Venlafaxine Extended-Release Capsules 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. This medicine should be taken with food and, if possible, 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 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. When increasing the dose, increase by no more than 75 mg daily at a time, with an interval of at least 4 days between increases. Patients with depression who are currently taking an immediate-release tablet containing this ingredient may be switched to this medicine. The dose should be as close as possible to the dose of the tablet. For example, a patient taking 37.5 mg of the immediate-release tablet 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 conducted in outpatients with panic disorder to evaluate the efficacy of this medicine, an initial dose of 37.5 mg once daily was administered for 7 days, followed by an increase to 75 mg once daily and then subsequent 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, increase by no more than 75 mg daily at a time, as needed, at intervals of 7 days or longer. 4. Dosing 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, the dose should be adjusted for each patient. 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 undergoing hemodialysis, the total daily dose should be reduced by 50%, and the medicine should be administered after hemodialysis is completed. Because drug clearance varies considerably among patients with renal impairment, the dose should be adjusted for each patient. 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 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 continued 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. For patients who have received this medicine for more than 6 weeks, the dose should be gradually reduced over at least 2 weeks. The period needed for dose reduction may vary depending on the dose, duration of treatment, and the 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 medicine, an interval of at least 14 days should be allowed. 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 should 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 interventional procedures, 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 stopped 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 restarted 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with non-intravenous administration of methylene blue (oral tablets or local injection), or intravenous administration of this medicine at 1mg/kg or less, is unclear. Nevertheless, clinicians should be aware of the possibility of emergency symptoms of serotonin syndrome with these uses.

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, especially in young patients aged 18 to 24, so careful observation is needed at the beginning of treatment and when changing dosages for this age group. This medication may persistently increase blood pressure in some patients, so regular blood pressure monitoring is necessary during treatment, and appropriate measures should be taken if abnormalities occur. Severe side effects similar to serotonin syndrome and neuroleptic malignant syndrome may occur, so caution is needed when combined with serotonergic medications, and treatment should be stopped immediately and medical advice sought if symptoms occur. This medication should not be given to certain patients, including those with hypersensitivity to its components, those taking MAO inhibitors, pregnant or breastfeeding women, and individuals under 18 years of age. Patients with a history of suicide attempts or seizures, impaired kidney or liver function, and heart disease should be treated with extra caution when administering this medication, and should notify healthcare professionals immediately if unusual symptoms appear. This medication may cause various side effects, so if unusual symptoms such as insomnia, nervousness, dizziness, nausea, sweating, sexual dysfunction occur during treatment, consult a healthcare professional. Abrupt discontinuation of this medication may induce withdrawal symptoms, so it is essential to taper the dosage gradually under a doctor's guidance when discontinuing. This medication may interact with other drugs, so be sure to inform your healthcare providers of any other medications you are taking, especially when combined with lithium, diazepam, cimetidine, haloperidol, or CYP450 enzyme inhibitors. Caution should be exercised during activities that require attention, such as driving or operating hazardous machinery, while taking this medication.

Headache, weakness, nausea, appetite loss, dry mouth, vomiting, dizziness, insomnia, nervousness, drowsiness, trembling, sweating, erectile dysfunction, vasodilation, hypertension, constipation, abnormal dreams, paresthesia, abnormal vision, abnormal ejaculation, hyperesthesia, agitation, yawning, decreased libido, anxiety, accidental trauma, palpitations, indigestion, weight loss, abnormal ejaculation, orgasmic disorder, lethargy, suicide attempt, withdrawal symptoms, facial swelling, rash, urticaria, sweating, petechiae, anemia, leukocytosis, leukopenia, lymphadenopathy, thrombocytosis, mucosal bleeding, thrombocytopenia, edema, increased serum cholesterol, weight gain, increased alkaline phosphatase, dehydration, diabetes, hypercholesterolemia, hyperglycemia, hyperuricemia, hypoglycemia, hypokalemia, abnormal liver function tests, thirst, hyponatremia, alcohol intolerance, hyperbilirubinemia, increased BUN, increased creatinine, diabetes mellitus, gout, hemochromatosis, hypercalciuria, hyperkalemia, hyperlipidemia, hyperphosphatemia, hypophosphatemia, hypoproteinemia, uremia, hepatitis, inappropriate antidiuretic hormone secretion syndrome, abnormal healing, hypocholesterolemia, increased prolactin, arthralgia, arthritis, arthropathy, bone pain, bone spur, bursitis, leg cramps, myasthenia, tendinitis, pathological fractures, myopathy, osteoporosis, osteosclerosis, rheumatoid arthritis, tendon rupture, plantar fasciitis, rhabdomyolysis, amnesia, confusion, depersonalization, emotional instability, sensory loss, abnormal dreams, decreased libido, increased muscle tone, oral opening dysfunction, tremor, abnormal thinking, inability to sit still, apathy, ataxia, perioral sensory disturbances, central nervous system stimulation, euphoria, hallucinations, hostility, sensory hypersensitivity, motor hyperactivity, decreased tension, desynchronization, increased libido, mania, paroxysmal muscle contractions, neuralgia, neuropathy, paranoia, psychosis, seizures, abnormal speech, confusion, numbness, agitation, immobility, alcohol abuse, aphasia, bradykinesia, akathisia, cerebrovascular accident, loss of consciousness, delusions, dementia, muscular dystonia, facial paralysis, abnormal gait, Guillain-Barré syndrome, decreased motor function, neuritis, nystagmus, psychotic depression, diminished reflexes, increased reflexes, suicidal thoughts, torticollis, convulsions, neuroleptic malignant syndrome, serotonin syndrome, feeling intoxicated, hyperacidity, impulse control disorder, incomplete paralysis, extrapyramidal symptoms, tardive dyskinesia, respiratory distress, increased cough, asthma, pulmonary congestion, epistaxis, hyperventilation, laryngospasm, laryngitis, pneumonia, voice changes, atelectasis, hemoptysis, respiratory depression, hypoxemia, pleuritis, pulmonary embolism, sleep apnea, laryngeal edema, eosinophilia, itching, sweating, rash, acne, alopecia, brittle nails, contact dermatitis, dry skin, eczema, skin thickening, papular purpuric rash, psoriasis, urticaria, allergic nodules, exfoliative dermatitis, lichen simplex, hair discoloration, skin discoloration, boil, hirsutism, vitiligo, pustular rash, vesicular rash, seborrhea, skin atrophy, skin appendages, erythema multiforme, mucocutaneous syndrome, abnormal coordination, pupil dilation, taste distortion, visual impairment, cataract, conjunctivitis, corneal lesions, diplopia, dry eye, exophthalmos, eye pain, auditory hypersensitivity, otitis media, olfactory dysfunction, photophobia, loss of taste, taste changes, vision loss, tinnitus, blepharitis, pigmentation syndrome, conjunctival edema, hearing loss, glaucoma, retinal hemorrhage, subconjunctival hemorrhage, keratitis, labyrinthitis, miosis, papilledema, decreased pupillary reflex, external otitis, scleritis, uveitis, closed-angle glaucoma, abnormal uterine bleeding, prostatitis, urination disorder, vaginitis, abnormal ejaculation, hyperaesthesia, erectile dysfunction, albuminuria, amenorrhea, cystitis, dysuria, hematuria, galactorrhea, leukorrhea, menorrhagia, nocturia, bladder pain, mastalgia, polyuria, pyuria, urinary incontinence, urinary retention, urgency, vaginal bleeding, abnormal orgasm, miscarriage, anuria, breast engorgement, breast enlargement, fibrocystic breast disease, calcium oxalate crystals, cervicitis, ovarian cysts, prolonged erection, gynecomastia, hypomenorrhea, kidney stones, renal colic, renal dysfunction, mastitis, menopause, pyelonephritis, frequent urination, salpingitis, urolithiasis, uterine bleeding, uterine contractions, balanitis, endometriosis, orchitis, vaginal dryness, anaphylaxis, angioedema, ventricular tachycardia, stress-induced cardiomyopathy, pancreatitis, agranulocytosis, aplastic anemia, pancytopenia, increased luteinizing hormone, psychomotor instability, delirium, coordination and balance disorders, tardive dyskinesia, interstitial lung disease, Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, closed-angle glaucoma, increased bleeding, menstrual disorders, increased frequency of urination, postpartum hemorrhage, fractures, tension, increased creatine phosphokinase, thrombophlebitis, atrial fibrillation, supraventricular tachycardia, ventricular ectopic beats, bleeding, liver disease, involuntary movements, increased LDH, sweating, panic, renal failure, electric shock-like syndrome, abdominal pain, agitation, indigestion, petechiae, epistaxis, myalgia, suicidal thoughts, self-harm, appetite loss, weight loss, increased blood pressure, increased blood cholesterol, insomnia, nervousness, mild euphoria, mania, aggression, impulsivity, inability to sit still, convulsions, withdrawal symptoms, mild euphoria, anxiety, confusion, coordination and balance disorders, depressed mood, emotional instability, hypersomnia, nightmares, fatigue, drowsiness, sensory abnormalities, muscle fiber contractures, flu-like symptoms, tinnitus, loss of appetite, diarrhea, hypertension

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. Furthermore, it is important to keep it in a cool place below 25 degrees Celsius to maintain its effectiveness.

Appearance

A capsule with gray upper and pink lower halves containing spherical white to grayish granules.

Package unit

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