Cofax SR Capsule 75 mg (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 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 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 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 per day and should be made at intervals of at least 4 days. Patients with depression who are currently taking conventional tablets containing this drug may be switched to this drug, with the dose being as close as possible to the tablet dose. For example, a patient taking conventional tablets containing this drug at 37.5 mg twice daily may take 75 mg of this drug once daily. Individual dose adjustment may be needed 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 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. If the dose is increased, it should be increased by no more than 75 mg daily as needed, at intervals of at least 7 days. 4. Administration in specific populations 1) Patients with hepatic impairment The dose should be reduced by 50 % in patients with moderate hepatic impairment. In patients with cirrhosis, there is considerable individual variability in drug clearance, so the dose should be adjusted for each patient. 2) Patients with renal impairment The total daily dose should be reduced by 25∼50% in patients with renal impairment (GFR=10∼70 mL/min). For patients receiving hemodialysis, the total daily dose should be reduced by 50%, and the dose should be administered after hemodialysis is fully completed. There is considerable individual variability in drug clearance in patients with renal impairment, so the dose should be adjusted for each patient. 5. Maintenance/continuation/long-term treatment The physician should regularly evaluate the effectiveness of long-term treatment with this drug for each patient. Although there is no clinical trial evidence regarding 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 continuous pharmacotherapy for several months or longer may be needed for acute depression. 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. The time required for dose reduction may vary depending on the dose, duration of treatment, and patient. 7. Switching from MAO inhibitors for the treatment of 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, if starting an MAO inhibitor for the treatment of psychiatric disorders, at least 7 days must have elapsed after discontinuing this drug. 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. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this drug; 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 receiving linezolid or intravenous methylene blue, or until 24 hours after the last dose, whichever comes first. Treatment with this drug 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 drug at a dose of 1mg/kg or less, is unclear.

This medication affects the central nervous system, so alcohol consumption should be avoided during treatment. Combined use with alcohol can enhance CNS depressant effects and may be dangerous. Additionally, this medication may increase suicidal thoughts or behaviors, so it should be used cautiously, especially in young patients aged 18 to 24. Patients and guardians should closely monitor for changes in suicidal thoughts or behaviors, especially at the start of treatment or during dosage adjustments. Blood pressure may increase, so regular monitoring of blood pressure is necessary, and if hypertension persists or worsens, consult a physician for dosage adjustment or discontinuation. Severe side effects such as serotonin syndrome and Neuroleptic Malignant Syndrome may occur, so caution is advised when used with serotonin-acting drugs. Seek immediate medical attention if unusual symptoms appear. This medication should not be administered to specific patients, such as those taking MAO inhibitors, pregnant women or women who may become pregnant, and patients under 18 years of age. Patients with a history of suicide attempts or seizures, or those with impaired kidney or liver function, and patients with heart disease require careful monitoring when using this medication. Avoid sudden discontinuation during treatment, and gradually reduce the dosage under the supervision of a physician. Inform your healthcare provider immediately if withdrawal symptoms or side effects occur. Various side effects may occur, such as sexual dysfunction, insomnia, nervousness, dizziness, nausea, dry mouth, etc. If symptoms are severe, consult a physician. This medication can interact with other drugs, so inform your healthcare provider of any other medications you are taking, especially when used with lithium, diazepam, cimetidine, haloperidol, and CYP450 enzyme inhibitors. Lastly, be cautious when engaging in activities that require concentration, such as driving or operating dangerous machinery, while taking this medication.

Headache, lethargy, nausea, loss of appetite, dry mouth, vomiting, dizziness, insomnia, nervousness, drowsiness, tremors, sweating, erectile dysfunction, vasodilation, hypertension, constipation, abnormal ejaculation, paraphilia, abnormal dreams, anxiety, yawning, abnormal vision, decreased libido, pharyngitis, palpitations, anxiety, orgasm disorder, lethargy/fatigue, chills, fever, sore throat, facial swelling, fatigue, suicide attempt, withdrawal symptoms, migraine, orthostatic hypotension, tachycardia, angina, arrhythmia, hypotension, peripheral vascular disorders, syncope, thrombophlebitis, arteritis, first-degree AV block, ectopic rhythm, bradycardia, conduction block, cerebral ischemia, coronary artery disease, congestive heart failure, cardiac arrest, mitral valve and blood circulation disorders, mucocutaneous bleeding, myocardial infarction, pallor, aortic aneurysm, capillary fragility, QT interval 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 ulcers, diarrhea, cheilitis, cholecystitis, cholelithiasis, hematemesis, gum bleeding, hepatitis, ileitis, jaundice, intestinal obstruction, oral motility syndrome, proctitis, hypersalivation, fecal incontinence, 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, basophilia, cyanosis, eosinophilia, lymphocytosis, prolonged bleeding time, multiple myeloma, purpura, hematologic disorders, 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 of inappropriate antidiuretic hormone secretion, increased prolactin, arthralgia, arthritis, arthrosis, bone pain, bone spur, bursitis, leg cramps, myasthenia, tendinitis, pathological fractures, myopathy, osteoporosis, osteosclerosis, rheumatoid arthritis, tendon rupture, plantar fasciitis, forgetfulness, confusion, dissociative episodes, emotional instability, sensory loss, abnormal dreams, decreased libido, increased muscle tone, jaw dystonia, inability to sit cross-legged, apathy, ataxia, sensory disturbances around the mouth, central nervous system excitation, euphoria, hallucinations, hostility, hypersensitivity, hyperactivity, reduced tension, lack of coordination, increased libido, mania, dystonic reactions, neuralgia, neuropathy, paranoia, psychosis, seizures, abnormal speech, confusion, numbness, anxiety, inability to move, alcohol abuse, aphasia, bradykinesia, akathisia, cerebrovascular accident, loss of consciousness, delusions, dementia, dystonia, facial paralysis, abnormal gait, Guillain-Barré syndrome, reduced motor function, neuritis, eye twitching, psychotic depression, decreased reflexes, increased reflexes, suicidal thoughts, torticollis, spasms, neuroleptic malignant syndrome, serotonin syndrome, feeling intoxicated, hyperacidic state, impulse control disorder, incomplete paralysis, extrapyramidal symptoms, tardive dyskinesia, dyspnea, increased coughing, asthma, pulmonary congestion, epistaxis, hyperventilation, laryngospasm, laryngitis, pneumonia, voice changes, atelectasis, hemoptysis, respiratory depression, hypoxemia, pleuritis, pulmonary embolism, obstructive sleep apnea, laryngeal edema, pulmonary eosinophilia, itching, sweating, rash, acne, alopecia, brittle nails, contact dermatitis, dry skin, eczema, skin thickening, papular rash, psoriasis, hives, erythrodermic nodules, exfoliative dermatitis, lichen simplex, hair discoloration, skin discoloration, abscess, hirsutism, vitiligo, pustular rash, vesicular rash, seborrhea, skin atrophy, seborrheic keratosis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, increased bleeding, increased frequency of urination, postpartum hemorrhage, fractures, tense syndrome, congenital malformations, 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 symptoms, abdominal pain, anxiety, dyspepsia, petechiae, epistaxis, myalgia, suicidal thoughts, self-harm, decreased appetite, weight loss, increased blood pressure, increased blood cholesterol, euphoria, anxiety, confusion, coordination and balance disorders, low mood, emotional instability, somnolence, nightmares, fatigue, sensory disturbances, spasms, seizures, muscle fasciculations, flu-like symptoms, tinnitus, loss of appetite, diarrhea, hypertension, increased blood pressure, increased heart rate, aggression, suicidal impulses, suicidal behaviors, insomnia, hostility, aggression, impulsivity, inability to sit still, mania, bipolar disorder, withdrawal symptoms

Store this medication in a tightly sealed container to prevent air or moisture from entering and keep it in a cool place below 25 degrees Celsius. This will help maintain the drug's effectiveness and prevent deterioration.

Appearance

Capsules with spherical off-white to grayish-white granules in a peach-colored shell.

Package unit

30 capsules/bottle, 200 capsules/bottle