Uniperidone 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 should be used whenever possible. Place this medicine on the tongue and, once it disintegrates within a few seconds, swallow it with or without water (orally disintegrating tablet only). 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 at doses above 10 mg/day compared with lower doses, and the risk of extrapyramidal symptoms may increase. Doses above 10 mg/day should be used only when the benefits for the individual patient are judged to outweigh the risks. (4) Do not administer doses above 16 mg/day because safety has not been established. (5) A benzodiazepine may be administered concomitantly if additional sedation is needed. 2) Dosing in specific 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 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, initiate this medicine while gradually reducing the dose of the previous medication. When switching from a depot antipsychotic, when medically appropriate, initiate this medicine in place of the next scheduled depot injection. The need to continue concomitant antiparkinsonian medication should be reassessed regularly. 2. Agitation, aggression, or psychotic symptoms in patients with dementia of the Alzheimer type The initial dose of this medicine is 0.25 mg 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, although the dose may be increased to 1 mg twice daily in some patients. 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 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 up to 1 mg/day at intervals of 24 hours or more. The optimal dose for most patients is within the range of 2–6 mg/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

Schizophrenia: Clinical experience in children and adolescents under 15 years of age is limited. Adjunctive therapy for mania associated with bipolar disorder: Clinical experience in children and adolescents under 15 years of age is limited. Disruptive behavior disorder and other disruptive behavior disorders, body weight 50 kg or more: The initial dose of this medicine is 0.5 mg once daily. If needed, depending on the patient, the dose may be increased by 0.5 mg/day 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. Disruptive behavior disorder and other disruptive behavior disorders, body weight under 50 kg: The initial dose is 0.25 mg once daily. If needed, depending on the patient, the dose may be increased by 0.25 mg/day 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. Disruptive behavior disorder and other disruptive behavior disorders: As with symptomatic treatment, the appropriateness of continued use of this medicine should be evaluated. Disruptive behavior disorder and other disruptive behavior disorders: Clinical experience in children under 5 years of age is limited.

This medication may increase mortality in elderly dementia patients, thus caution is required. Particular care should be taken when using this medication with specific diuretics such as furosemide, as the risk of death may be increased; therefore, the risks and benefits should be carefully assessed before concomitant administration. Care should be taken to avoid dehydration during treatment, as the risk of cerebrovascular adverse reactions may increase. The risk of venous thrombosis may also be present, hence thrombotic risk factors should be checked prior to use, and preventive measures should be taken. Patients with phenylketonuria should inform their physician before taking this medication since the artificial sweetener aspartame contained in this medication is metabolized into phenylalanine, and precautions should be exercised not to exceed the daily permissible amount of aspartame. This medication should not be administered to patients with a known allergy to this medication or its components, patients with central nervous system depression due to alcohol or central nervous system depressants, patients in a coma, or those receiving epinephrine. Patients with cardiovascular diseases or a history of arrhythmia, liver or kidney dysfunction, suicidal risks, Parkinson's disease or Lewy body dementia, diabetes, elderly patients, and pregnant or breastfeeding women should use this medication with caution. Patients may experience side effects such as drowsiness, dizziness, hypotension, orthostatic hypotension, weight gain, and hyperglycemia during treatment, and if these symptoms occur, consulting a physician is advised. Since this medication has central nervous system depressant effects, caution should be exercised if taken with alcohol or other central nervous system depressants, as symptoms may worsen. If pregnant or breastfeeding, consultation with a physician prior to taking this medication is a must, as it may affect the fetus or newborn; especially when breastfeeding, cessation of breastfeeding is recommended. In cases of overdose, symptoms such as drowsiness, hypotension, cardiac arrhythmias, and seizures may occur, necessitating immediate medical attention for appropriate treatment. This medication should be stored out of the reach of children and not be opened or tablets cut arbitrarily. Additionally, it should not be mixed with tea or cola, and care should be taken when mixing the solution with black tea, as sediment may occur.

Increased mortality rate, stroke, transient ischemic attack, venous thrombosis, nasopharyngitis, upper respiratory infection, sinusitis, urinary tract infection, anemia, hypersensitivity reaction, insomnia, anxiety, nervousness, Parkinsonism, akathisia, drowsiness, dizziness, sedation, tremors, muscle hypertonia, somnolence, orthostatic dizziness, dyskinesia, syncope, blurred vision, ear pain, orthostatic hypotension, tachycardia, hypotension, nasal congestion, dyspnea, epistaxis, nasal 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, erectile dysfunction, fatigue, weakness, fever, chest pain, increased blood creatinine phosphokinase, increased heart rate, urinary tract infection, pneumonia, soft tissue infection, decreased appetite, confusional state, transient ischemic attack, impaired consciousness, drooling, cerebrovascular accident, conjunctivitis, hypotension, cough, runny nose, dysphagia, fecal impaction, erythema, abnormal posture, joint swelling, peripheral edema, gait disturbance, pitting edema, elevated body temperature, upper respiratory infection, rhinitis, influenza, increased appetite, middle insomnia, lethargy, headache, stuttering, attention deficit, balance disorder, hypersomnia, palpitations, oropharyngeal pain, pulmonary congestion, itching, acne, myalgia, neck pain, nocturia, frequency of urination, galactorrhea, mood disorder, lethargy, chest discomfort, anxiety, akathisia, dyskinesia, dystonia, hypertension, musculoskeletal pain, gait abnormality, edema, pain, falls, ear infection, viral infection, pharyngitis, tonsillitis, bronchitis, eye infection, infection, localized infection, cystitis, otitis media, onychomycosis, acarophobia, bronchopneumonia, airway infection, tracheobronchitis, chronic otitis media, eosinophilia, reduced hematocrit, leukopenia, neutropenia, drug hypersensitivity reaction, glucosuria, hyperprolactinemia, hypothyroidism, decreased appetite, increased blood cholesterol, increased blood triglycerides, hyperglycemia, weight loss, flattened affect, sleep disorder, decreased libido, sexual dysfunction, depression, nightmares, unresponsiveness to stimuli, abnormal cooperation, loss of consciousness, language impairment, sensory deficit, movement disorder, generalized dyskinesia, cerebral ischemia, cerebrovascular accident disorder, neuroleptic malignant syndrome, diabetic coma, head tremors, seizures, psychomotor hyperactivity, tardive dyskinesia, cerebrovascular disorders, sensory abnormalities, ocular hyperemia, eye discharge, eye movement, eyelid swelling, photophobia, crust on eyelid margin, dry eye, increased tearing, glare, glaucoma, vision impairment, tinnitus, vertigo, bradycardia, tachycardia, palpitations, I-degree atrioventricular block, left bundle branch block, right bundle branch block, heart block, flushing, conduction disorder, abnormal electrocardiogram, prolonged QT interval on electrocardiogram, peripheral veins, bradycardia, wheezing, aspiration pneumonia, phonation disorder, wet cough, airway congestion, crepitations, respiratory distress, nasal edema, hyperventilation, fecal incontinence, gastritis, lip swelling, cheilitis, salivary deficiency, abdominal distension, gastroenteritis, tongue swelling, toothache, skin discoloration, skin lesions, skin disorder, erythematous rash, papular rash, generalized rash, papulopustular rash, eczema, musculoskeletal chest pain, joint stiffness, muscular weakness, rhabdomyolysis, micturition disorder, amenorrhea, gynecomastia, vaginal discharge, erectile dysfunction, ejaculation disorder, menstrual disorder, 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, drug adverse reactions, body temperature decrease, procedure-related pain, increased ALT, abnormal electrocardiogram, eosinophilia, increased AST, leukopenia, increased blood sugar, decreased hemoglobin, decreased hematocrit, body temperature drop, hypotension, increased transaminases, increased gamma-glutamyl transferase, increased liver enzymes, agranulocytosis, thrombocytopenia, anaphylactic reaction, abnormal secretion of antidiuretic hormone, diabetic ketoacidosis, diabetes, hypoglycemia, water intoxication, increased blood triglycerides, mania, dysgeusia, intraoperative iris tension reduction syndrome, atrial fibrillation, deep vein 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, liver dysfunction, hepatitis, dry mouth, xerostomia, urinary retention, polyuria, hiccups, excessive sweating, micturition disorder, leukopenia, arrhythmia, epistaxis, anemia, diarrhea, hangover, ocular motility seizures, acne, dysphagia, enuresis, tic disorder, respiratory distress, Rabbit syndrome, suicidal ideation, accident abnormalities, delusions, hallucinations, exacerbation of auditory hallucinations, tardive dyskinesia, neuroleptic malignant syndrome, confusion, insensitivity, postural instability, frequent falls, hyperglycemia, diabetes, weight gain, orthostatic hypotension, syncope, reduced core temperature, symptoms of drug overdose, QT interval prolongation, seizures

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is advisable to maintain storage temperatures between 1 to 30 degrees Celsius.

Appearance

Light orange rectangular film-coated tablets

Package unit

30 tablets/bottle, 300 tablets/bottle