Medication info

Donepezil Tartrate Capsule 3 mg

Prescription medicationHard capsuleOralExpired
Ingredient · strength
Rivastigmine Tartarate›4.8mg / 1 capsule
Manufacturer / importer
Donggu Bio Pharmaceutical Co., Ltd.
Appearance
A hard capsule with a white-to-yellow powder inside, orange-colored on the upper and lower parts.
Packaging
28 capsules/box [14 capsules/PTP × 2]
Approval status
Expired

MFDS item code 202002014 · Approved 2020.03.23

This product's status changed to Expired on 2025.03.23. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of symptoms of mild to moderate Alzheimer-type dementia and dementia associated with Parkinson's disease
Who takes it
Adults · Children
Adult dose
Dosage and administration: Rivastigmine should be 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 3mg of rivastigmine per day. For each patient, the dose should be increased at intervals of at least 2 weeks up to the maximum tolerated dose or the maximum recommended dose of 12mg per day. Since this medication showed greater efficacy at doses of 6mg per day and above 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 medication twice daily for at least 2 weeks; if well tolerated, the dose may be increased to 3mg twice daily. Further 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 loss of appetite) or weight loss occur, 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 3~12mg per day in 2 divided doses. (1.5~6mg per dose was administered twice daily.). The initial dose is 1.5mg of this medication twice daily. At intervals of at least 4 weeks between doses, and according to the patient's tolerability, the dose may be increased successively to 3mg twice daily, then 4.5mg twice daily, and then 6mg twice daily. If adverse reactions (for example, nausea, vomiting, abdominal pain, or loss of appetite), weight gain, or extrapyramidal symptoms (for example, tremor) occur during treatment, temporarily 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 medication orally twice daily. 4. Reinitiation 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, and 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
○ Children: This medication has not been studied in children; therefore, its use in children is not recommended.

Ingredients

Manufacturer
Donggu Bio Pharmaceutical Co., Ltd.

Efficacy & effects

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

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

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

How to take

Adult dose

Dosage and administration: Rivastigmine should be 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 3mg of rivastigmine per day. For each patient, the dose should be increased at intervals of at least 2 weeks up to the maximum tolerated dose or the maximum recommended dose of 12mg per day. Since this medication showed greater efficacy at doses of 6mg per day and above 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 medication twice daily for at least 2 weeks; if well tolerated, the dose may be increased to 3mg twice daily. Further 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 loss of appetite) or weight loss occur, 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 3~12mg per day in 2 divided doses. (1.5~6mg per dose was administered twice daily.). The initial dose is 1.5mg of this medication twice daily. At intervals of at least 4 weeks between doses, and according to the patient's tolerability, the dose may be increased successively to 3mg twice daily, then 4.5mg twice daily, and then 6mg twice daily. If adverse reactions (for example, nausea, vomiting, abdominal pain, or loss of appetite), weight gain, or extrapyramidal symptoms (for example, tremor) occur during treatment, temporarily 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 medication orally twice daily. 4. Reinitiation 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, and 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

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

Precautions

This medication contains the active ingredient rivastigmine and should not be administered to certain patient groups. For example, patients with an allergy to this medication's ingredients or severe liver dysfunction, as well as those who experienced skin allergic reactions from the transdermal patch form of this medication, should not use it. Patients with cardiac diseases, peptic ulcer, asthma, urinary retention, seizure, and extrapyramidal disorders should use this medication with caution, as the side effects may be more severe. Nausea, vomiting, and diarrhea, which are gastrointestinal symptoms, may commonly occur when taking this medication, especially at the beginning of treatment or during dosage adjustments. Additionally, neurological side effects such as dizziness, headache, drowsiness, and tremors may also occur. Patients with dementia related to Parkinson's disease may experience symptoms such as tremors or worsening motor function after taking this medication, so they should consult a doctor if these symptoms develop. This medication can interact with other drugs, especially anesthetics, muscle relaxants, cardiac medications, and psychiatric drugs, so it is essential to consult a physician or pharmacist when taking it together with these medications. Pregnant or breastfeeding women should consult an expert before taking this medication, as its safety has not been sufficiently confirmed. It is recommended to avoid taking this medication while breastfeeding. The safety and efficacy of this medication have not been confirmed in children, so its use is not recommended. In case of overdose, symptoms such as vomiting, diarrhea, dizziness, bradycardia, confusion may occur, and in such cases, immediate medical attention should be sought. Antidote treatments such as atropine may be performed if necessary. Lastly, this medication should be stored out of reach of children, and it is safer not to transfer it to other containers.

Side effects

  • Nausea
  • vomiting
  • dizziness
  • headache
  • drowsiness
  • tremor
  • syncope
  • convulsions
  • extrapyramidal symptoms
  • angina
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  • myocardial infarction
  • deep vein thrombosis
  • hypertension
  • diarrhea
  • loss of appetite
  • abdominal pain
  • dyspepsia
  • gastric ulcer
  • duodenal ulcer
  • gastrointestinal bleeding
  • pancreatitis
  • esophageal rupture
  • increased sweating
  • rash
  • itching
  • fatigue
  • weakness
  • lethargy
  • falls
  • weight loss
  • abnormal liver function tests
  • skin-mucosa syndrome
  • tremor
  • bradykinesia
  • movement disorders
  • cogwheel rigidity
  • hypokinesia
  • anxiety
  • insomnia
  • restlessness
  • urinary tract infection
  • hallucinations
  • bradycardia
  • atrial fibrillation
  • heart block
  • dehydration
  • increased sweating
  • gait disturbance
  • hypertension
  • hypotension
  • depression
  • urinary incontinence
  • cerebrovascular accident
  • delirium
  • erythema
  • hives
  • blisters
  • allergic dermatitis
  • confusion
  • tremor
  • somnolence
  • lethargy
  • salivary gland hypersecretion
  • sialorrhea
  • muscle tone abnormalities
  • muscle rigidity
  • balance disorders
  • musculoskeletal rigidity
  • stiffness
  • movement dysfunction
  • inability to sit
  • perceptual disturbances
  • confusion
  • personality disorders
  • stupor
  • pneumonia
  • sepsis
  • aggression
  • restlessness
  • dysautonomia
  • hepatitis

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture. It is important to keep the storage temperature between 1°C and 30°C to maintain its effectiveness and safely use it.

Appearance and packaging

Appearance

A hard capsule with a white-to-yellow powder inside, orange-colored on the upper and lower parts.

Package unit

28 capsules/box [14 capsules/PTP × 2]

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.

Questions about this medicine

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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.