Paroxetine Venlafaxine Extended Release Capsule 37.5 mg (Venlafaxine Hydrochloride)

Adult dosage

The therapeutic dose of this medication should be adjusted according to the patient's clinical condition, and the lowest effective dose should be administered whenever possible. This medication should be taken with food, preferably at a consistent time in the morning or evening. Do not divide, crush, chew, or dissolve the capsule in water. 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 medication before increasing to 75 mg once daily. If further clinical improvement is needed after 2 weeks of treatment, the dose may be increased to 150 mg once daily. If necessary, the dose may be increased to a maximum of 225 mg once daily. Increases should be no greater than 75 mg per day 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 medication at a dose closest to their tablet dose. For example, a patient taking 37.5 mg of the immediate-release tablet containing this ingredient twice daily may take 75 mg of this medication 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 evaluating the efficacy of this medication in outpatients with panic disorder, 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 once daily. Although the dose-response relationship for the efficacy of this medication 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 once daily. If the dose is increased, increases should be no greater than 75 mg per day 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, dosage adjustment should be individualized. 2) Patients with renal impairment In patients with renal impairment (GFR=10∼70 mL/min), clearance of this medication 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 medication should be administered after hemodialysis is complete. Because drug clearance varies considerably among patients with renal impairment, dosage adjustment should be individualized. 5. Maintenance/continuation/long-term treatment The physician should periodically evaluate the effectiveness of long-term treatment with this medication for each patient. Although there is no clinical-trial evidence regarding how long this medication 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 medication If this medication 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 medication for more than 6 weeks should have their dose gradually reduced over at least 2 weeks. Withdrawal symptoms associated with this medication have not been comprehensively evaluated; however, in retrospective reports during dose reduction and after discontinuation, adverse reactions occurring in more than 3% of patients and at least twice as often as in the placebo group included hypomania, anxiety, agitation, nervousness, confusion, insomnia or sleep disturbance, 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 patient. 7. Switching from or to MAO inhibitors used to treat psychiatric disorders When discontinuing an MAO inhibitor used to treat psychiatric disorders and starting treatment with this medication, 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 medication. 8. Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not start treatment with this medication 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 medication. If there is no alternative to linezolid or intravenous methylene blue 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 medication may be discontinued immediately and linezolid or intravenous methylene blue administered. Patients should be monitored for symptoms of serotonin syndrome for 7 days after starting linezolid or intravenous methylene blue, or until 24 hours after the last dose, whichever occurs first. Treatment with this medication may be restarted 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with methylene blue administered by a non-intravenous route (oral tablets or local injection) or with intravenous administration of this medication at a dose of 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 affects the central nervous system, so taking it with alcohol may worsen mental condition and increase central nervous system depressant effects, thus alcohol consumption should be avoided. This medication is used to treat depression or other psychiatric disorders, and careful monitoring by a physician and guardian is necessary during the initial usage or dose adjustment, especially in young patients aged 18 to 24 due to an increased risk of suicidal thoughts or behaviors. In some patients, this medication may continuously raise blood pressure, so regular blood pressure monitoring during treatment is necessary, and if abnormalities are found, dose adjustments or discontinuation may need to be considered. This medication can cause serious side effects such as serotonin syndrome, which includes symptoms like changes in mental state, high fever, tremors, and seizures; thus, caution is required when combined with other serotonin acting drugs, and if any abnormal symptoms occur, immediate consultation with medical personnel is necessary. This medication is contraindicated in certain patients, such as those with allergies to this drug or its components, those taking MAO inhibitors, pregnant or nursing women, and children under 18. Patients with a high risk of suicide or a history of seizures, those with impaired liver or kidney function, and those with a history of heart disease or aggression require special caution when administering this medication. During treatment, various side effects such as insomnia, dizziness, drowsiness, nausea, decreased appetite, sweating, sexual dysfunction, and others may occur, and if these symptoms are severe, consultation with a doctor is necessary. Abrupt discontinuation of this medication may lead to withdrawal symptoms; therefore, when discontinuing or reducing the dose, it should be done gradually according to a doctor's instructions. Be cautious of drowsiness or dizziness that could occur due to this medication when engaging in hazardous activities such as driving or operating machinery. This medication may interact with other drugs, so especially when combined with lithium, diazepam, cimetidine, haloperidol, etc., it should be communicated to medical personnel, and alcohol consumption should be avoided.

headache, weakness, nausea, loss of appetite, dry mouth, vomiting, dizziness, insomnia, nervousness, drowsiness, trembling, sweating, erectile dysfunction, vasodilation, hypertension, constipation, abnormal dreams, abnormal vision, abnormal ejaculation, paraphilia, decreased libido, anxiety, yawning, unease, single contraction, orgasm disorder, weight loss, increased blood pressure, fatigue, suicide attempt, withdrawal symptoms, facial swelling, accidental injury, rash, urticaria, sweating, itching, sweating, impaired control, pupil dilation, taste disorder, visual impairment, abnormal uterine bleeding, prostatitis, urination disorder, vaginitis, abnormal orgasm, sexual hyperesthesia, galactorrhea, leukorrhea, menorrhagia, nocturnal enuresis, bladder pain, breast pain, polyuria, pyuria, urinary incontinence, urinary retention, urgency, vaginal bleeding, abnormal orgasm, weakness, chills, fever, sore throat, migraine, orthostatic hypotension, tachycardia, angina, arrhythmia, extrasystole, hypotension, peripheral vascular disorder, syncope, thrombophlebitis, appendicitis, neoplasm, cellulitis, septicemia, granuloma, anaphylaxis, bruxism, colitis, dysphagia, tongue swelling, esophagitis, gastritis, gastroenteritis, gastric ulcer, gingivitis, glossitis, rectal bleeding, hemorrhoids, blood in stool, stomatitis, oral ulcer, diarrhea, cheilitis, cholecystitis, cholelithiasis, hematemesis, gum bleeding, hepatitis, enteritis, jaundice, intestinal obstruction, oral moniliasis, proctitis, sialorrhea, soft stool, tongue discoloration, esophageal spasm, duodenitis, sialadenitis, rectal disease, pancreatitis, thyroid enlargement, hyperthyroidism, hypothyroidism, thyroid nodule, thyroiditis, hyperprolactinemia, petechiae, anemia, leukocytosis, leukopenia, lymphadenopathy, thrombocytosis, mucosal bleeding, gastrointestinal bleeding, thrombocytopenia, eosinophilia, cyanosis, eosinophilia, lymphocytosis, prolonged bleeding time, multiple myeloma, purpura, hemolysis, edema, increased serum cholesterol, weight gain, increased alkaline phosphatase, dehydration, diabetes, hypercholesterolemia, hyperglycemia, hyperuricemia, hypoglycemia, hypokalemia, abnormal liver function test, thirst, hyponatremia, alcohol intolerance, hyperbilirubinemia, increased BUN, increased creatinine, diabetes mellitus, gout, hemachromatosis, hypercalciuria, hyperkalemia, hyperlipidemia, hyperphosphatemia, hypophosphatemia, hypoalbuminemia, uremia, hepatitis, transient symptoms of inappropriate antidiuretic hormone secretion, increased prolactin, arthralgia, arthritis, arthrosis, bone pain, exostosis, bursitis, leg cramps, myasthenia gravis, tenosynovitis, pathological fracture, myopathy, osteoporosis, osteosclerosis, rheumatoid arthritis, tendon rupture, plantar fasciitis, rhabdomyolysis, amnesia, confusion, depersonalization, emotional instability, sensory diminution, tremor, abnormal thought, speech disorder, inability to sit still, apathy, ataxia, perioral paresthesia, CNS excitation, euphoria, hallucinations, hostility, hypersensitivity, hyperactivity, decreased tension, lack of coordination, hypersexuality, mania, myotonic crisis, neuralgia, neuropathy, paranoia, psychosis, seizures, abnormal language, stupor, numbness, anxiety, inability to move, alcohol abuse, aphasia, bradykinesia, akatizia, cerebrovascular accident, loss of consciousness, delusion, dementia, dystonia, facial paralysis, abnormal gait, Guillain-Barré syndrome, reduced motor function, neuritis, eye twitching, psychotic depression, diminished reflexes, increased reflexes, suicidal thoughts, torticollis, convulsion, mania, neuroleptic malignant syndrome, serotonin syndrome, feeling drunk, hyperacidity, impulse control disorder, incomplete paralysis, extrapyramidal symptoms, tardive dyskinesia, dyspnea, increased cough, asthma, thoracic congestion, epistaxis, hyperventilation, laryngospasm, laryngitis, pneumonia, voice alteration, atelectasis, hemoptysis, respiratory reduction, hypoxemia, pleuritis, pulmonary embolism, sleep apnea, laryngeal edema, pulmonary eosinophilia, itching, acne, alopecia, brittle nails, contact dermatitis, dry skin, eczema, skin thickening, papular rash, psoriasis, urticaria, erythema nodosum, exfoliative dermatitis, dermatitis herpetiformis, hair discoloration, skin discoloration, abscess, hirsutism, vitiligo, pustular rash, vesicular rash, seborrhea, skin atrophy, skin appendages, erythema multiforme, mucocutaneous syndrome, impaired control, pupil dilation, taste disorder, visual impairment, cataract, conjunctivitis, corneal lesions, diplopia, dry eye, exophthalmos, ocular pain, auditory hypersensitivity, otitis media, olfactory abnormality, photophobia, taste loss, taste change, visual field loss, tinnitus, blepharitis, pigmentary disorders, conjunctival edema, hearing loss, glaucoma, retinal hemorrhage, subconjunctival hemorrhage, keratitis, labyrinthitis, miosis, papilledema, decreased pupillary reflex, external otitis, sclerectasia, uveitis, closed-angle glaucoma, abnormal uterine bleeding, prostatitis, urination disorder, vaginitis, abnormal ejaculation, sexual hyperesthesia, erectile dysfunction, albuminuria, amenorrhea, cystitis, dysuria, hematuria, galactorrhea, leukorrhea, menorrhagia, nocturnal enuresis, bladder pain, breast pain, polyuria, pyuria, urinary incontinence, urinary retention, urgency, vaginal bleeding, abnormal orgasm, miscarriage, anuria, breast engorgement, breast enlargement, fibrocystic breast disease, calcium oxalate crystalluria, cervicitis, ovarian cyst, prolonged erection, gynecomastia, oligomenorrhea, renal calculi, renal colic, renal dysfunction, mastitis, menopause, pyelonephritis, frequency of urination, salpingitis, urolithiasis, uterine bleeding, uterine cramping, balanitis, endometriosis, orchitis, vaginal dryness, anaphylaxis, angioedema, ventricular tachycardia, stress-induced cardiomyopathy, pancreatitis, agranulocytosis, aplastic anemia, pancytopenia, inappropriate secretion of antidiuretic hormone syndrome, abnormal liver function test, increased luteinizing hormone, rhabdomyolysis syndrome, psychomotor instability, delirium, extrapyramidal symptoms, coordination and balance disorders, tardive dyskinesia, interstitial lung disease, Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, closed-angle glaucoma, increased bleeding, irregular bleeding increase, menstrual disorders, increased frequency of urination, postpartum hemorrhage, fracture, tension syndrome, congenital malformation, increased creatine phosphokinase, deep vein thrombosis, EKG abnormalities, bleeding, liver disease, involuntary movement, increased LDH, sweating, panic, renal failure, electric shock-like shock, abdominal pain, anxiety, dyspepsia, petechiae, epistaxis, myalgia, suicidal thoughts, self-harm, hypomania, anxiety, confusion, coordination, and balance disorders, depressed mood, emotional instability, insomnia, sleep disorders, hypersomnia, nightmares, fatigue, drowsiness, sensory abnormalities, convulsions, seizures, muscle fasciculation, headache, flu-like symptoms, tinnitus, loss of appetite, diarrhea, hypertension

This medication is sensitive to air and moisture, so it should be stored in a tightly sealed container. Additionally, it is essential to keep it at a cool temperature below 25 degrees to maintain its effectiveness.

Appearance

A capsule with upper gray and lower light pink colors containing spherical white to grayish-white granules.

Package unit

30 capsules/bottle, 100 capsules/bottle