Alzacare
Generic Name
Donepezil Hydrochloride Extended-Release
Manufacturer
Sun Pharmaceutical Industries Ltd.
Country
India
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| alzacare 14 mg capsule | ৳ 25.00 | ৳ 150.00 |
Description
Overview of the medicine
Alzacare 14 mg Capsule contains Donepezil Hydrochloride Extended-Release and is used to treat symptoms of moderate to severe Alzheimer's disease. It works by improving the levels of a substance in the brain that helps with memory and thought.
Uses & Indications
Dosage
Adults
Initial dose 7 mg orally once daily. After 4 to 6 weeks, the dose may be increased to 14 mg orally once daily if tolerated. Maximum recommended dose is 28 mg orally once daily, which may be initiated after at least 4-6 weeks at 14 mg/day.
Elderly
No specific dose adjustment is generally required for elderly patients.
Renal_impairment
No dose adjustment is required for patients with mild to moderate renal impairment. Caution is advised in severe renal impairment as donepezil is primarily metabolized hepatically.
How to Take
Take orally once daily, preferably in the evening, with or without food. Swallow the capsule whole; do not chew, crush, or divide it.
Mechanism of Action
Donepezil is a reversible acetylcholinesterase inhibitor that increases the concentration of acetylcholine in the synaptic clefts by inhibiting its breakdown. This action enhances cholinergic function in the central nervous system, which is deficient in Alzheimer's disease.
Pharmacokinetics
Onset
Clinical benefits typically manifest after several weeks of consistent dosing.
Excretion
Excreted predominantly in urine (approximately 57%) and feces (approximately 14%), mainly as metabolites.
Half life
Approximately 70 hours, supporting once-daily dosing.
Absorption
Well absorbed from the gastrointestinal tract, with peak plasma concentrations reached in approximately 3-8 hours for extended-release formulations. Absolute bioavailability is approximately 100%.
Metabolism
Extensively metabolized in the liver by cytochrome P450 enzymes (primarily CYP2D6 and CYP3A4) into various inactive metabolites.
Side Effects
Contraindications
- Known hypersensitivity to donepezil, piperidine derivatives, or any component of the formulation.
- Patients with severe gastrointestinal bleeding or ulceration.
Drug Interactions
Anticholinergics
Donepezil may antagonize the effects of anticholinergic agents.
NSAIDs (Non-Steroidal Anti-Inflammatory Drugs)
Concomitant use may increase the risk of gastrointestinal bleeding or ulceration.
Succinylcholine, other neuromuscular blocking agents
Donepezil may potentiate the effects of succinylcholine-type neuromuscular blockers during anesthesia.
CYP3A4 and CYP2D6 inducers (e.g., Rifampicin, Phenytoin, Carbamazepine)
May decrease donepezil plasma concentrations, potentially reducing its efficacy.
CYP3A4 and CYP2D6 inhibitors (e.g., Ketoconazole, Quinidine, Fluoxetine, Paroxetine)
May increase donepezil plasma concentrations, potentially increasing the risk of side effects.
Storage
Store at controlled room temperature (20-25°C), protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include severe nausea, vomiting, salivation, sweating, bradycardia, hypotension, respiratory depression, collapse, and convulsions. Management involves general supportive measures and atropine as an antidote.
Pregnancy & Lactation
Pregnancy Category C. Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is unknown whether donepezil is excreted in human milk. Caution should be exercised when administered to a nursing mother.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24 to 36 months from the date of manufacture
Availability
Pharmacies, Hospitals
Approval Status
Approved (Generic versions available globally)
Patent Status
Generic available (Donepezil)
Clinical Trials
Donepezil extended-release formulations have been evaluated in clinical trials, demonstrating sustained plasma concentrations and comparable efficacy to immediate-release formulations, with a potentially improved tolerability profile due to reduced peak-to-trough fluctuations.
Lab Monitoring
- Liver function tests (baseline and periodically, especially if hepatic dysfunction symptoms occur)
- Heart rate and rhythm (due to potential vagotonic effects)
- Weight (especially in patients with anorexia)
Doctor Notes
- Emphasize to patients and caregivers that Alzacare is a symptomatic treatment for Alzheimer's disease and does not alter the underlying disease process.
- Monitor patients for significant bradycardia or other cardiovascular adverse events, especially those with pre-existing cardiac conditions.
- Advise caution regarding concomitant use of NSAIDs due to increased risk of GI bleeding.
Patient Guidelines
- Take Alzacare exactly as prescribed by your doctor and do not change the dose without consulting them.
- Swallow the capsule whole; do not chew, crush, or open it.
- Inform your doctor about all prescription, over-the-counter, and herbal medications you are taking.
- Report any severe gastrointestinal symptoms, unusual bleeding, or fainting spells to your doctor immediately.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. If it is almost time for your next scheduled dose, skip the missed dose and resume your regular schedule. Do not take two doses at once to make up for a missed dose.
Driving Precautions
Alzacare may cause dizziness, drowsiness, or fainting. Patients should avoid driving or operating hazardous machinery until they are certain how the medication affects them.
Lifestyle Advice
- Engage in mentally stimulating activities and maintain a balanced diet.
- Regular physical activity can be beneficial, as advised by your healthcare provider.
- Ensure a safe home environment to prevent falls, especially for elderly patients.
- Maintain good hydration.
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