NAMZARIC

NAMZARIC NAMZARIC was bioequivalent to co-administration of individual memantine hydrochloride extended-release and donepezil hydrochloride. Exposure (AUC and C max ) of memantine and donepezil following NAMZARIC administration in the fed or fasted state was similar. Further, exposure of memantine and donepezil following NAMZARIC administration as intact capsule or capsule contents sprinkled on applesauce was similar in healthy subjects. Memantine Hydrochloride Memantine is well absorbed after o...

The effectiveness of NAMZARIC as a treatment for patients with moderate to severe Alzheimer’s disease was established by demonstrating the bioequivalence of NAMZARIC with co-administered memantine hydrochloride extended-release and donepezil hydrochloride [see Clinical Pharmacology (12.3) ] . Memantine Hydrochloride The effectiveness of memantine hydrochloride extended-release as a treatment for patients with moderate to severe Alzheimer’s disease when coadministered with acetylcholinesterase inhibitors, including donepezil hydrochloride, was based on the results of a double-blind, placebo-con...

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 react...

NAMZARIC is contraindicated in patients with known hypersensitivity to memantine hydrochloride, donepezil hydrochloride, piperidine derivatives, or to any excipients used in the formulation . NAMZARIC is contraindicated in patients with known hypersensitivity to memantine hydrochloride, donepezil hydrochloride, piperidine derivatives, or to any excipients used in the formulation. ( 4 )

NAMZARIC is likely to exaggerate succinylcholine-type muscle relaxation during anesthesia. ( 5.1 ) NAMZARIC 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 ) NAMZARIC can cause diarrhea, nausea, and vomiting. ( 5.4 ) NAMZARIC may cause bladder outflow obstructions. ( 5.5 ) Conditions...

7 DRUG INTERACTIONS Combined use with NMDA antagonists: use with caution. ( 7.2 ) NAMZARIC 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 ...