Myungmoon Risperidone Tablet 1mg

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 (oral tablet only). 1. Schizophrenia 1) Adults (1) Initial dose: Administer 1 mg of risperidone orally twice daily and gradually increase the dose. (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 to the individual patient are considered 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, 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 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'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 the dose may be increased to 1 mg twice daily depending on the patient. Once the patient has reached the optimal dose, a once-daily dosing regimen 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 longer. The optimal dose for most patients is within 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.

Caution is advised when administering this drug to elderly patients with dementia as it may increase the mortality rate. In particular, the combination of this drug with furosemide may further increase the risk of death, so risks and benefits should be carefully considered before combination therapy. Additionally, this drug may induce venous thromboembolism, so thrombotic risk factors should be assessed and preventive measures taken before and after administration. This drug contains the artificial sweetener aspartame, so patients with certain genetic disorders such as phenylketonuria must be careful. Patients allergic to this drug or its components, patients with central nervous system depression, patients in a comatose state, patients receiving epinephrine, and patients with certain genetic lactose intolerance should not be administered this drug. It should be administered with caution to patients with cardiovascular disease, impaired liver or kidney function, a history of seizures, suicidality, Parkinson's disease or Lewy body dementia, diabetes, elderly patients, pregnant women, or nursing mothers. This drug may have various side effects, particularly neurologic symptoms, cardiovascular disturbances, gastrointestinal symptoms, and skin reactions have been reported. During treatment, patients should be periodically monitored for weight gain, hyperglycemia, and symptoms of diabetes, and it can be combined with other medications if sedation is needed. This drug may interfere with concentration, so it is advisable to avoid driving or operating machinery during the initial phase of treatment. Blood abnormalities such as leukopenia may occur, so blood tests should be carefully monitored at the beginning. There is a risk of acute intraoperative iris hypotension; thus, patients scheduled for cataract surgery should inform their medical personnel about taking this drug. This drug may cause orthostatic hypotension and syncope, so caution is needed during dose adjustments. Antipsychotic medications can affect temperature regulation, so excessive exercise, hot environments, and dehydration should be avoided. Caution should be exercised when taking this drug with other central nervous system depressants, alcohol, certain antihypertensive agents, and drugs that prolong the QT interval, and the possibility of drug interactions should always be considered. During pregnancy, it should only be administered if necessary due to the potential risks to the fetus, and it should be avoided during breastfeeding. Clinical experience in children and adolescents is limited, so special care is needed. In cases of overdose, contact healthcare professionals immediately and receive appropriate emergency treatment, as there is no antidote for this drug, necessitating supportive care based on symptoms. This medication should be taken immediately after opening and stored securely out of the reach of children; it is advisable not to mix it with tea or cola.

Death, stroke, transient ischemic attack, venous thrombosis, rhinopharyngitis, upper respiratory infection, sinusitis, urinary tract infection, anemia, hypersensitivity reaction, insomnia, anxiety, nervous hyperactivity, 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, nasal congestion, nausea, constipation, dyspepsia, vomiting, diarrhea, excessive salivation, 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 blood creatinine phosphokinase, increased heart rate, pneumonia, soft tissue infection, decreased appetite, confusion, transient ischemic attack, altered state of consciousness, sialorrhea, cerebrovascular accident, conjunctivitis, hypotension, cough, runny nose, dysphagia, fecal impaction, erythema, abnormal posture, joint swelling, peripheral edema, gait disturbance, pituitary edema, elevated body temperature, rhinitis, influenza, increased appetite, middle insomnia, lethargy, headache, stuttering, attention disorder, balance disorder, excessive sleep, palpitations, oropharyngeal pain, pulmonary congestion, itching, acne, myalgia, neck pain, nocturnal enuresis, frequent urination, galactorrhea, emotional disturbances, lethargy, chest discomfort, weight gain, elevated blood prolactin, anxiety, blunted affect, sleep disturbance, decreased libido, sexual dysfunction, depression, nightmares, lack of responsiveness to stimuli, coordination abnormalities, loss of consciousness, speech impairment, sensory loss, movement disorders, tardive dyskinesia, cerebral ischemia, cerebrovascular accident disability, neuroleptic malignant syndrome, diabetic coma, head tremor, convulsions, psychomotor hyperactivity, akinesia, cerebrovascular disorder, sensory disturbances, conjunctival congestion, ocular discharge, eye movement, eyelid edema, photophobia, eyelid crust, dry eyes, increased tear flow, glare, glaucoma, decreased vision, tinnitus, vertigo, bradycardia, paroxysmal atrial fibrillation, atrioventricular block, left bundle branch block, right bundle branch block, AV block, flushing, conduction disorder, abnormal electrocardiogram, prolonged QT interval on ECG, jugular vein obstruction, bradycardia, wheezing, aspiration pneumonia, vocal cord dysfunction, productive cough, airway congestion, crackles, respiratory distress, nasal cavity swelling, hyperventilation, fecal incontinence, gastritis, lip edema, cheilitis, sialadenosis, abdominal distension, enteritis, tongue swelling, dental pain, skin discoloration, skin lesions, skin disorders, erythematous rash, papular rash, systemic rash, papulovesicular rash, eczema, musculoskeletal chest pain, joint stiffness, muscle weakness, rhabdomyolysis, urinary disorders, amenorrhea, gynecomastia, vaginal discharge, erectile dysfunction, ejaculatory dysfunction, menstrual disorder, breast swelling, sexual dysfunction, retrograde ejaculation, nipple discharge, thirst, influenza-like syndrome, edema, malaise, facial swelling, discomfort, generalized edema, chills, peripheral vasoconstriction, drug withdrawal syndrome, adverse drug reactions, decreased body temperature, procedure-related pain, elevated ALT, electrocardiogram abnormalities, eosinophilia, elevated AST, leukopenia, elevated blood glucose, decreased hemoglobin, decreased hematocrit, hypothermia, decreased blood pressure, increased transaminases, elevated gamma-glutamyl transferase, liver enzyme elevation, falls, agranulocytosis, thrombocytopenia, dysregulation of antidiuretic hormone secretion, diabetic ketoacidosis, diabetes mellitus, hypoglycemia, water intoxication, thromboembolism, pulmonary embolism, sleep apnea syndrome, intestinal obstruction, pancreatitis, jaundice, vascular edema, hair loss, neonatal drug withdrawal syndrome, urinary retention, persistent erection, hypothermia, chest pain, liver dysfunction, hepatitis, dry mouth, xerostomia, urinary retention, polyuria, pain, hiccups, increased sweating, urination disorder, leukopenia, arrhythmia, epistaxis, anemia, diarrhea, hangover, ocular movement seizures, acne, dysphagia, enuresis, tic disorders, dyspnea, suicide attempts, mental disorder, delusion, hallucinations, exacerbation of hallucination symptoms, extrapyramidal symptoms, hyperthermia, muscle stiffness, autonomic nervous system anxiety, consciousness disorders, elevated serum creatine phosphokinase, myoglobinuria, acute kidney failure, confusion, insensitivity, postural instability, falls, hyperglycemia, worsening of diabetes, weight gain, orthostatic hypotension, syncope, reduced deep body temperature, antiemetic effect, Torsades de Pointes

This drug must be stored in a tightly closed container to protect it from air and moisture. It is important to maintain storage temperatures between 1 and 30 degrees Celsius.

Appearance

Oblong white film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle