Shinil Risperidone Tablets 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. 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 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 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 administered concomitantly if an additional sedative effect 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 an existing antipsychotic to this medicine When medically appropriate, start this medicine while gradually reducing the dose of the existing medicine. Also, when switching from an existing depot antipsychotic medicine, when medically appropriate, start 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 for 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 justification for 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 more. The optimal dose for most patients is within the range of 2∼6 mg per day. As with symptomatic treatment, the justification 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

· 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 drug 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.

This medication should be used with special caution in elderly patients with dementia as it may increase mortality. Particularly, the risk of death may increase when this medication is used together with furosemide, and the risks and benefits should be well considered before concomitant use. Moreover, precautions should be taken to prevent dehydration during the use of this medication, as cerebrovascular-related adverse reactions may appear more frequently in elderly dementia patients. This medication may increase the risk of thromboembolic diseases, such as venous thromboembolism, so thromboembolic risk factors should be reviewed and preventive measures taken before and during administration. Contains aspartame, an artificial sweetener, so precautions are required for patients with phenylketonuria. This medication should not be administered to patients who are hypersensitive to it, in a state of central nervous system depression or coma, those receiving epinephrine, and patients with certain genetic lactose intolerance disorders. Patients with cardiovascular diseases, decreased liver or kidney function, a history of seizures, suicidal risk, elderly patients, pregnant women, and nursing mothers should be administered with caution. While taking this medication, side effects such as drowsiness, dizziness, hypotension, insomnia, anxiety, and Parkinsonian symptoms may occur, and consultation with a physician is advised upon symptom occurrence. Additionally, as there are many interactions with other medications, caution is needed when used with central nervous system depressants, antihypertensive medications, or drugs related to CYP2D6 or CYP3A4. Pregnant women should preferably avoid use except in special circumstances as it may affect the fetus, and nursing mothers should discontinue breastfeeding. This medication may affect activities requiring concentration, such as driving or operating machinery, so it is recommended to avoid such activities during the initial period of administration. In case of overdose, immediate medical attention is required, and this medication should be stored out of the reach of children.

• Increased mortality
• cerebrovascular adverse reactions
• venous thromboembolism
• nasopharyngitis
• upper respiratory infection
• sinusitis
• urinary tract infection
• anemia
• hypersensitivity reactions
• insomnia

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is also recommended to store it at room temperature between 1 and 30 degrees Celsius, avoiding extremes of heat or cold.

Appearance

Oblong white film-coated tablets

Package unit

Bottle - 30 tablets/bottle, Bottle - 200 tablets/bottle