Prometax Capsule 4.5 mg (Rivastigmine Tartrate)

Adult dosage

Directions for use: Rivastigmine is administered orally twice daily with breakfast and dinner. ○ Adults: 1. Treatment of mild to moderate Alzheimer-type dementia The initial dose is 3mg of rivastigmine daily. Increase the dose for each patient at intervals of at least 2 weeks to the maximum tolerated dose or the maximum recommended dose of 12mg daily. Since this medicine showed greater efficacy at doses of 6mg daily and higher in clinical trials, a target dose range of 6~12mg daily is recommended for most patients. Recommended dose titration After administering 1.5mg of this medicine twice daily for at least 2 weeks, the dose may be increased to 3mg twice daily if well tolerated. 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 mild to moderate dementia associated with Parkinson's disease In controlled clinical trials in patients with dementia associated with Parkinson's disease, rivastigmine 3~12mg daily was administered in 2 divided doses. (1.5~6mg per dose was administered twice daily.). The initial dose is 1.5mg of this medicine twice daily. At intervals of at least 4 weeks between dose levels, the dose may then be increased sequentially according to patient 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, omitting one or more doses may reduce these symptoms. If adverse reactions persist, consider temporarily reducing the daily dose to the previously well-tolerated dose or discontinuing treatment. 3. Maximum recommended dose Administer 6 mg of this medicine orally twice daily. 4. Resumption of treatment The incidence and severity of adverse reactions generally increase at higher doses. If treatment is interrupted for 3 days or longer, 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, so more adverse reactions may occur. Therefore, use particular caution 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.

Children's dosage

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

This medication should not be administered to patients who are allergic to the active ingredient or other components. It is not recommended for patients with severe liver dysfunction, as there is no prior experience of using this drug in such patients. Patients who have developed allergic contact dermatitis from using the transdermal patch of this drug should not use this medication. Patients with cardiac diseases, gastric ulcers, duodenal ulcers, asthma, obstructive pulmonary disease, urinary retention, seizures, or extrapyramidal disorders should use this drug cautiously. When taking this medication, gastrointestinal adverse reactions such as nausea, vomiting, and diarrhea may frequently occur, so caution is required. Symptoms of neurological abnormalities such as dizziness, headache, drowsiness, and tremors may also occur, necessitating careful attention when driving or operating machinery. Patients with Parkinson's disease may experience a worsening of symptoms when taking this drug, so their condition should be closely monitored. This drug may have increased effects when taken with other cholinergic drugs and decreased effects when used in combination with anticholinergics, thus caution is needed with combined therapy. It is recommended to temporarily discontinue this drug before anesthesia, and dosage adjustments should be made strictly according to a doctor's instructions. Pregnant or nursing women must consult a physician before taking this medication. This drug is not recommended for children as its safety and efficacy have not been sufficiently established in this population. In case of overdose, symptoms such as vomiting, diarrhea, dizziness, bradycardia, and confusion may occur, and in severe cases, immediate medical treatment is necessary. This drug should be stored out of reach of children and should not be transferred to a different container. During treatment, the patient's condition and adverse reactions should be periodically monitored, and if adverse symptoms persist or worsen, medical consultation should be sought.

nausea, vomiting, diarrhea, loss of appetite, abdominal pain, indigestion, gastric ulcer, duodenal ulcer, gastrointestinal bleeding, pancreatitis, esophageal rupture, increased sweating, rash, itching, fatigue, weakness, lethargy, falls, weight loss, abnormal liver function test results, urinary tract infection, agitation, confusion, anxiety, insomnia, depression, hallucinations, dizziness, headache, drowsiness, tremors, fainting, seizures, extrapyramidal symptoms, angina, myocardial infarction, deep vein thrombosis, hypertension, bradycardia, atrial fibrillation, heart block, salivary secretion, increased perspiration, gait disturbance, muscle tone abnormality, hypokinesia, dyskinesia, cogwheel rigidity, hypokinesia, decreased appetite, dehydration, skin reactions, dermatitis, skin rash, urinary incontinence, cerebrovascular accident, delirium, erythema, urticaria, blisters, allergic dermatitis, trembling, somnolence, confusion, lethargy, salivary secretion, hypotension, decreased respiration, muscle weakness, fainting, aggression, restlessness, syndrome of inappropriate antidiuretic hormone secretion, hepatitis, allergic dermatitis, inability to sit still, sensory abnormalities, delirium, drowsiness, pneumonia, sepsis

This drug may be sensitive to air and moisture, so it should be stored in a sealed container. Additionally, it is best to keep it at room temperature, not in excessively hot or cold conditions.

Appearance

Red hard capsules containing a grayish-white to pale yellow powder.

Package unit

28 capsules (14 capsules/PTP packaging x 2)