Desvenlafaxine Extended-Release Tablets 50 mg (Desvenlafaxine Succinate Hemihydrate)

Adult dosage

1. Adults 1) Initial treatment 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 at doses exceeding 50mg once daily, and adverse reactions and treatment discontinuations occurred more frequently at higher doses. The dose may be increased if 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 depressive disorder 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 in patients with moderate renal impairment (creatinine clearance of 30-50mL/min) is 50mg once daily. The recommended dose in 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 in patients with moderate to severe hepatic impairment is 50mg once daily. Dose increases to more than 100mg once 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; therefore, monitor patients 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 to reduce the dose, but at a slower rate. For some patients, discontinuation may take several months or longer. 5. Switching from another antidepressant to this medicine Withdrawal symptoms have been reported when switching from other antidepressants, including venlafaxine, to this medicine. Gradual reduction of 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 MAOIs used to treat psychiatric disorders Treatment with this medicine should be initiated at least 14 days after discontinuation of an MAO inhibitor used to treat psychiatric disorders. In addition, allow at least 7 days between discontinuing this medicine and initiating an MAO inhibitor (see Precautions for Use, ‘6. Drug Interactions’). 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 stopped immediately and linezolid or intravenous methylene blue administered only if no alternative to linezolid or intravenous methylene blue is available and 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 used to treat depression and may increase the risk of suicidal thoughts or behavior, especially among younger people, so symptoms should be closely monitored during the initial treatment. This medication regulates the action of neurotransmitters serotonin and norepinephrine, and concurrent use with other serotonin-related medications can lead to life-threatening serotonin syndrome, so concomitant use should be avoided. Patients with certain heart conditions or hypertension should use this medication with caution, regularly monitoring blood pressure and heart rate. Patients with a history of mania or hypomania or seizure disorders should take this medication with special care. Patients with impaired kidney or liver function may need dose adjustments, and caution is also needed if there is an allergy to certain pigment components. While taking this medication, side effects such as nausea, dizziness, headache, insomnia, anxiety, sweating, constipation, drowsiness, and others may occur, and medical consultation should be sought if abnormal symptoms appear. Sexual dysfunction may occur, so patients should report related symptoms, and abrupt discontinuation of the medication can cause withdrawal symptoms, so the dose should be gradually reduced. This medication can increase the risk of bleeding, so caution is warranted when taken with anticoagulants such as aspirin or warfarin. Women who are pregnant or breastfeeding should carefully consider the risks and benefits of taking this medication, and its use is not recommended in children and adolescents due to established safety and efficacy concerns. Elderly patients are at higher risk of hyponatremia and orthostatic hypotension, so they should exercise additional caution while taking this medication. It is advisable to avoid alcohol during treatment, and in cases of overdose, immediate medical attention should be sought. Keep out of reach of children and ensure the medication is not transferred to another container.

Suicidal ideation, suicidal tendencies, agitation, hallucinations, delirium, coma, tachycardia, unstable blood pressure, dizziness, sweating, flushing, high fever, tremors, rigidity, clonic muscle spasms, opposition to inhibition, inability to perform coordinated movements, seizures, nausea, vomiting, diarrhea, vascular edema, increased blood pressure, nausea, dizziness, headache, vomiting, insomnia, hyperhidrosis, constipation, drowsiness, decreased appetite, anxiety, male sexual dysfunction, fatigue, chills, agitation, decreased appetite, tremor, attention deficit, nervousness, abnormal dreams, delayed urination, yawning, hyperhidrosis, blurred vision, mydriasis, tinnitus, dysgeusia, facial flushing, palpitations, tachycardia, diarrhea, acute pancreatitis, irritability, asthenia, hypersensitivity, weight gain, weight loss, abnormal liver function, increased serum prolactin levels, hyponatremia, muscle rigidity, headache, sensory disturbances, syncope, convulsions, abnormal muscle tone, serotonin syndrome, withdrawal syndrome, depersonalization, mania, hypomania, hallucinations, bruxism, urinary retention, epistaxis, rash, hair loss, photosensitivity reaction, vascular edema, Stevens-Johnson syndrome, orthostatic hypotension, peripheral coldness, postpartum hemorrhage, abnormal incidents, choking sensation, chest pain, fever, facial edema, generalized edema, ineffective drug, pharyngitis, Sjögren's syndrome, vestibular disorders, dysuria, exacerbation of angina, exacerbation of rheumatoid arthritis, fracture, unpleasant mood, agitation, sensory impairment, confusion, somnolence, emotional instability, hypomania, visual impairment, hypertension, rhabdomyolysis, vertigo, liver necrosis, death, changes in ECG, atrial and ventricular tachycardia, bradycardia, hypotension, psychomotor instability, insomnia, diarrhea, tremor, anxiety, fatigue, abnormal dreams, hyperhidrosis, sexual dysfunction, decreased libido, sexual arousal disorders, delayed ejaculation, erectile dysfunction, ejaculatory disorders, loss of ejaculatory function

This medication can be sensitive to air and moisture and should be stored in a tightly closed container. It is also important to store it at a temperature between 1°C and 30°C to maintain its efficacy.

Appearance

Light pink, square-shaped extended-release film-coated tablet with one side in a pyramid shape

Package unit

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