Donepezil

Selected oral and archived transdermal labels indicate dementia of the Alzheimer’s type, including mild, moderate and severe disease. Donepezil can help cognition and daily functioning, but the labels provide no evidence that it changes the underlying dementing process or cures Alzheimer’s disease. Other dementia diagnoses, preventive use and pediatric treatment are not inferred from this indication.

The selected patch record has a marketing-end date in 2025; verify current product/status and package instructions before use. Its historical label starts one 5 mg/day system, replaced every 7 days, with increase to one 10 mg/day system after 4–6 weeks. Oral 5 mg daily may switch to a 5 mg/day system; after ≥4–6 weeks of oral 5 mg it may switch directly to 10 mg/day. Oral 10 mg daily may switch to 10 mg/day. Apply the first system with the last oral dose. No labeled switch from oral 23 mg or multiple-patch regimen is supplied.

Wear only 1 system, remove the old one before applying another. Back away from spine is preferred; upper buttock or outer thigh may be used. Apply to clean, dry, healthy intact skin with little hair; avoid lotions, irritated/cut skin, shaving and tight-clothing friction. Rotate the exact site for ≥14 days after removal. Let the refrigerated pouch reach room temperature without external heat, apply within 24 hours of refrigeration removal, and press firmly for 30 seconds. Avoid prolonged external heat. If missed or detached, apply a new system immediately and replace it 7 days later; ask about retitration after interruption. Never cut a system.

Known hypersensitivity to donepezil or piperidine derivatives. The archived Adlarity label additionally contraindicates a history of allergic contact dermatitis with Adlarity. Formulation-specific excipient allergy also needs exact-package assessment.

The selected oral and archived patch labels have no boxed warning. Serious bradycardia, GI bleeding, anesthesia interaction and formulation-specific skin risks still apply.

Common oral effects include nausea, diarrhea, insomnia, vomiting, cramps, fatigue and appetite loss. Patch studies additionally reported local itching/dermatitis and headache. Postmarketing reports include QTc prolongation/torsade de pointes, heart block, seizures, severe muscle injury and other reactions; incidence or causality cannot reliably be assigned. Overdose can produce cholinergic crisis with vomiting, salivation, sweating, slow pulse, hypotension, breathing suppression and convulsions. Obtain immediate emergency/Poison Help assessment; remove any patch. Professional supportive care and atropine may be used; dialysis removal is unknown and no home antidote protocol is supplied.

Donepezil can interfere with anticholinergic medicines. Cholinergic agonists, other cholinesterase inhibitors and succinylcholine/similar neuromuscular blockers can have additive or synergistic effects. NSAIDs raise the GI-bleeding monitoring concern. Discuss these combinations and anesthesia plans before changes.

CYP2D6 and CYP3A4 contribute to metabolism. CYP2D6 inhibitors increased exposure in population analyses; ketoconazole increased oral donepezil concentrations in a small study, with uncertain clinical relevance. CYP3A inducers can increase elimination. These findings support individualized interaction/tolerance review, not a universal dose-reduction formula. Studied lack of PK effects with selected medicines does not establish absence of all interactions.

Selected labels give no routine renal/hepatic dose-adjustment schedule. In small studies, clearance was unchanged with moderate–severe renal impairment and decreased about 20% in stable alcoholic cirrhosis; these do not prove safety in every advanced disease state. Older adults constituted much of the oral trial population. At oral 23 mg, patients under 55 kg had more GI effects, weight loss and withdrawals; no invented weight-based dose formula is supplied.

Adequate pregnancy data are lacking and animal studies showed developmental harm during late pregnancy/lactation. Human milk presence, infant effects and milk-production data are unavailable; weigh breastfeeding benefits, maternal need and possible infant risks. Pediatric safety/effectiveness are unestablished. Neither oral nor patch adult dosing is a pediatric algorithm.

Reversible acetylcholinesterase inhibition raises acetylcholine availability and supports cholinergic neurotransmission. The proposed symptomatic action does not establish alteration of the underlying Alzheimer’s disease process.

Oral timing

Elimination half-life about 70 hours; steady state within about 15 days. Oral 10 mg peaks around 3 hours, 23 mg around 8 hours.

ODT

Selected 5/10 mg ODT and corresponding tablets are bioequivalent; this does not create a 23 mg ODT product.

Metabolism / elimination

CYP2D6 and CYP3A4 plus glucuronidation; intact drug and metabolites recovered in urine. Approximately 96% protein-bound.

Archived patch

Weekly 10 mg/day exposure comparable to oral 10 mg/day at steady state in a study; patch mean half-life about 91 hours, steady state within 22 days. Heat/site affects exposure; no oral peak-time transplant.

Follow functional/cognitive response and adherence with the patient/caregiver, appetite/weight, GI symptoms or bleeding, pulse/syncope, respiratory symptoms, urinary obstruction and seizures. Review other medicines and surgery plans. With a patch, check skin, correct site, change date and absence of an old system. These labels do not establish a universal ECG/laboratory interval or automatic continuation/deprescribing algorithm.

Use only the prescribed formulation/dose, once daily for oral treatment; do not independently escalate or restart after a long gap. Oral 23 mg must remain intact; ODT dissolves followed by water. Report fainting, black stool/bloody vomit, severe vomiting, weight loss, breathing changes or seizures. Archived patch instructions require one system at a time, a weekly log, site rotation, heat avoidance and secure disposal; seek pharmacist verification of current availability before relying on that historical product.

Ingredient / route

Donepezil hydrochloride 5 mg · oral film-coated tablet.

Appearance / imprint

White round tablet; 5 and ARICEPT on opposite faces.

Labeler / example NDC

Eisai · 62856-245-30, bottle of 30.

U.S. status

Prescription NDA020690 product; no DEA schedule.

Aricept tablets

5 mg white, 10 mg yellow, 23 mg reddish; brand and strength debossed.

Selected Unichem ODT

5 mg white round (250 / U), 10 mg yellow round (251 / U); NDCs 29300-250-87 and 29300-251-87, 30-tablet blister cartons. No 23 mg ODT supplied.

Archived Adlarity

Weekly systems labeled 5 mg/day or 10 mg/day; the daily delivery rate is not total system drug content. Selected record has marketing end September 19, 2025; do not assume present supply or approval withdrawal.

Other products

Current manufacturer-specific tablets, ODT or combination products need their exact label. No automatic oral-to-patch interchange, 23 mg patch or pediatric approval is inferred.

Selected Aricept tablets/ODT: 15–30°C. Selected Unichem oral tablets/ODT: 20–25°C; retain original labeled packaging. Archived Adlarity: refrigerate 2–8°C, do not freeze, keep sealed until use and follow its warming/application instructions. Fold used systems adhesive-to-adhesive and discard in trash out of children’s/pets’ reach; do not flush, and wash hands after handling. Confirm current exact package storage and status.