Jalirisperidone Tablets 2mg (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 effect 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 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 coadministered 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. Increases to doses of 1.5 mg or more twice daily should generally be made at intervals of at least 1 week. 3) Switching from existing antipsychotic medication to this medicine When medically appropriate, start this medicine while gradually reducing the dose of the existing medication. Also, when switching from an existing depot antipsychotic medication, when medically appropriate, start this medicine in place of the next scheduled injection of the depot formulation. The need to continue any 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 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. 3. Adjunctive treatment of 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 within 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 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

• Clinical experience in children and adolescents under 15 years of age is limited. • Clinical experience in children and adolescents under 15 years of age is limited. - Body weight 50 kg or more The initial dose is 0.5 mg of this medicine once daily. If needed, the dose may be increased by 0.5 mg per day at intervals of at least 2 days. 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 needed, the dose may be increased by 0.25 mg per day at intervals of at least 2 days. 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. • Clinical experience in children under 5 years of age is limited.

This medication may increase the risk of death in elderly dementia patients, and it should be used with extreme caution. Especially when used in conjunction with the certain diuretic furosemide, the mortality rate may increase, so the risks and benefits should be carefully considered before combined administration. Furthermore, this medication might increase the risk of venous thromboembolism, so thromboembolism risk factors must be assessed and preventive measures taken before and during administration. This medication contains the artificial sweetener aspartame, so patients with the genetic condition phenylketonuria must inform their healthcare provider and exercise caution before taking it. This medication should not be administered to patients with known allergy to specific components, those in a state of central nervous system depression or coma, those undergoing epinephrine treatment, and those with lactose intolerance. Dosing adjustments and caution are necessary for certain patient groups such as those with heart disease, liver or kidney dysfunction, seizure history, elderly patients, pregnant, and breastfeeding women. Various side effects such as drowsiness, dizziness, hypotension, insomnia, and anxiety may occur, and if any abnormal symptoms appear, patients should consult a healthcare professional immediately. Furthermore, the central nervous system depressant effects may be enhanced when this medication is combined with other CNS depressants or alcohol, so caution is warranted. Pregnant women should be careful as it may affect the fetus, and women who are pregnant or may become pregnant should definitely consult their doctor before taking this medicine, and those who are breastfeeding should discontinue breastfeeding. This medication may affect activities that require mental focus such as driving or operating machinery, so it is advisable to avoid such activities in the early stages of treatment. In case of overdose, serious side effects may occur, so immediate emergency treatment should be sought, and since there is no antidote for this medication, appropriate supportive treatment is necessary. This medication should be kept out of reach of children, and it is safest to take it immediately after opening the package. Lastly, it is important to regularly monitor health conditions such as weight gain, blood sugar changes, and blood pressure changes while taking this medication.

Increased mortality, stroke, transient ischemic attack, venous thromboembolism, rhinitis, upper respiratory infection, sinusitis, urinary tract infection, anemia, hypersensitivity reaction, insomnia, anxiety, neural hyperexcitability, Parkinsonism, 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, sialorrhea, dry mouth, abdominal discomfort, abdominal pain, gastrointestinal discomfort, epigastric pain, rash, dry skin, dandruff, seborrheic dermatitis, hyperkeratosis, back pain, arthralgia, limb pain, urinary incontinence, ejaculation failure, fatigue, asthenia, fever, chest pain, blood creatinine phosphokinase elevation, increased heart rate, pneumonia, soft tissue infection, decreased appetite, altered mental status, transient ischemic attack, decreased level of consciousness, hypersalivation, cerebrovascular accident, conjunctivitis, cough, runny nose, dysphagia, fecal impaction, erythema, abnormal posture, joint swelling, peripheral edema, gait disturbance, pituitary edema, elevated body temperature, rhinitis, influenza, increased appetite, mid-insomnia, lethargy, headache, stuttering, attention deficit, balance disorder, excessive sleep, palpitations, oropharyngeal pain, pulmonary congestion, itching, acne, myalgia, neck pain, nocturia, increased frequency of urination, galactorrhea, emotional disturbance, laziness, chest discomfort, weight gain, blood prolactin elevation, restlessness, blunted affect, sleep disorder, decreased libido, hypoactive sexual desire disorder, depression, nightmares, unresponsiveness to stimuli, abnormal cooperation, loss of consciousness, speech disorder, sensory loss, movement disorder, polymorphic dyskinesia, cerebral ischemia, cerebrovascular accident impairment, neuroleptic malignant syndrome, diabetic coma, head tremor, seizures, psychomotor agitation, delayed dyskinesia, cerebrovascular disorder, sensory disturbance, conjunctival injection, eye discharge, eye movement, eyelid edema, photophobia, eyelid crust, dry eyes, increased tear flow, glare, glaucoma, decreased vision, tinnitus, vertigo, bradycardia, tachycardia, I-degree atrioventricular block, left bundle branch block, right bundle branch block, heart block, flushing, conduction disorder, electrocardiogram abnormality, prolonged QT interval on electrocardiogram, deep vein thrombosis, bradycardia, wheezing, aspiration pneumonia, voice disorder, wet cough, airway congestion, crackles, respiratory distress, nasal cavity swelling, hyperventilation, fecal incontinence, gastritis, lip swelling, cheilitis, sialorrhea, abdominal distension, 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, voiding dysfunction, amenorrhea, gynecomastia, vaginal discharge, erectile dysfunction, ejaculation disorder, menstrual disorder, breast distension, sexual dysfunction, retrograde ejaculation, breast discharge, thirst, influenza-like syndrome, edema, malaise, facial swelling, discomfort, generalized edema, chills, peripheral coldness, drug withdrawal syndrome, adverse drug reactions, decreased body temperature, procedure-related pain, ALT increase, electrocardiogram abnormality, eosinophilia, AST increase, leukopenia, hyperglycemia, hemoglobin decrease, hematocrit decrease, hypothermia, hypotension, transaminase elevation, γ-glutamyl transferase elevation, liver enzyme increase, agranulocytosis, thrombocytopenia, antidiuretic hormone secretion disorder, diabetic ketoacidosis, diabetes, hypoglycemia, water intoxication, elevated serum cholesterol, elevated serum triglycerides, mania, dysgeusia, intraoperative iris tension reduction syndrome, atrial fibrillation, deep vein thrombosis, pulmonary embolism, sleep apnea syndrome, intestinal obstruction, pancreatitis, jaundice, vascular edema, hair loss, drug withdrawal syndrome in neonates, urinary retention, priapism, hypothermia, prolonged QT interval on electrocardiogram, chest pain, liver dysfunction, hepatitis, dry mouth, dry oral mucosa, urinary retention, polyuria, hiccups, increased sweating, leukopenia, arrhythmia, hangover, ocular movement seizures, tic disorder, respiratory distress, suicidal ideation, cognitive impairment, delusion, hallucination, exacerbation of auditory hallucinations, falls, drug hypersensitivity reaction, glycosuria, hyperprolactinemia, following symptoms, loss of appetite, elevated serum cholesterol, elevated serum triglycerides, hyperglycemia, weight loss, restlessness, blunted affect, sleep disorder, decreased libido, hypoactive sexual desire disorder, depression, nightmares, unresponsiveness to stimuli, abnormal cooperation, loss of consciousness, speech disorder, sensory loss, movement disorder, polymorphic dyskinesia, cerebral ischemia, cerebrovascular accident impairment, neuroleptic malignant syndrome, diabetic coma, head tremor, seizures, psychomotor agitation, delayed dyskinesia, cerebrovascular disorder, sensory disturbance, eyelid twitching, ocular movement disorder, dizziness, bradycardia, ventricular extrasystole, arrhythmia, hypertension, thromboembolism, postural orthostatic tachycardia syndrome, toothache, tongue spasm, excessive salivation, hemorrhoids, eczema, hyperhidrosis, itching, drug-induced rash, urticaria, buttock pain, delayed menstruation, delayed ejaculation, infrequent menstruation, breast discomfort, breast engorgement, breast hypertrophy, dysuria, anaphylaxis, pain, sclerosis, weight loss, γ-GT elevation, liver enzyme elevation, glycosuria, falls, priapism

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is important to maintain the storage temperature between 1 degree and 30 degrees Celsius. Storing it this way ensures that the drug's efficacy and safety are maintained for a long time.

Appearance

Oval orange film-coated tablets

Package unit

30 tablets/bottle, 200 tablets/bottle