Venexal XR Extended-Release Capsule 37.5 mg (Venlafaxine Hydrochloride)

Adult dosage

(Extended-release capsules) (Extended-release tablets) The therapeutic dose of this drug should be adjusted according to the patient's clinical condition, and the lowest effective dose should be administered whenever possible. 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 before taking them. 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 administered for 4∼7 days after starting treatment to allow the patient to adjust to the drug 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 and should be made at intervals of at least 4 days. Patients with depression who are currently taking the immediate-release tablet containing this drug's ingredient may switch to this drug; the dose should be as close as possible to the tablet dose. For example, a patient taking 37.5 mg of the immediate-release tablet containing this drug's 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 a dose of 75 mg/day may benefit from an increase up 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 7 days or more. 4. Dosage 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. Patients with cirrhosis may require individual dose adjustment because of substantial interpatient variability in drug clearance. 2) Patients with renal impairment In patients with renal impairment (GFR=10∼70 mL/min), 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. Individual dose adjustment may be necessary in patients with renal impairment because of substantial interpatient variability in drug clearance. 5. Maintenance/continuation/long-term treatment The physician should periodically evaluate the effectiveness of long-term treatment with this drug for each patient. Although there is no clinical trial evidence on how long this drug 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 drug therapy for several months or longer. 6. Discontinuation of treatment with this drug If treatment is discontinued after this drug has been 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 reported in retrospective surveys during dose reduction and after discontinuation that occurred in more than 3% of patients and at more than twice the rate 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 for the treatment of psychiatric disorders An interval of at least 14 days must be allowed after discontinuing an MAO inhibitor used to treat psychiatric disorders before starting treatment with this drug. Conversely, at least 7 days must elapse after discontinuing this drug 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 drug because of the increased risk of serotonin syndrome. For patients who require more urgent treatment of 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 drug. If no alternative to linezolid or intravenous methylene blue is available and the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome in a particular patient, this drug 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 comes first. Treatment with this drug may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with administration of methylene blue by a non-intravenous route (oral tablets or local injection) or intravenous administration of this drug 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 such use.

This medication can have negative effects on the central nervous system when taken with alcohol, so alcohol consumption should be avoided during treatment. This medication may increase the risk of suicidal thoughts or behaviors in children, adolescents, and young adults, so careful monitoring is especially recommended for patients in these age groups. Because it can raise blood pressure, patients should have their blood pressure monitored regularly during treatment and consult with a physician if blood pressure remains consistently high. Severe side effects such as serotonin syndrome and neuroleptic malignant syndrome may occur, so caution is particularly advised when combining with other serotonin-acting medications, and any unusual symptoms should be reported to a healthcare provider immediately. This medication should not be used in patients with hypersensitivity to this medication or its components, those taking MAO inhibitors, pregnant or breastfeeding women, and patients under 18 years of age. Patients at high risk of suicide, those with a history of seizures, and those with impaired kidney or liver function, or heart disease should use this medication cautiously and according to a physician's directives. During treatment, side effects such as insomnia, nervousness, appetite loss, sexual dysfunction, dizziness, drowsiness, and nausea may occur; if symptoms are severe, consultation with a healthcare provider is advised. Abrupt discontinuation can lead to withdrawal symptoms, so the dosage should be gradually reduced following a physician's advice, and careful monitoring should continue during discontinuation. This medication may affect blood coagulation, increasing bleeding risk, so patients on anticoagulants or platelet inhibitors should exercise caution. When driving or operating hazardous machinery, be careful, as this medication can affect cognitive function or motor skills. Because there may be interactions with other medications, all other medications being used should be disclosed to a healthcare provider.

Headache, weakness, nausea, decreased appetite, dry mouth, vomiting, dizziness, insomnia, neurosthenia, drowsiness, tremors, sweating, erectile dysfunction, vasodilation, hypertension, constipation, dysesthesia, abnormal vision, abnormal ejaculation, parathesia, anxiety, yawning, decreased libido, anxiety, single contraction, orgasm dysfunction, lethargy, suicidal attempt, withdrawal symptoms, facial swelling, appendicitis, carcinoma, phlegmon, bacteremia, granuloma, anaphylaxis, migraine, orthostatic hypotension, tachycardia, angina, arrhythmia, extrasystole, hypotension, peripheral vascular disorders, syncope, thrombophlebitis, arteritis, first-degree AV block, bigeminy, bradycardia, block, cerebral ischemia, coronary artery disease, congestive heart failure, cardiac arrest, mitral valve and circulatory disorders, mucosal bleeding, myocardial infarction, pallor, aortic aneurysm, capillary fragility, QT prolongation, 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 ulcer, diarrhea, cheilitis, cholecystitis, cholelithiasis, hematemesis, gum bleeding, hepatitis, enteritis, jaundice, intestinal obstruction, oral motility disorder, proctitis, increased salivation, loose stools, tongue discoloration, esophageal spasm, duodenitis, parotitis, rectal disorders, pancreatitis, goiter, hyperthyroidism, hypothyroidism, thyroid nodules, thyroiditis, galactorrhea, petechiae, anemia, leukocytosis, leukopenia, lymphadenopathy, thrombocytosis, mucosal bleeding, gastrointestinal bleeding, thrombocytopenia, eosinophilia, cyanosis, eosinophilia, lymphocytosis, prolonged bleeding time, multiple myeloma, purpura, blood dyscrasia, edema, increased serum cholesterol, weight loss, 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, transient symptoms due to inappropriate antidiuretic hormone secretion leading to syndrome of inappropriate antidiuretic hormone secretion, abnormal healing, hypocholesterolemia, increased prolactin, arthralgia, arthritis, arthrosis, bone pain, bone spurs, bursitis, leg cramps, myasthenia gravis, tendinitis, pathological fractures, myopathy, osteoporosis, osteosclerosis, rheumatoid arthritis, tendon rupture, plantar fasciitis, rhabdomyolysis, forgetfulness, confusion, derealization, emotional instability, sensory reduction, abnormal dreams, decreased libido, increased muscle tone, jaw opening disorder, inability to sit still, apathy, ataxia, perioral dysesthesia, central nervous system excitation, euphoria, hallucinations, hostility, hypersensitivity, psychomotor agitation, decreased tension, lack of coordination, increased libido, mania, myoclonic jerks, neuralgia, neuropathy, paranoia, psychosis, seizures, abnormal speech, stupor, numbness, anxiety, dyskinesia, alcohol abuse, aphasia, bradykinesia, akathisia, cerebrovascular accident, loss of consciousness, delusions, dementia, abnormal muscle tone, facial paralysis, abnormal gait, Guillain-Barré syndrome, reduced motor function, neuritis, eye tremors, psychotic depression, decreased reflexes, increased reflexes, suicidal thoughts, torticollis, convulsions, neuroleptic malignant syndrome, serotonin syndrome, feeling intoxicated, hyperacidity, impulse control disorder, incomplete paralysis, extrapyramidal symptoms, tardive dyskinesia, dyspnea, increased cough, asthma, thoracic congestion, epistaxis, hyperventilation, laryngospasm, laryngitis, pneumonia, voice distortion, atelectasis, hemoptysis, respiratory depression, hypoxemia, pleuritis, pulmonary embolism, obstructive sleep apnea, laryngeal edema, pulmonary eosinophilia, pruritus, acne, alopecia, brittle nails, contact dermatitis, dry skin, eczema, skin thickening, papular rash, psoriasis, urticaria, erythema nodosum, exfoliative dermatitis, lichen simplex chronicus, hair discoloration, skin discoloration, furuncle, hirsutism, vitiligo, pustular rash, vesicular rash, seborrhea, skin atrophy, skin appendages, polymorphous erythroderma, mucocutaneous syndrome, abnormal control ability, pupillary dilation, taste disturbance, visual impairment, cataracts, conjunctivitis, corneal lesions, double vision, dry eye, exophthalmos, eye pain, auditory hypersensitivity, otitis media, olfactory disturbances, photophobia, taste loss, taste changes, vision damage, tinnitus, blepharitis, pigmentation, conjunctival edema, hearing loss, glaucoma, retinal hemorrhage, subconjunctival hemorrhage, keratitis, labyrinthitis, mydriasis, papilledema, decreased pupillary reflex, otitis externa, scleral inflammation, uveitis, closed-angle glaucoma, abnormal uterine bleeding, prostatitis, urinary disorders, vaginitis, abnormal ejaculation, hypersensitivity to sexual stimuli, 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 in urine, cervicitis, ovarian cysts, prolonged erection, gynecomastia, hypomenorrhea, kidney stones, renal pain, renal dysfunction, mastitis, menopause, pyelonephritis, frequency of urination, salpingitis, urinary calculi, uterine bleeding, uterine contractions, balanitis, endometriosis, orchitis, vaginal dryness, anaphylaxis, angioedema, ventricular tachycardia, stress-induced cardiomyopathy, pancreatitis, agranulocytosis, aplastic anemia, pancytopenia, syndrome of inappropriate antidiuretic hormone secretion, abnormal liver function tests, increased luteinizing hormone, rhabdomyolysis syndrome, psychomotor instability, delirium, coordination and balance disorders, tardive dyskinesia, interstitial lung disease, Stevens-Johnson syndrome, toxic epidermal necrolysis, increased bleeding, increased frequency of urination, postpartum hemorrhage, fractures, tension syndrome, increased creatine phosphokinase, thrombogenic venous thrombosis, atrial fibrillation, supraventricular tachycardia, ventricular extrasystole, bleeding, liver disease, involuntary movements, increased LDH, hypomania, panic, renal failure, electric shock-like shock, abdominal pain, anxiety, dyspepsia, petechiae, epistaxis, myalgia, suicidal thoughts, self-harm, decreased appetite, weight loss, increased blood pressure, increased cholesterol levels, hypomanic episode, anxiety, confusion, coordination and balance disorders, depressed mood, emotional instability, hypersomnia, nightmares, fatigue, sensory disturbances, convulsions, muscle fiber bundle contractions, flu-like symptoms, tinnitus, loss of appetite, diarrhea, hypertension, vasodilation, increased blood pressure, increased heart rate, aggression, suicidal urge, suicidal behavior, insomnia, excitement, hostility, impulsiveness, akathisia, mania, bipolar disorder, persistent sexual dysfunction, interstitial pneumonia, eosinophilic pneumonia, fractures

This medication should be stored in a tightly sealed container to protect it from air and moisture and is best kept in a cool place below 25 degrees Celsius. This way of storage can help maintain the effectiveness of the medication for a longer period.

Appearance

A capsule with a gray upper part and a peach lower part containing white or off-white spherical granules.

Package unit

30 capsules (10 capsules/PTP packaging × 3), 30 capsules/bottle, 100 capsules/bottle