Risperidone 3 mg Tablet

Adult dose

The therapeutic dose of this drug should be adjusted according to the patient's clinical condition, and the lowest effective dose possible should be administered. Place this drug on the tongue. 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 risperidone 1 mg orally 2 times daily and increase the dose gradually. (2) Maintenance dose: Administer 1∼3 mg 2 times daily. Adjust the dose as appropriate according to age and symptoms. (3) No additional benefit 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 for the individual patient are considered 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 additional sedation is needed. 2) Administration in specific populations ⦁ Elderly patients and patients predisposed to hypotension The initial dose is 0.5 mg 2 times daily. Depending on the patient's condition, increase the dose by 0.5 mg 2 times daily until reaching 1～2 mg 2 times daily. In general, increases to doses of 1.5 mg or more 2 times daily should be made at intervals of at least 1 week. 3) Switching from an existing antipsychotic to this drug When medically appropriate, initiate treatment with this drug while gradually reducing the dose of the existing drug. Also, when switching from an existing depot antipsychotic, when medically appropriate, initiate treatment with this drug 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 drug 2 times daily. If necessary, depending on the patient, the dose may be increased by 0.25 mg per dose, 2 times daily, at intervals of at least 2 days. The optimal dose for most patients is 0.5 mg per dose, 2 times daily, but the dose may be increased to 1 mg per dose, 2 times 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 drug should be evaluated. 3. Adjunctive treatment of mania in bipolar disorder ⦁ The recommended initial dose is 2 mg of this drug 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 drug 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 drug with caution in these patients (see 5. General Precautions)

Child dose

⦁ There is insufficient clinical experience in children and adolescents under 15 years of age. ⦁ There is insufficient clinical experience in children and adolescents under 15 years of age. 4. Disruptive behavior disorder and other disruptive behavior disorders - Body weight 50 kg or more The initial dose is 0.5 mg of this drug once daily. If necessary, depending on the patient, the dose may be increased by 0.5 mg per 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. - Body weight under 50 kg The initial dose is 0.25 mg once daily. If necessary, depending on the patient, the dose may be increased by 0.25 mg per 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. ⦁ There is insufficient clinical experience in children under 5 years of age.

This medication should be used with great caution in elderly dementia patients as it may increase mortality. Especially when used in conjunction with furosemide, there may be a higher risk of mortality; therefore, the risks and benefits should be carefully considered before co-administration. Additionally, this drug carries a risk of venous thromboembolism, so factors contributing to thrombotic risk must be confirmed before and during treatment, and preventive measures must be taken. This medication contains the artificial sweetener aspartame, which should be avoided by individuals with certain genetic disorders such as phenylketonuria, and aspartame intake should be closely monitored. It should not be administered to those with hypersensitivity or those who are in a state of central nervous system depression due to alcohol or central nervous system depressants, in a state of coma, undergoing epinephrine treatment, or those with genetic issues such as lactose intolerance. Patients with cardiovascular disease, arrhythmia, a history of seizures, liver or kidney function impairment, suicidal risk, those with Parkinson's disease or Lewy body dementia, diabetes risk factors, the elderly, and pregnant or breastfeeding women should be treated with caution. While taking this medication, various side effects may occur, including insomnia, anxiety, dizziness, drowsiness, indigestion, weight gain, blood pressure changes, muscle cramps, rash, etc. Especially in elderly dementia patients, abnormal reactions such as pneumonia, urinary tract infections, confusion, and cerebrovascular accidents may occur more frequently. This drug can enhance central nervous system depression when taken with other central nervous system depressants or alcohol, so caution should be exercised in combination. Furthermore, there are interactions with hypotensive agents, QT prolonging medications, and drugs that inhibit or induce CYP2D6 and CYP3A4 enzymes; therefore, interactions with other administered medications must be thoroughly checked. Pregnant or breastfeeding women should avoid this medication or consult with a physician for careful consideration due to the risks to the fetus and neonate. In case of overdose, symptoms such as drowsiness, hypotension, cardiac arrhythmias, and seizures may appear, so immediate medical attention should be sought for appropriate treatment. This medication should be kept out of the reach of children, and care should be taken not to open the packaging carelessly or cut the tablets, and it is advisable not to mix it with beverages such as tea or cola.

Increased mortality, cerebrovascular adverse reactions, venous thromboembolism, nasopharyngitis, upper respiratory infection, sinusitis, urinary tract infection, anemia, hypersensitivity reactions, insomnia, anxiety, nervousness, Parkinsonism, 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, hypersalivation, dry mouth, abdominal discomfort, abdominal pain, gastrointestinal discomfort, epigastric 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, elevated body temperature, upper respiratory infection, rhinitis, influenza, increased appetite, middle insomnia, lethargy, headache, stuttering, attention deficit, balance disorder, hypersomnia, palpitations, pharyngeal-laryngeal pain, pulmonary congestion, itching, acne, myalgia, neck pain, nocturnal polyuria, frequency of urination, galactorrhea, emotional disorders, apathy, chest discomfort, restlessness, akathisia, dyskinesia, muscle tone disorders, hypertension, musculoskeletal pain, gait abnormalities, edema, pain, falls, ear infection, viral infection, pharyngitis, tonsillitis, bronchitis, eye infection, infection, localized infection, cystitis, otitis media, onychomycosis, scabies dermatitis, bronchopneumonia, airway infection, tracheobronchitis, chronic otitis media, eosinophilia, decreased hematocrit, leukopenia, neutropenia, drug hypersensitivity reactions, glycosuria, hyperprolactinemia, hyperphagia, increased blood cholesterol, increased triglycerides, hyperglycemia, weight loss, flattened affect, sleep disorders, decreased libido, sexual dysfunction, depression, nightmares, unresponsiveness to stimuli, cooperative abnormalities, loss of consciousness, speech disorders, sensory loss, movement disorders, generalized dystonia, cerebral ischemia, cerebrovascular accident disorders, neuroleptic malignant syndrome, diabetic coma, head tremors, seizures, psychomotor agitation, delay in movement, cerebrovascular disorders, sensory abnormalities, eye redness, eye discharge, eye movement, eyelid swelling, glare, eyelid crust, dry eyes, increased tearing, photophobia, glaucoma, decreased vision, tinnitus, vertigo, bradycardia, tachycardia, palpitations, I-degree AV block, left bundle branch block, right bundle branch block, AV block, flushing, conduction disorders, abnormal electrocardiogram, QT interval prolongation on ECG, venous insufficiency, bradycardia, wheezing, aspiration pneumonia, voice disorders, productive cough, airway congestion, rales, respiratory disorders, nasal congestion, hyperventilation, fecal incontinence, gastritis, lip swelling, cheilitis, hyposalivation, abdominal distension, gastroenteritis, tongue swelling, toothache, skin discoloration, skin lesions, skin disorders, erythematous rash, papular rash, generalized rash, papulovesicular rash, eczema, musculoskeletal chest pain, joint stiffness, muscle weakness, rhabdomyolysis, urinary disorders, amenorrhea, gynecomastia, vaginal discharge, erectile dysfunction, ejaculatory disorders, menstrual disorders, breast fullness, sexual dysfunction, retrograde ejaculation, breast discharge, thirst, influenza-like syndrome, edema, malaise, facial swelling, discomfort, generalized edema, chills, peripheral coldness, drug withdrawal syndrome, drug adverse reactions, decreased body temperature, procedure-related pain, elevated ALT, abnormal ECG findings, eosinophilia, elevated AST, leukopenia, increased blood glucose, decreased hemoglobin, decreased hematocrit, hypothermia, hypotension, elevated transaminases, elevated gamma-glutamyltransferase, increased liver enzymes, agranulocytosis, thrombocytopenia, anaphylactic reaction, abnormal antidiuretic hormone secretion, 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, QT prolongation on ECG, chest pain, abnormal liver function, hepatitis, thirst, dry mouth, urinary retention, polyuria, pain, hiccups, increased sweating, urinary disorders, leukopenia, arrhythmia, epistaxis, anemia, diarrhea, hangover, ocular movement seizures, acne, dysphagia, enuresis, tic disorder, dyspnea, suicidal ideation, accident psychosis, delusions, hallucinations, exacerbation of auditory hallucinations, extrapyramidal symptoms, hyperthermia, muscular rigidity, autonomic nervous instability, consciousness disorders, elevated serum creatine phosphokinase, myoglobinuria, acute renal failure, delirium, dullness, postural instability, frequent falls, weight gain, orthostatic hypotension, syncope, drowsiness, sedation, tachycardia, hypotension, QT interval prolongation, seizures, Torsades de Pointes

This drug should be stored in a sealed container to avoid exposure to light or air. The storage temperature should be maintained at room temperature between 1°C and 30°C.

Appearance

Oblong yellow film-coated tablet

Package unit

30 tablets/bottle, 200 tablets/bottle