Risdal Tablet 2 mg (Risperidone)

Adult dose

The therapeutic dose of this medication 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 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 efficacy 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 an individual patient are judged to outweigh the risks. (4) Doses of 16 mg or more per day should not be administered because 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 an existing antipsychotic medication to this medication When medically appropriate, initiate this medication while gradually reducing the dose of the existing medication. Also, when medically appropriate, when switching from an existing depot antipsychotic medication, initiate this medication 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 medication twice daily. If needed, 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 dosing may also be considered. As with symptomatic treatment, the appropriateness of continued use of this medication should be evaluated. 3. Adjunctive treatment of mania in bipolar disorder ⦁ The recommended initial dose is 2 mg of this medication 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 appropriateness of continued use of this medication 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 medication 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 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. ⦁ Clinical experience in children under 5 years of age is limited.

This drug should be used with special caution in elderly patients with dementia, as it may increase the mortality rate. The risk of death may also be higher when used with the diuretic furosemide, so the risks and benefits should be carefully evaluated before co-administration. There is also a risk of venous thrombosis, so it is essential to check for risk factors for thrombosis before and during treatment. Use is contraindicated in patients with a known allergy to this drug or its components, those who are under the influence of alcohol or central nervous system depressants, in a comatose state, or those receiving epinephrine. Patients with certain genetic issues, such as lactose intolerance, should not take this drug. Patients with cardiovascular disease or impaired liver or kidney function should receive adjusted dosing and careful monitoring. Furthermore, special attention is needed for patients with a history of suicide attempts or risk of suicide, Parkinson's disease or Lewy body dementia, diabetes, elderly patients, pregnant or nursing women. This drug can cause various side effects, common symptoms are drowsiness, dizziness, insomnia, anxiety, digestive disorders, and weight gain, but serious side effects can occur rarely. Regular monitoring of weight, blood sugar, and blood pressure during treatment is recommended. This drug may enhance the central nervous system depressant effects when taken with other central nervous system depressants or alcohol. Caution is also needed when co-administered with certain antihypertensive agents or medications that prolong the QT interval. Taking this drug during pregnancy can lead to extrapyramidal symptoms or withdrawal symptoms in newborns, so women who are pregnant or may become pregnant should consult their physician, and breastfeeding mothers should discontinue breastfeeding. There is limited clinical experience with this drug in children and adolescents, so it should be used carefully in pediatric patients. In cases of overdose, appropriate treatment should be obtained immediately, and as there is no antidote for this drug, supportive care based on symptoms is important. Finally, this drug should be kept out of reach of children and should not be transferred to another container.

Increased mortality, stroke, transient ischemic attack, venous thrombosis, rhinitis, upper respiratory infection, sinusitis, urinary tract infection, anemia, hypersensitivity, insomnia, anxiety, irritability, Parkinson's syndrome, akathisia, drowsiness, dizziness, sedation, tremor, muscle tone disorder, somnolence, orthostatic dizziness, movement disorder, syncope, blurriness, ear pain, orthostatic hypotension, tachycardia, hypotension, nasal congestion, dyspnea, epistaxis, sinus congestion, nausea, constipation, dyspepsia, vomiting, diarrhea, hypersalivation, dry mouth, abdominal discomfort, abdominal pain, gastrointestinal discomfort, upper abdominal 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, decreased consciousness, drooling, cerebrovascular accident, conjunctivitis, cough, runny nose, difficulty swallowing, stool mass, erythema, abnormal posture, joint swelling, peripheral edema, gait disturbance, pitting edema, increased body temperature, rhinitis, influenza, increased appetite, mid-insomnia, lethargy, headache, stuttering, attention deficit, equilibrium disorder, excessive sleep, palpitations, pharyngeal pain, pulmonary congestion, itching, acne, myalgia, neck pain, nocturia, polyuria, excessive lactation, emotional disturbance, lethargy, chest discomfort, weight gain, elevated blood prolactin, anxiety, blunted affect, sleep disorder, decreased libido, sexual dysfunction, depression, nightmares, unresponsiveness to stimuli, abnormal cooperation, loss of consciousness, speech disorder, sensory deficit, movement disorder, tardive dyskinesia, cerebral ischemia, cerebrovascular accident disorder, neuroleptic malignant syndrome, diabetic coma, head tremor, convulsions, psychomotor hyperactivity, delayed-onset movement disorder, cerebrovascular disorder, sensory disturbance, conjunctival congestion, eye discharge, eye movement, eyelid edema, photophobia, eyelid crusting, dry eyes, increased tearing, glare, glaucoma, vision impairment, tinnitus, vertigo, bradycardia, tachycardia, palpitations, I degree atrioventricular block, left bundle branch block, right bundle branch block, atrioventricular block, flushed skin, conduction disorder, abnormal electrocardiogram, prolonged QT interval on electrocardiogram, venous catheter, bradycardia, wheezing, aspiration pneumonia, voice disorder, wet cough, airway congestion, crackles, respiratory disorder, nasal swelling, hyperventilation, fecal incontinence, gastritis, lip swelling, cheilitis, salivary deficiency, abdominal swelling, enteritis, tongue swelling, dental pain, skin discoloration, skin lesions, skin disorders, erythematous rash, papular rash, generalized rash, papulovesicular rash, eczema, musculoskeletal chest pain, joint stiffness, muscle weakness, rhabdomyolysis, urination 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, malaise, systemic edema, chills, peripheral coolness, drug withdrawal syndrome, drug adverse reactions, lowered body temperature, procedure-related pain, increased ALT, abnormal electrocardiogram, eosinophilia, increased AST, decreased white blood cell count, increased blood sugar, decreased hemoglobin, decreased hematocrit, lowered body temperature, lowered blood pressure, increased transaminases, elevated gamma-glutamyl transferase, increased liver enzymes, agranulocytosis, thrombocytopenia, abnormal secretion of antidiuretic hormone, diabetic ketoacidosis, diabetes, hypoglycemia, water intoxication, increased blood cholesterol, increased blood triglycerides, mania, taste disturbance, intraoperative iris tension decrease syndrome, atrial fibrillation, deep vein thrombosis, pulmonary embolism, sleep apnea syndrome, intestinal obstruction, pancreatitis, jaundice, vascular edema, hair loss, neonatal drug withdrawal syndrome, urinary retention, persistent erection, hypothermia, prolonged QT interval on electrocardiogram, chest pain, liver dysfunction, hepatitis, thirst, dry mouth, urinary retention, polyuria, hiccups, increased sweating, leukopenia, arrhythmia, hangover, ocular motor seizure, acne, difficulty swallowing, enuresis, tic disorder, dyspnea, suicidal ideation, thought disorder, delusions, hallucinations, exacerbation of auditory hallucinations, falls, persistent erection

This drug should be stored in a tightly sealed container to prevent air or moisture from entering and should be kept at room temperature between 1 degree and 30 degrees Celsius. By storing it this way, the effectiveness of the medication can be maintained for a longer period.

Appearance

Oblong light orange film-coated tablet

Package unit

30 tablets/bottle, 200 tablets/bottle