Rivastone Capsule 3.0 mg (Rivastigmine Tartrate)

Adult dose

Administration: Rivastigmine is administered orally twice daily with the morning and evening meals. ○ Adults: 1. Treatment of mild to moderate Alzheimer's dementia The initial dose is 3 mg of rivastigmine daily. For each patient, increase the dose at intervals of at least 2 weeks to the highest tolerated dose or the maximum recommended dose of 12 mg daily. Because this drug showed greater efficacy in clinical trials at doses of 6 mg daily and above, a target dose range of 6~12 mg daily is recommended for most patients. Recommended dose titration Administer this drug at 1.5 mg per dose twice daily for at least 2 weeks. If well tolerated, the dose may be increased to 3 mg twice daily. For subsequent increases, administer 4.5 mg per dose twice daily; if well tolerated, after at least 2 weeks increase to 6 mg per dose twice daily. If adverse reactions (e.g., nausea, vomiting, abdominal pain, or decreased appetite) or weight loss are observed, one or more doses may be omitted. However, if adverse reactions or weight loss persist, reduce the daily dose to the dose that was previously well tolerated. 2. Treatment 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 3~12 mg daily in 2 divided doses (1.5~6 mg per dose twice daily). The initial dose is 1.5 mg per dose twice daily. At intervals of at least 4 weeks between dose levels, and according to patient tolerability, the dose may be increased in sequence to 3 mg per dose twice daily, then 4.5 mg per dose twice daily, and subsequently 6 mg per dose twice daily. If adverse reactions (e.g., nausea, vomiting, abdominal pain, or decreased appetite), weight gain, or extrapyramidal symptoms (e.g., tremor) are observed during treatment, withholding one or more doses may reduce these symptoms. If adverse reactions persist, temporarily reduce the daily dose to the dose previously well tolerated or consider discontinuing treatment. 3. Maximum recommended dose Administer 6 mg of this drug per dose orally twice daily. 4. Resumption of treatment The frequency and severity of adverse reactions generally increase at higher doses. If treatment is interrupted for 3 days or longer, 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 studies have not been conducted in these patients.

Child dose

○ Children: This drug has not been studied in children; therefore, its use in children is not recommended.

This medication should not be administered to patients who are allergic to specific ingredients. It is also advisable not to use this medication in patients with severe liver dysfunction. Caution is required for patients who have experienced dermatitis from transdermal forms of this medication. Patients with cardiac disease, a history of peptic ulcers, asthma, or chronic obstructive pulmonary diseases, as well as those with urinary retention disorders or seizures should be administered cautiously. Additionally, this medication may cause various side effects such as gastrointestinal disturbances, dizziness, drowsiness, tremors, and anxiety; hence, if any abnormal symptoms appear during administration, immediate consultation with a healthcare professional is required. During the initiation of therapy, gastrointestinal symptoms such as nausea, vomiting, and diarrhea may frequently occur; therefore, the dosage should be adjusted slowly. In cases of severe vomiting or dehydration, immediate treatment is necessary. This medication may exacerbate symptoms in Parkinson's disease patients, so it should be used carefully. There may be interactions when this medication is used with other cholinergic or anticholinergic drugs, so consultation with a healthcare professional is essential. Particularly, this medication should be discontinued for a certain period before anesthesia, and regular examinations are needed for patients with heart disease due to potential impacts on heart rate. Women who are pregnant or breastfeeding should consult a physician before use, as the safety of this medication has not been established. Use in children is not recommended. In case of overdose, severe symptoms such as nausea, vomiting, bradycardia, and confusion may occur, and immediate medical attention should be sought, with treatment possibly including atropine. This medication should be stored out of reach of children and not transferred to other containers for safety.

• Nausea
• vomiting
• diarrhea
• weight loss
• urinary tract infection
• anxiety
• confusion
• nightmares
• restlessness
• insomnia

This medication is sensitive to air and moisture; therefore, it should be stored in a tightly sealed container. It's important to maintain a storage temperature between 1 and 30 degrees Celsius at room temperature.

Appearance

Hard capsule containing white to pale yellow powder with orange color on the upper and lower parts

Package unit

28 capsules/box [14 capsules/PTP×2]