Risperdal 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. 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 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 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. Increases to doses of 1.5 mg or more twice daily should generally be made at intervals of at least 1 week. 3) Switching from another antipsychotic medicine to this medicine When medically appropriate, start treatment with this medicine while gradually reducing the dose of the existing medicine. Also, when switching from an existing depot antipsychotic medicine, when medically appropriate, start this medicine in place of the next scheduled injection of the depot formulation. 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 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 treatment of 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 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 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. Use this medicine with caution in 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 needed, 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 less than 50 kg: The initial dose is 0.25 mg once daily. If needed, 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 limited clinical experience in children under 5 years of age.

This drug should be used with caution as it may increase mortality in elderly dementia patients. The risk of death may be further increased in elderly dementia patients taking this drug together with a specific diuretic, furosemide, so careful assessment of risks and benefits should be conducted before co-administration. This drug is associated with the risk of venous thromboembolism, thus thromboembolism risk factors should be checked before and during administration and preventive measures should be employed. This drug should not be administered to patients with known allergies to this drug or its ingredients, those in a state of central nervous system depression, those in a comatose state, patients receiving epinephrine, and lactose intolerant patients. Additional caution is required when administering to patients with cardiovascular diseases, history of seizures, renal or hepatic impairment, suicidal risk patients, patients with Parkinson’s disease or Lewy body dementia, diabetes patients, and the elderly, pregnant, and breastfeeding women. This medication may cause various adverse reactions, particularly neurological symptoms (Parkinsonism, sedation, dizziness, etc.), gastrointestinal symptoms (nausea, constipation, etc.), psychiatric symptoms (insomnia, anxiety, etc.), and cardiovascular symptoms (orthostatic hypotension, etc.) are commonly reported. Additionally, severe side effects such as neuroleptic malignant syndrome or tardive dyskinesia may occur, and medical consultation should be sought immediately if symptoms arise. Caution should be exercised when this drug is taken with other central nervous system depressants or alcohol, as it may enhance central nervous system depression. Moreover, this drug may interact with various medications, so patients must inform their healthcare provider about any other medications they are taking. Women who are pregnant or breastfeeding must consult their physician prior to taking this drug, as it may affect the fetus or newborn. This drug may cause drowsiness or dizziness, so activities requiring alertness, such as driving or operating machinery, should be avoided at the beginning of treatment. In case of overdose, immediate medical attention should be sought as there is no antidote for this drug, and symptomatic treatment may be necessary. This drug should be kept out of reach of children, and care should be taken to avoid transferring to another container, which may lead to quality degradation or accidents.

Death, stroke, transient ischemic attack, venous thrombosis, rhinitis, upper respiratory tract infection, sinusitis, urinary tract infection, anemia, hypersensitivity reaction, insomnia, anxiety, neuroexcitation, Parkinsonism, akathisia, drowsiness, dizziness, sedation, tremor, muscle hypertonia, somnolence, orthostatic dizziness, dyskinesia, syncope, blurriness, ear pain, orthostatic hypotension, tachycardia, hypotension, nasal congestion, shortness of breath, nosebleed, 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, ejaculatory failure, fatigue, weakness, fever, chest pain, elevated blood creatinine phosphokinase, increased heart rate, urinary tract infection, pneumonia, soft tissue infection, decreased appetite, confusion, transient ischemic attack, decreased level of consciousness, drooling, cerebrovascular accident, conjunctivitis, hypotension, cough, runny nose, dysphagia, fecal impaction, erythema, abnormal posture, joint swelling, peripheral edema, gait disturbance, pedal edema, elevated body temperature, upper respiratory tract infection, rhinitis, influenza, increased appetite, middle insomnia, fatigue, headache, stuttering, attention deficit, equilibrium disturbance, excessive sleep, palpitations, oropharyngeal pain, pulmonary congestion, itching, acne, myalgia, neck pain, nocturia, frequent urination, galactorrhea, mood disturbances, lethargy, chest discomfort, weight gain, elevated blood prolactin, anxiety, blunted affect, sleep disturbances, decreased libido, sexual dysfunction, depression, nightmares, apathy, abnormal coordination, loss of consciousness, speech impairment, sensory deficit, motor disturbance, episodic dyskinesia, cerebral ischemia, cerebrovascular accident disorder, neuroleptic malignant syndrome, diabetic coma, head tremors, convulsions, psychomotor hyperactivity, delayed dyskinesia, cerebrovascular disorders, sensory abnormalities, conjunctival injection, eye discharge, eye movement, eyelid edema, photophobia, eyelid crusts, dryness of the eye, 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, electrocardiogram abnormalities, prolonged QT interval on ECG, inferior vena cava blockage, bradycardia, wheezing, aspiration pneumonia, speech disorders, productive cough, airway congestion, rales, respiratory distress, nasal cavity swelling, hyperventilation, fecal incontinence, gastritis, lip swelling, cheilitis, sialadenosis, abdominal distension, enteritis, 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, urinary disorders, 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, electrocardiogram abnormalities, eosinophilia, increased AST, leukopenia, increased blood glucose, decreased hemoglobin, decreased hematocrit, hypothermia, hypotension, increased transaminases, increased gamma-glutamyl transferase, increased liver enzymes, agranulocytosis, thrombocytopenia, anaphylaxis, abnormal secretion of antidiuretic hormone, diabetic ketoacidosis, diabetes mellitus, hypoglycemia, water intoxication, elevated cholesterol levels, increased triglycerides, mania, dysgeusia, intraoperative hypotonic iris 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, chest pain, liver dysfunction, hepatitis, thirst, xerostomia, bladder retention, polyuria, pain, hiccups, increased sweating, urinary problems, leukopenia, arrhythmia, nosebleeds, anemia, diarrhea, hangover, ocular movement seizures, acne, dysphagia, enuresis, tic disorders, respiratory distress, suicidal ideation, intellectual impairment, delusion, hallucination, exacerbation of auditory hallucinations, falls, priapism, orthostatic hypotension, syncope, hyperthermia, muscle rigidity, autonomic nervous anxiety, consciousness disturbance, elevated serum creatine phosphokinase, myoglobinuria, acute renal failure, confusion, insensitivity, postural instability, frequent falls, weight gain, extrapyramidal symptoms, tardive dyskinesia, extrapyramidal disorders, muscle stiffness, cogwheel rigidity, motor incapacity, bradycardia, decreased physical activity, mask-like facies, muscle rigidity, akathisia, restlessness, muscle spasm, involuntary contraction of muscles, muscle contracture, ocular deviation, tongue paralysis, tremors, chorea, choreoathetosis, motor disturbances, myoclonus, psychomotor agitation, akinesia, paresthesia, cephalalgia, neuroleptic malignant syndrome, eyelid spasm, eye movement disorders, dizziness, bradycardia, premature ventricular contractions, arrhythmia, thromboembolism, orthostatic hypotension syndrome, angioedema, acquired C1 esterase deficiency, perioral edema, facial swelling, laryngeal edema, tracheobronchial edema, ocular breathing syndrome, oral cavity edema, orbital periosteal edema, small bowel vascular edema, tongue edema, intraoperative hypotonic iris syndrome

This drug should be stored in a tightly closed container to prevent exposure to air or moisture, and it is safe to store between 1 to 30 degrees Celsius at room temperature. Proper storage conditions can help maintain the drug's effectiveness over time.

Appearance

Oblong yellow film-coated tablets

Package unit

Bottle - 30 tablets/bottle, Bottle - 200 tablets/bottle