Rispen ODT 1 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. Place this medication on the tongue and, once it has disintegrated within a few seconds, swallow it with or without water (for 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 as appropriate 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 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 the 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 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, start this medication while gradually reducing the dose of the existing medication. Also, when medically appropriate, when switching from an existing depot antipsychotic medication, start this medication 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 medication 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 the dose may be increased to 1 mg twice daily depending on the patient. Once the patient reaches 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 therapy for manic episodes 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 up to 1 mg per day at intervals of 24 hours or longer. The optimal dose for most patients is within 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 drug 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 medication can increase mortality when administered to elderly dementia patients, so caution is needed. Especially when used in conjunction with certain diuretics, the risk of death may be further increased, so the risks and benefits should be carefully assessed before concurrent administration. This medication contains aspartame, an artificial sweetener, and should not be taken by patients with phenylketonuria, a genetic disorder. The intake of aspartame should also be controlled to not exceed the recommended daily amount. Patients who are hypersensitive to this medication, patients whose central nervous system is depressed by alcohol or central nervous system depressants, patients in a coma, or patients receiving epinephrine should not use this medication. Patients with heart disease or blood pressure issues, those with poor liver or kidney function, patients with a history of seizures, those at risk of suicide, patients with Parkinson’s disease or Lewy body dementia, patients with diabetes risk factors, the elderly, pregnant and nursing mothers should use this medication cautiously. This medication can cause various side effects such as drowsiness, dizziness, hypotension, Parkinsonism, insomnia, anxiety, nausea, constipation, etc., so any abnormal symptoms should be reported to a doctor immediately. When taken with other central nervous system depressants or alcohol, this medication can exacerbate central nervous system depression, so caution is required. Furthermore, the risk of side effects may increase when used in conjunction with certain antihypertensive medications or drugs that prolong the QT interval. Women who are pregnant or breastfeeding should consult their doctor before taking this medication and it is recommended that this medication not be taken while nursing. During the course of this medication, it is advisable to avoid activities that require concentration, such as driving or operating machinery. In case of overdose, serious side effects may occur, so adhere strictly to the recommended dosage and contact a medical institution immediately if an overdose is suspected. Keep this medication out of reach of children, take it immediately after opening the package, and be careful not to cut or crush the tablets.

Increased mortality rate, stroke, transient ischemic attack, venous thrombosis, rhinitis, upper respiratory infection, sinusitis, urinary tract infection, anemia, allergic reactions, insomnia, anxiety, nervousness, Parkinson's disease, inability to sit, drowsiness, dizziness, sedation, tremors, muscle tension abnormalities, somnolence, orthostatic dizziness, movement disorders, syncope, blurred vision, ear pain, orthostatic hypotension, tachycardia, hypotension, nasal congestion, respiratory distress, nosebleed, sinus congestion, nausea, constipation, dyspepsia, vomiting, diarrhea, hypersalivation, dry mouth, abdominal discomfort, abdominal pain, gastrointestinal discomfort, epigastric pain, rash, dry skin, dandruff, seborrheic dermatitis, hyperkeratosis, back pain, joint pain, limb pain, urinary incontinence, ejaculation disorder, fatigue, weakness, fever, chest pain, increased serum creatinine phosphokinase, increased heart rate, pneumonia, soft tissue infection, decreased appetite, confusion, transient ischemic attack, decreased consciousness, drooling, cerebrovascular accident, conjunctivitis, hypotension, cough, runny nose, dysphagia, fecal impaction, erythema, abnormal posture, joint swelling, peripheral edema, gait disturbance, pit edema, elevated body temperature, rhinitis, influenza, increased appetite, middle insomnia, lethargy, headache, stuttering, attention disorder, balance disorder, excessive sleep, palpitations, pharyngolaryngeal pain, pulmonary congestion, itching, acne, myalgia, neck pain, nocturia, frequent urination, galactorrhea, emotional disturbance, laziness, chest discomfort, weight gain, increased blood prolactin, neutropenia, hyperglycemia, hyperuricemia, hyperinsulinemia, depression, early insomnia, delusions, hallucinations, depressive symptoms, paranoid delusions, suicidal ideation, increased libido, decreased libido, sexual dysfunction, sensory disturbances, seizures, tremors of hands and feet, psychomotor agitation, immobility, numbness, head discomfort, neuroleptic malignant syndrome, eyelid spasm, eye movement disorders, dizziness, bradycardia, ventricular extrasystoles, arrhythmia, hypertension, thromboembolism, postural orthostatic tachycardia syndrome, wheezing, aspiration pneumonia, voice disorders, wet cough, airway congestion, rales, respiratory disorders, nasal cavity edema, hyperventilation, fecal incontinence, gastritis, lip swelling, cheilitis, xerostomia, abdominal distension, gastroenteritis, tongue swelling, toothache, skin discoloration, skin lesions, skin disorders, erythematous rashes, papular rashes, generalized rash, papulopustular rash, eczema, musculoskeletal chest pain, joint stiffness, muscle weakness, rhabdomyolysis, urinary difficulty, amenorrhea, gynecomastia, vaginal discharge, erectile dysfunction, ejaculation disorders, menstrual disorders, breast engorgement, sexual dysfunction, retrograde ejaculation, breast discharge, thirst, influenza-like syndrome, edema, fatigue, facial swelling, discomfort, generalized edema, chills, peripheral coldness, drug withdrawal syndrome, adverse drug reactions, decreased body temperature, procedure-related pain, increased ALT, ECG abnormalities, increased eosinophil count, increased AST, decreased white blood cell count, increased blood sugar, decreased hemoglobin, decreased hematocrit, decreased body temperature, decreased blood pressure, increased transaminases, increased γ-glutamyl transferase, increased liver enzymes, falls, agranulocytosis, thrombocytopenia, anaphylactic reaction, abnormal secretion of antidiuretic hormone, diabetic ketoacidosis, diabetes, hypoglycemia, water intoxication, increased serum cholesterol, increased serum triglycerides, mania, dysgeusia, intraoperative iris tension reduction 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, 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, acne, dysphagia, enuresis, tic disorder, respiratory distress, Rabbit syndrome, suicidal ideation, accident abnormalities, delusions, hallucinations, worsening auditory hallucinations

This medication should be stored in a tightly closed container to protect it from air and moisture. Additionally, it is important to store the medication in a cool place below 30 degrees Celsius to maintain its effectiveness.

Appearance

White round orally disintegrating tablet

Package unit

100 tablets (10 tablets/PTP x 10)