Esven Sustained-Release Tablets 100 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 is an antidepressant used to treat psychiatric disorders such as major depression. Caution is required as there may be an increase in suicidal thoughts or behaviors, particularly in children, adolescents, and young adults while taking this medication. Changes in mental state should be closely monitored, especially at the start of treatment or when changing the dosage, and family members or guardians should also keep a close watch on the patient. Additionally, this medication can cause a potentially life-threatening condition known as serotonin syndrome, and the risk may increase when combined with other serotonergic drugs. Symptoms may include confusion, agitation, fever, muscle spasms, and any unusual symptoms should be reported to a doctor immediately. Risk may also be present when used with certain medications, particularly monoamine oxidase inhibitors (MAOIs), which must be separated by at least 14 days from this medication and should not be combined. Patients with hypertension or heart disease should regularly monitor their blood pressure and heart rate before and during treatment with this drug, as should those with a history of seizures. Patients with impaired liver or kidney function may need dosage adjustments due to increased drug concentrations in the body. This medication can cause allergic reactions; therefore, caution is required for patients with hypersensitivity or allergies to Tartrazine (Yellow No. 5). Side effects such as nausea, dizziness, headache, insomnia, anxiety, decreased appetite, sedation, and sexual dysfunction may occur. Stopping the medication suddenly can lead to withdrawal symptoms, so dosages should be gradually reduced according to a doctor’s instructions. This medication may increase the risk of bleeding; therefore, caution is needed for signs of bleeding when taken with drugs that affect blood coagulation. Pregnant or breastfeeding individuals should consult a doctor before use, as it may affect the fetus or newborn. The efficacy of this medication in children and adolescents has not been proven, and there is an increased risk of suicide, so special caution is necessary. Elderly patients are at higher risk of side effects such as hyponatremia and orthostatic hypotension, so they should take this medication with caution. It is advisable to avoid alcohol intake while taking this medication, and caution is needed when driving or operating dangerous machinery. In cases of overdose, severe side effects may occur, requiring immediate visit to a medical institution, and there is no specific antidote, so emergency treatment may be necessary. This medication should be stored out of reach of children, and it is advisable to avoid transferring it to another container.

• Suicidal impulses
• suicidal tendencies
• changes in mental state
• agitation
• hallucinations
• delirium
• coma
• tachycardia
• unstable blood pressure
• dizziness

This medication should be stored in a tightly sealed container to protect it from air and moisture. A storage temperature between 1 to 30 degrees Celsius at room temperature is recommended.

Appearance

Brick-red square sustained-release film-coated tablets

Package unit

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