Medication info
Pristiq Extended-Release 100 mg (Desvenlafaxine Dimesylate)

Pristiq Extended-Release 100 mg (Desvenlafaxine Dimesylate)

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

MFDS item code 202002460 · Approved 2020.04.07 · Insurance code 645306330

Summary

Main use
Treatment of major depressive disorder
Who uses it
Adults
Adult dosage
1. Adults 1) Initial dose The recommended dose of this drug is 50 mg once daily. This drug 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 did not demonstrate additional benefit with doses greater than 50 mg once daily, and adverse reactions and treatment discontinuations occurred more frequently at higher doses. The dose may be increased only when clinically indicated, based on clinical judgment, but should not exceed 200 mg once daily. When discontinuing treatment, gradually reduce the dose to minimize withdrawal symptoms. 2) Maintenance treatment Acute episodes of major depression usually require continuous pharmacotherapy for several months or longer. Patients should be reevaluated 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 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 to patients 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 of treatment Symptoms associated with discontinuation of this drug and serotonin-norepinephrine reuptake inhibitors (SNRIs) and selective serotonin reuptake inhibitors (SSRIs) have been reported; therefore, 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 treatment discontinuation, resuming the previously prescribed dose may be considered. The physician may then 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 drug Withdrawal symptoms have been reported when switching from other antidepressants, including venlafaxine, to this drug. Gradually tapering the dose of the previous antidepressant may be necessary to minimize these symptoms. 6. Concomitant use with monoamine oxidase inhibitors (MAOIs) 1) Switching from monoamine oxidase inhibitors (MAOIs) used to treat psychiatric disorders Treatment with this drug should be initiated at least 14 days after discontinuing an MAO inhibitor used to treat psychiatric disorders. In addition, allow at least 7 days between discontinuing this drug and starting an MAO inhibitor (see Precautions for Use, ‘6. Interactions’). 2) Use of this drug with other MAO inhibitors, such as linezolid or methylene blue: If a patient already receiving this drug requires urgent treatment with linezolid or intravenous methylene blue, this drug may be stopped immediately and linezolid or intravenous methylene blue administered only if no alternative drug is available and the potential benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome (see Precautions for Use, ‘6. Interactions’).

Ingredients

Manufacturer
Hanlim Pharmaceuticals Co., Ltd.

Efficacy & effects

Treatment of major depressive disorder

  • Major depression
View approved original text

This medication is used for the treatment of major depressive disorder.

Dosage and Administration

Adult dosage

1. Adults 1) Initial dose The recommended dose of this drug is 50 mg once daily. This drug 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 did not demonstrate additional benefit with doses greater than 50 mg once daily, and adverse reactions and treatment discontinuations occurred more frequently at higher doses. The dose may be increased only when clinically indicated, based on clinical judgment, but should not exceed 200 mg once daily. When discontinuing treatment, gradually reduce the dose to minimize withdrawal symptoms. 2) Maintenance treatment Acute episodes of major depression usually require continuous pharmacotherapy for several months or longer. Patients should be reevaluated 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 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 to patients 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 of treatment Symptoms associated with discontinuation of this drug and serotonin-norepinephrine reuptake inhibitors (SNRIs) and selective serotonin reuptake inhibitors (SSRIs) have been reported; therefore, 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 treatment discontinuation, resuming the previously prescribed dose may be considered. The physician may then 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 drug Withdrawal symptoms have been reported when switching from other antidepressants, including venlafaxine, to this drug. Gradually tapering the dose of the previous antidepressant may be necessary to minimize these symptoms. 6. Concomitant use with monoamine oxidase inhibitors (MAOIs) 1) Switching from monoamine oxidase inhibitors (MAOIs) used to treat psychiatric disorders Treatment with this drug should be initiated at least 14 days after discontinuing an MAO inhibitor used to treat psychiatric disorders. In addition, allow at least 7 days between discontinuing this drug and starting an MAO inhibitor (see Precautions for Use, ‘6. Interactions’). 2) Use of this drug with other MAO inhibitors, such as linezolid or methylene blue: If a patient already receiving this drug requires urgent treatment with linezolid or intravenous methylene blue, this drug may be stopped immediately and linezolid or intravenous methylene blue administered only if no alternative drug is available and the potential benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome (see Precautions for Use, ‘6. Interactions’).

Precautions

This medication is used to treat psychiatric disorders such as major depressive disorder. While taking this medication, young patients, especially those aged 18 to 24, should be very cautious as there may be an increased risk of suicidal thoughts or behaviors. This medication can cause a serious side effect called serotonin syndrome, which is more likely to occur when taken with other serotonin-related medications. This medication should not be taken with certain other drugs, especially monoamine oxidase inhibitors (MAOIs). Patients with hypertension or heart disease should consult a doctor before taking this medication, and blood pressure and heart rate should be monitored regularly during treatment. Patients with a history of mania or hypomania should take this medication with caution, and those with a history of seizures should also be careful. Patients with renal or liver impairment need dosage adjustments, and those with allergic reactions should inform their doctor before taking this medication. Taking this medication may lead to side effects such as nausea, dizziness, headache, vomiting, insomnia, anxiety, appetite loss, excessive sweating, and more. Notably, abrupt discontinuation may lead to withdrawal symptoms, so the dosage should be decreased gradually per physician's instructions. This medication can cause sexual dysfunction and may lead to electrolyte imbalances such as hyponatremia, so any symptoms should be reported to a doctor. Women who are pregnant or breastfeeding should consult a physician before taking this medication, and taking it during late pregnancy may lead to withdrawal symptoms in newborns. The effectiveness of this medication has not been proven in children and adolescents, and there may be an increased risk of suicide, requiring particular caution. Elderly patients may have an increased risk of hyponatremia and orthostatic hypotension when taking this medication, so dosage adjustments and caution are necessary. It is advisable to avoid alcohol while taking this medication, and patients should inform their doctor about any other medications they are taking due to potential interactions. Overdose may result in severe side effects, so patients should not exceed the prescribed dose and should seek medical attention immediately if any unusual symptoms develop. This medication should be kept out of reach of children, and it should not be transferred to another container.

Side effects

  • suicidal thoughts and behaviors
  • serotonin syndrome
  • angioedema
  • increased blood pressure
  • nausea
  • dizziness
  • headache
  • vomiting
  • dry mouth
  • constipation
Show 92 more
  • fatigue
  • chills
  • agitation
  • decreased appetite
  • drowsiness
  • tremors
  • attention deficit
  • insomnia
  • anxiety
  • nervousness
  • abnormal dreams
  • delayed urination
  • yawning
  • sweating
  • blurred vision
  • pupil dilation
  • tinnitus
  • abnormal taste perception
  • facial flushing
  • sexual dysfunction
  • decreased libido
  • sexual arousal disorder
  • delayed ejaculation
  • erectile dysfunction
  • ejaculation disorder
  • loss of ejaculation function
  • sexual dysfunction
  • palpitations
  • tachycardia
  • diarrhea
  • sensitivity
  • weakness
  • hypersensitivity
  • weight gain
  • weight loss
  • abnormal liver function
  • increased serum prolactin levels
  • hyponatremia
  • musculoskeletal stiffness
  • sensory disturbances
  • fainting
  • seizures
  • muscle rigidity
  • teeth grinding
  • urinary retention
  • nosebleeds
  • rash
  • hair loss
  • photosensitivity reaction
  • angioedema
  • Stevens-Johnson syndrome
  • orthostatic hypotension
  • peripheral coldness
  • postpartum hemorrhage
  • headache
  • difficulty concentrating
  • memory impairment
  • confusion
  • weakness
  • falls
  • hallucinations
  • seizures
  • coma
  • respiratory arrest
  • death
  • drowsiness
  • altered consciousness
  • ECG changes
  • bradycardia
  • hypotension
  • rhabdomyolysis
  • vertigo
  • liver necrosis
  • withdrawal syndrome
  • depersonalization
  • mania
  • hypomania
  • hallucinations
  • abnormal thoughts
  • neck sensation abnormalities
  • chest pain
  • fever
  • facial swelling
  • generalized swelling
  • ineffective medication
  • pharyngitis
  • Sjögren's syndrome
  • vestibular disorders
  • dysuria
  • exacerbation of angina
  • exacerbation of rheumatoid arthritis
  • fractures

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

Storage

This medication may be sensitive to air and humidity, so it should be stored in a tightly sealed container. It is best to maintain a storage temperature between 1 degrees and 30 degrees Celsius to preserve the medication's efficacy and safety.

Appearance and packaging

Appearance

Crimson square extended-release film-coated tablets

Package unit

28 tablets/box [(14 tablets/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.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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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.