PMS-Risperidone 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. Place this medicine on the tongue and, once it has disintegrated 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 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 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 existing antipsychotic medication to this medicine When medically appropriate, start treatment with this medicine while gradually reducing the dose of the existing medication. Also, when switching from an existing depot antipsychotic medication, when medically appropriate, start treatment with 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, the dose may be increased by 0.25 mg twice daily at intervals of at least 2 days, depending on the patient. The optimal dose for most patients is 0.5 mg twice daily, but the dose may be increased to up to 1 mg twice daily depending on the patient. 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 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 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. Exercise caution when administering this medicine to these patients (see 5. General Precautions)

Child dose

Schizophrenia: There is limited clinical experience in children and adolescents under 15 years of age. Adjunctive therapy for manic episodes of bipolar disorder: There is limited clinical experience in children and adolescents under 15 years of age. 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. Conduct disorder and other disruptive behavior disorders, 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. Conduct disorder and other disruptive behavior disorders: As with symptomatic treatment, the appropriateness of continued use of this drug should be evaluated. Conduct disorder and other disruptive behavior disorders: There is limited clinical experience in children under 5 years of age.

This medication may increase mortality when used in elderly patients with dementia, and caution should be exercised especially in this group. The risk of mortality increases further when elderly dementia patients take this medication in combination with certain diuretics (furosemide), requiring careful assessment before concomitant use. Thrombosis-related issues such as venous thromboembolism may occur; therefore, it is important to assess thrombotic risk factors and implement preventive measures prior to use. Patients with phenylketonuria should be cautious of the artificial sweetener aspartame contained in this medication and should limit its intake. This medication should not be used in patients with a known allergy to it or its components, severe central nervous system depression, comatose states, or in those receiving epinephrine. Caution and dose adjustments are necessary for patients with heart disease, blood pressure issues, seizure history, or liver or kidney dysfunction. Patients with diabetes or risk factors, the elderly, pregnant, or breastfeeding women also require special caution when using this medication. This medication may affect the central nervous system, causing various side effects such as drowsiness, dizziness, parkinsonism symptoms, and orthostatic hypotension, so patients should consult healthcare professionals immediately if any abnormal symptoms occur. Additionally, caution should be taken as this medication may enhance the central nervous system depressant effects when taken with other central nervous system depressants or alcohol. Use during pregnancy can affect the fetus, so consultation with a physician is essential if there is a possibility of pregnancy or if already pregnant. If breastfeeding, it is recommended to discontinue nursing as this medication can be passed into breast milk. Regular monitoring of weight changes, blood glucose levels, and blood pressure is important during treatment with this medication. This medication can cause orthostatic hypotension and fainting; thus, care should be taken while moving slowly when starting or changing doses. It is advisable to avoid activities requiring mental focus, such as driving or operating machinery, during treatment. In case of overdose, immediate medical attention should be sought for appropriate emergency treatment, as no specific antidote for this medication exists and treatment should be symptomatic. This medication should be kept out of the reach of children, and it should be taken immediately after opening the package. Do not mix this medication with tea or cola, and in the case of liquid formulations, caution should be taken as mixing with black tea can cause precipitation.

Coinfection, upper respiratory infection, sinusitis, urinary tract infection, anemia, hypersensitivity reaction, insomnia, anxiety, nervousness, Parkinson's disease, akathisia, drowsiness, dizziness, sedation, tremor, muscle tension abnormality, somnolence, orthostatic dizziness, movement disorder, syncope, blurred vision, ear pain, orthostatic hypotension, tachycardia, hypotension, nasal congestion, dyspnea, nosebleed, sinus congestion, nausea, constipation, indigestion, vomiting, diarrhea, excessive salivation, dry mouth, abdominal discomfort, abdominal pain, gastrointestinal discomfort, upper abdominal pain, rash, dry skin, dandruff, seborrheic dermatitis, hyperkeratosis, back pain, joint pain, limb pain, urinary incontinence, ejaculatory dysfunction, fatigue, weakness, fever, chest pain, elevated blood creatinine phosphokinase, increased heart rate, pneumonia, soft tissue infection, decreased appetite, confusion, transient ischemic attack, decreased level of consciousness, drooling, cerebrovascular accident, conjunctivitis, hypotension, cough, runny nose, dysphagia, fecal impaction, erythema, abnormal posture, joint swelling, peripheral edema, gait disturbance, dependent edema, elevated body temperature, upper respiratory infection, rhinitis, influenza, increased appetite, middle insomnia, lethargy, headache, stuttering, attention deficit, equilibrium disturbance, hypersomnia, palpitations, oropharyngeal pain, pulmonary congestion, itching, acne, myalgia, neck pain, nocturnal enuresis, frequent urination, galactorrhea, emotional disturbance, lethargy, chest discomfort, weight gain, elevated blood prolactin, anxiety, blunted affect, sleep disturbances, decreased libido, sexual dysfunction, depression, nightmares, unresponsiveness to stimuli, collaborative abnormality, loss of consciousness, speech disorder, sensory impairment, movement disorder, generalized movement disorder, cerebral ischemia, cerebrovascular accident disturbance, neuroleptic malignant syndrome, diabetic coma, head tremor, convulsions, psychomotor hyperactivity, delayed movement disorder, cerebrovascular disorder, sensory abnormalities, eye redness, eye discharge, eye rolling, 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, atrioventricular block, flushing, conduction disorder, abnormal electrocardiogram, prolonged QT interval on electrocardiogram, dextrocardia, bradycardia, wheezing, aspiration pneumonia, voice disorder, wet cough, airway congestion, rales, respiratory distress, nasal cavity swelling, 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, annular papular rash, eczema, musculoskeletal chest pain, joint stiffness, muscle weakness, rhabdomyolysis, urination disorder, amenorrhea, gynecomastia, vaginal discharge, erectile dysfunction, ejaculation disorder, menstrual disorder, breast swelling, sexual dysfunction, retrograde ejaculation, breast discharge, thirst, influenza-like syndrome, edema, fatigue, facial swelling, discomfort, generalized edema, chills, peripheral coldness, drug withdrawal syndrome, adverse drug reactions, decreased body temperature, procedure-related pain, weight loss, increased γ-GT, increased liver enzymes, glucosuria, chest pain, liver dysfunction, hepatitis, thirst, dry mouth, urinary retention, polyuria, pain, hiccups, increased sweating, urination disorder, leukopenia, arrhythmia, nosebleed, anemia, diarrhea, hangover, ocular movement seizures, acne, dysphagia, enuresis, tic disorder, respiratory distress, suicidal attempt, accident abnormalities, delusions, hallucinations, worsening of auditory hallucinations, agranulocytosis, thrombocytopenia, abnormal secretion of antidiuretic hormone, diabetic ketoacidosis, diabetes mellitus, hypoglycemia, water intoxication, increased blood cholesterol, increased blood triglycerides, mania, dysgeusia, intraoperative pupillary hypotension syndrome, atrial fibrillation, deep vein thrombosis, pulmonary embolism, sleep apnea syndrome, intestinal obstruction, pancreatitis, jaundice, vascular edema, hair loss, neonatal drug withdrawal syndrome, urinary retention, priapism, hypothermia

This medication should be stored in a tightly sealed container to protect it from air and moisture, and it should be kept at room temperature between 1°C and 30°C. Avoid exposure to direct sunlight or high temperatures and store it in a place that maintains the appropriate temperature.

Appearance

Pale orange oblong film-coated tablet

Package unit

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