PMS Duloxetine Capsule 60mg (Duloxetine Hydrochloride)

Adult dosage

Indications Treatment of major depressive disorder Initial dose: 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 them 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 dose: In general, the therapeutic response to antidepressants begins to appear after 2~4 weeks. Even after depressive symptoms have improved, continued use of the medicine for several months is recommended to prevent recurrence. The physician should periodically reassess the patient to determine whether continued treatment is needed. Treatment of generalized anxiety disorder Initial dose: 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 them 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 exceeding 60mg once daily is selected, it should be increased in increments of 30mg once daily. The safety of doses exceeding 120mg once daily has not been adequately evaluated. Maintenance dose: Generalized anxiety disorder is generally considered a chronic condition. The efficacy of long-term use of this medicine for generalized anxiety disorder, i.e., for more than 10 weeks, has not been systematically evaluated in controlled clinical trials. Physicians who elect to continue treatment with this medicine should periodically reassess the patient to determine whether continued treatment is needed. Treatment of diabetic peripheral neuropathic pain Initial dose: This medicine is administered at 60mg once daily, with or without food. Although it is safe and effective at 120mg once daily, there is no evidence of additional benefit at doses exceeding 60mg. Tolerability decreased at higher doses. For patients with concerns about tolerability, 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 dose: Diabetic peripheral neuropathic pain varies in its progression, and pain control is empirical; therefore, the effect of this medicine should be assessed individually. Although efficacy with treatment 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 dose: 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 higher doses are associated with a higher incidence of adverse reactions. Maintenance dose: 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 inadequately responsive to nonsteroidal anti-inflammatory drugs (NSAIDs) Initial dose: 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, then increase to 60mg once daily. For patients who do not respond to the recommended dose (60mg/day), doses exceeding 60mg per day provide no additional benefit and are associated with a higher incidence of adverse reactions. Maintenance dose: The safety and efficacy of this medicine for treatment of osteoarthritis pain at doses administered for more than 13 weeks have not been studied. Elderly: Dose adjustment based on age is not recommended. However, as with other medicines, caution is required during treatment, particularly because clinical data on use of the 120mg daily dose are limited. Patients with hepatic impairment: This medicine should not be used in patients with liver disease, as hepatic impairment may occur. 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). 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 treatment is discontinued after more than 1 week of use, it is recommended that the dose be gradually reduced over the 2 weeks prior to discontinuation to reduce the risk of withdrawal symptoms. During this period, the dose may be halved or taken every other day. However, the exact 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. Switching from MAO inhibitors used to treat psychiatric disorders: At least 14 days should elapse between discontinuing an MAO inhibitor used to treat psychiatric disorders and starting treatment with this medicine. Conversely, at least 5 days should elapse after discontinuing this medicine before starting an MAO inhibitor to treat psychiatric disorders. 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 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 a patient already receiving this medicine. If there is no alternative to linezolid or intravenous methylene blue and, for a particular patient, the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome, this medicine may be stopped 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 risk associated with administration of methylene blue by non-intravenous routes (oral tablets or local injection), or intravenous administration of this medicine at a dose of 1mg/kg or less, is 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 concerns regarding safety and efficacy, 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 may increase the risk of suicidal thoughts and behavior in children, adolescents, and young adults with major depressive disorder or psychiatric disorders; therefore, prescribing should be considered carefully by the physician. Patients of all ages should be closely monitored for abnormal behavioral changes such as worsening of the condition, suicidal tendencies, and aggression during treatment, and family members and caregivers should also observe the patient closely. There is a risk of a serious side effect called serotonin syndrome, which may increase when used in combination with certain medications, so consultation with a physician is essential. This medication is not to be administered to specific patients, for example, those who are allergic to its ingredients or have certain liver and kidney diseases, uncontrolled glaucoma or hypertension. Caution must be used with patients with a history of mania, epilepsy, unstable blood pressure, bleeding tendencies, or the elderly. Common side effects during use include nausea, headache, dry mouth, drowsiness, dizziness, which mostly occur at the beginning of treatment and diminish over time. Discontinuation of this medication may result in withdrawal symptoms such as dizziness, sensory disturbances, sleep disorders, anxiety, and nausea; therefore, dosages should be reduced gradually. Blood pressure increases and heart rate acceleration may occur, so patients with hypertension or heart disease should check their blood pressure regularly. Orthostatic hypotension and syncope can occur, so caution is needed when starting or increasing doses. There is an increased risk of bleeding, so patients taking anticoagulants or medications affecting platelet function should consult a physician. Severe skin reactions may occur, so if there are skin rashes, blisters, or mucosal injuries, use should be stopped immediately and consult healthcare professionals. Liver function anomalies have been reported, so patients with liver disease should be carefully administered this medication and undergo regular liver function tests. Drowsiness or dizziness may occur during driving or operating machinery, so caution is required. This medication may interact with other drugs, so patients should inform about any other medications they are taking. Women who are pregnant or breastfeeding should consult their physician regarding the use of this medication, especially in late pregnancy, as adverse effects may occur in newborns. This medication should not be used in children and adolescents under 18 years of age, as safety and efficacy have not been established. In case of overdose, coma, seizures, serotonin syndrome, etc., immediate emergency treatment is required. This medication should be kept out of reach of children and stored in its original container to maintain quality.

Nausea, headache, dry mouth, drowsiness, dizziness, depression, generalized anxiety disorder, reduced appetite, hyperglycemia, dehydration, hyponatremia, syndrome of inappropriate antidiuretic hormone secretion, insomnia, anxiety, decreased libido, anorgasmia, restlessness, abnormal dreams, suicidal ideation, bruxism, disorientation, sleep disorders, apathy, suicidal behavior, mania, hallucinations, aggression and anger, somnolence, tremors, paresthesia, myoclonus, restlessness syndrome, neuroticism, attention deficit, dysgeusia, movement disorders, restless legs syndrome, low sleep quality, serotonin syndrome, seizures, psychomotor agitation, extrapyramidal symptoms, blurred vision, pupillary dilation, visual impairment, glaucoma, tinnitus, vertigo, ear pain, palpitations, tachycardia, ventricular arrhythmia, hypertension, flushing, high blood pressure, peripheral coldness, orthostatic hypotension, syncope, hypertensive crisis, yawning, throat stiffness, epistaxis, constipation, diarrhea, abdominal pain, vomiting, dyspepsia, bloating, gastrointestinal bleeding, gastroenteritis, belching, gastritis, dysphagia, halitosis, stomatitis, hematochezia, elevated liver enzymes, hepatitis, acute liver injury, liver failure, jaundice, increased sweating, rash, night sweats, urticaria, contact dermatitis, photosensitivity reactions, cold sweat, tendency to bruise easily, Stevens-Johnson syndrome, angioedema, musculoskeletal pain, muscle cramps, muscle tension, myotonia, oral opening disorder, dysuria, increased frequency of urination, nocturia, urinary hesitancy, urinary retention, polyuria, decreased urinary flow, 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, lethargy, thirst, abnormal sensations, chills, gait disorders, weight loss, weight gain, elevated serum creatine phosphokinase, elevated serum potassium, elevated serum cholesterol, asthenia, migraine, dysgeusia, insomnia, sleep disorders, abnormal dreams, orgasm dysfunction, decreased libido, ejaculation disorder, penile dysfunction, cough, sore throat, hyperhidrosis, pruritus, facial flushing, acute pancreatitis, anaphylaxis, angioedema, erythema multiforme, extrapyramidal disorders, hyperhidrosis, cutaneous vasculitis, hallucinations, hyperglycemia, hyperprolactinemia, hypersensitivity reactions, hypertensive crisis, microscopic colitis, muscle cramps, seizures upon discontinuation, supraventricular arrhythmia, trismus, urticaria, exacerbation of depression, edema, gastric ulcer, intellectual disability, drug intoxication, hiccups, dyspnea, restlessness syndrome, suicide attempt, overdose

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. Additionally, to maintain the medication's effectiveness, it is preferable to store it at a cool temperature between 15 to 30 degrees Celsius.

Appearance

A hard capsule with a blue upper part and yellow-green lower part containing white to light brown delayed-release spherical granules.

Package unit

28 capsules/PTP