Serotonin syndrome symptoms may include mental status changes e. Patients should be monitored for the emergence of serotonin syndrome. No reports involved the administration of methylene blue by other routes such as oral tablets or local tissue injection or at lower doses. John's Wort is clinically warranted, be aware of a potential increased risk for serotonin syndrome, particularly during treatment initiation and dose increases.
Treatment with PAXIL and any concomitant serotonergic agents should be discontinued immediately if the above events occur and supportive symptomatic treatment should be initiated.
Angle-Closure Glaucoma The pupillary dilation that occurs following use of many antidepressant drugs including Paxil may trigger an angle closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy.
Potential Interaction With Thioridazine Thioridazine administration alone produces prolongation of the QTc interval, which is associated with serious ventricular arrhythmias, such as torsade de pointes-type arrhythmias, and sudden death.
This effect appears to be dose related. An in vivo study suggests that drugs which inhibit CYP2D6, such as paroxetine, will elevate plasma levels of thioridazine. Usage In Pregnancy Teratogenic Effects Epidemiological studies have shown that infants exposed to paroxetine in the first trimester of pregnancy have an increased risk of congenital malformations, particularly cardiovascular malformations.
The findings from these studies are summarized below: No increase in the risk of overall congenital malformations was seen in the paroxetine-exposed infants.
The cardiac malformations in the paroxetine-exposed infants were primarily ventricular septal defects VSDs and atrial septal defects ASDs. Septal defects range in severity from those that resolve spontaneously to those which require surgery. This study showed a trend towards an increased risk for cardiovascular malformations for paroxetine risk of 1. Of the 12 paroxetine-exposed infants with cardiovascular malformations, 9 had VSDs. In one study the odds ratio was 2.
Other studies have found varying results as to whether there was an increased risk of overall, cardiovascular, or specific congenital malformations. While subject to limitations, this meta-analysis suggested an increased occurrence of cardiovascular malformations prevalence odds ratio [POR] 1. It was not possible in this meta-analysis to determine the extent to which the observed prevalence of cardiovascular malformations might have contributed to that of overall malformations, nor was it possible to determine whether any specific types of cardiovascular malformations might have contributed to the observed prevalence of all cardiovascular malformations.
If a patient becomes pregnant while taking paroxetine, she should be advised of the potential harm to the fetus. For women who intend to become pregnant or are in their first trimester of pregnancy, paroxetine should only be initiated after consideration of the other available treatment options.
These studies have revealed no evidence of teratogenic effects. However, in rats, there was an increase in pup deaths during the first 4 days of lactation when dosing occurred during the last trimester of gestation and continued throughout lactation. The no-effect dose for rat pup mortality was not determined. The cause of these deaths is not known.
Such complications can arise immediately upon delivery. Reported clinical findings have included respiratory distress, cyanosis , apnea , seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia , hypotonia , hypertonia , hyperreflexia, tremor, jitteriness, irritability, and constant crying. PPHN occurs in 1 - 2 per 1, live births in the general population and is associated with substantial neonatal morbidity and mortality. Other studies do not show a significant statistical association.
Physicians should also note the results of a prospective longitudinal study of pregnant women with a history of major depression , who were either on antidepressants or had received antidepressants less than 12 weeks prior to their last menstrual period , and were in remission.
Women who discontinued antidepressant medication during pregnancy showed a significant increase in relapse of their major depression compared to those women who remained on antidepressant medication throughout pregnancy. When treating a pregnant woman with PAXIL, the physician should carefully consider both the potential risks of taking an SSRI, along with the established benefits of treating depression with an antidepressant.
In a subset of patients classified as bipolar, the rate of manic episodes was 2. As with all drugs effective in the treatment of major depressive disorder, PAXIL should be used cautiously in patients with a history of mania. Seizures During premarketing testing, seizures occurred in 0. PAXIL should be used cautiously in patients with a history of seizures.
It should be discontinued in any patient who develops seizures. Abnormal dreams , paresthesia , and dizziness. In the majority of patients, these events were mild to moderate and were self-limiting and did not require medical intervention.
Dysphoric mood, irritability, agitation, dizziness, sensory disturbances e. While these events are generally self-limiting, there have been reports of serious discontinuation symptoms. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered.
However, other studies have failed to demonstrate such a risk. It is uncertain whether the coadministration of paroxetine and tamoxifen has a significant adverse effect on the efficacy of tamoxifen. One study suggests that the risk may increase with longer duration of coadministration.
When tamoxifen is used for the treatment or prevention of breast cancer, prescribers should consider using an alternative antidepressant with little or no CYP2D6 inhibition. Akathisia The use of paroxetine or other SSRIs has been associated with the development of akathisia, which is characterized by an inner sense of restlessness and psychomotor agitation such as an inability to sit or stand still usually associated with subjective distress.
This is most likely to occur within the first few weeks of treatment. In many cases, this hyponatremia appears to be the result of the syndrome of inappropriate antidiuretic hormone secretion SIADH.
Discontinuation of PAXIL should be considered in patients with symptomatic hyponatremia and appropriate medical intervention should be instituted. Signs and symptoms of hyponatremia include headache, difficulty concentrating, memory impairment, confusion, weakness, and unsteadiness , which may lead to falls. Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs, warfarin, and other anticoagulants may add to this risk.
Case reports and epidemiological studies case-control and cohort design have demonstrated an association between use of drugs that interfere with serotonin reuptake and the occurrence of gastrointestinal bleeding. Patients should be cautioned about the risk of bleeding associated with the concomitant use of paroxetine and NSAIDs , aspirin, or other drugs that affect coagulation.
Bone Fracture 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.
Caution is advisable in using PAXIL in patients with diseases or conditions that could affect metabolism or hemodynamic responses.
A few cases of acute angle closure glaucoma associated with paroxetine therapy have been reported in the literature. As mydriasis can cause acute angle closure in patients with narrow angle glaucoma, caution should be used when PAXIL is prescribed for patients with narrow angle glaucoma. PAXIL has not been evaluated or used to any appreciable extent in patients with a recent history of myocardial infarction or unstable heart disease.
Patients with these diagnoses were excluded from clinical studies during the product's premarket testing. Patients should be cautioned about the risk of serotonin syndrome with the concomitant use of PAXIL and triptans, tramadol, or other serotonergic agents.
Patients should be advised that taking Paxil can cause mild pupillary dilation, which in susceptible individuals, can lead to an episode of angle closure glaucoma. Pre-existing glaucoma is almost always open-angle glaucoma because angle closure glaucoma, when diagnosed, can be treated definitively with iridectomy. Open-angle glaucoma is not a risk factor for angle closure glaucoma. Patients may wish to be examined to determine whether they are susceptible to angle closure, and have a prophylactic procedure e.
Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with PAXIL and should counsel them in its appropriate use. 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.
Clinical Worsening And Suicide Risk 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. Drugs That Interfere With Hemostasis e. Interference With Cognitive And Motor Performance Any psychoactive drug may impair judgment, thinking, or motor skills.
A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine. After you stop taking paroxetine you must wait at least 14 days before you start taking an MAO inhibitor.
To make sure paroxetine is safe for you, tell your doctor if you have: Your doctor should check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms. Taking paroxetine during pregnancy may cause serious lung problems, a heart defect, or other complications in the baby.
However, you may have a relapse of depression or other treated condition if you stop taking your antidepressant. Tell your doctor right away if you become pregnant. Do not use Brisdelle if you are pregnant. Paroxetine can pass into breast milk and may cause side effects in the nursing baby.
You should not breast-feed while using this medicine. Paroxetine is not approved for use by anyone younger than 18 years old. How should I take paroxetine? Take paroxetine exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not take this medicine in larger or smaller amounts or for longer than recommended.
Do not crush, chew, or break an extended-release paroxetine tablet. Shake the paroxetine oral suspension liquid well just before you measure a dose. Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one. It may take up to 4 weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.
Do not stop using paroxetine suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using paroxetine. Follow your doctor's instructions about tapering your dose. Store paroxetine at room temperature away from moisture, heat, and light. Dosage Information in more detail What happens if I miss a dose?
No reports involved the administration of methylene blue by other routes such as oral tablets or local tissue injection or at lower doses. A gradual reduction in paroxetine dose rather than abrupt cessation is recommended whenever possible. If a patient becomes pregnant while taking paroxetine, she should be advised of the potential harm to the fetus, order paroxetine hcl. Do not use paroxetine within 14 days before or 14 days after you have used a MAO inhibitorsuch as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine. Prescriptions for PAXIL should be written for the smallest order of paroxetine consistent with good patient management, in order to reduce the risk of overdose. Pre-existing glaucoma is almost always open-angle glaucoma because angle closure glaucoma, when diagnosed, can be treated definitively with iridectomy. Paroxetine may impair your thinking or reactions. Brisdelle is hcl for treating any other conditions. This study showed a trend towards an increased risk for cardiovascular malformations for paroxetine risk of 1. The following symptoms, order paroxetine hcl, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivityakathisia psychomotor restlessnesshypomaniaand maniahave 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. Akathisia 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. Drugs That Interfere With Hemostasis e. Prescribers or order health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with PAXIL and should counsel them hcl its appropriate use. Mutagenesis Paroxetine produced no genotoxic effects in a battery of 5 in vitro and 2 in vivo assays that included the following: In many cases, this hyponatremia appears to be the result of the syndrome of inappropriate antidiuretic hormone secretion SIADH.
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