Medication info

Shinshin Donepezil Solution 5 mg, 10 mg (Donepezil Hydrochloride Hydrate)

Prescription medicationSolution경구
Ingredient · strength
Donepezil Hydrochloride Hydrate›10.43mg / 1 packet
Manufacturer / importer
신신제약(주)
Appearance
Colorless or light yellow solution in an aluminum foil pouch
Packaging
30 packets/box [5ml/packet x 30], 30 packets/box [10ml/packet x 30]
Approval status
Active

MFDS item code 202202974 · Approved 2022.07.18 · Insurance code 643803541,643803551

Summary

Main use
Improvement of symptoms of Alzheimer's type dementia
Who takes it
Adults · Children
Adult dose
Adults: Administer 5 mL (5 mg) of Donepezil Hydrochloride once daily before bedtime. For the first 4 to 6 weeks, maintain the dosage at 5 mL (5 mg), and it may be increased to 10 mL (10 mg) thereafter. When increasing to 10 mL (10 mg) daily, monitor for gastrointestinal adverse reactions. Underweight females over 85 years should not exceed 5 mL (5 mg) per day and should be closely monitored.
Child dose
Pediatric: There is no experience in using this medication in children.

Ingredients

Manufacturer
신신제약(주)

Efficacy & effects

Improvement of symptoms of Alzheimer's type dementia

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

This medication is used to alleviate the symptoms of Alzheimer's type dementia. It improves symptoms such as memory decline and cognitive dysfunction, supporting the patient's ability to carry out daily activities. It helps slow the progression of dementia and improves the quality of life.

How to take

Adult dose

Adults: Administer 5 mL (5 mg) of Donepezil Hydrochloride once daily before bedtime. For the first 4 to 6 weeks, maintain the dosage at 5 mL (5 mg), and it may be increased to 10 mL (10 mg) thereafter. When increasing to 10 mL (10 mg) daily, monitor for gastrointestinal adverse reactions. Underweight females over 85 years should not exceed 5 mL (5 mg) per day and should be closely monitored.

Child dose

Pediatric: There is no experience in using this medication in children.

Precautions

This medication contains Donepezil Hydrochloride Hydrate as the active ingredient and is used to alleviate symptoms of Alzheimer's type dementia. This medication should not be given to patients who are allergic to Donepezil or similar components, and to women who are pregnant or nursing. Patients with heart diseases or cardiac conduction disorders should be cautious when using this medication, as there is a risk of heart problems such as bradycardia or arrhythmias. Patients with a history of peptic ulcers or those taking nonsteroidal anti-inflammatory drugs (NSAIDs) should use it cautiously due to the risk of gastrointestinal bleeding or exacerbation of ulcers. Patients with asthma or chronic obstructive pulmonary disease may experience bronchoconstriction or increased mucus secretion, worsening their symptoms, and should therefore be administered this medication with caution. Patients with extrapyramidal disorders such as Parkinson's disease may experience worsening of their symptoms due to this medication. This medication has been reported to cause side effects including cardiac abnormalities, gastrointestinal bleeding, liver function abnormalities, neurological problems, muscular problems, dyspnea, acute pancreatitis, acute renal failure, and sudden death, so any unusual symptoms should prompt immediate consultation with healthcare professionals. Additionally, various side effects such as nausea, vomiting, diarrhea, dizziness, insomnia, headache, fatigue, muscle pain, rash, anemia, and more may occur, so changes in symptoms during the course of treatment should be carefully monitored. This medication should be used only for Alzheimer's type dementia, as it is not approved for other types of dementia or memory disorders, so it should only be taken after a precise diagnosis. Caution is needed when driving or operating machinery while taking this medication, as dizziness or fatigue may occur. This medication may affect liver and kidney functions, necessitating regular examinations and monitoring. There may be drug interactions with other medications, so it is essential to inform healthcare professionals, especially if taking medications affecting CYP3A4, CYP2D6 enzymes, muscle relaxants, cholinergic drugs, anticholinergic drugs, beta-blockers, NSAIDs, etc. Pregnant or nursing women are advised to avoid this medication, and if necessary, a careful decision should be made after consultation with a specialist. In case of overdose, severe symptoms such as nausea, vomiting, bradycardia, and respiratory depression may occur, requiring immediate emergency treatment, and antidotes such as atropine may be used. This medication should be taken strictly according to the prescribed dose and should not be divided between doses. It should be stored in a safe place out of reach of children, and transferring it to another container should be avoided to maintain quality.

Side effects and when to seek care immediately

Serious side effects

Fainting, bradycardia, heart block, prolonged QT interval, myocardial infarction, heart failure, peptic ulcer, perforated duodenal ulcer, gastrointestinal bleeding, hepatitis, liver dysfunction, jaundice, cerebral seizure, cerebral hemorrhage, cerebrovascular disorders, extrapyramidal disorders (motor dysfunction, ataxia, dyskinesia, etc.), neuroleptic malignant syndrome, rhabdomyolysis, dyspnea, acute pancreatitis, acute renal failure, unexplained sudden death, cardiac arrest, seizures, confusion.

Mild side effects

Nausea, vomiting, loss of appetite, diarrhea, dizziness, insomnia, headache, fatigue, muscle pain, swelling, rash, itching, urinary incontinence, increased urination, constipation, abdominal pain, elevated blood pressure, palpitations, anxiety, drowsiness, hallucinations, aggressive behavior, tremors, gait disturbances, involuntary movements, decreased concentration, mental dullness, reduced blood levels (such as anemia, leukopenia, thrombocytopenia), mild cases of urticaria, sweating, fever, decreased body temperature, fatigue

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 and moisture exposure, ideally at room temperature between 1 degree and 30 degrees Celsius. Storing it this way will help maintain its effectiveness and prevent deterioration.

Appearance and packaging

Appearance

Colorless or light yellow solution in an aluminum foil pouch

Package unit

30 packets/box [5ml/packet x 30], 30 packets/box [10ml/packet x 30]

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.