What happens if I overdose Mopart?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.
Proper storage of Mopart controlled-release tablets:
Store Mopart controlled-release tablets at or below 77 degrees F (25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Mopart controlled-release tablets out of the reach of children and away from pets.
Overdose of Mopart in details
Human Experience with Overdosage
There is limited clinical experience with Mopart Capsules overdosage in humans, as there were no overdoses reported in the clinical studies.
Spontaneous cases of deliberate or accidental overdosage during Mopart treatment have been reported; some of these cases were fatal and some of the fatalities appeared to involve Mopart alone. Of nonfatal cases with known outcome, most recovered without sequelae. The largest known ingestion involved 2000 mg of Mopart (267 times the maximum recommended daily dose) in a patient who recovered.
Commonly reported adverse reactions associated with Mopart overdosage include somnolence, coma, nausea, tremor, tachycardia, confusion, vomiting, and dizziness. Other notable signs and symptoms observed with overdoses involving Mopart (alone or with other substances) include mydriasis, convulsions (including status epilepticus), ventricular dysrhythmias (including torsades de pointes), hypertension, aggressive reactions, syncope, hypotension, stupor, bradycardia, dystonia, rhabdomyolysis, symptoms of hepatic dysfunction (including hepatic failure, hepatic necrosis, jaundice, hepatitis, and hepatic steatosis), serotonin syndrome, manic reactions, myoclonus, acute renal failure, and urinary retention.
Management of Overdosage
Treatment should consist of those general measures employed in the management of overdosage with any SSRI. Consult with a certified poison control center for up-to-date guidance and advice on treatment of overdosage.
Ensure an adequate airway, oxygenation, and ventilation. Monitor cardiac rhythm and vital signs. General supportive and symptomatic measures are also recommended. Induction of emesis is not recommended. In managing overdosage, consider the possibility of multiple drug involvement.
What should I avoid while taking Mopart?
Ask your doctor before taking a nonsteroidal anti-inflammatory drug (NSAID) for pain, arthritis, fever, or swelling. This includes aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib (Celebrex), diclofenac, indomethacin, meloxicam, and others. Using an NSAID with Mopart may cause you to bruise or bleed easily.
Drinking alcohol can increase some of the side effects of Mopart.
This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.
Mopart warnings
Suicidal Thoughts and Behaviors
Mopart Capsules are not approved for any psychiatric condition.
Antidepressants, including those that contain an SSRI, increase the risk of suicidal thinking and behavior (suicidality) in pediatric and young adult patients when used to treat major depressive disorder (MDD) and other psychiatric disorders. There is limited information regarding suicidality in women who use Mopart Capsules for treatment of VMS. The Mopart Capsules trials excluded women with a presence or history of previous psychiatric disorders.
Consider discontinuing Mopart Capsules in patients with worsening depression or those who experience 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.
All patients being treated with Mopart Capsules should be observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of treatment.
Anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania have been reported in patients being treated with antidepressants for MDD as well as for other psychiatric and nonpsychiatric indications. 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.
Families and caregivers of patients being treated with Mopart Capsules 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.
Serotonin Syndrome
The development of a potentially life-threatening serotonin syndrome has been reported with SSRIs, including Mopart, alone but particularly with concomitant use of serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, and St. John’s Wort), and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat depression and others such as linezolid and intravenous methylene blue).
Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Monitor patients for the emergence of serotonin syndrome.
The concomitant use of Mopart Capsules with MAOIs is contraindicated. Do not start Mopart Capsules in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue. All reports with methylene blue that provided information on the route of administration involved intravenous administration in the dose range of 1 mg/kg to 8 mg/kg. No reports involved the administration of methylene blue by other routes (such as oral tablets or local tissue injection) or at lower doses. There may be circumstances when it is necessary to initiate treatment with an MAOI such as linezolid or intravenous methylene blue in a patient taking Mopart Capsules. Mopart Capsules should be discontinued before initiating treatment with the MAOI.
If concomitant use of Mopart Capsules with other serotonergic drugs (e.g., triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, and St. John’s Wort) is clinically warranted, consider the increased risk of serotonin syndrome and carefully observe the patient, particularly during treatment initiation.
Discontinue Mopart Capsules and any concomitant serotonergic agents immediately if the above events occur and initiate supportive symptomatic treatment.
Potential Impact on Tamoxifen Efficacy
It is uncertain whether the co-administration of Mopart and tamoxifen has a significant adverse effect on the efficacy of tamoxifen. Some studies have shown that the efficacy of tamoxifen, as measured by the risk of breast cancer relapse/mortality, may be reduced when co-prescribed with Mopart as a result of Mopart’s irreversible inhibition of CYP2D6. However, other studies have failed to demonstrate such a risk. When tamoxifen is used for the treatment or prevention of breast cancer, weigh the likely benefit of Mopart Capsules for treating VMS vs. the risk of possible decreased tamoxifen effectiveness, and consider avoiding the concomitant use of Mopart Capsules for VMS treatment.
Abnormal Bleeding
SSRIs, including Mopart Capsules, may increase the risk of bleeding events. Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), warfarin, and other anticoagulants may add to this risk. Case reports and epidemiological studies (case-control and cohort design) have demonstrated an association between use of drugs that interfere with serotonin reuptake and the occurrence of gastrointestinal bleeding. Bleeding events related to SSRIs have ranged from ecchymosis, hematoma, epistaxis, and petechiae to life-threatening hemorrhages. Caution patients about the risk of bleeding associated with the concomitant use of Mopart Capsules and NSAIDs, aspirin, or other drugs that affect coagulation.
Angle-Closure Glaucoma
The pupillary dilation that occurs following use of many antidepressants and Mopart Capsules may trigger an angle closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy.
Hyponatremia
Hyponatremia may occur as a result of treatment with SSRIs, including Mopart Capsules. Elderly patients may be at greater risk. In many cases, the hyponatremia appears to be the result of the syndrome of inappropriate antidiuretic hormone secretion (SIADH). Cases with serum sodium lower than 110 mmol/L have been reported in patients using SSRIs. Also, patients taking diuretics or who are volume-depleted can be at greater risk. Consider discontinuation of Mopart Capsules in patients with symptomatic hyponatremia and institute appropriate medical intervention.
Signs and symptoms of hyponatremia include headache, difficulty concentrating, memory impairment, confusion, weakness, and unsteadiness, which can lead to falls. Signs and symptoms associated with more severe and/or acute cases have included hallucination, syncope, seizure, coma, respiratory arrest, and death.
Bone Fracture
Epidemiological studies on bone fracture risk following exposure to SSRIs have reported an association between SSRI treatment and fractures. It is unknown to what extent fracture risk is directly attributable to SSRI treatment. If a Mopart Capsules-treated patient presents with unexplained bone pain, point tenderness, swelling, or bruising, consider the possibility of a fragility fracture.
Screening Patients for Bipolar Disorder and Monitoring for Mania/Hypomania
Mopart Capsules are only indicated for the treatment of moderate to severe VMS and are not approved for use in treating either depression or bipolar depression. However, prior to initiating treatment with Mopart Capsules, all patients should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression. It is generally believed (though not established in controlled trials) that use of an antidepressant alone may increase the likelihood of precipitation of a mixed/manic episode in patients at risk for bipolar disorder.
Seizures
In premarketing testing of Mopart, seizures occurred in 0.1% of Mopart-treated patients. Use Mopart Capsules cautiously in patients with a history of seizures or with conditions that potentially lower the seizure threshold. Evaluate and consider discontinuing use in any patient who develops seizures.
Akathisia
The use of Mopart 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. Discontinue treatment with Mopart Capsules if akathisia occurs.
Potential for Cognitive and Motor Impairment
Mopart Capsules have the potential to impair judgment, thinking, or motor skills. Patients should be cautioned about operating hazardous machinery, including motor vehicles, until they are reasonably certain that the drug treatment does not affect them adversely.
What should I discuss with my healthcare provider before taking Mopart?
You should not use this medicine if you are allergic to Mopart, or if:
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you are also taking pimozide or thioridazine; or
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you are being treated with methylene blue injection.
Do not use an MAO inhibitor within 14 days before or after you take Mopart. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine. After you stop taking Mopart you must wait at least 14 days before you start taking an MAO inhibitor.
To make sure Mopart is safe for you, tell your doctor if you have:
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heart disease, high blood pressure, history of stroke;
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liver or kidney disease;
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a bleeding or blood clotting disorder;
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seizures or epilepsy;
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bipolar disorder (manic depression), or a history of drug abuse or suicidal thoughts;
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narrow-angle glaucoma; or
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low levels of sodium in your blood.
Some young people have thoughts about suicide when first taking an antidepressant. Your doctor will need to check your progress at regular visits while you are using Mopart. Your family or other caregivers should also be alert to changes in your mood or symptoms.
FDA pregnancy category D. Taking an SSRI antidepressant during pregnancy may cause heart defects, serious lung problems, or other complications in the baby. However, you may have withdrawal symptoms or a relapse of depression if you stop taking your antidepressant. Tell your doctor right away if you become pregnant while taking Mopart. Do not start or stop taking this medicine during pregnancy without your doctor's advice.
Mopart can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.
Do not give Mopart to anyone younger than 18 years old without the advice of a doctor. Mopart is not approved for treating depression in children.
Mopart precautions
Suicidal Thoughts and Behaviors
Mopart Capsules are not approved for any psychiatric condition.
Antidepressants, including those that contain an SSRI, increase the risk of suicidal thinking and behavior (suicidality) in pediatric and young adult patients when used to treat major depressive disorder (MDD) and other psychiatric disorders. There is limited information regarding suicidality in women who use Mopart Capsules for treatment of VMS. The Mopart Capsules trials excluded women with a presence or history of previous psychiatric disorders.
Consider discontinuing Mopart Capsules in patients with worsening depression or those who experience 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.
All patients being treated with Mopart Capsules should be observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of treatment.
Anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania have been reported in patients being treated with antidepressants for MDD as well as for other psychiatric and nonpsychiatric indications. 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.
Families and caregivers of patients being treated with Mopart Capsules 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.
Serotonin Syndrome
The development of a potentially life-threatening serotonin syndrome has been reported with SSRIs, including Mopart, alone but particularly with concomitant use of serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, and St. John’s Wort), and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat depression and others such as linezolid and intravenous methylene blue).
Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Monitor patients for the emergence of serotonin syndrome.
The concomitant use of Mopart Capsules with MAOIs is contraindicated. Do not start Mopart Capsules in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue. All reports with methylene blue that provided information on the route of administration involved intravenous administration in the dose range of 1 mg/kg to 8 mg/kg. No reports involved the administration of methylene blue by other routes (such as oral tablets or local tissue injection) or at lower doses. There may be circumstances when it is necessary to initiate treatment with an MAOI such as linezolid or intravenous methylene blue in a patient taking Mopart Capsules. Mopart Capsules should be discontinued before initiating treatment with the MAOI.
If concomitant use of Mopart Capsules with other serotonergic drugs (e.g., triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, and St. John’s Wort) is clinically warranted, consider the increased risk of serotonin syndrome and carefully observe the patient, particularly during treatment initiation.
Discontinue Mopart Capsules and any concomitant serotonergic agents immediately if the above events occur and initiate supportive symptomatic treatment.
Potential Impact on Tamoxifen Efficacy
It is uncertain whether the co-administration of Mopart and tamoxifen has a significant adverse effect on the efficacy of tamoxifen. Some studies have shown that the efficacy of tamoxifen, as measured by the risk of breast cancer relapse/mortality, may be reduced when co-prescribed with Mopart as a result of Mopart’s irreversible inhibition of CYP2D6. However, other studies have failed to demonstrate such a risk. When tamoxifen is used for the treatment or prevention of breast cancer, weigh the likely benefit of Mopart Capsules for treating VMS vs. the risk of possible decreased tamoxifen effectiveness, and consider avoiding the concomitant use of Mopart Capsules for VMS treatment.
Abnormal Bleeding
SSRIs, including Mopart Capsules, may increase the risk of bleeding events. Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), warfarin, and other anticoagulants may add to this risk. Case reports and epidemiological studies (case-control and cohort design) have demonstrated an association between use of drugs that interfere with serotonin reuptake and the occurrence of gastrointestinal bleeding. Bleeding events related to SSRIs have ranged from ecchymosis, hematoma, epistaxis, and petechiae to life-threatening hemorrhages. Caution patients about the risk of bleeding associated with the concomitant use of Mopart Capsules and NSAIDs, aspirin, or other drugs that affect coagulation.
Angle-Closure Glaucoma
The pupillary dilation that occurs following use of many antidepressants and Mopart Capsules may trigger an angle closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy.
Hyponatremia
Hyponatremia may occur as a result of treatment with SSRIs, including Mopart Capsules. Elderly patients may be at greater risk. In many cases, the hyponatremia appears to be the result of the syndrome of inappropriate antidiuretic hormone secretion (SIADH). Cases with serum sodium lower than 110 mmol/L have been reported in patients using SSRIs. Also, patients taking diuretics or who are volume-depleted can be at greater risk. Consider discontinuation of Mopart Capsules in patients with symptomatic hyponatremia and institute appropriate medical intervention.
Signs and symptoms of hyponatremia include headache, difficulty concentrating, memory impairment, confusion, weakness, and unsteadiness, which can lead to falls. Signs and symptoms associated with more severe and/or acute cases have included hallucination, syncope, seizure, coma, respiratory arrest, and death.
Bone Fracture
Epidemiological studies on bone fracture risk following exposure to SSRIs have reported an association between SSRI treatment and fractures. It is unknown to what extent fracture risk is directly attributable to SSRI treatment. If a Mopart Capsules-treated patient presents with unexplained bone pain, point tenderness, swelling, or bruising, consider the possibility of a fragility fracture.
Screening Patients for Bipolar Disorder and Monitoring for Mania/Hypomania
Mopart Capsules are only indicated for the treatment of moderate to severe VMS and are not approved for use in treating either depression or bipolar depression. However, prior to initiating treatment with Mopart Capsules, all patients should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression. It is generally believed (though not established in controlled trials) that use of an antidepressant alone may increase the likelihood of precipitation of a mixed/manic episode in patients at risk for bipolar disorder.
Seizures
In premarketing testing of Mopart, seizures occurred in 0.1% of Mopart-treated patients. Use Mopart Capsules cautiously in patients with a history of seizures or with conditions that potentially lower the seizure threshold. Evaluate and consider discontinuing use in any patient who develops seizures.
Akathisia
The use of Mopart 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. Discontinue treatment with Mopart Capsules if akathisia occurs.
Potential for Cognitive and Motor Impairment
Mopart Capsules have the potential to impair judgment, thinking, or motor skills. Patients should be cautioned about operating hazardous machinery, including motor vehicles, until they are reasonably certain that the drug treatment does not affect them adversely.
What happens if I miss a dose of Mopart?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
References
- 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/dailyme... (accessed September 17, 2018).
- DrugBank. "paroxetine". http://www.drugbank.ca/drugs/DB00715 (accessed September 17, 2018).
- MeSH. "Cytochrome P-450 CYP2D6 Inhibitors". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
