Prineksa Sustained Release Tablet 50mg (Desvenlafaxine Besylate)

Adult dosage

1. Adults 1) Initial dose The recommended dose of this drug is 50 mg once daily. This drug 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 with doses greater than 50 mg once daily, and adverse reactions and treatment discontinuations occurred more frequently at higher doses. The dose may be increased only when clinically indicated, based on clinical judgment, but should not exceed 200 mg once daily. When discontinuing treatment, gradually reduce the dose to minimize withdrawal symptoms. 2) Maintenance treatment Acute episodes of major depression usually require continuous pharmacotherapy for several months or longer. Patients should be reevaluated regularly 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 to patients 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 of treatment Symptoms associated with discontinuation of this drug and serotonin-norepinephrine reuptake inhibitors (SNRIs) and selective serotonin reuptake inhibitors (SSRIs) have been reported; therefore, 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 treatment discontinuation, resuming the previously prescribed dose may be considered. The physician may then continue to reduce the dose, but at a slower rate. In some patients, discontinuation may take several months or longer. 5. Switching from other antidepressants to this drug Withdrawal symptoms have been reported when switching from other antidepressants, including venlafaxine, to this drug. Gradually tapering the dose of the previous antidepressant may be necessary to minimize these symptoms. 6. Concomitant use with monoamine oxidase inhibitors (MAOIs) 1) Switching from monoamine oxidase inhibitors (MAOIs) used to treat psychiatric disorders Treatment with this drug should be initiated at least 14 days after discontinuing an MAO inhibitor used to treat psychiatric disorders. In addition, allow at least 7 days between discontinuing this drug and starting an MAO inhibitor (see Precautions for Use, ‘6. Interactions’). 2) Use of this drug with other MAO inhibitors, such as linezolid or methylene blue: If a patient already receiving this drug requires urgent treatment with linezolid or intravenous methylene blue, this drug may be stopped immediately and linezolid or intravenous methylene blue administered only if no alternative drug 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 drug may increase the risk of suicidal thoughts or behaviors in children, adolescents, and young adults with major depressive disorder or other psychiatric disorders. Therefore, especially when administering to patients aged 18 to 24, careful judgment is necessary. Additionally, family members and caregivers should carefully monitor for any worsening of the patient's condition or the onset of abnormal behavioral changes such as suicidal tendencies, aggression, or anger while taking this medication. As this drug regulates serotonin levels, there is a risk of life-threatening serotonin syndrome if taken with other serotonergic drugs. Therefore, caution is needed when used with other antidepressants, triptans, lithium, opioids, tramadol, buspirone, amphetamines, and St. John's Wort. This medication should not be used in conjunction with specific MAO inhibitors, and at least 14 days must pass after discontinuing MAO inhibitors before starting this medication. Patients with hypertension or heart disease should regularly monitor blood pressure and heart rate before and during treatment with this drug. If blood pressure increases, consideration should be given to adjusting the dose or discontinuing the medication. Caution should be exercised in patients with a history of mania or hypomania or seizures, and dosage adjustments are needed for patients with impaired kidney or liver function. This medication contains certain dyes; therefore, patients allergic to them should be cautious. Common side effects during treatment may include nausea, dizziness, headache, vomiting, insomnia, anxiety, sweating, constipation, drowsiness, decreased appetite, and in some patients, sexual dysfunction. If the medication is suddenly discontinued, withdrawal symptoms such as dizziness, nausea, headache, and anxiety may occur, so the dosage should be gradually reduced according to the doctor's instructions. This drug may increase the risk of bleeding; therefore, caution should be exercised when used with anticoagulant medications such as aspirin, NSAIDs, or warfarin. During pregnancy, the risks and benefits to the fetus should be carefully considered, and during breastfeeding, as the medication can be passed through breast milk, consultation with a doctor regarding breastfeeding cessation or medication discontinuation is necessary. The efficacy of this medication in children and adolescents has not been established, and the risk of suicide may increase, so caution is needed. In elderly patients, there is a higher risk of hyponatremia and orthostatic hypotension, necessitating careful monitoring during administration. It is advisable to avoid alcohol consumption while taking this medication, as overdose can lead to serious side effects; if suspected, seek medical attention immediately. Finally, this medication should be kept out of the reach of children, and transferring it to another container may pose a risk of accidents, so caution is essential.

Thoughts of suicide and actions, symptoms of serotonin syndrome (agitation, hallucinations, delirium, coma, tachycardia, unstable blood pressure, dizziness, sweating, flushing, high fever, tremors, rigidity, myoclonus, akathisia, dysfunction of coordination, seizures, nausea, vomiting, diarrhea), angioedema, hypertension, increased heart rate, mania, seizures, nausea, dizziness, headache, vomiting, insomnia, hyperhidrosis, constipation, drowsiness, decreased appetite, anxiety, specific male sexual dysfunction, dry mouth, fatigue, chills, agitation, attention deficit, abnormal dreams, urinary retention, yawning, rash, blurred vision, pupil dilation, tinnitus, dysgeusia, facial flushing, sexual dysfunction, decreased libido, abnormal sexual arousal, delayed ejaculation, erectile dysfunction, ejaculation disorder, loss of ejaculation function, weight gain, weight loss, abnormal liver function, increased serum prolactin levels, hyponatremia, musculoskeletal rigidity, sensory disturbances, syncope, convulsions, abnormal muscle tone, withdrawal syndrome, depersonalization, mania, hypomania, hallucinations, bruxism, urinary retention, epistaxis, hair loss, photosensitivity, angioedema, Stevens-Johnson syndrome, orthostatic hypotension, peripheral coldness, postpartum hemorrhage, palpitations, tachycardia, stress-induced cardiomyopathy, diarrhea, irritability, asthenia, hypersensitivity, headache, sensory disturbances, syncope, convulsions, abnormal muscle tone, serotonin syndrome, withdrawal syndrome, depersonalization, mania, hypomania, hallucinations, bruxism, urinary retention, epistaxis, rash, hair loss, photosensitivity, angioedema, Stevens-Johnson syndrome, orthostatic hypotension, peripheral coldness, postpartum hemorrhage, tremors, chest pain, exacerbation of angina, dyspepsia, gastritis, abdominal pain, esophagitis, gastroesophageal reflux, enteritis, unusual events, choking sensation, fever, facial edema, generalized edema, ineffective medication, pharyngitis, Sjögren's syndrome, vestibular disorder, difficulty urinating, exacerbation of rheumatoid arthritis, fractures, tachycardia, altered consciousness, pupil dilation, seizures, vomiting, changes in electrocardiogram, atrial and ventricular tachycardia, bradycardia, hypotension, rhabdomyolysis, dizziness, hepatic necrosis, serotonin syndrome, death

This medication may be sensitive to air or moisture; it should be stored in a tightly sealed container. The recommended storage temperature is between 1 to 30 degrees Celsius at room temperature. This helps maintain the medication's efficacy and safety for a longer period.

Appearance

Pale pink square sustained-release film-coated tablet

Package unit

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