PMS-Risperidone 3 mg Tablets (Risperidone)

Adult dose

The therapeutic dose of this medicine should be adjusted according to the patient's clinical status, 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). 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 as appropriate 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 for 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. 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 other antipsychotic drugs to this medicine When medically appropriate, initiate treatment with this medicine while gradually reducing the dose of the previous medication. Also, when switching from a previous depot antipsychotic medication, if medically appropriate, initiate treatment with 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's 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 up to 1 mg twice daily. Once the patient reaches 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 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 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. 4. Conduct 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, 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 should be used with caution in elderly dementia patients as it may increase mortality. In particular, when used together with furosemide, the risk of death may be heightened, so careful consideration of risks and benefits is necessary before concurrent administration. This medication may cause venous thromboembolism; therefore, thromboembolism risk factors should be assessed before and during administration, and preventive measures should be implemented. It contains an artificial sweetener called aspartame, so patients with phenylketonuria should be cautious when taking this medicine. Patients with hypersensitivity to this medication, patients whose central nervous system is depressed by alcohol or central nervous system depressants, patients in a coma, and patients receiving epinephrine should not use this medication. Patients with cardiovascular disease, impaired liver or kidney function, a history of seizures, elderly patients, pregnant or lactating women should use this medication with caution. This medication may cause drowsiness, dizziness, orthostatic hypotension, insomnia, anxiety, and various side effects, so any abnormal symptoms should be reported to a physician immediately. As an antipsychotic medication, rare severe adverse effects such as neuroleptic malignant syndrome or tardive dyskinesia may occur, and treatment should be discontinued immediately if symptoms appear. Use with other central nervous system depressants or alcohol may intensify central nervous system depressant effects, so caution is advised. Women who are pregnant or may become pregnant should consult a physician before administration as it may affect the fetus, and those who are breastfeeding should discontinue breastfeeding. When taking this medication, there is a risk of weight gain, increased blood sugar, and worsening diabetes, so regular monitoring of blood sugar and weight is advisable. In cases of overdose, symptoms such as drowsiness, hypotension, arrhythmias, and seizures may occur, necessitating immediate medical attention. This medication should be stored out of reach of children, not transferred to other containers, and taken immediately after opening. It should not be mixed with tea or cola and care should be taken as the liquid formulation may precipitate when mixed with black tea.

Increased mortality, stroke, transient ischemic attack, venous thrombosis, rhinitis, upper respiratory infection, sinusitis, urinary tract infection, anemia, hypersensitivity reactions, insomnia, anxiety, neural hypersensitivity, Parkinson's disease, akathisia, drowsiness, dizziness, sedation, tremor, muscle rigidity, somnolence, 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, upper abdominal pain, rash, dry skin, dandruff, seborrheic dermatitis, hyperkeratosis, back pain, arthralgia, limb pain, urinary incontinence, ejaculatory failure, fatigue, asthenia, fever, chest pain, elevated serum 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, fatigue, headache, stuttering, attention disorder, balance disorder, excessive sleep, palpitations, oropharyngeal pain, pulmonary congestion, itching, acne, myalgia, neck pain, nocturia, polyuria, galactorrhea, emotional disturbances, lethargy, chest discomfort, weight gain, elevated serum prolactin, restlessness, blunted affect, sleep disorders, decreased libido, sexual dysfunction, depression, nightmares, unresponsiveness to stimuli, cooperative disorder, loss of consciousness, speech disorder, sensory loss, movement disorder, widespread dyskinesia, cerebral ischemia, cerebrovascular accident dysfunction, neuroleptic malignant syndrome, diabetic coma, head tremor, convulsions, psychomotor hyperactivity, akinesia, cerebrovascular disorder, sensory disturbances, conjunctival hyperemia, ocular discharge, eye movement, eyelid edema, photophobia, eyelid crust, dry eyes, increased tear production, glare, glaucoma, reduced vision, tinnitus, dizziness, bradycardia, tachycardia, palpitations, I-degree atrioventricular block, left bundle branch block, right bundle branch block, atrioventricular block, flushing, conduction disorder, abnormal electrocardiography, prolonged QT interval on electrocardiography, femoral vein, bradycardia, wheezing, aspiration pneumonia, voice disorder, moist cough, airway congestion, crackles, respiratory distress, nasal cavity 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, urinary dysfunction, amenorrhea, gynecomastia, vaginal discharge, erectile dysfunction, ejaculation disorder, menstrual disorder, breast swelling, sexual dysfunction, retrograde ejaculation, breast discharge, thirst, influenza-like syndrome, edema, malaise, facial swelling, discomfort, generalized swelling, chills, peripheral coldness, drug withdrawal syndrome, adverse drug reactions, decreased body temperature, procedure-related pain, elevated ALT, abnormal ECG, eosinophilia, elevated AST, leukopenia, increased blood glucose, decreased hemoglobin, decreased hematocrit, lowered body temperature, decreased blood pressure, elevated transaminases, increased gamma-glutamyl transferase, increased liver enzymes, agranulocytosis, thrombocytopenia, abnormal secretion of antidiuretic hormone, diabetic ketoacidosis, diabetes mellitus, hypoglycemia, water intoxication, increased serum cholesterol, increased serum 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, priapism, hypothermia, chest pain, liver function abnormalities, hepatitis, dry mouth, xerostomia, urinary retention, polyuria, pain, hiccups, increased sweating, urinary incontinence, leukopenia, arrhythmia, epistaxis, anemia, diarrhea, hangover, oculomotor seizures, acne, dysphagia, enuresis, tic disorder, respiratory distress, Rabbit syndrome, suicidal ideation, thought disorder, delusions, hallucinations, exacerbation of symptoms

This medication must be stored in a tightly sealed container to protect it from exposure to air or moisture, and it is important to maintain a storage temperature between 1 degree Celsius and 30 degrees Celsius. In other words, it should be safely stored at an appropriate temperature, not too hot or too cold, to properly maintain its effectiveness.

Appearance

Yellow oblong film-coated tablet

Package unit

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