What happens if I overdose Mydula?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local, or emergency room immediately.
Proper storage of Mydula delayed-release capsules:
Store Mydula delayed-release capsules at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Mydula delayed-release capsules out of the reach of children and away from pets.
Overdose of Mydula in details
There is limited clinical experience with Mydula overdose in humans. In premarketing clinical trials, no cases of fatal acute overdose of Mydula have been reported. Four nonfatal acute ingestions of Mydula (300-1400 mg), alone or in combination with other drugs have been reported.
There is no specific antidote to Mydula. In case of acute overdose, treatment should consist of those general measures employed in the management of overdose with any drug. An adequate airway, oxygenation and ventilation should be assured and cardiac rhythm and vital signs should be monitored. Induction of emesis is not recommended. Gastric lavage with a large-bore orogastric tube with appropriate airway protection, if needed, may be indicated if performed soon after ingestion or in symptomatic patients. Activated charcoal may be useful in limiting absorption of Mydula from the gastrointestinal tract. Due to the large volume of distribution of Mydula, forced diuresis, dialysis, hemoperfusion and exchange transfusion are unlikely to be beneficial. In managing overdose, the possibility of multiple drug involvement should be considered. A specific caution involves patients who are taking or have recently taken Mydula and might ingest excessive quantities of a tricyclic antidepressant (TCA). In such a case, decreased clearance of the parent tricyclic and/or its active metabolite may increase the possibility of clinically significant sequelae and extend the time needed for close medical observation.
What should I avoid while taking Mydula?
Avoid drinking alcohol. It may increase your risk of liver damage.
See also:
Mydula and alcohol (in more detail)
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 Mydula may cause you to bruise or bleed easily.
Mydula may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.
Severe dizziness or fainting can cause falls, accidents, or severe injuries.
Mydula warnings
Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults
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 18-24) 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.
The pooled analyses of placebo-controlled trials in children and adolescents with MDD, obsessive compulsive disorder (OCD), or other psychiatric disorders included a total of 24 short-term trials of 9 antidepressant drugs in over 4400 patients. The pooled analyses of placebo-controlled trials in adults with MDD or other psychiatric disorders included a total of 295 short-term trials (median duration of 2 months) of 11 antidepressant drugs in over 77,000 patients. There was considerable variation in risk of suicidality among drugs, but a tendency toward an increase in the younger patients for almost all drugs studied. There were differences in absolute risk of suicidality across the different indications, with the highest incidence in MDD. The risk of differences (drug vs placebo), however, were relatively stable within age strata and across indications. These risk differences (drug-placebo difference in the number of cases of suicidality per 1000 patients treated) are provided in Table 1.
| Age Range | Drug-Placebo Difference in Number of Cases of Suicidality per 1000 Patients Treated |
| Increases Compared to Placebo | |
| <18 | 14 additional cases |
| 18-24 | 5 additional cases |
| Decreases Compared to Placebo | |
| 25-64 | 1 fewer case |
| ≥65 | 6 fewer cases |
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 discontinuation can be associated with certain symptoms.
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 health care providers. Such monitoring should include daily observation by families and caregivers. Prescriptions for Mydula should be written for the smallest quantity of capsules consistent with good patient management, in order to reduce the risk of overdose.
Screening Patients for Bipolar Disorder — A major depressive episode may be the initial presentation of bipolar disorder. It is generally believed (though not established in controlled trials) that treating such an episode with an antidepressant alone may increase the likelihood of precipitation of a mixed/manic episode in patients at risk for bipolar disorder. Whether any of the symptoms described above represent such a conversion is unknown. However, prior to initiating treatment with an antidepressant, patients with depressive symptoms 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 should be noted that Mydula is not approved for use in treating bipolar depression.
Hepatotoxicity
There have been reports of hepatic failure, sometimes fatal, in patients treated with Mydula. These cases have presented as hepatitis with abdominal pain, hepatomegaly, and elevation of transaminase levels to more than twenty times the upper limit of normal with or without jaundice, reflecting a mixed or hepatocellular pattern of liver injury. Mydula should be discontinued in patients who develop jaundice or other evidence of clinically significant liver dysfunction and should not be resumed unless another cause can be established.
Cases of cholestatic jaundice with minimal elevation of transaminase levels have also been reported. Other postmarketing reports indicate that elevated transaminases, bilirubin, and alkaline phosphatase have occurred in patients with chronic liver disease or cirrhosis.
Mydula increased the risk of elevation of serum transaminase levels in development program clinical trials. Liver transaminase elevations resulted in the discontinuation of 0.3% (92/34,756) of Mydula-treated patients. In most patients, the median time to detection of the transaminase elevation was about two months. In adult placebo-controlled trials in any indication, for patients with normal and abnormal baseline ALT values, elevation of ALT >3 times the upper limit of normal occurred in 1.25% (144/11,496) of Mydula-treated patients compared to 0.45% (39/8716) of placebo-treated patients. In adult placebo-controlled studies using a fixed dose design, there was evidence of a dose response relationship for ALT and AST elevation of >3 times the upper limit of normal and >5 times the upper limit of normal, respectively.
Because it is possible that Mydula and alcohol may interact to cause liver injury or that Mydula may aggravate pre-existing liver disease, Mydula should not be prescribed to patients with substantial alcohol use or evidence of chronic liver disease.
5.3 Orthostatic Hypotension, Falls and Syncope
Orthostatic hypotension, falls and syncope have been reported with therapeutic doses of Mydula. Syncope and orthostatic hypotension tend to occur within the first week of therapy but can occur at any time during Mydula treatment, particularly after dose increases. The risk of falling appears to be related to the degree of orthostatic decrease in blood pressure as well as other factors that may increase the underlying risk of falls.
In an analysis of patients from all placebo-controlled trials, patients treated with Mydula reported a higher rate of falls compared to patients treated with placebo. Risk appears to be related to the presence of orthostatic decrease in blood pressure. The risk of blood pressure decreases may be greater in patients taking concomitant medications that induce orthostatic hypotension (such as antihypertensives) or are potent CYP1A2 inhibitors and in patients taking Mydula at doses above 60 mg daily. Consideration should be given to dose reduction or discontinuation of Mydula in patients who experience symptomatic orthostatic hypotension, falls and/or syncope during Mydula therapy.
Risk of falling also appeared to be proportional to a patient's underlying risk for falls and appeared to increase steadily with age. As elderly patients tend to have a higher underlying risk for falls due to a higher prevalence of risk factors such as use of multiple medications, medical comorbidities and gait disturbances, the impact of increasing age by itself is unclear. Falls with serious consequences including bone fractures and hospitalizations have been reported.
Serotonin Syndrome
The development of a potentially life-threatening serotonin syndrome has been reported with SNRIs and SSRIs, including Mydula, alone but particularly with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John's Wort) and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also 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), seizures, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Patients should be monitored for the emergence of serotonin syndrome.
The concomitant use of Mydula with MAOIs intended to treat psychiatric disorders is contraindicated. Mydula should also not be started 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 Mydula. Mydula should be discontinued before initiating treatment with the MAOI.
If concomitant use of Mydula with other serotonergic drugs including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, buspirone, tryptophan and St. John's Wort is clinically warranted, patients should be made aware of a potential increased risk for serotonin syndrome, particularly during treatment initiation and dose increases. Treatment with Mydula and any concomitant serotonergic agents, should be discontinued immediately if the above events occur and supportive symptomatic treatment should be initiated.
Abnormal Bleeding
SSRIs and SNRIs, including Mydula, may increase the risk of bleeding events. Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs, warfarin, and other anti-coagulants 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 and SNRIs use have ranged from ecchymoses, hematomas, epistaxis, and petechiae to life-threatening hemorrhages.
Patients should be cautioned about the risk of bleeding associated with the concomitant use of Mydula and NSAIDs, aspirin, or other drugs that affect coagulation.
Severe Skin Reactions
Severe skin reactions, including erythema multiforme and Stevens-Johnson Syndrome (SJS), can occur with Mydula. The reporting rate of SJS associated with Mydula use exceeds the general population background incidence rate for this serious skin reaction (1 to 2 cases per million person years). The reporting rate is generally accepted to be an underestimate due to underreporting.
Mydula should be discontinued at the first appearance of blisters, peeling rash, mucosal erosions, or any other sign of hypersensitivity if no other etiology can be identified.
Discontinuation of Treatment with Mydula
Discontinuation symptoms have been systematically evaluated in patients taking Mydula. Following abrupt or tapered discontinuation in adult placebo-controlled clinical trials, the following symptoms occurred at 1% or greater and at a significantly higher rate in Mydula-treated patients compared to those discontinuing from placebo: dizziness, headache, nausea, diarrhea, paresthesia, irritability, vomiting, insomnia, anxiety, hyperhidrosis, and fatigue.
During marketing of other SSRIs and SNRIs (serotonin and norepinephrine reuptake inhibitors), there have been spontaneous reports of adverse events occurring upon discontinuation of these drugs, particularly when abrupt, including the following: dysphoric mood, irritability, agitation, dizziness, sensory disturbances (e.g., paresthesias such as electric shock sensations), anxiety, confusion, headache, lethargy, emotional lability, insomnia, hypomania, tinnitus, and seizures. Although these events are generally self-limiting, some have been reported to be severe.
Patients should be monitored for these symptoms when discontinuing treatment with Mydula. 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.
Activation of Mania/Hypomania
In adult placebo-controlled trials in patients with major depressive disorder, activation of mania or hypomania was reported in 0.1% (4/3779) of Mydula-treated patients and 0.04% (1/2536) of placebo-treated patients. No activation of mania or hypomania was reported in DPNP, GAD, fibromyalgia, or chronic musculoskeletal pain placebo-controlled trials. Activation of mania or hypomania has been reported in a small proportion of patients with mood disorders who were treated with other marketed drugs effective in the treatment of major depressive disorder. As with these other agents, Mydula should be used cautiously in patients with a history of mania.
5.9 Angle-Closure Glaucoma
The pupillary dilation that occurs following use of many antidepressant drugs including Mydula may trigger an angle closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy.
Seizures
Mydula has not been systematically evaluated in patients with a seizure disorder, and such patients were excluded from clinical studies. In adult placebo-controlled clinical trials, seizures/convulsions occurred in 0.02% (3/12,722) of patients treated with Mydula and 0.01% (1/9513) of patients treated with placebo. Mydula should be prescribed with care in patients with a history of a seizure disorder.
Effect on Blood Pressure
In adult placebo-controlled clinical trials across indications from baseline to endpoint, Mydula treatment was associated with mean increases of 0.5 mm Hg in systolic blood pressure and 0.8 mm Hg in diastolic blood pressure compared to mean decreases of 0.6 mm Hg systolic and 0.3 mm Hg diastolic in placebo-treated patients. There was no significant difference in the frequency of sustained (3 consecutive visits) elevated blood pressure. In a clinical pharmacology study designed to evaluate the effects of Mydula on various parameters, including blood pressure at supratherapeutic doses with an accelerated dose titration, there was evidence of increases in supine blood pressure at doses up to 200 mg twice daily. At the highest 200 mg twice daily dose, the increase in mean pulse rate was 5.0 to 6.8 beats and increases in mean blood pressure were 4.7 to 6.8 mm Hg (systolic) and 4.5 to 7 mm Hg (diastolic) up to 12 hours after dosing.
Blood pressure should be measured prior to initiating treatment and periodically measured throughout treatment.
Clinically Important Drug Interactions
Both CYP1A2 and CYP2D6 are responsible for Mydula metabolism.
Potential for Other Drugs to Affect Mydula
CYP1A2 Inhibitors — Co-administration of Mydula with potent CYP1A2 inhibitors should be avoided.
CYP2D6 Inhibitors — Because CYP2D6 is involved in Mydula metabolism, concomitant use of Mydula with potent inhibitors of CYP2D6 would be expected to, and does, result in higher concentrations (on average of 60%) of Mydula.
Potential for Mydula to Affect Other Drugs
Drugs Metabolized by CYP2D6 — Co-administration of Mydula with drugs that are extensively metabolized by CYP2D6 and that have a narrow therapeutic index, including certain antidepressants (tricyclic antidepressants [TCAs], such as nortriptyline, amitriptyline, and imipramine), phenothiazines and Type 1C antiarrhythmics (e.g., propafenone, flecainide), should be approached with caution. Plasma TCA concentrations may need to be monitored and the dose of the TCA may need to be reduced if a TCA is co-administered with Mydula. Because of the risk of serious ventricular arrhythmias and sudden death potentially associated with elevated plasma levels of thioridazine, Mydula and thioridazine should not be co-administered.
Other Clinically Important Drug Interactions
Alcohol — Use of Mydula concomitantly with heavy alcohol intake may be associated with severe liver injury. For this reason, Mydula should not be prescribed for patients with substantial alcohol use.
CNS Acting Drugs — Given the primary CNS effects of Mydula, it should be used with caution when it is taken in combination with or substituted for other centrally acting drugs, including those with a similar mechanism of action.
Hyponatremia
Hyponatremia may occur as a result of treatment with SSRIs and SNRIs, including Mydula. In many cases, this 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 and appeared to be reversible when Mydula was discontinued. Elderly patients may be at greater risk of developing hyponatremia with SSRIs and SNRIs. Also, patients taking diuretics or who are otherwise volume depleted may be at greater risk. Discontinuation of Mydula 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. More severe and/or acute cases have been associated with hallucination, syncope, seizure, coma, respiratory arrest, and death.
Use in Patients with Concomitant Illness
Clinical experience with Mydula in patients with concomitant systemic illnesses is limited. There is no information on the effect that alterations in gastric motility may have on the stability of Mydula's enteric coating. In extremely acidic conditions, Mydula, unprotected by the enteric coating, may undergo hydrolysis to form naphthol. Caution is advised in using Mydula in patients with conditions that may slow gastric emptying (e.g., some diabetics).
Mydula has not been systematically evaluated in patients with a recent history of myocardial infarction or unstable coronary artery disease. Patients with these diagnoses were generally excluded from clinical studies during the product's premarketing testing.
Hepatic Impairment — Avoid use in patients with chronic liver disease or cirrhosis.
Severe Renal Impairment — Avoid use in patients with severe renal impairment, GFR <30 mL/min. Increased plasma concentration of Mydula, and especially of its metabolites, occur in patients with end-stage renal disease (requiring dialysis).
Glycemic Control in Patients with Diabetes — As observed in DPNP trials, Mydula treatment worsens glycemic control in some patients with diabetes. In three clinical trials of Mydula for the management of neuropathic pain associated with diabetic peripheral neuropathy, the mean duration of diabetes was approximately 12 years, the mean baseline fasting blood glucose was 176 mg/dL, and the mean baseline hemoglobin A1c (HbA1c) was 7.8%. In the 12-week acute treatment phase of these studies, Mydula was associated with a small increase in mean fasting blood glucose as compared to placebo. In the extension phase of these studies, which lasted up to 52 weeks, mean fasting blood glucose increased by 12 mg/dL in the Mydula group and decreased by 11.5 mg/dL in the routine care group. HbA1c increased by 0.5% in the Mydula and by 0.2% in the routine care groups.
Urinary Hesitation and Retention
Mydula is in a class of drugs known to affect urethral resistance. If symptoms of urinary hesitation develop during treatment with Mydula, consideration should be given to the possibility that they might be drug-related.
In post marketing experience, cases of urinary retention have been observed. In some instances of urinary retention associated with Mydula use, hospitalization and/or catheterization has been needed.
Laboratory Tests
No specific laboratory tests are recommended.
What should I discuss with my healthcare provider before taking Mydula?
- If you have an allergy to Mydula or any other part of Mydula (Mydula sprinkle capsules).
- If you are allergic to Mydula (Mydula sprinkle capsules); any part of Mydula (Mydula sprinkle capsules); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
- If you have any of these health problems: Kidney disease or liver disease.
- If you are taking thioridazine.
- If you are taking any of these drugs: Ciprofloxacin or fluvoxamine.
- If you are taking any of these drugs: Linezolid or methylene blue.
- If you have taken certain drugs for depression or Parkinson's disease in the last 14 days. This includes isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline. Very high blood pressure may happen.
This is not a list of all drugs or health problems that interact with Mydula (Mydula sprinkle capsules).
Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Mydula (Mydula sprinkle capsules) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
Mydula precautions
As with similar CNS active drugs, Mydula should be used cautiously in patients with a history of mania or a diagnosis of bipolar disorder, and/or seizures.
Mydriasis has been reported in association with Mydula, therefore, caution should be used when prescribing Mydula in patients with raised intraocular pressure, or those at risk of acute narrow-angle glaucoma.
Mydula hard gastroresistant capsule contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take Mydula.
Renal Impairment: Increased plasma concentrations of Mydula occur in patients with severe renal impairment on hemodialysis (CrCl <30 mL/min). For patients with severe renal impairment, see Contraindications. See Dosage & Administration for information on patients with mild or moderate renal dysfunction.
Increased Blood Pressure: Mydula is associated with an increase in blood pressure in some patients. In patients with known hypertension and/or other cardiac disease, blood pressure monitoring is recommended as appropriate.
Elevated Liver Enzymes: Elevations in liver enzymes were seen in some patients treated with Mydula in clinical trials. These were usually transient and self-limiting, or resolved upon discontinuation of Mydula. Severe elevations of liver enzymes (>10 times the upper limit of normal) or liver injury with a cholestatic or mixed pattern have been rarely reported, in some cases associated with excessive alcohol use or preexisting liver disease. Mydula should be used with caution in patients with substantial alcohol use or preexisting liver disease.
Use with Antidepressants: Cautions should be exercised when using Mydula in combination with antidepressants. In particular, the combination with selective reversible MAOIs is not recommended.
St. John's Wort: Adverse effects may be more common during concomitant use of Mydula and herbal preparations containing St. John's wort (Hypericum perforatum).
Suicide: The possibility of a suicide attempt is inherent in depression and other psychiatric disorders and may persist until significant remission occurs. Close supervision of high-risk patients should accompany drug therapy.
As with other drugs with similar pharmacological action [inhibitor of serotonin re-uptake (SSRI) or inhibitor of serotonin and norepinephrine re-uptake (SNRI)], isolated cases of suicidal ideation and suicidal behaviors have been reported during Mydula therapy or early after treatment discontinuation.
Mydula hydrochloride has not been studied in patients <18 years and is not intended for use in this age group. Although a causal role for Mydula in inducing such events has not been established some analyses from pooled studies of antidepressants in psychiatric disorders found an increased risk for suicidal ideation and/or suicidal behaviors in pediatric and young adult (<25 years) patients compared to placebo. Physicians should encourage patients to report any distressing thoughts or feelings at any time.
Hemorrhage: There have been reports of cutaneous bleeding abnormalities eg, ecchymoses and purpura with selective serotonin reuptake inhibitors (SSRIs). Caution is advised in patients taking anticoagulants and/or medicinal products known to affect platelet function and in patients with known bleeding tendencies.
Hyponatremia: Cases of hyponatremia (some with serum sodium <110 mmol/L) have been reported very rarely. The majority of these cases occurred in elderly patients, especially when coupled with a recent history of altered fluid balance or conditions predisposing to altered fluid balance. Hyponatremia may present with nonspecific signs and symptoms (eg, dizziness, weakness, nausea, vomiting, confusion, somnolence and lethargy). Signs and symptoms associated with more severe cases have included syncopal episodes, falls and seizure.
Abnormal Bleeding: SSRIs and SNRIs, including Mydula, may increase the risk of bleeding events, including gastrointestinal bleeding. Therefore, caution is advised in patients taking Mydula concomitantly with anticoagulants and/or medicinal products known to affect platelet function (eg, NSAIDs, aspirin) and in patients with known bleeding tendencies.
Discontinuation of Treatment: Some patients may experience symptoms on discontinuation of Mydula, particularly if treatment is stopped abruptly.
Effects on the Ability to Drive or Operate Machinery: Mydula may be associated with adverse effects eg, sedation and dizziness. Therefore, patients should be cautioned about operating hazardous machinery, including automobiles, while taking Mydula.
Use in pregnancy: There are no data on the use of Mydula in pregnant women. Studies in animals have shown reproductive toxicity at systemic exposure levels (AUC) of Mydula lower than the maximum clinical exposure.
The potential risk for humans is unknown. As with other serotoninergic drugs, discontinuation symptoms may occur in the neonate after maternal Mydula use near term. Mydula should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus. Discontinuation symptoms (eg, hypotonia, tremor, jitteriness, feeding difficulty, respiratory distress and seizures) may occur in the neonate after maternal Mydula use near term. The majority of cases have occurred either at birth or within a few days of birth. Women should be advised to notify their physician if they become pregnant, or intend to become pregnant, during therapy.
Use in lactation: Mydula is excreted into the milk of lactating women. The estimated daily infant dose on a mg/kg is approximately 0.14% of the maternal dose. Because the safety of Mydula in infants is not known, breastfeeding while on Mydula is not recommended.
Use in children: Mydula is not intended for use in children. The safety and efficacy in patients <18 years have not been established.
Use in the
Elderly: Only limited clinical data on the use of Mydula in the elderly patients with major depressive disorders is available. Therefore, caution should be exercised when treating the elderly.
What happens if I miss a dose of Mydula?
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
- DrugBank. "duloxetine". http://www.drugbank.ca/drugs/DB00476 (accessed September 17, 2018).
- MeSH. "Serotonin and Noradrenaline Reuptake Inhibitors". https://www.ncbi.nlm.nih.gov/mesh/20... (accessed September 17, 2018).
- FDA Medication Guides. "Cymbalta: FDA Medication Guides are paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events. ". https://www.accessdata.fda.gov/drugs... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
