Mycelta Capsule 60 mg (Duloxetine Hydrochloride)

Adult dosage

Adults 1) Treatment of major depressive disorder Initial treatment This medicine is administered at a dose of 60mg once daily, with or without food. In some patients, treatment may be started at 30mg once daily for 1 week to allow the patient to adjust to the medicine, and then increased to 60mg once daily. There is insufficient evidence of additional benefit at doses exceeding 60mg per day, and the dose-response relationship for the efficacy of this medicine has not been clearly established. Maintenance treatment In general, the therapeutic response to antidepressants begins to appear after 2~4 weeks. Even after depressive symptoms have improved, continued medication use for several months is recommended to prevent recurrence. The physician should periodically reevaluate the patient to determine whether continued treatment is necessary. 2) Treatment of generalized anxiety disorder Initial treatment This medicine is administered at a dose of 60mg once daily, with or without food. In some patients, treatment may be started at 30mg once daily for 1 week to allow the patient to adjust to the medicine, and then increased to 60mg once daily. Efficacy has been demonstrated at 120mg once daily, but there is no evidence of additional benefit at doses exceeding 60mg. Nevertheless, if a dose of more than 60mg once daily is chosen, the dose should be increased in increments of 30mg once daily. The safety of doses exceeding 120mg once daily has not been adequately evaluated. Maintenance treatment Generalized anxiety disorder is generally considered a chronic condition. The efficacy of long-term use of this medicine for generalized anxiety disorder, that is, for more than 10 weeks, has not been systematically evaluated in controlled clinical trials. Physicians who choose to extend treatment with this medicine should periodically reevaluate the patient to determine whether continued treatment is necessary. 3) Treatment of diabetic peripheral neuropathic pain Initial treatment This medicine is administered at 60mg once daily, with or without food. It is safe and effective at 120mg once daily, but there is no evidence of additional benefit at doses exceeding 60mg. Tolerability was reduced at higher doses. For patients with tolerability concerns, starting at a lower dose may be considered. For patients with renal impairment, which is often a complication of diabetes, starting at a lower dose and gradually increasing it should be considered. Maintenance treatment Because the course of diabetic peripheral neuropathic pain varies and pain control is empirical, the effect of this medicine should be evaluated individually. The efficacy of this medicine when administered for more than 12 weeks has not been systematically studied in placebo-controlled trials; however, a 1-year open-label safety study was conducted. 4) Treatment of fibromyalgia Initial treatment The recommended dose of this medicine is 60mg once daily. To allow the patient to adjust to the medicine, treatment should be started at 30mg once daily for 1 week and then increased to 60mg once daily. Some patients may respond to the starting dose. No evidence of additional benefit has been observed at doses exceeding 60mg/day, even in patients who do not respond to 60mg, and administration of higher doses is associated with a higher incidence of adverse reactions. Maintenance treatment Fibromyalgia is considered a chronic condition. In placebo-controlled trials of fibromyalgia treatment, the efficacy of this medicine was observed for up to 3 months. The efficacy of Cymbalta was not observed in long-term trials exceeding 3 months; however, the need for continued treatment should be determined based on each patient's response. 5) Treatment of osteoarthritis pain inadequately responsive to nonsteroidal anti-inflammatory drugs (NSAIDs) Initial treatment The recommended dose of this medicine is 60mg once daily. To allow the patient to adjust to the medicine, administer 30mg once daily for 1 week and then increase to 60mg once daily. Administration of doses exceeding 60mg per day to patients who do not respond to the recommended dose (60mg/day) provides no additional benefit and is associated with a higher incidence of adverse reactions. Maintenance treatment The safety and efficacy of this medicine for more than 13 weeks in the treatment of osteoarthritis pain have not been studied. 2. Elderly patients Dose adjustment based on age is not recommended. However, as with other medicines, caution is required during treatment, particularly because clinical data on the use of a dose of 120mg per day are limited. 4. Patients with hepatic impairment Because hepatic impairment may occur, this medicine should not be used in patients with liver disease. 5. Patients with renal impairment No dose adjustment is necessary in patients with mild or moderate renal impairment (creatinine clearance 30~ 80mL/min). This medicine should not be administered to patients with end-stage renal disease (patients requiring dialysis) or severe renal impairment (creatinine clearance less than 30mL/min). 6. Discontinuation of treatment When discontinuing this medicine, gradual dose reduction over at least 1~2 weeks is recommended whenever possible, rather than abrupt discontinuation. If discontinuing treatment after more than 1 week of medication use, it is recommended that the dose be gradually reduced starting 2 weeks before discontinuation to reduce the risk of withdrawal symptoms. During this period, the dose may be reduced by half or taken every other day. However, the exact approach should be determined based on the individual patient's circumstances, including the duration of treatment and the dose being taken at the time of discontinuation. 7. Switching from MAO inhibitors for the treatment of psychiatric disorders When discontinuing an MAO inhibitor used to treat psychiatric disorders and starting treatment with this medicine, an interval of at least 14 days should be allowed. Conversely, when starting an MAO inhibitor for the treatment of psychiatric disorders, at least 5 days should elapse after discontinuing this medicine. 8. Other MAO inhibitors such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not start treatment with this medicine because of the increased risk of serotonin syndrome. For patients requiring treatment of a more urgent psychiatric condition, including hospitalization or other interventional procedures, treatment should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this medicine. If no alternative to linezolid or intravenous methylene blue is available and the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome in a particular patient, this medicine may be discontinued immediately and linezolid or intravenous methylene blue administered. The patient should be monitored for symptoms of serotonin syndrome for 5 days after administration of linezolid or intravenous methylene blue, or until 24 hours after the last dose, whichever comes first. Treatment with this medicine may be restarted 24 hours after the last dose of linezolid or intravenous methylene blue. The risks of methylene blue administered by non-intravenous routes (oral tablets or local injection) or of intravenous administration of this medicine at a dose of 1mg/kg or less are unclear. Nevertheless, clinicians should be aware of the possibility of emergency symptoms of serotonin syndrome with these uses.

Children's dosage

Children and adolescents under 18 years of age Because of safety and efficacy concerns, this medicine should not be used to treat major depressive disorder in children and adolescents under 18 years of age. The safety and efficacy of this medicine for conditions other than major depressive disorder have not been studied.

This medication is used for the treatment of major depressive disorder, generalized anxiety disorder, diabetic peripheral neuropathic pain, fibromyalgia, and osteoarthritis pain. Particular care must be taken regarding suicidal tendencies and risks associated with antidepressants when taking this medication. There may be an increased risk of suicidal impulses and behavior in children, adolescents, and young adults, so the physician must decide carefully whether to prescribe it, and patients and caregivers should closely monitor any changes in behavior. There may be a serious side effect known as serotonin syndrome, so special caution is required when this medication is combined with other drugs that have serotonin activity. If symptoms such as changes in mental state, high fever, tremors, or convulsions occur, prompt medical attention must be sought. This medication should not be administered to certain patients who are allergic to the active ingredient or additives, those taking MAO inhibitors, or those who are administered it within a certain period after stopping MAO inhibitors, patients with liver disease, end-stage kidney disease, uncontrolled glaucoma or hypertension, etc. Patients with mania or bipolar disorder, renal impairment, hypertension or heart disease, bleeding tendencies, those taking antidepressants, elderly patients, etc., should use this medication with caution, and the condition should be periodically monitored considering the various potential side effects like hyponatremia, orthostatic hypotension, and bleeding risk. The most common side effects while taking this medication include nausea, headache, dry mouth, drowsiness, and dizziness; these generally appear at the beginning of treatment and gradually diminish. Rapid discontinuation may lead to withdrawal symptoms such as dizziness, sensory disturbances, sleep disorders, anxiety, nausea, and tremors, so the dosage should be tapered off gradually under the direction of a physician. Women who are pregnant or breastfeeding must consult a physician before taking this medication. Special caution is needed, especially in the late stages of pregnancy, as side effects may occur in newborns. This medication requires caution when driving or operating dangerous machinery, and when taken with alcohol or sedatives, side effects may be exacerbated. In the event of overdose, serious symptoms such as coma, tachycardia, serotonin syndrome, and seizures may occur, and immediate medical attention is necessary, along with appropriate emergency treatment. This medication must be kept out of reach of children and stored in its original container to prevent degradation of quality.

Nausea, headache, dry mouth, drowsiness, dizziness, depression, insomnia, anxiety, decreased libido, anorgasmia, agitation, abnormal dreams, suicidal ideation, bruxism, disorientation, sleep disorders, apathy, suicidal behavior, mania, hallucinations, aggression and anger, hypersomnia, tremors, sensory disturbances, dyskinesia, restlessness, irritability, attention deficit, dysgeusia, movement disorders, restless legs syndrome, poor sleep quality, serotonin syndrome, convulsions, psychomotor agitation, extrapyramidal symptoms, blurred vision, mydriasis, visual impairment, glaucoma, tinnitus, vertigo, ear pain, palpitations, tachycardia, arrhythmia of unknown origin, hypertension, flushing, high blood pressure, peripheral coldness, orthostatic hypotension, syncope, hypertensive crisis, yawning, pharyngitis, epistaxis, constipation, diarrhea, abdominal pain, vomiting, indigestion, bloating, gastrointestinal bleeding, gastroenteritis, belching, gastritis, dysphagia, halitosis, stomatitis, hematochezia, increased liver enzyme levels, hepatitis, acute liver damage, liver failure, jaundice, increased sweating, rash, night sweats, urticaria, contact dermatitis, photosensitivity reaction, cold sweats, tendency to bruise easily, Stevens-Johnson syndrome, angioedema, musculoskeletal pain, muscle spasms, muscle tension, myotonia, trismus, dysuria, frequency of urination, nocturia, urinary hesitancy, urinary retention, polyuria, decreased urine flow rate, abnormal urine odor, erectile dysfunction, ejaculation disorder, delayed ejaculation, gynecological bleeding, menstrual disorders, sexual dysfunction, testicular pain, menopausal symptoms, galactorrhea, hyperprolactinemia, postpartum hemorrhage, fatigue, falls, chest pain, hot/cold sensation, malaise, thirst, abnormal sensations, chills, gait disturbances, weight loss, weight gain, increased serum creatinine phosphokinase, increased serum potassium, increased serum cholesterol, myocardial infarction, ear pain, hypothyroidism, diplopia, visual impairment, gastric ulcer, black stools, chills, tremors, abnormal sensations, warmth sensation, cold sensation, bodily discomfort, gait disturbances, gastroenteritis, laryngitis, weight gain, dehydration, hyperlipidemia, dyslipidemia, muscle stiffness, concentration disorders, abnormal movement disorders, speech impairments, abnormal dreams, loss of directional sense, confusional state, severe mood swings, suicide attempts, dysuria, urinary urgency, nocturnal enuresis, polyuria, abnormal urine odor, sexual aversion, abnormal sexual arousal, menopausal syndrome, sexual dysfunction, pharyngeal constriction, orthostatic hypotension, peripheral coldness, acute pancreatitis, erythema multiforme, incontinence, cutaneous vasculitis, microscopic colitis, seizures upon discontinuation of treatment, supraventricular arrhythmia, trismus, urticaria, fever, dysphagia, dry skin, decreased blood pressure, onychomycosis, worsening of depression, edema, discomfort in the head, burning sensation, intellectual disability, state of intoxication from medication, hiccups, dyspnea

This medication should be stored in a sealed container to prevent air and moisture from entering, and kept in a cool place between 15 to 30 degrees Celsius. Storing it this way can help maintain the drug's efficacy and prevent deterioration.

Appearance

A blue-colored hard capsule with yellow-green lower part containing white to off-white enteric coated spherical granules

Package unit

28 capsules/box [(14 capsules/PTP×2)]