Risdone Tablets 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. 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 has been observed with doses of 10 mg or more per day compared with lower doses, and the risk of extrapyramidal symptoms may increase. Doses of 10 mg or more per day should be administered only when the benefits for 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 · 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. 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 other antipsychotic medicines to this medicine When medically appropriate, start this medicine while gradually reducing the dose of the previous medicine. Also, when switching from a depot antipsychotic medicine, if medically appropriate, start this medicine in place of the next scheduled depot injection. The need to continue concomitant antiparkinsonian medicines 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 needed, increase the dose 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 reaches the optimal dose, once-daily administration may also be considered. As with symptomatic treatment, the rationale for continued use of this medicine should be evaluated. 3. Adjunctive treatment of mania 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 1 mg per day at intervals of 24 hours or more. The optimal dose for most patients is in the range of 2∼6 mg per day. As with symptomatic treatment, the rationale for 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 treatment of mania 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 needed, the dose may be increased by 0.5 mg per day at intervals of at least 2 days, depending on the patient. 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 needed, the dose may be increased by 0.25 mg per day at intervals of at least 2 days, depending on the patient. 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 may increase the mortality rate when administered to elderly dementia patients, so special caution is required. Among elderly dementia patients, the risk of death may be higher, especially when used in combination with certain diuretics such as furosemide; therefore, the risks and benefits should be carefully considered before concomitant use. Additionally, there may be an increased risk of venous thromboembolism, so thromboembolic risk factors must be assessed and preventative measures taken before and during administration. Patients with hypersensitivity to this medication, those with central nervous system depression due to alcohol or CNS depressants, those in a comatose state, patients receiving epinephrine, and patients with genetic issues such as lactose intolerance should not use this medication. Patients with heart disease, liver or kidney dysfunction, seizure history, suicide risk, diabetes, elderly patients, and pregnant or nursing women should be closely monitored and dosage adjustments may be necessary. This medication can cause various adverse reactions, with common symptoms including sedation, dizziness, insomnia, anxiety, Parkinsonian symptoms, gastrointestinal symptoms, and weight gain; if such symptoms occur, it is advisable to consult a healthcare professional. Furthermore, caution should be exercised when used with other CNS depressants or alcohol, and when used in combination with certain antihypertensives or drugs that prolong the QT interval. Use of this medication during pregnancy may affect the fetus, and it should only be administered when necessary. If breastfeeding, discontinuation of breastfeeding is recommended. It is advisable to avoid activities requiring mental concentration, such as driving or operating machinery, while taking this medication. In case of overdose, contact a medical institution immediately for proper emergency treatment, and store this medication safely out of reach of children.

Increased mortality, cerebrovascular adverse reactions, venous thromboembolism, rhinitis, upper respiratory tract infection, sinusitis, urinary tract infection, anemia, hypersensitivity reactions, insomnia, anxiety, nerve irritability, Parkinson's disease, akathisia, drowsiness, dizziness, sedation, tremors, muscle spasms, hypersomnia, postural dizziness, movement disorders, fainting, blurred vision, ear pain, orthostatic hypotension, tachycardia, hypotension, nasal congestion, dyspnea, epistaxis, 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, joint pain, limb pain, urinary incontinence, erectile dysfunction, fatigue, asthenia, fever, chest pain, increased serum creatinine phosphokinase, increased heart rate, pneumonia, soft tissue infection, decreased appetite, confusion, transient ischemic attack, altered consciousness, drooling, cerebrovascular accident, conjunctivitis, cough, runny nose, dysphagia, fecal impaction, erythema, abnormal posture, joint swelling, peripheral edema, gait disturbance, dependent edema, increased body temperature, rhinitis, influenza, increased appetite, middle insomnia, lethargy, headache, stuttering, attention impairment, balance disorder, excessive sleep, palpitations, pharyngolaryngeal pain, pulmonary congestion, itching, acne, myalgia, neck pain, nocturnal enuresis, increased frequency of urination, hyperprolactinemia, emotional disturbances, lethargy, chest discomfort, weight gain, increased serum prolactin, anxiety, blunted affect, sleep disturbance, decreased libido, sexual dysfunction, depression, nightmares, non-responsiveness to stimuli, cooperative abnormalities, loss of consciousness, speech disorders, sensory impairment, motor disorders, paroxysmal movement disorders, cerebral ischemia, cerebrovascular accident disorder, neuroleptic malignant syndrome, diabetic coma, head tremors, seizures, psychomotor agitation, delayed motor disorders, cerebrovascular disorders, sensory abnormalities, eye congestion, eye discharge, eye movement, eyelid edema, photophobia, crust on eyelids, dry eyes, increased tearing, glare, glaucoma, decreased vision, tinnitus, dizziness, bradycardia, sinus bradycardia, palpitations, I-degree atrioventricular block, left bundle branch block, right bundle branch block, heart block, flushing, conduction disorders, ECG abnormalities, prolonged QT interval on ECG, pulmonary embolism, hypopnea, thickened sputum, vocal cord disorders, wet cough, airway congestion, rales, respiratory distress, nasal cavity swelling, hyperventilation, fecal incontinence, gastritis, lip swelling, cheilitis, salivary gland deficiency, distension, enteritis, 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 disorders, amenorrhea, gynecomastia, vaginal discharge, erectile dysfunction, ejaculation disorders, menstrual disorders, breast engorgement, sexual dysfunction, retrograde ejaculation, breast discharge, thirst, influenza-like syndrome, edema, lethargy, facial swelling, discomfort, generalized edema, chills, peripheral coldness, drug withdrawal syndrome, adverse drug reactions, decreased body temperature, procedure-related pain, increased ALT, ECG abnormalities, eosinophilia, increased AST, leukopenia, increased blood sugar, decreased hemoglobin, decreased hematocrit, decreased body temperature, decreased blood pressure, increased transaminases, increased gamma-glutamyl transferase, increased liver enzymes, agranulocytosis, thrombocytopenia, abnormal secretion of antidiuretic hormone, diabetic ketoacidosis, diabetes, hypoglycemia, water intoxication, thromboembolism, pulmonary embolism, atrial fibrillation, sleep apnea syndrome, intestinal obstruction, pancreatitis, jaundice, vascular edema, hair loss, neonatal drug withdrawal syndrome, urinary retention, priapism, hypothermia, prolonged QT on ECG, chest pain, liver dysfunction, hepatitis, dry mouth, xerostomia, urinary retention, polyuria, hiccups, increased sweating, leukopenia, arrhythmia, hangover, ocular movement seizures, tic disorders, respiratory distress, Rabbit syndrome, suicidal ideation, abnormal thoughts, delusions, hallucinations, worsening of auditory hallucinations, delayed abnormal movement, neuroleptic malignant syndrome, confusion, insensitivity, postural instability, falls, priapism, orthostatic hypotension, syncope, hyperthermia, muscular rigidity, autonomic instability, consciousness disorders, increased serum creatine phosphokinase, myoglobinuria, acute renal failure, anxiety, insomnia, akathisia, movement disorders, muscle rigidity, Parkinson's disease, hypertension, musculoskeletal pain, gait abnormality, edema, pain, falls

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

Appearance

Yellow oval film-coated tablet

Package unit

30 tablets/bottle, 200 tablets/bottle