Venlafaxine Extended-Release Capsule (Venlafaxine Hydrochloride)

Adult dosage

The therapeutic dose of this drug should be adjusted according to the patient's clinical condition, and the lowest effective dose possible should be administered. This drug should be taken with food, preferably at the same time each morning or evening. Do not divide, crush, chew, or dissolve the capsules in water. 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 administered for 4∼7 days after starting treatment to allow the patient to adjust to the medication before increasing the dose 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 greater 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 drug's active ingredient may switch to this drug; the dose should be closest to their tablet dose. For example, a patient taking 37.5 mg of immediate-release tablets containing this drug's active ingredient twice daily may take 75 mg of this drug 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 conducted in outpatients with panic disorder to evaluate the efficacy of this drug, an initial dose of 37.5 mg once daily was administered for 7 days, followed by an increase to 75 mg once daily, with subsequent increases of 75 mg at 1-week intervals up to 225 mg daily. Although the dose-response relationship for the efficacy of this drug in patients with panic disorder has not been clearly established, some patients who do not respond to this drug at a dose of 75 mg/day may benefit from an increase to a maximum of 225 mg daily. When increasing the dose, increases should be no greater than 75 mg daily as needed and should be made at intervals of 7 days or more. 4. Dosing 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, drug clearance varies considerably among individuals, 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 drug 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 the drug should be administered after hemodialysis is fully completed. In patients with renal impairment, drug clearance varies considerably among individuals, 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 drug for each patient. There is no clinical trial evidence indicating how long this drug should be administered to patients with depression, generalized anxiety disorder, social anxiety disorder, or panic disorder; however, it is generally agreed that acute depression requires continuous pharmacotherapy for several months or longer. 6. Discontinuation of treatment with this drug If this drug is discontinued after being administered for more than 1 week, the dose should be gradually reduced over several days to minimize withdrawal symptoms. In patients who have received this drug for more than 6 weeks, the dose should be gradually reduced over at least 2 weeks. Although withdrawal symptoms associated with this drug have not been comprehensively evaluated, adverse reactions that occurred in more than 3% of patients and at a rate more than twice that in the placebo group during dose reduction and after discontinuation, based on retrospective investigations, included hypomania, anxiety, agitation, nervousness, confusion, insomnia or sleep disturbance, fatigue, somnolence, paresthesia, dizziness, headache, sweating, dry mouth, anorexia, 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 patient. 7. Switching from MAO inhibitors used to treat psychiatric disorders When discontinuing an MAO inhibitor used to treat psychiatric disorders and starting treatment with this drug, an interval of at least 14 days should be allowed. Conversely, when starting an MAO inhibitor to treat psychiatric disorders, at least 7 days should elapse after discontinuing this drug. 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 an intravenous methylene blue preparation, or for 24 hours after the last dose, whichever occurs first. Treatment with this drug may be restarted 24 hours after the last dose of linezolid or an intravenous methylene blue preparation. The risk associated with administration of a methylene blue preparation by a non-intravenous route (oral tablet or local injection) or with intravenous administration of this drug at a dose of 1mg/kg or less is unclear.

This medication can have negative effects on the central nervous system when taken with alcohol, so alcohol consumption should be avoided during treatment. Additionally, this medication may increase the risk of suicidal thoughts or behaviors, especially in young adults aged 18 to 24 and children or adolescents, so careful judgment by a physician and close monitoring of the patient's condition is required when administering to patients in this age group. This medication may cause continuous increases in blood pressure in some patients, so regular blood pressure measurements should be taken during use, and dosage adjustments or discontinuation should be considered if necessary. Severe neurological reactions such as serotonin syndrome may occur, so caution should be taken when used in conjunction with other serotonin-active medications, and immediate consultation with a physician should be sought if abnormal symptoms appear. This medication should not be administered to certain patients, such as those who are hypersensitive to this medication or its ingredients, those taking MAO inhibitors, pregnant or breastfeeding women, and children and adolescents under 18 years of age. Patients with a history of suicide attempts or seizures, as well as those with diminished renal or hepatic function, or heart disease, require special caution when taking this medication. During treatment, side effects such as insomnia, nervousness, dizziness, nausea, vomiting, reduced appetite, may occur, and if these symptoms are severe or persist, consultation with a physician is necessary. Moreover, sudden discontinuation of this medication may lead to withdrawal symptoms, so the dosage should be gradually reduced according to a physician's instructions. This medication may require caution when driving or operating machinery, so patients should carefully observe their condition during such activities. Finally, this medication may interact with other drugs, so if other medications are being taken, it is essential to inform the physician or pharmacist.

Headache, weakness, nausea, loss of appetite, dry mouth, vomiting, dizziness, insomnia, nervousness, drowsiness, tremors, sweating, erectile dysfunction, vasodilation, hypertension, constipation, abnormal dreams, paresthesia, decreased libido, anxiety, pharyngitis, yawning, abnormal vision, abnormal ejaculation, paraphilia, orgasmic dysfunction, weight loss, elevated blood pressure, suicide attempts, rash, urticaria, facial swelling, lethargy, moniliasis, neck stiffness, pelvic pain, photophobic reactions, withdrawal symptoms, appendicitis, carcinoma, cellulitis, bacteremia, granuloma, anaphylaxis, migraine, orthostatic hypotension, tachycardia, angina, arrhythmia, premature contractions, hypotension, peripheral vascular disorders, syncope, thrombophlebitis, arteritis, first-degree AV block, bigeminy, bradycardia, complete block, cerebral ischemia, coronary artery disease, congestive heart failure, cardiac arrest, mitral valve and blood circulation disorders, mucosal and skin bleeding, myocardial infarction, pallor, aortic aneurysm, capillary fragility, prolonged QT interval, ventricular fibrillation, ventricular tachycardia, belching, increased appetite, decreased appetite, bruxism, colitis, dysphagia, tongue swelling, esophagitis, gastritis, gastroenteritis, gastric ulcer, gingivitis, glossitis, rectal bleeding, hemorrhoids, bloody stools, stomatitis, oral ulcers, diarrhea, cheilitis, cholecystitis, cholelithiasis, hematemesis, gingival bleeding, hepatitis, ileitis, jaundice, bowel obstruction, oral moniliasis, proctitis, increased salivation, diarrhea, tongue discoloration, esophageal spasm, duodenitis, parotitis, rectal disease, pancreatitis, goiter, hyperthyroidism, hypothyroidism, thyroid nodule, thyroiditis, galactorrhea, petechiae, anemia, leukocytosis, leukopenia, lymphadenopathy, thrombocythemia, mucosal bleeding, gastrointestinal bleeding, thrombocytopenia, eosinophilia, cyanosis, eosinophilia, lymphocytosis, prolonged bleeding time, multiple myeloma, purpura, blood dyscrasia, edema, increased serum cholesterol, weight gain, increased alkaline phosphatase, dehydration, diabetes, hypercholesterolemia, hyperglycemia, hyperuricemia, hypoglycemia, hypokalemia, liver function test abnormalities, thirst, hyponatremia, alcohol intolerance, bilirubinemia, increased BUN, increased creatinine, diabetes mellitus, gout, hemochromatosis, hypercaluria, hyperkalemia, hyperlipidemia, hyperphosphatemia, hypophosphatemia, hypoalbuminemia, uremia, hepatitis, syndrome of inappropriate antidiuretic hormone secretion, abnormal healing, hypocholesterolemia, elevated prolactin, arthralgia, arthritis, arthropathy, bone pain, bone hypertrophy, bursitis, leg cramps, myasthenia, tendinitis, pathological fractures, myopathy, osteoporosis, osteosclerosis, rheumatoid arthritis, tendon rupture, plantar fasciitis, forgetfulness, confusion, depersonalization, emotional instability, sensory impairment, decreased libido, increased muscle tone, tremors, abnormal thoughts, dysphonia, akathisia, anhedonia, ataxia, perioral sensory disturbances, CNS excitation, euphoria, hallucinations, hostility, hypersensitivity, hyperactivity, decreased muscle tone, manic episodes, myoclonus, psychiatric disorders, seizures, abnormal speech, stupor, numbness, anxiety, restlessness, panic attacks, insomnia, excitability, hostility, aggressiveness, impulsivity, akathisia, mania, mania, behavioral changes, worsening of depression, suicidal ideation, seizures, rash, urticaria, drug dependence, tolerance development, dosage increase, drug dependence behavior, increased blood pressure, change in mental state, restlessness, hallucinations, delirium, coma, autonomic nervous system dysfunction, tachycardia, unstable blood pressure, dizziness, sweating, flushing, high fever, tremors, clonus, myotonic contractions, seizures, headache, flu-like symptoms, tinnitus, loss of appetite, diarrhea, vomiting, visual impairment, hypertension

This medication should be stored in a tightly sealed container to prevent air or moisture from entering, and it is advisable to keep it in a cool place at a temperature below 25 degrees Celsius. Storing in this manner will help preserve the medication's efficacy for a long time.

Appearance

A pink capsule with white to grayish granules inside.

Package unit

100 capsules/box [(10 capsules/PTP)x10], 30 capsules/bottle, 100 capsules/bottle