Dimentis Capsule 1.5 mg (Rivastigmine Tartrate)

Adult dose

Dosage and administration: Rivastigmine is administered orally twice daily, in the morning and evening with meals. ○ Adults: 1. Treatment of mild to moderate symptoms of Alzheimer’s dementia The initial dose is 3 mg/day of rivastigmine. Increase the dose at intervals of at least 2 weeks for each patient to the highest tolerated dose or the maximum recommended dose of 12 mg/day. Since this medicine showed greater efficacy at doses of 6 mg/day and higher in clinical trials, a target dose range of 6~12 mg/day is recommended for most patients. Recommended dose titration Administer 1.5 mg 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 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 symptoms of 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 two divided doses (1.5~6 mg twice daily). The initial dose is 1.5 mg twice daily. Depending on the patient’s tolerability, the dose may then be increased consecutively to 3 mg twice daily, then 4.5 mg twice daily, and then 6 mg twice daily, with a minimum interval of 4 weeks between dose levels. If adverse reactions (e.g., nausea, vomiting, abdominal pain, or decreased appetite), weight gain, or extrapyramidal symptoms (e.g., 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 discontinuation of treatment may be considered. 3. Maximum recommended dose Administer 6 mg orally twice daily. 4. Resumption of 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. Do not administer to patients with severe hepatic impairment, as no studies have been conducted in these patients.

Child dose

Use is not recommended for children.

This medication should not be used in patients with allergies to certain ingredients. The safety has not been established in patients with severely impaired liver function, and administration should be avoided in these cases. Patients who have experienced allergic contact dermatitis with the patch form of this medication should also avoid its use. Caution is necessary in patients with cardiac diseases or history of peptic ulcers, asthma, urinary retention, or seizures. Gastrointestinal symptoms such as nausea, vomiting, and diarrhea may occur at the start of treatment, and this may be more frequent in female patients. This medication can cause neurological adverse reactions such as dizziness, headache, drowsiness, and tremors, requiring caution while driving or operating machinery. In patients with Parkinson's disease, symptoms may worsen, and dosing adjustments or discontinuation should be considered in these cases. Weight loss may occur, so weight changes should be monitored regularly during treatment. This medication can interact with anesthetics and enhance the effects of muscle relaxants, so it is essential to consult a physician before surgery. Caution is needed when combined with other cholinergic or anticholinergic medications, as side effects may increase. An ECG may be necessary before administration in patients with arrhythmias or risks of QT interval prolongation. Pregnant or breastfeeding women are advised against using this medication, as its safety has not been adequately established. The safety and efficacy in children have not been confirmed, and its use is not recommended. In case of overdose, symptoms may include vomiting, diarrhea, dizziness, bradycardia, and in severe cases, emergency treatment may be required. Keep out of reach of children and avoid transferring the medication to other containers.

• Nausea
• vomiting
• urinary tract infection
• agitation
• confusion
• nightmares
• anxiety
• insomnia
• depression
• hallucinations

This medication should be stored in a tightly closed container to prevent air or moisture ingress and kept at room temperature between 1 to 30 degrees Celsius. Proper storage will maintain the effectiveness and safety of the medication.

Appearance

A hard capsule with a white to pale yellow powder, with a yellow cap and body.

Package unit

28 capsules (14 capsules/PTP × 2 packs)