Rivastigmine Capsule 1.5 mg (Rivastigmine Tartrate)

Adult dose

Administration: Rivastigmine should be 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 of rivastigmine per day. For each patient, the dose should be increased at intervals of at least 2 weeks to the highest tolerated dose or the maximum recommended dose of 12mg per day. Since clinical trials showed greater efficacy at doses of 6mg per day and higher, a target dose range of 6~12mg per day is recommended for most patients. Recommended dose titration schedule 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 previously 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 per day in 2 divided doses. (1.5~6mg per dose twice daily.). The initial dose is 1.5mg per dose twice daily. Depending on patient tolerability, subsequent doses may be increased sequentially at intervals of at least 4 weeks between each dose level, first to 3mg per dose twice daily, then to 4.5mg per dose twice daily, and then to 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 previously well-tolerated dose or discontinuation of treatment may be considered. 3. Maximum recommended dose Administer 6mg per dose orally twice daily. 4. Reinitiation The frequency 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 with dose titration according to individual tolerability. 2. Do not administer to patients with severe hepatic impairment, as no studies have 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 used in patients who are allergic to the active ingredient or other components. It is recommended not to administer this medication to patients with severely impaired liver function, as its safety has not been established. Patients who have experienced allergic contact dermatitis from using this medication as a patch should also avoid its use. Patients with a history of heart disease, peptic ulcers, asthma, urinary retention, seizures, or extrapyramidal disorders should use this medication with caution. Gastrointestinal disturbances such as nausea, vomiting, and diarrhea may occur at the beginning of treatment or when increasing the dose, and these symptoms can be alleviated by adjusting the dosage. This medication may cause side effects such as dizziness, drowsiness, headache, and fatigue, so caution is needed when driving or operating machinery. In Parkinson's disease patients, symptoms may worsen, so any abnormal signs should be discussed with a doctor. Weight loss may occur during treatment, so it is important to check weight regularly. Women who are pregnant or breastfeeding should be administered this medication cautiously based on a doctor's judgement, as its safety has not been adequately established. This medication is not recommended for use in children. In case of an overdose, symptoms such as nausea, vomiting, bradycardia, and confusion may occur, and severe cases should seek immediate medical attention. This medication may interact with other cholinergic drugs, muscle relaxants, and heart medications, so it is important to inform healthcare providers of any ongoing medications. When storing, keep it out of reach of children and do not transfer it to another container.

• Nausea
• vomiting
• urinary tract infection
• restlessness
• confusion
• nightmares
• anxiety
• insomnia
• depression
• hallucinations

This medication should be stored in a tightly closed container to protect it from air and moisture. Room temperature should be maintained between 1 degree and 30 degrees Celsius. This helps maintain the effectiveness of the medication for a longer period.

Appearance

A hard capsule with a yellow exterior and white to off-yellow powder inside.

Package unit

28 capsules (14 capsules/PTP x 2)