Medication info
Riseton Capsule 3 mg (Rivastigmine Tartrate)

Riseton Capsule 3 mg (Rivastigmine Tartrate)

Prescription medicationHard capsuleOral
Ingredient · strength
Rivastigmine Tartarate›4.8mg / 1 capsule
Manufacturer / importer
Myeongin Pharmaceutical Co., Ltd.
Appearance
A hard capsule with a white powder inside and brownish-yellow upper and lower parts.
Packaging
30 capsules/bottle, 100 capsules/bottle
Approval status
Active

MFDS item code 201504070 · Approved 2015.06.22 · Insurance code 651904220

Summary

Main use
Treatment of symptoms of mild to moderate Alzheimer's disease dementia and dementia associated with Parkinson's disease
Who takes it
Adults · Children
Adult dose
Administration: Rivastigmine is administered orally twice daily, in the morning and evening, with meals. ○ Adults: 1. Treatment of mild to moderate Alzheimer-type dementia The initial dose is 3 mg of rivastigmine per day, and the dose should be increased at intervals of at least 2 weeks for each patient to the maximally tolerated dose or the maximum recommended dose of 12 mg per day. Since this medicine showed greater efficacy in clinical trials at doses of 6 mg per day and above, a target dose range of 6~12 mg per day is recommended for most patients. Recommended dose titration schedule Administer 1.5 mg per dose twice daily for at least 2 weeks. If well tolerated, the dose may be increased to 3 mg per dose twice daily. Further increases may be made to 4.5 mg per dose twice daily and, if well tolerated, after at least 2 weeks, to 6 mg 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, reduce the daily dose to the previous dose that was well tolerated. 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 was administered at 3~12 mg per day in 2 divided doses. (1.5~6 mg per dose twice daily.) The initial dose is 1.5 mg per dose twice daily. Depending on the patient's tolerability, the dose may then be increased in sequence, with a minimum interval of 4 weeks between dose levels, to 3 mg per dose twice daily, then 4.5 mg per dose twice daily, and then 6 mg 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, omitting 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 6 mg per dose orally twice daily. 4. Resumption of treatment The incidence and severity of adverse reactions generally increase at higher doses. If treatment is interrupted for more than 3 days, 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 this population.
Child dose
This drug has not been studied in children; therefore, its use in children is not recommended.

Ingredients

Manufacturer
Myeongin Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of symptoms of mild to moderate Alzheimer's disease dementia and dementia associated with Parkinson's disease

  • Alzheimer's-type dementia symptoms
  • dementia-related symptoms of Parkinson's disease
View approved original text

This medication is used to treat symptoms of mild to moderate Alzheimer's-type dementia and mild to moderate dementia-related symptoms of Parkinson's disease.

How to take

Adult dose

Administration: Rivastigmine is administered orally twice daily, in the morning and evening, with meals. ○ Adults: 1. Treatment of mild to moderate Alzheimer-type dementia The initial dose is 3 mg of rivastigmine per day, and the dose should be increased at intervals of at least 2 weeks for each patient to the maximally tolerated dose or the maximum recommended dose of 12 mg per day. Since this medicine showed greater efficacy in clinical trials at doses of 6 mg per day and above, a target dose range of 6~12 mg per day is recommended for most patients. Recommended dose titration schedule Administer 1.5 mg per dose twice daily for at least 2 weeks. If well tolerated, the dose may be increased to 3 mg per dose twice daily. Further increases may be made to 4.5 mg per dose twice daily and, if well tolerated, after at least 2 weeks, to 6 mg 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, reduce the daily dose to the previous dose that was well tolerated. 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 was administered at 3~12 mg per day in 2 divided doses. (1.5~6 mg per dose twice daily.) The initial dose is 1.5 mg per dose twice daily. Depending on the patient's tolerability, the dose may then be increased in sequence, with a minimum interval of 4 weeks between dose levels, to 3 mg per dose twice daily, then 4.5 mg per dose twice daily, and then 6 mg 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, omitting 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 6 mg per dose orally twice daily. 4. Resumption of treatment The incidence and severity of adverse reactions generally increase at higher doses. If treatment is interrupted for more than 3 days, 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 this population.

Child dose

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

Precautions

This medication should not be administered to certain patients. For example, patients who are allergic to the active ingredient or any components of this medication, those with severe liver impairment, and those who experienced dermatitis reactions while using the patch form of this medication should not use it. In addition, caution should be exercised when administering to patients with heart disease, peptic ulcers, asthma, chronic obstructive pulmonary disease, urinary retention, seizures, or extrapyramidal disorders. Such patients require special monitoring by a physician. Common gastrointestinal side effects such as nausea, vomiting, and diarrhea may occur when taking this medication, especially during the initial adjustment period. Neurological adverse reactions may also manifest, including dizziness, headache, drowsiness, and tremors. In dementia patients, psychiatric and systemic symptoms such as weight loss, fatigue, weakness, anxiety, insomnia, and hallucinations have also been reported. Rarely, cardiac-related adverse reactions or side effects such as skin rashes and allergic dermatitis may occur. This medication can interact with other drugs, so caution is required when used in combination with anesthetics, other cholinergic drugs, anticholinergic drugs, beta-blockers, and medications that prolong the QT interval. Always consult with a physician or pharmacist before co-administering. Women who are pregnant or breastfeeding should avoid this medication due to insufficient safety data. If pregnancy is possible or if currently pregnant, the decision to use this medication should be made following consultation with a physician, and it is advisable to avoid use while breastfeeding. The use of this medication is not recommended in children, and overdose can result in symptoms such as nausea, vomiting, dizziness, and bradycardia, requiring immediate medical attention. During the administration of this medication, the patient's condition should be regularly monitored, and any unusual symptoms should be reported to medical personnel immediately. Additionally, keep this medication out of reach of children and avoid transferring it to other containers.

Side effects

  • nausea
  • vomiting
  • urinary tract infection
  • agitation
  • confusion
  • nightmares
  • anxiety
  • insomnia
  • depression
  • hallucinations
Show 62 more
  • dizziness
  • headache
  • drowsiness
  • tremor
  • fainting
  • seizures
  • extrapyramidal symptoms
  • angina pectoris
  • myocardial infarction
  • deep vein thrombosis
  • bradycardia
  • heart block
  • atrial fibrillation
  • tachycardia
  • hypertension
  • diarrhea
  • loss of appetite
  • abdominal pain
  • dyspepsia
  • gastric ulcer
  • duodenal ulcer
  • gastrointestinal bleeding
  • pancreatitis
  • esophageal rupture
  • increased sweating
  • rash
  • pruritus
  • fatigue
  • weakness
  • lethargy
  • falling
  • weight loss
  • abnormal liver function tests
  • mucous membrane syndrome
  • tremor
  • bradykinesia
  • dyskinesia
  • cogwheel phenomenon
  • hypokinesia
  • decreased appetite
  • dehydration
  • increased sweating
  • gait disturbance
  • worsening of Parkinson's disease
  • abnormal muscle tone
  • muscle rigidity
  • balance disorder
  • musculoskeletal rigidity
  • stiffness
  • abnormal motor function
  • constipation
  • inability to sit still
  • sensory disturbances
  • delirium
  • erythema
  • urticaria
  • blisters
  • allergic dermatitis
  • aggression
  • restlessness
  • dysautonomia syndrome
  • hepatitis

Not everyone experiences these, and they can vary from person to person.

Storage

Store this medication in a sealed container to prevent exposure to air or moisture. It is important to maintain a storage temperature between 1 to 30 degrees Celsius at room temperature.

Appearance and packaging

Appearance

A hard capsule with a white powder inside and brownish-yellow upper and lower parts.

Package unit

30 capsules/bottle, 100 capsules/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.