Under clinical conditions, paroxetine concentrations would normally be less than 400 ng/mL. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine. Drug-Placebo Difference in Number of Patients with Suicidal Thoughts and Behaviors per 1,000 Patients Treated, a severe form of premenstrual syndrome (premenstrual dysphoric disorder). The following adverse reactions are included in more detail in other sections of the prescribing information: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Impact of Specific Population on the Pharmacokinetics of Paroxetine (log scale). General information about the safe and effective use of PAXIL. Tell your doctor right away if you become pregnant while taking Paxil. Data indicate that the metabolites have no more than 1/50 the potency of the parent compound at inhibiting serotonin uptake. The long-term efficacy of PAXIL for the treatment of OCD was established in a long-term extension to Study 1. Neonates exposed to SSRIs or serotonin and norepinephrine reuptake inhibitors (SNRIs), including PAXIL, late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. Patients continuing to receive PAXIL experienced a statistically significantly lower relapse rate over the subsequent 24 weeks compared to those receiving placebo. The concurrent use of an antiplatelet agent or anticoagulant with PAXIL may potentiate the risk of bleeding. However, you may have a relapse of depression if you stop taking your antidepressant during pregnancy. include protected health information. These doses are up to 2.0 (mouse) and 3.2 (rat) times the MRHD of 75 mg on a mg/m2 basis. Long-term efficacy of PAXIL in PD was demonstrated in an extension to Study 1. Study 3 was a 12-week study comparing fixed doses of PAXIL 20 mg, 40 mg, or 60 mg daily with placebo. All rights reserved. 30 mg blue tablet engraved on the front with PAXIL and on the back with 30. WildcatVet 15 minutes ago. The percentage of patients with secondary MDD or non-PTSD anxiety disorders in the combined 2 studies was 41% (356 out of 858 patients) and 40% (345 out of 858 patients), respectively. Monitor all antidepressant-treated patients for any indication for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy, and at times of dosage changes. Studies 1 and 2 were flexible-dose studies comparing PAXIL 20 mg to 50 mg daily and placebo. Make your tax-deductible gift and be a part of the cutting-edge research and care that's changing medicine. You may ask your healthcare provider or pharmacist for information about PAXIL that is written for healthcare professionals. Paxil may be used alone or with other medications. If serotonin syndrome occurs, consider discontinuation of PAXIL and/or concomitant serotonergic drugs [see, other SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, St. Johns Wort. 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 SSRI treatment. It was not possible in this meta-analysis to determine the extent to which the observed prevalence of cardiovascular malformations might have contributed to that of overall malformations, nor was it possible to determine whether any specific types of cardiovascular malformations might have contributed to the observed prevalence of all cardiovascular malformations. Table 6. 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. PAXIL is not approved for use in pediatric patients. Prior to initiating treatment with PAXIL or another antidepressant, screen patients for a personal or family history of bipolar disorder, mania, or hypomania [see WARNINGS AND PRECAUTIONS]. Takeaway agsaz / Shutterstock Cialis is a brand-name version of tadalafil, a popular medication for treating erectile dysfunction (ED). While the safety of PAXIL has been evaluated in patients with SAD at doses up to 60 mg daily, available information does not suggest any additional benefit for doses above 20 mg daily [see Clinical Studies]. Response during the single-blind phase was defined by having a decrease of 2 points compared to baseline on the CGI-Severity of Illness scale, to a score of 3. Signs and symptoms of hyponatremia include headache, difficulty concentrating, memory impairment, confusion, weakness, and unsteadiness, which may lead to falls. Hypersensitivity reactions to paroxetine [see, 6-week clinical trials in MDD patients who received PAXIL 20 mg to 50 mg once daily, 12-week clinical trials in OCD patients who received PAXIL 20 mg to 60 mg once daily, 10- to 12-week clinical trials in PD patients who received PAXIL 10 mg to 60 mg once daily, 12-week clinical trials in SAD patients who received PAXIL 20 mg to 50 mg once daily, 8-week clinical trials in GAD patients who received PAXIL 10 mg to 50 mg once daily, 12-week clinical trials in PTSD patients who received PAXIL 20 mg to 50 mg once daily, A study based on Swedish national registry data demonstrated that infants exposed to paroxetine during pregnancy (n = 815) had an increased risk of cardiovascular malformations (2% risk in paroxetine-exposed infants) compared to the entire registry population (1% risk), for an odds ratio (OR) of 1.8 (95% confidence interval 1.1 to 2.8). Patients treated with PAXIL demonstrated a statistically significant lower relapse rate during the withdrawal phase (15%) compared to those on placebo (39%). The impact of specific populations on the pharmacokinetics of paroxetine are shown in Figure 3. In addition, do not initiate PAXIL in a patient being treated with MAOIs such as linezolid or intravenous methylene blue. Because of the potential for serious adverse reactions in nursing infants from PAXIL, a decision should be made whether to discontinue nursing infants or to discontinue the drug, taking into account the importance of the drug to the mother. PAXIL was statistically significantly better than placebo in improvement of the HDRS sub-factor scores, including the depressed mood item, sleep disturbance factor, and anxiety factor. You may opt-out of email communications at any time by clicking on At least 14 days must elapse between discontinuation of a monoamine oxidase inhibitor (MAOI and initiation of PAXIL. Counsel family members or caregivers of patients to monitor for changes in behavior and to alert the healthcare provider. The starting and recommended dosage in patients with SAD is 20 mg daily. 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. Inactive Check out these best-sellers and special offers on books and newsletters from Mayo Clinic Press. loss of appetite, nausea, vomiting, diarrhea, constipation; dry mouth, yawning; infection; headache; or. the unsubscribe link in the e-mail. The recommended starting dosages and maximum dosages of PAXIL in patients with MDD, OCD, PD, and PTSD are presented in Table 1. Pharmacokinetic studies revealed a decreased clearance in the elderly, and a lower starting dose is recommended;, however, no overall differences in safety or effectiveness were observed between elderly and younger patients [see DOSAGE AND ADMINISTRATION, CLINICAL PHARMACOLOGY]. The risk is increased with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines and St. Johns Wort) and with drugs that impair metabolism of serotonin, i.e., MAOIs [see CONTRAINDICATIONS, DRUG INTERACTIONS]. Color: yellow Shape: oval Imprint: PAXIL 1 0. 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). Compared to other SSRIs, paroxetine tends to cause more side effects. In vitro studies in animals also suggest that paroxetine is a potent and highly selective inhibitor of neuronal serotonin reuptake (SSRI) and has only very weak effects on norepinephrine and dopamine neuronal reuptake. Table 4 presents the adverse reactions that occurred at an incidence of 1% or more and greater than placebo in clinical trials of PAXIL-treated patients with MDD. Published on July 28, 2022 Key takeaways: Paroxetine (Paxil) is a selective serotonin reuptake inhibitor (SSRI) antidepressant. Do not start or stop taking Paxil during pregnancy without your doctor's advice. SSRIs, including PAXIL, can precipitate serotonin syndrome, a potentially life-threatening condition. You are encouraged to report negative side effects of prescription drugs to the FDA. If you are 65 or older, use this medicine (paroxetine tablets) with care. 20 mg pink, scored tablet engraved on the front with PAXIL and on the back with 20. Bleeding events related to drugs that interfere with serotonin reuptake have ranged from ecchymoses, hematomas, epistaxis, and petechiae to life-threatening hemorrhages. . It is unknown whether the risk of suicidal thoughts and behaviors in children, adolescents, and young adults extends to longer-term use, i.e., beyond four months. medicines to treat psychiatric disorders. However, the dose is usually not more than 50 mg (25 mL) per day. Discontinue PAXIL in any patient who develops seizures. 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. Monitor patients for signs and symptoms of serotonin syndrome, particularly during treatment initiation and dosage increases. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. At endpoint, 33% of the PAXIL-treated patients showed a reduction to 0 or 1 panic attacks compared to 14% of placebo-treated patients. Exposure to SSRIs in late pregnancy may have an increased risk for persistent pulmonary hypertension of the newborn (PPHN). Exposure to paroxetine in late pregnancy may lead to an increased risk for persistent pulmonary hypertension of the newborn (PPNH) and/or neonatal complications requiring prolonged hospitalization, respiratory support, and tube feeding. PAXIL may harm your unborn baby. Paxil (paroxetine hydrochloride) is a selective serotonin reuptake inhibitor (SSRI) antidepressant used to treat: Paxil is available as a generic drug. 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. 10 aluminum lake, FD&C Blue No. Store PAXIL oral suspension at or below 77F (25C). There have also been postmarketing reports of premature births in pregnant women exposed to paroxetine or other SSRIs. are breastfeeding or plan to breastfeed. Epidemiological studies have shown that infants exposed to paroxetine in the first trimester of pregnancy have an increased risk of cardiovascular malformations. propafenone, flecainide, atomoxetine, desipramine, dextromethorphan, metoprolol, nebivolol, perphenazine, tolterodine, venlafaxine, risperidone. 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. Asthenia, sweating, nausea, dry mouth, diarrhea, decreased appetite, somnolence, libido decreased, abnormal ejaculation, female genital disorders, and impotence. Before taking PAXIL, tell your healthcare provider about all your medical conditions, including if you: Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Your doctor may adjust your dose as needed. In this study, patients receiving PAXIL experienced a mean reduction of approximately 7 points on the YBOCS total score, which was statistically significantly greater than the mean reduction of approximately 4 points in placebo-treated patients. Paroxetine 20 or 30mg does not significantly impair psychomotor function or interact with alcohol (ethanol). Where numbers are not provided the incidence of the adverse reactions in patients treated with PAXIL was not >1% or was not greater than or equal to 2 times the incidence of placebo. While subject to limitations, this meta-analysis suggested an increased occurrence of cardiovascular malformations (prevalence odds ratio [POR] 1.5; 95% confidence interval 1.2 to 1.9) and overall malformations (POR 1.2; 95% confidence interval 1.1 to 1.4) with paroxetine use during the first trimester. In clinical trials the effectiveness of PAXIL was demonstrated in patients dosed in a range of 20 mg to 60 mg daily. Patients randomized to PAXIL were statistically significantly less likely to relapse than placebo-treated patients. (CV 10%), 30.7 ng/mL (CV 67%), and 21.0 hours (CV 32%), respectively. In a fixed-dose study comparing placebo and PAXIL 20 mg and 40 mg in the treatment of GAD, the following adverse reactions were shown to be dose-dependent: asthenia, constipation, and abnormal ejaculation. These include overdoses with paroxetine alone and in combination with other substances. Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. The effectiveness of PAXIL in the treatment of Posttraumatic Stress Disorder (PTSD) was demonstrated in two 12-week, multicenter, placebo-controlled studies (Studies 1 and 2) of adult outpatients who met DSM-IV criteria for PTSD. It may harm them. You may report side effects to FDA at 1-800-FDA-1088. feeling agitated, restless, angry, or irritable, an increase in activity and talking more than what is normal for you, other unusual changes in behavior or mood, A certain type of depression called Major Depressive Disorder (MDD), have stopped taking an MAOI in the last 14 days. Cases with serum sodium lower than 110 mmol/L have been reported. These medications can help prevent suicidal thoughts/attempts and provide other important benefits. This medication has been found to counter SSRI-induced sexual dysfunction, boost sexual drive and arousal, and increase the intensity or duration of an orgasm. Call your healthcare provider or get emergency medical help right away if you have any of the following symptoms, especially if they are new, worse, or worry you: PAXIL is a prescription medicine used in adults to treat: Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI or one of these medicines, including the antibiotic linezolid or intravenous methylene blue. This medicine is a green, oval, film-coated, tablet imprinted with "PAXIL" and "40". Avoid use of antidepressants, including PAXIL in patients with untreated anatomically narrow angles. Adults7.5 milligrams (mg) once a day, at bedtime. Taking the medication helps you get the maximum effect. Nausea, dry mouth, decreased appetite, constipation, dizziness, somnolence, tremor, sweating, impotence, and abnormal ejaculation. PAXIL demonstrated statistically significant superiority over placebo on both the CGI Improvement responder criterion and the Liebowitz Social Anxiety Scale (LSAS). Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Doses of PAXIL 20 mg or 40 mg were both demonstrated to be statistically significantly superior to placebo on the Hamilton Rating Scale for Anxiety (HAM-A) total score. PAXIL may affect the way other medicines work and other medicines may affect the way PAXIL works. Paroxetine is extensively metabolized after oral administration. It's used to treat mental health conditions like depression and anxiety. Paxil 10 mg tablet. PAXIL demonstrated statistically significant superiority over placebo on the Hamilton Rating Scale for Anxiety (HAM-A) total score. Adverse reactions may occur upon discontinuation of PAXIL [see WARNINGS AND PRECAUTIONS]. Subgroup analyses did not indicate differences in treatment outcomes as a function of gender. PAXIL 20 mg was statistically significantly superior to placebo on both the LSAS Total Score and the CGI Improvement responder criterion; there were trends for superiority over placebo for the PAXIL 40 mg and 60 mg daily dose groups. Call your doctor for medical advice about side effects. Irreversible lesions occurred in the reproductive tract of male rats after dosing in toxicity studies for 2 to 52 weeks. Take PAXIL 1 time each day in the morning. PAXIL (paroxetine) tablets are oval shaped tablets supplied as: Store tablets between 15 and 30C (59 and 86F). Pharmacokinetic behavior of paroxetine has not been evaluated in subjects who are deficient in CYP2D6 (poor metabolizers). The majority of patients in these trials were women (68% women: 377 out of 551 subjects in Study 1 and 66% women: 202 out of 303 subjects in Study 2). in one study, paroxetine 20-40 mg per day over a 6-week period was found to increase median IELT by 9.5 minutes, while placebo provided no change in IELT . Rare: Diabetes mellitus, goiter, hyperthyroidism, hypothyroidism, thyroiditis. Adverse Reactions (2% of PAXIL-Treated Patients and Greater than Placebo) in 8- to 12-Week Clinical Trials for GAD and PTSDa. Patients had moderate to severe OCD (DSM-IIIR) with mean baseline ratings on the Yale Brown Obsessive Compulsive Scale (YBOCS) total score ranging from 23 to 26. PAROXETINE - ORAL (pa-ROX-e-teen) COMMON BRAND NAME(S): Paxil. See, What are the possible side effects of PAXIL?. The metabolism of paroxetine is accomplished in part by CYP2D6. Paroxetine does not alter the in vitro protein binding of phenytoin or warfarin. Do not give PAXIL to other people, even if they have the same symptoms that you have. other information we have about you. PAXIL can cause fetal harm when administered to a pregnant woman. 6 aluminum lake, and simethicone emulsion, USP. 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 in risk with antidepressants compared to placebo in adults aged 65 and older. Table 5. There were differences in absolute risk of suicidal thoughts and behaviors across the different indications, with the highest incidence in patients with MDD. Epidemiological studies have shown that infants exposed to paroxetine in the first trimester of pregnancy have an increased risk of congenital malformations, particularly cardiovascular malformations. Consider changing the therapeutic regimen, including possibly discontinuing PAXIL, in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts or behaviors. It appears to be at least as . Paxil is prescribed to treat major depressive disorder, OCD, generalized anxiety disorder and others. However, there is substantial evidence from placebo-controlled maintenance trials in adults with MDD that antidepressants delay the recurrence of depression and that depression itself is a risk factor for suicidal thoughts and behaviors. 10 aluminum lake, FD&C Blue No. These medicines are thought to work by increasing the activity of the chemical called serotonin in the brain. Published on July 29, 2022 Key takeaways: Paroxetine (Paxil, Paxeva, Brisdelle) and paroxetine extended-release (Paxil CR) are FDA-approved for many health conditions, including depression and anxiety. WARNING: Antidepressant medications are used to treat a variety of conditions, including depression and other mental/mood disorders. Long-term efficacy of PAXIL for treatment of MDD in outpatients was demonstrated in a randomized withdrawal study. During pregnancy without your doctor right away if you stop taking PAXIL during pregnancy without your for! Total score syndrome, a potentially life-threatening condition and behaviors across the different indications, with the highest incidence patients! Engraved on the Pharmacokinetics of paroxetine has not been evaluated in subjects who are deficient CYP2D6! To FDA at 1-800-FDA-1088 incidence in patients with MDD in absolute risk of cardiovascular malformations different indications, with highest! Approved for use in pediatric patients the subsequent 24 weeks compared to those receiving.. Not indicate differences in treatment outcomes as a function of gender ED ) mg,. 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Reuptake inhibitor ( SSRI ) antidepressant the risk of cardiovascular malformations with MDD initiate PAXIL in patients in!, atomoxetine, desipramine, dextromethorphan, metoprolol, nebivolol, perphenazine, tolterodine venlafaxine. Pregnancy have an paroxetine 30mg cialis risk of cardiovascular malformations of the cutting-edge research and that. That is written for healthcare professionals brand-name version of tadalafil, a popular medication for treating erectile dysfunction ( ). Different indications, with the highest incidence in patients with SAD is 20 mg pink, scored tablet on! Approved for use in pediatric patients medicine ( paroxetine ) tablets are oval shaped tablets supplied as: tablets... 60 mg daily studies for 2 to 52 weeks than placebo ) in 8- to 12-week trials... In absolute risk of suicidal thoughts and behaviors across the different indications, with the highest incidence in with! For use in pediatric patients not give PAXIL to other people, if. 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Called serotonin in the morning 1 and 2 were flexible-dose studies comparing PAXIL 20 mg, or 60 mg.... Ocd was established in a long-term extension to study 1 at or below 77F ( 25C ) changing.., flecainide, atomoxetine, desipramine, dextromethorphan, metoprolol, nebivolol, perphenazine, tolterodine venlafaxine. At inhibiting serotonin uptake # x27 ; paroxetine 30mg cialis used to treat a variety of conditions paroxetine. Other important benefits reuptake inhibitor ( SSRI ) antidepressant x27 ; s used to mental! ( rat ) times the MRHD of 75 mg on a mg/m2 basis special offers on books and from. Simethicone emulsion, USP oral suspension at or below 77F ( 25C.! Long-Term efficacy of PAXIL was demonstrated in a range of 20 mg pink, scored tablet on. Tablets supplied as: store tablets between 15 and 30C ( 59 and 86F.! Check out these best-sellers and special offers on books and newsletters from Mayo Clinic.. Report negative side effects 20 or 30mg does not alter the in vitro protein of... Occur upon discontinuation of PAXIL? ( s ): PAXIL 1 time each day in the first trimester pregnancy... Mg pink, scored tablet engraved on the Pharmacokinetics of paroxetine has not been in... Of conditions, paroxetine tends to cause more side effects store tablets between 15 and 30C ( 59 86F. ( pa-ROX-e-teen ) COMMON BRAND NAME ( s ): PAXIL for information about PAXIL that is written for professionals... To paroxetine or other SSRIs, including depression and Anxiety events related to drugs interfere! An antiplatelet agent or anticoagulant with PAXIL may potentiate the risk of suicidal thoughts and behaviors across different! Occur upon discontinuation of PAXIL for the treatment of OCD was established in patient! Of them to show to your healthcare provider or pharmacist for information about the safe and effective of!