Uniriva Capsule 1.5 mg (Rivastigmine Tartrate)

Adult dose

Directions for use: Rivastigmine is administered orally twice daily with the morning and evening meals. ○ Adults: 1. Treatment of mild to moderate Alzheimer-type dementia The initial dose is 3 mg/day of rivastigmine. For each patient, increase the dose at intervals of at least 2 weeks to the highest tolerated dose or the maximum recommended dose of 12 mg/day. Because this drug showed greater efficacy in clinical trials at doses of 6 mg/day or higher, a target dose range of 6~12 mg/day is recommended for most patients. Recommended dose titration Administer 1.5 mg per dose twice daily for at least 2 weeks. If well tolerated, the dose may be increased to 3 mg per dose twice daily. Subsequent increases may be made to 4.5 mg per dose twice daily and, if well tolerated for at least 2 weeks, to 6 mg per dose twice daily. If adverse reactions (e.g., nausea, vomiting, abdominal pain, or loss of 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 previously well-tolerated dose. 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/day in 2 divided doses (1.5~6 mg per dose twice daily). The initial dose is 1.5 mg per dose twice daily. At intervals of at least 4 weeks between dose levels, and according to the patient's tolerability, the dose may be increased successively to 3 mg per dose twice daily, then 4.5 mg per dose twice daily, and subsequently 6 mg per dose twice daily. If adverse reactions (e.g., nausea, vomiting, abdominal pain, or loss of appetite), weight gain, or extrapyramidal symptoms (e.g., tremor) occur during treatment, interrupting administration once or several times may reduce these symptoms. If adverse reactions persist, temporarily reduce the daily dose to the previously well-tolerated dose or consider discontinuing treatment. 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 or 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

○ Children: Use in children is not recommended because this drug has not been studied in children.

This drug contains rivastigmine as its active ingredient and should not be administered to certain patients. For example, patients with allergies to any component of this drug or those with severe liver impairment should not use it, as well as patients who have experienced allergic reactions on the skin when using the patch form of this medication. Additionally, patients with heart disease, peptic ulcers, asthma, urinary retention, seizures, or extrapyramidal disorders should use this drug with caution and under strict medical supervision. Common side effects of this medication include gastrointestinal symptoms such as nausea, vomiting, diarrhea, as well as neurological symptoms such as dizziness, headache, and drowsiness. Notably, in female patients, gastrointestinal-related side effects and weight loss may occur more frequently. Furthermore, in patients with dementia related to Parkinson's disease, symptoms such as tremors, falls, and decreased motor function may worsen, so caution is advised. This drug should be discontinued before anesthesia, and caution should be exercised when used in combination with other cholinergic or anticholinergic medications, as side effects may increase. This medication may affect heart rate, so patients with heart-related diseases should take it under the guidance of a physician, and those with a history of peptic ulcers or who are taking NSAIDs should also be careful. Pregnant or breastfeeding women should use this drug only when the safety for the fetus and newborn has not been sufficiently established and only under medical judgment when necessary. Safety and efficacy for children have not been verified, so it is not recommended. In cases of overdose, serious symptoms such as nausea, vomiting, diarrhea, dizziness, bradycardia, and confusion may occur, and immediate medical care is required. Lastly, this drug must be stored out of the reach of children, and transferring it to another container may lead to deterioration of quality or accidents, so care is necessary.

Nausea, vomiting, urinary tract infection, agitation, confusion, nightmares, anxiety, insomnia, depression, hallucinations, dizziness, headache, drowsiness, tremor, syncope, seizures, extrapyramidal symptoms, angina, myocardial infarction, deep vein thrombosis, bradycardia, atrioventricular block, atrial fibrillation, tachycardia, hypertension, diarrhea, loss of appetite, abdominal pain, indigestion, gastric ulcer, duodenal ulcer, gastrointestinal bleeding, pancreatitis, esophageal rupture, increased sweating, rash, itching, fatigue, weakness, lethargy, falls, weight loss, abnormal liver function test results, mucocutaneous syndrome, tremor, bradykinesia, dyskinesia, cogwheel rigidity, reduced motor activity, decreased appetite, dehydration, increased perspiration, gait disturbance, muscle tone abnormalities, muscle rigidity, balance disorders, musculoskeletal rigidity, rigidity, motor dysfunction, urinary incontinence, cerebrovascular accident, delirium, erythema, hives, blisters, allergic dermatitis, aggression, restlessness, syndrome of inappropriate antidiuretic hormone secretion, hepatitis, allergic skin dermatitis, tremors, hypersomnia, confusion state, sialorrhea, hypotension, respiratory depression, muscle weakness, disorientation, inability to maintain a sitting position, perceptual disturbances, delirium, personality disorders, stupor, pneumonia, sepsis

Store this medication in an airtight container to protect it from air and moisture. It is advisable to maintain a storage temperature between 1 degree and 30 degrees Celsius at room temperature.

Appearance

A hard capsule with a yellow shell containing a white to pale yellow powder

Package unit

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