Desvenlafaxine Sustained-release Tablets 50 mg (Desvenlafaxine Succinate Dihydrate)

Adult dosage

1. Adults 1) Initial treatment The recommended dose of this product is 50mg once daily. This product 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. Clinical trials did not demonstrate additional benefit at doses greater than 50mg once daily, and adverse reactions and treatment discontinuations occurred more frequently at higher doses. The dose may be increased only when necessary 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 pharmacotherapy for several months or longer. Patients should be regularly reassessed to determine the need for continued treatment. 2. Patients with renal impairment The recommended dose for patients with moderate renal impairment (creatinine clearance of 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 to more than 100mg daily are not recommended. 4. Discontinuation of treatment Symptoms associated with discontinuation of this product 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, consider resuming the previously prescribed dose. The physician may then 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 product Withdrawal symptoms have been reported when switching from other antidepressants, including venlafaxine, to this product. Gradually reducing the dose of the previous antidepressant may be necessary to minimize these symptoms. 6. Administration with monoamine oxidase inhibitors (MAOIs) 1) Switching to or from monoamine oxidase inhibitors (MAOIs) for the treatment of psychiatric disorders Treatment with this product should be initiated at least 14 days after discontinuation of an MAO inhibitor used to treat psychiatric disorders. In addition, allow an interval of at least 7 days after discontinuing this product before starting an MAO inhibitor (see Precautions for Use, ‘6. Interactions’). 2) Use of this product with other MAO inhibitors, such as linezolid or methylene blue: If a patient already receiving this product requires urgent treatment with linezolid or intravenous methylene blue, this product may be discontinued immediately and linezolid or intravenous methylene blue administered only if no alternative medication is available and the potential benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome (see Precautions for Use, ‘6. Interactions’).

This medication is an antidepressant used to treat major depression and other psychiatric disorders. It may increase the risk of suicidal thoughts or behaviors, particularly in children, adolescents, and young adults, so careful judgment and monitoring are required when prescribing to patients in this age group. Additionally, this medication can cause a serious side effect known as serotonin syndrome. Serotonin syndrome includes a variety of symptoms such as anxiety, confusion, high fever, tremors, seizures, and vomiting, and the risk increases when used with other serotonin-related medications. This medication should not be used in conjunction with certain drugs, particularly monoamine oxidase inhibitors (MAOIs), and a specific interval should be maintained before and after administration. Patients with hypertension or cardiac conditions should regularly monitor blood pressure and heart rate before and during the use of this medication, and if there is a significant increase in blood pressure, consideration should be given to adjusting the dosage or discontinuing use. Special caution is required for patients with a history of mania or hypomania or those with seizure disorders, and dosage adjustment is recommended for patients with reduced kidney or liver function. This medication contains a dye called Tartrazine (Yellow No. 5), so patients with allergies to this component should be cautious. Common side effects may include nausea, dizziness, headache, vomiting, insomnia, anxiety, sweating, constipation, drowsiness, and decreased appetite, along with reported sexual dysfunction. This medication may affect blood coagulation, increasing the risk of bleeding when taken with anticoagulants such as aspirin, non-steroidal anti-inflammatory drugs (NSAIDs), or warfarin. During pregnancy, there may be potential risks to the fetus and newborn, so consulting a doctor is necessary when taking this medication during pregnancy, and nursing mothers should consider stopping breastfeeding or changing medications as this drug is excreted in breast milk. Sudden discontinuation of this medication may lead to withdrawal symptoms, so the dosage should be gradually reduced under a doctor's guidance. Elderly patients are at a higher risk for side effects such as hyponatremia, requiring cautious administration. Serious symptoms may occur in case of overdose; therefore, it is crucial to adhere strictly to the dosage, and if an overdose is suspected, medical attention should be sought immediately. It is advisable to avoid alcohol while taking this medication and to exercise caution in activities requiring alertness, such as driving or operating machinery.

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

This medication should be stored in a tightly closed container to protect it from air and moisture, and it is important to maintain a storage temperature between 1 and 30 degrees Celsius. Storing it this way will help preserve the effectiveness of the medication for a longer time.

Appearance

Pale pink sustained-release film-coated tablets with one side shaped like a pyramid.

Package unit

28 tablets/box [(14 tablets/PTP x 2)]