Medication info
Donepezil 10 mg (Donepezil Hydrochloride Hydrate)

Donepezil 10 mg (Donepezil Hydrochloride Hydrate)

Prescription medicationTablet경구
Ingredient · strength
Donepezil Hydrochloride Hydrate›10.43mg / 1 tablet
Manufacturer / importer
(주)유앤생명과학
Appearance
Yellow round film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202000914 · Approved 2020.02.12 · Insurance code 058800570

Summary

Main use
Improvement of symptoms of Alzheimer's type dementia
Who takes it
Adults · Children
Adult dose
As donepezil hydrochloride, administer 5 mg once daily before bedtime. If bizarre dreams, nightmares, or insomnia occur, considering morning dosage may be an option. The concentration of donepezil reaches a steady state after 15 days of administration, so a dosage of 5 mg should be administered for 4 to 6 weeks. After clinical response evaluation, it can be increased to 10 mg, and caution should be taken regarding gastrointestinal adverse reactions when increasing the dosage to 10 mg per day. Patients with low body weight aged 85 and older should be monitored carefully as adverse reactions are more frequent, and low-weight elderly women should not exceed 5 mg per day.
Child dose
There is no experience in using this medication in pediatric patients.

Ingredients

Manufacturer
(주)유앤생명과학

Efficacy & effects

Improvement of symptoms of Alzheimer's type dementia

  • Symptoms of Alzheimer's type dementia
View approved original text

This medication is used for the treatment of symptoms of Alzheimer's type dementia.

How to take

Adult dose

As donepezil hydrochloride, administer 5 mg once daily before bedtime. If bizarre dreams, nightmares, or insomnia occur, considering morning dosage may be an option. The concentration of donepezil reaches a steady state after 15 days of administration, so a dosage of 5 mg should be administered for 4 to 6 weeks. After clinical response evaluation, it can be increased to 10 mg, and caution should be taken regarding gastrointestinal adverse reactions when increasing the dosage to 10 mg per day. Patients with low body weight aged 85 and older should be monitored carefully as adverse reactions are more frequent, and low-weight elderly women should not exceed 5 mg per day.

Child dose

There is no experience in using this medication in pediatric patients.

Precautions

This medication contains Donepezil Hydrochloride as the active ingredient and is used for the treatment of symptoms of Alzheimer's type dementia. This medication should not be administered to patients who are allergic to Donepezil Hydrochloride, piperidine derivatives, or any other components of this medication. Pregnant women, women who may become pregnant, and breastfeeding women should not take this medication. This medication contains lactose; therefore, patients with lactose intolerance or congenital lactose enzyme deficiency should avoid taking it. Patients with heart disease or cardiac conduction disorders should use this medication cautiously as it may slow down heart rate or cause arrhythmia. Patients taking non-steroidal anti-inflammatory drugs or with a history of peptic ulcers should be cautious as there may be a risk of gastrointestinal bleeding or ulcer exacerbation. Patients with asthma or obstructive pulmonary disease should be careful as bronchospasm or increased mucus secretion may worsen symptoms. Patients with extrapyramidal disorders such as Parkinson's disease should also be careful as this medication may worsen symptoms. This medication contains Yellow No. 5, and patients with hypersensitivity to this ingredient should be cautious. During the usage of this medication, abnormal cardiac reactions such as syncope, bradycardia, heart block, myocardial infarction, or heart failure may occur, and if any abnormal symptoms appear, immediate consultation with a healthcare provider is necessary. Gastrointestinal abnormalities such as peptic ulcers, gastrointestinal bleeding, nausea, vomiting, diarrhea may occur, and attention should also be given to liver dysfunctions or symptoms of jaundice. Neurological abnormalities such as seizures, intracerebral hemorrhage, movement disorders, tremors, and walking difficulties may appear. Severe adverse reactions such as respiratory distress, acute pancreatitis, acute renal failure, and sudden death have also been reported, so immediate treatment is required if symptoms occur. During treatment, patients' conditions should be regularly monitored, and appropriate measures should be taken in case of adverse reactions. This medication may affect driving or operating machinery, so attention is needed, especially at the beginning of treatment or with dosage adjustments. Since this medication can interact with other drugs, especially cardiac medications, antibiotics, antidepressants, antipsychotics, and anti-inflammatory drugs, consultation with a physician or pharmacist is essential when using them concurrently. It is principled that pregnant or breastfeeding women should not take this medication; if absolutely necessary, they should use it after consulting a specialist. The safety for pediatric patients has not been established; therefore, it is not administered to children. In case of overdose, severe symptoms such as nausea, vomiting, bradycardia, sweating, and respiratory depression may occur, so immediate medical treatment is required. This medication should be stored out of the reach of children and not transferred to other containers.

Side effects and when to seek care immediately

Serious side effects

  • Syncope
  • bradycardia
  • heart block
  • QT interval prolongation
  • myocardial infarction
  • heart failure
  • peptic ulcers
  • perforated duodenal perforation
  • gastrointestinal bleeding
  • hepatitis
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  • liver dysfunction
  • jaundice
  • seizures (epilepsy, convulsions, etc.)
  • intracerebral hemorrhage
  • cerebrovascular disorders
  • extrapyramidal disorders
  • neuroleptic malignant syndrome
  • rhabdomyolysis
  • respiratory distress
  • acute pancreatitis
  • acute renal failure
  • unexplained sudden death
  • cardiac arrest
  • vascular and lymphatic purpura
  • urticaria

Mild side effects

  • Loss of appetite, insomnia, drowsiness, dizziness, headache, fatigue, nausea, vomiting, diarrhea, constipation, abdominal pain, rash, itching, muscle pain, urinary incontinence, frequent urination, thrombocytopenia
  • Hallucinations, agitation, aggressive behavior, anxiety, drowsiness, delusions, confusion, depression, insomnia, tremors, walking difficulties, involuntary movements, decreased concentration, mental sluggishness, sweating, increased blood pressure, palpitations, hypotension, hypertension, atrial fibrillation, heart block, sinoatrial block, atrioventricular block

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

Storage

This medication should be stored in a tightly sealed container to prevent air from entering and kept at room temperature between 1 to 30 degrees Celsius. This will help maintain the medication's effectiveness over time.

Appearance and packaging

Appearance

Yellow round film-coated tablet

Package unit

30 tablets/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.

Questions about this medicine

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

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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.