Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/755
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Paroxetine (Tablet)
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| dailymed-instance:dosage |
Major Depressive Disorder:<br/>Usual Initial Dosage:<br/>Maintenance Therapy:<br/>Obsessive Compulsive Disorder:<br/>Usual Initial Dosage:<br/>Maintenance Therapy:<br/>Panic Disorder:<br/>Usual Initial Dosage:<br/>Maintenance Therapy:<br/>Generalized Anxiety Disorder:<br/>Usual Initial Dosage:<br/>Maintenance Therapy:<br/>Special Populations:<br/>Treatment of Pregnant Women During the Third Trimester:<br/>Dosage for Elderly or Debilitated Patients, and Patients With Severe Renal or Hepatic Impairment:<br/>Switching Patients to or From a Monoamine Oxidase Inhibitor:<br/>Discontinuation of Treatment With Paroxetine Tablets:
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| dailymed-instance:clinicalP... |
Pharmacodynamics:<br/>Pharmacokinetics:<br/>Absorption and Distribution:<br/>Metabolism and Excretion:<br/>Other Clinical Pharmacology Information:<br/>Specific Populations:<br/>Drug-Drug Interactions:<br/>Clinical Trials:<br/>Major Depressive Disorder:<br/>Obsessive Compulsive Disorder:<br/>Panic Disorder:<br/>Generalized Anxiety Disorder:
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| dailymed-instance:boxedWarn... |
Suicidality in Children and Adolescents:
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| dailymed-instance:inactiveI... |
dailymed-ingredient:D&C_Yellow_#10_Aluminum_Lake,
dailymed-ingredient:Dibasic_calcium_phosphate_anhydrous,
dailymed-ingredient:Dibasic_calcium_phosphate_dihydrate,
dailymed-ingredient:FD&C_Yellow_#6_Aluminum_Lake,
dailymed-ingredient:Hypromellose,
dailymed-ingredient:Lactose_monohydrate,
dailymed-ingredient:Magnesium_stearate,
dailymed-ingredient:Polyethylene_glycol,
dailymed-ingredient:Polysorbate_80,
dailymed-ingredient:Sodium_starch_glycolate,
dailymed-ingredient:Titanium_dioxide
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| dailymed-instance:precautio... |
General:<br/>Activation of Mania/Hypomania:<br/>Seizures:<br/>Discontinuation of Treatment With Paroxetine Tablets:<br/>Akathisia:<br/>Hyponatremia: Signs and symptoms of hyponatremia include headache, difficulty concentrating, memory impairment, confusion, weakness, and unsteadiness, which may lead to falls. Signs and symptoms associated with more severe and/or acute cases have included hallucination, syncope, seizure, coma, respiratory arrest, and death.<br/>Abnormal Bleeding:<br/>Use in Patients With Concomitant Illness:<br/>Information for Patients: Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with paroxetineand should counsel them in its appropriate use. A patient Medication Guide about���Antidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidal Thoughts or Actions���is available for paroxetine. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document. Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking paroxetine.<br/>Clinical Worsening and Suicide Risk:<br/>Drugs That Interfere With Hemostasis (e.g., NSAIDs, Aspirin, and Warfarin):<br/>Interference With Cognitive and Motor Performance:<br/>Completing Course of Therapy:<br/>Concomitant Medication:<br/>Alcohol:<br/>Pregnancy:<br/>Nursing:<br/>Laboratory Tests: There are no specific laboratory tests recommended.<br/>Drug Interactions:<br/>Tryptophan:<br/>Monoamine Oxidase Inhibitors:<br/>Pimozide:<br/>Serotonergic Drugs:<br/>Thioridazine:<br/>Warfarin:<br/>Triptans:<br/>Drugs Affecting Hepatic Metabolism:<br/>Cimetidine:<br/>Phenobarbital:<br/>Phenytoin:<br/>Drugs Metabolized by CYP2D6:<br/>Drugs Metabolized by Cytochrome CYP3A4:<br/>Tricyclic Antidepressants (TCAs):<br/>Drugs Highly Bound to Plasma Protein:<br/>Drugs That Interfere With Hemostasis (e.g., NSAIDs, Aspirin, and Warfarin):<br/>Alcohol:<br/>Lithium:<br/>Digoxin:<br/>Diazepam:<br/>Procyclidine:<br/>Beta-Blockers:<br/>Theophylline:<br/>Fosamprenavir/Ritonavir:<br/>Electroconvulsive Therapy (ECT):<br/>Carcinogenesis, Mutagenesis, Impairment of Fertility:<br/>Carcinogenesis:<br/>Mutagenesis:<br/>Impairment of Fertility:<br/>Pregnancy: See WARNINGS���Usage in Pregnancy: Teratogenic and Nonteratogenic Effects.<br/>Labor and Delivery: The effect of paroxetine on labor and delivery in humans is unknown.<br/>Nursing Mothers:<br/>Pediatric Use:<br/>Geriatric Use:
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Human Experience:<br/>Overdosage Management:
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| dailymed-instance:genericMe... |
Paroxetine hydrochloride
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| dailymed-instance:fullName |
Paroxetine (Tablet)
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| dailymed-instance:adverseRe... |
Associated With Discontinuation of Treatment:<br/>Commonly Observed Adverse Events:<br/>Major Depressive Disorder:<br/>Obsessive Compulsive Disorder:<br/>Panic Disorder:<br/>Generalized Anxiety Disorder:<br/>Incidence in Controlled Clinical Trials:<br/>Major Depressive Disorder: 2. Includes mostly���lump in throat���and���tightness in throat.��� 3. Percentage corrected for gender. 4. Mostly���ejaculatory delay.��� 5. Includes���anorgasmia,������erectile difficulties,������delayed ejaculation/orgasm,���and���sexual dysfunction,���and���impotence.��� 6. Includes mostly���difficulty with micturition���and���urinary hesitancy.��� 7. Includes mostly���anorgasmia���and���difficulty reaching climax/orgasm.���<br/>Obsessive Compulsive Disorder and Panic Disorder:<br/>Generalized Anxiety Disorder:<br/>Dose Dependency of Adverse Events:<br/>Adaptation to Certain Adverse Events:<br/>Male and Female Sexual Dysfunction With SSRIs:<br/>Weight and Vital Sign Changes:<br/>ECG Changes:<br/>Liver Function Tests:<br/>Hallucinations:<br/>Other Events Observed During the Premarketing Evaluation of Paroxetine:<br/>Body as a Whole:<br/>Cardiovascular System:<br/>Digestive System:<br/>Endocrine System:<br/>Hemic and Lymphatic Systems:<br/>Metabolic and Nutritional:<br/>Musculoskeletal System:<br/>Nervous System:<br/>Respiratory System:<br/>Skin and Appendages:<br/>Special Senses:<br/>Urogenital System:<br/>Postmarketing Reports:
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| dailymed-instance:warning |
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 to 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. 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 , for a description of the risks of discontinuation of paroxetine. 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. Prescriptions for paroxetine should be written for the smallest quantity of tablets consistent with good patient management, in order to reduce the risk of overdose.<br/>Screening Patients for Bipolar Disorder:<br/>Potential for Interaction With Monoamine Oxidase Inhibitors:<br/>Serotonin Syndrome:<br/>Potential Interaction With Thioridazine:<br/>Usage in Pregnancy:<br/>Teratogenic Effects:<br/>Animal Findings:<br/>Nonteratogenic Effects: Infants exposed to SSRIs in late pregnancy may have an increased risk for persistent pulmonary hypertension of the newborn (PPHN). PPHN occurs in 1 to 2 per 1,000 live births in the general population and is associated with substantial neonatal morbidity and mortality. In a retrospective case-control study of 377 women whose infants were born with PPHN and 836 women whose infants were born healthy, the risk for developing PPHN was approximately six-fold higher for infants exposed to SSRIs after the 20week of gestation compared to infants who had not been exposed to antidepressants during pregnancy. There is currently no corroborative evidence regarding the risk for PPHN following exposure to SSRIs in pregnancy; this is the first study that has investigated the potential risk. The study did not include enough cases with exposure to individual SSRIs to determine if all SSRIs posed similar levels of PPHN risk. There have also been postmarketing reports of premature births in pregnant women exposed to paroxetine or other SSRIs.
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Major Depressive Disorder:<br/>Obsessive Compulsive Disorder:<br/>Panic Disorder:<br/>Generalized Anxiety Disorder:
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| dailymed-instance:name |
Paroxetine
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