Desvenlafaxine Sustained Release Tablets 25 mg (Desvenlafaxine)

Adult dosage

1. Adults 1) Initial administration The recommended dose of this medicine is 50mg once daily. This medicine may be taken with or without food and should be taken at the same time each day. Swallow the tablet whole with liquid; do not split, crush, chew, or dissolve it in water. Clinical trials have not demonstrated additional benefit at doses above 50mg once daily, and adverse reactions and treatment discontinuations occurred more frequently at higher doses. The dose may be increased when clinically indicated, based on clinical judgment, but should not exceed 200mg once daily. When discontinuing treatment, gradually reduce the dose to minimize withdrawal symptoms. 2) Maintenance treatment Acute episodes of major depression generally require continuous drug therapy for several months or longer. Patients should be reassessed regularly to determine the need for continued treatment. 2. Patients with renal impairment The recommended dose for patients with moderate renal impairment (creatinine clearance 30-50mL/min) is 50mg once daily. The recommended dose for patients with severe renal impairment (creatinine clearance below 30mL/min) or end-stage renal disease (ESRD) is 50mg every other day. A supplemental dose should not be administered after hemodialysis. 3. Patients with hepatic impairment The recommended dose for patients with moderate to severe hepatic impairment is 50mg once daily. Dose increases to more than 100mg once daily are not recommended. 4. Discontinuation of treatment Symptoms associated with discontinuation of this medicine and serotonin-norepinephrine reuptake inhibitors (SNRIs) and selective serotonin reuptake inhibitors (SSRIs) have been reported; patients should be monitored for these symptoms when treatment is discontinued. Gradually reduce the dose rather than stopping treatment abruptly. If intolerable withdrawal symptoms occur after dose reduction or discontinuation, resuming the previously prescribed dose may be considered. Thereafter, the physician may continue to reduce the dose, but at a slower rate. Some patients may require several months or longer to discontinue treatment. 5. Switching from other antidepressants to this medicine Withdrawal symptoms have been reported when switching from other antidepressants, including venlafaxine, to this medicine. Gradual reduction of the dose of the previous antidepressant may be necessary to minimize these symptoms. 6. Administration with monoamine oxidase inhibitors (MAOIs) 1) Switching from monoamine oxidase inhibitors (MAOIs) used to treat psychiatric disorders Treatment with this medicine should begin at least 14 days after discontinuation of an MAO inhibitor used to treat psychiatric disorders. In addition, at least 7 days should elapse between discontinuation of this medicine and initiation of an MAO inhibitor (see Precautions for Use, '6. Interactions'). 2) Use of this medicine with other MAO inhibitors, such as linezolid or methylene blue: For a patient already receiving this medicine who requires urgent treatment with linezolid or intravenous methylene blue, this medicine may be discontinued immediately and linezolid or intravenous methylene blue administered only if no alternative drugs to linezolid or intravenous methylene blue are available and the potential benefit of treatment with linezolid or intravenous methylene blue is judged to outweigh the risk of serotonin syndrome (see Precautions for Use, '6. Interactions').

This drug may increase the risk of suicidal thoughts or behaviors in children, adolescents, and young adults with major depressive disorder or other psychiatric disorders, therefore physicians must carefully consider the necessity and risks of treatment. All patients taking this medication should be closely monitored for abnormal behavioral changes, such as suicidal tendencies, worsening depression, or aggression, especially during the initial months of treatment, and the patient's family or caregivers should also be vigilant. There is a serious risk of serotonin syndrome; therefore, extra caution is required when using other medications that affect serotonin, and if associated symptoms occur, the drug should be stopped immediately, and consultation with healthcare professionals is advised. This drug should not be taken with certain medications, particularly monoamine oxidase inhibitors (MAOIs), and a safe interval must be maintained between these medications. Patients with hypertension or heart disease should regularly monitor blood pressure and heart rate before and during treatment, and if hypertension develops, dosage adjustment or discontinuation may be necessary. Patients with a history of mania or hypomania, seizure history, or impaired renal or liver function should be treated with caution, and dosage adjustments may be necessary. This medication contains Yellow No. 5 and should be used with caution in patients allergic to it. Common side effects during treatment may include nausea, dizziness, headache, vomiting, insomnia, anxiety, sweating, constipation, drowsiness, and decreased appetite, and sexual dysfunction may also occur. Abruptly stopping this medication can result in withdrawal symptoms, so when discontinuing treatment, the dosage should be gradually reduced as per the doctor's instructions. Women who are pregnant or breastfeeding should consult a physician before taking this medication, as it may affect the fetus or newborn. Effectiveness in children and adolescents has not been established and special caution is needed due to the increased risk of suicide. Elderly patients are at higher risk of hyponatremia and orthostatic hypotension, necessitating more careful monitoring during use. It is advisable to avoid alcohol consumption during treatment, and all medications being taken should be reported to healthcare professionals due to possible drug interactions. Serious side effects may occur in the case of overdose, and if suspected, immediate medical assistance should be sought. Finally, this medication should be stored out of reach of children and not transferred to other containers for safety.

• Suicidal thoughts and behavior
• serotonin syndrome
• angioedema
• increased blood pressure
• nausea
• dizziness
• headache
• vomiting
• insomnia
• sweating

This medication may be sensitive to air and moisture, so it should be stored in a tightly closed container. It is recommended to maintain the storage temperature between 1 to 30 degrees Celsius.

Appearance

White square sustained release film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle