PMS Risperidone Tablet 1 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). Initial dose for adults with schizophrenia: Administer risperidone 1 mg per dose orally twice daily and increase the dose gradually. Maintenance dose for adults with schizophrenia: Administer 1∼3 mg per dose twice daily. Adjust the dose as appropriate according to age and symptoms. No additional benefit was observed at doses of 10 mg or more per day compared with lower doses, and the risk of extrapyramidal symptoms may increase. 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. Do not administer doses of 16 mg or more per day because safety has not been established. A benzodiazepine may be administered concomitantly if additional sedation is needed. For elderly patients and patients predisposed to hypotension, the initial dose is 0.5 mg per dose twice daily. Depending on the patient's condition, increase the dose by 0.5 mg per dose twice daily until a dose of 1～2 mg per dose twice daily is reached. In general, increases to doses of 1.5 mg or more per dose twice daily should be made at intervals of at least 1 week. When switching from an existing antipsychotic medicine to this medicine, start this medicine while gradually reducing the dose of the existing medicine, if medically appropriate. Also, when switching from an existing depot antipsychotic medicine, if medically appropriate, start this medicine in place of the next scheduled depot injection. The need to continue concomitant antiparkinsonian medicines should be reassessed regularly. For agitation, aggression, or psychotic symptoms in patients with dementia of the Alzheimer's type, the initial dose is 0.25 mg per dose twice daily. If needed, depending on the patient, the dose may be increased by 0.25 mg per dose twice daily at intervals of at least 2 days. The optimal dose for most patients is 0.5 mg per dose twice daily, but depending on the patient it may be increased to 1 mg per dose twice daily. Once the patient has reached the optimal dose, once-daily administration may also be considered. As with symptomatic treatment, the rationale for continued use of this medicine should be evaluated. For adjunctive treatment of mania associated with bipolar disorder, an initial dose of 2 mg of this medicine once daily is recommended. Depending on the patient, the dose may be increased by 1 mg once daily at intervals of 24 hours or longer. The optimal dose for most patients is in the range of 2∼6 mg per day. As with symptomatic treatment, the rationale for continued use of this medicine should be evaluated. Renal and hepatic impairment: In patients with impaired renal or hepatic function, 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. Disruptive behavior disorder and other disruptive behavior disorders, 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, 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 medication may increase mortality when used in elderly patients with dementia, so caution is particularly advised. The risk of death may be higher when used in combination with diuretics like furosemide, so careful assessment of risks and benefits is needed before combination therapy. Additionally, this drug may increase the risk of venous thromboembolism, so it is essential to check for risk factors for thrombosis and take preventive measures. This drug contains aspartame, an artificial sweetener, which may pose a problem for patients with phenylketonuria, so caution is required. This medication should not be administered to individuals with allergies to this drug or its components, those taking alcohol or central nervous system depressants, patients in a coma, those receiving epinephrine, and patients with specific genetic disorders such as lactose intolerance. Caution is essential for patients with heart disease, blood pressure abnormalities, liver or kidney dysfunction, a history of seizures, those at risk for suicide, patients with diabetes risk factors, pregnant or breastfeeding women, and the elderly. This drug may cause side effects such as drowsiness, dizziness, hypotension, anxiety, insomnia, and symptoms of Parkinsonism, so consultation with healthcare professionals is advised in case of these symptoms. It is also important to regularly monitor changes in blood sugar and weight during treatment. Caution should be exercised when this drug is taken with other central nervous system depressants or alcohol, as drowsiness or confusion may be worsened. During pregnancy, it may affect the fetus, so women of childbearing potential should consult a physician before use, and breastfeeding mothers are advised to discontinue nursing. Dosage adjustments may be necessary for children or the elderly, and in case of overdose, immediate medical attention should be sought. This drug is fragile, so do not open the packaging carelessly or cut the tablets, and it should be taken immediately after opening. Keep out of reach of children, and avoid transferring to another container.

Increased mortality, stroke, transient ischemic attack, venous thrombosis, nasopharyngitis, upper respiratory infection, sinusitis, urinary tract infection, anemia, hypersensitivity, insomnia, anxiety, nervousness, Parkinsonism, akathisia, drowsiness, dizziness, sedation, tremor, muscle rigidity, hypersomnolence, orthostatic dizziness, movement disorders, 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, ejaculation failure, fatigue, asthenia, fever, chest pain, elevated blood creatinine phosphokinase, increased heart rate, pneumonia, soft tissue inflammation, decreased appetite, confusion, transient ischemic attack, altered consciousness, drooling, cerebrovascular accident, conjunctivitis, hypotension, cough, runny nose, difficulty swallowing, stool mass, erythema, abnormal posture, joint swelling, peripheral edema, walking disturbances, pitting edema, elevated body temperature, rhinitis, influenza, increased appetite, moderate insomnia, lethargy, headache, stuttering, attention deficit, balance disorder, hypersomnia, palpitations, pharyngeal-laryngeal pain, pulmonary congestion, itching, acne, myalgia, neck pain, nocturia, polyuria, galactorrhea, emotional disturbance, lethargy, chest discomfort, weight gain, elevated blood prolactin, anxiety, blunted affect, sleep disturbance, decreased libido, sexual dysfunction, depression, nightmares, unresponsiveness to stimuli, cooperative disturbance, loss of consciousness, speech disorder, sensory loss, motor disorders, tardive dyskinesia, cerebral ischemia, cerebrovascular accident disorders, neuroleptic malignant syndrome, diabetic coma, head tremors, seizures, psychomotor hyperactivity, delayed motor dysfunction, cerebrovascular disorders, sensory disturbances, ocular hyperemia, eye discharge, eye movement, eyelid swelling, photophobia, crusting of eyelid edges, dry eyes, increased tearing, glare, glaucoma, decreased vision, tinnitus, vertigo, bradycardia, sinus 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 electrocardiogram, sinus venous, bradycardia, wheezing, aspiration pneumonia, voice disorder, moist cough, airway congestion, rales, respiratory distress, nasal edema, 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 disorders, menstrual disorders, breast engorgement, sexual function disorders, retrograde ejaculation, breast secretion, thirst, influenza-like syndrome, edema, fatigue, facial swelling, discomfort, generalized edema, chills, peripheral coldness, drug withdrawal syndrome, drug adverse reactions, decreased body temperature, procedure-related pain, increased ALT, abnormal electrocardiogram, increased eosinophil count, increased AST, decreased white blood cell count, increased blood glucose, decreased hemoglobin, decreased hematocrit, hypothermia, decreased blood pressure, increased transaminases, increased gamma-glutamyl transferase, increased liver enzymes, agranulocytosis, thrombocytopenia, abnormal secretion of antidiuretic hormone, diabetic ketoacidosis, diabetes, hypoglycemia, water intoxication, increased serum cholesterol, increased serum triglycerides, mania, dysgeusia, intraoperative mydriasis syndrome, atrial fibrillation, deep vein thrombosis, pulmonary embolism, sleep apnea syndrome, intestinal obstruction, pancreatitis, jaundice, vascular edema, alopecia, neonatal drug withdrawal syndrome, urinary retention, priapism, hypothermia, chest pain, liver function abnormalities, hepatitis, dry mouth, xerostomia, urinary retention, polyuria, pain, hiccups, increased sweating, urination disorders, leukopenia, arrhythmia, epistaxis, anemia, diarrhea, hangover, ocular movement seizure, acne, difficulty swallowing, enuresis, tic disorder, respiratory distress, Rabbit syndrome, suicidal ideation, accident abnormalities, delusions, hallucinations, exacerbation of auditory hallucination symptoms

This medication should be stored in a tightly closed container to protect it from air and moisture, and it is safe to store it at room temperature between 1°C and 30°C. Storing it this way can help maintain the effectiveness of the medication for a long time.

Appearance

White oblong film-coated tablet

Package unit

Bottle - 30 tablets/bottle, Bottle - 100 tablets/bottle