Prometax Capsule 6.0 mg (Rivastigmine Tartrate)

Adult dosage

Dosage and administration: Rivastigmine is administered orally twice daily with the morning and evening meals. ○ Adults: 1. Treatment of mild to moderate symptoms of Alzheimer-type dementia The initial dose is 3mg of rivastigmine per day. The dose should be increased at intervals of at least 2 weeks for each patient to the highest tolerated dose or the maximum recommended dose of 12mg per day. Since this drug showed greater efficacy at doses of 6mg per day and higher in clinical trials, a target dose range of 6~12mg per day 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 to 4.5mg twice daily and, if well tolerated for at least 2 weeks, 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 previous dose that was well tolerated. 2. Treatment of mild to moderate symptoms of dementia associated with Parkinson's disease In controlled clinical trials in patients with dementia associated with Parkinson's disease, 3~12mg of rivastigmine per day was administered in 2 divided doses. (1.5~6mg per dose was administered twice daily.) The initial dose is 1.5mg of this drug twice daily. Depending on the patient's tolerability, subsequent consecutive dose increases may be made at intervals of at least 4 weeks 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, 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 6mg of this drug orally twice daily. 4. Re-initiation of treatment The incidence 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 with dose titration according to individual tolerability. 2. Do not administer to patients with severe hepatic impairment, as no studies have been conducted in these patients.

Children's dosage

This drug has not been studied in children; therefore, its use in children is not recommended.

This medication should not be used in certain patients. For example, patients with allergies to the active ingredient or other components of this drug, those with severe liver impairment, and patients who have had skin allergic reactions to the transdermal patch of this drug should not use it. Additionally, it should be administered with caution in patients with a history of heart disease, peptic ulcer, or duodenal ulcer, and in those with asthma or obstructive pulmonary disease, urinary retention or seizure history, and those with extrapyramidal disorders. When taking this medication, gastrointestinal side effects such as nausea, vomiting, and diarrhea may commonly occur, so the dosage should be adjusted and monitored carefully. Particularly in female patients, gastrointestinal side effects and weight loss may occur more frequently. Neurological side effects may include dizziness, headache, drowsiness, and tremors, and in some patients, seizures or worsening of Parkinson's disease symptoms may occur. Cardiac side effects such as angina, myocardial infarction, bradycardia, and heart block have been reported rarely, so patients with heart diseases should be cautious. This medication may enhance the effects of other cholinergic drugs, so special caution is required when taken with these medications. Additionally, this medication should be discontinued for a certain period before the administration of anesthetics. Women who are pregnant or breastfeeding should only use this medication as determined necessary by a physician since its safety has not been fully established; it is advisable to avoid use during breastfeeding. This medication is not recommended for children due to the lack of adequate studies in pediatric populations. In case of overdose, severe vomiting, diarrhea, bradycardia, confusion, and seizures may occur, which can be life-threatening in severe cases, and immediate medical attention should be sought. This medication should be stored out of reach of children, and care should be taken as transferring to another container may affect its quality. Finally, during the use of this medication, dizziness or drowsiness may occur, so caution is needed when driving or operating machinery, and it is important to periodically monitor the patient's condition during treatment.

• Nausea
• vomiting
• dizziness
• headache
• drowsiness
• tremor
• anxiety
• confusion
• restlessness
• insomnia

This medication is susceptible to air and moisture, so it must be stored in a tightly sealed container. It is also advisable to keep it at room temperature, avoiding excessively hot or cold conditions.

Appearance

A hard capsule containing a powder that is light gray to light yellow: red on the top and orange on the bottom

Package unit

28 capsules (14 capsules/PTP packaging x 2)