Exelon Capsule 1.5 mg (Rivastigmine Tartrate)

Adult dose

Method of administration: Administer rivastigmine orally twice daily with breakfast and dinner. ○ Adults: 1. Treatment of mild to moderate Alzheimer's dementia The initial dose is 3 mg of rivastigmine per day. Increase the dose at intervals of at least 2 weeks for each patient to the highest tolerated dose or the maximum recommended dose of 12 mg per day. Since this medicine showed greater efficacy in clinical trials at doses of 6 mg per day and higher, a target dose range of 6~12 mg per day is recommended for most patients. Recommended dose titration Administer 1.5mg 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 are observed, 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 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 3~12 mg per day in 2 divided doses. (1.5~6mg per dose twice daily.) The initial dose is 1.5mg per dose twice daily. Depending on the patient's tolerability, subsequent doses may be increased consecutively at intervals of at least 4 weeks 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) are observed during treatment, withholding 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 6 mg 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: 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

○ Pediatric patients: This medicine has not been studied in pediatric patients; therefore, its use is not recommended in pediatric patients.

This medication should not be used in patients with specific allergic reactions or severe liver disorders. Patients with a history of heart disease, gastric ulcers, asthma, seizures, or urinary retention should use with caution. During the initial dose or when increasing the dose, gastrointestinal symptoms such as nausea, vomiting, and diarrhea may occur; these symptoms can be alleviated with dose adjustment. Patients with dementia may experience dizziness or drowsiness, so caution is needed when driving or operating machinery. This medication may affect heart rate, so patients with heart-related conditions should consult a doctor. Women who are pregnant or breastfeeding should consult a physician before taking this medication. It is not recommended for children, and overdose may result in symptoms such as vomiting, tremors, bradycardia, and immediate medical attention should be sought. There may be interactions when taken with other medications, so inform healthcare providers of all current medications. It is important to regularly monitor weight changes during the use of this medication. Store the medication out of the reach of children and avoid transferring it to other containers.

Nausea, vomiting, urinary tract infection, agitation, confusion, nightmares, anxiety, insomnia, depression, hallucinations, dizziness, headache, drowsiness, tremor, syncope, convulsions, extrapyramidal symptoms, angina, myocardial infarction, deep vein thrombosis, bradycardia, heart block, atrial fibrillation, tachycardia, 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, syndrome of inappropriate secretion of antidiuretic hormone, tremor, bradykinesia, dyskinesia, cogwheel rigidity, hypokinesia, muscle rigidity, dehydration, salivary gland secretion, gait disturbances, muscle stiffness, balance disorders, musculoskeletal rigidity, rigidity, motor dysfunction, urinary incontinence, cerebrovascular accident, delirium, erythema, urticaria, blisters, allergic dermatitis, tremor, somnolence, confused state, lethargy, salivation, hypotension, respiratory depression, muscle weakness, confused state, aggression, restlessness, dysautonomia, hepatitis, allergic contact dermatitis, inability to sit still, sensory disturbance, confusion, delirium, pneumonia, sepsis

This medication may be sensitive to air or moisture, so it must be stored in a tightly sealed container. It is important to maintain a storage temperature between 1 and 30 degrees Celsius to safely preserve its efficacy.

Appearance

Capsule of yellow color with white powder inside

Package unit

30 capsules/bottle, 100 capsules/bottle