Itakserivastigmine Capsule 4.5 mg (Rivastigmine Tartrate)

Adult dose

Directions for use: Rivastigmine is administered orally twice daily, in the morning and evening, with meals. ○ Adults: 1. Treatment of symptoms of mild to moderate Alzheimer-type dementia The initial dose is 3mg/day of rivastigmine. The dose should be increased at intervals of at least 2 weeks for each patient to the maximum tolerated dose or the maximum recommended dose of 12mg/day. Because clinical trials showed greater efficacy at doses of 6mg/day or higher, a target dose range of 6~12mg/day is recommended for most patients. Recommended dose titration Administer 1.5mg per dose twice daily for at least 2 weeks. If well tolerated, the dose may be increased to 3mg per dose twice daily. Subsequent increases may be made to 4.5mg per dose twice daily, and, if well tolerated, after at least 2 weeks to 6mg per dose twice daily. If adverse reactions (e.g., nausea, vomiting, abdominal pain, or decreased appetite) or weight loss occur, one or more doses may be omitted. However, if adverse reactions or weight loss persist, reduce the daily dose to the previous well-tolerated dose. 2. Treatment of symptoms of mild to moderate dementia associated with Parkinson's disease In a controlled clinical trial in patients with dementia associated with Parkinson's disease, rivastigmine was administered at 3~12mg/day in 2 divided doses. (1.5~6mg per dose twice daily.) The initial dose is 1.5mg per dose twice daily. Depending on the patient's tolerability, the dose may then be increased sequentially at intervals of at least 4 weeks between dose levels to 3mg per dose twice daily, then 4.5mg per dose twice daily, and then 6mg per dose twice daily. If adverse reactions (e.g., nausea, vomiting, abdominal pain, or decreased appetite), weight gain, or extrapyramidal symptoms (e.g., tremor) occur during treatment, withholding one or more doses may reduce these symptoms. If adverse reactions persist, the daily dose may be temporarily reduced to the previous well-tolerated dose, or discontinuation of treatment may be considered. 3. Maximum recommended dose Administer 6mg per dose orally twice daily. 4. Reinitiation of treatment The incidence and severity of adverse reactions generally increase at higher doses. If treatment is interrupted for more than 3 days, restart at the lowest daily dose and titrate as described above. ○ Patients with hepatic or renal impairment: 1. Exposure is increased in patients with moderate renal impairment and mild to moderate hepatic impairment, and more adverse reactions may occur. Therefore, take particular care when titrating the dose according to individual tolerability. 2. Do not administer to patients with severe hepatic impairment, as no studies have been conducted in this population.

Child dose

○ Pediatric patients: This medicine has not been studied in pediatric patients; therefore, its use in children is not recommended.

This medication should not be used in patients with allergies to certain components. It may be dangerous for patients with severely impaired liver function, so administration should be avoided. Patients who have experienced skin allergic reactions when using this medication in patch form should also avoid its use. Patients with history of heart problems, gastric ulcers, asthma, urinary retention, or seizures should be especially cautious when using this medication. This medication may cause side effects such as gastrointestinal disturbances, dizziness, drowsiness, headaches, etc., and these symptoms may be more common during the initial dose or when adjusting the dosage. Parkinson's disease patients may experience exacerbation of symptoms while taking this medication, so caution is required. During treatment, weight loss or dehydration symptoms may occur, so regular monitoring of the condition is necessary. This medication may interact with other medications, so if you are taking other medications, you must inform your doctor or pharmacist. Pregnant or breastfeeding women should consult a doctor before taking this medication and should avoid it while breastfeeding. It is not recommended for use in children as safety and efficacy have not been established. In cases of overdose, symptoms such as nausea, vomiting, bradycardia, confusion may occur, so if you experience any abnormal symptoms, you should seek medical attention immediately. Store this medication out of reach of children and do not transfer it to another container.

• nausea
• vomiting
• urinary tract infection
• agitation
• confusion
• nightmares
• anxiety
• insomnia
• depression
• hallucinations

This medication should be stored in a well-sealed container to avoid exposure to air or moisture. It is best to keep it at room temperature between 1 °C and 30 °C.

Appearance

A hard capsule of red color containing white-yellowish powder

Package unit

28 capsules/box [14 capsules/PTP×2]