Desvenlafaxine Extended-Release Tablets 50 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 used to treat psychiatric disorders such as major depressive disorder and should be used with caution, especially in children, adolescents, and young adults as it may increase the risk of suicidal thoughts and behaviors. This medication can cause a serious side effect known as serotonin syndrome, so caution is especially needed when taken with certain other serotonergic medications. This medication should not be taken with certain drugs, particularly monoamine oxidase inhibitors (MAOIs), as severe side effects may occur. Patients with hypertension or heart disease should have their blood pressure and heart rate regularly monitored before and during the use of this medication, and should be attentive to any increases in blood pressure. Patients with a history of mania or hypomania, seizures, kidney or liver dysfunction should be given this medication cautiously, and dosage adjustments may be necessary. This medication can cause allergic reactions, so patients with hypersensitivity to any of its components should not take it. While using this medication, side effects such as nausea, dizziness, headache, insomnia, anxiety, sweating, constipation, drowsiness, reduced appetite, may occur; if symptoms are severe, consult a physician. This medication may cause sexual dysfunction, which may persist even after discontinuation, so caution is needed. Abruptly stopping this medication may induce withdrawal symptoms; therefore, it should be weaned off gradually according to a doctor’s instructions. This medication may increase the risk of bleeding, especially when taken with aspirin, non-steroidal anti-inflammatory drugs (NSAIDs), or warfarin, so caution is warranted. Pregnant or breastfeeding women should consult a physician before taking this medication, as it may affect the fetus or newborn. Elderly patients are at higher risk for side effects like hyponatremia, so dosage adjustment and careful monitoring are essential. It is advisable to avoid alcohol while taking this medication, and caution is needed when driving or operating hazardous machinery. Overdose can lead to serious side effects; thus, it is important to adhere to the prescribed dosage and seek immediate medical attention if overdose is suspected. This medication should be kept out of reach of children, and it is advisable not to transfer it to another container.

Suicidal thoughts and behavior, symptoms of serotonin syndrome (agitation, hallucinations, delirium, coma, tachycardia, unstable blood pressure, dizziness, sweating, flushing, high fever, tremor, rigidity, clonus, dyskinesia, seizures, nausea, vomiting, diarrhea), vascular edema, increased blood pressure, elevated heart rate, nausea, dizziness, headache, vomiting, dry mouth, constipation, fatigue, chills, restlessness, decreased appetite, drowsiness, tremor, attention deficit, insomnia, anxiety, irritability, abnormal dreams, urinary retention, yawning, hyperhidrosis, blurred vision, pupillary dilation, tinnitus, dysgeusia, facial flushing, sexual dysfunction, decreased libido, abnormal sexual arousal, delayed ejaculation, erectile dysfunction, ejaculatory dysfunction, loss of ejaculatory function, sexual dysfunction, palpitations, tachycardia, diarrhea, acute pancreatitis, irritability, asthenia, hypersensitivity, weight gain, weight loss, abnormal liver function, increased serum prolactin levels, hyponatremia, musculoskeletal rigidity, headache, sensory disturbances, syncope, convulsions, muscle tone abnormalities, 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, trembling, chest pain, worsening angina, dyspepsia, gastritis, abdominal pain, esophagitis, gastroesophageal reflux, enteritis, abnormal incidents, sensation of choking, fever, facial swelling, generalized edema, ineffective medication, pharyngitis, Sjögren's syndrome, vestibular disorder, urination difficulties, exacerbation of rheumatoid arthritis, fractures, drowsiness, changes in consciousness, pupillary dilation, seizures, vomiting, ECG changes, bradycardia, hypotension, rhabdomyolysis, dizziness, liver necrosis, death, unpleasant mood, confusion, somnolence, emotional instability, hypomania, tinnitus, visual impairment, hypertension, respiratory distress, cyanosis, apnea, temperature instability, difficulty breastfeeding, hypoglycemia, hypotonia, hypertonia, clonus, tremor, limb tremors, agitation, persistent crying, withdrawal syndrome symptoms (dizziness, nausea, headache, agitation, insomnia, diarrhea, tremor, anxiety, fatigue, abnormal dreams, hyperhidrosis)

This medication is sensitive to air and humidity, so it should be stored in a tightly sealed container. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius. This will help preserve the medication's effectiveness for a longer period.

Appearance

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

Package unit

For domestic use - 30 tablets/bottle, For domestic use - 100 tablets/bottle, For export - 30 tablets/PTP [10 tablets/PTP x 3]