PMS Risperidone Tablet 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. 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 appropriately according to age and symptoms. (3) No additional benefit was 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 an 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 coadministered if additional sedation is required. 2) Administration in specific 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 existing antipsychotic medication to this medicine When medically appropriate, initiate treatment with this medicine while gradually reducing the dose of the existing medication. Also, when switching from an existing depot antipsychotic medication, if medically appropriate, initiate treatment with this medicine in place of the next scheduled injection of the depot preparation. 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 to 1 mg twice daily. Once the patient has reached the optimal dose, once-daily dosing may also be considered. As with symptomatic treatment, the appropriateness of continued use of this medicine should be evaluated. 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. For most patients, the optimal dose 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 medicine 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 can increase the risk of death when administered to elderly dementia patients, thus caution is advised. The concomitant use of this drug with certain diuretics like furosemide may lead to increased mortality, necessitating careful consideration of risks and benefits before co-administration. This drug carries a risk of venous thromboembolism; therefore, risk factors for thrombosis should be evaluated before and during treatment. Preparations containing aspartame, an artificial sweetener, should be used cautiously in patients with phenylketonuria, and aspartame content should be limited to levels below those recommended by WHO. This medication should not be administered to patients allergic to this drug or its components, those in a state of central nervous system depression, those in a coma, or those receiving epinephrine. Patients with cardiovascular diseases or a history of arrhythmias, patients with impaired liver or kidney function, patients at risk of suicide, patients with Parkinson's disease or Lewy body dementia, diabetic patients, elderly patients, and pregnant or breastfeeding women require extra caution when using this medication. This medication can cause various adverse reactions, particularly neuro-psychiatric symptoms, cardiovascular anomalies, and gastrointestinal discomfort; if such symptoms occur during use, medical consultation should be sought immediately. This medication may intensify central nervous system depression when taken with other CNS depressants or alcohol, hence caution is needed with concomitant use. This drug is associated with specific liver metabolic enzymes (CYP2D6, CYP3A4), and may cause changes in blood concentrations when used concomitantly with drugs that inhibit or induce these enzymes, therefore dosage adjustments may be necessary. Use during pregnancy may affect the fetus; therefore, it should be administered under a doctor's judgment, and breastfeeding should be discontinued if the mother is nursing. In case of overdose, immediate medical attention is required, and ECG monitoring and supplementary treatment according to symptoms may be necessary. This medication should not be unpacked by pressing the packaging or cut, and it is recommended not to be mixed with tea or cola. Store in a place out of reach of children and do not transfer to another container for safety.

Coinfection, upper respiratory tract infection, sinusitis, urinary tract infection, anemia, hypersensitivity, insomnia, anxiety, nervousness, Parkinson's disease, akathisia, drowsiness, dizziness, sedation, tremors, muscle tension abnormalities, hypersomnia, postural dizziness, movement disorders, syncope, blurred vision, ear pain, orthostatic hypotension, tachycardia, hypotension, nasal congestion, dyspnea, nosebleeds, sinus congestion, nausea, constipation, dyspepsia, vomiting, diarrhea, hypersalivation, dry mouth, abdominal discomfort, abdominal pain, gastrointestinal discomfort, epigastric pain, rash, dry skin, dandruff, seborrheic dermatitis, back pain, joint pain, limb pain, urinary incontinence, ejaculatory dysfunction, fatigue, asthenia, fever, chest pain, increased serum creatinine phosphokinase, increased heart rate, pneumonia, soft tissue infection, decreased appetite, confusion, transient ischemic attack, decreased consciousness, drooling, cerebrovascular accident, conjunctivitis, cough, runny nose, dysphagia, fecal mass, erythema, abnormal posture, joint swelling, peripheral edema, gait disturbance, pit edema, elevated body temperature, upper respiratory tract infection, 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, galactorrhea, emotional disturbances, lethargy, chest discomfort, weight gain, increased serum prolactin, restlessness, slowed affect, sleep disturbances, decreased libido, sexual dysfunction, depression, nightmares, unresponsiveness to stimuli, cooperation abnormalities, loss of consciousness, language disorders, sensory impairment, movement disorders, generalized movement disorders, cerebral ischemia, cerebrovascular accident disorders, neuroleptic malignant syndrome, diabetic coma, head tremors, seizures, psychomotor agitation, delayed movement disorders, cerebrovascular disorders, sensory abnormalities, eye congestion, eye discharge, eye rotation, eyelid edema, photophobia, eyelid crusting, dry eyes, increased tearing, glare, glaucoma, decreased vision, tinnitus, vertigo, bradycardia, tachycardia, palpitations, I-degree atrioventricular block, left bundle branch block, right bundle branch block, heart block, flushing, conduction disturbances, electrocardiogram abnormalities, prolonged QT interval on electrocardiogram, venous bradycardia, bradycardia, wheezing, aspiration pneumonia, voice disturbances, wet cough, airway congestion, crackles, respiratory disturbance, nasal cavity edema, hyperventilation, fecal incontinence, gastritis, lip swelling, cheilitis, salivary deficiency, abdominal distention, gastroenteritis, tongue swelling, toothache, skin discoloration, skin lesions, skin disorders, erythematous rash, papular rash, generalized rash, annular papular rash, eczema, musculoskeletal chest pain, joint rigidity, muscle weakness, rhabdomyolysis, urination disorder, amenorrhea, gynecomastia, vaginal discharge, erectile dysfunction, ejaculatory disorder, menstrual disorders, breast engorgement, sexual dysfunction, retrograde ejaculation, breast discharge, thirst, influenza-like syndrome, edema, languor, facial edema, discomfort, generalized edema, chills, peripheral coldness, drug withdrawal syndrome, adverse drug reactions, decreased body temperature, procedure-related pain, weight loss, increased gamma-GT, increased liver enzymes, glucose in urine, chest pain, liver dysfunction, hepatitis, thirst, dry mouth, urinary retention, polyuria, pain, hiccups, increased sweating, urination disorders, leukopenia, arrhythmia, nosebleeds, anemia, diarrhea, hangover, ocular movement seizure, acne, dysphagia, nocturnal enuresis, tic disorder, dyspnea, Rabbit syndrome, suicide attempt, accident anomaly, delusions, hallucinations, symptom exacerbation of auditory hallucinations, agranulocytosis, thrombocytopenia, anaphylaxis, abnormal secretion of antidiuretic hormone, diabetic ketoacidosis, diabetes, hypoglycemia, water intoxication, increased serum cholesterol, increased serum triglycerides, mania, dysgeusia, intraoperative iris tension decrease syndrome, atrial fibrillation, deep vein thrombosis, pulmonary embolism, sleep apnea syndrome, intestinal obstruction, pancreatitis, jaundice, vascular edema, hair loss, neonatal drug withdrawal syndrome, urinary obstruction, priapism, hypothermia, prolonged QT interval on electrocardiogram

This medication must be stored in a tightly sealed container to prevent air or moisture ingress. It is important to maintain storage temperatures between 1 degree and 30 degrees Celsius, as this will help preserve the medication's efficacy.

Appearance

Brownish-red rectangular film-coated tablet

Package unit

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