Memantine

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• 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. Special 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 Cockroft-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
• 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.
• Severe renal impairment: recommended dose is 5 mg twice daily.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Quoted from the official label, section “Overdosage”.

Use in children

Safety and effectiveness in pediatric patients have not been established.

Quoted from the official label, section “Pediatric Use”.

Use in older people

• 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 year old.

Quoted from the official label, section “Geriatric Use”.

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 Dr.
• Reddy’s Laboratories Inc., at 1-888-375-3784 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 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.
• 6.2 Postmarketing 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.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• See FDA-approved patient labeling (Patient Information).
• To assure safe and effective use of memantine hydrochloride, the following information and instructions 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.

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

• 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

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• 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 in blistercards of 30.
• Blistercards of 30 NDC 0615-8192-39 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 in blistercards of 15 and 30.
• Blistercards of 15 NDC 0615-8100-05 Blistercards of 30 NDC 0615-8100-39
• Store at 20°-25°C (68°-77°F); [See USP Controlled Room Temperature.]

Quoted from the official label, section “How Supplied”.

What is in it

• 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 HCl USP occurs as a white to off-white colored powder and is slightly 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:
• 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

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

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Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

9 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

See every product with Memantine