Desvenlafaxine Extended-Release Tablets 100 mg (Desvenlafaxine)

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 depressive disorder. While taking this medication, thoughts or behaviors related to suicide may increase, so young patients aged 18 to 24 should be closely monitored and evaluated by a physician. This medication can cause a severe side effect known as serotonin syndrome, which may increase the risk when taken with other serotonergic medications. Therefore, during the course of treatment, do not take other antidepressants or specific medications without consulting your doctor. Patients with hypertension or heart disease should frequently check their blood pressure and heart rate before and during treatment because this medication may elevate blood pressure. Patients with a history of mania or hypomania should be cautious, as symptoms may worsen during treatment with this medication. Patients with a history of seizures should also exercise caution, as there is a risk of seizures occurring. Patients with impaired kidney or liver function may need to adjust the dosage, and those with hypersensitivity or allergies to Yellow No. 5 should also be careful. This medication can commonly cause side effects such as nausea, dizziness, headache, insomnia, anxiety, excessive sweating, constipation, and drowsiness. Sexual dysfunction may also occur, so consult your doctor if these symptoms arise. During treatment, the risk of bleeding may increase, so be particularly cautious when taking this medication with blood-thinning agents such as aspirin, NSAIDs, or warfarin. During pregnancy, carefully weigh the risks and benefits to the fetus, especially in the late stages of pregnancy, as withdrawal symptoms may occur in the newborn, requiring monitoring. If breastfeeding, consider stopping the medication or the breastfeeding, as this medication is excreted in breast milk. The efficacy of this medication has not been established in children and adolescents, and there may be an increased risk of suicide, thus requiring special caution. In elderly patients, there is a higher risk of hyponatremia and orthostatic hypotension, so dosage adjustment and monitoring are necessary. Abrupt discontinuation of this medication can lead to withdrawal symptoms, so tapering off should be done according to a physician's instructions. In cases of overdose, severe side effects may occur, so seek medical attention immediately if an overdose is suspected. Finally, this medication should be kept out of the reach of children, and transferring it to another container should be avoided.

Suicidal thoughts and behaviors, serotonin syndrome, angioedema, increased blood pressure, nausea, dizziness, headache, vomiting, dry mouth, constipation, fatigue, chills, agitation, decreased appetite, drowsiness, tremors, attention deficit, insomnia, anxiety, irritability, abnormal dreams, urinary retention, yawning, hyperhidrosis, blurred vision, pupillary dilation, tinnitus, dysgeusia, facial flushing, sexual dysfunction, decreased libido, sexual arousal disorder, delayed ejaculation, erectile dysfunction, ejaculation disorder, loss of ejaculation function, sexual dysfunction, palpitations, tachycardia, diarrhea, hypersensitivity, asthenia, sensitivity, weight gain, weight loss, abnormal liver function, increased serum prolactin levels, hyponatremia, musculoskeletal stiffness, headache, sensory abnormalities, fainting, seizures, abnormal muscle tone, withdrawal syndrome, depersonalization, manic episodes, hypomania, hallucinations, bruxism, urinary retention, nasal hemorrhage, rash, hair loss, phototoxic reactions, angioedema, Stevens-Johnson syndrome, orthostatic hypotension, peripheral coldness, postpartum hemorrhage, tremors, chest pain, exacerbation of angina, dyspepsia, gastritis, abdominal pain, esophagitis, gastroesophageal reflux, enteritis, abnormal accidents, sensation of throat tightening, fever, facial edema, generalized edema, ineffective medication, pharyngitis, Sjögren's syndrome, vestibular disorders, urinary difficulties, exacerbation of rheumatoid arthritis, fractures, myocardial ischemia, myocardial infarction, vascular remodeling requiring coronary artery occlusion, tachycardia, changes in consciousness, pupillary dilation, seizures, vomiting, ECG changes, atrial and ventricular tachycardia, bradycardia, hypotension, rhabdomyolysis, vertigo, liver necrosis, serotonin syndrome, death, unpleasant mood, excitement, agitation, sensory impairment, confusion, hypersomnia, emotional instability, hypomania, tinnitus, visual impairment, hypertension

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

Appearance

A square extended-release film-coated tablet that is reddish-brown with one side shaped like a pyramid.

Package unit

For domestic use) 30 tablets/bottle, 100 tablets/bottle, for export) 30 tablets/PTP (10 tablets/PTP x 3)