Pristiq Extended-Release Tablets 100mg (Desvenlafaxine Succinate Hemihydrate)

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 medication is an antidepressant used to treat symptoms associated with major depression. There is an increased risk of suicidal thoughts or behaviors during treatment with this medication, particularly in young adults aged 18 to 24 and in children and adolescents, who should be closely monitored. Serotonin syndrome, a serious adverse effect, can occur, so it is essential to consult a physician when taking this medication alongside other drugs that affect serotonin. Patients with a history of allergy to this medication or its components, or those who have recently taken monoamine oxidase inhibitors (MAOIs), should not use this medication. Patients with hypertension or heart disease should take this medication cautiously and regularly monitor their blood pressure and heart rate. Patients with a history of mania or hypomania and those with a history of seizures should also be cautious when using this medication. Patients with impaired kidney or liver function may need dose adjustments, so they should consult a physician. This medication contains a specific dye (yellow 5), so patients allergic to this component should be careful. Common side effects during treatment may include nausea, dizziness, headaches, vomiting, insomnia, anxiety, decreased appetite, and sexual dysfunction. Other side effects such as increased blood pressure, orthostatic hypotension, increased risk of bleeding, and pupil dilation may also occur, so if unusual symptoms arise, consult a physician immediately. This medication may affect the fetus during pregnancy, so if you are pregnant or planning to become pregnant, consult a physician. During breastfeeding, this medication may be transferred to breast milk and affect the baby, so discuss with your physician whether to continue breastfeeding. The safety and efficacy of this medication in children and adolescents have not been established, and there may be an increased risk of suicide, requiring special caution. Elderly patients are at higher risk for hyponatremia and orthostatic hypotension, so they should be cautious while taking this medication. Sudden discontinuation of this medication may result in withdrawal symptoms, so it should be tapered off gradually under a physician's guidance. In cases of overdose, severe side effects may occur, so adhere to the prescribed dosage and seek medical attention if overdose is suspected. It is advisable to avoid alcohol during treatment, and if you are taking other medications, inform your physician of the potential for drug interactions.

• Suicidal thoughts and behaviors
• serotonin syndrome
• angioedema
• elevated blood pressure
• nausea
• dizziness
• headache
• vomiting
• insomnia
• sweating

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture, and the storage temperature should be kept between 1 and 30 degrees Celsius. Storing it this way will help maintain the medication's effectiveness for a longer period.

Appearance

A square, extended-release film-coated tablet with a pyramid shape on one side and a reddish color.

Package unit

28 tablets (14 tablets per blister x 2)