Ajustelon Capsule 1.5 mg (Rivastigmine Tartrate)

Adult dose

Dosage and Administration: Rivastigmine should be administered orally twice daily, in the morning and evening, with meals. ○ Adults: 1. Treatment of symptoms of mild to moderate Alzheimer-type dementia The initial dose is 3 mg of rivastigmine per day. For each patient, the dose should be increased at intervals of at least 2 weeks to the maximally tolerated dose or the maximum recommended dose of 12 mg per day. Because this medicine showed greater efficacy in clinical trials at doses of 6 mg per day or higher, a target dose range of 6~12 mg per day is recommended for most patients. Recommended dose titration schedule Administer 1.5 mg per dose twice daily for at least 2 weeks. If well tolerated, the dose may be increased to 3 mg twice daily. Further increases may be made to 4.5 mg twice daily; if well tolerated, after at least 2 weeks the dose may be increased to 6 mg 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 previous dose that was well tolerated. 2. Treatment of symptoms 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, divided into two daily doses (1.5~6 mg per dose twice daily). The initial dose is 1.5 mg per dose twice daily. Depending on the patient's tolerability, subsequent doses may be increased sequentially at intervals of at least 4 weeks between dose levels 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 loss of appetite), weight gain, or extrapyramidal symptoms (e.g., tremor) occur during treatment, omitting 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 per dose orally twice daily. 4. Reinitiation 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, titrate the dose with particular care according to individual tolerability. 2. Do not administer to patients with severe hepatic impairment, as no studies have been conducted in this population.

Child dose

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

This medication should not be administered to certain patients. For example, patients allergic to the active ingredient or components of this medication, patients with severe liver dysfunction, and those who have experienced allergic dermatitis from this medication in patch form should not use it. Additionally, caution should be exercised when administering to patients with heart disease, a history of gastric ulcers, asthma, obstructive pulmonary disease, urinary retention, seizures, or extrapyramidal disorders. Gastrointestinal side effects such as nausea, vomiting, and diarrhea may commonly occur upon administration, necessitating dosage adjustments. These side effects and weight loss may occur more frequently in female patients. This medication may affect heart rhythms, so patients with heart conditions require careful monitoring by a physician. Interactions may occur when used with other medications, especially anesthetics, other cholinergic agents, anticholinergic drugs, beta-blockers, and drugs that prolong the QT interval, so caution is warranted. Pregnant or breastfeeding women should consult a physician before use as the safety of this medication has not been established; it is advisable to avoid administration while breastfeeding. There are no adequate clinical trials for pediatric use, hence its use is not recommended. In cases of overdose, symptoms such as nausea, vomiting, bradycardia, and confusion may occur, and in severe cases, professional treatment may be required. This medication should be stored out of reach of children and transferring to another container should be avoided. During treatment, it is important to regularly monitor the patient’s weight, cardiac condition, gastrointestinal symptoms, etc. Driving or operating machinery may be impaired, so caution is necessary when engaging in these activities. Finally, this medication should be used under the diagnosis and supervision of a professional, and the patient and caregiver should be adequately informed about potential side effects during medication use.

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

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is advisable to maintain a storage temperature between 1°C and 30°C.

Appearance

Hard capsule with white powder, yellow at the lower part

Package unit

30 capsules/bottle, 100 capsules/bottle