Rivastigmine Capsule 3mg (Rivastigmine Tartrate)

Adult dose

Administration: Administer rivastigmine orally twice daily with the morning and evening meals. 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: 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. Do not administer to patients with severe hepatic impairment, as no studies have been conducted in these patients.

Child dose

This medicine has not been studied in children; therefore, its use in children is not recommended.

This medication should not be administered to patients with an allergy to certain components. It should be avoided in patients with severe liver dysfunction as its safety has not been confirmed in these patients. Patients who have had skin allergic reactions due to this drug's patch formulation in the past should also not use it. Patients with heart disease, gastric ulcers, asthma, obstructive pulmonary disease, urinary retention, seizures, and extrapyramidal disorders should use this medication cautiously. Gastrointestinal side effects such as nausea, vomiting, and diarrhea are common during treatment, so caution is needed. Neurological adverse reactions such as dizziness, headache, drowsiness, and tremors may also occur. This medication can slow heart rate, so patients with heart-related diseases should be careful. When starting treatment, a low dose should be used initially and gradually increased, and dosage adjustments are important. This medication may enhance the effects of other cholinergic drugs when taken together, so caution is required in combination. It should be discontinued for a certain period before anesthesia, and interactions with other medications should be considered as well. Women who are pregnant or breastfeeding should consult their doctor before taking this medication. There is no appropriate clinical trial for children, so it is not recommended for usage in children. In case of overdose, serious symptoms such as nausea, vomiting, bradycardia, and confusion may occur, so caution is required, and emergency treatment may be needed. This medication should be kept out of reach of children, and it is advisable not to transfer it to another container. During treatment, the patient’s weight and adverse reactions should be monitored regularly, and appropriate measures should be taken in case of adverse reactions.

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

This medication should be stored in a tightly closed container to protect it from air and moisture. It is advisable to maintain a storage temperature between 1°C and 30°C room temperature. This will help maintain the medication's efficacy for a longer period.

Appearance

Orange hard capsules containing a white to light yellow powder

Package unit

28 capsules/box [14 capsules/PTP×2]