Donecare 5 mg Tablet (Donepezil Hydrochloride Hydrate)

Adult dose

As Donepezil Hydrochloride, administer 5 mg once daily before bedtime. In case of unusual dreams, nightmares, or insomnia, morning dosing of this medication may be considered. Donepezil concentrations reach a steady state after 15 days of administration, and the frequency of adverse reactions may be influenced by the rate of dose escalation, thus 5 mg should be administered for 4 to 6 weeks. Clinical responses during this period should be evaluated.

Child dose

There is no experience in the use of this medication in pediatric patients.

This drug contains Donepezil Hydrochloride Hydrate as its active ingredient and is used for the treatment of Alzheimer's type dementia. First, this drug should not be used in patients who are allergic to Donepezil Hydrochloride, piperidine derivatives, or any of this drug's components, as well as in pregnant or potentially pregnant women and nursing mothers. Additionally, since it contains lactose, it should not be administered to patients with genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. Patients with heart diseases, especially those with bradycardia or cardiac conduction disorders, should use this drug cautiously because it may stimulate the vagus nerve and cause bradycardia or arrhythmias. Patients taking non-steroidal anti-inflammatory drugs or those with a history of peptic ulcers should be cautious as this may increase gastric acid secretion and gastrointestinal motility, posing a risk of worsening ulcers. Patients with a history of asthma or chronic obstructive pulmonary disease should also be careful as this may lead to bronchoconstriction and increased mucus secretion, exacerbating symptoms. Moreover, careful dosing is required in patients with extrapyramidal disorders such as Parkinson's disease, as it may worsen symptoms. This drug can cause various adverse reactions, including cardiac issues (bradycardia, heart block, myocardial infarction), gastrointestinal problems (peptic ulcers, gastrointestinal bleeding), liver function abnormalities, cerebrovascular issues, motor function disorders, neuroleptic malignant syndrome, rhabdomyolysis, respiratory distress, acute pancreatitis, acute renal failure, and sudden death. Common mild adverse reactions include nausea, vomiting, diarrhea, decreased appetite, dizziness, insomnia, headache, and fatigue. This drug is not approved for use in other forms of dementia or memory disorders outside of Alzheimer's type dementia, and treatment should be conducted under the supervision of an experienced physician. The therapeutic effects should be regularly evaluated, and if ineffective, discontinuation should be considered. This drug may affect cardiac conduction and can cause serious arrhythmias, hence patients with a history of heart disease or prolonged QT interval should undergo ECG monitoring. Additionally, since it may stimulate gastric acid secretion and exacerbate peptic ulcers, patients with a history of gastric disorders should take precautions. It may impact the ability to drive or operate machinery, requiring caution during the initial dosing or when increasing the dose, as fatigue or dizziness may occur. This drug may interact with other medications; hence caution is necessary when used in combination with specific antibiotics, antidepressants, antiarrhythmics, etc. It is especially metabolized by the enzymes CYP3A4 and CYP2D6, which may alter its efficacy when used with related medications. Pregnant or nursing women are advised not to use this drug; if necessary, consult with a professional before administration. Safety in pediatric patients has not been established, and there is no experience with its use. In case of overdose, symptoms may include nausea, vomiting, sweating, bradycardia, respiratory depression, and seizures, necessitating immediate medical attention; atropine may be used as an antidote. Finally, this drug should be stored out of reach of children, and it is recommended not to transfer it to other containers.

Serious side effects

Syncope, bradycardia, heart block, QT interval prolongation, myocardial infarction, heart failure, peptic ulcers, perforated duodenal ulcer, gastrointestinal bleeding, hepatitis, liver dysfunction, jaundice, cerebral attacks, epilepsy, seizures, cerebral hemorrhage, cerebrovascular disorders, rhabdomyolysis, renal dysfunction, renal failure, acute pancreatitis, sudden death, severe allergic reactions, respiratory distress, torsades de pointes, neuroleptic malignant syndrome, severe edema accompanied by increased blood pressure.

Mild side effects

• Nausea
• vomiting
• diarrhea
• loss of appetite
• headache
• fatigue
• fever
• dizziness
• insomnia
• drowsiness

This drug should be stored in an airtight container, preferably at room temperature between 1°C and 30°C. Proper storage can help maintain the medication's effectiveness.

Appearance

Yellow round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle