Velacan Extended-Release Capsule 75mg (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. 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 administering 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 immediate-release tablets containing this drug may be switched to this drug; the dose should be as close as possible to the tablet dose. For example, a patient taking immediate-release tablets containing this drug at 37.5 mg twice daily may take this drug at 75 mg 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, an initial dose of 37.5 mg once daily was administered for 7 days, then increased to 75 mg once daily, followed by weekly increases of 75 mg to a maximum of 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. 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. Because drug clearance varies considerably among patients with cirrhosis, dosage adjustment according to the patient is necessary. 2) Patients with renal impairment In patients with renal impairment (GFR=10∼70 mL/min), the 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 undergoing hemodialysis, the total daily dose should be reduced by 50% and administered after hemodialysis is fully completed. Because drug clearance varies considerably among patients with renal impairment, dosage adjustment according to the patient is necessary. 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 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 acute depression requires continuous pharmacotherapy for several months or longer. 6. Discontinuation of treatment with this drug If this drug is discontinued after administration 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 that occurred in more than 3% of patients and at least twice as often as in the placebo group during dose reduction and after discontinuation, based on retrospective assessments, included hypomania, anxiety, agitation, nervousness, confusion, insomnia or sleep disturbance, 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 MAO inhibitors used to treat psychiatric disorders When discontinuing an MAO inhibitor used to treat a psychiatric disorder 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 for the treatment of a psychiatric disorder. 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 treatment for a more urgent 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 have a negative impact on the central nervous system when taken with alcohol, so it is very important not to drink alcohol during treatment. This medication may increase the risk of suicidal thoughts or behavior in some young patients, so especially patients aged between 18 and 24 should be prescribed under careful judgment of the physician. This medication can raise blood pressure, so patients with high blood pressure should regularly monitor their blood pressure and consult a doctor if there are any abnormalities. Severe neurological side effects such as serotonin syndrome can occur, so caution is required when taken alongside other serotonin-active medications. This medication should not be combined with certain drugs, especially MAO inhibitors, so it is essential to inform the doctor and take it with caution. Women who are pregnant or may become pregnant, patients under 18 years of age, and nursing mothers should not take this medication. During the treatment with this medication, careful observation of changes in mental state such as risk of suicide, anxiety, and aggressiveness should be conducted, and family members or caretakers should closely monitor the patient. Patients with liver or kidney function impairment should have their dosage adjusted, and patients with a history of seizures should take it with more caution. This medication can lead to withdrawal symptoms if stopped suddenly, so it should be gradually tapered off as per the doctor's instructions. Activities requiring concentration such as driving or operating machinery should be approached with caution after taking this medication. This medication may cause side effects such as sexual dysfunction, weight changes, insomnia, dizziness, etc., so if unusual symptoms occur, consultation with a physician is necessary. There may be interactions with other medications, so patients should inform healthcare professionals of any other medications they are taking. This medication should also be used with caution in patients with heart disease, as it may present issues with heart rate or EKG, which may require regular monitoring. If abnormal symptoms like skin rashes, breathing difficulties, severe headaches, etc., occur during the use of this medication, immediate medical attention should be sought.

Headache, weakness, nausea, loss of appetite, dry mouth, vomiting, dizziness, insomnia, nervousness, drowsiness, tremors, sweating, erectile dysfunction, vasodilation, hypertension, constipation, abnormal sensations, abnormal vision, abnormal ejaculation, hyperesthesia, anxiety, pharyngitis, yawning, decreased libido, anxiety, accidental trauma, abdominal pain, palpitations, diarrhea, indigestion, weight loss, abnormal dreams, muscle hypertonia, single contraction, vascular edema, anaphylaxis, 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 agitation, neuroleptic malignant syndrome, serotonin syndrome, delirium, extrapyramidal symptoms, coordination and balance disorder, tardive dyskinesia, interstitial lung disease, Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, angle-closure glaucoma, increased bleeding, menstrual disorders, increased frequency of urination, postpartum hemorrhage, fractures, tension syndrome, increased creatine phosphokinase, cardiac venous thrombosis, EKG abnormalities, bleeding, liver disease, involuntary movements, increased LDH, excessive sweating, panic, renal failure, electric shock-like syndrome, suicide attempts, suicidal thoughts, suicidal tendencies, hostility, aggression, impulsivity, akathisia, hypomania, mania, worsening of depression, insomnia, nervousness, convulsions, seizures, muscle fasciculations, flu-like symptoms, tinnitus, weight gain, edema, forgetfulness, confusion, derealization, emotional instability, sensory loss, tremor, abnormal thinking, oral dystonia, akathisia, apathy, ataxia, perioral sensory abnormalities, central nervous system excitation, euphoria, hallucinations, animosity, hypersensitivity, hyperkinesis, decreased tension, dysregulation, increased libido, toxic myoclonus, neuralgia, neuropathy, paranoia, psychosis, abnormal speech, delirium, numbness, anxiety, inability to move, alcohol abuse, aphasia, bradykinesia, bell's palsy syndrome, cerebrovascular accident, loss of consciousness, delusions, dementia, dystonia, facial paralysis, abnormal gait, Guillain-Barré syndrome, decreased motor function, neuritis, eye twitching, psychotic depression, decreased reflexes, increased reflexes, torticollis, mania, feeling drunk, hyperchlorhydria, impulse control disorder, incomplete paralysis, extrapyramidal response, tardive movement disorders, dyspnea, increased coughing, asthma, pulmonary congestion, nosebleeds, hyperventilation, laryngeal spasm, laryngitis, pneumonia, voice changes, atelectasis, hemoptysis, decreased respiration, hypoxemia, pleuritis, pulmonary embolism, sleep apnea, laryngeal edema, pulmonary eosinophilia, itching, sweating, rash, acne, alopecia, brittle nails, contact dermatitis, dry skin, eczema, skin thickening, papular rash, psoriasis, urticaria, erythrema nodosum, exfoliative dermatitis, nummular dermatitis, hair discoloration, skin discoloration, abscess, hypertrichosis, vitiligo, pustular rash, vesicular rash, seborrhea, skin atrophy, skin adenoma, erythema multiforme, mucocutaneous syndrome, impaired control ability, mydriasis, taste disturbance, visual impairment, cataract, conjunctivitis, corneal lesions, diplopia, dry eye, exophthalmos, ocular pain, auditory hypersensitivity, otitis media, olfactory disturbances, photophobia, loss of taste, taste changes, visual field loss, tinnitus, blepharitis, pigmentation disorders, conjunctival edema, hearing loss, glaucoma, retinal hemorrhage, subconjunctival hemorrhage, keratitis, labyrinthitis, miosis, papilledema, decreased pupillary reflex, external auditory canal inflammation, scleritis, uveitis, angle-closure glaucoma, abnormal uterine bleeding, prostatitis, urination disorders, vaginitis, abnormal ejaculation, hypersexuality, erectile dysfunction, albuminuria, amenorrhea, cystitis, dysuria, hematuria, galactorrhea, leukorrhea, menorrhagia, nocturia, 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 crystals in urine, diabetes, gout, hemochromatosis, hypercalciuria, hyperkalemia, hyperlipidemia, hyperphosphatemia, hypophosphatemia, hypoproteinemia, uremia, hepatitis, inappropriate secretion of antidiuretic hormone, hypocholesterolemia, increased prolactin, arthralgia, arthritis, arthrosis, bone pain, bone protrusion, bursitis, leg cramps, myasthenia gravis, tendinitis, pathological fractures, myopathy, osteoporosis, osteosclerosis, rheumatoid arthritis, tendon rupture, plantar fasciitis

This medication should be stored in a tightly closed container to avoid exposure to air or moisture. It is also recommended to store it at a cool temperature below 25 degrees Celsius.

Appearance

A capsule consisting of pink upper and lower parts containing white to grayish-white granules.

Package unit

30 capsules/bottle, 100 capsules/bottle