugs that may affect the serotonergic neurotransmitter systems, such as triptans, lithium, fentanyl, tramadol, or St. John's Wort (see WARNINGS: Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-like Reactions). The concomitant use of PAXIL CR with MAOIs (including linezolid and methylene blue) is contraindicated (see CONTRAINDICATIONS). The concomitant use of PAXIL CR with other SSRIs, SNRIs or tryptophan is not recommended (see PRECAUTIONS: Drug Interactions, ).
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See CONTRAINDICATIONS and WARNINGS.
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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. Since there is little clinical experience, the concomitant administration of PAXIL CR and warfarin should be undertaken with caution (see PRECAUTIONS: Drugs That Interfere With Hemostasis).
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There have been rare postmarketing reports of serotonin syndrome with the use of an SSRI and a triptan. If concomitant use of PAXIL CR with a triptan is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases (see WARNINGS: Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-like Reactions)
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The metabolism and pharmacokinetics of paroxetine may be affected by the induction or inhibition of drug-metabolizing enzymes.
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Cimetidine inhibits many cytochrome P (oxidative) enzymes. In a study where immediate-release paroxetine (30 mg once daily) was dosed orally for 4 weeks, steady-state plasma concentrations of paroxetine were increased by approximately 50% during coadministration with oral cimetidine (300 mg three times daily) for the final week. Therefore, when these drugs are administered concurrently, dosage adjustment of PAXIL CR after the starting dose should be guided by clinical effect. The effect of paroxetine on cimetidine’s pharmacokinetics was not studied.
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Phenobarbital induces many cytochrome P (oxidative) enzymes. When a single oral 30-mg dose of immediate-release paroxetine was administered at phenobarbital steady state (100 mg once daily for 14 days), paroxetine AUC and T were reduced (by an average of 25% and 38%, respectively) compared to paroxetine administered alone. The effect of paroxetine on phenobarbital pharmacokinetics was not studied. Since paroxetine 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 with PAXIL CR is considered necessary when coadministered with phenobarbital; any subsequent adjustment should be guided by clinical effect.
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When a single oral 30-mg dose of immediate-release paroxetine was administered at phenytoin steady state (300 mg once daily for 14 days), paroxetine AUC and T were reduced (by an average of 50% and 35%, respectively) compared to immediate-release paroxetine administered alone. In a separate study, when a single oral 300-mg dose of phenytoin was administered at paroxetine steady state (30 mg once daily for 14 days), phenytoin AUC was slightly reduced (12% on average) compared to phenytoin administered alone. Since both drugs exhibit nonlinear pharmacokinetics, the above studies may not address the case where the 2 drugs are both being chronically dosed. No initial dosage adjustments are considered necessary when PAXIL CR is coadministered with phenytoin; any subsequent adjustments should be guided by clinical effect (see ADVERSE REACTIONS: Postmarketing Reports).
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An in vivo interaction study involving the coadministration under steady-state conditions of paroxetine and terfenadine, a substrate for CYP3A4, revealed no effect of paroxetine on terfenadine pharmacokinetics. In addition, in vitro studies have shown ketoconazole, a potent inhibitor of CYP3A4 activity, to be at least 100 times more potent than paroxetine as an inhibitor of the metabolism of several substrates for this enzyme, including terfenadine, astemizole, cisapride, triazolam, and cyclosporine. Based on the assumption that the relationship between paroxetine’s in vitro K and its lack of effect on terfenadine's in vivo clearance predicts its effect on other CYP3A4 substrates, paroxetine’s extent of inhibition of CYP3A4 activity is not likely to be of clinical significance.
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Caution is indicated in the coadministration of TCAs with PAXIL CR, because paroxetine may inhibit TCA metabolism. Plasma TCA concentrations may need to be monitored, and the dose of TCA may need to be reduced, if a TCA is coadministered with PAXIL CR (see PRECAUTIONS: Drugs Metabolized by Cytochrome CYP2D6).
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Because paroxetine is highly bound to plasma protein, administration of PAXIL CR to a patient taking another drug that is highly protein bound may cause increased free concentrations of the other drug, potentially resulting in adverse events. Conversely, adverse effects could result from displacement of paroxetine by other highly bound drugs.
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Serotonin release by platelets plays an important role in hemostasis. Epidemiological studies of the case-control and cohort design that have demonstrated an association between use of psychotropic drugs that interfere with serotonin reuptake and the occurrence of upper gastrointestinal bleeding have also shown that concurrent use of an NSAID or aspirin may potentiate this risk of bleeding. Altered anticoagulant effects, including increased bleeding, have been reported when SSRIs or SNRIs are coadministered with warfarin. Patients receiving warfarin therapy should be carefully monitored when paroxetine is initiated or discontinued.
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Although paroxetine does not increase the impairment of mental and motor skills caused by alcohol, patients should be advised to avoid alcohol while taking PAXIL CR.
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A multiple-dose study with immediate-release paroxetine hydrochloride has shown that there is no pharmacokinetic interaction between paroxetine and lithium carbonate. However, due to the potential for serotonin syndrome, caution is advised when immediate-release paroxetine hydrochloride is coadministered with lithium.
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The steady-state pharmacokinetics of paroxetine was not altered when administered with digoxin at steady state. Mean digoxin AUC at steady state decreased by 15% in the presence of paroxetine. Since there is little clinical experience, the concurrent administration of PAXIL CR and digoxin should be undertaken with caution.
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Under steady-state conditions, diazepam does not appear to affect paroxetine kinetics. The effects of paroxetine on diazepam were not evaluated.
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Daily oral dosing of immediate-release paroxetine (30 mg once daily) increased steady-state AUC, C, and C values of procyclidine (5 mg oral once daily) by 35%, 37%, and 67%, respectively, compared to procyclidine alone at steady state. If anticholinergic effects are seen, the dose of procyclidine should be reduced.
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In a study where propranolol (80 mg twice daily) was dosed orally for 18 days, the established steady-state plasma concentrations of propranolol were unaltered during coadministration with immediate-release paroxetine (30 mg once daily) for the final 10 days. The effects of propranolol on paroxetine have not been evaluated (see ADVERSE REACTIONS: Postmarketing Reports).
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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.
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Co-administration of fosamprenavir/ritonavir with paroxetine significantly decreased plasma levels of paroxetine. Any dose adjustment should be guided by clinical effect (tolerability and efficacy).
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There are no clinical studies of the combined use of ECT and PAXIL CR.
Carcinogenesis, Mutagenesis, Impairment of Fertility
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Two-year carcinogenicity studies were conducted in rodents given paroxetine in the diet at 1, 5, and 25 mg/kg/day (mice) and 1, 5, and 20 mg/kg/day (rats). These doses are up to approximately 2 (mouse) and 3 (rat) times the MRHD on a mg/m basis. There was a significantly greater number of male rats in the high-dose group with reticulum cell sarcomas (1/100, 0/50, 0/50, and 4/50 for control, low-, middle-, and high-dose groups, respectively) and a significantly increased linear trend across dose groups for the occurrence of lymphoreticular tumors in male rats. Female rats were not affected. Although there was a dose-related increase in the number of tumors in mice, there was no drug-related increase in the number of mice with tumors. The relevance of these findings to humans is unknown.
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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.
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Pregnancy
Pregnancy Category D. See WARNINGS: Usage in Pregnancy: and.
Labor and Delivery
The effect of paroxetine on labor and delivery in humans is unknown.
Nursing Mothers
Like many other drugs, paroxetine is secreted in human milk, and caution should be exercised when PAXIL CR is administered to a nursing woman.
Pediatric Use
Safety and effectiveness in the pediatric population have not been established (see BOX WARNING and WARNINGS: Clinical Worsening and Suicide Risk). Three placebo-controlled trials in 752 pediatric patients with MDD have been conducted with immediate-release PAXIL, and the data were not sufficient to support a claim for use in pediatric patients. Anyone considering the use of PAXIL CR in a child or adolescent must balance the potential risks with the clinical need. Decreased appetite and weight loss have been observed in association with the use of SSRIs. Consequently, regular monitoring of weight and growth should be performed in children and adolescents treated with an SSRI such as PAXIL CR.
In placebo-controlled clinical trials conducted with pediatric patients, the following adverse events were reported in at least 2% of pediatric patients treated with immediate-release paroxetine hydrochloride and occurred at a rate at least twice that for pediatric patients receiving placebo: emotional lability (including self-harm, suicidal thoughts, attempted suicide, crying, and mood fluctuations), hostility, decreased appetite, tremor, sweating, hyperkinesia, and agitation.
Events reported upon discontinuation of treatment with immediate-release paroxetine hydrochloride in the pediatric clinical trials that included a taper phase regimen, which occurred in at least 2% of patients who received immediate-release paroxetine hydrochloride and which occurred at a rate at least twice that of placebo, were: emotional lability (including suicidal ideation, suicide attempt, mood changes, and tearfulness), nervousness, dizziness, nausea, and abdominal pain (see DOSAGE AND ADMINISTRATION: ).
Geriatric Use
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 event (see PRECAUTIONS: Hyponatremia).
In worldwide premarketing clinical trials with immediate-release paroxetine hydrochloride, 17% of paroxetine-treated patients (approximately 700) were 65 years or older. Pharmacokinetic studies revealed a decreased clearance in the elderly, and a lower starting dose is recommended; there were, however, no overall differences in the adverse event profile between elderly and younger patients, and effectiveness was similar in younger and older patients (see CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION).
In a controlled study focusing specifically on elderly patients with major depressive disorder, PAXIL CR was demonstrated to be safe and effective in the treatment of elderly patients (>60 years) with major depressive disorder (see CLINICAL PHARMACOLOGY: Clinical Trials and ADVERSE REACTIONS: Table 3.)
What are the side effects of PAXILCR?
The information included under the “Adverse Findings Observed in Short-Term, Placebo-Controlled Trials With PAXIL CR” subsection of ADVERSE REACTIONS is based on data from 11 placebo-controlled clinical trials. Three of these studies were conducted in patients with major depressive disorder, 3 studies were done in patients with panic disorder, 1 study was conducted in patients with social anxiety disorder, and 4 studies were done in female patients with PMDD. Two of the studies in major depressive disorder, which enrolled patients in the age range 18 to 65 years, are pooled. Information from a third study of major depressive disorder, which focused on elderly patients (60 to 88 years), is presented separately as is the information from the panic disorder studies and the information from the PMDD studies. Information on additional adverse events associated with PAXIL CR and the immediate-release formulation of paroxetine hydrochloride is included in a separate subsection (see Other Events Observed During the Clinical Development of Paroxetine).
Adverse Findings Observed in Short-Term, Placebo-Controlled Trials With PAXIL CR:
Adverse Events Associated With Discontinuation of Treatment
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| PAXIL CR | (n = 212) | Placebo | (n = 211) | |
| Nausea | 3.7% | 0.5% | ||
| Asthenia | 1.9% | 0.5% | ||
| Dizziness | 1.4% | 0.0% | ||
| Somnolence | 1.4% | 0.0% | ||
| PAXIL CR | (n = 104) | Placebo | (n = 109) | |
| Nausea | 2.9% | 0.0% | ||
| Headache | 1.9% | 0.9% | ||
| Depression | 1.9% | 0.0% | ||
| LFT’s abnormal | 1.9% | 0.0% |
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Eleven percent (50/444) of patients treated with PAXIL CR in panic disorder studies discontinued treatment due to an adverse event. Events meeting the above criteria included the following:
| (n = 444) | (n = 445) | |
| Nausea | 2.9% | 0.4% |
| Insomnia | 1.8% | 0.0% |
| Headache | 1.4% | 0.2% |
| Asthenia | 1.1% | 0.0% |
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Three percent (5/186) of patients treated with PAXIL CR in the social anxiety disorder study discontinued treatment due to an adverse event. Events meeting the above criteria included the following:
| (n = 186) | (n = 184) | |
| Nausea | 2.2% | 0.5% |
| Headache | 1.6% | 0.5% |
| Diarrhea | 1.1% | 0.5% |
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| (n = 348) | (n = 333) | (n = 349) | |
| TOTAL | 15% | 9.9% | 6.3% |
| Nausea | 6.0% | 2.4% | 0.9% |
| Asthenia | 4.9% | 3.0% | 1.4% |
| Somnolence | 4.3% | 1.8% | 0.3% |
| Insomnia | 2.3% | 1.5% | 0.0% |
| Concentration Impaired | 2.0% | 0.6% | 0.3% |
| Dry mouth | 2.0% | 0.6% | 0.3% |
| Dizziness | 1.7% | 0.6% | 0.6% |
| Decreased Appetite | 1.4% | 0.6% | 0.0% |
| Sweating | 1.4% | 0.0% | 0.3% |
| Tremor | 1.4% | 0.3% | 0.0% |
| Yawn | 1.1% | 0.0% | 0.0% |
| Diarrhea | 0.9% | 1.2% | 0.0% |
Commonly Observed Adverse Events
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In the pool of panic disorder studies, the adverse events meeting these criteria were: Abnormal ejaculation, somnolence, impotence, libido decreased, tremor, sweating, and female genital disorders (generally anorgasmia or difficulty achieving orgasm).
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In the social anxiety disorder study, the adverse events meeting these criteria were: Nausea, asthenia, abnormal ejaculation, sweating, somnolence, impotence, insomnia, and libido decreased.
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Incidence in Controlled Clinical Trials
Table 2 enumerates adverse events that occurred at an incidence of 1% or more among patients treated with PAXIL CR, aged 18 to 65, who participated in 2 short-term (12-week) placebo-controlled trials in major depressive disorder in which patients were dosed in a range of 25 mg to 62.5 mg/day. Table 3 enumerates adverse events reported at an incidence of 5% or greater among elderly patients (ages 60 to 88) treated with PAXIL CR who participated in a short-term (12-week) placebo-controlled trial in major depressive disorder in which patients were dosed in a range of 12.5 mg to 50 mg/day. Table 4 enumerates adverse events reported at an incidence of 1% or greater among patients (19 to 72 years) treated with PAXIL CR who participated in short-term (10-week) placebo-controlled trials in panic disorder in which patients were dosed in a range of 12.5 mg to 75 mg/day. Table 5 enumerates adverse events reported at an incidence of 1% or greater among adult patients treated with PAXIL CR who participated in a short-term (12-week), double-blind, placebo-controlled trial in social anxiety disorder in which patients were dosed in a range of 12.5 to 37.5 mg/day. Table 6 enumerates adverse events that occurred at an incidence of 1% or more among patients treated with PAXIL CR who participated in three, 12-week, placebo-controlled trials in PMDD in which patients were dosed at 12.5 mg/day or 25 mg/day and in one 12-week placebo-controlled trial in which patients were dosed for 2 weeks prior to the onset of menses (luteal phase dosing) at 12.5 mg/day or 25 mg/day. Reported adverse events were classified using a standard COSTART-based Dictionary terminology.
The prescriber should be aware that these figures cannot be used to predict the incidence of side effects in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and nondrug factors to the side effect incidence rate in the population studied.
a. Adverse events for which the PAXIL CR reporting incidence was less than or equal to the placebo incidence are not included. These events are: Abnormal dreams, anxiety, arthralgia, depersonalization, dysmenorrhea, dyspepsia, hyperkinesia, increased appetite, myalgia, nervousness, pharyngitis, purpura, rash, respiratory disorder, sinusitis, urinary frequency, and weight gain.
b. <1% means greater than zero and less than 1%.
c. Mostly flu.
d. A wide variety of injuries with no obvious pattern.
e. Pain in a variety of locations with no obvious pattern.
f. Most frequently seasonal allergic symptoms.
g. Usually flushing.
h. Mostly blurred vision.
i. Based on the number of males or females.
j. Mostly anorgasmia or delayed ejaculation.
k. Mostly anorgasmia or delayed orgasm.
a. Adverse events for which the PAXIL CR reporting incidence was less than or equal to the placebo incidence are not included. These events are nausea and respiratory disorder.
b. <1% means greater than zero and less than 1%.
c. Based on the number of males.
d. Mostly anorgasmia or delayed ejaculation.
a. Adverse events for which the reporting rate for PAXIL CR was less than or equal to the placebo rate are not included. These events are: Abnormal dreams, allergic reaction, back pain, bronchitis, chest pain, concentration impaired, confusion, cough increased, depression, dizziness, dysmenorrhea, dyspepsia, fever, flatulence, headache, increased appetite, infection, menstrual disorder, migraine, pain, paresthesia, pharyngitis, respiratory disorder, rhinitis, tachycardia, taste perversion, thinking abnormal, urinary tract infection, and vomiting.
b. < 1% means greater than zero and less than 1%.
c. Various physical injuries.
d. Mostly flushing.
e. Mostly muscle tightness or stiffness.
f. Mostly blurred vision.
g. Based on the number of male patients.
h. Mostly anorgasmia or delayed ejaculation.
i. Based on the number of female patients.
j. Mostly anorgasmia or difficulty achieving orgasm.
a. Adverse events for which the reporting rate for PAXIL CR was less than or equal to the placebo rate are not included. These events are: Dysmenorrhea, flatulence, gastroenteritis, hypertonia, infection, pain, pharyngitis, rash, respiratory disorder, rhinitis, and vomiting.
b. <1% means greater than zero and less than 1%.
c. Various physical injuries.
d. Most frequently seasonal allergic symptoms.
e. Mostly blurred vision.
f. Based on the number of male patients.
g. Mostly anorgasmia or delayed ejaculation.
h. Based on the number of female patients.
i. Mostly anorgasmia or difficulty achieving orgasm.
a. Adverse events for which the reporting rate of PAXIL CR was less than or equal to the placebo rate are not included. These events for continuous dosing are: Abdominal pain, back pain, pain, trauma, weight gain, myalgia, pharyngitis, respiratory disorder, rhinitis, sinusitis, pruritis, dysmenorrhea, menstrual disorder, urinary tract infection, and vomiting. The events for luteal phase dosing are: Allergic reaction, back pain, headache, infection, pain, trauma, myalgia, anxiety, pharyngitis, respiratory disorder, cystitis, and dysmenorrhea.
b. <1% means greater than zero and less than 1%.
c. The luteal phase and continuous dosing PMDD trials were not designed for making direct comparisons between the 2 dosing regimens. Therefore, a comparison between the 2 dosing regimens of the PMDD trials of incidence rates shown in Table 6 should be avoided.
d. Mostly anorgasmia or difficulty achieving orgasm.
| Body System/Adverse Event | % Reporting Event | ||||||
| PAXIL CR | Placebo | ||||||
| Body as a Whole | |||||||
| Headache | 27% | 20% | |||||
| Asthenia | 14% | 9% | |||||
| Infection | 8% | 5% | |||||
| Abdominal Pain | 7% | 4% | |||||
| Back Pain | 5% | 3% | |||||
| Trauma | 5% | 1% | |||||
| Pain | 3% | 1% | |||||
| Allergic Reaction | 2% | 1% | |||||
| Cardiovascular System | |||||||
| Tachycardia | 1% | 0% | |||||
| Vasodilatation | 2% | 0% | |||||
| Digestive System | |||||||
| Nausea | 22% | 10% | |||||
| Diarrhea | 18% | 7% | |||||
| Dry Mouth | 15% | 8% | |||||
| Constipation | 10% | 4% | |||||
| Flatulence | 6% | 4% | |||||
| Decreased Appetite | 4% | 2% | |||||
| Vomiting | 2% | 1% | |||||
| Nervous System | |||||||
| Somnolence | 22% | 8% | |||||
| Insomnia | 17% | 9% | |||||
| Dizziness | 14% | 4% | |||||
| Libido Decreased | 7% | 3% | |||||
| Tremor | 7% | 1% | |||||
| Hypertonia | 3% | 1% | |||||
| Paresthesia | 3% | 1% | |||||
| Agitation | 2% | 1% | |||||
| Confusion | 1% | 0% | |||||
| Respiratory System | |||||||
| Yawn | 5% | 0% | |||||
| Rhinitis | 4% | 1% | |||||
| Cough Increased | 2% | 1% | |||||
| Bronchitis | 1% | 0% | |||||
| Skin and Appendages | |||||||
| Sweating | 6% | 2% | |||||
| Photosensitivity | 2% | 0% | |||||
| Special Senses | |||||||
| Abnormal Vision | 5% | 1% | |||||
| Taste Perversion | 2% | 0% | |||||
| Urogenital System | |||||||
| Abnormal Ejaculation | 26% | 1% | |||||
| Female Genital Disorder | 10% | <1% | |||||
| Impotence | 5% | 3% | |||||
| Urinary Tract Infection | 3% | 1% | |||||
| Menstrual Disorder | 2% | <1% | |||||
| Vaginitis | 2% | 0% | |||||
| Body System/Adverse Event | % Reporting Event | ||||||
| PAXIL CR | (n = 104) | Placebo | (n = 109) | ||||
| Body as a Whole | |||||||
| Headache | 17% | 13% | |||||
| Asthenia | 15% | 14% | |||||
| Trauma | 8% | 5% | |||||
| Infection | 6% | 2% | |||||
| Digestive System | |||||||
| Dry Mouth | 18% | 7% | |||||
| Diarrhea | 15% | 9% | |||||
| Constipation | 13% | 5% | |||||
| Dyspepsia | 13% | 10% | |||||
| Decreased Appetite | 12% | 5% | |||||
| Flatulence | 8% | 7% | |||||
| Nervous System | |||||||
| Somnolence | 21% | 12% | |||||
| Insomnia | 10% | 8% | |||||
| Dizziness | 9% | 5% | |||||
| Libido Decreased | 8% | <1% | |||||
| Tremor | 7% | 0% | |||||
| Skin and Appendages | |||||||
| Sweating | 10% | <1% | |||||
| Urogenital System | |||||||
| Abnormal Ejaculation | 17% | 3% | |||||
| Impotence | 9% | 3% | |||||
| Body System/Adverse Event | % Reporting Event | ||||||
| PAXIL CR | (n = 444) | Placebo | (n = 445) | ||||
| Body as a Whole | |||||||
| Asthenia | 15% | 10% | |||||
| Abdominal Pain | 6% | 4% | |||||
| Trauma | 5% | 4% | |||||
| Cardiovascular System | |||||||
| Vasodilation | 3% | 2% | |||||
| Digestive System | |||||||
| Nausea | 23% | 17% | |||||
| Dry Mouth | 13% | 9% | |||||
| Diarrhea | 12% | 9% | |||||
| Constipation | 9% | 6% | |||||
| Decreased Appetite | 8% | 6% | |||||
| Metabolic/Nutritional Disorders | |||||||
| Weight Loss | 1% | 0% | |||||
| Musculoskeletal System | |||||||
| Myalgia | 5% | 3% | |||||
| Nervous System | |||||||
| Insomnia | 20% | 11% | |||||
| Somnolence | 20% | 9% | |||||
| Libido Decreased | 9% | 4% | |||||
| Nervousness | 8% | 7% | |||||
| Tremor | 8% | 2% | |||||
| Anxiety | 5% | 4% | |||||
| Agitation | 3% | 2% | |||||
| Hypertonia | 2% | <1% | |||||
| Myoclonus | 2% | <1% | |||||
| Respiratory System | |||||||
| Sinusitis | 8% | 5% | |||||
| Yawn | 3% | 0% | |||||
| Skin and Appendages | |||||||
| Sweating | 7% | 2% | |||||
| Special Senses | |||||||
| Abnormal Vision | 3% | <1% | |||||
| Urogenital System | |||||||
| Abnormal Ejaculation | 27% | 3% | |||||
| Impotence | 10% | 1% | |||||
| Female Genital Disorders | 7% | 1% | |||||
| Urinary Frequency | 2% | <1% | |||||
| Urination Impaired | 2% | <1% | |||||
| Vaginitis | 1% | <1% | |||||
| Body System/Adverse Event | % Reporting Event | ||||||
| PAXIL CR | (n = 186) | Placebo | (n = 184) | ||||
| Body as a Whole | |||||||
| Headache | 23% | 17% | |||||
| Asthenia | 18% | 7% | |||||
| Abdominal Pain | 5% | 4% | |||||
| Back Pain | 4% | 1% | |||||
| Trauma | 3% | <1% | |||||
| Allergic Reaction | 2% | <1% | |||||
| Chest Pain | 1% | <1% | |||||
| Cardiovascular System | |||||||
| Hypertension | 2% | 0% | |||||
| Migraine | 2% | 1% | |||||
| Tachycardia | 2% | 1% | |||||
| Digestive System | |||||||
| Nausea | 22% | 6% | |||||
| Diarrhea | 9% | 8% | |||||
| Constipation | 5% | 2% | |||||
| Dry Mouth | 3% | 2% | |||||
| Dyspepsia | 2% | <1% | |||||
| Decreased Appetite | 1% | <1% | |||||
| Tooth Disorder | 1% | 0% | |||||
| Metabolic/Nutritional Disorders | |||||||
| Weight Gain | 3% | 1% | |||||
| Weight Loss | 1% | 0% | |||||
| Nervous System | |||||||
| Insomnia | 9% | 4% | |||||
| Somnolence | 9% | 4% | |||||
| Libido Decreased | 8% | 1% | |||||
| Dizziness | 7% | 4% | |||||
| Tremor | 4% | 2% | |||||
| Anxiety | 2% | 1% | |||||
| Concentration Impaired | 2% | 0% | |||||
| Depression | 2% | 1% | |||||
| Myoclonus | 1% | <1% | |||||
| Paresthesia | 1% | <1% | |||||
| Respiratory System | |||||||
| Yawn | 2% | 0% | |||||
| Skin and Appendages | |||||||
| Sweating | 14% | 3% | |||||
| Eczema | 1% | 0% | |||||
| Special Senses | |||||||
| Abnormal Vision | 2% | 0% | |||||
| Abnormality of Accommodation | 2% | 0% | |||||
| Urogenital System | |||||||
| Abnormal Ejaculation | 15% | 1% | |||||
| Impotence | 9% | 0% | |||||
| Female Genital Disorders | 3% | 0% | |||||
| Body System/Adverse Event | % Reporting Event | ||||||
| Continuous Dosing | Luteal Phase Dosing | ||||||
| PAXIL CR | (n = 681) | Placebo | (n = 349) | PAXIL CR | (n = 246) | Placebo | (n = 120) |
| Body as a Whole | |||||||
| Asthenia | 17% | 6% | 15% | 4% | |||
| Headache | 15% | 12% | - | - | |||
| Infection | 6% | 4% | - | - | |||
| Abdominal pain | - | - | 3% | 0% | |||
| Cardiovascular System | |||||||
| Migraine | 1% | <1% | - | - | |||
| Digestive System | |||||||
| Nausea | 17% | 7% | 18% | 2% | |||
| Diarrhea | 6% | 2% | 6% | 0% | |||
| Constipation | 5% | 1% | 2% | <1% | |||
| Dry Mouth | 4% | 2% | 2% | <1% | |||
| Increased Appetite | 3% | <1% | - | - | |||
| Decreased Appetite | 2% | <1% | 2% | 0% | |||
| Dyspepsia | 2% | 1% | 2% | 2% | |||
| Gingivitis | - | - | 1% | 0% | |||
| Metabolic and Nutritional Disorders | |||||||
| Generalized Edema | - | - | 1% | <1% | |||
| Weight Gain | - | - | 1% | <1% | |||
| Musculoskeletal System | |||||||
| Arthralgia | 2% | 1% | - | - | |||
| Nervous System | |||||||
| Libido Decreased | 12% | 5% | 9% | 6% | |||
| Somnolence | 9% | 2% | 3% | <1% | |||
| Insomnia | 8% | 2% | 7% | 3% | |||
| Dizziness | 7% | 3% | 6% | 3% | |||
| Tremor | 4% | <1% | 5% | 0% | |||
| Concentration Impaired | 3% | <1% | 1% | 0% | |||
| Nervousness | 2% | <1% | 3% | 2% | |||
| Anxiety | 2% | 1% | - | - | |||
| Lack of Emotion | 2% | <1% | - | - | |||
| Depression | - | - | 2% | <1% | |||
| Vertigo | - | - | 2% | <1% | |||
| Abnormal Dreams | 1% | <1% | - | - | |||
| Amnesia | - | - | 1% | 0% | |||
| Respiratory System | |||||||
| Sinusitis | - | - | 4% | 2% | |||
| Yawn | 2% | <1% | - | - | |||
| Bronchitis | - | - | 2% | 0% | |||
| Cough Increased | 1% | <1% | - | - | |||
| Skin and Appendages | |||||||
| Sweating | 7% | <1% | 6% | <1% | |||
| Special Senses | |||||||
| Abnormal Vision | - | - | 1% | 0% | |||
| Urogenital System | |||||||
| Female Genital Disorders | 8% | 1% | 2% | 0% | |||
| Menorrhagia | 1% | <1% | - | - | |||
| Vaginal Moniliasis | 1% | <1% | - | - | |||
| Menstrual Disorder | - | - | 1% | 0% |
Array
Array
| (n = 348) | (n = 333) | (n = 349) | |
| Common Adverse Event | |||
| Sweating | 8.9% | 4.2% | 0.9% |
| Tremor | 6.0% | 1.5% | 0.3% |
| Concentration Impaired | 4.3% | 1.5% | 0.6% |
| Yawn | 3.2% | 0.9% | 0.3% |
| Paresthesia | 1.4% | 0.3% | 0.3% |
| Hyperkinesia | 1.1% | 0.3% | 0.0% |
| Vaginitis | 1.1% | 0.3% | 0.3% |
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| Major Depressive Disorder | Panic Disorder | Social Anxiety Disorder | Continuous Dosing | Luteal Phase Dosing | ||||||
| PAXIL CR | Placebo | PAXIL CR | Placebo | PAXIL CR | Placebo | PAXIL CR | Placebo | PAXIL CR | Placebo | |
| n (males) | 78 | 78 | 162 | 194 | 88 | 97 | n/a | n/a | n/a | n/a |
| Decreased Libido | 10% | 5% | 9% | 6% | 13% | 1% | n/a | n/a | n/a | n/a |
| Ejaculatory Disturbance | 26% | 1% | 27% | 3% | 15% | 1% | n/a | n/a | n/a | n/a |
| Impotence | 5% | 3% | 10% | 1% | 9% | 0% | n/a | n/a | n/a | n/a |
| n (females) | 134 | 133 | 282 | 251 | 98 | 87 | 681 | 349 | 246 | 120 |
| Decreased Libido | 4% | 2% | 8% | 2% | 4% | 1% | 12% | 5% | 9% | 6% |
| Orgasmic Disturbance | 10% | <1% | 7% | 1% | 3% | 0% | 8% | 1% | 2% | 0% |
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Significant weight loss may be an undesirable result of treatment with paroxetine for some patients but, on average, patients in controlled trials with PAXIL CR or the immediate-release formulation, had minimal weight loss (about 1 pound). No significant changes in vital signs (systolic and diastolic blood pressure, pulse, and temperature) were observed in patients treated with PAXIL CR, or immediate-release paroxetine hydrochloride, in controlled clinical trials.
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In an analysis of ECGs obtained in 682 patients treated with immediate-release paroxetine and 415 patients treated with placebo in controlled clinical trials, no clinically significant changes were seen in the ECGs of either group.
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In pooled clinical trials of immediate-release paroxetine hydrochloride, hallucinations were observed in 22 of 9,089 patients receiving drug and in 4 of 3,187 patients receiving placebo.
Other Events Observed During the Clinical Development of Paroxetine
The following adverse events were reported during the clinical development of PAXIL CR and/or the clinical development of the immediate-release formulation of paroxetine.
Adverse events for which frequencies are provided below occurred in clinical trials with the controlled-release formulation of paroxetine. During its premarketing assessment in major depressive disorder, panic disorder, social anxiety disorder, and PMDD, multiple doses of PAXIL CR were administered to 1,627 patients in phase 3 double-blind, controlled, outpatient studies. Untoward events associated with this exposure were recorded by clinical investigators using terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse events without first grouping similar types of untoward events into a smaller number of standardized event categories.
In the tabulations that follow, reported adverse events were classified using a COSTART-based dictionary. The frequencies presented, therefore, represent the proportion of the 1,627 patients exposed to PAXIL CR who experienced an event of the type cited on at least 1 occasion while receiving PAXIL CR. All reported events are included except those already listed in Tables 2 through 7 and those events where a drug cause was remote. If the COSTART term for an event was so general as to be uninformative, it was deleted or, when possible, replaced with a more informative term. It is important to emphasize that although the events reported occurred during treatment with paroxetine, they were not necessarily caused by it.
Events are further categorized by body system and listed in order of decreasing frequency according to the following definitions: Frequent adverse events are those occurring on 1 or more occasions in at least 1/100 patients (only those not already listed in the tabulated results from placebo-controlled trials appear in this listing); infrequent adverse events are those occurring in 1/100 to 1/1,000 patients; rare events are those occurring in fewer than 1/1,000 patients.
Adverse events for which frequencies are not provided occurred during the premarketing assessment of immediate-release paroxetine in phase 2 and 3 studies of major depressive disorder, obsessive compulsive disorder, panic disorder, social anxiety disorder, generalized anxiety disorder, and posttraumatic stress disorder. The conditions and duration of exposure to immediate-release paroxetine varied greatly and included (in overlapping categories) open and double-blind studies, uncontrolled and controlled studies, inpatient and outpatient studies, and fixed-dose and titration studies. Only those events not previously listed for controlled-release paroxetine are included. The extent to which these events may be associated with PAXIL CR is unknown.
Events are listed alphabetically within the respective body system. Events of major clinical importance are also described in the PRECAUTIONS section.
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Infrequent were chills, face edema, fever, flu syndrome, malaise; rare were abscess, anaphylactoid reaction, anticholinergic syndrome, hypothermia; also observed were adrenergic syndrome, neck rigidity, sepsis.
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Infrequent were angina pectoris, bradycardia, hematoma, hypertension, hypotension, palpitation, postural hypotension, supraventricular tachycardia, syncope; rare were bundle branch block; also observed were arrhythmia nodal, atrial fibrillation, cerebrovascular accident, congestive heart failure, low cardiac output, myocardial infarct, myocardial ischemia, pallor, phlebitis, pulmonary embolus, supraventricular extrasystoles, thrombophlebitis, thrombosis, vascular headache, ventricular extrasystoles.
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Infrequent were bruxism, dysphagia, eructation, gastritis, gastroenteritis, gastroesophageal reflux, gingivitis, hemorrhoids, liver function test abnormal, melena, pancreatitis, rectal hemorrhage, toothache, ulcerative stomatitis; rare were colitis, glossitis, gum hyperplasia, hepatosplenomegaly, increased salivation, intestinal obstruction, peptic ulcer, stomach ulcer, throat tightness; also observed were aphthous stomatitis, bloody diarrhea, bulimia, cardiospasm, cholelithiasis, duodenitis, enteritis, esophagitis, fecal impactions, fecal incontinence, gum hemorrhage, hematemesis, hepatitis, ileitis, ileus, jaundice, mouth ulceration, salivary gland enlargement, sialadenitis, stomatitis, tongue discoloration, tongue edema.
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Infrequent were ovarian cyst, testes pain; rare were diabetes mellitus, hyperthyroidism; also observed were goiter, hypothyroidism, thyroiditis.
Array
Infrequent were anemia, eosinophilia, hypochromic anemia, leukocytosis, leukopenia, lymphadenopathy, purpura; rare were thrombocytopenia; also observed were anisocytosis, basophilia, bleeding time increased, lymphedema, lymphocytosis, lymphopenia, microcytic anemia, monocytosis, normocytic anemia, thrombocythemia.
Array
Infrequent were generalized edema, hyperglycemia, hypokalemia, peripheral edema, SGOT increased, SGPT increased, thirst; rare were bilirubinemia, dehydration, hyperkalemia, obesity; also observed were alkaline phosphatase increased, BUN increased, creatinine phosphokinase increased, gamma globulins increased, gout, hypercalcemia, hypercholesteremia, hyperphosphatemia, hypocalcemia, hypoglycemia, hyponatremia, ketosis, lactic dehydrogenase increased, non-protein nitrogen (NPN) increased.
Array
Infrequent were arthritis, bursitis, tendonitis; rare were myasthenia, myopathy, myositis; also observed were generalized spasm, osteoporosis, tenosynovitis, tetany.
Array
Frequent were depression; infrequent were amnesia, convulsion, depersonalization, dystonia, emotional lability, hallucinations, hyperkinesia, hypesthesia, hypokinesia, incoordination, libido increased, neuralgia, neuropathy, nystagmus, paralysis, vertigo; rare were ataxia, coma, diplopia, dyskinesia, hostility, paranoid reaction, torticollis, withdrawal syndrome; also observed were abnormal gait, akathisia, akinesia, aphasia, choreoathetosis, circumoral paresthesia, delirium, delusions, dysarthria, euphoria, extrapyramidal syndrome, fasciculations, grand mal convulsion, hyperalgesia, irritability, manic reaction, manic-depressive reaction, meningitis, myelitis, peripheral neuritis, psychosis, psychotic depression, reflexes decreased, reflexes increased, stupor, trismus.
Array
Frequent were pharyngitis; infrequent were asthma, dyspnea, epistaxis, laryngitis, pneumonia; rare were stridor; also observed were dysphonia, emphysema, hemoptysis, hiccups, hyperventilation, lung fibrosis, pulmonary edema, respiratory flu, sputum increased.
Array
Frequent were rash; infrequent were acne, alopecia, dry skin, eczema, pruritus, urticaria; rare were exfoliative dermatitis, furunculosis, pustular rash, seborrhea; also observed were angioedema, ecchymosis, erythema multiforme, erythema nodosum, hirsutism, maculopapular rash, skin discoloration, skin hypertrophy, skin ulcer, sweating decreased, vesiculobullous rash.
Array
Infrequent were conjunctivitis, earache, keratoconjunctivitis, mydriasis, photophobia, retinal hemorrhage, tinnitus; rare were blepharitis, visual field defect; also observed were amblyopia, anisocoria, blurred vision, cataract, conjunctival edema, corneal ulcer, deafness, exophthalmos, glaucoma, hyperacusis, night blindness, parosmia, ptosis, taste loss.
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Postmarketing Reports
Voluntary reports of adverse events in patients taking immediate-release paroxetine hydrochloride that have been received since market introduction and not listed above that may have no causal relationship with the drug include acute pancreatitis, elevated liver function tests (the most severe cases were deaths due to liver necrosis, and grossly elevated transaminases associated with severe liver dysfunction), Guillain-Barré syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis, priapism, syndrome of inappropriate ADH secretion, symptoms suggestive of prolactinemia and galactorrhea; extrapyramidal symptoms which have included akathisia, bradykinesia, cogwheel rigidity, dystonia, hypertonia, oculogyric crisis which has been associated with concomitant use of pimozide; tremor and trismus; status epilepticus, acute renal failure, pulmonary hypertension, allergic alveolitis, anaphylaxis, eclampsia, laryngismus, optic neuritis, porphyria, restless legs syndrome (RLS), ventricular fibrillation, ventricular tachycardia (including torsade de pointes), thrombocytopenia, hemolytic anemia, events related to impaired hematopoiesis (including aplastic anemia, pancytopenia, bone marrow aplasia, and agranulocytosis), and vasculitic syndromes (such as Henoch-Schönlein purpura). There has been a case report of an elevated phenytoin level after 4 weeks of immediate-release paroxetine and phenytoin coadministration. There has been a case report of severe hypotension when immediate-release paroxetine was added to chronic metoprolol treatment.
What should I look out for while using PAXILCR?
The use of MAOIs intended to treat depression with, or within 14 days of treatment with, PAXIL CR is contraindicated (see WARNINGS).
Do not start PAXIL CR in a patient who is being treated with a reversible MAOI such as linezolid or methylene blue because of an increased risk of serotonin syndrome or neuroleptic malignant syndrome (NMS)-like reactions (see WARNINGS).
Concomitant use with thioridazine is contraindicated (see WARNINGS and PRECAUTIONS).
Concomitant use in patients taking pimozide is contraindicated (see PRECAUTIONS).
PAXIL CR is contraindicated in patients with a hypersensitivity to paroxetine or to any of the inactive ingredients in PAXIL CR.
What might happen if I take too much PAXILCR?
How should I store and handle PAXILCR?
Store at controlled room temperature 15° to 30°C (59° to 86°F).Dispense in tightly-closed, light-resistant container (USP).Store at controlled room temperature 15° to 30°C (59° to 86°F).Dispense in tightly-closed, light-resistant container (USP).PAXIL CR is supplied as an enteric film-coated, controlled-release, round tablet, as follows: 12.5-mg yellow tabletsNDC 54868-5347-0 Bottles of 30 (engraved with PAXIL CR and 12.5)25-mg pink tabletsNDC 54868-4791-0 Bottles of 30 (engraved with PAXIL CR and 25)37.5 mg blue tabletsNDC 54868-5365-0 Bottles of 30 (engraved with PAXIL CR and 37.5) Store at or below 25°C (77°F) [see USP]. PAXIL CR is a registered trademark of GlaxoSmithKline.GEOMATRIX is a trademark of Jago Pharma, Muttenz, Switzerland. GlaxoSmithKlineResearch Triangle Park, NC 27709©2011, GlaxoSmithKline. All rights reserved.July 2011 PCR:40PIAdditional barcode labeling by:PAXIL CR is supplied as an enteric film-coated, controlled-release, round tablet, as follows: 12.5-mg yellow tabletsNDC 54868-5347-0 Bottles of 30 (engraved with PAXIL CR and 12.5)25-mg pink tabletsNDC 54868-4791-0 Bottles of 30 (engraved with PAXIL CR and 25)37.5 mg blue tabletsNDC 54868-5365-0 Bottles of 30 (engraved with PAXIL CR and 37.5) Store at or below 25°C (77°F) [see USP]. PAXIL CR is a registered trademark of GlaxoSmithKline.GEOMATRIX is a trademark of Jago Pharma, Muttenz, Switzerland. GlaxoSmithKlineResearch Triangle Park, NC 27709©2011, GlaxoSmithKline. All rights reserved.July 2011 PCR:40PIAdditional barcode labeling by:PAXIL CR is supplied as an enteric film-coated, controlled-release, round tablet, as follows: 12.5-mg yellow tabletsNDC 54868-5347-0 Bottles of 30 (engraved with PAXIL CR and 12.5)25-mg pink tabletsNDC 54868-4791-0 Bottles of 30 (engraved with PAXIL CR and 25)37.5 mg blue tabletsNDC 54868-5365-0 Bottles of 30 (engraved with PAXIL CR and 37.5) Store at or below 25°C (77°F) [see USP]. PAXIL CR is a registered trademark of GlaxoSmithKline.GEOMATRIX is a trademark of Jago Pharma, Muttenz, Switzerland. GlaxoSmithKlineResearch Triangle Park, NC 27709©2011, GlaxoSmithKline. All rights reserved.July 2011 PCR:40PIAdditional barcode labeling by:PAXIL CR is supplied as an enteric film-coated, controlled-release, round tablet, as follows: 12.5-mg yellow tabletsNDC 54868-5347-0 Bottles of 30 (engraved with PAXIL CR and 12.5)25-mg pink tabletsNDC 54868-4791-0 Bottles of 30 (engraved with PAXIL CR and 25)37.5 mg blue tabletsNDC 54868-5365-0 Bottles of 30 (engraved with PAXIL CR and 37.5) Store at or below 25°C (77°F) [see USP]. PAXIL CR is a registered trademark of GlaxoSmithKline.GEOMATRIX is a trademark of Jago Pharma, Muttenz, Switzerland. GlaxoSmithKlineResearch Triangle Park, NC 27709©2011, GlaxoSmithKline. All rights reserved.July 2011 PCR:40PIAdditional barcode labeling by:PAXIL CR is supplied as an enteric film-coated, controlled-release, round tablet, as follows: 12.5-mg yellow tabletsNDC 54868-5347-0 Bottles of 30 (engraved with PAXIL CR and 12.5)25-mg pink tabletsNDC 54868-4791-0 Bottles of 30 (engraved with PAXIL CR and 25)37.5 mg blue tabletsNDC 54868-5365-0 Bottles of 30 (engraved with PAXIL CR and 37.5) Store at or below 25°C (77°F) [see USP]. PAXIL CR is a registered trademark of GlaxoSmithKline.GEOMATRIX is a trademark of Jago Pharma, Muttenz, Switzerland. GlaxoSmithKlineResearch Triangle Park, NC 27709©2011, GlaxoSmithKline. All rights reserved.July 2011 PCR:40PIAdditional barcode labeling by:PAXIL CR is supplied as an enteric film-coated, controlled-release, round tablet, as follows: 12.5-mg yellow tabletsNDC 54868-5347-0 Bottles of 30 (engraved with PAXIL CR and 12.5)25-mg pink tabletsNDC 54868-4791-0 Bottles of 30 (engraved with PAXIL CR and 25)37.5 mg blue tabletsNDC 54868-5365-0 Bottles of 30 (engraved with PAXIL CR and 37.5) Store at or below 25°C (77°F) [see USP]. PAXIL CR is a registered trademark of GlaxoSmithKline.GEOMATRIX is a trademark of Jago Pharma, Muttenz, Switzerland. GlaxoSmithKlineResearch Triangle Park, NC 27709©2011, GlaxoSmithKline. All rights reserved.July 2011 PCR:40PIAdditional barcode labeling by:PAXIL CR is supplied as an enteric film-coated, controlled-release, round tablet, as follows: 12.5-mg yellow tabletsNDC 54868-5347-0 Bottles of 30 (engraved with PAXIL CR and 12.5)25-mg pink tabletsNDC 54868-4791-0 Bottles of 30 (engraved with PAXIL CR and 25)37.5 mg blue tabletsNDC 54868-5365-0 Bottles of 30 (engraved with PAXIL CR and 37.5) Store at or below 25°C (77°F) [see USP]. PAXIL CR is a registered trademark of GlaxoSmithKline.GEOMATRIX is a trademark of Jago Pharma, Muttenz, Switzerland. GlaxoSmithKlineResearch Triangle Park, NC 27709©2011, GlaxoSmithKline. All rights reserved.July 2011 PCR:40PIAdditional barcode labeling by:PAXIL CR is supplied as an enteric film-coated, controlled-release, round tablet, as follows: 12.5-mg yellow tabletsNDC 54868-5347-0 Bottles of 30 (engraved with PAXIL CR and 12.5)25-mg pink tabletsNDC 54868-4791-0 Bottles of 30 (engraved with PAXIL CR and 25)37.5 mg blue tabletsNDC 54868-5365-0 Bottles of 30 (engraved with PAXIL CR and 37.5) Store at or below 25°C (77°F) [see USP]. PAXIL CR is a registered trademark of GlaxoSmithKline.GEOMATRIX is a trademark of Jago Pharma, Muttenz, Switzerland. GlaxoSmithKlineResearch Triangle Park, NC 27709©2011, GlaxoSmithKline. All rights reserved.July 2011 PCR:40PIAdditional barcode labeling by:PAXIL CR is supplied as an enteric film-coated, controlled-release, round tablet, as follows: 12.5-mg yellow tabletsNDC 54868-5347-0 Bottles of 30 (engraved with PAXIL CR and 12.5)25-mg pink tabletsNDC 54868-4791-0 Bottles of 30 (engraved with PAXIL CR and 25)37.5 mg blue tabletsNDC 54868-5365-0 Bottles of 30 (engraved with PAXIL CR and 37.5) Store at or below 25°C (77°F) [see USP]. PAXIL CR is a registered trademark of GlaxoSmithKline.GEOMATRIX is a trademark of Jago Pharma, Muttenz, Switzerland. GlaxoSmithKlineResearch Triangle Park, NC 27709©2011, GlaxoSmithKline. All rights reserved.July 2011 PCR:40PIAdditional barcode labeling by:PAXIL CR is supplied as an enteric film-coated, controlled-release, round tablet, as follows: 12.5-mg yellow tabletsNDC 54868-5347-0 Bottles of 30 (engraved with PAXIL CR and 12.5)25-mg pink tabletsNDC 54868-4791-0 Bottles of 30 (engraved with PAXIL CR and 25)37.5 mg blue tabletsNDC 54868-5365-0 Bottles of 30 (engraved with PAXIL CR and 37.5) Store at or below 25°C (77°F) [see USP]. PAXIL CR is a registered trademark of GlaxoSmithKline.GEOMATRIX is a trademark of Jago Pharma, Muttenz, Switzerland. GlaxoSmithKlineResearch Triangle Park, NC 27709©2011, GlaxoSmithKline. All rights reserved.July 2011 PCR:40PIAdditional barcode labeling by:PAXIL CR is supplied as an enteric film-coated, controlled-release, round tablet, as follows: 12.5-mg yellow tabletsNDC 54868-5347-0 Bottles of 30 (engraved with PAXIL CR and 12.5)25-mg pink tabletsNDC 54868-4791-0 Bottles of 30 (engraved with PAXIL CR and 25)37.5 mg blue tabletsNDC 54868-5365-0 Bottles of 30 (engraved with PAXIL CR and 37.5) Store at or below 25°C (77°F) [see USP]. PAXIL CR is a registered trademark of GlaxoSmithKline.GEOMATRIX is a trademark of Jago Pharma, Muttenz, Switzerland. GlaxoSmithKlineResearch Triangle Park, NC 27709©2011, GlaxoSmithKline. All rights reserved.July 2011 PCR:40PIAdditional barcode labeling by:PAXIL CR is supplied as an enteric film-coated, controlled-release, round tablet, as follows: 12.5-mg yellow tabletsNDC 54868-5347-0 Bottles of 30 (engraved with PAXIL CR and 12.5)25-mg pink tabletsNDC 54868-4791-0 Bottles of 30 (engraved with PAXIL CR and 25)37.5 mg blue tabletsNDC 54868-5365-0 Bottles of 30 (engraved with PAXIL CR and 37.5) Store at or below 25°C (77°F) [see USP]. PAXIL CR is a registered trademark of GlaxoSmithKline.GEOMATRIX is a trademark of Jago Pharma, Muttenz, Switzerland. GlaxoSmithKlineResearch Triangle Park, NC 27709©2011, GlaxoSmithKline. All rights reserved.July 2011 PCR:40PIAdditional barcode labeling by:PAXIL CR is supplied as an enteric film-coated, controlled-release, round tablet, as follows: 12.5-mg yellow tabletsNDC 54868-5347-0 Bottles of 30 (engraved with PAXIL CR and 12.5)25-mg pink tabletsNDC 54868-4791-0 Bottles of 30 (engraved with PAXIL CR and 25)37.5 mg blue tabletsNDC 54868-5365-0 Bottles of 30 (engraved with PAXIL CR and 37.5) Store at or below 25°C (77°F) [see USP]. PAXIL CR is a registered trademark of GlaxoSmithKline.GEOMATRIX is a trademark of Jago Pharma, Muttenz, Switzerland. GlaxoSmithKlineResearch Triangle Park, NC 27709©2011, GlaxoSmithKline. All rights reserved.July 2011 PCR:40PIAdditional barcode labeling by:PAXIL CR is supplied as an enteric film-coated, controlled-release, round tablet, as follows: 12.5-mg yellow tabletsNDC 54868-5347-0 Bottles of 30 (engraved with PAXIL CR and 12.5)25-mg pink tabletsNDC 54868-4791-0 Bottles of 30 (engraved with PAXIL CR and 25)37.5 mg blue tabletsNDC 54868-5365-0 Bottles of 30 (engraved with PAXIL CR and 37.5) Store at or below 25°C (77°F) [see USP]. PAXIL CR is a registered trademark of GlaxoSmithKline.GEOMATRIX is a trademark of Jago Pharma, Muttenz, Switzerland. GlaxoSmithKlineResearch Triangle Park, NC 27709©2011, GlaxoSmithKline. All rights reserved.July 2011 PCR:40PIAdditional barcode labeling by:PAXIL CR is supplied as an enteric film-coated, controlled-release, round tablet, as follows: 12.5-mg yellow tabletsNDC 54868-5347-0 Bottles of 30 (engraved with PAXIL CR and 12.5)25-mg pink tabletsNDC 54868-4791-0 Bottles of 30 (engraved with PAXIL CR and 25)37.5 mg blue tabletsNDC 54868-5365-0 Bottles of 30 (engraved with PAXIL CR and 37.5) Store at or below 25°C (77°F) [see USP]. PAXIL CR is a registered trademark of GlaxoSmithKline.GEOMATRIX is a trademark of Jago Pharma, Muttenz, Switzerland. GlaxoSmithKlineResearch Triangle Park, NC 27709©2011, GlaxoSmithKline. All rights reserved.July 2011 PCR:40PIAdditional barcode labeling by:
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
The efficacy of paroxetine in the treatment of major depressive disorder, panic disorder, social anxiety disorder, and premenstrual dysphoric disorder (PMDD) is presumed to be linked to potentiation of serotonergic activity in the central nervous system resulting from inhibition of neuronal reuptake of serotonin (5-hydroxy-tryptamine, 5-HT). Studies at clinically relevant doses in humans have demonstrated that paroxetine blocks the uptake of serotonin into human platelets. In vitro studies in animals also suggest that paroxetine is a potent and highly selective inhibitor of neuronal serotonin reuptake and has only very weak effects on norepinephrine and dopamine neuronal reuptake. In vitro radioligand binding studies indicate that paroxetine has little affinity for muscarinic, alpha-, alpha-, beta-adrenergic-, dopamine (D)-, 5-HT-, 5-HT-, and histamine (H)-receptors; antagonism of muscarinic, histaminergic, and alpha-adrenergic receptors has been associated with various anticholinergic, sedative, and cardiovascular effects for other psychotropic drugs.
Because the relative potencies of paroxetine’s major metabolites are at most 1/50 of the parent compound, they are essentially inactive.
Non-Clinical Toxicology
The use of MAOIs intended to treat depression with, or within 14 days of treatment with, PAXIL CR is contraindicated (see WARNINGS).Do not start PAXIL CR in a patient who is being treated with a reversible MAOI such as linezolid or methylene blue because of an increased risk of serotonin syndrome or neuroleptic malignant syndrome (NMS)-like reactions (see WARNINGS).
Concomitant use with thioridazine is contraindicated (see WARNINGS and PRECAUTIONS).
Concomitant use in patients taking pimozide is contraindicated (see PRECAUTIONS).
PAXIL CR is contraindicated in patients with a hypersensitivity to paroxetine or to any of the inactive ingredients in PAXIL CR.
The information included under the “Adverse Findings Observed in Short-Term, Placebo-Controlled Trials With PAXIL CR” subsection of ADVERSE REACTIONS is based on data from 11 placebo-controlled clinical trials. Three of these studies were conducted in patients with major depressive disorder, 3 studies were done in patients with panic disorder, 1 study was conducted in patients with social anxiety disorder, and 4 studies were done in female patients with PMDD. Two of the studies in major depressive disorder, which enrolled patients in the age range 18 to 65 years, are pooled. Information from a third study of major depressive disorder, which focused on elderly patients (60 to 88 years), is presented separately as is the information from the panic disorder studies and the information from the PMDD studies. Information on additional adverse events associated with PAXIL CR and the immediate-release formulation of paroxetine hydrochloride is included in a separate subsection (see Other Events Observed During the Clinical Development of Paroxetine).
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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