Risdon 1 mg Tablet (Risperidone)

Adult dose

The therapeutic dose of this drug should be adjusted according to the patient's clinical condition, and the minimum effective dose should be used whenever possible. 1. Schizophrenia 1) Adults (1) Initial dose: Administer 1 mg of risperidone orally per dose twice daily and increase gradually. (2) Maintenance dose: Administer 1∼3 mg per dose twice daily. Adjust the dose as appropriate according to age and symptoms. (3) No additional effect has been 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 benefits to the individual patient are judged to outweigh the risks. (4) Do not administer doses exceeding 16 mg daily, 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 per dose twice daily. Depending on the patient's condition, increase by 0.5 mg per dose twice daily until a dose of 1～2 mg per dose twice daily is reached. In general, increases to doses of 1.5 mg or more per dose twice daily should be made at intervals of at least 1 week. 3) Switching from an existing antipsychotic to this drug When medically appropriate, start this drug while gradually reducing the dose of the existing medication. Also, when switching from an existing depot antipsychotic, when medically appropriate, start this drug in place of the next scheduled depot injection. Regularly reassess whether concomitant antiparkinsonian medication needs to be continued. 2. Agitation, aggression, or psychotic symptoms in patients with dementia of the Alzheimer type The initial dose is 0.25 mg of this drug per dose twice daily. If necessary, depending on the patient, the dose may be increased by 0.25 mg per dose twice daily at intervals of at least 2 days. The optimal dose for most patients is 0.5 mg per dose twice daily, but depending on the patient, the dose may be increased to 1 mg per dose twice daily. Once the patient reaches the optimal dose, once-daily administration may also be considered. As with symptomatic treatment, the appropriateness of continued use of this drug should be evaluated.. 3. Adjunctive therapy for manic episodes of bipolar disorder • The recommended initial dose is 2 mg of this drug once daily. Depending on the patient, the dose may be increased by 1 mg daily at intervals of at least 24 hours. The optimal dose for most patients is in the range of 2∼6 mg daily. As with symptomatic treatment, the appropriateness of continued use of this drug should be evaluated. 4. Conduct disorder and other disruptive behavior disorders As with symptomatic treatment, the appropriateness of continued use of this drug should be evaluated. Renal and hepatic impairment For patients with renal or hepatic impairment, administer half the initial and maintenance doses and adjust the dose more gradually. Use this drug 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 drug once daily. If necessary, depending on the patient, the dose may be increased by 0.5 mg daily at intervals of at least 2 days. The optimal dose for most patients is 1 mg once daily. Depending on the patient, 0.5∼1.5 mg may be administered once daily. - Body weight under 50 kg The initial dose is 0.25 mg once daily. If necessary, depending on the patient, the dose may be increased by 0.25 mg daily at intervals of at least 2 days. The optimal dose for most patients 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 medication can increase mortality when administered to elderly dementia patients, so caution is essential. In particular, the concomitant use with furosemide may further increase the risk of death; therefore, careful consideration of risks and benefits before co-administration is required. This medication may increase the risk of venous thromboembolism, so risk factors for thrombosis should be assessed and preventive measures taken before and during treatment. Patients with allergies to this medication or its components, patients with central nervous system depression due to alcohol or central nervous system depressants, patients in a coma, patients receiving epinephrine, and patients with specific genetic disorders such as lactose intolerance should not take this medication. Special caution is required for patients with cardiovascular disease or dehydration, patients with a history of arrhythmia or risk of QT interval prolongation, patients with a history of seizures, patients with liver or kidney dysfunction, patients at risk of suicide, patients with Parkinson's disease or Lewy body dementia, diabetic patients, elderly patients, and women who are pregnant or nursing. This medication can cause adverse neurological reactions such as drowsiness, dizziness, hypotension, insomnia, anxiety, and Parkinsonian symptoms, and especially in elderly dementia patients, side effects such as urinary tract infections, pneumonia, and confusion may occur more frequently. Additionally, this drug may induce serious side effects such as weight gain, hyperglycemia, worsening of diabetes, leukopenia, and agranulocytosis; therefore, regular monitoring of health status is necessary during use. This medication may enhance central nervous system depressive effects when taken with other central nervous system depressants or alcohol, so caution is needed when co-administered. Furthermore, certain medications may interact and alter the blood concentration of this drug; thus, it is crucial to inform healthcare professionals if other medications are being taken. Women who are pregnant or nursing should consult a doctor before taking this medication as it may cause side effects in the fetus or newborn. Experience with this drug in children or adolescents is limited; therefore, careful judgment is needed, and in older adults, the dosage should be adjusted considering the possibility of renal impairment. In cases of overdose, serious side effects may occur, and immediate medical attention is required. This medication should be kept out of reach of children and should not be transferred to other containers for safety.

Increased mortality, cerebrovascular adverse reactions, venous thrombosis, rhinitis, upper respiratory infections, sinusitis, urinary tract infections, anemia, hypersensitivity reactions, insomnia, anxiety, irritability, Parkinsonism, akathisia, drowsiness, dizziness, sedation, tremors, muscle rigidity, hypersomnia, orthostatic dizziness, dyskinesia, syncope, blurred vision, ear pain, orthostatic hypotension, tachycardia, hypotension, nasal congestion, dyspnea, nosebleeds, sinus congestion, nausea, constipation, indigestion, 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 failure, fatigue, asthenia, fever, chest pain, elevated blood creatinine phosphokinase, increased heart rate, pneumonia, soft tissue infection, decreased appetite, confusion, transient ischemic attack, altered consciousness, drooling, cerebrovascular accident, conjunctivitis, cough, runny nose, difficulty swallowing, stool mass, erythema, abnormal posture, joint swelling, peripheral edema, gait disturbances, pitting edema, elevated body temperature, rhinitis, influenza, increased appetite, middle insomnia, lassitude, headache, stuttering, attention deficit, balance disorders, excessive sleep, palpitations, oropharyngeal pain, pulmonary congestion, itching, acne, myalgia, neck pain, nocturia, pollakiuria, galactorrhea, emotional disturbances, lethargy, chest discomfort, anxiety, blunted affect, sleep disturbances, decreased libido, sexual dysfunction, depression, nightmares, unresponsive to stimuli, disturbance in cooperation, loss of consciousness, speech disorders, sensory impairment, movement disorders, multifocal dyskinesia, cerebral ischemia, cerebrovascular accident disorders, neuroleptic malignant syndrome, diabetic coma, head tremors, seizures, psychomotor agitation, delayed dyskinesia, cerebrovascular disorders, sensory disturbances, conjunctival injection, ocular discharge, eye movement, eyelid edema, photophobia, crusting of eyelid margins, dry eyes, increased tearing, glare, glaucoma, decreased vision, tinnitus, dizziness, pulse deficit, bradycardia, palpitations, atrioventricular block I, left bundle branch block, right bundle branch block, heart block, flushing, conduction disorder, ECG abnormalities, prolonged QT interval in ECG, distal venous problems, bradycardia, wheezing, aspiration pneumonia, phonation disorders, wet cough, airway swelling, crackles, respiratory difficulties, nasal cavity swelling, hyperventilation, fecal incontinence, gastritis, lip swelling, cheilitis, salivary deficiency, abdominal distension, enteritis, tongue swelling, toothache, skin discoloration, skin lesions, skin disorders, erythematous rashes, papular rash, generalized rash, papulovesicular rash, eczema, musculoskeletal chest pain, joint stiffness, muscle weakness, rhabdomyolysis, urination disorders, amenorrhea, gynecomastia, vaginal discharge, erectile dysfunction, ejaculatory disorders, menstrual disorders, breast engorgement, sexual dysfunction, retrograde ejaculation, breast discharge, thirst, influenza-like syndrome, edema, fatigue, facial swelling, discomfort, systemic edema, chills, peripheral coldness, drug withdrawal syndrome, adverse drug reactions, hypothermia, procedure-related pain, elevated ALT, ECG abnormalities, eosinophilia, elevated AST, leukopenia, increased blood sugar, decreased hemoglobin, decreased hematocrit, hypothermia, hypotension, increased transaminases, elevated γ-glutamyl transferase, increased liver enzymes, agranulocytosis, thrombocytopenia, anaphylactic reactions, abnormal antidiuretic hormone secretion, diabetic ketoacidosis, diabetes, hypoglycemia, water intoxication, increased cholesterol levels, increased triglyceride levels, mania, dysgeusia, intraoperative iris tension decrease syndrome, atrial fibrillation, deep venous thrombosis, pulmonary embolism, sleep apnea syndrome, bowel obstruction, pancreatitis, jaundice, vascular edema, hair loss, neonatal drug withdrawal syndrome, urinary retention, priapism, hypothermia, prolonged QT interval, chest pain, abnormal liver function, hepatitis, thirst, dry mouth, urinary retention, polyuria, pain, hiccups, increased sweating, urination disorders, leukopenia, arrhythmia, nosebleeds, anemia, diarrhea, hangover, ocular movement seizures, acne, difficulty swallowing, nocturnal enuresis, tic disorders, dyspnea, suicidal ideation, abnormal thoughts, delusions, hallucinations, exacerbation of auditory hallucinations, falls, priapism, hypothermia

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. The recommended storage temperature is room temperature between 1°C and 30°C. This will help maintain the medication's effectiveness and allow safe use.

Appearance

Oblong white film-coated tablet

Package unit

30 tablets/bottle, 200 tablets/bottle