Medication info
Donepezil ODT 10 mg (Donepezil Hydrochloride Monohydrate)

Donepezil ODT 10 mg (Donepezil Hydrochloride Monohydrate)

Prescription medicationOrally disintegrating Tablet경구
Ingredient · strength
Donepezil Hydrochloride Hydrate›10.43mg / 1 tablet
Manufacturer / importer
한미약품(주)
Appearance
Yellow circular orally disintegrating tablet
Packaging
30 tablets per box [10 tablets/PTPX3]
Approval status
Active

MFDS item code 201002066 · Approved 2010.03.12 · Insurance code 643505540

Summary

Main use
Improvement of symptoms in Alzheimer's-type dementia
Who takes it
Adults
Adult dose
Administer 5 mg of donepezil hydrochloride once a day before bedtime. For 4-6 weeks, administer the 5 mg dose, and after assessing the clinical response, it can be increased to 10 mg. If increasing to 10 mg daily, be cautious of gastrointestinal adverse reactions. This medication is an orally disintegrating tablet that can be placed on the tongue and allowed to dissolve, to be taken with or without water.

Ingredients

Manufacturer
한미약품(주)

Efficacy & effects

Improvement of symptoms in Alzheimer's-type dementia

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

This medication is used in the treatment of symptoms of Alzheimer's-type dementia. It helps to improve dementia symptoms such as memory decline and cognitive function impairment. Regular use may have positive effects on daily living abilities.

How to take

Adult dose

Administer 5 mg of donepezil hydrochloride once a day before bedtime. For 4-6 weeks, administer the 5 mg dose, and after assessing the clinical response, it can be increased to 10 mg. If increasing to 10 mg daily, be cautious of gastrointestinal adverse reactions. This medication is an orally disintegrating tablet that can be placed on the tongue and allowed to dissolve, to be taken with or without water.

Precautions

This medication should not be administered to patients with phenylketonuria as it contains the artificial sweetener aspartame which is broken down into phenylalanine in the body. It should not be given to patients with hypersensitivity to donepezil hydrochloride or any other components of this medication, to pregnant women or women who may become pregnant, and to nursing mothers. Patients with heart conditions, especially those with bradycardia, heart conduction disorders, or syncope, should use this medication cautiously as it may stimulate the vagus nerve and affect heart rhythms. Patients taking non-steroidal anti-inflammatory drugs or with a history of peptic ulcers should be cautious as this medication may increase the risk of gastrointestinal bleeding or worsen ulcers. Patients with a history of asthma or obstructive pulmonary disease should also use this medication carefully as respiratory symptoms may worsen. Patients with Parkinson’s disease or extrapyramidal disorders should exercise caution as this medication may worsen symptoms. This medication contains yellow No. 4 and yellow No. 5 dyes, so patients with allergies or hypersensitivity to these components should use it carefully. This medication can cause various adverse reactions, particularly cardiovascular adverse reactions, gastrointestinal bleeding, liver dysfunction, neurological seizures, and muscle anomalies. When used in dementia patients, the therapeutic effect and side effects should be regularly evaluated, and medical consultation should be sought immediately if any unusual symptoms occur. This medication may increase the risk of arrhythmia in patients with heart disease or electrolyte imbalance, and an electrocardiogram may be necessary. Pregnant and nursing women are advised not to use this medication unless absolutely necessary and should consult a specialist. The safety of this medication in children has not been established, and it should not be used in pediatric patients. As this medication has many drug interactions, patients should inform healthcare providers of any other medications they are taking. In case of overdose, serious side effects such as vomiting, bradycardia, or respiratory depression may occur, and immediate emergency treatment is required. This medication may affect the ability to drive or operate machinery, so caution should be exercised during the initial dosage or when changing dosages.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, mouth/eye mucosal pain, shortness of breath or difficulty breathing, asthma attacks, cough with fever accompanied by respiratory distress, jaundice (yellowing of the skin or eyes), profound lassitude, sudden and severe headache, lightning headache, seizures, confusion, visual disturbances, paralysis, urination problems

Mild side effects

  • Decreased appetite
  • nausea
  • vomiting
  • diarrhea
  • dizziness
  • headache
  • pain
  • insomnia
  • drowsiness
  • fatigue
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  • fever
  • swelling
  • thrombocytopenia
  • anxiety
  • hallucinations
  • agitation
  • aggressive behavior
  • delusions
  • depression
  • confusion
  • apathy
  • hyperactivity
  • increased libido
  • hypersexuality
  • tremor
  • gait disturbance
  • involuntary movements
  • decreased concentration
  • mental dullness
  • blood disorders
  • dehydration
  • weight loss
  • arthritis
  • skin rash
  • itching
  • petechiae
  • abnormal dreams
  • enuresis

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

Storage

Store this medication in a tightly closed container to prevent air exposure, and keep it at room temperature between 1 and 30 degrees Celsius. This helps maintain the effectiveness of the medication and prevent degradation.

Appearance and packaging

Appearance

Yellow circular orally disintegrating tablet

Package unit

30 tablets per 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

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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.