Medication info
Desvenlafaxine Sustained-Release Tablet 100mg (Desvenlafaxine Besylate)

Desvenlafaxine Sustained-Release Tablet 100mg (Desvenlafaxine Besylate)

Prescription medicationTabletOral · Intravenous injection
Ingredient · strength
Desvenlafaxine Benzoate›146.37mg / 1 tablet
Manufacturer / importer
Nexpharm Korea Co., Ltd.
Appearance
Brick red square sustained-release film-coated tablet
Packaging
28 tablets/box[(14T/PTP)*2], 30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 202002456 · Approved 2020.04.07 · Insurance code 662504450

Summary

Main use
Treatment of major depressive disorder
Who uses it
Adults
Adult dosage
1. Adults 1) Initial treatment The recommended dose of this medication is 50mg once daily. 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. 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 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. 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.

Ingredients

Manufacturer
Nexpharm Korea Co., Ltd.

Efficacy & effects

Treatment of major depressive disorder

  • Major depression
View approved original text

This medication is used for major depression.

Dosage and Administration

Adult dosage

1. Adults 1) Initial treatment The recommended dose of this medication is 50mg once daily. 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. 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 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. 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.

Precautions

This medication is a treatment for psychiatric disorders such as major depression and may increase the risk of suicidal thoughts or behavior, especially in children, adolescents, and young adults, so caution is required. When taken with other serotonergic medications, serotonin syndrome, which can be life-threatening, may occur; therefore, symptoms should be closely monitored when combined. This medication may cause specific allergic reactions, so patients with hypersensitivity should not be administered this medication. Patients with hypertension or heart disease should periodically monitor blood pressure and heart rate, and dosage adjustment or cautious administration is necessary for patients with a history of seizures or compromised liver/kidney function. During treatment, side effects such as nausea, dizziness, insomnia, sweating, and anxiety may occur, and sexual dysfunction may also arise, thus consultation with a physician should be sought if symptoms occur. Suddenly discontinuing this medication may result in withdrawal symptoms; therefore, the dosage should be gradually reduced under a physician's guidance. This medication may affect blood coagulation, so caution is needed when taken with aspirin, NSAIDs, or warfarin due to an increased risk of bleeding. If pregnant or nursing, consultation with a physician is necessary as it may affect the fetus or newborn. Elderly patients may have an increased risk of side effects such as hyponatremia, thus dosage adjustment and caution are required. In cases of overdose, symptoms such as abnormal heart rates, changes in consciousness, and seizures may occur, necessitating immediate medical attention. This medication should be kept out of reach of children, and transferring it to another container should be avoided.

Side effects

Suicidal thoughts and behaviors, symptoms of serotonin syndrome (agitation, hallucinations, delirium, coma, tachycardia, unstable blood pressure, dizziness, sweating, flushing, hyperthermia, tremor, rigidity, clonus, akathisia, dyskinesia, seizures, nausea, vomiting, diarrhea), angioedema, increased blood pressure, increased heart rate, nausea, dizziness, headache, vomiting, insomnia, diaphoresis, constipation, drowsiness, decreased appetite, anxiety, specific male sexual dysfunction, dry mouth, fatigue, chills, restlessness, attention deficit, irritability, abnormal dreams, urinary retention, yawning, diaphoresis, blurred vision, pupil dilation, tinnitus, taste disturbance, facial flushing, sexual dysfunction, decreased libido, sexual excitement abnormalities, delayed ejaculation, erectile dysfunction, ejaculatory dysfunction, ejaculatory failure, sexual dysfunction, palpitations, tachycardia, diarrhea, hypersensitivity, asthenia, hyperesthesia, weight gain, weight loss, abnormal liver function, increased serum prolactin levels, hyponatremia, musculoskeletal rigidity, sensory disturbances, syncope, seizures, muscle tone abnormalities, withdrawal syndrome, depersonalization, mania, hypomania, hallucinations, bruxism, urinary retention, epistaxis, rash, hair loss, photosensitivity reactions, angioedema, Stevens-Johnson syndrome, orthostatic hypotension, peripheral coldness, postpartum hemorrhage, tremors, chest pain, worsening angina, dyspepsia, gastritis, abdominal pain, esophagitis, gastroesophageal reflux, enteritis, adverse events, sensation of choking, fever, facial swelling, generalized edema, ineffective medication, pharyngitis, Sjögren's syndrome, vestibular disorders, urinary difficulties, exacerbation of rheumatoid arthritis, fractures, myocardial ischemia, myocardial infarction, requirement for vascular reformation in coronary artery obstruction, tachycardia, altered consciousness, pupil dilation, seizures, vomiting, electrocardiogram changes, atrial and ventricular tachycardia, bradycardia, hypotension, rhabdomyolysis, dizziness, liver necrosis, serotonin syndrome, death

Not everyone experiences these, and they can vary from person to person.

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. The appropriate storage temperature is room temperature between 1 to 30 degrees Celsius, avoiding excessively hot or cold places.

Appearance and packaging

Appearance

Brick red square sustained-release film-coated tablet

Package unit

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

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.