Rivastigmine Capsule 4.5mg (Rivastigmine Tartrate)

Adult dose

Directions for use: Rivastigmine is administered orally twice daily, with the morning and evening meals. ○ Adults: 1. Treatment of symptoms of mild to moderate Alzheimer-type dementia The initial dose is 3mg per day of rivastigmine, and the dose should be increased at intervals of at least 2 weeks for each patient to the maximum tolerated dose or the maximum recommended dose of 12mg per day. Since this medicine showed greater efficacy in clinical trials at doses of 6mg per day and above, a target dose range of 6~12mg per day is recommended for most patients. Recommended dose titration After administration of 1.5mg per dose twice daily for at least 2 weeks, if well tolerated, the dose may be increased to 3mg per dose twice daily. For subsequent increases, administer 4.5mg per dose twice daily and, if well tolerated, after at least 2 weeks, the dose may be increased to 6mg per dose 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, the daily dose should be reduced to the previously well-tolerated dose. 2. Treatment of symptoms of mild to moderate dementia associated with Parkinson's disease In controlled clinical trials in patients with dementia associated with Parkinson's disease, rivastigmine was administered at 3~12mg per day twice daily. (1.5~6mg per dose was administered twice daily.). The initial dose is 1.5mg per dose twice daily of this medicine, with a minimum interval of 4 weeks between each dose level; depending on the patient's tolerability, the dose may then be increased sequentially to 3mg per dose twice daily, followed by 4.5mg per dose twice daily, and then 6mg 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, these symptoms may decrease if administration is interrupted once or several times. If adverse reactions persist, temporary reduction of the daily dose to the previously well-tolerated dose or discontinuation of treatment may be considered. 3. Maximum recommended dose Administer 6 mg per dose orally twice daily. 4. Re-initiation The incidence and severity of adverse reactions generally increase at higher doses. If treatment is interrupted for 3 days or longer, 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, so 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

This medication has not been tested in children, so its use in pediatric patients is not recommended.

This medication should not be used in patients with allergies to certain components. It is safe not to administer it to patients with severely impaired liver function. Patients who have previously experienced allergic contact dermatitis after using this medication should exercise caution. Patients with heart disease, gastric ulcers, asthma, obstructive pulmonary disease, urinary retention, seizures, or extrapyramidal disorders should use this medication carefully. Digestive symptoms such as nausea, vomiting, and diarrhea may occur while taking this medication, and if symptoms are severe, consultation with a physician is necessary. This medication can cause neurological abnormal reactions such as dizziness, drowsiness, headache, and tremors, so caution should be taken when driving or operating machinery. For patients with Parkinson's disease, symptoms may worsen, so careful observation of symptom changes is necessary. This medication may have enhanced effects when used with other cholinergic drugs, so caution is necessary when used in combination. Administration should be temporarily stopped before anesthesia, and the physician must be informed of any medications currently being taken due to potential drug interactions. Women who are pregnant or breastfeeding should consult a physician before using this medication, and it is advisable to avoid use while breastfeeding. Safety has not been established for use in children, so it is not recommended. Overdose may cause symptoms such as nausea, vomiting, dizziness, and bradycardia, requiring immediate medical assistance. The medication should be kept out of the reach of children, and should not be transferred to other containers.

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

This medication should be stored in a sealed container to protect it from air and moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius. Proper storage like this helps to safely preserve the effectiveness of the medication.

Appearance

A hard capsule with white to yellowish powder, with red-colored upper and lower parts.

Package unit

28 capsules/box [14 capsules/PTP × 2]