Rispin 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 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 (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 appropriately according to the patient's age and symptoms. (3) No additional effects have 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 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, start this medicine while gradually reducing the dose of the existing medication. Also, when medically appropriate, when switching from an existing depot antipsychotic, start 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 is 0.25 mg of this medicine twice daily. If necessary, 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 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 treatment of manic episodes 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 at least 24 hours. 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 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 dosage more gradually. Use this medicine 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 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.

Caution is required when administering this drug to elderly dementia patients as it may increase mortality. In particular, the combination with furosemide may increase mortality, hence the risks and benefits should be carefully considered when co-administering. Due to the risk of venous thrombosis, it is important to identify risk factors for venous thrombosis and take preventive measures before using this drug. This drug contains the artificial sweetener aspartame, and patients with phenylketonuria should consult their doctor before taking it and be cautious not to exceed the daily allowable amount of aspartame. This drug should not be administered to those with hypersensitivity to this drug or its components, patients in a state of central nervous system depression due to alcohol or central nervous system depressants, patients in a comatose state, or those receiving epinephrine. In patients with cardiovascular diseases such as heart failure, myocardial infarction, conduction abnormalities, dehydration, hypovolemia, or cerebrovascular diseases, the initial dose should be increased gradually and administered carefully. Dose adjustment may be necessary if hypotension occurs. Patients with a history of arrhythmias or congenital long QT syndrome, those with a history of seizures or at risk of seizures, and patients with liver or kidney dysfunction should also be monitored closely. Special care should be taken when administering this drug to patients with a history of suicide attempts, those at risk of suicide, patients with Parkinson's disease or Lewy body dementia, those with risk factors such as diabetes, hyperglycemia, or obesity, elderly patients, pregnant women, and breastfeeding mothers. This drug may cause various adverse reactions, especially neurological symptoms, cardiovascular abnormalities, gastrointestinal symptoms, and skin reactions. Any abnormal symptoms that occur during treatment should be reported to medical staff immediately. Caution is required as the combined use of this drug with other central nervous system depressants or alcohol may enhance central nervous system depression. If a pregnant woman takes this drug, it may affect the fetus, so she must consult her doctor, and breastfeeding should be discontinued if breastfeeding mothers take this drug. There is insufficient clinical experience regarding the use of this drug in children and adolescents, so caution is warranted. In case of overdose, immediate emergency treatment is necessary, and since there is no antidote for this drug, symptoms must be managed through supportive care. This drug must be kept out of reach of children, and it should not be transferred to another container. It is advisable to take it immediately after opening.

Increased mortality, stroke, transient ischemic attack, venous thromboembolism, rhinitis, upper respiratory tract infection, sinusitis, urinary tract infection, anemia, hypersensitivity reaction, insomnia, anxiety, nervous hyperexcitability, Parkinsonism, akathisia, drowsiness, dizziness, sedation, tremor, 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, 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 dysfunction, fatigue, weakness, 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, hypotension, cough, runny nose, dysphagia, fecal impaction, erythema, abnormal posture, joint swelling, peripheral edema, gait disturbance, pitting edema, increased body temperature, rhinitis, influenza, increased appetite, middle insomnia, lethargy, headache, stuttering, attention deficit, balance disorder, excessive sleep, palpitations, oropharyngeal pain, pulmonary congestion, itching, acne, myalgia, neck pain, nocturia, frequency of urination, galactorrhea, emotional disturbances, lethargy, chest discomfort, weight gain, elevated blood prolactin, anxiety, blunted affect, sleep disorders, decreased libido, sexual dysfunction, depression, nightmares, unresponsiveness to stimuli, coordination disorders, 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, tardive dyskinesia, cerebrovascular disorders, sensory disturbances, conjunctival injection, eye discharge, eye movement, eyelid edema, photophobia, crusting of eyelid margins, dry eyes, increased tearing, glare, glaucoma, decreased vision, tinnitus, vertigo, sinus bradycardia, sinus tachycardia, palpitations, I degree atrioventricular block, left bundle branch block, right bundle branch block, atrioventricular block, flushing, conduction disorders, abnormal electrocardiogram, prolonged QT interval on electrocardiogram, sinus venosus, bradycardia, wheezing, aspiration pneumonia, dysphonia, wet cough, airway congestion, rales, respiratory distress, nasal cavity edema, hyperventilation, fecal incontinence, gastritis, lip swelling, cheilitis, salivary gland deficiency, abdominal distension, enterocolitis, tongue swelling, toothache, skin discoloration, skin lesions, skin disorders, erythematous rash, papular rash, systemic rash, papulovesicular rash, eczema, musculoskeletal chest pain, joint stiffness, muscle weakness, rhabdomyolysis, voiding disorders, amenorrhea, gynecomastia, vaginal discharge, erectile dysfunction, ejaculatory disorders, menstrual disorders, breast engorgement, sexual dysfunction, retrograde ejaculation, breast discharge, thirst, influenza-like syndrome, edema, malaise, facial swelling, discomfort, generalized edema, chills, peripheral coldness, drug withdrawal syndrome, adverse drug reactions, decreased body temperature, procedure-related pain, elevated ALT, abnormal electrocardiogram, eosinophilia, elevated AST, leukopenia, increased blood glucose, decreased hemoglobin, decreased hematocrit, hypothermia, decreased blood pressure, increased transaminases, increased γ-glutamyl transferase, elevated liver enzymes, agranulocytosis, thrombocytopenia, anaphylactic reaction, abnormal secretion of antidiuretic hormone, diabetic ketoacidosis, diabetes mellitus, hypoglycemia, water intoxication, increased blood cholesterol, increased blood triglycerides, mania, dysgeusia, intraoperative iris hypotension syndrome, atrial fibrillation, deep venous thrombosis, pulmonary embolism, sleep apnea syndrome, intestinal obstruction, pancreatitis, jaundice, vascular edema, alopecia, neonatal drug withdrawal syndrome, urinary retention, persistent erection, hypothermia, prolonged QT interval on electrocardiogram, chest pain, liver dysfunction, hepatitis, dry mouth, xerostomia, urinary retention, polyuria, pain, hiccups, increased sweating, voiding disorders, leukopenia, arrhythmia, epistaxis, anemia, diarrhea, hangover, ocular motor seizures, acne, dysphagia, enuresis, tic disorders, respiratory distress, Rabbit syndrome, suicidal ideation, accident abnormalities, delusions, hallucinations, exacerbation of auditory hallucinations, tardive dyskinesia, neuroleptic malignant syndrome, confusion, insensitivity, postural instability, falls, hyperglycemia, diabetes, weight gain, persistent erection, orthostatic hypotension, syncope

This drug should be stored in a tightly closed container to prevent exposure to air and moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius.

Appearance

Yellow, oblong film-coated tablets

Package unit

30 tablets/bottle, 200 tablets/bottle