Memantine Hydrochloride And Donepezil Hydrochloride
Generic Name: memantine hydrochloride and donepezil hydrochloride
Brand Names:
Memantine Hydrochloride And Donepezil Hydrochloride
11 DESCRIPTION Memantine and donepezil hydrochlorides extended-release capsules contains memantine, an orally active NMDA receptor antagonist, as the hydrochloride salt and donepezil, a reversible inhibitor of the enzyme acetylcholinesterase, as the hydrochloride salt.
Overview
11 DESCRIPTION Memantine and donepezil hydrochlorides extended-release capsules contains memantine, an orally active NMDA receptor antagonist, as the hydrochloride salt and donepezil, a reversible inhibitor of the enzyme acetylcholinesterase, as the hydrochloride salt.
Uses
1 INDICATIONS AND USAGE Memantine and donepezil hydrochlorides extended-release capsules is 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 is 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
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.
Side Effects
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.
Interactions
7 DRUG INTERACTIONS Combined use with NMDA antagonists: use with caution. ( 7.2 ) Memantine and donepezil hydrochlorides extended-release capsules 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.
Warnings
5 WARNINGS AND PRECAUTIONS Memantine and donepezil hydrochlorides extended-release capsules is 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. 4 CONTRAINDICATIONS Memantine and donepezil hydrochlorides extended-release capsules is contraindicated in patients with known hypersensitivity to memantine hydrochloride, donepezil hydrochloride, piperidine derivatives, or to any excipients used in the formulation.
Pregnancy
8.1 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. Adverse developmental effects (mortality and decreased body weight and skeletal ossification) were observed in the offspring of rats administered memantine or donepezil during pregnancy at doses associated with minimal maternal toxicity.
Storage
16.2 Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature] . Dispense in a tight, light-resistant container, as defined in the USP.
Frequently Asked Questions
What is Memantine Hydrochloride And Donepezil Hydrochloride used for?▼
1 INDICATIONS AND USAGE Memantine and donepezil hydrochlorides extended-release capsules is 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 is 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 )
What are the side effects of Memantine Hydrochloride And Donepezil Hydrochloride?▼
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.
Can I take Memantine Hydrochloride And Donepezil Hydrochloride during pregnancy?▼
8.1 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. Adverse developmental effects (mortality and decreased body weight and skeletal ossification) were observed in the offspring of rats administered memantine or donepezil during pregnancy at doses associated with minimal maternal toxicity.
What are the important warnings for Memantine Hydrochloride And Donepezil Hydrochloride?▼
5 WARNINGS AND PRECAUTIONS Memantine and donepezil hydrochlorides extended-release capsules is 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. 4 CONTRAINDICATIONS Memantine and donepezil hydrochlorides extended-release capsules is contraindicated in patients with known hypersensitivity to memantine hydrochloride, donepezil hydrochloride, piperidine derivatives, or to any excipients used in the formulation.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.