Velakans Sustained-Release Capsule 37.5 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, preferably at a consistent time in the morning or evening. Do not divide, crush, chew, or dissolve the capsule in water before taking it. Adults 1. Depression and generalized anxiety disorder The recommended starting 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 an immediate-release tablet containing this drug's active ingredient may be switched to this drug; the dose should be the closest equivalent to the tablet dose. For example, a patient taking 37.5 mg of the immediate-release tablet 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 starting 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, the initial dose was 37.5 mg once daily 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 to a maximum of 225 mg daily. If the dose is increased, increases should be no greater than 75 mg daily as needed and should be made at intervals of at least 7 days. 4. Administration 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, dose adjustment should be individualized. 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. Because drug clearance varies considerably among patients with renal impairment, dose adjustment should be individualized. 5. Maintenance/continuation/long-term treatment The physician should periodically evaluate the efficacy 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, there is general agreement that acute depression requires continuous drug therapy for several months or longer. 6. Discontinuation of treatment with this drug If this drug 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 drug for more than 6 weeks should have their dose 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 at least twice that in the placebo group during dose reduction and in retrospective surveys after discontinuation included symptoms such as hypomania, anxiety, agitation, nervousness, confusion, insomnia or sleep disturbances, 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 or to 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, at least 7 days should elapse after discontinuing this drug before starting an MAO inhibitor to treat 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 requiring more urgent treatment of a psychiatric condition, including hospitalization, other interventions 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, for a particular patient, the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome, 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 administration of linezolid or intravenous methylene blue, or until 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 intravenous methylene blue. The risk associated with administration of methylene blue by non-intravenous routes (oral tablets or local injection), or with 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 these uses.

This medication can negatively affect the central nervous system when taken with alcohol, so alcohol consumption should be avoided during treatment. Severe side effects may occur in case of overdose, so you must adhere to the prescribed minimum dose. This medication may increase the risk of suicidal thoughts or behaviors, especially in young patients aged 18 to 24, so careful monitoring by patients and guardians is required during initial treatment or dosage adjustment. Some patients may experience a persistent rise in blood pressure, so blood pressure should be monitored regularly, and any abnormalities should be discussed with a doctor. This medication can cause serious neurological side effects such as serotonin syndrome and neuroleptic malignant syndrome, so caution is required when used with other serotonin-active drugs. This medication should not be taken with certain drugs, especially MAO inhibitors, and it should not be administered to women during pregnancy or breastfeeding, or to children and adolescents under 18 years of age. Patients at risk of suicide, those with a history of seizures, patients with decreased kidney or liver function, and those who have recently experienced a myocardial infarction or have heart disease should use this drug with caution. If allergic reactions such as rash or urticaria occur during use, notify your doctor immediately. This medication can cause various side effects including insomnia, nervousness, decreased appetite, nausea, dizziness, drowsiness, sweating, sexual dysfunction, etc., so if symptoms are severe or persistent, consult a healthcare professional. Abrupt discontinuation can lead to withdrawal symptoms such as dizziness, anxiety, and sleep disturbances, so the dosage should be gradually reduced according to the doctor's instructions. Caution is required when engaging in dangerous activities such as driving or operating machinery, as this medication may affect cognitive abilities and reaction speeds. During the use of this medication, it is advisable to regularly check blood pressure, heart rate, and blood cholesterol levels. Interactions with other medications are possible, so inform your doctor or pharmacist of any other medications you are taking.

Headache, weakness, nausea, loss of appetite, dry mouth, vomiting, dizziness, insomnia, nervousness, drowsiness, tremors, sweating, erectile dysfunction, vasodilation, constipation, abnormal dreams, abnormal vision, abnormal ejaculation, decreased libido, restlessness, yawning, hypertension, weight loss, unusual sensations, pharyngitis, anxiety, accidental trauma, abdominal pain, palpitations, dyspepsia, diarrhea, decreased libido, insomnia, nervousness, inability to sit still, apathy, ataxia, hallucinations, hostility, hypersensitivity, hyperkinesia, decreased tension, disharmony, mania, paroxysmal muscle spasms, neuralgia, neuropathy, paranoia, psychosis, seizures, abnormal speech, confusion, numbness, restlessness, suicidal thoughts, torticollis, convulsions, neuroleptic malignant syndrome, serotonin syndrome, feelings of intoxication, hyperchlorhydria, impulse control disorder, incomplete paralysis, shortness of breath, increased cough, itching, sweating, rash, acne, alopecia, brittle nails, contact dermatitis, dry skin, eczema, skin thickening, papular eruption, psoriasis, hives, impaired control ability, pupil dilation, taste disorder, visual impairment, abnormal uterine bleeding, prostatitis, urination disorders, vaginitis, abnormal ejaculation, hyperesthesia, erectile dysfunction, albuminuria, amenorrhea, cystitis, difficulty urinating, hematuria, galactorrhea, leukorrhea, menorrhagia, nocturia, bladder pain, breast pain, polyuria, pyuria, urinary incontinence, urinary retention, urinary urgency, vaginal bleeding, abnormal orgasm, miscarriage, anuria, breast engorgement, breast enlargement, fibrocystic breast disease, calcium oxalate crystals in urine, sustained erection, gynecomastia, hypomenorrhea, renal stones, renal colic, renal dysfunction, mastitis, menopause, pyelonephritis, frequent urination, salpingitis, urinary calculi, 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 tests, 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, angle-closure glaucoma, increased or irregular bleeding, increased frequency of urination, postpartum hemorrhage, fractures, tension, increased creatine phosphokinase, thrombotic vein inflammation, EKG abnormalities, hemorrhage, liver disease, involuntary movements, increased LDH, sweating, panic, renal failure, electric shock-like symptoms, suicidal thoughts, suicidal tendencies, self-harm, hostility, aggression, impulsivity, akathisia, hypomania, mania, withdrawal symptoms, convulsions, seizures, muscle fasciculation, flu-like symptoms, tinnitus, loss of appetite, diarrhea, vomiting, visual impairment, hypertension

This medication should be stored in a tightly sealed container to prevent exposure to air and moisture, and it is advisable to keep it in a cool place below 25 degrees Celsius. This helps to maintain the medication's effectiveness over time.

Appearance

A capsule with a gray upper section and pink lower section containing white to grayish granules.

Package unit

30 capsules/bottle, 100 capsules/bottle