Venlafaxine Extended-Release Capsule 37.5 mg (Venlafaxine Hydrochloride)

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. Take this medicine with food, preferably at the same time each morning or evening. Do not divide, crush, chew, or dissolve the capsules in water. Adults 1. Depression and generalized anxiety disorder The recommended initial dose is 75 mg of venlafaxine hydrochloride orally once daily. Depending on the patient, 37.5 mg once daily may be given 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. Increases should be no more than 75 mg daily and should be made at intervals of at least 4 days. Patients with depression who are currently taking immediate-release tablets containing this ingredient may be switched to this medicine; the dose should be as close as possible to their tablet dose. For example, a patient taking 37.5 mg of immediate-release tablets containing this ingredient twice daily may take 75 mg of this medicine once daily. Individual dose adjustment may be necessary when switching. 2. Social anxiety disorder The recommended dose is 75 mg of venlafaxine hydrochloride 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 evaluating the efficacy of this medicine in outpatients with panic disorder, the initial dose of 37.5 mg once daily was given for 7 days, then increased to 75 mg once daily, followed by further 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 75 mg/day may benefit from an increase to a maximum of 225 mg daily. If the dose is increased, increases should be no more than 75 mg daily as needed and should be made at intervals of at least 7 days. 4. Dosage in special populations 1) Patients with hepatic impairment In patients with hepatic impairment, 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. Because drug clearance varies considerably among patients with cirrhosis, individual dose adjustment is necessary. 2) Patients with renal impairment In patients with renal impairment (GFR=10∼70 mL/min), clearance of this medicine is reduced and the half-lives of venlafaxine and ODV are increased compared with those in healthy individuals. 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 administered after hemodialysis is completed. Because drug clearance varies considerably among patients with renal impairment, individual dose adjustment is necessary. 5. Maintenance/continuation/long-term treatment The physician should periodically evaluate the effectiveness of long-term treatment with this medicine for each patient. Although there is no clinical trial evidence specifying 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 continued drug therapy 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. Patients who have received this medicine for more than 6 weeks should have their dose gradually reduced over at least 2 weeks. Although withdrawal symptoms associated with this medicine have not been comprehensively evaluated, adverse reactions reported in retrospective reviews during dose reduction and after discontinuation in more than 3% of patients, and at more than twice the rate seen with placebo, included hypomania, anxiety, agitation, nervousness, confusion, insomnia or sleep disturbances, fatigue, somnolence, paresthesia, dizziness, headache, sweating, dry mouth, loss of appetite, diarrhea, nausea, and vomiting. These withdrawal symptoms were mild and resolved without treatment. The time required for dose reduction may vary depending on the dose, duration of treatment, and the patient. 7. Switching from or to MAO inhibitors for the treatment of psychiatric disorders At least 14 days should elapse after discontinuing an MAO inhibitor used to treat psychiatric disorders before starting treatment with this medicine. Conversely, at least 7 days should elapse after discontinuing this medicine before starting an MAO inhibitor for the treatment of psychiatric disorders. 8. Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue must not start treatment with this medicine because of the increased risk of serotonin syndrome. For patients requiring more urgent treatment for a psychiatric condition, including hospitalization or other interventions, treatment should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this medicine. If no alternative to linezolid or intravenous methylene blue is available and, for a particular patient, the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome, this medicine may be discontinued immediately and linezolid or intravenous methylene blue administered. 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 resumed 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with administration of methylene blue by non-intravenous routes (oral tablets or local injection) or intravenous administration of this medicine at doses of 1mg/kg or less is unclear. Nevertheless, clinicians should be aware of the possibility of emergency symptoms of serotonin syndrome with such use.

This medication may have negative effects on the central nervous system when taken with alcohol, so it is important to avoid alcohol consumption during treatment. This medication may increase the risk of suicidal thoughts or behaviors in young adults and adolescents, particularly those aged 18 to 24, so caution should be exercised when administering to patients within this age group, and patients and their families should closely monitor for changes in behavior. Since it can lead to sustained increases in blood pressure, it is advisable to regularly monitor blood pressure during treatment and consult a physician about dosage adjustment or discontinuation if blood pressure rises. Severe side effects such as serotonin syndrome and neuroleptic malignant syndrome may occur, therefore, it is prohibited to take this medication alongside serotonin-acting drugs or MAO inhibitors, and immediate medical attention should be sought if symptoms occur. This medication should not be administered to patients with hypersensitivity, patients on MAO inhibitors, pregnant women or women who may become pregnant, nursing mothers, or children under 18. Patients with a history of suicide attempts or seizures, liver or kidney function impairment, cardiovascular disease, or aggression should take this medication cautiously. Patients should promptly inform their doctor if they experience a rash, hives, or allergic reactions during treatment, and it is essential to disclose any history of substance abuse to the physician due to the risk of drug abuse. Sudden discontinuation of this medication may result in withdrawal symptoms, so the dosage should be gradually reduced following the doctor's directives, and any changes in suicidal thoughts or behavior should be carefully monitored upon discontinuation. This medication may cause various side effects such as sexual dysfunction, insomnia, agitation, dizziness, drowsiness, tremors, sweating, vasodilation, decreased libido, yawning, abnormal vision, erectile dysfunction, abnormal ejaculation, orgasm disorder, constipation, bloating, weight loss, increased blood pressure, elevated cholesterol levels, anxiety, and restlessness, so it is advisable to consult a physician if these symptoms are severe. Caution is required when driving vehicles or operating dangerous machinery, particularly at the beginning of treatment or following a change in dosage. This medication may affect blood coagulation, so patients at risk of bleeding or on anticoagulants should be careful, and regular testing is necessary as blood cholesterol levels may increase. There may be potential interactions with other medications, so if other medications are being taken, it is essential to inform the doctor or pharmacist.

headache, weakness, nausea, loss of appetite, dry mouth, vomiting, dizziness, insomnia, nervousness, drowsiness, trembling, sweating, erectile dysfunction, vasodilation, hypertension, constipation, weight loss, abnormal dreams, paresthesia, decreased libido, anxiety, yawning, abnormal vision, abnormal ejaculation, paroxysmal dyskinesia, orgasmic dysfunction, vasodilation, palpitations, anxiety, accidental trauma, abdominal pain, indigestion, diarrhea, sexual dysfunction, sweating, mania, hypomania, suicide attempt, suicidal thoughts, suicidal tendencies, suicidal impulses, suicidal behavior, suicidal ideation, hostility, aggressiveness, impulsivity, akathisia, changes in mental state, anxiety, hallucinations, delirium, coma, tachycardia, unstable blood pressure, dizziness, sweating, flushing, high fever, trembling, exaltation, focal muscle spasms, petechial hemorrhage, ataxia, dyskinesia, seizures, nausea, vomiting, diarrhea, rash, urticaria, allergic reaction, sweating, agranulocytosis, aplastic anemia, pancytopenia, syndrome of inappropriate antidiuretic hormone secretion, abnormal liver function tests, increased luteinizing hormone, rhabdomyolysis syndrome, psychomotor instability, neuroleptic malignant syndrome, serotonin syndrome, delirium, extrapyramidal symptoms, coordination and balance disorders, tardive dyskinesia, interstitial lung disease, Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, closed-angle glaucoma, hemorrhage, fracture, tension syndrome, increased creatine phosphokinase, deep venous thrombosis, atrial fibrillation, supraventricular tachycardia, ventricular extrasystole, liver disease, involuntary movements, fatigue, panic, renal failure, electrical shock-like shock, abdominal pain, anxiety, indigestion, petechial hemorrhage, nosebleed, myalgia, hypomania, anxiety, confusion, coordination and balance disorders, depressive mood, emotional instability, insomnia, somnolence, nightmares, fatigue, drowsiness, sensory disturbances, convulsions, trembling, seizures, muscle fiber bundle contractions, headache, flu-like symptoms, tinnitus, loss of appetite, diarrhea, hypertension

This medication should be stored in a tightly closed container to prevent exposure to air or moisture and kept in a cool place below 25 degrees Celsius. Storing it this way can help maintain the medication's effectiveness over time.

Appearance

A capsule with a gray upper part and an apricot-colored lower part, containing white to grayish granules.

Package unit

30 capsules/bottle, 100 capsules/bottle