Nexthimin Capsule 3mg (Rivastigmine Tartrate)

Adult dose

○ Adults: 1. Treatment of mild to moderate dementia symptoms 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 maximum tolerated dose or the maximum recommended dose of 12 mg per day. Because 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 schedule Administer 1.5 mg of this medicine twice daily for at least 2 weeks. If well tolerated, the dose may be increased to 3 mg twice daily. Subsequent increases may be made to 4.5 mg twice daily and, if well tolerated, after at least 2 weeks to 6 mg 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 previously well-tolerated dose. 2. Treatment of mild to moderate dementia symptoms 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 of this medicine twice daily. At intervals of at least 4 weeks between dose levels, the dose may subsequently be increased in succession according to the patient’s tolerability to 3 mg twice daily, then 4.5 mg twice daily, and then 6 mg twice daily. If adverse reactions (e.g., nausea, vomiting, abdominal pain, or decreased appetite), weight gain, or extrapyramidal symptoms (e.g., tremor) occur during treatment, these symptoms may decrease if one or more doses are withheld. 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 of this medicine orally twice daily. 4. Resumption of treatment The incidence and severity of adverse reactions generally increase at higher doses. If treatment is interrupted for more than 3 days, restart treatment 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 in children is not recommended.

This drug should not be administered to patients who are allergic to the active ingredient or other components of this drug. Patients with severely impaired liver function should avoid using this drug as its safety has not been confirmed. Patients who have developed allergic dermatitis from the patch formulation of this drug in the past should also avoid using this drug. Patients with heart disease, history of gastric ulcers, asthma, or chronic obstructive pulmonary disease should be cautious when using this drug. Patients with a history of urinary retention or seizures should also use this drug carefully. Gastrointestinal symptoms such as nausea, vomiting, and diarrhea may occur during the use of this drug, and if these symptoms are severe, the dosage should be reduced or discontinued. Patients with Parkinson's disease may experience tremors or worsening motor function while taking this drug, so their condition should be closely monitored. Patients with dementia may experience weight loss, so weight changes should be periodically checked during treatment. Pregnant or nursing women should consult a physician as the safety of this drug has not been adequately established. The use of this drug in children is not recommended. This drug may enhance the effects or increase the side effects when used with other cholinergic drugs, so caution is needed when coadministering. Patients with electrical abnormalities of the heart or bradycardia should closely monitor their cardiac condition while taking this drug. Overdose of this drug may result in symptoms such as nausea, vomiting, bradycardia, and confusion, so the prescribed dosage must be adhered to. Store this drug out of reach of children and do not remove it from its original container for safety.

• Nausea
• vomiting
• dizziness
• headache
• drowsiness
• tremors
• fainting
• seizures
• extrapyramidal symptoms
• angina pectoris

This drug may be sensitive to air and moisture, so it must be stored in a tightly sealed container. It is best to store it at room temperature between 1 to 30 degrees Celsius. Storing it this way helps maintain the effectiveness of the medication for a longer period.

Appearance

Orange hard capsule containing white powder

Package unit

28 capsules (14 capsules x 2 in PTP packaging)