Pristiq Extended Release Tablet 50 mg (Desvenlafaxine Succinate Dihydrate)

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 have not demonstrated additional benefit 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 when necessary, based on clinical judgment, but should not exceed 200mg once daily. In addition, if treatment is discontinued, gradually reduce the dose 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 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 of 30-50mL/min) is 50mg daily. The recommended dose for patients with severe renal impairment (creatinine clearance below 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 daily. Increasing the dose to more than 100mg daily is 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, patients should be monitored for these symptoms when treatment is discontinued. Reduce the dose gradually rather than discontinuing treatment abruptly. If intolerable withdrawal symptoms occur after dose reduction or discontinuation of treatment, restarting the previously prescribed dose may be considered. Thereafter, the physician may 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 medicine Withdrawal symptoms have been reported when switching from other antidepressants, including venlafaxine, to this medicine. Gradually reducing 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 monoamine oxidase inhibitors (MAOIs) for the treatment of psychiatric disorders Treatment with this medicine should not be started until at least 14 days after discontinuing an MAO inhibitor used to treat psychiatric disorders. In addition, allow an interval of at least 7 days between discontinuing this medicine and starting an MAO inhibitor (see ‘6. Drug Interactions’ under Precautions for Use). 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 discontinued immediately and linezolid or intravenous methylene blue administered only if no alternative to linezolid or intravenous methylene blue is available and the potential benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome (see ‘6. Drug Interactions’ under Precautions for Use).

This medicine is an antidepressant used in the treatment of psychiatric disorders such as major depressive disorder. While taking this medicine, there is a risk of suicidal thoughts or behaviors, so young adults and adolescents aged 18 to 24 should take it under the careful judgment of a physician. There may be a serious side effect called serotonin syndrome, so special caution is needed when taking this medicine with other medications that affect serotonin. This medicine should not be administered to patients who are taking certain medications or who have hypersensitivity, especially in combination with monoamine oxidase inhibitors (MAOIs). Patients with hypertension or heart disease should regularly check their blood pressure and heart rate before and during treatment with this medicine. Patients with a history of mania or hypomania, those with a history of seizures, and those with impaired kidney or liver function should be cautious when taking this medicine. This medicine can cause various adverse reactions, common side effects include nausea, dizziness, headache, insomnia, sweating, constipation, drowsiness, decreased appetite, and anxiety. There may also be sexual dysfunction and withdrawal symptoms, so the dosage should be gradually reduced rather than stopping suddenly. This medicine may increase the risk of bleeding, so caution is required when used in combination with medications that pose a bleeding risk. During pregnancy, the risks and benefits to the fetus should be carefully considered, and breastfeeding mothers should decide to discontinue breastfeeding as this medicine is excreted in breast milk. The safety and efficacy of this medicine in children and adolescents have not been established, and there may be an increased risk of suicide, so its use is not recommended. Elderly patients may be more susceptible to side effects such as hyponatremia and orthostatic hypotension, so caution is needed when taking this medicine. In case of overdose, immediate medical attention should be sought for appropriate emergency treatment, as there is no specific antidote and rapid treatment is important. It is advisable to avoid alcohol while taking this medicine, and caution is needed when driving or operating dangerous machinery. Finally, this medicine should be kept out of reach of children and should not be transferred to other containers.

• Suicidal thoughts and behaviors
• serotonin syndrome
• angioedema
• increased blood pressure
• increased heart rate
• nausea
• dizziness
• headache
• vomiting
• insomnia

This medicine may be sensitive to air or moisture, so it should be stored in a tightly closed container. It is best to maintain storage temperatures between 1 degree and 30 degrees Celsius to safely preserve its efficacy.

Appearance

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

Package unit

28 tablets (14 tablets/blister X 2)