namenda
Pharmaranks rates Namenda 3.6/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Namenda (Memantine Hydrochloride) is a n-methyl-d-aspartate receptor antagonist used to treat Alzheimer Disease.
Memantine Hydrochloride · by Abbvie
Available as a generic: Memantine Hydrochloride
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
- Memantine Hydrochloride
- Drug class
- N-Methyl-D-Aspartate Receptor Antagonist
- Form
- Kit, Tablet
- Strength
- Memantine Hydrochloride 10MG · Memantine Hydrochloride 5MG
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- alzheimer disease
- Manufacturer
- Abbvie
- Half-life
- about 60 to 80 hours (how long it stays in your system)
- What the pharmacy pays
- ~$2.46 for 30 — not your price
- FDA application
- NDA021487
- Availability
- Discontinued (per FDA)
What is Namenda?
From the FDA label:Memantine hydrochloride tablets are an orally active NMDA receptor antagonist. 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 and is soluble in water. Memantine hydrochloride is available as tablets. Memantine hydrochloride tablets are available for oral administration as capsule-shaped, film-coated tablets containing 5 mg and 10 mg of memantine hydrochloride. The tablets also contain the following inactive ingredients: microcrystalline cellulose/colloidal silicon dioxide, talc, croscarmellose sodium, and magnesium stearate. In addition, the following inactive ingredients are also present as components of the film coat: hypromellose, titanium dioxide, polyethylene glycol 400, FD&C yellow #6 and FD&C blue #2 (5 mg tablets), and hypromellose, titanium dioxide, macrogol/polyethylene glycol 400 and iron oxide black (10 mg tablets). The following structural formula for Memantine hydrochloride tablets are an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride.
How to use
Namenda is sold in more than one form (Kit and Tablet), and each is dosed differently. The instructions below come from the FDA label for application NDA021487 — follow the label that came with the product you were actually prescribed.
The recommended starting dose of memantine hydrochloride tablets is 5 mg once daily. The dose should be increased in 5 mg increments to 10 mg/day (5 mg twice daily), 15 mg/day (5 mg and 10 mg as separate doses), and 20 mg/day (10 mg twice daily). The minimum recommended interval between dose increases is one week. The dosage shown to be effective in controlled clinical trials is 20 mg/day. Memantine hydrochloride tablets can be taken with or without food. If a patient misses a single dose of memantine hydrochloride, that patient should not double up on the next dose. The next dose should be taken as scheduled. If a patient fails to take memantine hydrochloride tablets for several days, dosing may need to be resumed at lower doses and retitrated as described above. Specific Populations Renal Impairment A target dose of 5 mg twice daily is recommended in patients with severe renal impairment (creatinine clearance of 5 – 29 mL/min based on the Cockcroft-Gault equation). Hepatic Impairment Memantine hydrochloride tablets should be administered with caution to patients with severe hepatic impairment [see Clinical Pharmacology ( 12.3 )] . May be taken with or without food. ( 2 ) Initial dose is 5 mg once daily. Increase dose in 5 mg increments to a maintenance dose of 10 mg twice daily. A minimum of 1 week of treatment with the previous dose should be observed before increasing the…
Side effects
Most common adverse reactions (≥ 5 % and greater than placebo) are dizziness, headache, confusion and constipation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Actavis at 1-800-272-5525 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Memantine hydrochloride was evaluated in eight double-blind placebo-controlled trials involving a total of 1862 dementia (Alzheimer’s disease, vascular dementia) patients (940 patients treated with memantine hydrochloride and 922 patients treated with placebo) for a treatment period up to 28 weeks. 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 clinical practice. Adverse Events Leading to Discontinuation In placebo-controlled trials in which dementia patients received doses of memantine hydrochloride up to 20 mg/day, the likelihood of discontinuation because of an adverse reaction was the same in the memantine hydrochloride group (10.1%) as in the placebo group (11.5%). No individual adverse reaction was associated with the discontinuation of treatment in 1% or more of memantine hydrochloride-treated patients and at a rate greater than placebo. Most Common Adverse Reactions In double-blind…
Warnings
Important safety information
Conditions that raise urine pH may decrease the urinary elimination of memantine, resulting in increased plasma levels of memantine. ( 5.1 , 7.1 ) 5.1 Genitourinary Conditions Conditions that raise urine pH may decrease the urinary elimination of memantine resulting in increased plasma levels of memantine [see Drug Interactions ( 7.1 )] .
Who should not take Namenda
Memantine hydrochloride tablets are contraindicated in patients with known hypersensitivity to memantine hydrochloride or to any excipients used in the formulation. Memantine hydrochloride tablets are contraindicated in patients with known hypersensitivity to memantine hydrochloride or to any excipients used in the formulation. ( 4 )
Overdose — what happens if you take too much
Signs and symptoms most often accompanying memantine overdosage 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 2.0 grams in a patient who took memantine in conjunction with unspecified antidiabetic medications. The patient experienced coma, diplopia, and agitation, but subsequently recovered. Fatal outcome has been very rarely reported with memantine, and the relationship to memantine was unclear. Because strategies for the management of overdose are continually evolving, it is advisable to contact a poison control center to determine the latest recommendations for the management of an overdose of any drug. As in any cases of overdose, general supportive measures should be utilized, and treatment should be symptomatic. Elimination of memantine can be enhanced by acidification of urine.
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
7. 1 Drugs that Make t he 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 effects. 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 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.
How long does Memantine Hydrochloride stay in your body?
The elimination half-life of memantine hydrochloride is about 60 to 80 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. This is the terminal elimination half-life the label reports for memantine itself; the label gives it as a range and does not narrow it further. Memantine is not a prodrug, and it has no long-lasting active metabolite to worry about: roughly 48% of a dose is excreted unchanged in urine, and the label describes the three metabolites it does form (the N-glucuronide conjugate, 6-hydroxy memantine, and 1-nitroso-deaminated memantine) as possessing only minimal NMDA-receptor antagonistic activity. Populations the label names: in older adults, the label states that the pharmacokinetics in young and elderly subjects are similar. In kidney impairment, the terminal elimination half-life is longer — increased by about 18% in mild, 41% in moderate, and 95% (roughly double) in severe renal impairment. In moderate liver impairment (Child-Pugh B), the terminal half-life increased by about 16%, with overall exposure unchanged; severe hepatic impairment has not been evaluated.
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 — MEMANTINE HYDROCHLORIDE (memantine tablet, film coated), §12.3 Pharmacokinetics.
Drug class
May treat (source: NIH RxClass)
Dosage forms
Kit and Tablet
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.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Namenda treat?
- Namenda (Memantine Hydrochloride) may be used to treat alzheimer disease, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How is Namenda rated?
- pharmaranks gives Namenda a composite score of 3.6 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 Namenda 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 $2.46 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 Namenda?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Namenda. 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 Namenda?
- Namenda is marketed by Abbvie. You can see Abbvie's full profile, rating, and other products on pharmaranks.
- Is Namenda a brand-name or generic drug?
- Namenda is a brand-name product with the active ingredient Memantine Hydrochloride. Lower-cost generic equivalents containing Memantine Hydrochloride are available — ask your pharmacist.
- Is Namenda available over the counter?
- No. Namenda 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 Namenda come in?
- Namenda is currently marketed as kit and tablet, per the FDA's National Drug Code Directory.
- What class of drug is Namenda?
- Namenda is classified as n-methyl-d-aspartate receptor antagonist, per the FDA's Established Pharmacologic Class.
- Is Namenda FDA-registered?
- Namenda is on record with the U.S. FDA under application number NDA021487. You can verify this on its official FDA label.
- Has Namenda been recalled by the FDA?
- Namenda has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Namenda safe?
- There's no single safe-or-not verdict. pharmaranks gives Namenda a recall-safety score of 72/100, based on its FDA recall history (no recalls under its own FDA application) — 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 Namenda?
- Namenda's side effects are taken directly from its FDA label. From the label: Most common adverse reactions (≥ 5 % and greater than placebo) are dizziness, headache, confusion and constipation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Actavis at 1-800-272-5525 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.… 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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namenda
72/100