Donepezil Hydrochloride / Memantine Hydrochloride

What it is and how it works

Mechanism of Action Memantine and donepezil hydrochlorides extended-release capsules contain two approved medications: memantine hydrochloride and donepezil hydrochloride. Each of those medications is postulated to have a different mechanism in Alzheimer’s disease. Memantine Persistent activation of central nervous system NMDA receptors by the excitatory amino acid glutamate has been hypothesized to contribute to the symptomatology of Alzheimer’s disease. Memantine is postulated to exert its therapeutic effect through its action as a low to moderate affinity uncompetitive (open channel) NMDA receptor antagonist which binds preferentially to the NMDA receptor-operated cation channels.

Indications

Memantine and donepezil hydrochlorides extended-release capsules are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type in patients stabilized on 10 mg of donepezil hydrochloride once daily. Memantine and donepezil hydrochlorides extended-release capsules are a combination of memantine hydrochloride, an NMDA receptor antagonist, and donepezil hydrochloride, an acetylcholinesterase inhibitor, indicated for the treatment of moderate to severe dementia of the Alzheimer’s type in patients stabilized on 10 mg of donepezil hydrochloride once daily.

Dosage and administration (summary)

• For patients on donepezil hydrochloride 10 mg only, the recommended starting dose of memantine and donepezil hydrochlorides extended-release capsules is 7 mg/10 mg, taken once daily in the evening. The dose should be increased in 7 mg increment to the recommended maintenance dose of 28 mg /10 mg. the minimum recommended interval between dose increases is one week.

Contraindications

Memantine and donepezil hydrochlorides extended-release capsules are contraindicated in patients with known hypersensitivity to memantine hydrochloride, donepezil hydrochloride, piperidine derivatives, or to any excipients used in the formulation. Memantine and donepezil hydrochlorides extended-release capsules are contraindicated in patients with known hypersensitivity to memantine hydrochloride, donepezil hydrochloride, piperidine derivatives, or to any excipients used in the formulation.

Warnings and precautions

• Memantine and donepezil hydrochlorides extended-release capsules are likely to exaggerate succinylcholine-type muscle relaxation during anesthesia. • Memantine and donepezil hydrochlorides extended-release capsules may have vagotonic effects on the sinoatrial and atrioventricular nodes manifesting as bradycardia or heart block. • Monitor patients for symptoms of active or occult gastrointestinal bleeding, especially those at increased risk for developing ulcers. • Memantine and donepezil hydrochlorides extended-release capsules can cause diarrhea, nausea, and vomiting.

Pregnancy

Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of memantine and donepezil hydrochlorides extended-release capsules or its active ingredients (memantine hydrochloride and donepezil hydrochloride) in pregnant women.

Storage and supply

How Supplied Memantine and donepezil hydrochlorides extended-release capsules, 14 mg/10 mg: White capsules imprinted with “184” on cap with black ink and plain body. Bottle of 30s: NDC 33342-312-07 Bottle of 90s: NDC 33342-312-10 100 Capsules (10×10s): NDC 33342-312-12 Memantine and donepezil hydrochlorides extended-release capsules, 28 mg/10 mg: L…

Source: Memantine And Donepezil (Memantine And Donepezil) — US FDA prescribing information, 2025-07-10, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.