Cymbalta Capsule 60 mg (Duloxetine Hydrochloride)

Adult dosage

1. Adults 1) Treatment of major depressive disorder Initial dosage 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 once daily, and the dose-response relationship for its efficacy has not been clearly established. Maintenance dosage Generally, the therapeutic response to antidepressants begins to appear after 2~4 weeks. It is recommended that medication be continued for several months after depressive symptoms improve to prevent recurrence. The physician should periodically reassess the patient to determine whether continued treatment is necessary. 2) Treatment of generalized anxiety disorder Initial dosage 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 selected, 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 dosage 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 dosage 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, consider starting at a lower dose and gradually increasing it. Maintenance dosage Diabetic peripheral neuropathic pain has a variable course, and pain control is empirical; therefore, the effect of this drug should be assessed individually. Although efficacy with treatment exceeding 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 dosage 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 higher doses are associated with a higher incidence of adverse reactions. Maintenance dosage 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. 5) Treatment of osteoarthritis pain inadequately responsive to nonsteroidal anti-inflammatory drugs (NSAIDs) Initial dosage 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 the dose to 60mg once daily. In 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 dosage The safety and efficacy of this drug for treatment of osteoarthritis pain for more than 13 weeks have not been studied. 2. Elderly patients Dosage 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 once daily 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 dosage adjustment is necessary 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. When discontinuing treatment after more than 1 week of medication use, it is recommended that the dose be gradually reduced starting 2 weeks beforehand to reduce the risk of withdrawal symptoms. During this period, the dose may be halved or the medication taken every other day. However, the appropriate 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 or to MAO inhibitors for treatment of psychiatric disorders When discontinuing an MAO inhibitor used to treat psychiatric disorders and starting treatment with this drug, an interval of at least 14 days must be allowed. Conversely, when starting an MAO inhibitor for treatment of psychiatric disorders, at least 5 days must elapse after discontinuing this drug. 8. Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not start treatment with this drug because of the increased risk of serotonin syndrome. For patients who require other interventions, including hospitalization, or treatment of a more urgent psychiatric condition, treatment should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this drug. If no alternative medication 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 occurs first. Treatment with this drug may be restarted 24 hours after the last dose of linezolid or intravenous methylene blue. The risks of administering methylene blue by a nonintravenous route (oral tablets or local injection), or administering this drug by intravenous injection 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

3. Pediatric patients and adolescents under 18 years of age Due to concerns about safety and efficacy, this medicine should not be used to treat major depressive disorder in pediatric patients and adolescents under 18 years of age. The safety and efficacy of this medicine have not been established for other indications either.

This medication may increase the risk of suicidal thoughts or behaviors in children, adolescents, and young adults with major depressive disorder or psychiatric illnesses, so careful observation is required. This medication can cause a serious side effect called serotonin syndrome, which can be life-threatening when used in combination with certain medications, so it must be discussed with a healthcare professional. This medication should not be administered to patients with allergies to the active ingredient or excipients, certain liver diseases, kidney diseases, uncontrolled glaucoma, or hypertension. Patients with a history of mania, epilepsy, renal impairment, hypertension, or bleeding tendencies need special attention when using this medication. Common side effects include nausea, headache, dry mouth, drowsiness, and dizziness, usually occurring at the beginning of treatment and subsiding over time. Abruptly stopping this medication can lead to withdrawal symptoms like dizziness, sensory abnormalities, insomnia, and anxiety, so the dosage should be gradually decreased. This medication can cause increased blood pressure and heart rate, so hypertensive or cardiac patients should frequently monitor their blood pressure. Orthostatic hypotension or fainting symptoms may occur, and if symptoms arise, medical consultation should be sought immediately. The risk of bleeding may increase; hence, caution is needed for patients taking anticoagulants or drugs affecting platelet function. Severe skin reactions may occur; if rashes, blisters, or mucosal damage appear, the medication should be discontinued immediately and medical attention sought. This medication may cause liver damage, so any symptoms indicating liver dysfunction must be reported to a healthcare professional right away. Sexual dysfunction may occur and may persist after discontinuation in some patients. Drowsiness or dizziness may occur while driving or operating machinery, so caution is advised. During pregnancy, there may be risks to the fetus; consult a doctor if planning for pregnancy or are currently pregnant, and it is not recommended during breastfeeding. It is not established as safe and effective for children or adolescents under 18, so it should not be administered. For the elderly, although special dosage adjustment is not recommended, caution is necessary during treatment. In case of overdose, severe symptoms such as coma, seizures, or serotonin syndrome may occur, so immediate emergency treatment is necessary. Keep this medication out of reach of children, and it is safe to store it in its original container.

• Nausea
• headache
• dry mouth
• drowsiness
• dizziness
• laryngitis
• anaphylactic reactions
• hypersensitivity disorders
• hypothyroidism
• decreased appetite

This medication should be stored in a tightly closed container to prevent exposure to air or moisture, and the storage temperature should be maintained between 1°C and 30°C. Storing it this way can help maintain the medication's effectiveness over a longer period.

Appearance

A hard capsule with a blue upper part and yellow-green lower part containing white enteric-coated spherical granules

Package unit

28 capsules (14 capsules/PTPX2)/carton