Drugplain

Memantine and Donepezil 10 mg/1

Memantine and Donepezil · CAPSULE, EXTENDED RELEASE · Macleods Pharmaceuticals Limited

No Recall HistoryCurrently in Shortage
Plain English

Memantine and Donepezil is a capsule, extended release containing memantine and donepezil at 10 mg/1, taken oral. Manufactured by Macleods Pharmaceuticals Limited.

Key Facts

Brand Name
Memantine and Donepezil
Generic Name
Memantine and Donepezil
NDC Code (Product)
33342-312
Manufacturer
Macleods Pharmaceuticals Limited
Strength
10 mg/1
Dosage Form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Marketing Status
Application #
ANDA208672
Marketing Start
07/15/2025

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

interstitial lung disease1 reports
pleural effusion1 reports
pulmonary oedema1 reports
pulmonary toxicity1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE 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. (1)

Dosage & Administration

2 DOSAGE AND ADMINISTRATION 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 increments to the recommended maintenance dose of 28 mg/10 mg. The minimum recommended interval between dose increases is one week. (2.1) Patients on memantine hydrochloride (10 mg twice daily or 28 mg extended-release once daily) and donepezil hydrochloride 10 mg once daily can be switched to memantine and donepezil hydrochlorides extended-release capsules 28 mg/10 mg, taken once daily in the evening. (2.1) Memantine and donepezil hydrochlorides extended-release capsules can be taken with or without food, whole or sprinkled on applesauce; do not divide, chew, or crush. (2.2) Severe renal impairment: the recommended maintenance dose for memantine and donepezil hydrochlorides extended-release capsules is 14 mg/10 mg once daily in the evening. (2.3) 2.1 Recommended Dosing The recommended dose of memantine and donepezil hydrochlorides extended-release capsules is 28 mg/10 mg once daily. For patients stabilized on donepezil and…

Contraindications

4 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. (4)

Drug Interactions

7 DRUG INTERACTIONS Combined use with NMDA antagonists: use with caution. (7.2) Memantine and donepezil hydrochlorides extended-release may interfere with anticholinergic medications. (7.4) Concomitant administration of succinylcholine, similar neuromuscular blocking agents, or cholinergic agonists may lead to synergistic effect. (7.5) 7.1 Use of Memantine with Drugs That Make the Urine Alkaline The clearance of memantine was reduced by about 80% under alkaline urine conditions at pH 8. Therefore, alterations of urine pH towards the alkaline condition may lead to an accumulation of the drug with a possible increase in adverse reactions. Urine pH is altered by diet, drugs (e.g., carbonic anhydrase inhibitors, sodium bicarbonate) and clinical state of the patient (e.g., renal tubular acidosis or severe infections of the urinary tract). Hence, memantine should be used with caution under these conditions. 7.2 Use of Memantine with Other N-methyl-D-aspartate (NMDA) Antagonists The combined use of memantine hydrochloride with other NMDA antagonists (amantadine, ketamine, and dextromethorphan) has not been systematically evaluated and such use should be approached with caution. 7.3 Effect…

Adverse Reactions

6 ADVERSE REACTIONS The following serious adverse reactions are discussed below and elsewhere in the labeling. Cardiovascular Conditions [see Warnings and Precautions (5.2) ] Peptic Ulcer Disease and Gastrointestinal Bleeding [see Warnings and Precautions (5.3) ] Nausea and Vomiting [see Warnings and Precautions (5.4) ] Genitourinary Conditions [see Warnings and Precautions (5.5) ] Seizures [see Warnings and Precautions (5.6) ] Pulmonary Conditions [see Warnings and Precautions (5.7) ] The most common adverse reactions, occurring at a frequency of at least 5% and greater than placebo with memantine hydrochloride extended-release 28 mg/day, were headache, diarrhea, and dizziness. (6.1) The most common adverse reactions occurring at a frequency of at least 5% in patients receiving donepezil and at twice or more the placebo rate, include diarrhea, anorexia, vomiting, nausea, and ecchymosis. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trial…

Frequently Asked Questions

What is Memantine and Donepezil used for?

Memantine and Donepezil contains Memantine and Donepezil. It is a capsule, extended release taken oral. Consult your doctor for specific uses.

Is Memantine and Donepezil a controlled substance?

Memantine and Donepezil is not classified as a controlled substance by the DEA.

What is the generic name for Memantine and Donepezil?

The generic name for Memantine and Donepezil is Memantine and Donepezil. There are 6 other brand versions of Memantine and Donepezil.

What is the NDC code for Memantine and Donepezil 10 mg/1?

The NDC (National Drug Code) for Memantine and Donepezil 10 mg/1 is 33342-312, listed by Macleods Pharmaceuticals Limited.

Product NDC

33342-312

Package NDC

33342-312-07

Other Memantine and Donepezil Dosages

Other Memantine Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)