Duloxetine 30mg (Duloxetine Hydrochloride)

Adult dosage

1. Adults 1) 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 initiated 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 of this drug exceeding 60mg daily, and the dose-response relationship for the efficacy of this drug has not been clearly established. Maintenance treatment In general, a therapeutic response to antidepressants begins to appear after 2~4 weeks. After depressive symptoms have improved, continued medication use for several months is recommended to prevent recurrence. The physician should periodically reassess the patient to determine whether continued treatment is necessary. 2) 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 initiated 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 prescribed, 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 drug 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 drug should periodically reassess the patient to determine whether continued treatment is necessary. 3) Treatment of diabetic peripheral neuropathic pain Initial treatment This drug is administered at 60mg once daily, with or without food. Although 120mg once daily is safe and effective, 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 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 drug should be evaluated individually. Although the efficacy of this drug when administered for more than 12 weeks has not been systematically studied in placebo-controlled trials, a 1-year open-label safety study was conducted. 4) 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 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 of this drug exceeding 60mg/day, and administration of higher doses is associated with a higher incidence of adverse reactions. Maintenance treatment Fibromyalgia is known to be 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 individual patient's response. 5) Treatment of osteoarthritis pain with an inadequate response 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), administering doses exceeding 60mg daily provides no additional benefit and is associated with a higher incidence of adverse reactions. Maintenance treatment The safety and efficacy of this drug when administered for more than 13 weeks for the treatment of osteoarthritis pain have not been studied. 2. 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 120mg daily dose are limited. 4. Patients with hepatic impairment Because hepatic impairment may occur, this drug should not be used in patients with liver disease. 5. Patients with renal impairment No dose adjustment is required in 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 (patients requiring dialysis) or severe renal impairment (creatinine clearance less than 30mL/min). 6. Discontinuation of treatment When discontinuing this drug, gradual dose reduction over at least 1~2 weeks is recommended, if 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 beginning 2 weeks beforehand to reduce the risk of withdrawal symptoms. During this period, the dose may be reduced by half or the medication may be 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 MAOIs for the treatment of psychiatric disorders At least 14 days should elapse between discontinuation of an MAOI used to treat psychiatric disorders and initiation of treatment with this drug. Conversely, at least 5 days should elapse after discontinuing this drug before initiating an MAOI for the treatment of psychiatric disorders. 8. Other MAOIs, 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 who require more urgent treatment for a psychiatric condition, including hospitalization or other interventions, treatment should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to patients already receiving this drug. If no alternative to linezolid or intravenous methylene blue is available 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 drug 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 comes 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 non-intravenous routes (oral tablets or local injection) or with intravenous administration of this drug at doses 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 medication should not be used to treat major depressive disorder in children and adolescents under 18 years of age. The safety and efficacy of this medication for indications other than major depressive disorder have not been studied.

This drug is mainly used to treat psychiatric disorders related to depression, and caution is needed since there may be an increased risk of suicidal thoughts or behavior, especially in children, adolescents, and young adults. A serious side effect called serotonin syndrome can occur, which is more dangerous when taken with other serotonergic medications; therefore, caution is required when co-administering. This drug should not be used in certain patients, such as those with poor liver function, severely impaired kidney function, uncontrolled hypertension, and individuals with specific genetic disorders. Common side effects such as dizziness, drowsiness, nausea, and dry mouth may occur when taking this drug, usually during the initial treatment phase or when adjusting the dosage. Abrupt withdrawal from treatment can lead to withdrawal symptoms, such as dizziness, anxiety, and headache; therefore, the dosage should be gradually reduced according to the doctor's instructions. Blood pressure increases or elevated heart rates may occur, so patients with hypertension or heart disease should regularly monitor their blood pressure and heart rate. Caution is needed for patients with a tendency to bleed or those taking anticoagulants, as the risk of bleeding may be increased. Care should be taken when driving or operating dangerous machinery due to the risk of accidents from dizziness or drowsiness. Women who are pregnant or breastfeeding should consult a doctor before using this medication, especially in late pregnancy when side effects may appear in the newborn. This drug is not recommended for use in children under 18 as its safety and efficacy have not been established. In case of overdose, severe symptoms like coma, seizures, and serotonin syndrome may occur, and immediate medical attention should be sought. This medication should be kept out of the reach of children and stored 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 prevent exposure to air or moisture. It is important to maintain a storage temperature between 1°C and 30°C. Keeping it this way will help maintain the drug's efficacy and safety for a long time.

Appearance

White, round enteric-coated film-coated tablet

Package unit

30 tablets/bottle