General MedicinePrescription OnlyPregnancy Cat. Not classifiedFDA Yes
Memantine And Donepezil Hydrochlorides
MEMANTINE AND DONEPEZIL HYDROCHLORIDES
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...
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Brand names:MEMANTINE AND DONEPEZIL HYDROCHLORIDES
Quick Reference
Medicine ClassGeneral Medicine
FDA ApprovedYes
PregnancyCategory Not classified
Quick Facts
- Active ingredient
- MEMANTINE AND DONEPEZIL HYDROCHLORIDES
- Medicine class
- General Medicine
- Brand names
- MEMANTINE AND DONEPEZIL HYDROCHLORIDES
- Availability
- Prescription only (Rx)
- Pregnancy category
- Not classified
- Half-life
- half-life of about 60-80 hours
- FDA approved
- Yes
What Is Memantine And Donepezil Hydrochlorides?
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...
Memantine And Donepezil Hydrochlorides (MEMANTINE AND DONEPEZIL HYDROCHLORIDES) belongs to the General Medicine class of medications. It was first approved by the FDA in Yes. This medication requires a prescription from a licensed healthcare provider.
Key Safety Information
- •Always follow the dose recommended by your healthcare professional. Taking more than prescribed increases the risk of side effects including serious complications.
- •Seek emergency care if you experience signs of an allergic reaction — hives, swelling, difficulty breathing, or rash. Stop the medication and call your doctor immediately.
- •Some medications can increase the risk of cardiovascular events. Tell your doctor if you have high blood pressure, a history of heart attack or stroke, or any pre-existing health condition.
- •Avoid or limit alcohol while taking Memantine And Donepezil Hydrochlorides. Do not drink alcohol without first discussing it with your healthcare provider as it may increase adverse effects.
- •Take Memantine And Donepezil Hydrochlorides with food or a full glass of water if stomach upset occurs. Stop use and talk to your doctor if you experience persistent stomach pain or GI symptoms.
- •Tell your doctor about all medications, supplements, and vitamins you take. Some combinations significantly increase the risk of harm.
This is a summary only. Always read the full prescribing information and consult your healthcare provider for personalized medical advice.
Uses & Indications
Memantine And Donepezil Hydrochlorides is prescribed for the following conditions. Some uses are FDA-approved indications; others may be evidence-based off-label uses. Consult your healthcare provider for personalized guidance.
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.
Dosage Guide
The following are general dosing guidelines only. Your actual dose should be determined by your healthcare provider based on your condition, renal/hepatic function, and other medications.
AD
Adult Dosage
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 m
Available Forms
Available Strengths
Side Effects
Common
- 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 hydrochloride and at twice or more the placebo rate, include diarrhea, anorexia, vomiting, nausea, and ecchymosis.
- ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact ANI Pharmaceuticals, Inc.
- at 1-855-204-1431 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 trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
- Memantine Hydrochloride Memantine hydrochloride extended-release was evaluated in a double-blind, placebo-controlled trial in 676 patients with moderate to severe dementia of the Alzheimer's type (341 patients treated with memantine 28 mg/day dose and 335 patients treated with placebo) for a treatment period up to 24 weeks.
Serious
- 5 WARNINGS AND PRECAUTIONS • Memantine and donepezil hydrochlorides extended-release capsules are likely to exaggerate succinylcholine-type muscle relaxation during anesthesia.
- ( 5.1 ) • Memantine and donepezil hydrochlorides extended-release capsules may have vagotonic effects on the sinoatrial and atrioventricular nodes manifesting as bradycardia or heart block.
- ( 5.2 ) • Monitor patients for symptoms of active or occult gastrointestinal bleeding, especially those at increased risk for developing ulcers.
- ( 5.3 ) • Memantine and donepezil hydrochlorides extended-release capsules can cause diarrhea, nausea, and vomiting.
- ( 5.4 ) • Memantine and donepezil hydrochlorides extended-release capsules may cause bladder outflow obstructions.
Rare
Medicine Interactions
Always inform your healthcare provider and pharmacist about ALL medications you take, including prescriptions, OTC medicines, vitamins, and supplements.
MajorModerateMinor
Warnings & Contraindications
5 WARNINGS AND PRECAUTIONS • Memantine and donepezil hydrochlorides extended-release capsules are likely to exaggerate succinylcholine-type muscle relaxation during anesthesia. ( 5.1 ) • Memantine and donepezil hydrochlorides extended-release capsules may have vagotonic effects on the sinoatrial and atrioventricular nodes manifesting as bradycardia or heart block. ( 5.2 ) • Monitor patients for sy
How Memantine And Donepezil Hydrochlorides Works
12.1 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. There is no evidence that memantine prevents or slows neurodegeneration in patients with Alzheimer's d
Pharmacokinetics
Absorption
Absorption After multiple dose administration of memantine hydrochloride extended-release, memantine peak concentrations occur around 9-12 hours postdose
Half-Life
half-life of about 60-80 hours
Metabolism
Metabolism Memantine undergoes partial hepatic metabolism
Pregnancy & Breastfeeding Safety
Not classified
Breastfeeding
Many medications pass into breast milk in varying amounts. Before using Memantine And Donepezil Hydrochlorideswhile breastfeeding, discuss the benefits and risks with your healthcare provider or pharmacist — they can weigh your dose, your infant's age, and available lactation safety data to find the safest option for you and your baby.
Storage & Handling
Store at room temperature. Keep away from moisture and heat. Keep out of reach of children.
Frequently Asked Questions
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Memantine And Donepezil Hydrochlorides dosage guide
Adult, pediatric, renal, and hepatic dosing for Memantine And Donepezil Hydrochlorides
- Detail
Memantine And Donepezil Hydrochlorides side effects
Complete adverse effect profile including common, serious, and rare reactions
Sources & References
- • FDA Prescribing Information — Official labeling and package insert for Memantine And Donepezil Hydrochlorides
- • U.S. National Library of Medicine — MedlinePlus drug information
- • American Hospital Formulary Service (AHFS) — Clinical pharmacology monograph
- • PubMed / MEDLINE — View clinical studies
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Medical Disclaimer
The information on this page is for educational purposes only and is not intended as medical advice, diagnosis, or treatment. Always consult your doctor, pharmacist, or qualified healthcare provider before starting, stopping, or changing any medication.