Riperdone Tablet 0.5 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 possible should be administered. Place this medicine on the tongue and, once it disintegrates within a few seconds, swallow it without water or with water (orally disintegrating tablets only.). 1. Schizophrenia 1) Adults (1) Initial dose: Administer 1 mg of risperidone 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 effects were 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 an individual patient are judged to outweigh the risks. (4) Do not administer doses of 16 mg or more per day, as their safety has not been established. (5) A benzodiazepine may be administered concomitantly if an additional sedative effect 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 existing antipsychotic medication to this medicine When medically appropriate, initiate this medicine while gradually reducing the dose of the existing medication. Also, when switching from an existing depot antipsychotic medication, if 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's type The initial dose is 0.25 mg of this medicine 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, but depending on the patient, the dose may be increased to 1 mg twice daily. 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 1 mg per day at intervals of at least 24 hours. For most patients, the optimal dose 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. Exercise caution when administering this medicine to these patients (see 5. General Precautions)

Child dose

⦁ There is limited clinical experience in children and adolescents under 15 years of age. ⦁ There is limited clinical experience in children and adolescents under 15 years of age. - 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. ⦁ There is limited clinical experience in children under 5 years of age.

This medication may increase mortality in elderly dementia patients, so it should be administered cautiously, especially when used with furosemide, considering risks versus benefits. There is a risk of venous thromboembolism, therefore check for risk factors that could cause it and take preventive measures before using this medication. Patients with phenylketonuria should be cautious about phenylalanine intake due to the artificial sweetener aspartame contained in this medication. Do not administer this medication to patients with hypersensitivity to this or its components, those whose central nervous system is depressed by alcohol or central nervous system depressants, comatose patients, those receiving epinephrine, or patients with lactose intolerance. Use this medication with caution in patients with cardiovascular disease, a history of arrhythmias, a history of seizures, liver and kidney dysfunction, patients at risk of suicide, Parkinson's disease patients, patients with risk factors for diabetes, the elderly, pregnant or breastfeeding women, and patients allergic to Yellow No. 5. This medication can cause various side effects, such as drowsiness, dizziness, orthostatic hypotension, insomnia, anxiety, and Parkinsonian symptoms, so caution is necessary. In elderly dementia patients, adverse reactions like urinary tract infections, pneumonia, confusion, drowsiness, and cerebrovascular accidents may occur more frequently. This medication may enhance the central nervous system depressant effects when used with other CNS depressants or alcohol. Additionally, it may reduce the effects of dopamine agonists and can cause hypotension when used with antihypertensives, necessitating dosage adjustments. There is a risk of arrhythmias when used with drugs that prolong the QT interval, so it should be used cautiously. In pregnant women, the medication should only be used when the risk to the fetus is justified by the benefits; it should be avoided during breastfeeding. Safety and efficacy in children and adolescents have not been sufficiently confirmed, so it should be used with caution. Overdosage may result in drowsiness, hypotension, electrocardiogram abnormalities, seizures, and immediate medical attention is required. Do not crush or cut this medication but take it whole on the tongue until it dissolves within a few seconds; do not mix with tea or cola and keep out of the reach of children.

Increased mortality rate, stroke, transient ischemic attack, venous thrombosis, rhinitis, upper respiratory infection, sinusitis, urinary tract infection, anemia, hypersensitivity, insomnia, anxiety, neuromuscular irritability, Parkinson's syndrome, akathisia, drowsiness, dizziness, sedation, tremors, muscle rigidity, hypersomnia, orthostatic dizziness, dyskinesia, syncope, 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, gastrointestinal discomfort, epigastric 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 infection, decreased appetite, confusion, transient ischemic attack, altered consciousness, drooling, cerebrovascular accident, conjunctivitis, hypotension, cough, runny nose, difficulty swallowing, fecal impaction, erythema, abnormal posture, joint swelling, peripheral edema, gait disturbance, pitting edema, elevated body temperature, rhinitis, influenza, increased appetite, moderate insomnia, lethargy, headache, stuttering, attention deficit, balance disorders, hypersomnia, palpitations, oropharyngeal pain, pulmonary congestion, itching, acne, myalgia, neck pain, nocturia, frequent urination, galactorrhea, mood disturbances, lethargy, chest discomfort, weight gain, elevated blood prolactin, restlessness, decreased affect, sleep disorders, decreased libido, sexual dysfunction, depression, nightmares, unresponsiveness to stimuli, abnormal cooperation, loss of consciousness, speech disorders, sensory deficits, movement disorders, generalized dyskinesia, cerebral ischemia, cerebrovascular accident disorders, neuroleptic malignant syndrome, diabetic coma, head tremors, seizures, psychomotor hyperactivity, delayed dyskinesia, cerebrovascular disorders, sensory abnormalities, conjunctival injection, ocular discharge, eye movement, eyelid swelling, photophobia, eyelid crusting, dry eyes, increased tearing, glare, glaucoma, decreased vision, tinnitus, vertigo, bradycardia, tachycardia, palpitations, I degree atrioventricular block, left bundle branch block, right bundle branch block, atrioventricular block, flushing, conduction disorders, abnormal electrocardiogram, QT interval prolongation on electrocardiogram, venous thrombosis, bradycardia, wheezing, aspiration pneumonia, phonation disorder, wet cough, airway congestion, crepitations, respiratory distress, nasal cavity swelling, hyperventilation, fecal incontinence, gastritis, lip swelling, cheilitis, salivary deficiency, abdominal distension, gastroenteritis, tongue swelling, toothache, skin discoloration, skin lesions, skin disorders, erythematous rash, papular rash, generalized rash, papulopustular rash, eczema, musculoskeletal chest pain, joint stiffness, muscle weakness, rhabdomyolysis, urination disorders, amenorrhea, gynecomastia, vaginal discharge, erectile dysfunction, ejaculation disorders, menstrual disorders, breast engorgement, sexual function disorders, retrograde ejaculation, mammary secretion, thirst, influenza-like syndrome, edema, lethargy, facial swelling, discomfort, generalized edema, chills, peripheral coldness, drug withdrawal syndrome, drug adverse reactions, decreased body temperature, procedure-related pain, increased ALT, abnormal electrocardiogram, eosinophilia, increased AST, leukopenia, increased blood glucose, decreased hemoglobin, decreased hematocrit, decreased body temperature, decreased blood pressure, increased transaminases, increased γ-glutamyl transferase, increased liver enzymes, agranulocytosis, thrombocytopenia, dysregulation of antidiuretic hormone secretion, diabetic ketoacidosis, diabetes, hypoglycemia, water intoxication, increased blood cholesterol, increased blood triglycerides, mania, altered taste, intraoperative iris tension lowering syndrome, atrial fibrillation, deep vein thrombosis, pulmonary embolism, sleep apnea syndrome, intestinal obstruction, pancreatitis, jaundice, vascular edema, alopecia, drug withdrawal syndrome in newborns, urinary retention, priapism, hypothermia, QT interval prolongation on electrocardiogram, chest pain, liver dysfunction, hepatitis, dry mouth, oral dryness, urinary retention, polyuria, pain, hiccups, increased sweating, urination disorders, leukopenia, arrhythmias, epistaxis, anemia, diarrhea, hangover, ocular motor seizures, acne, dysphagia, enuresis, tic disorder, respiratory distress, suicidal ideation, alteration in consciousness, delusions, hallucinations, exacerbation of auditory hallucinations, falls, drug hypersensitivity reaction, hypertension, gait abnormalities, pain, falls, anaphylactic reaction, elevated blood prolactin, thromboembolism, postural orthostatic tachycardia syndrome, angioedema, acquired C1 esterase deficiency, periorbital edema, eyelid swelling, facial swelling, hereditary angioedema, laryngeal edema, laryngotracheal edema, eye breathing syndrome, oral edema, orbital periosteal edema, small bowel vascular edema, tongue swelling

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

Appearance

Red-brown, rectangular film-coated tablet

Package unit

30 tablets/bottle, 300 tablets/bottle