Elperidon Tablet 3 mg (Risperidone)

Adult dose

The therapeutic dose of this medicine should be adjusted according to the patient’s clinical condition, and the lowest effective dose should be administered whenever possible. 1. Schizophrenia 1) Adults (1) Initial dose: Administer risperidone 1 mg orally twice daily and increase the dose gradually. (2) Maintenance dose: Administer 1∼3 mg twice daily. Adjust the dose appropriately according to age and symptoms. (3) No additional benefit was observed with doses of 10 mg or more daily compared with lower doses, and such doses may increase the risk of extrapyramidal symptoms. Doses of 10 mg or more daily should be administered only when the benefit to the individual patient is judged to outweigh the risk. (4) Do not administer doses of 16 mg or more daily because safety has not been established. (5) A benzodiazepine may be administered concomitantly if additional sedation is needed. 2) Administration in special populations ⦁Older adults and patients predisposed to hypotension The initial dose is 0.5 mg twice daily. Depending on the patient’s condition, increase the dose by 0.5 mg twice daily until reaching 1～2 mg twice daily. Increases to doses of 1.5 mg or more twice daily should generally be made at intervals of at least 1 week. 3) Switching from another antipsychotic medicine to this medicine When medically appropriate, initiate treatment with this medicine while gradually reducing the dose of the previous medicine. When switching from a depot antipsychotic medicine, when medically appropriate, initiate treatment with this medicine in place of the next scheduled depot injection. The need to continue any concomitant antiparkinsonian medicine should be reassessed regularly. 2. Agitation, aggression, or psychotic symptoms in patients with dementia of the Alzheimer type The initial dose is 0.25 mg of this medicine twice daily. If needed, depending on the patient, the dose may be increased by 0.25 mg twice daily at intervals of at least 2 days. The optimal dose for most patients is 0.5 mg twice daily, but depending on the patient, it may be increased to 1 mg twice daily. Once the patient has reached the optimal dose, once-daily administration may also be considered. As with symptomatic treatment, the appropriateness of continued use of this medicine should be evaluated. 3. Adjunctive treatment of mania associated with bipolar disorder ⦁ The recommended initial dose is 2 mg of this medicine once daily. Depending on the patient, the dose may be increased by 1 mg daily at intervals of 24 hours or longer. The optimal dose for most patients is within the range of 2∼6 mg daily. As with symptomatic treatment, the appropriateness of continued use of this medicine should be evaluated. Renal and hepatic impairment In patients with renal or hepatic impairment, administer half the initial and maintenance doses and adjust the dose more gradually. Use this medicine with caution in these patients (see section 5, “General Precautions”).

Child dose

Clinical experience in children and adolescents under 15 years of age is limited. Clinical experience in children and adolescents under 15 years of age is limited. Body weight 50 kg or more The initial dose is 0.5 mg of this medicine once daily. If necessary, the dose may be increased by 0.5 mg per day at intervals of at least 2 days, depending on the patient. For most patients, the optimal dose is 1 mg once daily. Depending on the patient, 0.5∼1.5 mg may be administered once daily. Body weight less than 50 kg The initial dose is 0.25 mg once daily. If necessary, the dose may be increased by 0.25 mg per day at intervals of at least 2 days, depending on the patient. For most patients, the optimal dose is 0.5 mg once daily. Depending on the patient, 0.25∼0.75 mg may be administered once daily. ⦁ Clinical experience in children under 5 years of age is limited.

Caution is needed when administering this drug to elderly dementia patients, as it may increase mortality rates. In particular, the concomitant use of this drug with certain diuretics may raise the risk of death, necessitating careful assessment of the risks and benefits before combination. Due to the risk of venous thrombosis, risk factors for thrombosis should be evaluated and preventive measures taken before and during the use of this drug. This drug should not be administered to patients with hypersensitivity to it, those in a comatose state, patients in a state of central nervous system depression, or those receiving epinephrine. Patients with cardiovascular diseases, liver or kidney dysfunction, suicidal risk, the elderly, and pregnant or nursing women should use this drug cautiously. This drug can cause various side effects, so any unusual symptoms should be discussed with a healthcare professional immediately. Special attention is required for tardive dyskinesia, neuroleptic malignant syndrome, orthostatic hypotension, blood sugar abnormalities, and weight gain. Caution should be taken as the combined use of this drug with substances that have central nervous system depressant effects, including alcohol, may enhance CNS depression. This drug may interact with various medications, so patients currently taking other medications must inform their healthcare provider. Women who are pregnant or nursing should only use this drug after consulting a specialist, as it may affect the fetus or newborn. Dosing adjustments and monitoring are necessary for children and the elderly, and in case of overdose, immediate emergency treatment should be sought. This drug should be stored out of reach of children and care should be taken not to transfer it to another container.

Candidiasis, upper respiratory tract infection, sinusitis, urinary tract infection, anemia, hypersensitivity, insomnia, anxiety, neurosensitivity, Parkinson's disease, akathisia, drowsiness, dizziness, sedation, tremor, muscle tension abnormality, hypersomnia, orthostatic dizziness, movement disorder, syncope, blurred vision, ear pain, orthostatic hypotension, tachycardia, hypotension, nasal congestion, dyspnea, epistaxis, sinus congestion, nausea, constipation, dyspepsia, vomiting, diarrhea, hypersalivation, dry mouth, abdominal discomfort, abdominal pain, gastrointestinal discomfort, epigastric pain, rash, dry skin, dandruff, seborrheic dermatitis, hyperkeratosis, back pain, joint pain, limb pain, urinary incontinence, ejaculatory dysfunction, fatigue, weakness, fever, chest pain, blood creatinine phosphokinase elevation, increased heart rate, urinary tract infection, pneumonia, soft tissue infection, decreased appetite, confusion, transient ischemic attack, altered consciousness, drooling, cerebrovascular accident, conjunctivitis, hypotension, cough, runny nose, difficulty swallowing, fecal mass, erythema, abnormal posture, joint swelling, peripheral edema, gait disturbance, pitting edema, elevated body temperature, upper respiratory tract infection, rhinitis, influenza, increased appetite, mid-sleep insomnia, lethargy, headache, stuttering, attention deficit, balance disorder, hypersomnia, palpitations, pharyngolaryngeal pain, pulmonary congestion, itching, acne, myalgia, neck pain, nocturia, frequent urination, galactorrhea, emotional disturbance, lethargy, chest discomfort, weight gain, elevated blood prolactin, anxiety, blunted affect, sleep disorder, decreased libido, sexual dysfunction, depression, nightmares, unresponsiveness to stimuli, abnormal cooperation, loss of consciousness, language disorder, sensory impairment, movement disorder, multifocal movement disorder, cerebral ischemia, cerebrovascular accident disorder, neuroleptic malignant syndrome, diabetic coma, head tremor, convulsions, psychomotor hyperactivity, delayed movement disorder, cerebrovascular disorder, sensory abnormalities, conjunctival injection, eye discharge, eye movement, eyelid edema, photophobia, eyelid crusting, dry eyes, increased tearing, glare, glaucoma, vision impairment, tinnitus, dizziness, bradycardia, tachycardia, palpitations, complete atrioventricular block, left bundle branch block, right bundle branch block, heart block, flushing, conduction disturbance, electrocardiogram abnormality, prolonged QT interval in ECG, venous thrombosis, bradycardia, wheezing, aspiration pneumonia, phonation disorder, wet cough, airway congestion, crackles, respiratory disturbance, nasal cavity swelling, hyperventilation, fecal incontinence, gastritis, lip swelling, cheilitis, salivary hyposecretion, distention, gastroenteritis, tongue swelling, toothache, skin discoloration, skin lesions, skin disorders, erythematous rash, papular rash, generalized rash, papulopustular rash, eczema, musculoskeletal chest pain, joint rigidity, muscle weakness, rhabdomyolysis, urination disorder, amenorrhea, gynecomastia, vaginal discharge, erectile dysfunction, ejaculatory disturbance, menstrual disorder, breast engorgement, sexual dysfunction, retrograde ejaculation, breast discharge, thirst, influenza-like syndrome, edema, malaise, facial edema, discomfort, general edema, chills, peripheral coldness, drug withdrawal syndrome, adverse drug reactions, decreased body temperature, procedure-related pain, weight loss, increased γ-GT, increased liver enzymes, urine glucose detection, chest pain, liver function abnormality, hepatitis, thirst, dry mouth, urinary retention, polyuria, pain, hiccups, increased sweating, urination disorder, leukopenia, arrhythmia, epistaxis, anemia, diarrhea, hangover, ocular movement seizures, acne, difficulty swallowing, enuresis, tic disorder, dyspnea, Rabbit syndrome, suicidal ideation, accident anomalies, delusions, hallucinations, exacerbation of auditory hallucination symptoms, agranulocytosis, thrombocytopenia, anaphylactic reaction, abnormal secretion of antidiuretic hormone, diabetic ketoacidosis, diabetes, hypoglycemia, water intoxication, increased serum cholesterol, increased serum triglycerides, mania, dysgeusia, intraoperative iris hypotension syndrome, atrial fibrillation, deep vein thrombosis, pulmonary embolism, sleep apnea syndrome, intestinal obstruction, pancreatitis, jaundice, vascular edema, alopecia, neonatal drug withdrawal syndrome, urinary retention, priapism, hypothermia, prolonged QT in ECG

This medication should be stored in a tightly closed container to protect it from air and moisture. It is recommended to maintain the storage temperature between 1 and 30 degrees Celsius.

Appearance

Yellow film-coated oblong tablet

Package unit

30 tablets/bottle, 200 tablets/bottle