Rivastigmine Capsule 1.5 mg (Rivastigmine Tartrate)

Adult dosage

Administration: Rivastigmine is administered orally twice daily with the morning and evening meals. ○ Adults: 1. Treatment of mild to moderate dementia of the Alzheimer type The initial dose is 3mg of rivastigmine per day. For each patient, increase the dose at intervals of at least 2 weeks to the highest tolerated dose or the maximum recommended dose of 12mg per day. Since this medicine showed greater efficacy in clinical trials 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 of this medicine per dose twice daily for at least 2 weeks; if well tolerated, the dose may be increased to 3mg 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 last dose that was well tolerated. 2. Treatment 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 in 2 divided doses. (1.5~6mg per dose, twice daily.) The initial dose is 1.5mg of this medicine per dose twice daily. At intervals of at least 4 weeks between dose levels, the dose may subsequently be increased 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, these symptoms may lessen if treatment is withheld for one or more doses. 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 6 mg of this medicine per dose orally twice daily. 4. Restarting treatment 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, which may result in more adverse reactions. 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 this population.

Children's dosage

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

This medication contains the active ingredient rivastigmine and should not be administered to specific patients. In particular, patients who are hypersensitive to this medication or have severe liver dysfunction should not use it. Additionally, patients who have previously experienced allergic contact dermatitis from using the patch formulation of this medication should avoid it. Patients with heart disease, gastric ulcers, asthma, obstructive pulmonary disease, urinary retention, seizures, or extrapyramidal disorders should use this medication with caution. This medication can commonly result in gastrointestinal adverse reactions such as nausea, vomiting, and diarrhea, particularly during the initial dose or during dosage adjustments. Neurological and psychiatric adverse reactions such as dizziness, headache, drowsiness, tremors, anxiety, and insomnia have also been reported. Rarely, symptoms like cardiac arrhythmias, skin rashes, weight loss, and fatigue may occur. In patients with Parkinson's related dementia, tremors or motor disorders may worsen, necessitating caution. When used with anesthetics, this medication can enhance the effect of muscle relaxants, so it should be discontinued a certain period before anesthesia. Caution should be taken when combined with other cholinergic medications as it may enhance effects or increase side effects. Women who are pregnant or breastfeeding should only use this medication when absolutely necessary, under the judgement of a physician, as its safety has not been sufficiently established. Safety in children has not been confirmed, and its use in children is not recommended. In case of overdose, symptoms such as nausea, vomiting, dizziness, bradycardia, and confusion may occur, and severe cases may require urgent treatment. If these symptoms occur, the medical staff should be notified immediately. During the treatment with this medication, regular weight monitoring is necessary, and if adverse reactions persist or worsen, it is advisable to consult a physician. Additionally, it must be stored out of reach of children, and it is recommended not to transfer to other containers.

• nausea
• vomiting
• dizziness
• headache
• drowsiness
• tremor
• fainting
• convulsion
• angina
• myocardial infarction

This medication should be stored in a tightly sealed container to prevent exposure to air and moisture. It is best to store it at room temperature between 1 and 30 degrees Celsius.

Appearance

A capsule with white powder, upper yellow part

Package unit

30 capsules/bottle, 100 capsules/bottle