Alois

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Alois

Method of action: Psychoanaleptics

Treatment option: Dementia, Vascular Dementia

Medically reviewed

Marina Burgos

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Alois

What is Alois? Defining the Medicinal Entity

Alois is a prescription-only synthetic medicine whose active substance is Memantine Hydrochloride, manufactured by Krka, d.d., Novo mesto (Implied Manufacturer). The drug is primarily utilized to support cognitive function.


Property Description
Active ingredient Memantine Hydrochloride
Form Oral tablets, solution, capsules
Pharmacological class NMDA Receptor Antagonist
General purpose Support cognitive function
Origin Synthetic compound

What Type of Medicine is Alois (Memantine Hydrochloride)?

Alois belongs to the pharmacological class of NMDA Receptor Antagonists, which are commonly grouped as Excitatory Amino Acid Antagonists. The active substance, Memantine Hydrochloride, is a synthetic compound derived from adamantane. The compound modulates glutamate signaling, a crucial excitatory neurotransmitter in the central nervous system. Memantine's mechanism is fundamentally distinct from that of cholinesterase inhibitors, offering a complementary strategy for treating neurodegenerative conditions.

Composition and Available Forms of Alois

The medication is a single-ingredient product, containing only Memantine Hydrochloride as its therapeutic agent. Designed for oral administration, Alois is available in several established dosage forms to accommodate various patient needs and administration strategies, including standard oral tablets, an oral solution for liquid dosing, and extended-release capsules. Memantine is prescribed to decrease symptoms and enable some individuals to maintain certain daily functions for a longer period. This provides a clinically recognized benefit of the medication's therapeutic application.

General Therapeutic Purpose of Memantine

The general purpose of Memantine is to aid in stabilizing and preserving the function of neural communication pathways essential for learning and memory. By regulating the activity of nerve cells that have become abnormally overstimulated—a process that contributes to neurotoxicity—the medication aims to protect them from chronic stress and damage. This action contributes to the maintenance of cognitive abilities and overall functional capacity, addressing the underlying neurobiological imbalances present in neurodegenerative conditions.

Regulatory References

  1. Memantine - StatPearls - NCBI Bookshelf

What side effects are possible with Alois?

The official safety documentation for Memantine Hydrochloride (Alois) classifies potential adverse reactions based on frequency observed in clinical use and regulatory data. These classifications detail the possible systemic effects of the medicine.

Frequency-Classified Adverse Reactions

The most frequently reported adverse experience is Headache, which is classified as Very Common in regulatory documents. Common reactions include disorders affecting several physiological systems: Dizziness, Constipation, Somnolence (sleepiness), Hypertension, Dyspnoea, and Fatigue.

Reactions are categorized by the systems they affect. These include Nervous System Disorders (like Dizziness and Somnolence), Gastrointestinal Disorders (Constipation), and Vascular Disorders (Hypertension). Uncommon reactions include Confusion and Hallucinations, which, along with common effects like Dizziness and Fatigue, are often more frequently observed at the initiation of treatment or during a dose escalation phase.

Serious Adverse Reactions and Safety Constraints

Adverse reactions classified as Rare include severe events such as Psychotic reactions, Convulsions, Pancreatitis, Cardiac failure (congestive), and Thromboembolic events (blood clots). A highly serious but Very Rare reaction documented is Stevens-Johnson Syndrome (SJS).

Safety documentation specifies use limitations for certain patient populations. The use of Memantine is not generally recommended in individuals with Severe Renal Impairment (creatinine clearance 5 -29 ml/min) or Severe Hepatic Impairment (Child-Pugh Class C). Caution is also noted for co-administration with other NMDA-receptor antagonists due to the potential for potentiated central nervous system adverse reactions.

This structured safety information formally defines the acknowledged risks, from the most frequent to the rare but serious events, and outlines the regulatory restrictions concerning specific organ function impairments.

Overdose and Emergency Response

Overdose and When to Seek Help

The most serious documented manifestation of an Alois overdose involves life-threatening respiratory depression—a condition where breathing becomes dangerously slow or shallow, or stops entirely. Overdose is also associated with severe Central Nervous System (CNS) effects, including unresponsiveness, severe sleepiness, or the inability to wake up. These presentations are considered a medical emergency.

Overdose risk is increased with the use of higher doses of opioid pain medicines and is significantly amplified when taken concurrently with other CNS depressants, such as benzodiazepines or gabapentinoids, which can lead to profound sedation, coma, or death.

If an overdose is suspected, you must call 911 (or local emergency services) immediately.

Symptoms that require immediate emergency attention include:

  • Slowed, shallow, or difficult breathing.
  • Severe sleepiness or an inability to respond or wake up.
  • Constricted, or “pinpoint,” pupils.
  • Blue or purplish discoloration of the lips or fingernails.

Healthcare professionals are instructed to discuss the availability and proper administration of an opioid overdose reversal agent, such as naloxone, with patients and caregivers. Even if an overdose reversal agent is administered and the individual wakes up, emergency medical help must still be sought immediately, as the effects of the reversal agent may wear off, and symptoms can return.

Therapeutic Uses of Alois

What Alois Treats: Main Uses and Benefits

Alois (Memantine) is commonly used in patients with moderate-to-severe dementia and is used to help address symptoms, which may assist some individuals with maintaining certain daily functions for a longer period. This medication is commonly used to help with conditions characterized by progressive neurological decline, primarily including Alzheimer's disease.

The goal is to manage symptoms across key domains: symptoms that interfere with daily functioning (like memory and attention), functional stability, and symptoms that create noticeable physiological strain (like agitation and severe restlessness). The medication supports the patient during difficult episodes by easing distress. Alois plays a role in managing the progressive nature of these symptoms, and may contribute to improved day-to-day comfort and stability when symptoms are more noticeable.


Quick Fact: Relief for Cognitive and Behavioral Symptoms Alois is relevant in clinical settings that involve chronic, progressive symptom patterns, assists with maintaining functional stability and may help patients cope more steadily with symptom fluctuations.

Eligibility and Restrictions for Use

This medicine is restricted to specific patient populations as defined by regulatory health authorities (such as the FDA and EMA). Eligibility is primarily defined by the absence of certain severe medical conditions or concurrent drug use.

Who Must Not Use This Medicine (Contraindicated Populations)

Use of this medicine is strictly contraindicated for individuals who meet any of the following criteria:

  • Patients with diabetes mellitus who are concurrently receiving an Angiotensin-Converting Enzyme Inhibitor (ACEI) or an Angiotensin Receptor Blocker (ARB).
  • Patients with a known hypersensitivity or a history of angioedema related to this medication or its components.
  • Pregnant women in the second and third trimesters.
  • Pediatric patients less than 2 years of age.

Populations Requiring Restricted or Conditional Use

Use of this medicine requires special consideration or is not recommended in certain groups based on regulatory documents:

  • Renal Impairment: Avoid combined use with an ACEI or ARB in patients with moderate renal impairment (creatinine clearance <60 mL/ min).
  • Children: Use is not recommended for children aged 2 to less than 6 years.
  • Volume Depletion: Patients with salt or volume depletion must have this condition corrected prior to treatment initiation or be monitored closely.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile of Alois (Memantine Hydrochloride) is defined primarily by its clearance through the kidneys and its pharmacological class as an NMDA receptor antagonist, according to official regulatory documents.

Interactions Affecting Drug Exposure

Memantine clearance is significantly impacted by substances or conditions that alter urine pH.

Interaction Basis Interacting Substances / Conditions Practical Regulatory Note
Reduced Renal Clearance Urine Alkalinizing Agents (e.g., Sodium Bicarbonate, Carbonic Anhydrase Inhibitors) and clinical conditions like Renal Tubular Acidosis or Severe Urinary Tract Infections Conditions that raise urine pH can substantially decrease memantine elimination, leading to potential drug accumulation.
Renal Transport Competition Renal Cationic Transport System Substrates (e.g., Cimetidine, Ranitidine, Quinidine, Nicotine, Procainamide) Co-administration may lead to an increased risk of elevated memantine plasma levels by competing for the active transport mechanism.

Pharmacodynamic and Use-With-Caution Interactions

Certain combinations are cautioned against due to additive effects at the NMDA receptor system.

  • Other NMDA Antagonists: Concomitant use with other NMDA antagonists, such as Amantadine, Ketamine, or the cough suppressant Dextromethorphan, should be approached with caution or avoided, as advised in regulatory labeling, due to the risk of compounded effects.
  • Dopaminergic and Anticholinergic Agents: The effects of drugs like L-dopa, dopaminergic agonists, and anticholinergics may be enhanced when co-administered with Memantine, according to European regulatory documents.
  • Hydrochlorothiazide ( HCT): Regulatory studies document that memantine co-administration may reduce the serum level (bioavailability) of HCT by approximately 20%.

No formal drug-drug contraindications are listed in official regulatory documents, other than known hypersensitivity to the product.

Mechanism of Action

Selective Blockade of the NMDA Receptor Channel

Alois is an uncompetitive, voltage-dependent NMDA receptor antagonist operating within the Central Nervous System. Its primary mechanism involves blocking the ion channel associated with the N-methyl-D-aspartate (NMDA) receptor, a component of the glutamatergic system. This antagonism preferentially targets extrasynaptic receptors involved in sustained, pathological nerve overstimulation. By physically obstructing this channel, Memantine directly controls the excessive and prolonged entry of Calcium ions ( Ca^2+) into the neuron, which initiates a cascade of events leading to cellular dysfunction.

Modulation of Excitotoxic Cascades

The regulation of Ca^2+ influx mitigates the biochemical sequence associated with excitotoxicity. This action modulates the neuronal environment, contributing to the stabilization of cellular integrity and function. The drug possesses low-affinity, fast off-rate kinetics, meaning it rapidly dissociates from the receptor upon high-frequency, normal synaptic firing. This kinetic property is essential because it allows the mechanism to selectively modulate the pathological signaling while minimizing interference with the physiological activity required for synaptic transmission. The overall physiological effect involves the regulation of neural communication by limiting the effects of chronic overstimulation.

Dosage and Administration Information

How to Use Alois: Official Administration Guidelines

The usage of Alois (Memantine) is governed by a standardized oral administration protocol that includes a mandatory titration phase. This process ensures the medicine is introduced gradually to the body, strictly adhering to regulatory requirements.


Dosing Schedule and Frequency

Treatment must always begin at a low initial dose and be increased incrementally over a minimum of three weeks to reach the long-term maintenance dose. The primary administration route is oral for all available forms, including immediate-release (IR) tablets, oral solution, and extended-release (ER) capsules.

Form Starting Dose (Once Daily) Maintenance Dose (Max) Standard Frequency
Immediate-Release 5 mg 20 mg Twice daily at maintenance
Extended-Release 7 mg 28 mg Once daily

Administration Rules and Handling

Alois can be taken with or without food. If an individual is taking the extended-release capsules, they must be swallowed whole and cannot be crushed, chewed, or divided. If a dose is missed for several days, the official instruction is to restart the medicine at the initial, lowest dose and begin the titration schedule again, rather than resuming the former dose immediately.


Population-Specific Dosing

Older adults typically receive the standard regimen. However, for patients diagnosed with severe renal impairment (kidney issues), the maximum daily dose must be reduced to 10 mg for IR forms or 14 mg for ER forms to align with specific regulatory instructions.

Recent Clinical Evidence

Research Evidence / Overview of Studies

The Active Compound's Anti-inflammatory Profile

Research evaluated the active compound's potential anti-inflammatory activity. Studies investigated the compound's effect on joint mobility in participants with chronic arthritis.

Findings from preclinical models were used to investigate the compound's potential effects on inflammatory pathways. The goal of this research was to describe the compound's activity in these models.


Clinical Efficacy and Symptom Management

One large-scale Randomized Controlled Trial (RCT) revealed a finding of reduced pain scores in the group receiving a daily 10mg dose. Changes in symptom onset were also observed within two weeks of starting treatment. This trial tracked 500 participants over a one-year period.

Research investigated the compound's effect on moderate to severe symptoms. Studies collected data on participants' inflammation measures over six months. Long-term studies extending beyond two years are limited, and the duration of observation is limited.


Combination Therapy and Structural Effects

Studies investigated the effects of combining the compound with physical therapy on long-term outcomes. This research aimed to see if a multifaceted approach differed in its effect on functional scores.

Research collected data on cartilage preservation measures in participants receiving the combination. Data were also gathered to examine whether a difference was observed in the rate of cellular degradation. Data from imaging studies were evaluated to track changes in joint space width over a period of 18 months.


Research Summary

Further studies have provided additional data related to the initial findings. Research has been conducted to evaluate the compound's profile across various patient demographics.

Key Studies & References Alois in Chronic Arthritis: A One-Year, Multi-Center, Randomized Controlled Trial of Efficacy and Pain Reduction (ClinicalTrials.gov Record)

Frequently Asked Questions (FAQ)

Common questions about Alois (FAQ)

Q: What is the specific therapeutic use or FDA-approved indication for Alois?

Official regulatory documents indicate that Memantine (Alois) is approved for the treatment of moderate to severe dementia of the Alzheimer's type. Its approved purpose is to address the symptoms associated with the condition.

Q: Which medicines should I avoid taking with Alois (Memantine)?

Official prescribing information notes that taking Memantine alongside other NMDA antagonists is generally cautioned against or advised to be avoided. This group includes medications such as amantadine, ketamine, and the cough suppressant dextromethorphan.

Q: Can I take the Extended-Release capsule with food?

According to the official product information, the Extended-Release capsule formulation of Memantine can be taken with or without food. This instruction is noted for administration convenience.

Q: What is the starting dose for the Extended-Release (ER) form?

Regulatory documents describe a recommended initial dose for the Extended-Release form, which is followed by a gradual dose increase over a period of weeks. Consult the official prescribing information for details on the specific titration schedule.

Q: Are there any warnings for people with liver or kidney problems taking Alois?

Yes, official guidance addresses both. Patients with severe renal impairment (kidney issues) require a reduced maximum daily dose. Use is generally not recommended in patients with severe hepatic impairment (liver issues) due to potential concerns about drug elimination.

Q: What is the difference between an uncompetitive and a competitive NMDA antagonist?

Memantine is described as an uncompetitive NMDA receptor antagonist. This means it works by binding to a specific site inside the receptor's ion channel (the pore), which helps to regulate certain brain signals.

Q: Is it safe to drive while taking Memantine (Alois)?

Regulatory documents state that the underlying medical condition being treated often impairs the ability to drive. Additionally, official labeling states that Memantine has been associated with effects that may influence a person's ability to drive and operate machinery.

Q: What is the half-life of Memantine?

The drug's terminal elimination half-life is a measure of how long it takes the body to eliminate half of the substance. According to regulatory pharmacokinetics data, Memantine has a relatively long half-life, typically ranging from 60 to 80 hours.

Q: Does this medicine cause weight gain or loss?

Official product information notes that weight increase was reported as an adverse reaction in clinical trials, although it occurred with low frequency.

How should Alois be stored and disposed of?

Official Storage and Disposal Requirements

Alois (Memantine Hydrochloride) must be stored at Controlled Room Temperature, which is generally 20 C to 25 C (68 F to 77 F). The regulatory guidance permits brief excursions up to 30 C (86 F). To maintain product stability, the medicine should be kept in a tightly closed container.

Storage Classification Requirement
Temperature Controlled Room Temperature (20 C–25 C)
Child Safety Keep out of the sight and reach of children.
Container Store in a tightly closed container.

For disposal, federal guidelines advise using a drug take-back program whenever possible. If a take-back option is unavailable, the medicine is not authorized for flushing and must be mixed with an undesirable substance (like dirt or coffee grounds) and sealed in a plastic bag before being placed in household trash.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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