Risperdal Tablets 2 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 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 are judged to outweigh the risks for the individual patient. (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 another antipsychotic medicine to this medicine When medically appropriate, start this medicine while gradually reducing the dose of the existing medicine. 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 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 reaches the optimal dose, once-daily administration may also be considered. As with all symptomatic treatments, the continued use of this medicine should be continually evaluated and justified. 3. Adjunctive therapy for 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 24 hours or more. The optimal dose for most patients is in the range of 2∼6 mg per day. As with all symptomatic treatments, the continued use of this medicine should be continually evaluated and justified. Renal and hepatic impairment For patients with renal or hepatic impairment, administer half the initial and maintenance doses and adjust the dose more gradually. Exercise caution when administering this medicine to 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 medication 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. There is limited clinical experience in children under 5 years of age.

This medication may increase mortality rates when used in elderly dementia patients, thus special caution is required. If elderly dementia patients are taking this medication with certain diuretics such as furosemide, the risk of death may be further elevated; therefore, the risks and benefits should be carefully considered before concomitant administration. It is crucial to identify risk factors for venous thromboembolism and take preventive measures before using this medication. It should not be administered to individuals allergic to this drug or its components, patients with central nervous system depression, comatose patients, patients receiving epinephrine, or those with genetic issues such as lactose intolerance. Caution should be exercised in patients with cardiovascular diseases, impaired liver or kidney function, a history of seizures, or those at risk of suicide, as well as in patients with Parkinson's disease or Lewy body dementia, diabetes mellitus, the elderly, and pregnant or breastfeeding women. This medication can cause various side effects such as drowsiness, dizziness, orthostatic hypotension, Parkinsonism, insomnia, anxiety, gastrointestinal disturbances; patients should consult a healthcare provider immediately upon experiencing symptoms. During the course of this medication, caution is required as concomitant use with alcohol or central nervous system depressants may enhance central nervous system depressant effects. Additionally, the potential for drug interactions exists, so it is essential to inform healthcare providers of all medications being taken. Pregnant women or those who may become pregnant should consider the risks to the fetus before use, and breastfeeding women are advised to discontinue breastfeeding. Clinical experience in children or adolescents under 15 years is limited, so the use of this medication should be carefully considered. In cases of overdose, immediate medical attention is required for appropriate treatment and monitoring; as there is no specific antidote for this medication, supportive treatment depending on symptoms is necessary. This medication should be kept out of reach of children and stored in its original packaging.

Increased mortality, stroke, transient ischemic attack, venous thrombosis, rhinitis, upper respiratory infection, sinusitis, urinary tract infection, anemia, hypersensitivity reactions, insomnia, anxiety, irritability, Parkinsonism, akathisia, drowsiness, dizziness, sedation, tremor, muscle rigidity, somnolence, orthostatic dizziness, dyskinesia, syncope, blurriness, 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, back pain, arthralgia, limb pain, urinary incontinence, ejaculatory dysfunction, fatigue, asthenia, fever, chest pain, increased blood creatinine phosphokinase, increased heart rate, pneumonia, soft tissue infection, decreased appetite, confusion, transient ischemic attack, decreased consciousness level, drooling, cerebrovascular accident, conjunctivitis, 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, moderate insomnia, lethargy, headache, stuttering, attention deficit, balance disorders, excessive sleep, palpitations, oropharyngeal pain, pulmonary congestion, itching, acne, myalgia, neck pain, nocturnal enuresis, polyuria, galactorrhea, mood disorders, lethargy, chest discomfort, increased blood prolactin, eosinopenia, hyperprolactinemia, parkinsonism, anorexia, increased blood cholesterol, increased blood triglycerides, hyperglycemia, weight loss, anxiety, blunted affect, sleep disorders, decreased libido, sexual dysfunction, depression, nightmares, unresponsiveness, cooperation abnormalities, loss of consciousness, speech disorders, sensory loss, movement disorders, chorea-acanthocytosis, cerebral ischemia, cerebrovascular pathology, neuroleptic malignant syndrome, diabetic coma, head tremor, seizures, psychomotor agitation, delayed dyskinesia, cerebrovascular disorders, sensory abnormalities, conjunctival injection, ocular discharge, eye rotation, eyelid swelling, photophobia, eyelid crusting, dry eyes, increased tearing, glare, glaucoma, vision loss, tinnitus, vertigo, bradycardia, tachycardia, palpitations, I-degree atrioventricular block, left bundle branch block, right bundle branch block, heart block, flushing, conduction disorders, abnormal electrocardiogram, prolonged QT interval on EKG, venous stasis, bradycardia, wheezing, aspiration pneumonia, dysphonia, productive cough, airway congestion, crackles, respiratory disorders, nasal congestion, hyperventilation, fecal incontinence, gastritis, lip swelling, cheilitis, salivary deficiency, bloating, 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, urination disorders, amenorrhea, gynecomastia, vaginal discharge, erectile dysfunction, ejaculation disorder, menstrual disorders, breast engorgement, sexual dysfunction, retrograde ejaculation, breast discharge, thirst, influenza-like illness, edema, malaise, facial swelling, discomfort, generalized edema, chills, peripheral coldness, withdrawal syndrome, adverse drug reactions, hypothermia, procedure-related pain, increased ALT, abnormal electrocardiogram, increased eosinophils, increased AST, decreased white blood cell count, increased blood sugar, decreased hemoglobin, decreased hematocrit, hypothermia, decreased blood pressure, increased transaminases, increased gamma-glutamyl transferase, increased liver enzymes, agranulocytosis, thrombocytopenia, dysfunction of antidiuretic hormone secretion, diabetic ketoacidosis, diabetes, hypoglycemia, water intoxication, tremors, mania, sleepwalking, sleep-related eating disorders, dysgeusia, intraoperative iris tension decrease syndrome, atrial fibrillation, deep vein thrombosis, pulmonary embolism, sleep apnea syndrome, intestinal obstruction, pancreatitis, jaundice, angioedema, hair loss, drug reactions with eosinophilia and systemic symptoms, Stevens-Johnson syndrome, toxic epidermal necrolysis, neonatal drug withdrawal syndrome, urinary retention, priapism, hypothermia, prolonged QT on electrocardiogram, chest pain, liver dysfunction, hepatitis, thirst, dry mouth, urinary retention, polyuria, pain, hiccups, increased sweating, urination disorders, leukopenia, arrhythmia, epistaxis, anemia, diarrhea, hangover, oculomotor seizures, acne, dysphagia, nocturia, tic disorder, dyspnea, Rabbit syndrome, suicidal ideation, accident-related abnormalities, delusions, hallucinations, exacerbation of symptoms.

This medication should be stored in a tightly sealed container to protect it from exposure to air or moisture. It is recommended to maintain a storage temperature in the range of 1 to 30 degrees Celsius at room temperature.

Appearance

Light orange rectangular film-coated tablets

Package unit

30 tablets/bottle, 200 tablets/bottle