Rivastone Capsule 4.5 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 medicine has not been studied in children; therefore, its use in children is not recommended.

This medication should not be used in patients with hypersensitivity to certain ingredients. Its safety has not been confirmed in patients with severely impaired liver function, so it should not be administered. Patients with a history of allergic dermatitis should exercise caution when using the patch formulation of this drug. Patients with heart disease, peptic ulcers, duodenal ulcers, asthma, obstructive pulmonary disease, urinary retention, seizures, and extrapyramidal disorders should be given this medication cautiously. Gastrointestinal symptoms such as nausea, vomiting, and diarrhea may appear at the beginning of treatment or during dosage adjustments, so caution is required, and if these symptoms are severe, consultation with a physician is necessary. This medication can affect heart rate, so patients with heart conditions should undergo an electrocardiogram during treatment. Dizziness or drowsiness may occur during treatment, so caution is needed when driving or operating machinery. Women who are pregnant or breastfeeding should only use this medication when absolutely necessary, as its safety has not been sufficiently established, and it is advisable to avoid breastfeeding. There have been no appropriate clinical trials in children, so its use in pediatrics is not recommended. This medication may interact with other cholinergic or anticholinergic medications, so it is essential to inform the physician. Symptoms such as nausea, vomiting, bradycardia, and confusion may occur in the case of overdose, requiring immediate medical attention. Keep this medication out of reach of children and do not transfer it to other containers for safety.

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

This medication should be stored in a tightly closed container to avoid exposure to air or moisture, preferably at room temperature between 1°C and 30°C. This will help maintain the medication's effectiveness and safety.

Appearance

A hard red capsule containing a white to yellowish powder

Package unit

28 capsules/box [14 capsules/PTP × 2]