Rivastigmine Capsule 3 mg (Rivastigmine Tartarate)

Adult dose

Dosage: Rivastigmine is administered orally twice daily, in the morning and evening with meals. 1. Treatment of symptoms of mild to moderate Alzheimer’s dementia The initial dose is 3mg of rivastigmine per day. For each patient, increase the dose at intervals of at least 2 weeks up to the highest tolerated dose or the maximum recommended dose of 12mg per day. Because this drug showed greater efficacy at doses of 6mg per day or higher 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. Further 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 occur, 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 symptoms 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 3~12mg per day in 2 divided doses. (1.5~6mg per dose twice daily.). The initial dose is 1.5mg of this drug twice daily. At intervals of at least 4 weeks between dose levels, and according to the patient’s tolerability, the dose may be increased sequentially 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) occur during treatment, withholding 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 frequency and severity of adverse reactions generally increase at higher doses. If treatment is interrupted for more than 3 days, restart treatment 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

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

This medication contains the ingredient Rivastigmine and should not be administered to certain patients. For example, patients allergic to this medication or similar components, those with severe liver dysfunction, and patients who have previously experienced allergic skin reactions from this medication's patch formulation should not use it. Additionally, caution should be exercised when administering to patients with heart disease, a history of peptic ulcers or duodenal ulcers, asthma or chronic obstructive pulmonary disease, urinary retention or seizure history, and patients with extrapyramidal disorders. During the use of this medication, gastrointestinal symptoms such as nausea, vomiting, and diarrhea may frequently occur, particularly more during the initial treatment phase or dosage adjustment period. Female patients may experience gastrointestinal adverse reactions and weight loss more often than male patients. This medication can also cause CNS adverse reactions such as dizziness, headache, drowsiness, and tremors, and cardiovascular adverse reactions such as arrhythmia or high blood pressure may occur rarely. Skin rash, itching, fatigue, weakness, and weight loss have also been reported. Caution is particularly necessary for dementia patients related to Parkinson's disease due to the possibility of tremors or worsened motor function. This medication may interact with other drugs; therefore, especially when used with anesthetics, other cholinergic drugs, beta-blockers, and medications that prolong the QT interval, consultation with a healthcare professional is necessary. Women who are pregnant or nursing should use this medication cautiously only when necessary, as its safety has not been fully established. It is advised to avoid taking this medication while breastfeeding. This medication has not been proven safe and effective in children and is not recommended for use. In case of overdose, symptoms such as nausea, vomiting, diarrhea, dizziness, bradycardia, and confusion may occur, and immediate medical assistance should be sought. This medication should be kept out of reach of children and should not be transferred to other containers for safety.

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

This medication is sensitive to air and moisture, so it must be stored in a tightly closed container. The storage temperature should be kept at room temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the medication's effectiveness for a longer period.

Appearance

Orange hard capsule containing white to light yellow powder

Package unit

28 capsules (14 capsules/PTP x 2)