Osgmin Capsule 3.0 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 3mg of rivastigmine per day. For each patient, the dose should be increased at intervals of at least 2 weeks to the maximum tolerated dose or the maximum recommended dose of 12mg per day. Since this drug showed greater efficacy at doses of 6mg per day or 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, after 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 previously well-tolerated dose. 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, 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. At intervals of at least 4 weeks between each dose, and according to the patient's tolerability, the dose may subsequently be increased in sequence to 3mg twice daily, then 4.5mg twice daily, and then 6mg twice daily. If adverse reactions (for example, nausea, vomiting, abdominal pain, or decreased appetite), weight gain, or extrapyramidal symptoms (for example, tremor) are observed during treatment, skipping one or more doses may reduce these symptoms. 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. 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, 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.

Child dose

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

This medication should not be used in patients who are allergic to certain ingredients or those with severe liver impairment. Additionally, it should be administered with caution to those with a history of heart disease, gastric ulcers, asthma, urinary retention, seizures, or extrapyramidal disorders. During treatment, gastrointestinal adverse reactions such as nausea, vomiting, and diarrhea may occur, especially during the dose adjustment period. Neurological symptoms such as dizziness, headache, drowsiness, and tremor may also appear, requiring caution when driving or operating machinery. Symptoms may worsen in patients with Parkinson's disease, so dosage should be adjusted according to a physician's guidance. This medication may interact when taken with other cholinergic drugs, and special care is needed when used concurrently. The safety of this medication during pregnancy or breastfeeding has not been adequately confirmed, and it should be used cautiously only when necessary. It is not recommended for children as there are no appropriate clinical trials.

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

This medication must be stored in a tightly closed container to prevent exposure to air or moisture. It is best stored at room temperature between 1 degree and 30 degrees Celsius.

Appearance

A hard capsule with a white-yellow powder inside, with an orange-colored body and cap.

Package unit

28 capsules/box [(14 capsules/PTP*2)]