namzaric
Pharmaranks rates Namzaric 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Namzaric is a combination medicine containing Donepezil Hydrochloride and Memantine Hydrochloride.
Donepezil Hydrochloride and Memantine Hydrochloride · by Abbvie
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Donepezil Hydrochloride and Memantine Hydrochloride
- Form
- Capsule
- Strength
- Donepezil Hydrochloride 10MG; Memantine Hydrochloride 14MG · Donepezil Hydrochloride 10MG; Memantine Hydrochloride 21MG · Donepezil Hydrochloride 10MG; Memantine Hydrochloride 28MG · Donepezil Hydrochloride 10MG; Memantine Hydrochloride 7MG
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Abbvie
- Half-life
- about 70 hours (how long it stays in your system)
- What the pharmacy pays
- ~$1.45 for 30 — not your price
- FDA application
- NDA206439
What is Namzaric?
From the FDA label:NAMZARIC 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. Memantine Hydrochloride The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula: The molecular formula is C 12 H 21 N•HCl and the molecular weight is 215.76. Memantine hydrochloride occurs as a fine white to off-white powder. Donepezil Hydrochloride The chemical name for donepezil hydrochloride is 2,3-dihydro-5,6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. The molecular formula is C 24 H 29 NO 3 •HCl and the molecular weight is 415.96. Donepezil hydrochloride is a white crystalline powder. NAMZARIC extended-release capsules contain 7 mg, 14 mg, 21 mg or 28 mg memantine hydrochloride, 10 mg donepezil hydrochloride, and the following inactive ingredients: colloidal silicon dioxide, corn starch, ethylcellulose, hypromellose, lactose monohydrate, magnesium stearate, medium chain triglycerides, microcrystalline cellulose, oleic acid, polyethylene glycol, povidone, sugar spheres, and talc. The capsule shells contain gelatin and titanium dioxide and are imprinted with shellac glaze and black iron oxide. Colorants are FD&C Blue No. 1 (7 mg/10 mg, 14 mg/10 mg, 28 mg/10 mg),…
How to use
For patients on donepezil hydrochloride 10 mg only, the recommended starting dose of NAMZARIC 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 NAMZARIC 28 mg/10 mg, taken once daily in the evening. ( 2.1 ) NAMZARIC 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 NAMZARIC is 14 mg/10 mg once daily in the evening. ( 2.3 ) 2.1 Recommended Dosing The recommended dose of NAMZARIC is 28 mg/10 mg once daily. For patients stabilized on donepezil and not currently on memantine: For patients stabilized on donepezil hydrochloride 10 mg and not currently on memantine hydrochloride, the recommended starting dose of NAMZARIC is 7 mg/10 mg, taken once a day in the evening. The dose should be increased in 7 mg increments of the memantine hydrochloride component to the recommended maintenance dose of 28 mg/10 mg once daily. The minimum recommended interval between dose increases is one week. The dose should only be increased if the previous dose…
Side effects
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 AbbVie Inc. at 1-800-633-9110 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…
Warnings
Important safety information
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 that raise urine pH may decrease the urinary elimination of memantine, resulting in increased plasma levels of memantine. ( 5.5 , 7.1 ) 5.1 Anesthesia Donepezil hydrochloride, an active ingredient in NAMZARIC, as a cholinesterase inhibitor, is likely to exaggerate succinylcholine-type muscle relaxation during anesthesia. 5.2 Cardiovascular Conditions Because of their pharmacological action, cholinesterase inhibitors may have vagotonic effects on the sinoatrial and atrioventricular nodes. This effect may manifest as bradycardia or heart block in patients both with and without known underlying cardiac conduction abnormalities. Syncopal episodes have been reported in association with the use of donepezil hydrochloride, an active ingredient in NAMZARIC. 5.3 Peptic Ulcer Disease and Gastrointestinal Bleeding Through their primary action, cholinesterase inhibitors may be expected to increase gastric acid secretion due to increased cholinergic activity. Clinical studies of donepezil hydrochloride in a dose of 5 mg/day to 10 mg/day have shown no increase, relative to placebo, in the incidence of either peptic ulcer disease or gastrointestinal bleeding. Patients treated with NAMZARIC should be monitored closely for symptoms of active or occult gastrointestinal bleeding, especially those at increased risk for developing ulcers, e.g., those with a history of ulcer disease or those receiving concurrent nonsteroidal anti-inflammatory drugs (NSAIDs). 5.4 Nausea and Vomiting Donepezil hydrochloride, an active ingredient in NAMZARIC, when initiated, as a predictable consequence of its pharmacological properties, has been shown to produce diarrhea, nausea, and vomiting. Although in most cases, these effects have been mild and transient, sometimes lasting one to three weeks, and have resolved during continued use of donepezil hydrochloride, patients should be observed closely at the initiation of treatment. 5.5 Genitourinary Conditions Although not observed in clinical trials of donepezil hydrochloride, an active ingredient in NAMZARIC, cholinomimetics may cause bladder outflow obstruction. Conditions that raise urine pH may decrease the urinary elimination of memantine, an active ingredient in NAMZARIC, resulting in increased plasma levels of memantine [see Drug Interactions (7.1) ] . 5.6 Seizures Cholinomimetics, including donepezil hydrochloride, an active ingredient in NAMZARIC, are believed to have some potential to cause generalized convulsions. However, seizure activity also may be a manifestation of Alzheimer’s disease. 5.7 Pulmonary Conditions Because of their cholinomimetic actions, cholinesterase inhibitors should be prescribed with care to patients with a history of asthma or obstructive pulmonary disease.
Who should not take Namzaric
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 )
Overdose — what happens if you take too much
Memantine hydrochloride and donepezil hydrochloride are the two active ingredients of NAMZARIC. No specific antidote for memantine hydrochloride overdose is known; however, elimination of memantine can be increased by acidification of the urine. Tertiary anticholinergics such as atropine may be used as an antidote for donepezil hydrochloride overdose. In managing cases of overdose, consider the possibility of multiple drug involvement. In case of overdose, call Poison Control Center at 1-800-222-1222 for the latest recommendation. In general, supportive measures should be utilized, and treatment should be symptomatic. Memantine Hydrochloride Signs and symptoms most often accompanying overdosage with other formulations of memantine in clinical trials and from worldwide marketing experience, alone or in combination with other drugs and/or alcohol, include agitation, asthenia, bradycardia, confusion, coma, dizziness, ECG changes, increased blood pressure, lethargy, loss of consciousness, psychosis, restlessness, slowed movement, somnolence, stupor, unsteady gait, visual hallucinations, vertigo, vomiting, and weakness. The largest known ingestion of memantine worldwide was 2 grams in an individual who took memantine in conjunction with unspecified antidiabetic medications. This person experienced coma, diplopia, and agitation, but subsequently recovered. One patient participating…
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
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 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 of Other Drugs on the Metabolism of Donepezil Inhibitors of CYP3A4 (e.g., ketoconazole) and CYP2D6 (e.g., quinidine), inhibit donepezil metabolism in vitro . Whether there is a clinical effect of quinidine is not known. Inducers of CYP3A4 (e.g., phenytoin, carbamazepine, dexamethasone, rifampin, and phenobarbital) could increase the rate of elimination of donepezil. 7.4 Use of Donepezil with Anticholinergics Because of their mechanism of action, cholinesterase inhibitors, including donepezil hydrochloride, have the potential to interfere with the activity of anticholinergic medications. 7.5 Use of Donepezil with Cholinomimetics and Other Cholinesterase Inhibitors A synergistic effect may be expected when cholinesterase inhibitors, including donepezil hydrochloride, are given concurrently with succinylcholine, similar neuromuscular blocking agents, or cholinergic agonists such as bethanechol.
How long does Donepezil Hydrochloride and Memantine Hydrochloride stay in your body?
The elimination half-life of donepezil hydrochloride and memantine hydrochloride is about 70 hours — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. The label states plainly: "The elimination half life of donepezil is about 70 hours" — one figure, no separate distribution/terminal phases reported. That is unusually long for an oral drug: the label notes donepezil accumulates 4- to 7-fold with repeat dosing and does not reach steady state for about 15 days. Active metabolite: donepezil is extensively metabolized (CYP2D6 and CYP3A4) to four major metabolites, two of them active. The main one, 6-O-desmethyl donepezil, is reported to inhibit acetylcholinesterase to the same extent as donepezil in vitro and circulates at roughly 20% of donepezil's plasma concentration — but the label does NOT state its half-life, so no number is given here. Populations the label names: clearance falls with age (a 90-year-old has about 17% lower clearance than a 65-year-old; a 40-year-old about 33% higher), which the label calls possibly not clinically significant. In stable alcoholic cirrhosis, clearance was about 20% lower. In moderate-to-severe renal impairment (CrCl < 18 mL/min/1.73 m2), clearance did not differ from healthy matched subjects. CYP2D6 poor metabolizers clear it about 31.5% more slowly; ultra-rapid metabolizers about 24% faster. Half-life describes how the body clears the drug — it is not a drug-test detection window and not dosing guidance.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: DailyMed — DONEPEZIL HYDROCHLORIDE tablet, film coated (FDA label, §12.3 Pharmacokinetics).
Dosage forms
Capsule
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
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Frequently asked questions
- How is Namzaric rated?
- pharmaranks gives Namzaric a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Namzaric cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $1.45 for 30, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Namzaric?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Namzaric. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Namzaric?
- Namzaric is marketed by Abbvie. You can see Abbvie's full profile, rating, and other products on pharmaranks.
- Is Namzaric a brand-name or generic drug?
- Namzaric is a brand-name product with the active ingredient Donepezil Hydrochloride and Memantine Hydrochloride.
- Is Namzaric available over the counter?
- No. Namzaric is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Namzaric come in?
- Namzaric is currently marketed as capsule, per the FDA's National Drug Code Directory.
- Is Namzaric FDA-registered?
- Namzaric is on record with the U.S. FDA under application number NDA206439. You can verify this on its official FDA label.
- Has Namzaric been recalled by the FDA?
- Yes. Namzaric has 1 recorded FDA recall event in the openFDA enforcement database. A recall removes specific lots from the market — usually for manufacturing, contamination, potency, or labeling issues — and does not mean the drug is unsafe to take; your specific lot was almost certainly never affected. This recall history is factored into its safety score above. Always check the FDA recall database or your pharmacist for current alerts.
- Is Namzaric safe?
- There's no single safe-or-not verdict. pharmaranks gives Namzaric a recall-safety score of 70/100, based on its FDA recall history (1 recorded recall event) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Namzaric?
- Namzaric's side effects are taken directly from its FDA label. From the label: 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)… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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