Memantine Hydrochloride 5 mg Tablet, Film Coated, 100-count
Other active recalls for Memantine Hydrochloride (different manufacturers) — 1 · tap to view
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the N-methyl-D-aspartate Receptor Antagonist class.
Where does this data come from?
🏭 Manufacturer & labeler
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🩺 Clinical
Memantine is used to treat the symptoms of Alzheimer's disease (AD; a brain disease that affects memory, thinking, and behavior). Memantine is in a class of medications called NMDA receptor antagonists. It works by changing the activity of certain natural substances in the brain.
Read the full MedlinePlus article ↗- Memantine helps manage the symptoms of moderate to severe Alzheimer's disease. It works by blocking certain brain receptors that are overstimulated in Alzheimer's, which is thought...
- What does memantine actually do for Alzheimer's disease?
- No — memantine can be taken with or without food, whichever is easier to stick with. For the extended-release capsule form, food does slightly affect the timing of when the drug pe...
- Just skip the missed dose and take your next dose at the regularly scheduled time. Never double up to make up for a missed one. If you've missed several days in a row, don't just r...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Memantine Hydrochloride — tap one for details:
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💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII L06K8R7DQK
A synthetic blue dye approved by the FDA for use in medications and foods. It serves as a colorant to make pills and liquids visually distinct and easier to identify.
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UNII H77VEI93A8
A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
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UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
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UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII 3WJQ0SDW1A
Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
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UNII FZ989GH94E
Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
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UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
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UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
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UNII 7SEV7J4R1U
A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
11 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.080 | $8.01 / 100 tablet |
| Medicaid paysCMS SDUD · 12 mo | $0.2680 | $26.80 / 100 tablet |
| Medicare drug plans payPart D · Q2 2026 | $0.1890 | $18.90 / 100 tablet |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| memantine hydrochloride 5 mg 00591-3870-44 | Actavis | 100 tablets | $0.080 | — | Availability likely | — |
| Memantine Hydrochloride 5 mg 00832-1112-60 | Upsher-Smith | 60 tablets | $0.080 | AB | Availability likely | — |
| Memantine Hydrochloride 5 mgthis 00904-6505-61 | Major | 100 tablets | $0.080 | AB | Availability likely | — |
| Memantine Hydrochloride 5 mg 29300-0171-05 | Unichem | 500 tablets | $0.080 | AB | Availability likely | — |
| Memantine Hydrochloride 5 mg 33342-0297-09 | Macleods | 60 tablets | $0.080 | AB | Availability likely | — |
| Memantine Hydrochloride 5 mg 50268-0587-13 | AvPAK | 1 tablet | $0.080 | AB | Availability likely | — |
| Memantine 5 mg 60687-0173-57 | American | 60 tablets | $0.080 | AB | Availability likely | — |
| Memantine Hydrochloride 5 mg 61442-0192-05 | Carlsbad | 500 tablets | $0.080 | AB | Availability likely | — |
| memantine 5 mg 62135-0895-60 | Chartwell | 60 tablets | $0.080 | — | Availability likely | — |
| memantine hydrochloride 5 mg 65162-0173-06 | Amneal | 60 tablets | $0.080 | AB | Availability likely | — |
| Memantine hydrochloride 5 mg 68180-0229-07 | Lupin | 60 tablets | $0.080 | AB | Availability likely | — |
| Memantine 5 mg 72603-0118-01 | NorthStar | 60 tablets | $0.080 | AB | Availability likely | — |
| Memantine 5 mg 00615-8192-39 | NCS | 30 tablets | — | AB | FDA listed | — |
| Memantine Hydrochloride 5 mg 27241-0070-05 | Ajanta | 500 tablets | — | AB | FDA listed | — |
| memantine hydrochloride 5 mg 31722-0807-02 | Camber | 200 tablets | — | AB | FDA listed | — |
| Memantine Hydrochloride 5 mg 46708-0451-10 | Alembic | 100 tablets | — | AB | FDA listed | — |
| Memantine Hydrochloride 5 mg 47335-0321-08 | Sun | 100 tablets | — | AB | FDA listed | — |
| Memantine Hydrochloride 5 mg 50090-5926-00 | A-S | 60 tablets | — | AB | FDA listed | — |
| Memantine Hydrochloride 5 mg 50090-6291-00 | A-S | 60 tablets | — | AB | FDA listed | — |
| memantine hydrochloride 5 mg 50090-7348-00 | A-S | 60 tablets | — | AB | FDA listed | — |
| memantine hydrochloride 5 mg 52605-0071-10 | POLYGEN | 1000 tablets | — | AB | FDA listed | — |
| Memantine hydrochloride 5 mg 53746-0173-10 | Amneal | 1000 tablets | — | AB | FDA listed | — |
| Memantine Hydrochloride 5 mg 55111-0596-01 | Dr. | 100 tablets | — | AB | FDA listed | — |
| memantine hydrochloride 5 mg 55154-2666-00 | Cardinal | 10 tablets | — | — | FDA listed | — |
| Memantine Hydrochloride 5 mg 55154-4151-00 | Cardinal | 10 tablets | — | AB | FDA listed | — |
| Memantine Hydrochloride 5 mg 62332-0075-10 | Alembic | 100 tablets | — | AB | FDA listed | — |
| Memantine Hydrochloride 5 mg 63629-2513-01 | Bryant | 500 tablets | — | AB | FDA listed | — |
| Memantine Hydrochloride 5 mg 63629-2514-01 | Bryant | 60 tablets | — | AB | FDA listed | — |
| Memantine Hydrochloride 5 mg 65862-0652-03 | Aurobindo | 10 tablets | — | — | FDA listed | — |
| Memantine Hydrochloride 5 mg 67046-1471-03 | Coupler | 30 tablets | — | AB | FDA listed | — |
| Memantine Hydrochloride 5 mg 70518-3338-00 | REMEDYREPACK | 30 tablets | — | AB | Discontinued | — |
| Memantine Hydrochloride 5 mg 70771-1119-00 | Zydus | 1000 tablets | — | AB | FDA listed | — |
| Memantine Hydrochloride 5 mg 71335-1732-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Memantine Hydrochloride 5 mg 71335-2013-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Memantine Hydrochloride 5 mg 71610-0911-60 | Aphena | 90 tablets | — | AB | FDA listed | — |
| Memantine Hydrochloride 5 mg 71610-0979-80 | Aphena | 180 tablets | — | AB | FDA listed | — |
| Memantine Hydrochloride 5 mg 72162-2003-05 | Bryant | 500 tablets | — | AB | FDA listed | — |
| Memantine Hydrochloride 5 mg 72189-0294-30 | DirectRx | 30 tablets | — | AB | FDA listed | — |
| Memantine Hydrochloride 5 mg 72578-0003-01 | Viona | 100 tablets | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 00904-6505-06 | 50 BLISTER PACK in 1 CARTON (0904-6505-06) / 1 TABLET in 1 BLISTER PACK | $0.0801 / ea | $4.00 | 2015-07-20 | Active |
| 00904-6505-61 You're viewing this | 100 BLISTER PACK in 1 CARTON (0904-6505-61) / 1 TABLET in 1 BLISTER PACK | $0.0801 / ea | $8.01 | 2015-07-20 | Active |
This pack effectively ties for the lowest per-ea cost of the 2 priced pack sizes ($0.0801 NADAC).
Pack size FAQ
What quantity is in NDC 00904-6505-61?
What is the difference between NDC 00904-6505-61 and NDC 00904-6505-06?
What NDC number is used to bill for this package of Memantine Hydrochloride 5 mg Tablet, Film Coated?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Memantine hydrochloride tablets are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type. Memantine hydrochloride is an N-methyl-D-aspartate (NMDA) receptor antagonist indicated for the treatment of moderate to severe dementia of the Alzheimer’s type. (1)
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION The recommended starting dose of memantine hydrochloride 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 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 to 29 mL/min based on the Cockcroft-Gault equation).
Hepatic Impairment Memantine hydrochloride 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 dose. ( 2 ) • Severe renal impairment: recommended dose is 5 mg twice daily. ( 2 )
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Memantine hydrochloride tablets USP, 5 mg are orange colored, capsule shaped, biconvex, film coated tablets debossed with ‘RDY’ on one side and ‘596’ on other side. Memantine hydrochloride tablets USP, 10 mg are grey colored, capsule shaped, biconvex, film coated tablets debossed with ‘RDY’ on one side and ‘597’ on other side. Tablets: 5 mg and 10 mg (3)
⛔ Contraindications ▾
4 CONTRAINDICATIONS 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)
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Conditions that raise urine pH may decrease the urinary elimination of memantine, resulting in increased plasma levels of memantine. (5.1, 7.1)
5.1Genitourinary 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 )].
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS Most common adverse reactions (≥ 5 % and greater than placebo) are dizziness, headache, confusion and constipation. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Dr. Reddy’s Laboratories Inc., at 1-888-375-3784 or FDA at 1-800-FDA-1088 orwww.fda.gov/medwatch.
6.1Clinical 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 placebo-controlled trials involving dementia patients, the most common adverse reactions (incidence ≥ 5% and higher than placebo) in patients treated with memantine hydrochloride were dizziness, headache, confusion and constipation.
Table 1 lists all adverse reactions that occurred in at least 2% of patients treated with memantine hydrochloride and at an incidence greater than placebo. Table 1: Adverse Reactions Reported in Controlled Clinical Trials in at Least 2% of Patients Receiving Memantine Hydrochloride and at a Higher Frequency than Placebo-treated Patients Adverse Reactions Placebo (N = 922) % Memantine Hydrochloride (N = 940) % Body as a Whole Fatigue 1 2 Pain 1 3 Cardiovascular System Hypertension 2 4 Central and Peripheral Nervous System Dizziness 5 7 Headache 3 6 Gastrointestinal System Constipation 3 5 Vomiting 2 3 Musculoskeletal System Back pain 2 3 Psychiatric Disorders Confusion 5 6 Somnolence 2 3 Hallucination 2 3 Respiratory System Coughing 3 4 Dyspnea 1 2 The overall profile of adverse reactions and the incidence rates for individual adverse reactions in the subpopulation of patients with moderate to severe Alzheimer’s disease were not different from the profile and incidence rates described above for the overall dementia population.
Seizures Memantine hydrochloride has not been systematically evaluated in patients with a seizure disorder. In clinical trials of memantine hydrochloride, seizures occurred in 0.2% of patients treated with memantine hydrochloride and 0.5% of patients treated with placebo.
6.2Postmarketing Experience The following adverse reactions have been identified during post-approval use of memantine. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These reactions include: Blood and Lymphatic System Disorders -agranulocytosis, leukopenia (including neutropenia), pancytopenia, thrombocytopenia, thrombotic thrombocytopenic purpura.
Cardiac Disorders -cardiac failure congestive. Gastrointestinal Disorders -pancreatitis. Hepatobiliary Disorders – hepatitis.
Psychiatric Disorders -suicidal ideation. Renal and Urinary Disorders -acute renal failure (including increased creatinine and renal insufficiency). Skin Disorders -Stevens Johnson syndrome.
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS
7.1Drugs 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 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.
7.2Use 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.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of memantine hydrochloride in pregnant women. Adverse developmental effects (decreased body weight, and skeletal ossification) were observed in the offspring of rats administered memantine during pregnancy at doses associated with minimal maternal toxicity. These doses are higher than those used in humans at the maximum recommended daily dose of memantine hydrochloride [see Data] .
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown. Data Animal Data Oral administration of memantine (0, 2, 6, or 18 mg/kg/day) to rats during the period of organogenesis resulted in decreased skeletal ossification in fetuses at the highest dose tested.
The higher no-effect dose for adverse developmental effects (6 mg/kg) is 3 times the maximum recommended human daily dose (MRHD) of memantine hydrochloride (20 mg) on a body surface area (mg/m 2 ) basis. Oral administration of memantine to rabbits (0, 3, 10, or 30 mg/kg/day) during the period of organogenesis resulted in no adverse developmental effects. The highest dose tested is approximately 30 times the MRHD of memantine hydrochloride on a mg/m 2 basis.
In rats, memantine (0, 2, 6, or 18 mg/kg/day) was administered orally prior to and throughout mating and, in females, through the period of organogenesis or continuing throughout lactation to weaning. Decreased skeletal ossification in fetuses and decreased body weight in pups were observed at the highest dose tested. The higher no-effect dose for adverse developmental effects (6 mg/kg/day) is 3 times the MRHD of memantine hydrochloride on a mg/m 2 basis.
Oral administration of memantine (0, 2, 6, or 18 mg/kg/day) to rats from late gestation throughout lactation to weaning, resulted in decreased pup weights at the highest dose tested. The higher no-effect dose (6 mg/kg/day) is approximately 3 times the MRHD of memantine hydrochloride on a mg/m 2 basis.
8.2Lactation Risk Summary There are no data on the presence of memantine in human milk, the effects on the breastfed infant, or the effects of memantine hydrochloride on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for memantine hydrochloride and any potential adverse effects on the breastfed infant from memantine hydrochloride or from the underlying maternal condition.
8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established. Memantine failed to demonstrate efficacy in two 12-week controlled clinical studies of 578 pediatric patients aged 6 to 12 years with autism spectrum disorders (ASD), including autism, Asperger’s disorder and Pervasive Development Disorder - Not Otherwise Specified (PDD-NOS). Memantine has not been studied in pediatric patients under 6 years of age or over 12 years of age.
Memantine treatment was initiated at 3 mg/day and the dose was escalated to the target dose (weight-based) by week 6. Oral doses of memantine 3, 6, 9, or 15 mg extended-release capsules were administered once daily to patients with weights < 20 kg, 20 to 39 kg, 40 to 59 kg and ≥ 60 kg, respectively. In a randomized, 12-week double-blind, placebo-controlled parallel study (Study A) in patients with autism, there was no statistically significant difference in the Social Responsiveness Scale (SRS) total raw score between patients randomized to memantine (n=54) and those randomized to placebo (n=53).
In a 12-week responder-enriched randomized withdrawal study (Study B) in 471 patients with ASD, there was no statistically significant difference in the loss of therapeutic response rates between patients randomized to remain on full-dose mema…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of memantine hydrochloride in pregnant women. Adverse developmental effects (decreased body weight, and skeletal ossification) were observed in the offspring of rats administered memantine during pregnancy at doses associated with minimal maternal toxicity. These doses are higher than those used in humans at the maximum recommended daily dose of memantine hydrochloride [see Data] .
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown. Data Animal Data Oral administration of memantine (0, 2, 6, or 18 mg/kg/day) to rats during the period of organogenesis resulted in decreased skeletal ossification in fetuses at the highest dose tested.
The higher no-effect dose for adverse developmental effects (6 mg/kg) is 3 times the maximum recommended human daily dose (MRHD) of memantine hydrochloride (20 mg) on a body surface area (mg/m 2 ) basis. Oral administration of memantine to rabbits (0, 3, 10, or 30 mg/kg/day) during the period of organogenesis resulted in no adverse developmental effects. The highest dose tested is approximately 30 times the MRHD of memantine hydrochloride on a mg/m 2 basis.
In rats, memantine (0, 2, 6, or 18 mg/kg/day) was administered orally prior to and throughout mating and, in females, through the period of organogenesis or continuing throughout lactation to weaning. Decreased skeletal ossification in fetuses and decreased body weight in pups were observed at the highest dose tested. The higher no-effect dose for adverse developmental effects (6 mg/kg/day) is 3 times the MRHD of memantine hydrochloride on a mg/m 2 basis.
Oral administration of memantine (0, 2, 6, or 18 mg/kg/day) to rats from late gestation throughout lactation to weaning, resulted in decreased pup weights at the highest dose tested. The higher no-effect dose (6 mg/kg/day) is approximately 3 times the MRHD of memantine hydrochloride on a mg/m 2 basis.
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established. Memantine failed to demonstrate efficacy in two 12-week controlled clinical studies of 578 pediatric patients aged 6 to 12 years with autism spectrum disorders (ASD), including autism, Asperger’s disorder and Pervasive Development Disorder - Not Otherwise Specified (PDD-NOS). Memantine has not been studied in pediatric patients under 6 years of age or over 12 years of age.
Memantine treatment was initiated at 3 mg/day and the dose was escalated to the target dose (weight-based) by week 6. Oral doses of memantine 3, 6, 9, or 15 mg extended-release capsules were administered once daily to patients with weights < 20 kg, 20 to 39 kg, 40 to 59 kg and ≥ 60 kg, respectively. In a randomized, 12-week double-blind, placebo-controlled parallel study (Study A) in patients with autism, there was no statistically significant difference in the Social Responsiveness Scale (SRS) total raw score between patients randomized to memantine (n=54) and those randomized to placebo (n=53).
In a 12-week responder-enriched randomized withdrawal study (Study B) in 471 patients with ASD, there was no statistically significant difference in the loss of therapeutic response rates between patients randomized to remain on full-dose memantine (n=153) and those randomized to switch to placebo (n=158). The overall risk profile of memantine in pediatric patients was generally consistent with the known risk profile in adults [see Adverse Reactions ( 6.1 )] . In Study A, the adverse reactions in the memantine group (n=56) that were reported in at least 5% of patients and at least twice the frequency of the placebo group (N=58) are listed in Table 2: Table 2: Study A Commonly Reported Adverse Reactions with a Frequency ≥ 5% and Twice That of Placebo Adverse Reaction Memantine N=56 Placebo N=58 Cough 8.9% 3.4% Influenza 7.1% 3.4% Rhinorrhea 5.4% 0% Agitation 5.4% 1.7% Discontinuations due to adverse reactions a Aggression 3.6% 1.7% Irritability 1.8% 3.4% a Reported adverse reactions leading to discontinuation in more than one patient in either treatment group.
The adverse reactions that were reported in at least 5% of patients in the 12 to 48 week open-label study to identify responders to enroll in Study B are listed in Table 3: Table 3: 12 to 48 Week Open Label Lead-In study to Study B Commonly Reported Adverse Reactions with a Frequency ≥ 5% Adverse Reaction Memantine N=903 Headache 8.0% Nasopharyngitis 6.3% Pyrexia 5.8% Irritability 5.4% Discontinuations due to adverse reactions a Irritability 1.2% Aggression 1.0% a At least 1% incidence of adverse reactions leading to premature discontinuation.
In the randomized withdrawal study (Study B), the adverse reaction in patients randomized to placebo (n=160) and reported in at least 5% of patients and at twice the frequency of the full-dose memantine treatment group (n=157) was irritability (5% vs 2.5%). Juvenile Animal Study In a study in which memantine (0, 15, 30 or 45 mg/kg/day) was orally administered to rats during the juvenile period of development (postnatal days [PND] 14 through 70), delays in sexual maturation were noted in males and females at all but the lowest dose tested, and body weight was reduced at the high dose.
In rats orally administered memantine as a single dose (PND 14) or three daily doses (PND 14 to 16), neuronal lesions were observed in several areas of the brain at all but the lowest dose tested. Adverse neurobehavioral effects (decreased auditory startle habituation) were observed at the high dose. The no-effect dose for developmental toxicity was the lowest dose tested (15 mg/kg/day).
In a second juvenile animal study, memantine (0, 1, 3, 8, 15, 30, and 45 mg/kg/day) was orally administered to male and female rats beginning on PND 7 and continuing for various periods during postnatal development. Because of early memantine-related mortality, the 30 and 45 mg/kg/day groups were terminated without fur…
🧓 Geriatric Use ▾
8.5Geriatric Use The majority of people with Alzheimer’s disease are 65 years and older. In the clinical studies of memantine hydrochloride the mean age of patients was approximately 76; over 90% of patients were 65 years and older, 60% were 75 years and older, and 12% were at or above 85 years of age. The efficacy and safety data presented in the clinical trial sections were obtained from these patients.
There were no clinically meaningful differences in most adverse events reported by patient groups ≥65 years old and <65 years old.
🆘 Overdosage ▾
10 OVERDOSAGE 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 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.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Persistent activation of central nervous system N-methyl-D-aspartate (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 disease.
12.2Pharmacodynamics Memantine showed low to negligible affinity for GABA, benzodiazepine, dopamine, adrenergic, histamine and glycine receptors and for voltage-dependent Ca 2+ , Na + or K + channels. Memantine also showed antagonistic effects at the 5HT 3 receptor with a potency similar to that for the NMDA receptor and blocked nicotinic acetylcholine receptors with one-sixth to one-tenth the potency. In vitro studies have shown that memantine does not affect the reversible inhibition of acetylcholinesterase by donepezil, galantamine, or tacrine.
12.3Pharmacokinetics Absorption Following oral administration memantine is highly absorbed with peak concentrations reached in about 3 to 7 hours. Memantine has linear pharmacokinetics over the therapeutic dose range. Food has no effect on the absorption of memantine.
Distribution The mean volume of distribution of memantine is 9 to 11 L/kg and the plasma protein binding is low (45%). Metabolism Memantine undergoes partial hepatic metabolism. The hepatic microsomal CYP450 enzyme system does not play a significant role in the metabolism of memantine.
Elimination Memantine is excreted predominantly (about 48%) unchanged in urine and has a terminal elimination half-life of about 60 to 80 hours. The remainder is converted primarily to three polar metabolites which possess minimal NMDA receptor antagonistic activity: the N-glucuronide conjugate, 6-hydroxy memantine, and 1-nitroso-deaminated memantine. A total of 74% of the administered dose is excreted as the sum of the parent drug and the N-glucuronide conjugate.
Renal clearance involves active tubular secretion moderated by pH dependent tubular reabsorption. Pharmacokinetics in Specific Populations Gender Following multiple dose administration of memantine hydrochloride tablets 20 mg daily, females had about 45% higher exposure than males, but there was no difference in exposure when body weight was taken into account. Elderly The pharmacokinetics of memantine hydrochloride in young and elderly subjects are similar.
Renal Impairment Memantine pharmacokinetics were evaluated following single oral administration of 20 mg memantine hydrochloride in 8 subjects with mild renal impairment (creatinine clearance, CLcr, >50 to 80 mL/min), 8 subjects with moderate renal impairment (CLcr 30 to 49 mL/min), 7 subjects with severe renal impairment (CLcr 5 to 29 mL/min) and 8 healthy subjects (CLcr > 80 mL/min) matched as closely as possible by age, weight and gender to the subjects with renal impairment. Mean AUC 0-∞ increased by 4%, 60%, and 115% in subjects with mild, moderate, and severe renal impairment, respectively, compared to healthy subjects.
The terminal elimination half-life increased by 18%, 41%, and 95% in subjects with mild, moderate, and severe renal impairment, respectively, compared to healthy subjects. No dosage adjustment is recommended for patients with mild and moderate renal impairment. Dosage should be reduced in patients with severe renal impairment [see Dosage and Administration (2 ) ] .
Hepatic Impairment Memantine pharmacokinetics were evaluated following the administration of single oral doses of 20 mg in 8 subjects with moderate hepatic impairment (Child-Pugh Class B, score 7 to 9) and 8 subjects who were age-, gender-, and weight-matched to the hepatically-impaired subjects. There was no change in memantine exposure (based on C ma…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Persistent activation of central nervous system N-methyl-D-aspartate (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 disease.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Memantine hydrochloride tablets USP, 5 mg are orange colored, capsule shaped, biconvex, film coated tablets debossed with ‘RDY’ on one side and ‘596’ on other side. They are supplied Cartons of 50 film coated tablets (10 film coated tablets each blister pack x 5), NDC 0904-6505-06 Cartons of 100 film coated tablets (10 film coated tablets each blister pack x 10), NDC 0904-6505-61 Memantine hydrochloride tablets USP, 10 mg are grey colored, capsule shaped, biconvex, film coated tablets debossed with ‘RDY’ on one side and ‘597’ on other side.
They are supplied Cartons of 50 film coated tablets (10 film coated tablets each blister pack x 5), NDC 0904-6506-06 Cartons of 100 film coated tablets (10 film coated tablets each blister pack x 10), NDC 0904-6506-61 WARNING: These Unit Dose packages are not child resistant and are Intended for Institutional Use Only. Keep this and all drugs out of the reach of children. Store at 20°-25°C (68°-77°F); [See USP Controlled Room Temperature.]
📋 Description ▾
11 DESCRIPTION Memantine hydrochloride is 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, USP occurs as a white to off-white colored powder and is slightly soluble in water.
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: colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, povidone and talc. In addition the following inactive ingredients are also present as components of the film coat: hypromellose, polyethylene glycol, titanium dioxide, FD & C Yellow #6 and FD & C blue #2 (5 mg tablets), black iron oxide (10 mg tablets). structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Patient Information). To assure safe and effective use of memantine hydrochloride, the following information provided in the patient information section should be discussed with patients and caregivers. Patients/caregivers should be instructed to follow the dose titration schedule provided by their physician or healthcare professional for memantine hydrochloride.
They should be warned not to use any tablets of memantine hydrochloride that are damaged or show signs of tampering. If a patient misses a single dose of memantine hydrochloride tablets, 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 should not be resumed without consulting that patient’s healthcare professional. All other trademarks are the property of their respective owners.
💬 Patient Medication Information ▾
Patient Information Memantine Hydrochloride Tablets, USP (mem' an teen hye'' droe klor' ide) Read this Patient Information that comes with memantine hydrochloride tablets before you start taking it and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment.
What is memantine hydrochloride? Memantine hydrochloride is a prescription medicine used for the treatment of moderate to severe dementia in people with Alzheimer’s disease. Memantine hydrochloride belongs to a class of medicines called NMDA (N-methyl-D-aspartate) inhibitors.
It is not known if memantine hydrochloride tablets are safe and effective in children. Who should not take memantine hydrochloride tablets? Do not take memantine hydrochloride tablets if you are allergic to memantine or any of the ingredients in memantine hydrochloride tablets.
See the end of this leaflet for a complete list of ingredients in memantine hydrochloride tablets. What should I tell my doctor before taking memantine hydrochloride tablets? Before you take memantine hydrochloride tablets, tell your doctor if you: • have or have had seizures • have or have had problems passing urine daf • have or have had bladder or kidney problems • have liver problems • have any other medical conditions • are pregnant or plan to become pregnant.
It is not known if memantine hydrochloride will harm your unborn baby. • are breastfeeding or plan to breastfeed. It is not known if memantine passes into your breast milk. Talk to your doctor about the best way to feed your baby if you take memantine hydrochloride tablets.
Tell your doctor about all the medicines you take , including prescription and non-prescription medicines, vitamins, and herbal supplements. Taking memantine hydrochloride with certain other medicines may affect each other. Taking memantine hydrochloride with other medicines can cause serious side effects.
Especially tell your doctor if you take: • other NMDA antagonists such as amantadine, ketamine, and dextromethorphan • medicines that make your urine alkaline such as carbonic anhydrase inhibitors and sodium bicarbonate Ask your doctor or pharmacist for a list of these medicines, if you are not sure. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.
How should I take memantine hydrochloride tablets? • Your doctor will tell you how much memantine hydrochloride to take and when to take it. • Your doctor may change your dose if needed. • Memantine hydrochloride tablets can be taken with food or without food. • Do not use any tablets of memantine hydrochloride that are damaged or show signs of tampering. • If you forget to take one dose of memantine hydrochloride tablets, do not double up on the next dose. You should take only the next dose as scheduled. • If you have forgotten to take memantine hydrochloride for several days, you should not take the next dose until you talk to your doctor. • If you take too much memantine hydrochloride tablets, call your doctor or poison control center right away, or go to the nearest hospital emergency room.
What are the possible side effects of memantine hydrochloride tablets? Memantine hydrochloride tablets may cause side effects, including: The most common side effects of memantine hydrochloride tablets include: • dizziness • confusion • headache • constipation These are not all the possible side effects of memantine hydrochloride tablets. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store memantine hydrochloride tablets? • Store memantine hydrochloride tablets at room temperature between 20°-25°C (68°-77°F).
What are the ingredients in memantine hydrochloride tablets? Active ingredients: memantine hydrochloride Inactive ingredients: colloidal silicon dioxi…