Duloxetine 60 mg Capsules (Duloxetine Hydrochloride)

Adult dosage

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 initiated 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, response to antidepressant treatment begins to appear after 2∼4 weeks. Even after depressive symptoms have improved, continued medication use for several months is recommended to prevent relapse. The physician should periodically reevaluate the patient to determine whether continued treatment is necessary. 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 initiated 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 continue treatment with this medicine should periodically reevaluate the patient to determine whether continued treatment is necessary. Treatment of diabetic peripheral neuropathic pain Initial treatment This medicine is administered at 60mg once daily, with or without food. Doses of 120mg once daily are safe and effective, but there is no evidence of additional benefit at doses exceeding 60mg. Tolerability decreased at higher doses. For patients with tolerability concerns, starting at a lower dose may be considered. For patients with renal impairment, which often occurs as a complication of diabetes, consider starting at a lower dose and gradually increasing it. Maintenance treatment Because the course of diabetic peripheral neuropathic pain varies and pain control is empirical, the effects of this medicine should be evaluated individually. Although efficacy with administration of this medicine for more than 12 weeks has not been systematically studied in placebo-controlled trials, a 1-year open-label safety study was conducted. 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 initiated at 30mg once daily for 1 week and then increased to 60mg once daily. Some patients may respond to the starting dose. Even in patients who do not respond to 60mg, no evidence of additional benefit has been observed at doses exceeding 60mg/day, 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 for the treatment of fibromyalgia, 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. Treatment of osteoarthritis pain with an inadequate response 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 the dose to 60mg once daily. In patients who do not respond to the recommended dose (60mg/day), administration of doses exceeding 60mg per 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. 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. 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). 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, gradual reduction of the dose beginning 2 weeks beforehand is recommended to reduce the risk of withdrawal symptoms. During this period, the dose may be reduced by half or taken every other day. However, the appropriate method 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. When discontinuing an MAO inhibitor used to treat psychiatric disorders and starting treatment with this medicine, an interval of at least 14 days must be allowed. Conversely, when starting an MAO inhibitor for the treatment of psychiatric disorders, at least 5 days must have elapsed after discontinuing this medicine. Treatment with this medicine should not be initiated in patients receiving linezolid or intravenous methylene blue because of the increased risk of serotonin syndrome. For patients who require treatment for 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 patients already receiving this medicine. If there is no alternative to linezolid or intravenous methylene blue 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. Patients 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 occurs first. Treatment with this medicine may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with administration of methylene blue by non-intravenous routes (oral tablets or local injection) or intravenous administration of this medicine at doses of 1mg/kg or less is unclear. Nevertheless, clinicians should be aware of the possibility of emergency symptoms of serotonin syndrome with such use.

Children's dosage

The safety and efficacy of this drug have not been studied in children and adolescents under 18 years of age. Therefore, its use is not recommended.

This drug is primarily used for the treatment of depression, anxiety disorders, diabetic peripheral neuropathic pain, and fibromyalgia. When taking this medication, there may be an increased risk of suicidal thoughts or behavior, especially among younger individuals aged 18 to 24, who require careful monitoring. There is a risk of a serious side effect known as serotonin syndrome; therefore, it should not be taken in conjunction with other serotonin-related medications. If any unusual symptoms occur, immediate consultation with healthcare professionals is necessary. This medicine should not be administered to patients with specific liver diseases, end-stage renal disease, uncontrolled glaucoma, or hypertension. Patients with a history of mania, bipolar disorder, seizures, elderly patients, dehydrated patients, etc., should exercise caution when using this drug. Initially, common side effects may include nausea, headache, dry mouth, drowsiness, and dizziness, which typically improve over time. Abruptly stopping this medication can lead to withdrawal symptoms such as dizziness, sensory disturbances, sleep disturbances, anxiety, nausea, and tremors, so it's important to taper off gradually. Due to possible increases in blood pressure and heart rate, patients with hypertension should monitor their blood pressure frequently, and those with a tendency to bleed should be aware of the bleeding risks. Women who are pregnant or breastfeeding should consult a physician before taking this medication, especially during late pregnancy, as it may affect the newborn. This medication is generally not recommended for use in children and adolescents as safety and effectiveness have not been established. Caution is necessary when driving or operating machinery, as drowsiness or dizziness may occur. Drug interactions may occur with this medication; therefore, patients should inform their healthcare provider of any other medications they are taking. In case of overdose, there is a risk of coma, seizures, and serotonin syndrome, so it's vital to adhere to prescribed dosages and seek medical attention immediately if abnormal symptoms arise. Finally, this medication should be stored out of reach of children in its original container to maintain its quality.

Nausea, headache, dry mouth, drowsiness, dizziness, depression, generalized anxiety disorder, decreased appetite, hyperglycemia, dehydration, hyponatremia, syndrome of inappropriate antidiuretic hormone secretion, insomnia, anxiety, decreased libido, anorgasmia, agitation, abnormal dreams, suicidal thoughts, bruxism, disorientation, sleep disorders, apathy, suicidal behavior, mania, hallucinations, aggressiveness and anger, hypersomnia, tremors, paresthesia, myoclonus, restlessness, neurogenic hypersensitivity, attention deficit, taste abnormalities, movement disorders, restless legs syndrome, poor sleep quality, serotonin syndrome, seizures, psychomotor agitation, extrapyramidal symptoms, blurred vision, dilated pupils, visual impairment, glaucoma, tinnitus, vertigo, ear pain, palpitations, tachycardia, nonsustained ventricular tachycardia, increased blood pressure, flushing, hypertension, peripheral coldness, orthostatic hypotension, syncope, hypertensive crisis, yawning, throat tightness, epistaxis, constipation, diarrhea, abdominal pain, vomiting, dyspepsia, bloating, gastrointestinal bleeding, gastroenteritis, belching, gastritis, dysphagia, halitosis, stomatitis, rectal bleeding, elevated liver enzymes, hepatitis, acute liver injury, 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 cramps, muscle tension, myotonia, trismus, dysuria, frequency, nocturia, urinary hesitance, urinary retention, polyuria, decreased urine flow, abnormal urine odor, erectile dysfunction, ejaculation disorders, delayed ejaculation, gynecological bleeding, menstrual disorders, sexual dysfunction, testicular pain, menopausal symptoms, galactorrhea, hyperprolactinemia, postpartum hemorrhage, fatigue, falls, chest pain, hot/cold sensations, lethargy, thirst, abnormal sensations, chills, gait disturbances, weight loss, weight gain, increased serum creatine phosphokinase, hyperkalemia, hypercholesterolemia, acute pancreatitis, anaphylaxis, erythema multiforme, drooling, cutaneous vasculitis, microscopic colitis, seizures upon discontinuation, supraventricular arrhythmias, trismus, decreased blood pressure, onychomycosis, worsening depression, edema, head discomfort, burning sensation, intellectual disability, drug intoxication, hiccups, dyspnea, restlessness, abnormal dreams, emotional lability, suicide attempts, overdose

This medication should be stored in a tightly sealed container to prevent air or moisture infiltration. Additionally, it is important to keep this medication at room temperature, between 15 to 30 degrees Celsius, to maintain its efficacy.

Appearance

A hard capsule with a blue upper part and a yellow-green lower part containing spherical enteric granules that are white to light brown in color.

Package unit

28 capsules/PTP