Rivastigmine Capsule 3.0mg (Rivastigmine Tartrate)

Adult dose

Dosage and Administration: Rivastigmine should be administered orally twice daily, in the morning and evening, with meals. ○ Adults: 1. Treatment of mild to moderate symptoms of Alzheimer-type dementia The initial dose is 3mg of rivastigmine per day, and 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 per day. Since this drug showed greater efficacy at doses of 6mg per day and above in clinical trials, a target dose range of 6~12mg per day is recommended for most patients. Recommended dose titration schedule Administer 1.5mg of this drug twice daily for at least 2 weeks; if well tolerated, the dose may be increased to 3mg twice daily. Subsequent dose increases may be made to 4.5mg twice daily and, if well tolerated for at least 2 weeks, to 6mg 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 previous dose that was well tolerated. 2. Treatment of mild to moderate symptoms of 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, divided into 2 daily doses. (1.5~6mg per dose was administered twice daily.) The initial dose is 1.5mg of this drug twice daily. At intervals of at least 4 weeks between dose levels, the dose may then be increased sequentially according to the patient's tolerability to 3mg twice daily, then 4.5mg twice daily, and then 6mg twice daily. If adverse reactions (for example, nausea, vomiting, abdominal pain, or decreased appetite), weight gain, or extrapyramidal symptoms (for example, tremor) are observed during treatment, interrupting treatment for 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 of this drug 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 these patients.

Child dose

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

This medication should not be used in patients with allergies to specific ingredients or severe liver dysfunction. Patients with heart disease, gastric ulcers, asthma, urinary retention, seizures, or extrapyramidal disorders should use this medication with caution. Gastrointestinal symptoms such as nausea, vomiting, and diarrhea may frequently occur during treatment, requiring dosage adjustments. Neurological symptoms such as dizziness, drowsiness, and tremors may also occur, necessitating caution. This medication may enhance the effects of other cholinergic drugs and increase side effects when used together, hence caution is advised for combination therapy. During anesthesia, this medication can enhance the effects of muscle relaxants, so it should be discontinued for a certain period before anesthesia. The safety of this medication during pregnancy has not been established due to potential risks to the fetus; it should only be used when absolutely necessary. It is advisable to avoid use while breastfeeding. Safety and efficacy in pediatric patients have not been confirmed, so it is not recommended for children. Overdose may present symptoms such as vomiting, diarrhea, bradycardia, and confusion, and in severe cases, may be life-threatening, necessitating immediate medical assistance. During treatment with this medication, weight loss and worsening of motor function may occur, thus regular monitoring is required. Caution is needed as dizziness or drowsiness may occur when driving or operating machinery. This medication should be stored in a safe place out of reach of children, and transferring to another container should be avoided.

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

This medication may be sensitive to air and moisture, so it must be stored in a tightly sealed container. Ideal storage temperature should be kept between 1 to 30 degrees Celsius. This helps maintain the drug's efficacy and safety over time.

Appearance

An orange hard capsule containing white powder

Package unit

28 capsules (14 capsules x 2 in PTP packaging)