Risperdal 0.5 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

Schizophrenia: There is limited clinical experience in children and adolescents under 15 years of age. Adjunctive treatment of mania associated with bipolar disorder: There is limited clinical experience in children and adolescents under 15 years of age. Disruptive behavior disorder and other disruptive behavior disorders, 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. Disruptive behavior disorder and other disruptive behavior disorders, 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. Disruptive behavior disorder and other disruptive behavior disorders: As with symptomatic treatment, the appropriateness of continued use of this medicine should be evaluated. There is limited clinical experience in children under 5 years of age.

This medication may increase mortality rates when administered to elderly dementia patients, so caution is required. The risk of death may be greater among elderly dementia patients taking this medication in combination with certain diuretics, so the risks and benefits should be carefully considered before concomitant use. This medication carries a risk of venous thrombosis, so risk factors for thrombosis should be checked and preventive measures should be taken before and during administration. Patients with allergies to this drug or its components, those with central nervous system depression due to alcohol or central nervous system depressants, comatose patients, patients undergoing epinephrine treatment, and patients with certain genetic lactose intolerance conditions should not be treated with this medication. Patients with impaired cardiac function or pre-existing conditions such as myocardial infarction, arrhythmia, or cerebrovascular diseases should have their dosage gradually adjusted and be closely monitored. Patients with liver or kidney dysfunction may have delayed metabolism and excretion of this medication, so initial and maintenance doses should be reduced, and dosage increases should be gradual. This medication may increase the risk of seizures, so caution is advised in patients with a history of seizures. Women who are pregnant or may become pregnant, as well as those who are breastfeeding, should consult a healthcare professional before taking this medication, as it may affect the fetus or newborn. While taking this medication, side effects such as drowsiness, dizziness, anxiety, insomnia, indigestion, weight gain, orthostatic hypotension, and Parkinsonian symptoms may occur, and any abnormal symptoms should be reported to a healthcare professional immediately. This medication may enhance the central nervous system depressant effects when taken with other CNS depressants or alcohol, so caution is warranted during concomitant use. Drug interactions may alter the blood concentration of this medication when taken with certain liver enzyme inhibitors or inducers, so patients should consult healthcare professionals regarding potential interactions. Caution should be exercised when driving or operating machinery that requires mental alertness while taking this medication. In the case of overdose, symptoms such as drowsiness, sedation, cardiac arrhythmias, and seizures may occur, requiring immediate medical treatment. This medication should be kept out of reach of children and not be transferred to other containers for safety.

Increased mortality, cerebrovascular adverse reactions, venous thrombosis, pharyngitis, upper respiratory infection, sinusitis, urinary tract infection, anemia, hypersensitivity, insomnia, anxiety, nervousness, Parkinsonism, akathisia, drowsiness, dizziness, sedation, tremor, muscle rigidity, somnolence, postural dizziness, movement disorders, syncope, blurriness, ear pain, orthostatic hypotension, tachycardia, hypotension, nasal congestion, dyspnea, epistaxis, 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, ejaculation 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, fecal impaction, erythema, abnormal posture, joint swelling, peripheral edema, gait disturbance, pitting edema, increased body temperature, rhinitis, influenza, increased appetite, moderate insomnia, lethargy, headache, stuttering, attention deficit, balance disorder, excessive sleep, palpitations, oropharyngeal pain, pulmonary congestion, itching, acne, myalgia, neck pain, nocturia, frequent urination, excessive milk secretion, 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 problems, loss of consciousness, language disorder, sensory loss, movement disorder, generalized dyskinesia, cerebral ischemia, cerebrovascular accident impairment, neuroleptic malignant syndrome, diabetic coma, head tremor, convulsions, psychomotor hyperactivity, delayed movement disorder, cerebrovascular disorders, sensory abnormalities, conjunctival injection, ocular discharge, eye movement, eyelid edema, photophobia, eye crust, dry eyes, increased tear production, glare, glaucoma, decreased vision, tinnitus, vertigo, bradycardia, sinus tachycardia, palpitations, grade I AV block, left bundle branch block, right bundle branch block, AV block, flushing, conduction disorders, abnormal ECG, prolonged QT interval on ECG, sinoatrial node dysfunction, bradycardia, wheezing, aspiration pneumonia, voice disorders, moist cough, airway congestion, rales, respiratory disorders, nasal cavity edema, hyperventilation, fecal incontinence, gastritis, lip swelling, cheilitis, salivary deficiency, abdominal distension, gastroenteritis, 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 dysfunction, amenorrhea, gynecomastia, vaginal discharge, erectile dysfunction, ejaculation disorders, menstrual disorders, breast engorgement, sexual dysfunction, retrograde ejaculation, breast secretion, thirst, influenza-like syndrome, edema, malaise, facial edema, discomfort, generalized edema, chills, peripheral coldness, withdrawal syndrome, drug adverse reactions, decreased body temperature, procedure-related pain, increased ALT, abnormal ECG, eosinophilia, increased AST, decreased white blood cell count, increased blood sugar, decreased hemoglobin, decreased hematocrit, hypothermia, decreased 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 cholesterol levels, increased triglycerides, mania, dysgeusia, intraoperative iris hypotension syndrome, atrial fibrillation, deep vein thrombosis, pulmonary embolism, sleep apnea syndrome, intestinal obstruction, pancreatitis, jaundice, vascular edema, alopecia, neonatal drug withdrawal syndrome, urinary retention, persistent erection, hypothermia, chest pain, abnormal liver function, hepatitis, dry mouth, xerostomia, urinary retention, polyuria, pain, hiccups, increased sweating, urination disorders, leukopenia, arrhythmia, epistaxis, anemia, diarrhea, hangover, ocular movement seizures, acne, difficulty swallowing, enuresis, tic disorder, dyspnea, Rabbit syndrome, suicide attempt, accident abnormality, delusion, hallucination, exacerbation of symptoms

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture, and it is important to maintain a storage temperature between 1°C to 30°C. Therefore, it should be kept away from direct sunlight and not placed in excessively hot or cold locations.

Appearance

Oblong reddish-brown film-coated tablet

Package unit

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