Venlafaxine Extended-Release Capsules 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, taken 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 more 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 as close as possible to the tablet dose. For example, a patient taking an immediate-release tablet containing this drug's active ingredient at 37.5 mg 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, taken 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 a clinical trial 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 to a maximum of 225 mg daily. When increasing the dose, increases should be no more than 75 mg daily, as needed, and should be made at intervals of at least 7 days. 4. Dosing in special populations 1) Patients with hepatic impairment In patients with hepatic impairment, the clearance of venlafaxine and O-desmethylvenlafaxine (ODV) is decreased and their half-lives are prolonged; therefore, the dose should be reduced by 50 % in patients with moderate hepatic impairment. Patients with cirrhosis have substantial individual variability in drug clearance, so the dose should be adjusted for each patient. 2) Patients with renal impairment In patients with renal impairment (GFR=10∼70 mL/min), the clearance of this drug is decreased 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%. In patients receiving hemodialysis, the total daily dose should be reduced by 50%, and the drug should be administered after hemodialysis is completely finished. Patients with renal impairment have substantial individual variability in drug clearance, so the dose should be adjusted for each patient. 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 continued pharmacotherapy for several months or longer. 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. Patients who have received this drug for more than 6 weeks should have their dose 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, when starting an MAO inhibitor for the treatment of psychiatric disorders, at least 7 days should have elapsed after discontinuing this drug. 8. Other MAO inhibitors, such as linezolid or methylene blue It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this drug. 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 drug may be discontinued immediately and linezolid or intravenous methylene blue administered. The patient 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.

This medication can have negative effects on the central nervous system when taken with alcohol, so alcohol intake should be avoided during treatment. This drug is not approved for use in children and adolescents under 18 years, and special care is needed as there may be an increase in suicidal thoughts or behaviors, particularly in young adults. In some patients, blood pressure may continuously increase while taking this medication, so regular blood pressure monitoring is necessary, and dosage adjustment or discontinuation should be considered if necessary. This medication can cause serious side effects similar to serotonin syndrome and neuroleptic malignant syndrome, so it should not be combined with serotonin-acting drugs or MAO inhibitors, and immediate consultation and monitoring by healthcare professionals are necessary when combined. Patients who are hypersensitive to this medication, taking MAO inhibitors, pregnant or breastfeeding women, and patients under 18 years of age should not be treated with this medication. The medication should be used cautiously in patients with suicidal tendencies, a history of seizures, severe kidney or liver disease, cardiovascular disease, or a history of aggression, and symptoms should be closely monitored during treatment. This medication can cause various adverse reactions, commonly including nausea, dizziness, insomnia, drowsiness, sweating, and sexual dysfunction, which may require discontinuation of treatment in severe cases. When discontinuing treatment, withdrawal symptoms may occur, so it should not be stopped abruptly; the dosage should be gradually reduced according to a doctor's directions. This medication may have cardiovascular effects such as increased blood pressure, increased heart rate, and increased blood cholesterol, so special caution is needed for patients with cardiovascular diseases. There may be potential interactions with other medications taken concurrently, so especially when combined with MAO inhibitors, serotonin-acting drugs, or CYP450 enzyme inhibitors, it is essential to consult with healthcare professionals. During the use of this medication, care should be taken when engaging in activities that require attention, such as driving or operating machinery, and any adverse reactions should be reported to healthcare professionals immediately.

Headache, Weakness, Nausea, Appetite Decrease, Thirst, Vomiting, Dizziness, Insomnia, Irritability, Drowsiness, Tremors, Sweating, Erectile Dysfunction, Vasodilation, Hypertension, Constipation, Abnormal Ejaculation, Paraphilia, Abnormal Dreams, Anxiety, Yawning, Decreased Libido, Pharyngitis, Palpitations, Anxiety, Traumatic Injuries, Abdominal Pain, Diarrhea, Weight Loss, Abnormal Vision, Orgasm Disorder, Hypertension, Migraine, Orthostatic Hypotension, Tachycardia, Angina, Arrhythmia, Ectopic Beats, Hypotension, Peripheral Vascular Disorders, Syncope, Thrombophlebitis, Arteritis, First-degree AV Block, Bifid Pulse, Bradycardia, Heart Block, Cerebral Ischemia, Coronary Artery Disease, Congestive Heart Failure, Cardiac Arrest, Mitral Valve and Circulatory Disorders, Mucocutaneous 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, Blood in Stool, Stomatitis, Oral Ulcers, Cheilitis, Cholecystitis, Cholelithiasis, Hematemesis, Gum Bleeding, Hepatitis, Ileitis, Jaundice, Intestinal Obstruction, Oral Moniliasis, Proctitis, Increased Salivation, Loose Stools, Tongue Discoloration, Esophageal Spasm, Duodenitis, Parotitis, Rectal Disorders, Pancreatitis, Goiter, Hyperthyroidism, Hypothyroidism, Thyroid Nodules, Thyroiditis, Excess Lactation, Purpura, Anemia, Leukocytosis, Leukopenia, Lymphadenopathy, Thrombocytosis, Mucosal Bleeding, Gastrointestinal Bleeding, Thrombocytopenia, Eosinophilia, Cyanosis, Eosinophilia, Lymphocytosis, Prolonged Bleeding Time, Multiple Myeloma, Purpura, Hematologic Dyscrasia, Edema, Increased Serum Cholesterol, 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, Gout, Hemochromatosis, Hypercalciuria, Hyperkalemia, Hyperlipidemia, Hyperphosphatemia, Hypophosphatemia, Hypoalbuminemia, Uremia, Hepatitis, Syndrome of Inappropriate Antidiuretic Hormone Secretion, Abnormal Healing, Hypocholesterolemia, Increased Prolactin, Arthralgia, Arthritis, Arthrosis, Bone Pain, Osteophytes, Bursitis, Leg Cramps, Myasthenia, Tendonitis, Pathological Fracture, Myopathy, Osteoporosis, Osteosclerosis, Rheumatoid Arthritis, Tendon Rupture, Plantar Fasciitis, Rhabdomyolysis, Amnesia, Confusion, Depersonalization, Emotional Instability, Sensory Impairment, Decreased Libido, Increased Muscle Tone, Tremors, Abnormal Thoughts, Oromandibular Dystonia, Inability to Sit Still, Apathy, Ataxia, Perioral Paresthesia, CNS Stimulation, Euphoria, Hallucinations, Irritability, Sensitivity to Stimuli, Psychomotor Agitation, Decreased Muscle Tone, Lack of Coordination, Increased Libido, Mania, Tonic-Clonic Seizure, Neuropathic Pain, Neuropathy, Paranoia, Psychosis, Seizures, Abnormal Speech, Somnolence, Numbness, Anxiety, Inability to Move, Alcohol Abuse, Aphasia, Bradykinesia, Akathisia Syndrome, Cerebrovascular Accident, Loss of Consciousness, Delusions, Dementia, Dystonia, Facial Paralysis, Abnormal Gait, Guillain-Barré Syndrome, Decreased Motor Function, Neuritis, Nystagmus, Psychotic Depression, Diminished Reflexes, Augmented Reflexes, Suicidal Thoughts, Torticollis, Spasms, Neuroleptic Malignant Syndrome, Serotonin Syndrome, Feeling Intoxicated, Hyperacidity, Impulse Control Disorder, Incomplete Paralysis, Extrapyramidal Reactions, Tardive Dyskinesia, Dyspnea, Increased Cough, Asthma, Chest Congestion, Nosebleed, Hyperventilation, Laryngeal Spasm, Laryngitis, Pneumonia, Voice Changes, Atelectasis, Hemoptysis, Respiratory Depression, Hypoxemia, Pleuritis, Pulmonary Embolism, Sleep Apnea, Laryngeal Edema, Pulmonary Eosinophilia, Pruritus, Sweating, Rash, Acne, Alopecia, Brittle Nails, Contact Dermatitis, Dry Skin, Eczema, Skin Thickening, Maculopapular Rash, Psoriasis, Urticaria, Erythema Nodosum, Exfoliative Dermatitis, Lichen Simplex Chronicus, Hair Discoloration, Skin Discoloration, Boils, Hirsutism, Vitiligo, Pustular Rash, Vesicular Rash, Seborrhea, Skin Atrophy, Skin Appendages, Erythema Multiforme, Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis, Abnormal Bleeding, Irregular Bleeding Increase, Menstrual Disorders, Increased Frequency of Urination, Postpartum Hemorrhage, Fracture, Tension, Congenital Anomalies, Increased Creatine Phosphokinase, Thrombotic Venous Insufficiency, EKG Abnormalities, Bleeding, Liver Disease, Involuntary Movements, Increased LDH, Hyperhidrosis, Panic, Renal Failure, Electric Shock-Like Shock, Abdominal Pain, Anxiety, Indigestion, Purpura, Nosebleed, Myalgia, Suicidal Thoughts, Self-Harm, Appetite Decrease, Weight Loss, Increased Blood Pressure, Increased Blood Cholesterol, Mild Mania, Anxiety, Confusion, Lack of Coordination, Depressive Mood, Emotional Instability, Hypersomnia, Nightmares, Fatigue, Sensory Abnormalities, Muscle Fiber Twitching, Headache, Flu-Like Symptoms, Tinnitus, Thirst, Diarrhea, Hypertension, Suicidal Impulse, Suicidal Behavior, Hostility, Aggression, Impulsiveness, Inability to Sit Still, Mania, Bipolar Disorder, Insomnia, Excitation, Anxiety, Panic Attacks, Insomnia, Excitation, Hostility, Aggression, Impulsiveness, Inability to Sit Still, Mild Mania, Mania, Suicidal Tendencies, Increased Risk of Suicidal Tendencies, Decreased Risk of Suicidal Tendencies, Onset of Suicidal Tendencies, Risk of Onset of Suicidal Tendencies, Increased Risk of Onset of Suicidal Tendencies, Decreased Risk of Onset of Suicidal Tendencies, Possibility of Increased Risk of Onset of Suicidal Tendencies, Possibility of Decreased Risk of Onset of Suicidal Tendencies, Increased Risk of Onset of Suicidal Tendencies Risk, Decreased Risk of Onset of Suicidal Tendencies Risk, Increased Risk of Onset of Suicidal Tendencies Risk Possibility, Decreased Risk of Onset of Suicidal Tendencies Risk Possibility

This medication should be stored in a tightly closed container to prevent exposure to air or moisture and should be kept in a cool place below 25 degrees Celsius. Doing so will help maintain the effectiveness of the medication and ensure safe usage.

Appearance

A peach-colored capsule containing white to grayish granules

Package unit

30 capsules/bottle, 100 capsules/bottle