Risperidone 1 mg Tablet

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. Initial dose for adults with schizophrenia: Administer risperidone 1 mg orally 2 times daily and increase the dose gradually. Maintenance dose for adults with schizophrenia: Administer 1∼3 mg 2 times daily. Adjust the dose as appropriate according to age and symptoms. 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 for the individual patient are considered to outweigh the risks. Do not administer doses of 16 mg or more per day, as safety has not been established. A benzodiazepine may be administered concomitantly if additional sedation is needed. Elderly patients and patients predisposed to hypotension: The initial dose is 0.5 mg 2 times daily. Depending on the patient's condition, increase the dose by 0.5 mg 2 times daily until reaching 1～2 mg 2 times daily. In general, increases to doses of 1.5 mg or more 2 times daily should be made at intervals of at least 1 week. When switching from an existing antipsychotic to this drug, initiate treatment with this drug while gradually reducing the dose of the existing drug, when medically appropriate. Also, when switching from an existing depot antipsychotic, when medically appropriate, initiate treatment with this drug in place of the next scheduled depot injection. Regularly reassess whether concomitant antiparkinsonian medication needs to be continued. Agitation, aggression, or psychotic symptoms in patients with dementia of the Alzheimer type: The initial dose is 0.25 mg of this drug 2 times daily. If necessary, depending on the patient, the dose may be increased by 0.25 mg per dose, 2 times daily, at intervals of at least 2 days. The optimal dose for most patients is 0.5 mg per dose, 2 times daily, but the dose may be increased to 1 mg per dose, 2 times 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 drug should be evaluated. Adjunctive treatment of mania in bipolar disorder: The recommended initial dose is 2 mg of this drug once daily. Depending on the patient, the dose may be increased by up to 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 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. Use this drug with caution in these patients (see 5. General Precautions)

Child dose

There is insufficient clinical experience in children and adolescents under 15 years of age. There is insufficient 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 drug once daily. If necessary, depending on the patient, the dose may be increased by 0.5 mg per day at intervals of at least 2 days. The optimal dose for most patients 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 necessary, depending on the patient, the dose may be increased by 0.25 mg per day at intervals of at least 2 days. The optimal dose for most patients is 0.5 mg once daily. Depending on the patient, 0.25∼0.75 mg may be administered once daily. There is insufficient clinical experience in children under 5 years of age.

This medication should be used with caution as it may increase mortality when administered to elderly patients with dementia. In particular, when taken with furosemide, the risk of death may be higher, so the risks and benefits should be carefully considered before combination. Due to the risk of venous thromboembolism, factors that may exacerbate thrombosis should be assessed and preventive measures taken before administration. Patients with phenylketonuria should be mindful of the consumption of aspartame, an artificial sweetener included in this medication. This medication should not be administered to patients with known allergy to this drug or its components, severely depressed central nervous system, patients in a coma, patients receiving epinephrine, or patients with certain hereditary lactose intolerance. Caution is required in patients with cardiovascular disease, impaired liver or kidney function, history of seizures, or patients at risk for suicide, and Parkinson's disease. This medication may have various side effects, so the patient's condition should be closely monitored during treatment, and any unusual symptoms should be reported to healthcare professionals immediately. There may be increased CNS depression if taken with other CNS depressants or alcohol. Pregnant or breastfeeding women should consult their doctor before taking this medication, and breastfeeding is especially recommended to be discontinued. Dose adjustments and careful administration are required for children and the elderly, and immediate emergency treatment is needed in case of overdose. It is advisable to avoid activities requiring concentration, such as driving or operating machinery, during treatment with this medication. This medication may interact with certain drugs, so healthcare professionals must be informed of any other medications being taken.

Increased mortality, cerebrovascular adverse reactions, venous thrombosis, nasopharyngitis, upper respiratory infection, sinusitis, urinary tract infection, anemia, hypersensitivity reactions, insomnia, anxiety, nervous excitability, Parkinsonism, akathisia, drowsiness, dizziness, sedation, tremor, muscle tone abnormalities, somnolence, orthostatic dizziness, movement disorders, syncope, blurred vision, ear pain, orthostatic hypotension, tachycardia, hypotension, nasal congestion, dyspnea, epistaxis, 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, 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, cough, runny nose, difficulty swallowing, fecaloma, erythema, abnormal posture, joint swelling, peripheral edema, gait disturbances, pitting edema, elevated body temperature, upper respiratory infection, rhinitis, influenza, increased appetite, middle insomnia, lethargy, headache, stuttering, attention deficit, balance disorders, hypersomnia, palpitations, oropharyngeal pain, pulmonary congestion, itching, acne, myalgia, neck pain, nocturia, polyuria, excess milk secretion, emotional disturbances, lethargy, chest discomfort, weight gain, elevated blood prolactin, anxiety, blunted affect, sleep disorders, decreased libido, sexual dysfunction, depression, nightmares, unresponsive to stimuli, coordination disorders, loss of consciousness, speech disorders, sensory impairment, movement disorders, hyperkinetic movement disorders, cerebral ischemia, cerebrovascular accident disturbances, neuroleptic malignant syndrome, diabetic coma, head tremors, seizures, psychomotor agitation, delayed dyskinesia, cerebrovascular disorders, sensory disturbances, conjunctival hyperemia, ocular discharge, eye movement, eyelid edema, photophobia, scab formation on eyelids, dry eyes, increased lacrimation, glare, glaucoma, vision loss, tinnitus, dizziness, bradycardia, tachycardia, palpitations, first-degree AV block, left bundle branch block, right bundle branch block, heart block, flushing, conduction disturbances, abnormal electrocardiogram, prolonged QT interval on ECG, inferior vena cava, bradycardia, wheezing, aspiration pneumonia, speech disorders, wet cough, airway congestion, rales, respiratory disorders, nasal edema, hyperventilation, fecal incontinence, gastritis, lip edema, cheilitis, salivary deficiency, abdominal distension, gastroenteritis, tongue swelling, dental pain, skin discoloration, skin lesions, skin disorders, erythematous rash, papular rash, generalized rash, papulovesicular rash, eczema, musculoskeletal chest pain, joint rigidity, 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, adverse drug reactions, decreased body temperature, procedure-related pain, ALT elevation, abnormal ECG, eosinophilia, AST elevation, leukopenia, elevated blood sugar, decreased hemoglobin, decreased hematocrit, decreased body temperature, hypotension, transaminase elevation, γ-glutamyl transferase elevation, increased liver enzymes, falls, agranulocytosis, thrombocytopenia, anaphylactic reaction, disturbance in antidiuretic hormone secretion, diabetic ketoacidosis, diabetes, hypoglycemia, water intoxication, increased blood cholesterol, increased blood triglycerides, mania, taste disturbances, intraoperative pupillary 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 retention, priapism, hypothermia, chest pain, liver function abnormalities, hepatitis, dry mouth, xerostomia, urinary retention, polyuria, pain, hiccups, increased sweating, urination disorders, leukopenia, arrhythmia, epistaxis, anemia, diarrhea, hangover, ocular motility seizures, acne, difficulty swallowing, nocturia, tic disorders, dyspnea, Rabbit syndrome, suicide attempts, abnormal thought processes, delusions, hallucinations, exacerbation of auditory hallucinations

This medication may be sensitive to air or moisture; it should be stored in a tightly sealed container. The storage temperature should be kept between 1 to 30 degrees Celsius (room temperature) to maintain the drug's effectiveness for an extended period.

Appearance

Oblong white film-coated tablet

Package unit

30 tablets/bottle, 200 tablets/bottle