Desvenlafaxine Extended-Release Tablets 25 mg (Desvenlafaxine Succinate)

Adult dosage

1. Adults 1) Initial dosing 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 divide, crush, chew, or dissolve it in water. In clinical trials, no additional benefit was demonstrated with doses exceeding 50mg once daily, and adverse reactions and treatment discontinuations occurred more frequently at higher doses. The dose may be increased if clinically indicated, but should not exceed 200mg once daily. When discontinuing treatment, gradually reduce the dose to minimize withdrawal symptoms. 2) Maintenance dosing Acute episodes of major depression usually 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 less than 30mL/min) or end-stage renal disease (ESRD) is 50mg every other day. Do not administer a supplemental dose after hemodialysis. 3. Patients with hepatic impairment The recommended dose for patients with moderate to severe hepatic impairment is 50mg once daily. Dose increases above 100mg 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; monitor for these symptoms when discontinuing treatment. Gradually reduce the dose rather than stopping abruptly. If intolerable withdrawal symptoms occur after a dose reduction or discontinuation, restarting the previously prescribed dose may be considered. The physician may then continue to reduce the dose, but at a slower rate. In some patients, discontinuation may take several months or longer. 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 previous antidepressant dose 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 Start treatment with this medicine at least 14 days after discontinuing an MAO inhibitor used to treat psychiatric disorders. Also, allow an interval of at least 7 days between discontinuing this medicine and starting an MAO inhibitor (see “6. Interactions” under Precautions for Use). 2) Use of this medicine with other MAO inhibitors, such as linezolid or methylene blue: If a patient already receiving this medicine 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 to linezolid or intravenous methylene blue is available and the potential benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome (see “6. Interactions” under Precautions for Use).

This drug is an antidepressant used for the treatment of major depression. During treatment with this drug, especially in children, adolescents, and young adults, there may be an increased risk of suicidal thoughts or behaviors, so it is essential to exercise caution. Patients and caregivers should closely monitor for changes in abnormal behaviors such as worsening of depression, suicidal tendencies, or aggression, and if any concerning signs occur, consult a physician immediately. Caution is necessary when used in combination with other serotonin-related medications, as it can lead to life-threatening serotonin syndrome. It should especially not be used in conjunction with monoamine oxidase inhibitors (MAOIs), and a sufficient interval should be maintained between treatments. Patients with hypertension or heart disease should regularly monitor their blood pressure and heart rate before and during treatment with this drug, and should consider dosage adjustment or discontinuation if blood pressure rises. Patients with a history of mania or hypomania or seizures should use this drug cautiously, and those with impaired renal or hepatic function should have their dosage adjusted. Common side effects during treatment include nausea, dizziness, headache, insomnia, anxiety, diaphoresis, constipation, etc., and if symptoms are severe, consult a physician. This drug may cause withdrawal symptoms upon abrupt discontinuation, so when stopping the medication, dosage should be gradually reduced according to a physician's instructions. Women who are pregnant or breastfeeding should consult a physician before taking this drug, as it may affect the fetus or newborn and should be used with caution. Elderly patients are at higher risk for side effects such as hyponatremia or orthostatic hypotension, so special precautions are necessary during treatment. It is advisable to avoid alcohol consumption while taking this medication, and it is also important to inform the physician about any other medications being taken due to potential interactions. In case of overdose, serious side effects may occur, and if suspected, immediate medical attention should be sought. This medication should be stored out of reach of children and should not be transferred to another container.

• suicidal thoughts
• suicidal tendencies
• agitation
• hallucinations
• delirium
• coma
• tachycardia
• unstable blood pressure
• dizziness
• sweating

This drug should be stored in a tightly sealed container to prevent exposure to air or moisture. It is important to maintain storage temperatures between 1 and 30 degrees Celsius to preserve the drug's efficacy and safety over time.

Appearance

White square extended-release film-coated tablets

Package unit

28 tablets/box[((14T/PTP)*2)], 30 tablets/bottle, 100 tablets/bottle