Rivastigmine Capsule 6mg (Rivastigmine Tartrate)

Adult dose

Directions for use: Rivastigmine is administered 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 per day of rivastigmine, and the dose should be increased at intervals of at least 2 weeks for each patient to the maximum 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 above, a target dose range of 6~12mg per day is recommended for most patients. Recommended dose titration After administration of 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. For subsequent increases, administer 4.5mg per dose twice daily and, if well tolerated, after at least 2 weeks, the dose may be increased to 6mg 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, the daily dose should be reduced 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 twice daily. (1.5~6mg per dose was administered twice daily.). The initial dose is 1.5mg per dose twice daily of this medicine, with a minimum interval of 4 weeks between each dose level; depending on the patient's tolerability, the dose may then be increased sequentially to 3mg per dose twice daily, followed by 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) are observed during treatment, these symptoms may decrease if administration is interrupted once or several times. If adverse reactions persist, temporary reduction of the daily dose to the previously well-tolerated dose or discontinuation of treatment may be considered. 3. Maximum recommended dose Administer 6 mg per dose orally twice daily. 4. Re-initiation The incidence and severity of adverse reactions generally increase at higher doses. If treatment is interrupted for 3 days or longer, 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, so 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 medicine has not been studied in children; therefore, its use in children is not recommended.

This medication should not be used in patients with certain allergic reactions. It should be avoided in patients with severe liver dysfunction as its safety has not been established. Care should be taken when administering to patients with a history of heart disease or a history of peptic ulcers, as well as to patients with asthma or obstructive pulmonary disease. Additionally, careful dosing is required in patients with urinary retention, seizures, or extrapyramidal disorders. This drug may commonly lead to gastrointestinal side effects, such as nausea, vomiting, and diarrhea, particularly during the initial dose adjustment period. Such symptoms may be alleviated by reducing the dose, and patients should consult their doctor if symptoms persist. Neurological adverse reactions may include dizziness, headache, drowsiness, and tremors, and in some patients, symptoms of Parkinson's disease may worsen. Psychiatric symptoms have been reported, including restlessness, confusion, nightmares, and anxiety. Cardiac side effects may include bradycardia or arrhythmias, so caution is needed in patients with a history of heart disease. This medication may enhance effects or interact with other cholinergic drugs, hence it is essential to consult healthcare professionals when taking other medications. Particularly, this medication should be discontinued for a certain period before anesthesia, and the risk of bradycardia may be increased when taken with beta-blockers. Women who are pregnant or breastfeeding should consult a doctor before taking this medication, and it is advisable to avoid use during breastfeeding. Safety and efficacy have not been established in children, and its use is not recommended. In cases of overdose, symptoms such as nausea, vomiting, diarrhea, dizziness, confusion, and bradycardia may occur, and in severe cases, it may become life-threatening, so immediate medical attention is required. When storing this medication, keep it out of reach of children and avoid transferring it to another container. During treatment, it is important to regularly monitor the patient's weight, heart condition, and gastrointestinal symptoms, and if adverse reactions are severe, consider dose adjustment or discontinuation.

• nausea
• vomiting
• dizziness
• headache
• drowsiness
• tremor
• fainting
• convulsion
• extrapyramidal symptoms
• angina pectoris

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. It is important to maintain a storage temperature between 1 and 30 degrees Celsius to preserve the effectiveness and safety of the drug.

Appearance

A hard capsule with a red upper part and an orange lower part containing white to yellowish powder

Package unit

28 capsules/box [14 capsules/PTP x 2]