Hupendalin Tablets 1 mg (Risperidone)

Adult dose

The therapeutic dose of this drug 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 the patient's 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 to the individual patient are judged to outweigh the risks. (4) Doses of 16 mg or more per day should not be administered because safety has not been established. (5) A benzodiazepine may be administered concomitantly if additional sedation is needed. 2) Dosing 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 drugs to this drug When medically appropriate, initiate treatment with this drug while gradually reducing the dose of the existing drug. Also, when switching from an existing depot antipsychotic drug, when medically appropriate, initiate treatment with this drug 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 drug 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 drug should be evaluated. 3. Adjunctive therapy for mania associated with bipolar disorder ⦁ The recommended initial dose is 2 mg of this drug once daily. Depending on the patient, the dose may be increased by 1 mg per day at intervals of at least 24 hours. 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 drug 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 drug to 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. 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, 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 under 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, 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 administered with particular caution to elderly patients with dementia due to a potential increase in mortality. The risk of death may be further heightened when this medication is co-administered with specific diuretics such as furosemide, so the risks and benefits should be carefully considered before concurrent use. This medication can increase the risk of venous thromboembolism, thus thrombotic risk factors should be evaluated and preventive measures taken before and during administration. It contains aspartame as an artificial sweetener, therefore caution is warranted for patients with hereditary conditions such as phenylketonuria. This medication should not be administered to individuals with hypersensitivity to it, those in a state of central nervous system depression or coma, patients receiving epinephrine, and those who are lactose intolerant. Caution is also needed for patients with cardiovascular diseases, history of seizures, reduced liver or kidney function, those at risk of suicide, and patients with Parkinson's disease. Pregnant or nursing women should weigh the effects on the fetus and newborn before use, as drug effects may pose risks to the newborn, especially in the later stages of pregnancy. This medication can cause various adverse reactions; hence, the patient's condition should be closely monitored during treatment, and any unusual symptoms should be reported to medical personnel immediately. When used in conjunction with other central nervous system depressants or alcohol, the sedative effects may be enhanced, warranting caution. This medication may interact with several drugs, so if taking other medications, it is imperative to inform healthcare providers. In cases of overdose, immediate emergency treatment is necessary, and as there is no antidote for this medication, appropriate care and monitoring based on symptoms are crucial. Store this medication in a place inaccessible to children, and it should be taken immediately after opening the package, and should not be mixed with tea, cola, or similar beverages.

Death, stroke, transient ischemic attack, venous thrombosis, rhinopharyngitis, upper respiratory infection, sinusitis, urinary tract infection, anemia, hypersensitivity reaction, insomnia, anxiety, nervousness, Parkinson's disease, akathisia, drowsiness, dizziness, sedation, tremor, muscle rigidity, hypersomnolence, 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, epigastric pain, rash, dry skin, dandruff, seborrheic dermatitis, hyperkeratosis, back pain, arthralgia, 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 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, rhinitis, influenza, increased appetite, middle insomnia, lethargy, headache, stuttering, attention deficit, balance disorder, hypersomnia, palpitations, pharyngolaryngeal pain, pulmonary congestion, itching, acne, myalgia, neck pain, nocturia, frequency of urination, galactorrhea, emotional disturbances, lethargy, chest discomfort, increased prolactin in blood, anxiety, blunted affect, sleep disorders, decreased libido, anorgasmia, depression, nightmares, unresponsiveness to stimuli, abnormal cooperation, loss of consciousness, speech disorders, sensory deficits, movement disorders, generalized dyskinesia, cerebral ischemia, cerebrovascular accident disorder, neuroleptic malignant syndrome, diabetic coma, head tremors, seizures, psychomotor hyperactivity, delayed dyskinesia, cerebrovascular disorders, sensory disturbances, conjunctival injection, eye discharge, eye movement, eyelid edema, photophobia, eyelid crusting, dry eyes, increased tearing, glare, glaucoma, visual impairment, tinnitus, vertigo, bradycardia, tachycardia, palpitations, I degree atrioventricular block, left bundle branch block, right bundle branch block, atrioventricular block, flushing, conduction disorders, abnormal electrocardiogram, prolonged QT interval on electrocardiogram, right saphenous vein, bradycardia, wheezing, aspiration pneumonia, voice disorders, moist cough, airway congestion, crackles, respiratory disorders, nasal cavity swelling, hyperventilation, fecal incontinence, gastritis, lip swelling, cheilitis, salivary deficiency, distention, gastroenteritis, tongue swelling, toothache, skin discoloration, skin lesions, skin disorders, erythematous rash, papular rash, generalized rash, papulovesicular rash, eczema, musculoskeletal chest pain, joint stiffness, muscle weakness, rhabdomyolysis, urination disorders, amenorrhea, gynecomastia, vaginal discharge, erectile dysfunction, ejaculation disorder, menstrual disorders, breast engorgement, sexual dysfunction, retrograde ejaculation, breast discharge, thirst, influenza-like syndrome, edema, malaise, facial swelling, discomfort, generalized edema, chills, peripheral coldness, drug withdrawal syndrome, drug adverse reactions, decreased body temperature, procedure-related pain, increased ALT, abnormal electrocardiogram, eosinophilia, increased AST, leukopenia, elevated blood glucose, decreased hemoglobin, decreased hematocrit, hypothermia, decreased blood pressure, elevated transaminases, increased gamma-glutamyl transferase, elevated liver enzymes, agranulocytosis, thrombocytopenia, abnormal secretion of antidiuretic hormone, diabetic ketoacidosis, diabetes mellitus, hypoglycemia, water intoxication, thromboembolism, vascular edema, alopecia, neonatal drug withdrawal syndrome, urinary retention, priapism, hypothermia, atrial fibrillation, deep vein thrombosis, pulmonary embolism, sleep apnea syndrome, intestinal obstruction, pancreatitis, jaundice, anaphylactic reaction, fall, orthostatic hypotension, syncope, extrapyramidal symptoms, musculoskeletal rigidity, cogwheel rigidity, akinesia, bradycardia, reduced mobility, mask-like face, muscle rigidity, restlessness, muscle spasms, involuntary contraction of muscles, muscle tightness, ocular deviation, tongue paralysis, tremors, chorea, choreoathetoid movement, movement disorders, muscle cramps, psychomotor agitation, akinesia, paresthesia, head discomfort, eyelid spasms, eye movement disorders, dizziness, priapism, drug hypersensitivity, hypertension, musculoskeletal pain, walking abnormalities, pain, falls, suicidal attempts, accident abnormalities, delusions, hallucinations, exacerbation of symptoms

This medication should be stored in a tightly sealed container to protect it from air and moisture. The storage temperature should be maintained between 1 degree and 30 degrees Celsius to ensure the prolonged efficacy and safety of the drug.

Appearance

Elliptical white film-coated tablet

Package unit

For domestic use - 30 tablets/bottle, For domestic use - 200 tablets/bottle