Elperidon 2 mg Tablets (Risperidone)

Adult dose

The therapeutic dose of this medicine should be adjusted according to the patient's clinical condition, and the lowest effective dose possible should be administered. 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 as appropriate according to age and symptoms. (3) No additional benefit was observed with doses of 10 mg or more per day compared with lower doses, and such doses may increase the risk of extrapyramidal symptoms. Doses of 10 mg or more per day should be administered only when the benefits to the individual patient are considered to outweigh the risks. (4) Do not administer doses of 16 mg or more per day, as safety has not been established. (5) A benzodiazepine may be administered concomitantly if additional sedation is needed. 2) Administration in special populations ⦁ Elderly patients 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 a dose of 1～2 mg twice daily is reached. In general, increases to doses of 1.5 mg or more twice daily should be made at intervals of at least 1 week. 3) Switching from another antipsychotic to this medicine When medically appropriate, start treatment with this medicine while gradually reducing the dose of the previous medicine. Also, when medically appropriate, when switching from a depot antipsychotic, start this medicine in place of the next scheduled injection of the depot preparation. The need to continue concomitant antiparkinsonian medication should be reassessed regularly. 2. Agitation, aggression, or psychotic symptoms in patients with dementia of the Alzheimer's type The initial dose is 0.25 mg of this medicine twice daily. If necessary, the dose may be increased by 0.25 mg twice daily at intervals of at least 2 days, depending on the patient. The optimal dose for most patients is 0.5 mg twice daily, but the dose may be increased to 1 mg twice daily depending on the patient. 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 therapy for manic episodes in bipolar disorder ⦁ The recommended initial dose is 2 mg of this medicine once daily. Depending on the patient, the dose may be increased by up to 1 mg per day at intervals of 24 hours or longer. The optimal dose for most patients is in the range of 2∼6 mg per day. 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 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.

This drug should be used with caution in elderly dementia patients as it may increase mortality. Particularly, when used in conjunction with certain diuretics, the risk of death may be higher, so the combination should be decided carefully. There is a risk of developing venous thromboembolism, so factors contributing to thrombus risk should be assessed before using this drug and preventative measures should be taken if necessary. This drug should not be used in patients with hypersensitivity to it, those in a state of central nervous system depression, coma patients, or patients receiving epinephrine. Patients with lactose intolerance or genetic lactose metabolism disorders should also not take this drug. In patients with heart disease, dehydration, reduced blood volume, or cerebrovascular diseases, orthostatic hypotension may occur, so doses should be adjusted slowly and administered with caution. Patients with arrhythmias or a risk of QT interval prolongation, as well as those with a history of seizures, should be careful. Dosing should be reduced and gradually increased for patients with liver or kidney function impairment due to reduced drug excretion and metabolism capabilities. Caution should be exercised when using this drug in patients at risk for suicide, or those with Parkinson’s disease or Lewy body dementia as it may worsen symptoms. Diabetic patients or those with risk factors for hyperglycemia should monitor blood sugar changes closely. Pregnant women or those who may become pregnant, as well as nursing mothers, should use this drug only when absolutely necessary, considering its effects on the fetus or newborn. This drug may have various adverse effects, so if any uncomfortable symptoms occur during use, immediate consultation with medical personnel is necessary. This drug may enhance the central nervous system depressant effect when used with other central nervous system depressants or alcohol, so caution is needed. Additionally, it may interact with drugs involving liver enzymes that metabolize drugs, so it is essential to inform medical personnel about any other medications being taken. This drug may impair concentration, so initially, it is advisable to avoid driving or operating machinery. In cases of overdose, severe drowsiness, hypotension, arrhythmias, and seizures may occur, requiring immediate emergency treatment. This drug should be stored out of reach of children, and it is safe not to change the packaging container.

Increased mortality, cerebrovascular adverse reactions, venous thrombosis, hypersensitivity, central nervous system depression, orthostatic hypotension, hypotension, insomnia, anxiety, nervousness, Parkinsonism, akathisia, drowsiness, dizziness, sedation, tremor, muscle rigidity, somnolence, positional dizziness, movement disorders, syncope, blurred vision, ear pain, tachycardia, nasal congestion, dyspnea, nosebleed, sinus congestion, nausea, constipation, dyspepsia, vomiting, diarrhea, excessive salivation, dry mouth, abdominal discomfort, abdominal pain, gastrointestinal discomfort, epigastric pain, rash, dry skin, dandruff, seborrheic dermatitis, hyperkeratosis, back pain, arthralgia, limb pain, urinary incontinence, ejaculatory dysfunction, fatigue, weakness, fever, chest pain, urinary tract infection, pneumonia, soft tissue infection, decreased appetite, confusion, transient ischemic attack, decreased consciousness, drooling, cerebrovascular accident, conjunctivitis, cough, runny nose, dysphagia, fecal impaction, erythema, abnormal posture, joint swelling, peripheral edema, gait disturbance, pitting edema, increased body temperature, upper respiratory infection, rhinitis, influenza, increased appetite, intermediate insomnia, lethargy, headache, stuttering, attention disorder, excessive sleep, palpitation, oropharyngeal pain, pulmonary congestion, itching, acne, myalgia, neck pain, nocturia, frequent urination, galactorrhea, emotional disturbances, lethargy, chest discomfort, increased serum creatinine phosphokinase, increased heart rate, restlessness, blunted affect, sleep disturbances, decreased libido, anhedonia, depression, nightmares, unresponsiveness to stimuli, abnormal cooperation, loss of consciousness, speech disorders, sensory loss, motor dysfunction, generalized motor dyskinesia, cerebral ischemia, cerebrovascular accident disorders, neuroleptic malignant syndrome, diabetic coma, head tremors, seizures, psychomotor hyperactivity, tardive dyskinesia, cerebrovascular disorders, sensory disturbances, eye congestion, eye discharge, eye movement, eyelid edema, photophobia, eyelid crust, dry eyes, increased tearing, glare, glaucoma, decreased vision, tinnitus, vertigo, bradycardia, sinus tachycardia, palpitations, I-degree atrioventricular block, left bundle branch block, right bundle branch block, heart block, flushing, conduction disturbances, abnormal electrocardiogram, prolonged QT interval on electrocardiogram, sinus vein, bradycardia, wheezing, aspiration pneumonia, voice disorders, productive cough, airway obstruction, crackles, respiratory difficulties, nasal cavity edema, hyperventilation, fecal incontinence, gastritis, lip swelling, cheilitis, salivary gland deficiency, abdominal distension, gastroenteritis, tongue swelling, toothache, skin discoloration, skin lesions, skin disorders, erythematous rash, papular rash, generalized rash, annular papular rash, eczema, musculoskeletal chest pain, joint stiffness, muscle weakness, rhabdomyolysis, urinary dysfunction, amenorrhea, gynecomastia, vaginal secretions, erectile dysfunction, ejaculatory disorders, menstrual disorders, breast engorgement, sexual dysfunction, retrograde ejaculation, breast discharge, thirst, influenza-like syndrome, edema, malaise, facial edema, discomfort, generalized edema, chills, peripheral coldness, drug withdrawal syndrome, adverse drug reactions, decreased body temperature, procedure-related pain, elevated ALT, abnormal electrocardiogram, increased eosinophil count, elevated AST, decreased white blood cell count, increased blood glucose, decreased hemoglobin, decreased hematocrit, hypothermia, decreased blood pressure, increased transaminase, elevated gamma-glutamyl transferase, increased liver enzymes, agranulocytosis, thrombocytopenia, abnormal secretion of antidiuretic hormone, diabetic ketoacidosis, diabetes mellitus, 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 interval on electrocardiogram, chest pain, liver dysfunction, hepatitis, thirst, dry mouth, urinary retention, polyuria, pain, hiccups, increased sweating, urinary difficulties, leukopenia, arrhythmia, nosebleed, anemia, diarrhea, hangover, ocular motor seizures, acne, dysphagia, enuresis, tic disorder, respiratory difficulty, suicide attempt, abnormal behavior, delusions, hallucinations, exacerbation of symptoms, falls, priapism, angioedema, acquired deficiency of C1 esterase, periorbital edema, facial edema, laryngeal edema, laryngeal tracheal edema, eye breathing syndrome, oral edema, orbital periosteal edema, small intestinal vascular edema, tongue swelling

This drug may be sensitive to air or moisture, so it must be stored in a tightly closed container. The storage temperature should be at room temperature between 1 to 30 degrees Celsius. This will help maintain the drug's effectiveness for a longer period.

Appearance

Oblong light orange film-coated tablets

Package unit

30 tablets/bottle, 200 tablets/bottle