Rivastigmine Capsule 3.0 mg (Rivastigmine Tartrate)

Adult dosage

Administration: Rivastigmine is administered orally twice daily, in the morning and evening, with meals. ○ Adults: 1. Treatment of symptoms of mild to moderate Alzheimer-type dementia The initial dose is 3mg of rivastigmine per day. For each patient, the dose should be increased 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 at doses of 6mg per day and 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 medicine 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 twice daily, and, if well tolerated after at least 2 weeks, to 6mg twice daily. If adverse reactions (e.g., nausea, vomiting, abdominal pain, or loss of 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 a controlled clinical trial in patients with dementia associated with Parkinson's disease, rivastigmine was administered at doses of 3~12mg per day, divided into 2 doses. (1.5~6mg per dose, twice daily.). The initial dose is 1.5mg of this medicine twice daily. Depending on the patient's tolerability, subsequent doses may be increased sequentially at intervals of at least 4 weeks to 3mg twice daily, then 4.5mg twice daily, and then 6mg twice daily. If adverse reactions (for example, nausea, vomiting, abdominal pain, or loss of appetite), weight gain, or extrapyramidal symptoms (for example, tremor) are observed during treatment, omitting one or more doses may reduce these symptoms. 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 6mg of this medicine 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, 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.

Children's dosage

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

This drug should not be used in patients with specific allergic reactions or severely impaired liver function. Patients with a history of heart disease, gastric ulcers, asthma, urinary retention, seizures, extrapyramidal disorders should use this drug with caution. Taking this medication can cause gastrointestinal and neurological side effects, such as nausea, vomiting, diarrhea, dizziness, headache, and drowsiness, and gastrointestinal adverse reactions may occur more frequently in female patients. Rare side effects such as skin rash, itching, hypertension, and angina have also been reported. This medication may interact when taken with other muscle relaxants or cholinergic medications, so attention is required. Patients with heart-related conditions should be particularly careful as it may affect heart rate. Patients with a history of gastric ulcers or those taking NSAIDs may have an increased risk of gastrointestinal bleeding; therefore, caution is necessary. For patients with asthma or obstructive lung disease, usage experience is limited, so administration should be cautious. It is crucial to adjust the dosage of this medicine, and abrupt discontinuation or resumption of the medication can result in severe vomiting or esophageal damage, so it must be taken according to a doctor's instructions. During treatment, patients' weight and occurrence of adverse reactions should be monitored consistently, especially as patients with lower body weight may experience side effects more often. This medication may cause dizziness or drowsiness when driving or operating machinery, so caution is needed. Women who are pregnant or breastfeeding should consult their physician before using this drug, as its safety has not been fully established. Safety and efficacy in children have not been confirmed, and therefore, use is not recommended. In case of overdose, symptoms may include nausea, vomiting, diarrhea, bradycardia, confusion, and urgent treatment may be necessary in severe cases. This medication should be stored out of reach of children and not transferred to other containers. During the course of treatment, skin reactions such as allergic dermatitis may occur, so skin conditions should be monitored closely. Additionally, this drug can affect heart rhythms and may cause dangerous arrhythmias, so patients with heart conditions should definitely discuss it with their healthcare providers.

Dizziness, vomiting, headache, drowsiness, tremors, fainting, seizures, extrapyramidal symptoms, angina, myocardial infarction, deep vein thrombosis, hypertension, diarrhea, loss of appetite, abdominal pain, dyspepsia, gastric ulcer, duodenal ulcer, gastrointestinal bleeding, pancreatitis, esophageal rupture, increased sweating, rash, itching, fatigue, weakness, lethargy, falls, weight loss, abnormal liver function test results, mucous membrane syndrome, tremors, bradykinesia, dyskinesia, cogwheel rigidity, hypokinesia, anxiety, insomnia, restlessness, decreased appetite, dehydration, increased perspiration, gait disturbances, urinary tract infection, hallucinations, restlessness, depression, muscle tone abnormalities, bradycardia, atrial fibrillation, heart block, urinary incontinence, cerebrovascular accident, delirium, erythema, urticaria, blisters, allergic dermatitis, tremor, somnolence, confused state, lethargy, saliva secretion, hypotension, respiratory depression, muscle weakness, fainting, aggression, restlessness, syndrome of inappropriate antidiuretic hormone secretion, hepatitis, allergic dermatitis, constipation, inability to sit cross-legged, sensory disturbances, confusion, stupor, pneumonia, sepsis

This medication should be stored in a tightly closed container to prevent exposure to air or moisture. It is important to maintain the storage temperature between 1 and 30 degrees Celsius.

Appearance

A hard capsule with a white to yellowish powder inside, and an orange-colored base.

Package unit

28 capsules (14 capsules/PTP × 2)