Memantine Hydrochloride

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.

• 2.
• DOSAGE AND ADMINISTRATION The recommended starting dose of memantine hydrochloride is 5 mg (2.5 mL) once daily.
• The dose should be increased in 5 mg increments to 10 mg/day (2.5 mL twice daily), 15 mg/day (2.5 mL and 5 mL as separate doses), and 20 mg/day (5 mL 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 (5 mL twice daily). ​Dosing Titration Schedule Memantine hydrochloride 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.
• Do not mix memantine hydrochloride oral solution with any other liquid.
• Memantine hydrochloride is administered with a dosing device that comes with the drug and consists of a syringe, press in bottle adaptor, a patient needs to administer the drug.
• The supplied syringe should be used to withdraw the correct volume of oral solution and the oral solution should be slowly squirted into the corner of the patient’s mouth.
• Special Populations Renal Impairment A target dose of 5 mg (2.5 mL) 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 (2.5 mL) once daily.
• Increase dose in 5 mg increments to a maintenance dose of 10 mg (5 mL) 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 (2.5 mL) twice daily.
• (2) dosing-titration-schedule

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

• 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 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 (Alzheimers 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.
• 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.
• Table 1
• 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”.

Strengths and forms

• 3. DOSAGE FORMS AND STRENGTHS Memantine hydrochloride 2 mg/mL oral solution:
• clear colourless, alcohol-free, sugar-free, and peppermint flavored. Oral Solution:
• 2 mg/mL (3)

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

What it looks like and how it is packed

• Memantine Hydrochloride Oral Solution 2 mg/mL (10 mg = 5 mL) 12 fl. oz. (360 mL) bottle NDC #13925-540-12
• Store at 25°C (77°F); excursions permitted between 15° to 30°C (59°to 86°F). [see USP Controlled Room Temperature.] Dispense in tightly closed containers.

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 occurs as a fine white to off-white powder and is soluble in water. Memantine hydrochloride oral solution contains memantine hydrochloride in a strength equivalent to 2 mg of memantine hydrochloride in each mL. The oral solution also contains the following inactive ingredients:
• sorbitol solution (70%), methylparaben, propylparaben, propylene glycol, glycerin, peppermint flavor 0516161, citric acid, sodium citrate, and purified water. memantine-structure

Quoted from the official label, section “Description”.

Ingredients people check for

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Same active substance, strength and form in other countries

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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

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