Medication info
Donepezil ODT 5 mg (Donepezil Hydrochloride Monohydrate)

Donepezil ODT 5 mg (Donepezil Hydrochloride Monohydrate)

Prescription medicationOrally disintegrating Tablet경구
Ingredient · strength
Donepezil Hydrochloride Hydrate›5.22mg / 1 tablet
Manufacturer / importer
한미약품(주)
Appearance
White, round orodispersible tablet
Packaging
30 tablets/box [10 tablets/PTPX3]
Approval status
Active

MFDS item code 201002238 · Notified 2010.03.23 · Insurance code 643505550

Summary

Main use
Improvement of Alzheimer's type dementia symptoms
Who takes it
Adults · Children
Adult dose
As Donepezil Hydrochloride, administer 5 mg once daily before bedtime. After 4-6 weeks of 5 mg dosage, evaluate clinical response and may increase to 10 mg. When increasing to 10 mg daily, caution regarding gastrointestinal adverse reactions is advised. This medication is an orodispersible tablet and can be either placed on the tongue and taken with water or taken without water.
Child dose
There is no experience of use in pediatric patients.

Ingredients

Manufacturer
한미약품(주)

Efficacy & effects

Improvement of Alzheimer's type dementia symptoms

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

This medication is used for the treatment of Alzheimer's type dementia symptoms. It helps improve memory deterioration, cognitive function decline, and difficulties in daily life caused by dementia. It contributes to enhancing cognitive function in patients and improving their quality of life. Regular intake can slow the progression of dementia symptoms.

How to take

Adult dose

As Donepezil Hydrochloride, administer 5 mg once daily before bedtime. After 4-6 weeks of 5 mg dosage, evaluate clinical response and may increase to 10 mg. When increasing to 10 mg daily, caution regarding gastrointestinal adverse reactions is advised. This medication is an orodispersible tablet and can be either placed on the tongue and taken with water or taken without water.

Child dose

There is no experience of use in pediatric patients.

Precautions

This medication should not be given to patients with the genetic disorder phenylketonuria. This is because the artificial sweetener aspartame contained in this medication is metabolized to phenylalanine in the body. This medication should not be used in patients who are allergic to donepezil hydrochloride, piperidine derivatives, or other components of this medication. Additionally, pregnant women, women who may become pregnant, and breastfeeding mothers should not take this medication. Patients with heart disease, especially those with bradycardia or heart conduction disorders, should use this medication with caution. This medication may slow the heartbeat or cause arrhythmia. Patients taking non-steroidal anti-inflammatory drugs or those with a history of peptic ulcers should closely monitor their gastrointestinal condition when taking this medication. This medication may increase gastric acid secretion and enhance gastrointestinal motility, potentially worsening ulcer symptoms. Patients with a history of asthma or chronic obstructive pulmonary disease should also exercise caution when taking this medication. This medication may constrict bronchial muscles and increase mucus secretion, worsening symptoms. Patients with extrapyramidal disorders such as Parkinson's disease should be cautious as this medication may exacerbate symptoms or cause new ones. This medication may cause various adverse reactions. Cardiac symptoms may include syncope, bradycardia, heart block, and myocardial infarction, while gastrointestinal symptoms may include gastric ulcers and gastrointestinal bleeding. Additionally, hepatic dysfunction, cerebrovascular disorders, motor function disorders, and severe muscular adverse symptoms have also been reported. Psychiatric adverse reactions may include hallucinations, anxiety, insomnia, and depression, while neurological symptoms may include dizziness, seizures, and tremors. This medication may affect driving ability and the ability to operate machinery, so caution is necessary while taking it. This drug may interact with various medications. Especially, when used in conjunction with drugs metabolized in the liver, the efficacy may change, so it's important to consult with a doctor or pharmacist. Pregnant or nursing women should preferably avoid this medication, and if necessary, should consult specialists thoroughly. Safety in pediatric patients has not been established, thus it is not used in children. In case of overdose, symptoms such as nausea, vomiting, bradycardia, and respiratory depression may occur, and immediate medical help should be sought. This medication should be taken by dissolving it on the tongue if in oral tablet form, and should be kept out of reach of children. It should also be stored unopened to prevent discoloration from light exposure.

Side effects and when to seek care immediately

Serious side effects

Syncope, bradycardia, heart block, prolonged QT interval, myocardial infarction, heart failure, peptic ulcers, perforated duodenal perforation, gastrointestinal bleeding, hepatitis, liver dysfunction, jaundice, cerebral seizures, intracerebral hemorrhage, cerebrovascular disorders, extrapyramidal disorders (motor dysfunction, ataxia, movement disorders, dystonia, tremors, involuntary movements, gait disturbances, abnormal posture, speech disorders), neuroleptic malignant syndrome (stupor, extreme rigidity, dysphagia,

Mild side effects

  • Nausea
  • vomiting
  • diarrhea
  • appetite decrease
  • headache
  • fatigue
  • dizziness
  • insomnia
  • drowsiness
  • rash
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  • itching
  • muscle pain
  • urinary incontinence
  • urination disorders
  • anxiety
  • hallucinations
  • aggressive behavior
  • tremors
  • gait disturbances
  • involuntary movements
  • decreased concentration
  • mental dullness
  • decreased body temperature
  • thrombocytopenia
  • anemia
  • petechiae
  • dehydration
  • hyperlipidemia
  • hypoglycemia
  • weight loss
  • arthritis
  • arthralgia
  • restlessness
  • irritability
  • confusion
  • emotional instability
  • personality

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

Storage

This medication should be stored in a sealed container to prevent air exposure, ideally at room temperature between 1°C and 30°C. By storing it this way, its efficacy can be maintained and degradation prevented.

Appearance and packaging

Appearance

White, round orodispersible tablet

Package unit

30 tablets/box [10 tablets/PTPX3]

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.