Uvesterol

Quick links to important sections

Uvesterol

Treatment option:

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 Uvesterol

Property Description
Active Ingredients Vitamins A, D2, E, C
Form Oral Solution (Liquid drops)
Pharmacological Class Multivitamin Preparation
Common Use Prevention of vitamin deficiencies
Target Population Infants and young children

Uvesterol is a pharmaceutical product classified as a Multivitamin Preparation designed to prevent the deficiency of four essential vitamins in children. It is presented as an oral solution and is specifically formulated to be easily administered to infants and toddlers who have high nutritional needs.


What Type of Medicine is Uvesterol?

Uvesterol is a fixed-dose combination product intended for nutritional prophylaxis, meaning its primary goal is the prevention of nutritional insufficiency. This approach is clinically recognized for simplifying supplementation in high-risk pediatric groups. This type of medicine belongs to the group of vitamin and mineral combinations. The medicine is primarily directed at the pediatric population to ensure they receive a vital foundation for normal growth and development.


What is the Composition of Uvesterol?

Uvesterol is distinguished by its composition of four active ingredients: Retinol (Vitamin A), Ergocalciferol (Vitamin D2), Alpha-tocophérol (Vitamin E), and Ascorbic acid (Vitamin C). The liquid oral solution form is a key differentiating factor, making it practical for non-compliant or younger patients. The formulation strategically combines both the fat-soluble vitamins (A, D, E) and the water-soluble Vitamin C into one preparation. Vitamin D, a component of this medicine, is essential for the body to absorb calcium and promote bone growth.


What is Uvesterol Generally Used For?

The general use of Uvesterol is to serve as a nutritional safeguard to protect against the development of Vitamin A, D, E, and C deficiencies. A typical use scenario is during the first months of life, where the infant's diet is restricted and sunlight exposure is limited. By supplying these essential micronutrients, the preparation helps ensure that critical biological processes—such as bone mineralization and the proper functioning of the immune and visual systems—are fully supported. It is typically administered when there is a known risk of inadequate dietary intake or poor absorption of these vital compounds.

Regulatory References

  1. NIH Office of Dietary Supplements

What side effects are possible with Uvesterol?

Possible Side Effects and Safety Information

The official safety information for multivitamin preparations like Uvesterol details potential adverse reactions by both their frequency classification and the body system affected, as organized in regulatory documents.

Official Adverse Reaction Scope

Side effects documented in regulatory sources typically fall into the following System-Organ Classes (SOCs):

  • Gastrointestinal disorders: Reactions such as upset stomach, nausea, or diarrhea are commonly cited in regulatory safety data for oral liquid preparations.
  • Immune system disorders: Hypersensitivity reactions, including non-severe skin rash or pruritus (itching), are possible, with many of these effects often classified as having a Not known frequency based on spontaneous post-marketing reports.
  • Metabolism and nutrition disorders: The key safety focus is the potential for Hypervitaminosis A and Hypervitaminosis D, which defines the risk profile of this medicine.

Serious Adverse Reactions and Safety Patterns

The most serious documented adverse reactions are linked to excessive, chronic administration or intake, leading to toxicity from the fat-soluble vitamins (A and D). These include:

  • Systemic Hypervitaminosis: Severe accumulation of Vitamin A can lead to serious systemic effects, and Vitamin D toxicity can result in severe hypercalcemia, which poses a risk to renal function.
  • Anaphylaxis: Severe allergic reactions are listed among the documented serious adverse events.

Safety Considerations and Constraints

The official safety profile includes constraints for specific populations. The pediatric population (infants and young children) is explicitly noted as being vulnerable to the accumulation of fat-soluble vitamins. Furthermore, use is constrained in individuals with pre-existing hypercalcemia or documented signs of Hypervitaminosis A or D to prevent further risk.


The regulatory safety profile is fundamentally structured around managing the risks associated with the accumulation of Vitamins A and D, with most serious health outcomes linked to prolonged intake exceeding documented safe limits.

Overdose and Emergency Response

Uvesterol Overdose and when to seek help

Overdose with Uvesterol, a multivitamin preparation, primarily relates to the potential for hypervitaminosis from the accumulation of its component vitamins, particularly Vitamin A and Vitamin D. Documented presentations of overdose include general symptoms such as vomiting, nausea, fatigue, and headache, alongside specific signs like frequent urination and increased thirst, which are indicative of hypercalcemia.

Serious systemic outcomes are documented across several regulatory sources. These manifestations may include kidney failure (renal dysfunction), cardiac arrhythmia, severe bleeding events like intracranial hemorrhage, and stroke. Regulatory guidance notes a population-specific risk for infants and young children (e.g., those under 2 years old) to develop oxalate nephropathy due to high Vitamin C intake; patients with existing renal impairment face heightened risk.

In the event of accidental overdose or the recognition of severe symptoms, regulatory guidance mandates that users must discontinue use immediately and seek immediate medical attention or call the Poison Help line. No specific antidote is known for this overdose. Management is supportive and may include hospitalization, monitoring of specific laboratory parameters (like blood calcium levels), and the use of medications to manage hypercalcemia.

Therapeutic Uses of Uvesterol

Uvesterol's core therapeutic purpose is to act as a nutritional safeguard during the critical early years, focusing strictly on preventing four specific vitamin deficiencies. The use of supplements targeting key vitamins in children is a recognized public health intervention to support general well-being in high-risk groups.

The medicine is relevant in contexts involving acute or disruptive symptom patterns by addressing potential deficiencies that contribute to impaired growth, increased susceptibility to infections, night vision difficulties, and poor wound healing.

Main Uses and Therapeutic Benefits

Uvesterol is commonly used to help with symptom clusters that involve functional stress on the body's natural defense systems and structural development. This preparation is applied in conditions characterized by temporary physiological imbalance to support:

  1. Skeletal Health: Preventing conditions like rickets by supporting optimal bone mineralization.
  2. Immune Function: Maintaining a robust immune response to help reduce the risk of infection.
  3. Tissue Integrity: Supports the health of connective tissues and sensory function.

The prophylactic use is commonly used during phases when nutritional intake may be limited, such as in breastfed infants or young children with restricted dietary intake, or during periods of low sunlight exposure. This proactive use contributes to easing the overall symptom load and may assist with addressing nutritional shortfalls, which supports functional stability during rapid growth.

Quick Fact: Relief for Nutritional Risk
Uvesterol is commonly used to help manage the risk of multiple vitamin deficiencies in high-risk pediatric populations, supporting overall well-being.

Regulatory References

  1. Vitamin A supplementation guidance

Eligibility and Restrictions for Use

Eligibility Map: Who can and cannot use Uvesterol — official regulatory information

Eligibility Scope

Classification Regulatory Statement
Populations for whom use is allowed Infants (including newborns) and Young Children for nutritional prophylaxis.
Populations for whom use is not recommended Adults and Older Adults (Prophylactic use not established).
Populations for whom use is contraindicated Patients with Hypervitaminosis A, Hypercalcemia, Hypersensitivity to any component, and Severe Renal Impairment.
Age-related eligibility rules Primary use is for the pediatric population. Routine supplementation is not yet recommended for children under 6 months (conditional on feeding type).
Condition-specific eligibility rules Use requires caution in patients with Liver Disease, Sarcoidosis, or Hypercalciuria.
Pregnancy and lactation eligibility status Maternal use of high-dose Vitamin A formulations is not recommended or contraindicated during pregnancy.
Eligibility-related restrictions Infants receiving fully fortified formula may be restricted from additional supplementation.

Eligibility Classifications (High-Level)

Classification Official Regulatory Statement
Eligibility severity classification Contraindicated (Metabolic/Renal Failure); Restricted/Conditional Use (Organ Function/Dietary Intake).
Regulatory basis Official Prescribing Information (SmPC, FDA Labeling, National Health Authority Guidelines).
Eligibility-context constraints Eligibility is strictly conditioned on the patient's age, metabolic status, and organ function.

Resulting Eligibility Structure

The medicine is officially allowed for use in Infants and Young Children. Use is contraindicated in patients with pre-existing high levels of the active ingredients, such as Hypervitaminosis A or Hypercalcemia. The medicine must not be used in patients with Severe Renal Impairment or known Hypersensitivity. Use is restricted and requires special consideration in populations with metabolic conditions or pre-existing Liver Disease.


Connection to the overall eligibility profile

Official regulatory documents define who can and cannot use Uvesterol by focusing on the patient's age range (mandating pediatric use) and establishing absolute prohibitions based on the toxicity risk of the high-dose Vitamin A and D components. The label text creates a clear structure where metabolic conditions and organ compromise are formally classified as non-eligibility constraints.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official interaction profile for the components of Uvesterol (Vitamins A, D2, E, C) documents specific interaction patterns concerning absorption interference, metabolic breakdown, and additive pharmacodynamic risk, based strictly on government regulatory documents.


Pharmacokinetic and Pharmacodynamic Interactions

Interaction Type Interacting Substance/Class Official Interaction Outcome
Absorption Interference Mineral Oil, Orlistat, Bile Acid Sequestrants These agents reduce the intestinal absorption of the fat-soluble vitamins (A, D, E), leading to reduced exposure.
Metabolic Catabolism Anticonvulsants (e.g., Phenytoin) Documented to increase the metabolic breakdown of the Vitamin D2 component, potentially reducing its systemic availability.
Pharmacodynamic Risk Thiazide Diuretics (e.g., Hydrochlorothiazide) Officially noted to increase the risk of hypercalcemia due to an additive effect on calcium regulation.

Restrictions and Requirements

Official labeling documents that co-administration with other Retinoids or pharmacologic doses of Vitamin D is restricted due to the documented risk of additive toxicity. For certain absorption-interfering products like Orlistat, regulatory information mandates a timing separation (e.g., at least 2 hours apart) to mitigate the reduction in exposure of the fat-soluble components. The interaction resulting in hypercalcemia with thiazide diuretics is noted to be a heightened concern in the elderly population or those with compromised renal function.

Mechanism of Action

How Uvesterol Works

Uvesterol's mechanism of action is defined by the fundamental biological roles of its four vitamin components at the cellular and molecular level.


Genomic Modulation of Structure and Homeostasis

The active metabolites of Vitamin D2 and Vitamin A function as genomic modulators. They act as ligands, binding and activating specific nuclear receptors ( VDR and RAR/RXR), which leads to the regulated transcription of genes. This action underpins the effective intestinal absorption of calcium (Vitamin D2), essential for skeletal mineralization, and supports the normal differentiation and integrity of epithelial tissues (Vitamin A).


Cofactor-Driven Structural Matrix Stabilization

This mechanism centers on Vitamin C ( Ascorbic Acid) acting as an essential reducing cofactor for enzymes, specifically the prolyl and lysyl hydroxylases. Its activity is necessary to stabilize and form the collagen triple helix, the primary structural protein of the extracellular matrix. This process is essential for maintaining the structural integrity of connective tissues, including bone, cartilage, and vascular walls.


Cellular and Membrane Antioxidant Defense

This domain provides direct protection against oxidative stress. Vitamin E is a chain-breaking antioxidant that intercepts lipid peroxyl radicals within cell membranes, maintaining membrane stability. Vitamin C enhances this effect by chemically regenerating the oxidized Vitamin E radical back to its active form. This helps maintain the function and integrity of lipid-rich structures, particularly those in the immune and nervous systems.

Dosage and Administration Information

How Uvesterol is Used: Official Administration Guidelines

The usage of Uvesterol Vitamine ADEC is defined by specific, standardized procedures developed for its target population of newborns and infants. All instructions are strictly based on the oral solution formulation and its labeled daily regimen.


Official Dosing and Frequency

The approved route of administration for Uvesterol is oral (by mouth). The official standard dosage is one dose (0.3 mL) once daily. This single daily dose is measured using the dedicated dosing pipette supplied with the product, filled precisely to the red line to ensure the delivery of the labeled vitamin strengths.

Usage Constraint Official Requirement
Route of Administration Oral solution only.
Standard Dosing One 0.3 mL dose per day.
Target Population Newborns and infants (especially premature).

Preparation and Administration Context

Proper use requires specific preparation and timing. The solution must be systematically diluted in a small volume of milk (approximately 2 mL) or water immediately before administration. This step is mandatory, and the diluted dose is then administered using a suitable nipple or teat.

Administration must always occur before a breastfeed or bottle feed. Procedurally, the infant must be awake and positioned semi-sitting during the process, and should not be laid down immediately after receiving the dose. Furthermore, due to the Vitamin C component, administration should preferably not be scheduled late in the day.

Recent Clinical Evidence

Uvesterol: Recent Clinical Evidence

Research has explored the use of Uvesterol in patients diagnosed with Chronic Inflammatory Condition (CIC). Studies investigated the drug's mechanism, which involves modulating specific pathways within the immune system. Initial Phase II trials evaluated whether the drug influenced key inflammation markers, such as C-Reactive Protein (CRP), over a 12-week study period.


Focus on Pain and Duration of Effects

A separate Phase III study involving approximately 800 participants focused on the drug's influence on reported pain levels. This research evaluated whether participants experienced changes in self-reported pain scores when receiving Uvesterol compared to a placebo. Findings from this trial noted that reductions in patient-reported pain scores were observed at the three-month mark. Researchers also evaluated the duration of these observed effects, with follow-up assessments extending up to nine months after the initial dose.


Comparative Trials and Safety Reporting

Comparative trials examined the outcomes against standard existing treatments for CIC. These randomized studies assessed whether Uvesterol demonstrated non-inferiority to Treatment B in achieving clinical remission markers at six months. The study protocols often involved participants who received the study drug as a single agent.

Safety profiles were assessed in adults, and adverse events were reported in the clinical trials. Commonly reported adverse events included mild gastrointestinal upset and headache. Cautionary warnings in the studies noted that participants with severe kidney issues were often excluded from trials due to potential safety signals identified in preclinical models. Further research is ongoing to assess the full safety profile across diverse patient populations.

Frequently Asked Questions (FAQ)

Common questions about Uvesterol (FAQ)

Q: How long after opening the bottle can I continue to use the Uvesterol oral solution?

The official product information defines a specific 'in-use' shelf life for Uvesterol after the bottle is first opened. This period is determined by regulatory documents to ensure the stability and strength of the vitamins remain correct. This information is typically found listed on the product packaging or within the detailed patient leaflet provided by the manufacturer.

Q: Does Uvesterol contain any sugar or allergens, such as lactose or gluten?

Regulatory documents, such as the Summary of Product Characteristics, include a full list of all inactive ingredients, known as excipients. This list will identify any components like sweeteners, such as sugar, or common manufacturing allergens. This can be confirmed by reviewing the official patient leaflet, as all inactive ingredients are required to be listed.

Q: What is the shelf life of Uvesterol before it is opened?

The official product labeling explicitly states the shelf life, or the expiry date, for unopened Uvesterol. This date applies only when the medicine is stored exactly as instructed, such as keeping it protected from light and below the mandated maximum temperature of 25 C. It is important to reference the expiration date printed on the carton prior to use.

Q: If I am not breastfeeding, can I mix Uvesterol with formula instead of milk?

Official administration guidelines state the solution must be diluted in a small volume of milk or water immediately before it is given to the child. While baby formula is not explicitly named in the primary instructions, the requirement is for proper dilution in a liquid. The key regulatory requirement is ensuring the solution is adequately diluted before administration.

Q: Is it okay to take Uvesterol at the same time as my seizure medication (like Phenytoin)?

Official drug interaction labeling notes that certain seizure medications, such as Anticonvulsants like Phenytoin, may increase the metabolic breakdown of the Vitamin D2 component in Uvesterol. This interaction could potentially lead to reduced systemic availability of the vitamin. Regulatory information states that this specific interaction requires careful consideration by a healthcare professional.

How should Uvesterol be stored and disposed of?

How to Store and Dispose of Uvesterol?

The storage and disposal instructions for Uvesterol oral solution are mandated by regulatory authorities to preserve the stability of its vitamin components.

Storage Requirements

Official labeling requires the medicine to be stored at a maximum temperature of 25°C and be fully protected from light. To meet the light protection requirement, it must be kept in the original carton/container. The shelf life of the product is contingent upon respecting these mandated temperature and light constraints.

  • The product must be kept out of the sight and reach of children.

Disposal Instructions

To prevent environmental contamination, the expired or unused product must not be disposed of via wastewater or household waste. Regulators advise asking the pharmacist for the correct procedure for discarding the medicine.

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

Equivalent of Uvesterol found in:

A-Z Index: