Monsti Capsule 3mg (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 3 mg 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 12 mg per day. Since this medicine showed greater efficacy at doses of 6 mg per day and higher in clinical trials, a target dose range of 6~12 mg per day is recommended for most patients. Recommended dose titration After administering 1.5 mg per dose twice daily for at least 2 weeks, the dose may be increased to 3 mg per dose twice daily if well tolerated. Subsequent increases may be made to 4.5 mg per dose twice daily, followed by 6 mg per dose twice daily after at least 2 weeks if well tolerated. 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 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 per 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, the dose may subsequently be increased in succession according to patient tolerability to 3 mg per dose twice daily, then 4.5 mg per dose twice daily, and then 6 mg 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, omitting one or several doses 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 3 days or longer, 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

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

This medication contains the ingredient rivastigmine and should not be used in certain patients. For example, individuals who have had an allergic reaction to this medication, those with severe liver impairment, and those who have experienced skin allergic reactions when using this drug's patch should not take it. Patients with a history of heart issues, gastric ulcers, asthma, urinary obstruction, seizures, or extrapyramidal disorders should use this medication cautiously, as these conditions may worsen. Taking this medication may lead to gastrointestinal and neurological adverse reactions such as nausea, vomiting, diarrhea, dizziness, and headaches. Particularly, gastrointestinal disturbances and weight loss are reported to occur more frequently in female patients. In patients with dementia associated with Parkinson's disease, tremors or motor disabilities may worsen, requiring careful monitoring. Using this medication in conjunction with other cholinergic drugs may enhance effects or increase side effects, so caution is advised when combined. In particular, the risk of cardiac-related side effects may increase when used with anesthetics, beta-blockers, or QT interval prolonging medications. Women who are pregnant or breastfeeding should use this medication only if absolutely necessary, under a physician's guidance, as its safety has not been adequately confirmed. This medication is not recommended for children as its safety and efficacy have not been established. In cases of overdose, symptoms such as vomiting, diarrhea, bradycardia, confusion, and convulsions may occur, thus immediate contact with a medical institution is required, where an antidote such as atropine may be used if necessary. Regular monitoring of weight and adverse reactions is advised during the course of this medication, and caution should be exercised regarding dizziness or drowsiness while driving or operating machinery. Finally, it is safe to store this medication out of reach of children and not to transfer it to other containers.

Nausea, vomiting, urinary tract infection, agitation, confusion, nightmares, anxiety, insomnia, depression, hallucinations, dizziness, headache, drowsiness, tremors, syncope, seizures, extrapyramidal symptoms, angina, myocardial infarction, deep vein thrombosis, hypertension, diarrhea, loss of appetite, abdominal pain, indigestion, gastric ulcer, duodenal ulcer, gastrointestinal bleeding, pancreatitis, esophageal rupture, increased sweating, rash, itching, fatigue, weakness, malaise, falls, weight loss, abnormal liver function test results, Stevens-Johnson syndrome, tremor, akinesia, dyskinesia, cogwheel rigidity, bradykinesia, bradycardia, atrial fibrillation, heart block, decreased appetite, dehydration, increased sweating, gait disturbances, hypertension, hypotension, urinary incontinence, cerebrovascular accident, delirium, erythema, hives, blisters, allergic dermatitis, tremor, somnolence, altered mental status, salivation, hypotension, respiratory depression, muscle weakness, syncope, malaise, constipation, dysesthesia, cognitive disturbance, confusion, pneumonia, sepsis, aggression, restlessness, syndrome of inappropriate antidiuretic hormone secretion, hepatitis

This medication should be stored in a tightly closed container to prevent air or moisture ingress, and it is advisable to keep it at a temperature between 1 and 30 degrees Celsius. This will help maintain the potency of the medication and prevent degradation.

Appearance

A capsule filled with a white to off-white powder in a brownish-yellow hard capsule.

Package unit

30 capsules/bottle, 100 capsules/bottle