Effexor XR Sustained Release Capsule 75 mg

Adult dosage

The therapeutic dose of this medicine should be adjusted according to the patient's clinical condition, and the lowest effective dose possible should be administered. This medicine should be taken with food, preferably at the same time each morning or evening. Do not divide, crush, chew, or dissolve the capsule in water before taking it. 1. Depression and generalized anxiety disorder The recommended initial dose is 75 mg of venlafaxine hydrochloride administered orally once daily. Depending on the patient, 37.5 mg once daily may be administered for 4∼7 days after starting treatment to allow the patient to adjust to the medicine before increasing to 75 mg daily. If further clinical improvement is needed after 2 weeks of treatment, the dose may be increased to 150 mg daily. If necessary, the dose may be increased to a maximum of 225 mg daily. Dose increases should be no more than 75 mg daily, with at least 4 days between increases. Patients with depression who are currently taking conventional tablets containing this ingredient may be switched to this medicine; the dose should be as close as possible to the tablet dose. For example, a patient taking conventional tablets containing this ingredient at 37.5 mg twice daily may take this medicine at 75 mg once daily. Individual dose adjustment may be necessary when switching. 2. Social anxiety disorder The recommended dose is 75 mg of venlafaxine hydrochloride administered orally once daily. There is no evidence of additional benefit from increasing the dose. 3. Panic disorder The recommended initial dose is 37.5 mg of venlafaxine hydrochloride once daily for 7 days. In clinical trials conducted in outpatients with panic disorder to evaluate the efficacy of this medicine, the initial dose of 37.5 mg once daily was administered for 7 days, then increased to 75 mg once daily, followed by increases of 75 mg at 1-week intervals up to 225 mg daily. Although the dose-response relationship for the efficacy of this medicine in patients with panic disorder has not been clearly established, some patients who do not respond to a dose of 75 mg/day may benefit from an increase to a maximum of 225 mg daily. If the dose is increased, it should be increased by no more than 75 mg daily as needed, at intervals of at least 7 days. 4. Administration in special populations 1) Patients with hepatic impairment In patients with hepatic impairment, the clearance of venlafaxine and O-desmethylvenlafaxine (ODV) is reduced and their half-lives are prolonged; therefore, the dose should be reduced by 50 % in patients with moderate hepatic impairment. In patients with cirrhosis, there is considerable individual variability in drug clearance, so the dose should be adjusted for each patient. 2) Patients with renal impairment In patients with renal impairment (GFR=10∼70 mL/min), the clearance of this medicine is reduced and the half-lives of venlafaxine and ODV are increased compared with those in individuals with normal renal function. Therefore, the total daily dose should be reduced by 25∼50%. For patients receiving hemodialysis, the total daily dose should be reduced by 50%, and the medicine should be administered after hemodialysis is completed. There is considerable individual variability in drug clearance in patients with renal impairment, so the dose should be adjusted for each patient. 5. Maintenance/continuation/long-term treatment The physician should periodically evaluate the efficacy of long-term treatment with this medicine in each patient. Although there is no clinical trial evidence regarding how long this medicine should be administered to patients with depression, generalized anxiety disorder, social anxiety disorder, or panic disorder, it is generally agreed that acute depression requires continuous pharmacotherapy for several months or longer. 6. Discontinuation of treatment with this medicine If this medicine is discontinued after being taken for more than 1 week, the dose should be gradually reduced over several days to minimize withdrawal symptoms. In patients who have received this medicine for more than 6 weeks, the dose should be gradually reduced over at least 2 weeks. 7. Switching from MAO inhibitors for the treatment of psychiatric disorders When discontinuing an MAO inhibitor used to treat psychiatric disorders and starting treatment with this medicine, an interval of at least 14 days should be allowed. Conversely, when starting an MAO inhibitor for the treatment of psychiatric disorders, at least 7 days must have elapsed after discontinuing this medicine. 8. Other MAO inhibitors, such as linezolid or methylene blue Patients should be monitored for symptoms of serotonin syndrome for 7 days after administration of linezolid or intravenous methylene blue, or until 24 hours after the last dose, whichever occurs first. Treatment with this medicine may be restarted 24 hours after the last dose of linezolid or intravenous methylene blue. The risks associated with administration of methylene blue by a non-intravenous route (oral tablets or local injection), or with intravenous administration of this medicine at a dose of 1mg/kg or less, are unclear.

This medication can negatively affect the central nervous system when taken with alcohol, so it is very important to avoid alcohol consumption during treatment. Serious side effects can occur from overdose, so it is essential to take only the minimum dose prescribed by a doctor. The use of this medication is not approved for children and adolescents under 18 years of age, and special caution is needed in this age group due to an increased risk of suicidal thoughts or behaviors. This medication can increase blood pressure, so regular blood pressure monitoring should be performed, and consultation with a doctor is necessary if abnormalities are detected. Serious neurological side effects, such as serotonin syndrome, may occur, so caution is advised when used with other serotonergic medications. This medication must not be taken with certain drugs, particularly MAO inhibitors, as serious side effects may occur, and it is essential to consult a doctor before use. It is recommended that pregnant women, women who could become pregnant, and nursing mothers avoid taking this medication. During treatment, worsening of depressive symptoms, suicidal thoughts, aggression, anxiety, and other mental changes may occur, so patients and their families or guardians should observe for any abnormal symptoms and immediately inform healthcare professionals. Patients with a history of seizures may experience seizures while taking this medication, so it should be used with caution, and if a seizure occurs, use should be discontinued immediately. Patients with decreased liver or kidney function may have delayed metabolism and excretion of this medication, so they should start with a low dose and take it under a doctor's guidance. Abrupt cessation of this medication can cause withdrawal symptoms, so doses should be gradually tapered under a doctor's guidance when discontinuing. Caution is needed when driving or operating dangerous machinery as drowsiness or dizziness may occur, so patients should closely monitor their condition. This medication may cause side effects such as sexual dysfunction, decreased appetite, weight changes, insomnia, irritability, nausea, thirst, trembling, sweating, etc. Patients with a history of hypertension or cardiovascular disease should consult a doctor before taking this medication, and blood pressure and heart condition should be routinely monitored during treatment. Interactions may occur with other medications, so it is essential to inform healthcare professionals of any other medications being taken, especially concerning lithium, diazepam, cimetidine, haloperidol, and CYP450 enzyme inhibitors.

Negative interactions with alcohol, suicidal thoughts and behaviors, persistent hypertension, serotonin syndrome, neuroleptic malignant syndrome-like reactions, anxiety, restlessness, panic attacks, insomnia, agitation, hostility, aggression, anger, akathisia, hypomania, manic episodes, worsening of depression, seizures, rash, urticaria, asthenia, nausea, loss of appetite, thirst, vomiting, dizziness, insomnia, irritability, drowsiness, tremors, sweating, erectile dysfunction, vasodilation, headache, increased blood pressure, constipation, abnormal dreams, abnormal sensations, abnormal vision, abnormal ejaculation, decreased libido, restlessness, yawning, hypertension, vasodilation, palpitations, dyspepsia, weight loss, anxiety, psychomotor agitation, delirium, extrapyramidal symptoms, coordination and balance disturbances, tardive dyskinesia, dyspnea, itching, sweating, rash, acne, alopecia, dry skin, eczema, urticaria, cataracts, conjunctivitis, corneal lesions, diplopia, dry eyes, exophthalmos, eye pain, hyperacusis, otitis media, abnormal olfaction, photophobia, taste loss, taste changes, visual impairment, tinnitus, abnormal uterine bleeding, prostatitis, urinary disorders, vaginitis, abnormal orgasms, hyperesthesia, erectile dysfunction, albuminuria, amenorrhea, cystitis, urinary difficulty, hematuria, galactorrhea, leukorrhea, menorrhagia, nocturia, bladder pain, mastalgia, polyuria, pyuria, urinary incontinence, urinary retention, urgency incontinence, vaginal bleeding, miscarriage, anuria, breast engorgement, breast enlargement, fibrocystic breast disease, calcium oxalate crystals in urine, gynecomastia, hypomenorrhea, renal stones, renal colic, renal dysfunction, mastitis, menopause, pyelonephritis, increased urinary frequency, salpingitis, urolithiasis, uterine bleeding, uterine cramps, balanitis, endometriosis, orchitis, vaginal dryness, anaphylaxis, angioedema, ventricular tachycardia, stress-induced cardiomyopathy, pancreatitis, agranulocytosis, aplastic anemia, pancytopenia, inappropriate antidiuretic hormone secretion syndrome, liver dysfunction, increased luteinizing hormone, rhabdomyolysis syndrome, psychomotor agitation, neuroleptic malignant syndrome, serotonin syndrome, delirium, extrapyramidal symptoms, interstitial lung disease, Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, angle-closure glaucoma, menstrual disorders, increased frequency of urination, postpartum hemorrhage, fractures, tension disorders, congenital malformations, increased creatine phosphokinase, venous thromboembolism, atrial fibrillation, supraventricular tachycardia, ventricular premature contractions, bleeding, liver disease, involuntary movements, increased LDH, hyperhidrosis, panic, renal failure, electrical shock-like reaction, abdominal pain, restlessness, dyspepsia, petechiae, epistaxis, myalgia, hypomania, confusion, coordination and balance disturbances, emotional instability, somnolence, nightmares, fatigue, sensory disturbances, muscle fasciculation, flu-like symptoms, tinnitus, anorexia, diarrhea, visual impairment, hypertension, insomnia, irritability, sexual dysfunction, interstitial lung disease, eosinophilic pneumonia, fractures

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture, and it is best to keep it in a cool temperature below 25 degrees. This will help maintain the medication's effectiveness for longer.

Appearance

A sustained release capsule with white to grayish-white granules in a peach-colored upper and lower capsule.

Package unit

28 capsules (14 capsules/blister x 2)