Rivastigmine Capsule 1.5mg (Rivastigmine Tartrate)

Adult dose

Administration: Administer rivastigmine orally twice daily with the morning and evening meals. ○ Adults: 1. Treatment of symptoms of mild to moderate Alzheimer-type dementia The initial dose is 3mg of rivastigmine per day. Increase the dose at intervals of at least 2 weeks for each patient to the maximum tolerated dose or the maximum recommended dose of 12mg per day. Because this drug showed greater efficacy in clinical trials at doses of 6mg per day and above, 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 for 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 controlled clinical trials in patients with dementia associated with Parkinson's disease, rivastigmine was administered at 3~12mg per day, divided twice daily (1.5~6mg per dose twice daily). The initial dose is 1.5mg per dose twice daily. At intervals of at least 4 weeks between dose levels, the dose may be increased sequentially according to the patient's tolerability 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, omitting one or more doses may reduce these symptoms. If adverse reactions persist, temporarily reduce the daily dose to the previously well-tolerated dose or consider discontinuing treatment. 3. Maximum recommended dose Administer 6 mg of this drug per dose orally twice daily. 4. Restarting 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

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

This medication should not be used in certain patients. For example, it must be avoided by patients with allergies to the active ingredient or other components, those with severe liver impairment, and those who have experienced skin allergic reactions while using the transdermal patch of this medication. Additionally, patients with heart disease, peptic ulcers, asthma, obstructive pulmonary disease, urinary retention, seizures, and extrapyramidal disorders should use this medication with caution. While taking this medication, gastrointestinal disturbances such as nausea, vomiting, and diarrhea may commonly occur, especially when starting or increasing the dose. If these symptoms are severe, the dosage may be reduced or discontinued. Neurological symptoms such as dizziness, headache, drowsiness, and tremors may also occur, so caution should be exercised when driving or operating machinery. This medication can worsen Parkinson's disease symptoms, thus such patients should take it under strict medical supervision. Weight loss may occur during treatment, so it is important to check weight regularly. This medication may interact with other drugs, especially anesthetics, other cholinergic medications, beta-blockers, and drugs that prolong the QT interval, thus caution is advised when taken in combination. Women who are pregnant or breastfeeding should only use this medication after consulting with a physician, as its safety has not been fully established. It is not recommended for children. In case of overdose, severe symptoms such as nausea, vomiting, bradycardia, and confusion may occur, requiring immediate medical attention. This medication should be kept out of reach of children and should not be transferred to other containers.

• Dizziness
• nausea
• urinary tract infection
• agitation
• confusion
• nightmares
• anxiety
• insomnia
• depression
• hallucination

This medication may be sensitive to air and moisture, so it must be stored in a tightly sealed container. It's important to maintain the storage temperature between 1°C and 30°C. This will help preserve the medication's efficacy and safety for a long time.

Appearance

A hard capsule filled with a white to pale yellow powder, with the lower part being yellow.

Package unit

28 capsules/box [14 capsules/PTP×2 pieces]