Elperidone 1 mg Tablet (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

1. Schizophrenia: Clinical experience in children and adolescents under 15 years of age is limited. 3. Adjunctive therapy for manic episodes in bipolar disorder: Clinical experience in children and adolescents under 15 years of age is limited. 4. Conduct disorder and other disruptive behavior disorders — 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. 4. Conduct disorder and other disruptive behavior disorders — 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. 4. Conduct disorder and other disruptive behavior disorders: Clinical experience in children under 5 years of age is limited.

Caution should be especially exercised when using this drug in elderly dementia patients as it may increase mortality. The risk of death may be higher when this drug is administered with a specific diuretic, furosemide, in elderly dementia patients; therefore, the risks and benefits should be carefully considered before concomitant use. There is a risk of venous thromboembolism, so risk factors for thrombosis should be checked and preventive measures taken before and during use of this medication. It should not be used in patients with allergies to this drug or its components, patients whose central nervous system is inhibited by alcohol or central nervous system depressants, patients in a comatose state, patients receiving epinephrine, and patients with genetic issues such as lactose intolerance. It should be administered cautiously in patients with heart disease, dehydration, liver or kidney dysfunction, history of seizures, suicidal risk, Parkinson's disease or Lewy body dementia, diabetes, elderly patients, and women who are pregnant or breastfeeding. This drug can cause various side effects such as drowsiness, dizziness, orthostatic hypotension, insomnia, anxiety, muscle rigidity, and extrapyramidal symptoms, and patients should consult a doctor immediately if abnormal symptoms occur. Although rare, severe side effects such as serious blood disorders, allergic reactions, cardiac arrhythmia, liver dysfunction, and deep vein thrombosis may occur, and caution is advisable. This medication may enhance central nervous system depressant effects when taken with other central nervous system depressants or alcohol, so caution is required when taking them together. Furthermore, there may be interactions with specific antihypertensive agents, antidepressants, antifungals, anticonvulsants, etc., so it is essential to inform healthcare providers of all medications being taken. If this drug is taken during pregnancy, there is a risk of extrapyramidal symptoms or withdrawal symptoms in the newborn; thus, the decision to take it should be made after consulting a doctor if pregnancy is possible or if the patient is pregnant. It is recommended to discontinue breastfeeding while taking this drug, as it is secreted in breast milk. During the use of this drug, metabolic changes such as weight gain and elevated blood sugar may occur, so regular monitoring is necessary. In cases of overdose, symptoms such as drowsiness, hypotension, heart arrhythmia, and seizures may appear; immediate emergency treatment is required, as there is no antidote for this drug, making symptomatic support essential. This medication should be stored out of reach of children and should not be transferred to another container for safety.

Increased mortality, cerebrovascular adverse reactions, venous thromboembolism, nasopharyngitis, upper respiratory tract infections, sinusitis, urinary tract infections, anemia, hypersensitivity reactions, insomnia, anxiety, nervousness, Parkinsonism, akathisia, drowsiness, dizziness, sedation, tremors, muscle tone abnormalities, somnolence, orthostatic dizziness, movement disorders, syncope, blurred vision, ear pain, orthostatic hypotension, tachycardia, hypotension, nasal congestion, dyspnea, nosebleeds, sinus congestion, nausea, constipation, dyspepsia, vomiting, diarrhea, excessive salivation, dry mouth, abdominal discomfort, abdominal pain, gastric discomfort, upper abdominal pain, rash, dry skin, dandruff, seborrheic dermatitis, hyperkeratosis, back pain, arthralgia, limb pain, urinary incontinence, erectile dysfunction, fatigue, asthenia, fever, chest pain, elevated blood creatinine phosphokinase, increased heart rate, pneumonia, soft tissue infections, decreased appetite, confusion, transient ischemic attack, altered consciousness, drooling, cerebrovascular accident, conjunctivitis, cough, runny nose, difficulty swallowing, stool impaction, erythema, abnormal posture, joint swelling, peripheral edema, gait disturbance, pitting edema, elevated body temperature, rhinitis, influenza, increased appetite, moderate insomnia, fatigue, headache, stuttering, attention deficit, balance disorders, hypersomnia, palpitations, oropharyngeal pain, pulmonary congestion, itching, acne, myalgia, neck pain, nocturia, frequent urination, hyperlactation, emotional disturbances, lethargy, chest discomfort, elevated blood prolactin, restlessness, blunted affect, sleep disorders, decreased libido, sexual dysfunction, depression, nightmares, unresponsiveness to stimuli, coordination disorders, loss of consciousness, language disorders, sensory loss, motor disorders, tardive dyskinesia, cerebral ischemia, cerebrovascular accident impairments, neuroleptic malignant syndrome, diabetic coma, head tremors, seizures, excessive psychomotor activity, delayed motor abnormalities, cerebrovascular disorders, sensory abnormalities, conjunctival hyperemia, eye discharge, eye movement, eyelid edema, photophobia, eyelid crust, dry eyes, increased tearing, glare, glaucoma, decreased vision, tinnitus, vertigo, bradycardia, tachycardia, palpitations, I degree AV block, left bundle branch block, right bundle branch block, AV block, flushing, conduction disorders, abnormal electrocardiogram, prolonged QT interval on electrocardiogram, deep vein thrombosis, bradycardia, wheezing, aspiration pneumonia, vocal disturbances, moist cough, airway congestion, rales, respiratory distress, nasal mucosal swelling, hyperventilation, fecal incontinence, gastritis, lip swelling, cheilitis, sialadenosis, bloating, gastroenteritis, tongue swelling, toothache, skin discoloration, skin lesions, skin disorders, erythematous rash, papular rash, generalized rash, papulopustular rash, eczema, musculoskeletal chest pain, joint stiffness, muscular weakness, rhabdomyolysis, urination disorders, amenorrhea, gynecomastia, vaginal discharge, erectile dysfunction, ejaculation disorders, menstrual disorders, breast engorgement, sexual dysfunction, retrograde ejaculation, breast discharge, thirst, influenza-like syndrome, edema, malaise, facial swelling, discomfort, generalized edema, chills, peripheral coldness, drug withdrawal syndrome, drug adverse reactions, decreased body temperature, procedural-related pain, elevated ALT, abnormal electrocardiogram, eosinophilia, elevated AST, leukopenia, elevated blood glucose, decreased hemoglobin, decreased hematocrit, hypothermia, hypotension, elevated transaminases, elevated gamma-glutamyl transferase, increased liver enzymes, falls, agranulocytosis, thrombocytopenia, abnormal secretion of anti-diuretic 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, bowel obstruction, pancreatitis, jaundice, vascular edema, alopecia, neonatal drug withdrawal syndrome, urinary retention, persistent erection, hypothermia, chest pain, abnormal liver function, hepatitis, dry mouth, oral dryness, urinary retention, polyuria, hiccups, leukopenia, arrhythmia, hangover, oculomotor seizures, tic disorders, respiratory distress, suicide attempts, accidental differences, delusions, hallucinations, worsening of auditory hallucinations, extrapyramidal symptoms, delayed movement abnormalities, neuroleptic malignant syndrome, confusion, insensitivity, postural instability, frequent falls, hyperglycemia, worsening of diabetes, weight gain, orthostatic hypotension, syncope, decreased core body temperature, drug withdrawal syndrome, drug adverse reactions, falls

This medication may be sensitive to air and moisture, so it should be stored in a sealed container. Additionally, it should be kept away from very hot or very cold places, ideally stored at room temperature between 1 and 30 degrees Celsius.

Appearance

Oblong white film-coated tablets

Package unit

30 tablets/bottle, 200 tablets/bottle