EBIXA 10/MG FC TAB 28/FC TAB

Indications

Approved Uses

Treatment of moderate to severe dementia of the Alzheimer’s type (Alzheimer’s disease).

Off-Label Uses

Off-label (variable evidence): vascular dementia and other neurocognitive disorders; limited/experimental use in OCD and neuropathic pain (not routinely recommended).

Dosage & Administration

Dosing by Condition

Alzheimer’s dementia (moderate-severe), immediate-release: Week 1: 5 mg once daily; Week 2: 10 mg/day (5 mg twice daily or 10 mg once daily per local labeling); Week 3: 15 mg/day (5 mg + 10 mg in divided doses); Week 4+: 20 mg/day maintenance (10 mg twice daily).

Initial Dose

5 mg once daily for the first week

Maintenance Dose

20 mg once daily (after 4-week titration)

Maximum Dose

20 mg/day for immediate-release tablets.

Children's Dosage

Safety and effectiveness in pediatric patients have not been established.

Dose Adjustment Notes

Titrate in 5 mg increments at weekly intervals to target 20 mg/day; reduce dose in renal impairment-CrCl 30-49 mL/min: max 10 mg/day; CrCl 5-29 mL/min: max 10 mg/day; may be taken with or without food.

How to Take

Swallow whole with water; can be taken with or without food; administer once daily at the same time each day

Side Effects

Common Side Effects

Dizziness, headache, confusion, constipation, somnolence/drowsiness, and hypertension.

Side Effect Frequency

Common (≥5% and >placebo): dizziness, headache, confusion, constipation; other reactions reported at lower frequencies include fatigue, hypertension, somnolence, hallucinations, vomiting, cough/back pain (rates vary by study/label).

Safety & Warnings

Contraindications

Hypersensitivity to memantine hydrochloride or to any excipients.

Warnings & Precautions

Use with caution in seizure disorders/history of convulsions; in renal impairment (dose adjust) and conditions/drugs that alkalinize urine (e.g., renal tubular acidosis, severe UTI) which can increase exposure; caution in significant cardiovascular disease (recent MI, uncompensated heart failure, uncontrolled hypertension); may cause dizziness/somnolence affecting driving/machinery.

Age Restriction

Not approved/recommended for use in children and adolescents (<18 years).

Driving Warning

May Cause Drowsiness

Drug Interactions

Drug Interactions

Avoid/monitor with other NMDA antagonists (amantadine, ketamine, dextromethorphan); caution with urine-alkalinizing agents (e.g., sodium bicarbonate, carbonic anhydrase inhibitors) which reduce clearance; caution with drugs using renal cationic transport (e.g., cimetidine, ranitidine, procainamide, quinidine, metformin) which may increase memantine exposure; possible additive effects with dopaminergics/anticholinergics.

Interaction Severity

Avoid/major: other NMDA antagonists (amantadine, ketamine, dextromethorphan) due to additive CNS toxicity; Moderate: urinary alkalinizers/carbonic anhydrase inhibitors (e.g., sodium bicarbonate, acetazolamide) and drugs competing for renal cation transport (e.g., cimetidine, ranitidine, procainamide, quinidine, metformin) which may increase memantine exposure.

Food Interaction

No restriction.

Alcohol Interaction

Avoid

Special Populations

Pregnancy

Consult Doctor

Children

Safety and effectiveness in pediatric patients have not been established.

Elderly

Standard adult dosing applies; dose titration should proceed cautiously; renal function should be assessed before and during treatment as elderly patients commonly have reduced renal clearance

Kidney Impairment

CrCl 50-80 mL/min: no adjustment; CrCl 30-49 mL/min: target 10 mg/day (often 5 mg BID) after titration; CrCl 5-29 mL/min: target 10 mg/day (5 mg BID); CrCl <5 mL/min: not recommended/insufficient data-use only with specialist advice if at all.

Liver Impairment

Mild-moderate hepatic impairment (Child-Pugh A/B): no dose adjustment; severe hepatic impairment (Child-Pugh C): use with caution (not well studied).

Storage & Patient Advice

Missed Dose

If a dose is missed, take the next dose at the usual time (do not double); if several doses are missed, contact the prescriber as re-titration may be needed.

Stopping the Medicine

Do not stop abruptly without consulting the prescriber; if discontinuation is needed, do so under medical advice/monitoring.

Overdose

Symptoms: CNS effects such as agitation/restlessness, confusion, hallucinations/psychosis, somnolence/stupor, dizziness, gait disturbance, seizures/coma; Management: supportive/symptomatic care, consider urine acidification to enhance elimination; no specific antidote; seek urgent medical care.

Patient Counseling

Take exactly as prescribed and follow the titration schedule; may take with or without food; may cause dizziness/somnolence-use caution with driving; do not double doses if missed and call the prescriber if several doses are missed; inform clinicians about other NMDA antagonists (amantadine/ketamine/dextromethorphan) and kidney problems; this medicine helps symptoms but does not cure Alzheimer’s disease.

Monitoring Requirements

Monitor clinical response/tolerability and cognition/functional status periodically; assess renal function (especially in older adults or known CKD) and consider blood pressure monitoring.

Pharmacology

Mechanism of Action

Non-competitive NMDA receptor antagonist that reduces pathologic, sustained glutamatergic activity while preserving physiologic neurotransmission.

Onset of Action

Symptomatic effects may begin within days to 1-2 weeks after initiation/titration; full clinical benefit is typically assessed after reaching maintenance dose, often within ~4-8 weeks.

Duration of Effect

Approximately 24 hours per dose (supports once-daily dosing); clinical symptomatic benefit is maintained with continued daily therapy.

Half-Life

60-100 hours

Bioavailability

Approximately 100% (essentially complete oral bioavailability).

Metabolism

Minimal hepatic metabolism; a portion is converted to three inactive/polar metabolites (e.g., N-glucuronide conjugate, hydroxylated memantine, and nitroso derivative), and metabolism is not meaningfully CYP450-mediated.

Excretion

Primarily renal; about 48% of a dose is excreted unchanged in urine, with additional drug recovered as metabolites; renal clearance involves pH-dependent tubular reabsorption (alkaline urine reduces clearance).

Protein Binding

45%

Product Information

Available Dosage Forms

Film-coated tablet (oral) for this SFDA-registered product (EBIXA 10 mg FC tab).

Composition per Dose

Each film-coated tablet: 10 mg memantine as memantine hydrochloride

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Psych Class

N-methyl-D-aspartate (NMDA) receptor antagonist

Controlled Substance

No

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