Paronex Uses

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What is Paronex?

Paronex is an antidepressant in a group of drugs called selective serotonin reuptake inhibitors (SSRIs). Paronex affects chemicals in the brain that may become unbalanced.

Paronex is used to treat depression, obsessive-compulsive disorder, anxiety disorders, post-traumatic stress disorder (PTSD), and premenstrual dysphoric disorder (PMDD).

The Brisdelle brand of Paronex is used to treat hot flashes related to menopause. Brisdelle is not for treating any other conditions.

Paronex may also be used for purposes not listed in this medication guide.

Paronex indications

infoAn indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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Major Depressive Disorder

Paronex tablets, USP are indicated for the treatment of major depressive disorder.

The efficacy of Paronex in the treatment of a major depressive episode was established in 6-week controlled trials of outpatients whose diagnoses corresponded most closely to the DSM-III category 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 Paronex in hospitalized depressed patients have not been adequately studied.

The efficacy of Paronex in maintaining a response in major depressive disorder for up to 1 year was demonstrated in a placebo-controlled trial. Nevertheless, the physician who elects to use Paronex for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

Obsessive Compulsive Disorder

Paronex tablets, USP are indicated for the treatment of obsessions and compulsions in patients with obsessive compulsive disorder (OCD) as defined in the DSM-IV. The obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning.

The efficacy of Paronex was established in two 12-week trials with obsessive compulsive outpatients whose diagnoses corresponded most closely to the DSM-IIIR category of obsessive compulsive disorder.

Obsessive compulsive disorder is characterized by recurrent and persistent ideas, thoughts, impulses, or images (obsessions) that are ego-dystonic and/or repetitive, purposeful, and intentional behaviors (compulsions) that are recognized by the person as excessive or unreasonable.

Long-term maintenance of efficacy was demonstrated in a 6-month relapse prevention trial. In this trial, patients assigned to Paronex showed a lower relapse rate compared to patients on placebo. Nevertheless, the physician who elects to use Paronex for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

Panic Disorder

Paronex tablets, USP are indicated for the treatment of panic disorder, with or without agoraphobia, as defined in DSM-IV. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks.

The efficacy of Paronex was established in three 10- to 12-week trials in panic disorder patients whose diagnoses corresponded to the DSM-IIIR category of panic disorder.

Panic disorder (DSM-IV) is characterized by recurrent unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which 4 (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart, or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded, or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes.

Long-term maintenance of efficacy was demonstrated in a 3-month relapse prevention trial. In this trial, patients with panic disorder assigned to Paronex demonstrated a lower relapse rate compared to patients on placebo. Nevertheless, the physician who prescribes Paronex for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

Social Anxiety Disorder

Paronex tablets, USP are indicated for the treatment of social anxiety disorder, also known as social phobia, as defined in DSM-IV (300.23). 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 efficacy of Paronex was established in three 12-week trials in adult patients with social anxiety disorder (DSM-IV). Paronex has not been studied in children or adolescents with social phobia.

The effectiveness of Paronex in long-term treatment of social anxiety disorder, i.e., for more than 12 weeks, has not been systematically evaluated in adequate and well-controlled trials. Therefore, the physician who elects to prescribe Paronex for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

Generalized Anxiety Disorder

Paronex tablets, USP are indicated for the treatment of Generalized Anxiety Disorder (GAD), as defined in DSM-IV. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.

The efficacy of Paronex in the treatment of GAD was established in two 8-week placebo-controlled trials in adults with GAD. Paronex has not been studied in children or adolescents with Generalized Anxiety Disorder.

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.

The efficacy of Paronex in maintaining a response in patients with Generalized Anxiety Disorder, who responded during an 8-week acute treatment phase while taking Paronex and were then observed for relapse during a period of up to 24 weeks, was demonstrated in a placebo-controlled trial. Nevertheless, the physician who elects to use Paronex for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

How should I use Paronex?

Use Paronex as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Paronex comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Paronex refilled.
  • Take Paronex by mouth with or without food.
  • Some brands of Paronex should be swallowed whole, and should not be crushed or chewed. If you cannot swallow Paronex whole, check with your pharmacist to see if your brand of Paronex can be crushed.
  • Taking Paronex at the same time each day will help you remember to take it.
  • Continue to take Paronex even if you feel well. Do not miss any doses.
  • Do not suddenly stop taking Paronex without checking with your doctor. Side effects may occur. They may include mental or mood changes, numbness or tingling of the skin, dizziness, confusion, headache, trouble sleeping, or unusual tiredness. You will be closely monitored when you start Paronex and whenever a change in dose is made.
  • If you miss a dose of Paronex, take it as soon as possible. If it almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Paronex.

Uses of Paronex in details

infoThere are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
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Paronex is used in adults in the treatment of depression, obsessive compulsive disorder or OCD (repetitive, obsessive thoughts with uncontrollable behavior), Panic disorder (panic attacks, including those caused by fear of open spaces called agoraphobia), generalized anxiety disorder (general feeling of nervousness or anxiety), Social anxiety (fear of social surroundings), Post-traumatic stress disorder/PTSD (anxiety caused by a traumatic event).

Paronex description

Paronex hydrochloride and Paronex mesylate belong to a class of antidepressant agents known as selective serotonin-reuptake inhibitors (SSRIs). Despite distinct structural differences between compounds in this class, SSRIs possess similar pharmacological activity. As with other antidepressant agents, several weeks of therapy may be required before a clinical effect is seen. SSRIs are potent inhibitors of neuronal serotonin reuptake. They have little to no effect on norepinephrine or dopamine reuptake and do not antagonize α- or β-adrenergic, dopamine D2 or histamine H1 receptors. During acute use, SSRIs block serotonin reuptake and increase serotonin stimulation of somatodendritic 5-HT1A and terminal autoreceptors. Chronic use leads to desensitization of somatodendritic 5-HT1A and terminal autoreceptors. The overall clinical effect of increased mood and decreased anxiety is thought to be due to adaptive changes in neuronal function that leads to enhanced serotonergic neurotransmission. Side effects include dry mouth, nausea, dizziness, drowsiness, sexual dysfunction and headache. Side effects generally occur during the first two weeks of therapy and are usually less severe and frequent than those observed with tricyclic antidepressants. Paronex hydrochloride and mesylate are considered therapeutic alternatives rather than generic equivalents by the US Food and Drug Administration (FDA); both agents contain the same active moiety (i.e. Paronex), but are formulated as different salt forms. Clinical studies establishing the efficacy of Paronex in various conditions were performed using Paronex hydrochloride. Since both agents contain the same active moiety, the clinical efficacy of both agents is thought to be similar. Paronex may be used to treat major depressive disorder (MDD), panic disorder with or without agoraphobia, obsessive-compulsive disorder (OCD), social anxiety disorder (social phobia), generalized anxiety disorder (GAD), post-traumatic stress disorder (PTSD) and premenstrual dysphoric disorder (PMDD). Paronex has the most evidence supporting its use for anxiety-related disorders of the SSRIs. It has the greatest anticholinergic activity of the agents in this class and compared to other SSRIs, Paronex may cause greater weight gain, sexual dysfunction, sedation and constipation.

Paronex dosage

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Major Depressive Disorder

Usual Initial Dosage

Paronex should be administered as a single daily dose with or without food, usually in the morning. The recommended initial dose is 20 mg/day. Patients were dosed in a range of 20 to 50 mg/day in the clinical trials demonstrating the effectiveness of Paronex in the treatment of major depressive disorder. As with all drugs effective in the treatment of major depressive disorder, the full effect may be delayed. Some patients not responding to a 20 mg dose may benefit from dose increases, in 10 mg/day increments, up to a maximum of 50 mg/day. Dose changes should occur at intervals of at least 1 week.

Maintenance Therapy

There is no body of evidence available to answer the question of how long the patient treated with Paronex should remain on it. It is generally agreed that acute episodes of major depressive disorder require several months or longer of sustained pharmacologic therapy. Whether the dose needed to induce remission is identical to the dose needed to maintain and/or sustain euthymia is unknown.

Systematic evaluation of the efficacy of Paronex has shown that efficacy is maintained for periods of up to 1 year with doses that averaged about 30 mg.

Obsessive Compulsive Disorder

Usual Initial Dosage

Paronex should be administered as a single daily dose with or without food, usually in the morning. The recommended dose of Paronex in the treatment of OCD is 40 mg daily. Patients should be started on 20 mg/day and the dose can be increased in 10 mg/day increments. Dose changes should occur at intervals of at least 1 week. Patients were dosed in a range of 20 to 60 mg/day in the clinical trials demonstrating the effectiveness of Paronex in the treatment of OCD. The maximum dosage should not exceed 60 mg/day.

Maintenance Therapy

Long-term maintenance of efficacy was demonstrated in a 6-month relapse prevention trial. In this trial, patients with OCD assigned to Paronex demonstrated a lower relapse rate compared to patients on placebo. OCD is a chronic condition, and it is reasonable to consider continuation for a responding patient. Dosage adjustments should be made to maintain the patient on the lowest effective dosage, and patients should be periodically reassessed to determine the need for continued treatment.

Panic Disorder

Usual Initial Dosage

Paronex should be administered as a single daily dose with or without food, usually in the morning. The target dose of Paronex in the treatment of panic disorder is 40 mg/day. Patients should be started on 10 mg/day. Dose changes should occur in 10 mg/day increments and at intervals of at least 1 week. Patients were dosed in a range of 10 to 60 mg/day in the clinical trials demonstrating the effectiveness of Paronex. The maximum dosage should not exceed 60 mg/day.

Maintenance Therapy

Long-term maintenance of efficacy was demonstrated in a 3-month relapse prevention trial. In this trial, patients with panic disorder assigned to Paronex demonstrated a lower relapse rate compared to patients on placebo. Panic disorder is a chronic condition, and it is reasonable to consider continuation for a responding patient. Dosage adjustments should be made to maintain the patient on the lowest effective dosage, and patients should be periodically reassessed to determine the need for continued treatment.

Social Anxiety Disorder

Usual Initial Dosage

Paronex should be administered as a single daily dose with or without food, usually in the morning. The recommended and initial dosage is 20 mg/day. In clinical trials the effectiveness of Paronex was demonstrated in patients dosed in a range of 20 to 60 mg/day. While the safety of Paronex has been evaluated in patients with social anxiety disorder at doses up to 60 mg/day, available information does not suggest any additional benefit for doses above 20 mg/day.

Maintenance Therapy

There is no body of evidence available to answer the question of how long the patient treated with Paronex should remain on it. Although the efficacy of Paronex beyond 12 weeks of dosing has not been demonstrated in controlled clinical trials, social anxiety disorder is recognized as a chronic condition, and it is reasonable to consider continuation of treatment for a responding patient. Dosage adjustments should be made to maintain the patient on the lowest effective dosage, and patients should be periodically reassessed to determine the need for continued treatment.

Generalized Anxiety Disorder

Usual Initial Dosage

Paronex should be administered as a single daily dose with or without food, usually in the morning. In clinical trials the effectiveness of Paronex was demonstrated in patients dosed in a range of 20 to 50 mg/day. The recommended starting dosage and the established effective dosage is 20 mg/day. There is not sufficient evidence to suggest a greater benefit to doses higher than 20 mg/day. Dose changes should occur in 10 mg/day increments and at intervals of at least 1 week.

Maintenance Therapy

Systematic evaluation of continuing Paronex for periods of up to 24 weeks in patients with Generalized Anxiety Disorder who had responded while taking Paronex during an 8-week acute treatment phase has demonstrated a benefit of such maintenance. Nevertheless, patients should be periodically reassessed to determine the need for maintenance treatment.

Posttraumatic Stress Disorder

Usual Initial Dosage

Paronex should be administered as a single daily dose with or without food, usually in the morning. The recommended starting dosage and the established effective dosage is 20 mg/day. In 1 clinical trial, the effectiveness of Paronex was demonstrated in patients dosed in a range of 20 to 50 mg/day. However, in a fixed dose study, there was not sufficient evidence to suggest a greater benefit for a dose of 40 mg/day compared to 20 mg/day. Dose changes, if indicated, should occur in 10 mg/day increments and at intervals of at least 1 week.

Maintenance Therapy

There is no body of evidence available to answer the question of how long the patient treated with Paronex should remain on it. Although the efficacy of Paronex beyond 12 weeks of dosing has not been demonstrated in controlled clinical trials, PTSD is recognized as a chronic condition, and it is reasonable to consider continuation of treatment for a responding patient. Dosage adjustments should be made to maintain the patient on the lowest effective dosage, and patients should be periodically reassessed to determine the need for continued treatment.

Special Populations

Treatment of Pregnant Women During the Third Trimester

Neonates exposed to Paronex and other SSRIs or SNRIs, late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. When treating pregnant women with Paronex during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. The physician may consider tapering Paronex in the third trimester.

Dosage for Elderly or Debilitated Patients, and Patients With Severe Renal or Hepatic Impairment

The recommended initial dose is 10 mg/day for elderly patients, debilitated patients, and/or patients with severe renal or hepatic impairment. Increases may be made if indicated. Dosage should not exceed 40 mg/day.

Switching Patients to or From a Monoamine Oxidase Inhibitor

At least 14 days should elapse between discontinuation of an MAOI intended to treat depression and initiation of therapy with Paronex. Conversely, at least 14 days should be allowed after stopping Paronex before starting an MAOI antidepressant.

Use of Paronex With Reversible MAOIs Such as Linezolid or Methylene Blue

Do not start Paronex

Oral Suspension in a patient who is being treated with linezolid or methylene blue because there is increased risk of serotonin syndrome or NMS-like reactions. In a patient who requires more urgent treatment of a psychiatric condition, non-pharmacological interventions, including hospitalization, should be considered. In some cases, a patient receiving therapy with Paronex may require urgent treatment with linezolid or methylene blue. If acceptable alternatives to linezolid or methylene blue treatment are not available and the potential benefits of linezolid or methylene blue treatment are judged to outweigh the risks of serotonin syndrome or NMS-like reactions in a particular patient, Paronex

Oral Suspension should be stopped promptly, and linezolid or methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome or NMS-like reactions for 2 weeks or until 24 hours after the last dose of linezolid or methylene blue, whichever comes first. Therapy with Paronex may be resumed 24 hours after the last dose of linezolid or methylene blue.

Discontinuation of Treatment with Paronex

Symptoms associated with discontinuation of Paronex have been reported. Patients should be monitored for these symptoms when discontinuing treatment, regardless of the indication for which Paronex is being prescribed. 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. Subsequently, the physician may continue decreasing the dose but at a more gradual rate.

NOTE: SHAKE SUSPENSION WELL BEFORE USING.

Paronex interactions

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Serotonergic Drugs: As with other SSRIs, co-administration with serotonergic drugs may lead to an incidence of 5-HT associated effects. Caution should be advised and a closer clinical monitoring is required when serotonergic drugs (such as L-tryptophan, triptans, tramadol, SSRIs, lithium, fentanyl and St. John's Wort-Hypericum perforatum-preparations) are combined with Paronex (Seroxat). Concomitant use of Paronex (Seroxat) and MAO inhibitors [including linezolid, an antibiotic which is a reversible non-selective MAO inhibitor and methylthioninium chloride (methylene blue)] is contraindicated.

Pimozide: Increased pimozide levels have been demonstrated in a study of a single low dose pimozide (2 mg) when co-administered with Paronex. This is explained by the known CYP2D6 inhibitory properties of Paronex. Due to the narrow therapeutic index of pimozide and its known ability to prolong QT interval, concomitant use of pimozide and Paronex (Seroxat) is contraindicated.

Drug Metabolising Enzymes: The metabolism and pharmacokinetics of Paronex may be affected by the induction or inhibition of drug metabolising enzymes.

When Paronex (Seroxat) is to be co-administered with a known drug metabolising enzyme inhibitor, consideration should be given to using doses at the lower end of the range.

No initial dosage adjustment is considered necessary when the drug is to be co-administered with known drug metabolising enzyme inducers (e.g. carbamazepine, rifampicin, phenobarbital, phenytoin). Any subsequent dosage adjustment should be guided by clinical effect (tolerability and efficacy).

Fosamprenavir/Ritonavir: Co-administration of fosamprenavir/ritonavir with Paronex significantly decreased plasma levels of Paronex. Any dose adjustment should be guided by clinical effect (tolerability and efficacy).

Procyclidine: Daily administration of Paronex increases significantly the plasma levels of procyclidine. If anti-cholinergic effects are seen, the dose of procyclidine should be reduced.

Anticonvulsants: Carbamazepine, phenytoin, sodium valproate. Concomitant administration does not seem to show any effect on pharmacokinetic/dynamic profile in epileptic patients.

CYP2D6 Inhibitory Potency of Paronex: As with other antidepressants, including other SSRIs, Paronex inhibits the hepatic cytochrome P450 enzyme CYP2D6. Inhibition of CYP2D6 may lead to increased plasma concentrations of co-administered drugs metabolised by this enzyme. These include certain tricyclic antidepressants (e.g. amitriptyline, nortriptyline, imipramine and desipramine), phenothiazine neuroleptics (e.g. perphenazine and thioridazine, see Contraindications), risperidone, atomoxetine, certain Type 1c antiarrhythmics (e.g. propafenone and flecainide) and metoprolol.

Tamoxifen has an important active metabolite, endoxifen, which is produced by CYP2D6 and contributes significantly to the efficacy of tamoxifen. Irreversible inhibition of CYP2D6 by Paronex leads to reduced plasma concentrations of endoxifen.

CYP3A4: An in vivo interaction study involving the co-administration under steady state conditions of Paronex and terfenadine, a substrate for cytochrome CYP3A4, revealed no effect of Paronex on terfenadine pharmacokinetics. A similar in vivo interaction study revealed no effect of Paronex on alprazolam pharmacokinetics and vice-versa. Concurrent administration of Paronex with terfenadine, alprazolam and other drugs that are CYP3A4 substrates would not be expected to cause a hazard.

Drugs Affecting Gastric pH: In vitro data have shown that dissociation of Paronex from the oral liquid is pH-dependent. Therefore, drugs that alter gastric pH (such as proton pump inhibitors or histamine H2-receptor antagonists) may affect plasma Paronex concentrations in patients taking the oral liquid.

Clinical studies have shown the absorption and pharmacokinetics of Paronex to be unaffected or only marginally affected (i.e. at a level which warrants no change in dosing regimen) by: Food; antacids; digoxin; propranolol; alcohol: Paronex does not increase the impairment of mental and motor skills caused by alcohol, however, the concomitant use of Paronex (Seroxat) and alcohol is not advised.

Paronex side effects

Associated With Discontinuation of Treatment

Twenty percent (1,199/6,145) of patients treated with Paronex in worldwide clinical trials in major depressive disorder and 16.1% (84/522), 11.8% (64/542), 9.4% (44/469), 10.7% (79/735), and 11.7% (79/676) of patients treated with Paronex in worldwide trials in social anxiety disorder, OCD, panic disorder, GAD, and PTSD, respectively, discontinued treatment due to an adverse event. The most common events (≥1%) associated with discontinuation and considered to be drug related (i.e., those events associated with dropout at a rate approximately twice or greater for Paronex compared to placebo) included the following:

Where numbers are not provided the incidence of the adverse events in patients treated with Paronex was not >1% or was not greater than or equal to 2 times the incidence of placebo.

a Incidence corrected for gender.

Commonly Observed Adverse Events

Major Depressive Disorder

The most commonly observed adverse events associated with the use of Paronex (incidence of 5% or greater and incidence for Paronex at least twice that for placebo, derived from Table 2) were: Asthenia, sweating, nausea, decreased appetite, somnolence, dizziness, insomnia, tremor, nervousness, ejaculatory disturbance, and other male genital disorders.

Obsessive Compulsive Disorder

The most commonly observed adverse events associated with the use of Paronex (incidence of 5% or greater and incidence for Paronex at least twice that of placebo, derived from Table 3) were: Nausea, dry mouth, decreased appetite, constipation, dizziness, somnolence, tremor, sweating, impotence, and abnormal ejaculation.

Panic Disorder

The most commonly observed adverse events associated with the use of Paronex (incidence of 5% or greater and incidence for Paronex at least twice that for placebo, derived from Table 3) were: Asthenia, sweating, decreased appetite, libido decreased, tremor, abnormal ejaculation, female genital disorders, and impotence.

Social Anxiety Disorder

The most commonly observed adverse events associated with the use of Paronex (incidence of 5% or greater and incidence for Paronex at least twice that for placebo, derived from Table 3) were: Sweating, nausea, dry mouth, constipation, decreased appetite, somnolence, tremor, libido decreased, yawn, abnormal ejaculation, female genital disorders, and impotence.

Generalized Anxiety Disorder

The most commonly observed adverse events associated with the use of Paronex (incidence of 5% or greater and incidence for Paronex at least twice that for placebo, derived from Table 4) were: Asthenia, infection, constipation, decreased appetite, dry mouth, nausea, libido decreased, somnolence, tremor, sweating, and abnormal ejaculation.

Posttraumatic Stress Disorder

The most commonly observed adverse events associated with the use of Paronex (incidence of 5% or greater and incidence for Paronex at least twice that for placebo, derived from Table 4) were: Asthenia, sweating, nausea, dry mouth, diarrhea, decreased appetite, somnolence, libido decreased, abnormal ejaculation, female genital disorders, and impotence.

Incidence in Controlled Clinical Trials

The prescriber should be aware that the figures in the tables following 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 populations studied.

Major Depressive Disorder

Table 2 enumerates adverse events that occurred at an incidence of 1% or more among paroxetine-treated patients who participated in short-term (6-week) placebo-controlled trials in which patients were dosed in a range of 20 mg to 50 mg/day. Reported adverse events were classified using a standard COSTART-based Dictionary terminology.

a Events reported by at least 1% of patients treated with Paronex are included, except the following events which had an incidence on placebo ≥ Paronex: Abdominal pain, agitation, back pain, chest pain, CNS stimulation, fever, increased appetite, myoclonus, pharyngitis, postural hypotension, respiratory disorder (includes mostly “cold symptoms” or "URI"), trauma, and vomiting.

b Includes mostly "lump in throat" and "tightness in throat".

c Percentage corrected for gender.

d Mostly "ejaculatory delay".

e Includes "anorgasmia", "erectile difficulties", "delayed ejaculation/orgasm" and "sexual dysfunction” and "impotence".

f Includes mostly "difficulty with micturition" and "urinary hesitancy".

g Includes mostly "anorgasmia" and "difficulty reaching climax/orgasm".

Obsessive Compulsive Disorder, Panic Disorder, and Social Anxiety Disorder

Table 3 enumerates adverse events that occurred at a frequency of 2% or more among OCD patients on Paronex who participated in placebo-controlled trials of 12-weeks duration in which patients were dosed in a range of 20 mg to 60 mg/day or among patients with panic disorder on Paronex who participated in placebo-controlled trials of 10- to 12-weeks duration in which patients were dosed in a range of 10 mg to 60 mg/day or among patients with social anxiety disorder on Paronex who participated in placebo-controlled trials of 12-weeks duration in which patients were dosed in a range of 20 mg to 50 mg/day.

a Events reported by at least 2% of OCD, panic disorder, and social anxiety disorder in patients treated with Paronex are included, except the following events which had an incidence on placebo ≥ Paronex: [OCD]: Abdominal pain, agitation, anxiety, back pain, cough increased, depression, headache, hyperkinesia, infection, paresthesia, pharyngitis, respiratory disorder, rhinitis, and sinusitis. [panic disorder]: Abnormal dreams, abnormal vision, chest pain, cough increased, depersonalization, depression, dysmenorrhea, dyspepsia, flu syndrome, headache, infection, myalgia, nervousness, palpitation, paresthesia, pharyngitis, rash, respiratory disorder, sinusitis, taste perversion, trauma, urination impaired, and vasodilation. [social anxiety disorder]: Abdominal pain, depression, headache, infection, respiratory disorder, and sinusitis.

b Percentage corrected for gender.

Generalized Anxiety Disorder and Posttraumatic Stress Disorder

Table 4 enumerates adverse events that occurred at a frequency of 2% or more among GAD patients on Paronex who participated in placebo-controlled trials of 8-weeks duration in which patients were dosed in a range of 10 mg/day to 50 mg/day or among PTSD patients on Paronex who participated in placebo-controlled trials of 12-weeks duration in which patients were dosed in a range of 20 mg/day to 50 mg/day.

a Events reported by at least 2% of GAD and PTSD in patients treated with Paronex are included, except the following events which had an incidence on placebo ≥ Paronex. [GAD]: Abdominal pain, back pain, trauma, dyspepsia, myalgia, and pharyngitis. [PTSD]: Back pain, headache, anxiety, depression, nervousness, respiratory disorder, pharyngitis, and sinusitis.

b Percentage corrected for gender.

Dose Dependency of Adverse Events

A comparison of adverse event rates in a fixed-dose study comparing 10, 20, 30, and 40 mg/day of Paronex with placebo in the treatment of major depressive disorder revealed a clear dose dependency for some of the more common adverse events associated with use of Paronex, as shown in Table 5:

a Rule for including adverse events in table: Incidence at least 5% for 1 of Paronex groups and ≥ twice the placebo incidence for at least 1 Paronex group.

In a fixed-dose study comparing placebo and 20, 40, and 60 mg of Paronex in the treatment of OCD, there was no clear relationship between adverse events and the dose of Paronex to which patients were assigned. No new adverse events were observed in the group treated with 60 mg of Paronex compared to any of the other treatment groups.

In a fixed-dose study comparing placebo and 10, 20, and 40 mg of Paronex in the treatment of panic disorder, there was no clear relationship between adverse events and the dose of Paronex to which patients were assigned, except for asthenia, dry mouth, anxiety, libido decreased, tremor, and abnormal ejaculation. In flexible-dose studies, no new adverse events were observed in patients receiving 60 mg of Paronex compared to any of the other treatment groups.

In a fixed-dose study comparing placebo and 20, 40, and 60 mg of Paronex in the treatment of social anxiety disorder, for most of the adverse events, there was no clear relationship between adverse events and the dose of Paronex to which patients were assigned.

In a fixed-dose study comparing placebo and 20 and 40 mg of Paronex in the treatment of generalized anxiety disorder, for most of the adverse events, there was no clear relationship between adverse events and the dose of Paronex to which patients were assigned, except for the following adverse events: Asthenia, constipation, and abnormal ejaculation.

In a fixed-dose study comparing placebo and 20 and 40 mg of Paronex in the treatment of posttraumatic stress disorder, for most of the adverse events, there was no clear relationship between adverse events and the dose of Paronex to which patients were assigned, except for impotence and abnormal ejaculation.

Adaptation to Certain Adverse Events

Over a 4- to 6-week period, there was evidence of adaptation to some adverse events with continued therapy (e.g., nausea and dizziness), but less to other effects (e.g., dry mouth, somnolence, and asthenia).

Male and Female Sexual Dysfunction With SSRIs

Although changes in sexual desire, sexual performance, and sexual satisfaction often occur as manifestations of a psychiatric disorder, they may also be a consequence of pharmacologic treatment. In particular, some evidence suggests that selective serotonin reuptake inhibitors (SSRIs) can cause such untoward sexual experiences.

Reliable estimates of the incidence and severity of untoward experiences involving sexual desire, performance, and satisfaction are difficult to obtain, however, in part because patients and physicians may be reluctant to discuss them. Accordingly, estimates of the incidence of untoward sexual experience and performance cited in product labeling are likely to underestimate their actual incidence.

In placebo-controlled clinical trials involving more than 3,200 patients, the ranges for the reported incidence of sexual side effects in males and females with major depressive disorder, OCD, panic disorder, social anxiety disorder, GAD, and PTSD are displayed in Table 6.

There are no adequate and well-controlled studies examining sexual dysfunction with Paronex treatment.

Paronex treatment has been associated with several cases of priapism. In those cases with a known outcome, patients recovered without sequelae.

While it is difficult to know the precise risk of sexual dysfunction associated with the use of SSRIs, physicians should routinely inquire about such possible side effects.

Weight and Vital Sign Changes

Significant weight loss may be an undesirable result of treatment with Paronex for some patients but, on average, patients in controlled trials had minimal (about 1 pound) weight loss versus smaller changes on placebo and active control. No significant changes in vital signs (systolic and diastolic blood pressure, pulse and temperature) were observed in patients treated with Paronex in controlled clinical trials.

ECG Changes

In an analysis of ECGs obtained in 682 patients treated with Paronex and 415 patients treated with placebo in controlled clinical trials, no clinically significant changes were seen in the ECGs of either group.

Liver Function Tests

In placebo-controlled clinical trials, patients treated with Paronex exhibited abnormal values on liver function tests at no greater rate than that seen in placebo-treated patients. In particular, the paroxetine-versus-placebo comparisons for alkaline phosphatase, SGOT, SGPT, and bilirubin revealed no differences in the percentage of patients with marked abnormalities.

Hallucinations

In pooled clinical trials of immediate-release Paronex hydrochloride, hallucinations were observed in 22 of 9089 patients receiving drug and 4 of 3187 patients receiving placebo.

Other Events Observed During the Premarketing Evaluation of Paronex

During its premarketing assessment in major depressive disorder, multiple doses of Paronex were administered to 6,145 patients in phase 2 and 3 studies. The conditions and duration of exposure to Paronex 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. During premarketing clinical trials in OCD, panic disorder, social anxiety disorder, generalized anxiety disorder, and posttraumatic stress disorder, 542, 469, 522, 735, and 676 patients, respectively, received multiple doses of Paronex. 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 standard COSTART-based Dictionary terminology. The frequencies presented, therefore, represent the proportion of the 9,089 patients exposed to multiple doses of Paronex who experienced an event of the type cited on at least 1 occasion while receiving Paronex. All reported events are included except those already listed in Tables 2 to 5, those reported in terms so general as to be uninformative and those events where a drug cause was remote. It is important to emphasize that although the events reported occurred during treatment with Paronex, 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. Events of major clinical importance are also described in the section.

Body as a Whole

Infrequent: Allergic reaction, chills, face edema, malaise, neck pain; rare: Adrenergic syndrome, cellulitis, moniliasis, neck rigidity, pelvic pain, peritonitis, sepsis, ulcer.

Cardiovascular System

Frequent: Hypertension, tachycardia; infrequent: Bradycardia, hematoma, hypotension, migraine, postural hypotension, syncope; rare: Angina pectoris, arrhythmia nodal, atrial fibrillation, bundle branch block, cerebral ischemia, cerebrovascular accident, congestive heart failure, heart block, low cardiac output, myocardial infarct, myocardial ischemia, pallor, phlebitis, pulmonary embolus, supraventricular extrasystoles, thrombophlebitis, thrombosis, varicose vein, vascular headache, ventricular extrasystoles.

Digestive System

Infrequent: Bruxism, colitis, dysphagia, eructation, gastritis, gastroenteritis, gingivitis, glossitis, increased salivation, liver function tests abnormal, rectal hemorrhage, ulcerative stomatitis; rare: Aphthous stomatitis, bloody diarrhea, bulimia, cardiospasm, cholelithiasis, duodenitis, enteritis, esophagitis, fecal impactions, fecal incontinence, gum hemorrhage, hematemesis, hepatitis, ileitis, ileus, intestinal obstruction, jaundice, melena, mouth ulceration, peptic ulcer, salivary gland enlargement, sialadenitis, stomach ulcer, stomatitis, tongue discoloration, tongue edema, tooth caries.

Endocrine System

Rare: Diabetes mellitus, goiter, hyperthyroidism, hypothyroidism, thyroiditis.

Hemic and Lymphatic Systems

Infrequent: Anemia, leukopenia, lymphadenopathy, purpura; rare: Abnormal erythrocytes, basophilia, bleeding time increased, eosinophilia, hypochromic anemia, iron deficiency anemia, leukocytosis, lymphedema, abnormal lymphocytes, lymphocytosis, microcytic anemia, monocytosis, normocytic anemia, thrombocythemia, thrombocytopenia.

Metabolic and Nutritional

Frequent: Weight gain; infrequent: Edema, peripheral edema, SGOT increased, SGPT increased, thirst, weight loss; rare: Alkaline phosphatase increased, bilirubinemia, BUN increased, creatinine phosphokinase increased, dehydration, gamma globulins increased, gout, hypercalcemia, hypercholesteremia, hyperglycemia, hyperkalemia, hyperphosphatemia, hypocalcemia, hypoglycemia, hypokalemia, hyponatremia, ketosis, lactic dehydrogenase increased, non-protein nitrogen (NPN) increased.

Musculoskeletal System

Frequent: Arthralgia; infrequent: Arthritis, arthrosis; rare: Bursitis, myositis, osteoporosis, generalized spasm, tenosynovitis, tetany.

Nervous System

Frequent: Emotional lability, vertigo; infrequent: Abnormal thinking, alcohol abuse, ataxia, dystonia, dyskinesia, euphoria, hallucinations, hostility, hypertonia, hypesthesia, hypokinesia, incoordination, lack of emotion, libido increased, manic reaction, neurosis, paralysis, paranoid reaction; rare: Abnormal gait, akinesia, antisocial reaction, aphasia, choreoathetosis, circumoral paresthesias, convulsion, delirium, delusions, diplopia, drug dependence, dysarthria, extrapyramidal syndrome, fasciculations, grand mal convulsion, hyperalgesia, hysteria, manic-depressive reaction, meningitis, myelitis, neuralgia, neuropathy, nystagmus, peripheral neuritis, psychotic depression, psychosis, reflexes decreased, reflexes increased, stupor, torticollis, trismus, withdrawal syndrome.

Respiratory System

Infrequent: Asthma, bronchitis, dyspnea, epistaxis, hyperventilation, pneumonia, respiratory flu; rare: Emphysema, hemoptysis, hiccups, lung fibrosis, pulmonary edema, sputum increased, stridor, voice alteration.

Skin and Appendages

Frequent: Pruritus; infrequent: Acne, alopecia, contact dermatitis, dry skin, ecchymosis, eczema, herpes simplex, photosensitivity, urticaria; rare: Angioedema, erythema nodosum, erythema multiforme, exfoliative dermatitis, fungal dermatitis, furunculosis; herpes zoster, hirsutism, maculopapular rash, seborrhea, skin discoloration, skin hypertrophy, skin ulcer, sweating decreased, vesiculobullous rash.

Special Senses

Frequent: Tinnitus; infrequent: Abnormality of accommodation, conjunctivitis, ear pain, eye pain, keratoconjunctivitis, mydriasis, otitis media; rare: Amblyopia, anisocoria, blepharitis, cataract, conjunctival edema, corneal ulcer, deafness, exophthalmos, eye hemorrhage, glaucoma, hyperacusis, night blindness, otitis externa, parosmia, photophobia, ptosis, retinal hemorrhage, taste loss, visual field defect.

Urogenital System

Infrequent: Amenorrhea, breast pain, cystitis, dysuria, hematuria, menorrhagia, nocturia, polyuria, pyuria, urinary incontinence, urinary retention, urinary urgency, vaginitis; rare: Abortion, breast atrophy, breast enlargement, endometrial disorder, epididymitis, female lactation, fibrocystic breast, kidney calculus, kidney pain, leukorrhea, mastitis, metrorrhagia, nephritis, oliguria, salpingitis, urethritis, urinary casts, uterine spasm, urolith, vaginal hemorrhage, vaginal moniliasis.

Postmarketing Reports

Voluntary reports of adverse events in patients taking Paronex 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 Paronex and phenytoin coadministration. There has been a case report of severe hypotension when Paronex was added to chronic metoprolol treatment.

Paronex contraindications

Monoamine Oxidase Inhibitors

Concomitant use of an MAOI with Paronex or within 14 days of stopping treatment with Paronex is contraindicated because of an increased risk of serotonin syndrome. The use of Paronex within 14 days of stopping an MAOI is also contraindicated.

Starting Paronex in a patient who is being treated with linezolid or intravenous methylene blue, both of which inhibit monoamine oxidase, is also contraindicated because of an increased risk of serotonin syndrome.

Thioridazine

Concomitant use of Paronex with thioridazine is contraindicated, because thioridazine prolongs the QT interval, and Paronex can increase thioridazine levels.

Pimozide

Concomitant use of Paronex with pimozide is contraindicated because pimozide prolongs the QT interval, and Paronex increases pimozide levels.

Hypersensitivity to any Ingredient in Paronex

Paronex are contraindicated in patients with a history of hypersensitivity to Paronex or any of the other ingredients in Paronex.

Pregnancy

Menopausal VMS does not occur during pregnancy and Paronex may cause fetal harm.



Active ingredient matches for Paronex:

Paroxetine in Switzerland.

Paroxetine hydrochloride in Switzerland.


Unit description / dosage (Manufacturer)Price, USD
Tablet, Film-Coated; Oral; Paroxetine Hydrochloride 20 mg
Tablet, Film-Coated; Oral; Paroxetine Hydrochloride 40 mg
Tablets, Film-Coated; Oral; Paroxetine Hydrochloride 20 mg
Tablets, Film-Coated; Oral; Paroxetine Hydrochloride 40 mg

List of Paronex substitutes (brand and generic names):

Paronet 25mg Tablet CR (Medo Pharma)$ 0.20
Paropex 12.5mg Tablet CR (Shilpex Pharmysis)$ 0.14
Paropex 25mg Tablet CR (Shilpex Pharmysis)$ 0.20
PAROPEX-CR-12.5 TABLET 1 strip / 10 tablet crs each (Shilpex Pharmysis)$ 1.25
PAROPEX-CR-25 TABLET 1 strip / 10 tablet crs each (Shilpex Pharmysis)$ 1.97
PAROT 10MG TABLET 1 strip / 10 tablets each (ZDL(Zodiacal) Pharmaceutics Pvt.Ltd)$ 1.21
PAROT 20MG TABLET 1 strip / 10 tablets each (ZDL(Zodiacal) Pharmaceutics Pvt.Ltd)$ 1.66
PAROT 40MG TABLET 1 strip / 10 tablets each (ZDL(Zodiacal) Pharmaceutics Pvt.Ltd)$ 2.75
PAROT CR 12.5MG TABLET 1 strip / 10 tablets each (ZDL(Zodiacal) Pharmaceutics Pvt.Ltd)$ 1.40
Parot 12.5mg Tablet CR (ZDL(Zodiacal) Pharmaceutics Pvt.Ltd)$ 0.14
Parot 20mg Tablet (ZDL(Zodiacal) Pharmaceutics Pvt.Ltd)$ 0.17
Parot 25mg Tablet CR (ZDL(Zodiacal) Pharmaceutics Pvt.Ltd)$ 0.18
Parot 40mg Tablet (ZDL(Zodiacal) Pharmaceutics Pvt.Ltd)$ 0.27
PAROT CR 25MG TABLET 1 strip / 10 tablets each (ZDL(Zodiacal) Pharmaceutics Pvt.Ltd)$ 1.77
Tablet; Oral; Paroxetine Hydrochloride 20 mg (Cipla)
Tablet; Oral; Paroxetine Hydrochloride 30 mg (Cipla)
PAROTIN Capsule/ Tablet / 20mg / 10 units (Cipla)$ 1.58
PAROTIN Capsule/ Tablet / 40mg / 10 units (Cipla)$ 2.79
PAROTIN Capsule/ Tablet / 10mg / 10 units (Cipla)$ 1.08
PAROTIN Modified Release Capsule/ Tablet / 12.5mg / 10 units (Cipla)$ 1.27
PAROTIN Capsule/ Tablet / 30mg / 10 units (Cipla)$ 2.21
PAROTIN Modified Release Capsule/ Tablet / 25mg / 10 units (Cipla)$ 1.75
10 mg x 10's (Cipla)$ 1.16
20 mg x 10's (Cipla)$ 1.69
30 mg x 10's (Cipla)$ 2.21
40 mg x 10's (Cipla)$ 2.79
Parotin 75 mg x 100's (Cipla)
Parotin 75 mg x 1000's (Cipla)
Parotin 10mg FC-TAB / 10 (Cipla)$ 1.16
Parotin 20mg FC-TAB / 10 (Cipla)$ 1.69
Parotin 30mg FC-TAB / 10 (Cipla)$ 2.21
Parotin 40mg FC-TAB / 10 (Cipla)$ 2.79
Parotin 10 mg x 10's (Cipla)
Parotin 20 mg x 30's (Cipla)
Tablets, Film-Coated; Oral; Paroxetine Hydrochloride 10 mg (Cipla)
Tablets, Film-Coated; Oral; Paroxetine Hydrochloride 20 mg (Cipla)
Tablets, Film-Coated; Oral; Paroxetine Hydrochloride 30 mg (Cipla)

References

  1. DailyMed. "PAROXETINE MESYLATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailymed/se... (accessed September 18, 2017).
  2. PubChem. "paroxetine". https://pubchem.ncbi.nlm.nih.gov/compoun... (accessed September 18, 2017).

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