Dalus

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Dalus

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 Dalus

Dalus is a pharmaceutical preparation that contains the active ingredient Citicoline, a substance identical to a critical, naturally occurring compound in the brain. Its primary function is to support the structural integrity and metabolic health of nerve cells.

Property Description
Active ingredient Citicoline (CDP-choline)
Form Tablets, Oral Solution, Solution for Injection
Pharmacological class Nootropic and Neuroprotective Agent
General purpose Support structural and functional brain health
Origin Derived compound (chemically identical to an endogenous compound)

What is Dalus and What is its Active Ingredient?

Dalus is the commercial designation for a medicine containing the active ingredient Citicoline, which is chemically defined as Cytidine 5'-diphosphocholine (CDP-choline). This substance is an endogenous compound naturally synthesized in the human body, serving as a vital precursor in the formation of Phosphatidylcholine, the key structural lipid of neuronal membranes. The medicine is a single product formulation, with Citicoline as its sole therapeutic component.

The unique molecular structure of Citicoline has a recognized role in enhancing the structural health of neurological tissues.

What Type of Medicine is Citicoline?

Citicoline is formally classified as a Nootropic Agent and a Neuroprotective Agent, placing it within the category of Psychoanaleptics. This classification signifies its general purpose is to support metabolic and functional processes in the central nervous system. Citicoline supports brain health by stabilizing neuronal membranes and promoting phospholipid synthesis. This means the compound is generally recognized for helping to preserve the physical integrity and function of nerve cells.

Its primary role involves providing the necessary building blocks for the brain to maintain and repair neuronal membranes following metabolic stress, such as conditions that may compromise cerebral blood flow.

In What Forms is Dalus Available?

Dalus is supplied in several pharmaceutical preparations to accommodate varying clinical needs. These dosage forms include formats for oral medication, such as tablets and a liquid oral solution. The medicine is also provided as a sterile solution for injection, suitable for intramuscular or intravenous route of administration, allowing for flexible use in acute or chronic supportive care for the patient group of adults and the elderly.

Regulatory References

  1. MedlinePlus: Drugs, Herbs and Supplements

What side effects are possible with Dalus?

Possible Side Effects and Safety Information

The following section details the officially documented adverse effects and safety characteristics of Dalus (Citicoline), based strictly on government regulatory sources.

Adverse Reaction Scope

The most prominent safety classification in regulatory documentation is that all listed adverse reactions are reported as Very Rare (occurring in less than 1 in 10,000 patients treated). No reaction is explicitly designated as a "Serious Adverse Reaction."

Adverse effects are officially grouped by the following System-Organ Classes (SOCs):

System-Organ Class (SOC) Examples of Very Rare Effects
Nervous System Headache, dizziness, tremor, insomnia
Gastrointestinal Disorders Nausea, vomiting, diarrhea, gastric pain, hypersalivation
Vascular Disorders Arterial hypertension, arterial hypotension
General & Other Disorders Edema, redness, trembling, increase of body temperature, insignificant change of hepatic function indexes, hallucinations, dyspnea

Safety Restrictions and Special Populations

Official regulatory labeling outlines specific limitations and populations requiring special consideration:

  • Contraindications: Dalus is contraindicated in patients with known hypersensitivity to the preparation or those with hypertonia of the parasympathetic nervous system (increased parasympathetic nervous system tone).
  • Cautions: Caution is advised when administering the medicine to patients with Parkinson's disease or a history of depression, and if there is persistent intracranial bleeding.
  • Children and Pregnancy: Administration is advised only in cases where the expected benefit for the mother outweighs any potential risk for the fetus or child, due to limited data in these groups. No dose adjustment is required for the elderly based on age alone.
  • Interaction Note: The medicine should not be used concurrently with drugs that contain meclofenoxate.

This framework ensures that the safety profile is understood through documented risks and mandatory restrictions, as defined by government regulatory authorities.

Overdose and Emergency Response

The official regulatory profile for Dalus (Citicoline) overdose is distinguished by the compound's low inherent toxicity. Governmental documents confirm that the substance exhibits a very low toxicity profile in humans. This characteristic results in the regulatory classification that the appearance of intoxication is unlikely even when the therapeutic doses are accidentally exceeded. Consistent with this assessment, no specific severe or life-threatening outcomes resulting from acute overdose are formally documented in official prescribing information. Furthermore, some regulatory labels state that no case of overdose has been reported.

Required Emergency Action

In the event of an accidental ingestion of amounts exceeding the prescribed dose, immediate action is mandated by regulatory guidance. You must immediately go to the nearest hospital casualty department or contact a doctor. This required action ensures a necessary professional clinical assessment and observation.

The official procedural response is clearly defined in the management section: the treatment involves carrying out symptomatic therapy. This approach is used because there is no specific antidote known for the compound. No specific population-based considerations regarding overdose severity (such as for elderly patients) are explicitly detailed in the official regulatory overdose sections.

Therapeutic Uses of Dalus

Dalus is generally considered relevant in therapeutic areas that require supportive management for neurological function and cognitive health. The medication is commonly used to provide support that helps ease the overall symptom burden in conditions like cerebrovascular disorders (including ischemic stroke) and head injury, and is considered relevant in clinical settings that involve acute or disruptive symptom patterns.

The medicine is used for managing the symptomatic patterns of impaired memory, reduced attention, and general mental slowness. For patients in rehabilitation, it may assist with maintaining functional stability following a stroke or TBI. This therapeutic support contributes to improved day-to-day comfort during symptomatic periods. Dalus is relevant across conditions presenting with acute episodes and chronic decline, including vascular dementia, Mild Cognitive Impairment (MCI), and the recovery phase after head trauma.

Quick Fact: Symptom Support: Impaired Memory Dalus is commonly applied when symptoms create noticeable functional strain, particularly issues with concentration and memory loss in the elderly patient group.

This supportive relief helps maintain a sense of stability when cognitive symptoms are more noticeable, assisting with general well-being during symptomatic phases.

Regulatory References

  1. FDA Verification Portal (Philippines)

Eligibility and Restrictions for Use

Who Can and Cannot Use Dalus?

The official eligibility profile for Dalus (Citicoline) is defined by strict exclusions and conditional use guidelines documented in governmental regulatory sources.

Category Regulatory Status
Absolute Contraindication Strictly prohibited for patients with known hypersensitivity to Citicoline or any component of the preparation. Also contraindicated in patients with hypertonia of the parasympathetic nervous system.
Approved Age Group Use is established for adults and the elderly patient populations.
Conditional Use (Caution) Requires special caution for patients with acute or persistent intracranial hemorrhage, as official warnings note that large doses could potentially aggravate cerebral blood flow.
Pediatric Eligibility Use in children and adolescents is often described as having limited experience or insufficient data to establish safety; the medicine is only prescribed when the expected benefits significantly outweigh potential risks.
Reproductive Status Use during pregnancy and breastfeeding is not recommended due to a lack of sufficient reliable data to confirm safety. It is only permitted if the potential benefit is determined to justify the potential risk to the fetus or infant.

These guidelines govern who is officially eligible for Dalus use based on patient history, physiological status, and age, as per authorized labeling.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documentation on the active ingredient Citicoline (Dalus) defines the interaction profile based on specific drug–drug constraints, a formal prohibition, and substance restrictions.


Formal Prohibitions

The co-administration of Dalus with medicinal products containing meclofenoxate (clophenoxate) is formally contraindicated and must not be administered simultaneously, as mandated by regulatory labeling. This is an explicit, label-based exclusion.


Documented Drug–Drug Interactions

A specific pharmacodynamic interaction is documented with the substance L-dopa (levodopa), which is used in the treatment of Parkinson's disease. Regulatory information states that Citicoline potentiates the effects of L-dopa when co-administered. This interaction is classified as a clinically significant synergistic effect.


Drug–Substance Restrictions

An interaction restriction regarding a non-medicinal substance is included in prescribing information. Regulatory labeling states that alcohol should not be consumed during the period of Dalus usage. This constraint establishes a necessary limitation on the concomitant use of the medicine with alcohol. No specific pharmacokinetic (e.g., CYP enzyme) or transporter-based interactions are documented in regulatory labeling.

Mechanism of Action

Dalus, containing piracetam, accumulates selectively within the central nervous system, particularly in the cerebral cortex. It is hypothesized to function as a positive allosteric modulator of the alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA) receptor, thereby facilitating postsynaptic excitatory transmission mediated by glutamate. Piracetam also modulates cell membrane fluidity, particularly in red blood cells and neurons, through physicochemical interactions with the phospholipid bilayer. This interaction stabilizes neuronal membranes and influences ion channel function, leading to a generalized increase in neuronal excitability. Downstream consequences include the enhancement of cholinergic neurotransmission by increasing acetylcholine release or receptor sensitivity. Furthermore, the molecule acts as a protective agent against cerebral hypoxia by maintaining cellular energy homeostasis and reducing the impact of oxygen deprivation on neuronal integrity, modulating mitochondrial function. System-level physiological consequences involve increased inter-hemispheric communication and modulation of cerebral microcirculation.

Dosage and Administration Information

How to Use Dalus (Citicoline): Official Administration Guidelines

The administration of Dalus, which contains the active ingredient Citicoline, follows established administration guidelines. The medicine is available for both oral and parenteral use, and dosing is standardized for adults.

Feature Administration Guidelines
Route of Administration Oral (tablet or solution), Intramuscular (IM), or Intravenous (IV).
Dosing Schedule The usual adult daily dose ranges from 500 mg to 1000 mg, which may be increased up to a maximum of 2000 mg per day.
Timing in Relation to Meals Oral forms of the medicine can be taken with or without food.
Age-Group Rules Elderly patients typically do not require dosage adjustment and may receive the standard adult dose.

Procedural Administration Conditions

When Dalus is administered by the intravenous route, specific procedural conditions are established to ensure proper use:

  • Intravenous Speed: Direct intravenous (IV) injection is administered very slowly, typically over a period of 3 to 5 minutes.
  • IV Infusion Rate: For IV drop perfusion (drip), the recommended speed is 40 to 60 drops per minute.
  • Incompatibilities: The medicine is not administered in conjunction with other medicines that contain meclofenoxate (clophenoxate).

These guidelines define the standardized use of Dalus, ensuring the correct dose is delivered via the approved route, including the required slow rate for intravenous administration.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Dalus

Evidence for Use in Acute Ischemic Stroke

Research into Dalus has included large-scale Randomized Controlled Trials (RCTs) and comprehensive reviews. These studies was studied for adults and the elderly in the immediate period after experiencing an acute ischemic stroke. Researchers monitored these patients to measure outcomes reflecting daily functioning or activity level.

Findings describe patterns observed in the studies. The research explored functional recovery in specific patient subgroups that had more moderate-to-severe symptoms at the start of the study. However, when researchers looked at the results across all patients in the largest, comprehensive trials, the findings were mixed. The consistency of findings across all major RCTs remains low due to the variation in results, meaning certainty regarding the full scope of the research profile is limited across the entire range of stroke patients.

Evidence for Use in Mild Cognitive Impairment (MCI) and Age-Associated Memory Issues

Dalus was evaluated in older adults who were experiencing Mild Cognitive Impairment (MCI) or general age-associated memory issues. The research examined outcomes related to changes in neurocognitive performance, such as general cognitive status and specific skills like episodic memory and attention.

Findings indicate patterns that appear to describe an association with maintaining performance in specific cognitive domains, particularly in those individuals who had lower performance scores when the study began. However, the follow-up durations were limited in many of these studies. This means that while research provides insight into short-term changes, long-term effects are not fully established regarding whether these changes last or whether they alter the course of cognitive decline over multiple years.

Evidence Quality and Key Limitations of the Research

It is important to understand that evidence quality varies across studies and across the different conditions for which Dalus was evaluated in. Key limitations include sample sizes were modest in some cognitive studies and the fact that follow-up durations were limited across many conditions, meaning long-term data is sparse.

Findings describe group patterns, not personal outcomes, and the research does not determine whether an individual will respond similarly. Evidence highlights what is known — and what is still uncertain — and should be considered within the context of these research limitations.

Key Studies & References Is Citicoline Effective in Preventing and Slowing Down Dementia?—A Systematic Review and a Meta-Analysis

Frequently Asked Questions (FAQ)

Common questions about Dalus (FAQ)

Q: What are the most common side effects people talk about with Dalus?

A: Regulatory safety information classifies all listed adverse reactions for Dalus as Very Rare, meaning they are seen in less than 1 in 10,000 treated patients. Among the adverse reactions documented in this rare category, effects on the gastrointestinal system, such as nausea, vomiting, and diarrhea, are commonly noted.

Q: Does taking Dalus make you feel tired or sleepy?

A: Official safety documentation on the nervous system lists effects like dizziness, tremor, and difficulty sleeping (insomnia) as Very Rare. Effects such as sleepiness (somnolence) or general fatigue are not among the adverse reactions explicitly listed in the official regulatory labeling.

Q: Can Dalus cause stomach upset or nausea?

A: Yes, official documents confirm that Dalus can have effects on the gastrointestinal system. Documented effects include nausea, vomiting, diarrhea, and gastric pain. However, these are classified by regulatory authorities as Very Rare, occurring in less than 1 in 10,000 patients.

Q: How long does it typically take for Dalus to start working?

A: Pharmacokinetic information shows that after taking an oral dose, the components of the active ingredient reach their peak levels in the bloodstream in approximately one hour. Clinical studies examining its effects on memory or function often monitor changes in outcomes over periods ranging from several weeks to a few months.

Q: What foods or drinks should be avoided while using Dalus?

A: Official prescribing information establishes a formal interaction restriction against consuming alcohol while using Dalus. Regulatory documentation does not list any other specific foods or drinks that must be strictly avoided during treatment.

Q: Why is Dalus usually taken once a day (if applicable)?

A: The official daily dose for adults is typically in the 500 mg to 1000 mg range. The active ingredient has a long elimination half-life, reported to be approximately 50 to 70 hours for the components. This pharmacokinetic profile is supportive of a once-daily dosing regimen.

Q: Does Dalus affect the ability to drive or operate machinery?

A: Official patient information addresses the potential for effects on the ability to drive and operate machinery. This is a standard caution because documented Very Rare side effects include those that affect the nervous system, such as headache and dizziness.

Q: How do the official sources describe the expected 'benefit' of Dalus?

A: Official labeling classifies Dalus as a nootropic and neuroprotective agent. Its general purpose is defined as supporting the structural integrity and metabolic health of nerve cells. The research examined its ability to support functional recovery and changes in neurocognitive performance in specific patient groups.

Q: Is Dalus prescribed for short-term or long-term use?

A: The available research evidence indicates that Dalus was studied over defined periods, such as the immediate phase after an event and in trials lasting up to several months for age-associated issues. Due to limitations in follow-up duration, official information is generally sparse regarding long-term effects for continuous use over multiple years.

Q: I heard Dalus is in the same class as [Similar Drug]—is that correct?

A: Official sources classify the active ingredient in Dalus, Citicoline, as a Nootropic Agent and a Neuroprotective Agent, placing it within the general category of Psychoanaleptics. This classification defines its formal pharmacological category and aligns with its described general purpose of supporting metabolic and functional processes in the central nervous system.

Q: What happens if I miss a dose of Dalus?

A: Official patient information advises that a forgotten dose should be taken as soon as it is remembered. However, if it is almost time for the next scheduled dose, the missed dose should be skipped to prevent taking two doses too close together.

Q: Is there a generic version of Dalus available?

A: Dalus is the commercial name for the active ingredient, Citicoline. As this substance is chemically identical to a compound naturally produced in the body, multiple manufacturers supply products containing this substance, which may be supplied under different commercial names in various markets.

Q: How long does Dalus stay in the body after the last dose?

A: Pharmacokinetic data indicates that the administered components of the active ingredient have a long half-life in the body. The elimination half-life for the administered components of Dalus is reported to be approximately 50 to 70 hours, with the components being excreted primarily through respiration and urine.

Q: Is Dalus considered habit-forming or addictive?

A: The active ingredient in Dalus is not classified as a controlled substance in official listings. It is not described in official documentation as having a risk of dependency or being habit-forming.

Q: Are there any long-term health concerns associated with using Dalus?

A: Official safety reviews of the active ingredient have described its toxicity profile as negligible. However, clinical studies have typically involved follow-up periods of several months to one year. As a result, long-term safety data for use extending over multiple years remains sparse.

Q: Is Dalus still being studied for other conditions?

A: Research using the active ingredient is ongoing and documented in government registries such as ClinicalTrials.gov. Studies are examining its potential role in various neurological conditions beyond the currently documented uses, including in specific pediatric populations.

Q: Does Dalus contain any common allergens like gluten or lactose?

A: The specific inactive ingredients (excipients) in Dalus vary by the pharmaceutical form (e.g., tablet or solution). Official documents list excipients such as Sorbitol and specific coloring agents that may necessitate caution due to known sensitivities or allergic reactions. The complete list of inactive ingredients (excipients) can provide specific information regarding known allergens.

Q: What is the most serious side effect listed for Dalus in official documents?

A: Official regulatory documentation provides a complete safety profile and states that all listed adverse reactions are classified as Very Rare. No reaction is explicitly designated as a 'Serious Adverse Reaction' in the safety profile provided by the regulatory authorities.

Q: Is it normal for the drug's effect to feel different after several weeks?

A: The research studies conducted on Dalus, particularly those examining age-associated memory issues, monitored patient performance over periods of several weeks or months. This suggests that any changes in performance, as documented in the evidence, may become apparent gradually over time.

Q: Has Dalus been approved in other countries besides the US/EU?

A: Yes, regulatory documentation confirms that the active ingredient in Dalus has been approved and is used in many countries worldwide. These include regions in Asia and Africa, in addition to regulatory approvals across Europe and other continents.

Q: Can children or teenagers use Dalus?

A: Official regulatory documentation notes that experience and data on the use of Dalus in children and adolescents are limited. Official documentation advises administration in these age groups only when the potential benefit is determined to justify any potential risk, due to limited available data.

Q: Is a headache a side effect that often happens with Dalus?

A: Headache is listed in the official documentation as a documented adverse effect. However, it is classified as a Very Rare event, meaning it is reported to occur in less than 1 in 10,000 patients treated with the medicine.

Q: Can Dalus cause changes in mood or anxiety levels?

A: Official documentation lists a caution for patients with a history of depression. Additionally, adverse reactions such as anxiety and agitation are listed among the documented effects, although they are classified as Very Rare events.

How should Dalus be stored and disposed of?

Storage and Disposal Requirements

Storage and disposal must strictly adhere to instructions specified in the official product labeling. The product is required to be stored at a temperature not exceeding 30°C and must be protected from direct sunlight and moisture. It is explicitly stated that the medicine must not be frozen.

Storage Restriction Requirement
Temperature Store below 30°C.
Prohibited Environment Do not freeze.
Child Safety Keep out of the sight and reach of children.
Container Rule Keep the medicine in the original container and keep the package tightly closed (for oral forms).
Injection Stability Solution for injection is for single use only and must be used immediately after opening.

Disposal of any unused product or expired medicine is mandatory according to local regulation. It is strictly prohibited to discard Dalus via wastewater or routine household waste; patients should consult a pharmacist for guidance on proper disposal.

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

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