Prineksa Sustained-release Tablet 25 mg (Desvenlafaxine Besylate)

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 split, crush, chew, or dissolve it in water. Clinical trials did not demonstrate additional benefit at doses exceeding 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, reduce the dose gradually to minimize withdrawal symptoms. 2) Maintenance treatment Acute episodes of major depression generally require continuous drug therapy 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 30-50mL/min) is 50mg 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 daily. Dose increases above 100mg 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; patients should be monitored for these symptoms when treatment is discontinued. Reduce the dose gradually rather than stopping treatment abruptly. If intolerable withdrawal symptoms occur after dose reduction or discontinuation, resuming the previously prescribed dose may be considered. The physician may then continue to reduce the dose, but at a slower rate. Some patients may need several months or longer to discontinue treatment. 5. Switching from other antidepressants 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. Use with monoamine oxidase inhibitors (MAOIs) 1) Switching from monoamine oxidase inhibitors (MAOIs) used to treat psychiatric disorders Treatment with this medicine should be started at least 14 days after discontinuing an MAO inhibitor used to treat psychiatric disorders. In addition, allow at least 7 days between discontinuing this medicine and starting an MAO inhibitor (see Precautions for Use, ‘6. 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, and there are no alternative medicines to linezolid or intravenous methylene blue and the potential benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome, this medicine may be discontinued immediately and linezolid or intravenous methylene blue administered (see Precautions for Use, ‘6. Interactions’).

This medication is used to treat psychiatric disorders such as major depression, and it may particularly increase the risk of suicidal thoughts or behavior in younger individuals, so caution is needed. During treatment with this medication, family members or guardians should closely monitor for any changes in suicidal tendencies or behavior, anxiety, aggression, or other abnormal behaviors, and if any unusual symptoms are detected, immediate consultation with a healthcare provider is necessary. Additionally, taking this medication together with other serotoninergic medications may lead to potentially life-threatening serotonin syndrome, so other medications should not be combined without consulting a physician. This medication is dangerous when used with certain drugs, especially monoamine oxidase inhibitors (MAOIs). It should not be started until at least 14 days have passed after discontinuing an MAOI. Patients with hypertension or heart disease should regularly check their blood pressure and heart rate before and during treatment with this medication, and if blood pressure elevation is significant, dose adjustment or discontinuation may be necessary. This medication should be used cautiously in patients with a history of mania or hypomania, seizure history, or impaired kidney or liver function, and dosage adjustments may be required. This medication contains Yellow No. 5, and patients allergic to this ingredient should take caution. Common side effects include nausea, dizziness, headache, insomnia, sweating, constipation, drowsiness, decreased appetite, anxiety, and the like; if these symptoms are severe or persistent, the healthcare provider should be informed. Moreover, this medication can cause sexual dysfunction, and abrupt discontinuation may lead to withdrawal symptoms; therefore, the dosage should be gradually reduced according to a physician's instructions when discontinuing. In elderly patients, there is a higher risk of hyponatremia that requires monitoring through blood tests, and caution is necessary during driving or operating machinery. Pregnant or breastfeeding women should consult with a physician before taking this medication, as it may impact the fetus or neonate. In case of overdose, serious side effects may occur, so the dosage should be strictly adhered to, and if an overdose is suspected, immediate medical attention should be sought. This medication should be stored out of reach of children and should not be transferred to other containers.

Suicidal thoughts and behavior, serotonin syndrome symptoms (agitation, hallucinations, delirium, coma, tachycardia, unstable blood pressure, dizziness, sweating, flushing, high fever, tremors, rigidity, generalized muscle spasms, akathisia, dyskinesia, seizures, nausea, vomiting, diarrhea), angioedema, increased blood pressure, increased heart rate, nausea, dizziness, headache, vomiting, insomnia, hyperhidrosis, constipation, drowsiness, appetite loss, anxiety, specific male sexual dysfunction, dry mouth, fatigue, chills, agitation, tremors, attention deficit, irritability, abnormal dreams, urinary retention, yawning, rash, blurred vision, pupil dilation, tinnitus, dysgeusia, facial flushing, palpitations, tachycardia, diarrhea, acute pancreatitis, irritability, asthenia, hypersensitivity, weight gain, weight loss, abnormal liver function, increased serum prolactin level, hyponatremia, musculoskeletal rigidity, headache, paresthesia, syncope, convulsions, abnormal muscle tension, withdrawal syndrome, depersonalization, mania, hypomania, hallucinations, bruxism, urinary retention, nasal bleeding, hair loss, photosensitivity reaction, angioedema, Stevens-Johnson syndrome, orthostatic hypotension, peripheral coldness, postpartum hemorrhage, abnormal thoughts, choking sensation, chest pain, generalized edema, ineffective medication, pharyngitis, Sjögren's syndrome, vestibular disorder, dysuria, exacerbation of angina, exacerbation of rheumatoid arthritis, fractures, drowsiness, irritability, confusion, hypersomnia, emotional instability, hypomania, visual impairment, hypertension, rhabdomyolysis, vertigo, hepatic necrosis, death

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture, and it is recommended to store it at room temperature between 1 degree and 30 degrees Celsius. Proper storage will help maintain the medication's efficacy over time.

Appearance

White square-shaped sustained-release film-coated tablets

Package unit

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