Desvenlafaxine Prolonged-Release Tablets 100 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. In children, adolescents, and young adults (ages 18-24), there may be an increased risk of suicidal thoughts or behaviors, thus doctors should carefully evaluate the risks and benefits before prescribing this medication. This medication alleviates depressive symptoms by inhibiting the reuptake of neurotransmitters serotonin and norepinephrine, but serious side effects such as serotonin syndrome may occur if used with other serotonergic drugs. This syndrome includes symptoms such as anxiety, confusion, high fever, muscle spasms, and if these symptoms appear, medication should be stopped immediately and medical attention should be sought. This medication should not be used in conjunction with certain drugs, particularly monoamine oxidase inhibitors (MAO inhibitors), and should only be started after at least 14 days have passed since discontinuing an MAO inhibitor. Patients with hypertension or heart disease should regularly monitor their blood pressure and heart rate before and during treatment with this medication, and if elevated blood pressure persists, dosage adjustments or discontinuation should be considered. Patients with a history of mania or hypomania or those with seizure disorders should use this medication with caution, and dosage adjustments may be necessary for patients with impaired kidney or liver function. This medication may have various side effects, with common ones including nausea, dizziness, headache, insomnia, drowsiness, decreased appetite, and anxiety. Sexual dysfunction, hyponatremia, increased bleeding tendency, and withdrawal symptoms may also occur, so caution is advised. Women who are pregnant or breastfeeding should discuss with their doctor whether to use this medication as it may affect the fetus or newborn. This medication is not approved for use in children and adolescents, and caution should be taken when prescribing to the elderly, considering the risks of renal impairment and hyponatremia. In case of overdose, serious side effects may occur, and medical care should be sought immediately if overdose is suspected. Finally, during the use of this medication, avoid alcohol consumption and be cautious when driving or operating dangerous machinery.

• Suicidal thoughts and behaviors
• serotonin syndrome
• angioedema
• increased blood pressure
• nausea
• dizziness
• headache
• vomiting
• dry mouth
• constipation

This medication should be stored in a tightly closed container to prevent exposure to air or moisture. It is best to maintain storage temperature between 1 and 30 degrees Celsius.

Appearance

A delayed-release film-coated tablet that is square-shaped with one side in a pyramid shape and is reddish in color.

Package unit

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