Dulera Capsule 60mg (Duloxetine Hydrochloride)

Adult dosage

Adults Treatment of major depressive disorder Initial treatment This drug 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 medication, 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 drug has not been clearly established. Maintenance treatment In general, response to antidepressant treatment begins after 2~4 weeks. After depressive symptoms improve, continued medication use for several months is recommended to prevent relapse. The physician should periodically reassess the patient to determine whether continued treatment is necessary. Treatment of generalized anxiety disorder Initial treatment This drug 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 medication, 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, it 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 drug for generalized anxiety disorder, i.e., for more than 10 weeks, has not been systematically evaluated in controlled clinical trials. Physicians who choose to extend treatment with this drug should periodically reassess the patient to determine whether continued treatment is necessary. Treatment of diabetic peripheral neuropathic pain Initial treatment This drug is administered at 60mg once daily, with or without food. A dose of 120mg once daily is safe and effective, but 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, 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 drug should be evaluated individually. The efficacy of treatment with this drug for more than 12 weeks has not been systematically studied in placebo-controlled trials; however, a 1-year open-label safety study was conducted. Treatment of fibromyalgia Initial treatment The recommended dose of this drug is 60mg once daily. To allow the patient to adjust to the medication, 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 for the treatment of fibromyalgia, the efficacy of this drug 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 treatment The recommended dose of this drug is 60mg once daily. To allow the patient to adjust to the medication, administer 30mg once daily for 1 week, then increase to 60mg once daily. In patients who do not respond to the recommended dose (60mg/day), doses exceeding 60mg per day do not provide additional benefit and are associated with a higher incidence of adverse reactions. Maintenance treatment The safety and efficacy of this drug for more than 13 weeks in the treatment of osteoarthritis pain have not been studied. Elderly patients Dose adjustment based on age is not recommended. However, as with other medications, caution is required during treatment, particularly because clinical data on the use of a dose of 120mg per day are limited. Patients with hepatic impairment This drug should not be used in patients with liver disease, as hepatic impairment may occur. Patients with renal impairment No dose adjustment is necessary for patients with mild or moderate renal impairment (creatinine clearance 30~ 80mL/min). This drug should not be administered to patients with end-stage renal disease (requiring dialysis) or severe renal impairment (creatinine clearance less than 30mL/min). Discontinuation of treatment When discontinuing this drug, 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 medication use, it is recommended that the dose be gradually reduced starting 2 weeks beforehand to decrease the risk of withdrawal symptoms. During this period, reduce the dose by half or take it every other day. However, the precise 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. Switching to or from MAO inhibitors for the treatment of psychiatric disorders At least 14 days should elapse after discontinuing an MAO inhibitor used to treat psychiatric disorders before starting treatment with this drug. Conversely, at least 5 days should elapse after discontinuing this drug before starting an MAO inhibitor for the treatment of psychiatric disorders. Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not be started on this drug because of the increased risk of serotonin syndrome. For patients requiring more urgent treatment of a psychiatric condition, including hospitalization, other interventions should be considered. There may be a need to urgently administer linezolid or intravenous methylene blue to a patient already receiving this drug. If no alternative to linezolid or intravenous methylene blue is available and, in a particular patient, the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome, this drug 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 receiving linezolid or intravenous methylene blue, or until 24 hours after the last dose, whichever occurs first. Treatment with this drug may be restarted 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with administration of methylene blue by a non-intravenous route (oral tablets or local injection), or with intravenous administration of this drug 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: 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. The safety and efficacy of this medicine for indications other than major depressive disorder have not been studied.

This medication is used to treat psychiatric disorders such as major depressive disorder, and caution is necessary as the risk of suicidal thoughts or behaviors may increase, particularly in young patients aged 18 to 24. During the treatment, suicidal tendencies, aggression, anger, and other abnormal behavioral changes should be closely monitored, and family members or guardians should also observe the patient attentively. A serious side effect known as serotonin syndrome may occur; therefore, this medication should not be taken with certain serotonin-acting drugs or MAO inhibitors. It should not be administered to patients with liver disease, severe renal impairment, uncontrolled hypertension, or certain genetic metabolic abnormalities. Blood pressure and heart rate should be monitored regularly during treatment, and caution is needed as orthostatic hypotension or fainting symptoms may occur. Patients with a tendency to bleed or those taking anticoagulants or medications affecting platelet function should be carefully managed due to increased bleeding risk. This drug can cause severe skin reactions, so if symptoms such as rash or blisters occur, discontinuation of the drug should be immediate, and consultation with a healthcare provider is necessary. Sudden discontinuation may lead to withdrawal symptoms such as dizziness, sensory disturbances, and sleep disorders; therefore, it is important to taper the dose gradually under a physician's guidance. Women who are pregnant or planning to become pregnant must consult a physician regarding the use of this medication, and breastfeeding mothers are advised to avoid breastfeeding while on this drug. This medication is not recommended for use in children and adolescents under 18 years due to established safety and efficacy not being confirmed. Caution is required when driving or operating hazardous machinery due to the potential for dizziness or drowsiness. In case of overdose, symptoms such as coma, seizures, and serotonin syndrome may occur; immediate medical attention is necessary along with appropriate emergency treatment. This drug should be stored out of the reach of children and kept in its original container to maintain quality.

• Nausea
• headache
• dry mouth
• drowsiness
• dizziness
• depression
• insomnia
• anxiety
• decreased libido
• anorgasmia

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is best to maintain the storage temperature between 15 and 30 degrees Celsius. This will help preserve the drug's efficacy and safety.

Appearance

A blue hard capsule with a yellow-green base containing spherical granules that are white to light brown in color.

Package unit

28 capsules (14 capsules/PTP packaging X 2)