Desvenlafaxine Extended-Release Tablets 50 mg (Desvenlafaxine Besylate)

Adult dosage

1. Adults 1) Initial treatment The recommended dose of this medication is 50mg once daily. This medication 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. In clinical trials, no additional benefit was demonstrated 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 if necessary based on clinical judgment, but should not exceed 200mg once daily. In addition, when discontinuing treatment, gradually reduce the dose to minimize withdrawal symptoms. 2) Maintenance treatment 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 to 100mg or more once daily are not recommended. 4. Discontinuation Because symptoms associated with discontinuation of this medication 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 treatment abruptly. If intolerable withdrawal symptoms occur after dose reduction or discontinuation, consider resuming the previously prescribed dose. The physician may then continue reducing the dose, but at a slower rate. In some patients, discontinuation may require several months or longer. 5. Switching from another antidepressant to this medication Withdrawal symptoms have been reported when switching from other antidepressants, including venlafaxine, to this medication. Gradually reducing the dose of the previous antidepressant may be necessary to minimize these symptoms. 6. Use with monoamine oxidase inhibitors (MAOIs) 1) Switching to or from a monoamine oxidase inhibitor (MAOI) used to treat psychiatric disorders Start treatment with this medication at least 14 days after discontinuing an MAO inhibitor used to treat psychiatric disorders. In addition, allow at least 7 days between discontinuing this medication and starting an MAO inhibitor (see Precautions for Use, ‘6. Drug Interactions’). 2) Use of this medication with other MAO inhibitors, such as linezolid or methylene blue: If a patient already receiving this medication requires urgent treatment with linezolid or intravenous methylene blue, and no alternative medication to linezolid or intravenous methylene blue is available, this medication may be discontinued immediately and linezolid or intravenous methylene blue administered only if 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. Drug Interactions’).

This medication may increase the risk of suicidal thoughts or behavior in children, adolescents, and young adults with major depressive disorder or other psychiatric conditions, so the physician should carefully consider the necessity of treatment and the risks involved. This medication can cause a life-threatening serious condition known as serotonin syndrome, so caution is required when taken with other serotonin-related medications. This medication is risky when used with certain drugs, especially monoamine oxidase inhibitors (MAOIs), and a certain period should be allowed between administrating these medications. Patients with hypertension or heart disease should regularly monitor their blood pressure and heart condition before and during the use of this medication, and consider dose adjustments or discontinuation if an increase in blood pressure occurs. Patients with a history of mania or hypomania should use this medication with caution, and patients with a history of seizures should also take it carefully. Patients with impaired kidney or liver function may have higher concentrations of this medication in their body, so dose adjustments may be necessary. This medication contains ingredients that can cause allergic reactions, so patients with a history of allergies should be cautious. During treatment, side effects such as nausea, dizziness, headache, insomnia, sweating, constipation, drowsiness, decreased appetite, anxiety, irritability, abnormal dreams, urinary retention, yawning, hair loss, orthostatic hypotension, peripheral coldness, sexual dysfunction, musculoskeletal rigidity, sensory disturbances, fainting, seizures, muscle spasms, withdrawal syndrome, depersonalization, mania, hypomania, hallucinations, bruxism, urinary retention, epistaxis, angioedema, photosensitivity reactions, postpartum hemorrhage, weight gain, and weight loss may occur, so symptoms should be closely monitored. This medication may cause sexual dysfunction, and symptoms may persist even after discontinuation, so consult a doctor if necessary. If discontinuation of this medication is abrupt, withdrawal symptoms (e.g., dizziness, nausea, headache, anxiety, etc.) may occur, so the dose should be gradually reduced according to the physician's guidance. This medication may increase the risk of bleeding, so caution is necessary for symptoms of bleeding when taken with aspirin, non-steroidal anti-inflammatory drugs (NSAIDs), or warfarin. Pregnant or breastfeeding women should consult a doctor before taking this medication, as it may affect the fetus or newborn. The use of this medication is not approved in children and adolescents, and there may be an increased risk of suicide in this age group, so special attention is needed. Elderly patients are at increased risk of side effects such as hyponatremia or orthostatic hypotension, so dose adjustments and monitoring are necessary. This medication may require caution when driving or operating machinery, and it is advisable to avoid alcohol consumption. In case of overdose, serious side effects may occur, so the dosage must be strictly followed, and if abnormal symptoms appear, immediate medical attention should be sought. This medication should be kept out of reach of children and it is advised not to transfer it to another container to maintain quality.

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

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. The storage temperature should be kept at room temperature between 1 degree and 30 degrees Celsius. Storing it this way will help maintain the medicine's effectiveness for a long time.

Appearance

Pale pink, square, extended-release film-coated tablet

Package unit

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