Itaxrivastigmine Capsule 6.0 mg (Rivastigmine Tartrate)

Adult dose

Administration: Rivastigmine is administered orally twice daily with the morning and evening meals. ○ Adults: 1. Treatment of mild to moderate dementia of the Alzheimer’s type The initial dose is rivastigmine 3mg per day, and the dose should be increased at intervals of at least 2 weeks for each patient up 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 Administer 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. Subsequent increases may be made to 4.5mg per dose twice daily and, if well tolerated for 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 previous 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 3~12mg per day was administered in 2 divided doses. (1.5~6mg per dose was administered twice daily.) The initial dose is 1.5mg per dose twice daily. At intervals of at least 4 weeks between each dose, and according to patient tolerability, the dose may be increased sequentially to 3mg per dose twice daily, then 4.5mg per dose twice daily, and then 6mg per dose twice daily. If adverse reactions (such as nausea, vomiting, abdominal pain, or decreased appetite), weight gain, or extrapyramidal symptoms (such as 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 treatment discontinuation may be considered. 3. Maximum recommended dose Administer 6 mg 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, and more adverse reactions may occur. Therefore, take particular care when titrating the dose according to individual tolerability. 2. No studies have been conducted in patients with severe hepatic impairment; do not administer this medicine.

Child dose

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

This medication should not be used in patients with allergies to specific ingredients or severe liver impairment. Furthermore, patients who have had allergic contact dermatitis from this medication in the past should avoid its administration. Caution is advised for patients with heart disease, gastric ulcers, asthma, urinary retention, seizures, or extrapyramidal disorders. Gastrointestinal disturbances such as nausea, vomiting, and diarrhea may occur during the initial dosage or when increasing the dosage, so monitoring is necessary. This medication may cause neurological adverse reactions such as dizziness or drowsiness, so caution should be exercised when driving or operating machinery. Patients with Parkinson's disease may experience worsening symptoms when taking this medication; therefore, dosage adjustments should be made under a doctor's guidance. Weight loss may occur, so regular monitoring of weight changes is advised during treatment. Use during pregnancy or breastfeeding should be approached with caution as its safety has not been sufficiently established. Interactions may occur when taken with other medications, so consultation with a doctor or pharmacist is recommended before use. In cases of overdose, severe vomiting, bradycardia, and confusion may occur, requiring immediate medical assistance. The safety and efficacy of this medication in children have not been established; therefore, it is not recommended for use in pediatric patients. When storing, keep it out of reach of children and avoid changing containers.

nausea, vomiting, urinary tract infection, restlessness, confusion, nightmares, anxiety, insomnia, depression, hallucinations, dizziness, headache, drowsiness, tremor, fainting, convulsions, extrapyramidal symptoms, angina pectoris, myocardial infarction, deep vein thrombosis, hypertension, diarrhea, anorexia, 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, tremor, bradykinesia, dyskinesia, cogwheel rigidity, hypokinesia, bradycardia, atrial fibrillation, heart block, decreased appetite, dehydration, increased perspiration, gait disturbance, hypertension, hypotension, urinary incontinence, cerebrovascular accident, delirium, erythema, hives, blisters, allergic dermatitis, trembling, somnolence, confused state, salivation, hypotension, respiratory depression, muscle weakness, fainting, lethargy, constipation, inability to sit cross-legged, sensory disturbance, disorientation, personality disorder, confusion, pneumonia, sepsis, dehydration, aggression, restlessness, syndrome of inappropriate antidiuretic hormone secretion, hepatitis

This medication should be stored in a tightly closed container to prevent air and moisture from entering. It is best to keep it at room temperature between 1 degrees and 30 degrees Celsius.

Appearance

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

Package unit

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