Hanwha Risperidone Tablets 1 mg

Adult dosage

1. Schizophrenia Adults Initial dose: Administer 1 mg of risperidone orally twice daily and increase the dose gradually. Maintenance dose: Administer 1∼3 mg twice daily. Adjust the dose appropriately according to age and symptoms. No additional benefit was observed with doses of 10 mg or more daily compared with lower doses, and such doses may increase the risk of extrapyramidal symptoms. Doses of 10 mg or more daily should be administered only when the benefits for the individual patient are judged to outweigh the risks. Do not administer doses of 16 mg or more daily, as safety has not been established. A benzodiazepine may be administered concomitantly if additional sedation is required. 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. 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 medically appropriate, when switching from an existing depot antipsychotic, start this medicine in place of the next scheduled injection of the depot preparation. 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 necessary, 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, 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 up to 1 mg daily at intervals of at least 24 hours. The optimal dose for most patients is within the range of 2∼6 mg daily. 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).

Children's dosage

1. Schizophrenia There is insufficient clinical experience in children and adolescents under 15 years of age. 3. Adjunctive therapy for manic episodes in bipolar disorder There is insufficient 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, depending on the patient, the dose may be increased by 0.5 mg daily 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 daily 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 in elderly patients with dementia, as it may increase the risk of death. When used in conjunction with another diuretic, Furosemide, the mortality may further increase, so the risks and benefits should be carefully considered before co-administration. This drug may increase the risk of thrombosis, particularly venous thrombosis, so thrombotic risk factors should be assessed and preventive measures taken before and during treatment. It contains aspartame, an artificial sweetener, and should be used with caution in patients with certain genetic disorders such as phenylketonuria. This medication should not be administered to patients with hypersensitivity to it, patients who are suppressed by alcohol or central nervous system depressants, patients in a coma, those receiving epinephrine, and certain genetically lactose intolerant patients. Patients with cardiovascular diseases, liver or kidney dysfunction, a history of seizures, suicidal risks, Parkinson's disease, diabetes, and the elderly, as well as pregnant and lactating women, should have their dosage adjusted and monitored more carefully. This medication may cause various side effects such as drowsiness, dizziness, hypotension, Parkinsonism, insomnia, nausea, constipation, weight gain, etc., and if any abnormal symptoms occur, immediate consultation with healthcare professionals is necessary. This drug has central nervous system depressant effects, so caution is advised when taken with alcohol or other central nervous system depressants, as symptoms may worsen. If a pregnant woman takes this medication, extrapyramidal symptoms or withdrawal symptoms may occur in the newborn, so it should only be taken after consulting a doctor during pregnancy. While breastfeeding, it is recommended to discontinue breastfeeding, as this medication may be transmitted through breast milk. In case of overdose, severe drowsiness, hypotension, arrhythmia, seizures, etc., may occur, requiring immediate emergency care, and there is no antidote for this medication. This drug should be kept out of reach of children, and transferring to another container may affect the quality.

• Increased mortality
• stroke
• transient ischemic attack
• venous thrombosis
• nasopharyngitis
• upper respiratory infection
• sinusitis
• urinary tract infection
• anemia
• hypersensitivity reaction

This medication can be sensitive to air or moisture, so it should be stored in a sealed container. It is important to maintain a storage temperature between 1 to 30 degrees Celsius to safely preserve the drug's effectiveness.

Appearance

Oblong white film-coated tablet

Package unit

30 tablets/bottle, 200 tablets/bottle