Samsung Rivastigmine Capsule 6.0 mg (Rivastigmine Tartrate)

Adult dose

Administration: Rivastigmine is administered orally twice daily with breakfast and the evening meal. ○ Adults: 1. Treatment of mild to moderate dementia of the Alzheimer's type The initial dose is 3mg of rivastigmine per day. For each patient, increase the dose at intervals of at least 2 weeks to the highest tolerated dose or the maximum recommended dose of 12mg per day. Because 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 of this medicine twice daily for at least 2 weeks. If well tolerated, the dose may be increased to 3mg twice daily. The next increase is to 4.5mg twice daily; if well tolerated, after at least 2 weeks the dose may be increased 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, reduce the daily dose to the last 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 3~12mg per day in two divided doses (1.5~6mg twice daily). The initial dose is 1.5mg of this medicine twice daily. Depending on the patient's tolerability, subsequent doses may be increased consecutively, with a minimum interval of 4 weeks between each dose level: first to 3mg twice daily, then to 4.5mg twice daily, and then to 6mg twice daily. If adverse reactions (e.g., nausea, vomiting, abdominal pain, or loss of appetite), weight gain, or extrapyramidal symptoms (e.g., tremor) are observed during treatment, these symptoms may decrease if one or more doses are withheld. If adverse reactions persist, temporarily reduce the daily dose to the last well-tolerated dose or consider discontinuing treatment. 3. Maximum recommended dose Administer 6 mg of this medicine orally twice daily. 4. Reinitiation of treatment The frequency and severity of adverse reactions generally increase with 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

This medicine has not been studied in children; therefore, its use in children is not recommended.

This drug should not be used in patients with allergies to certain components or severe liver dysfunction. Additionally, patients who have had allergic reactions on their skin after using this drug should avoid administration. It should be used with caution in patients with a history of heart disease, peptic ulcers, asthma, urinary retention, or seizures. This drug can cause gastrointestinal symptoms such as nausea, vomiting, and diarrhea, especially at the initial treatment or when increasing the dosage. Female patients may experience gastrointestinal-related side effects more frequently than males. Neurological symptoms such as dizziness, headache, drowsiness, and tremors may also commonly occur, so caution is needed when driving or operating machinery. Patients with Parkinson's disease may have worsening symptoms from taking this drug, so they should adjust the dosage according to their doctor's instructions. Weight loss may occur, so it is important to monitor weight changes during treatment. This drug may interact with other cholinergic or anticholinergic medications, so caution is needed when taking them together. Women who are pregnant or nursing should consult their doctor about using this drug and should preferably not use it while breastfeeding. Safety and efficacy in children have not been established, so it is not recommended. In case of overdose, severe vomiting, bradycardia, confusion, and other symptoms may occur, and immediate medical assistance should be sought. This drug should be kept out of the reach of children, and it is advisable not to transfer it to other containers during storage.

Area, vomiting, urinary tract infection, restlessness, confusion, nightmares, anxiety, insomnia, depression, hallucinations, dizziness, headache, drowsiness, tremors, syncope, seizures, extrapyramidal symptoms, angina, myocardial infarction, deep vein thrombosis, bradycardia, atrioventricular 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, mucosal syndrome, tremors, hypokinesia, dyskinesia, cogwheel rigidity, hypomimia, reduced appetite, dehydration, increased perspiration, gait disturbance, muscle hypertonia, urinary incontinence, cerebrovascular accident, delirium, erythema, urticaria, blisters, allergic dermatitis, aggression, restlessness, dysautonomia syndrome, hepatitis, allergic skin dermatitis, constipation, inability to maintain sitting position, sensory abnormalities, confusion, somnolence, pneumonia, sepsis, tremors, hypersomnia, confusional state, lethargy, salivation, hypotension, respiratory depression, muscle weakness, syncope due to vagal tone effects on cardiac activity, movement disorders, muscle rigidity, balance disorders, musculoskeletal rigidity, rigidity, motor dysfunction

This drug should be stored in a tightly closed container to protect it from air and moisture. Additionally, it is best to keep it at room temperature, that is, between 1 degree and 30 degrees Celsius, avoiding extremes.

Appearance

Red top and orange bottom hard capsules containing a white to light yellow powder.

Package unit

28 capsules (14 capsules/PTP x 2)