Exelon Capsule 4.5 mg (Rivastigmine Tartrate)

Adult dose

Administration: Rivastigmine is administered orally twice daily with the morning and evening meals. 1. Treatment of mild to moderate Alzheimer-type dementia The initial dose is 3mg of rivastigmine daily, and should be increased at intervals of at least 2 weeks for each patient to the maximally tolerated dose or the maximum recommended dose of 12mg daily. Since this drug showed greater efficacy at doses of 6mg daily and above in clinical trials, a target dose range of 6~12mg daily is recommended for most patients. Recommended dose titration Administer 1.5mg of this drug twice daily for at least 2 weeks. If well tolerated, the dose may be increased to 3mg twice daily. Subsequent increases may be made by administering 4.5mg twice daily and, if well tolerated, after at least 2 weeks increasing to 6mg 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 dose that was previously 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 daily in two divided doses (1.5~6mg per dose twice daily). The initial dose is 1.5mg of this drug twice daily. At intervals of at least 4 weeks between dose levels, the dose may be successively increased according to the patient's tolerability to 3mg twice daily, then 4.5mg twice daily, and then 6mg 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, these symptoms may be reduced by omitting one or more doses. If adverse reactions persist, temporarily reduce the daily dose to the previously well-tolerated dose or consider discontinuing treatment. 3. Maximum recommended dose Administer 6mg of this drug 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: Exposure is increased in patients with moderate renal impairment or mild to moderate hepatic impairment, and more adverse reactions may occur. Therefore, take particular care when titrating the dose according to individual tolerability. Do not administer to patients with severe hepatic impairment, as no studies have been conducted in these patients.

Child dose

This medication has not been tested in children and is not recommended for use in children.

This medication should not be used in patients with allergies to specific ingredients or severe liver dysfunction. Caution is required in patients with heart disease, gastric ulcers, asthma, urinary retention, seizures, etc. while using this medication. During treatment with this medication, gastrointestinal disturbances such as nausea, vomiting, and diarrhea may commonly occur, especially upon initial administration or dose escalation. Neurological symptoms such as dizziness, drowsiness, headache, and tremors may also appear, necessitating caution when driving or operating machinery. In patients with Parkinson's disease, symptoms may worsen, so careful monitoring is required. This medication may interact with other drugs, so it is important to consult a physician or pharmacist, especially when used with anesthetics, cardiac medications, or other cholinergic drugs. For pregnant or breastfeeding women, the safety of this drug has not been adequately established, so it should only be used cautiously when necessary. It is not recommended for children as safety and efficacy have not been confirmed. In case of overdose, severe symptoms such as nausea, vomiting, dizziness, bradycardia may occur, and medical attention should be sought immediately, and treatment such as atropine may be necessary. This drug should be kept out of reach of children and should preferably not be transferred to another container.

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

This medication may be sensitive to air or moisture, so it should be stored in a sealed container. It is advisable to keep it in a cool room away from direct sunlight.

Appearance

Red hard capsule containing a powder that is grayish-white to light yellow

Package unit

28 capsules (14 capsules/PTP pack x 2)