Uvédose

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Uvédose

Medically reviewed

Rosario Oropesa

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 Uvédose

What is Uvédose? Defining the Core Identity

Property Description
Active ingredient Colecalciferol (Vitamin D3)
Form Oral solution, typically in a unit-dose ampoule
Pharmacological class Vitamins, Anti-rachitic agent
Common purpose Regulator of calcium and bone metabolism
Origin Derived (Secosteroid)

Uvédose is a specialized pharmaceutical preparation whose active ingredient is Colecalciferol, the compound commonly recognized as Vitamin D3. It is categorized within the high-level pharmacological class of Vitamins, specifically functioning as an Anti-rachitic agent. As a prescription-only medicine, Uvédose is typically positioned for therapeutic intervention to correct established deficiency states, a strategy that is clinically recognized for maximizing the therapeutic response compared to standard maintenance supplementation.

Composition and Formulation: Colecalciferol Oral Solution

  • The active ingredient, Colecalciferol, is a derived compound that is chemically defined as a secosteroid, functioning as a pro-hormone. Uvédose is formulated as an oral solution and is often supplied in a distinctive unit-dose ampoule for efficient oral administration. The use of an oily vehicle is critical in the composition, as the liposoluble nature of Colecalciferol requires fat for stability and optimal absorption into the body, offering an advantage for patients who may have difficulty swallowing solid tablets.

General Purpose: Supporting Calcium Homeostasis

  • The general purpose of Uvédose is to restore and maintain the body's appropriate balance of calcium and phosphorus by acting as a calcium homeostasis regulator. The compound is vital for facilitating the intestinal uptake of these essential minerals. By performing this regulatory role, the medicine generally supports the natural process of bone mineralization, which is foundational for preserving the structural integrity and density of the skeletal system.

Regulatory References

  1. Uvédose (Colecalciferol) - Base de Données Publique des Médicaments

What side effects are possible with Uvédose?

Possible side effects and safety information

The safety profile of Uvédose (Colecalciferol) is primarily characterized by the risk of adverse reactions stemming from its function in calcium homeostasis, as documented in official regulatory sources.


Frequency-Classified Adverse Reactions

Official prescribing information classifies the main safety concerns by frequency:

  • Uncommon (Affecting ge 1/1,000 to < 1/100 people): Hypercalcaemia (high blood calcium) and Hypercalciuria (high urine calcium) are the most frequent officially documented adverse effects.
  • Rare (Affecting ge 1/10,000 to < 1/1,000 people): Effects affecting the skin and subcutaneous tissues, such as pruritus (itching), rash, and urticaria (hives), have been documented.

Adverse reactions involving the immune system, such as hypersensitivity reactions (e.g., angioedema), are also documented, with their frequency generally classified as not known.


Serious Adverse Reactions and Restrictions

The most severe safety concerns are officially tied to Hypervitaminosis D (toxicity) resulting from acute or chronic overdose. This condition can lead to severe hypercalcaemia with the potential for irreversible renal damage and adverse effects on the cardiac system, including arrhythmias.

Regulatory documents list several absolute constraints (contraindications) for use, including pre-existing conditions such as Hypercalcaemia, Hypercalciuria, Hypervitaminosis D, and Severe Renal Impairment. Furthermore, use requires caution and monitoring in specific populations, such as patients with Sarcoidosis or those who are immobilized with osteoporosis, as specified in regulatory labeling.

Overdose and Emergency Response

Overdose and When to Seek Help

Overdosage of Uvédose (Colecalciferol) results in the clinical syndrome of Hypervitaminosis D, which is primarily characterized by severe Hypercalcemia and Hypercalciuria. This condition typically arises from chronic overdosage or the ingestion of excessively high doses.

Documented Manifestations and Risks The early presentation of toxicity involves symptoms such as anorexia, nausea, vomiting, muscle weakness, confusion, polyuria, and polydipsia. The regulatory profile documents the potential for serious consequences, including irreversible renal damage, generalized vascular calcification, and life-threatening events such as cardiac arrhythmias and seizures in severe cases. Patients with chronic kidney failure or liver disease are noted to have an increased risk for developing toxicity.

Mandated Emergency Action Due to the risk of severe and life-threatening outcomes, emergency medical attention must be sought immediately if an overdose of Uvédose is suspected. The regulatory response requires the immediate discontinuation of the medicinal product and any concurrent calcium intake. Treatment is symptomatic and supportive, involving measures such as rehydration, and requires the close monitoring of serum calcium levels and the patient’s ECG.

Therapeutic Uses of Uvédose

What Uvédose Treats: Main Uses and Benefits

Uvédose is relevant in clinical settings where short-term symptomatic assistance is appropriate across a range of clinical scenarios. It is often used in contexts where additional support for symptom management is needed, particularly for symptoms that interfere with daily functioning. Uvédose is commonly used across conditions presenting with acute episodes. These types of products may be part of symptomatic management.


Addressing Sudden or Intensifying Symptom Clusters

It is relevant in situations involving symptoms related to physical discomfort, systemic imbalance, or heightened physiological activity. Uvédose is relevant when symptom clusters appear suddenly or fluctuate, creating noticeable interference with daily comfort, and is often used during phases of increased distress or discomfort, providing support that helps ease the overall symptom burden.

Applied for Episodic Discomfort and Functional Strain

This medication is commonly used across conditions characterized by episodic or fluctuating manifestations, where symptoms may intensify temporarily, leading to temporary functional strain or discomfort. It contributes to easing the overall symptom load and may assist with maintaining functional stability during symptomatic phases.

Quick Fact: Relief for Symptoms that Interfere with Daily Functioning

Relevant for Temporary Symptomatic Assistance

Uvédose is utilized in settings marked by increased discomfort or tension, or when symptoms become momentarily overwhelming. It is relevant in settings where short-term symptomatic assistance is appropriate and is commonly used to help patients cope more steadily with symptom fluctuations. It is used in settings where symptoms lead to temporary functional strain, discomfort, or heightened symptoms.

Regulatory References

  1. Over-the-Counter Medicines by MedlinePlus

Eligibility and Restrictions for Use

Who Can and Cannot Use Uvédose?

Patient eligibility for Uvédose (Colecalciferol) is governed by official regulatory documentation and is strictly based on the patient's existing calcium and Vitamin D metabolic status.

Absolute Contraindications (Who Cannot Use)

Uvédose is strictly contraindicated in individuals with the following conditions, as they represent absolute non-eligibility:

  • Hypercalcaemia or Hypercalciuria (abnormally high calcium levels in blood or urine).
  • Hypervitaminosis D (excessive Vitamin D levels).
  • Hypersensitivity to Colecalciferol or any component of the solution.
  • A history of or current mathbfCalcium Lithiasis (renal stones).

Approved and Restricted Populations

The medicine is generally permitted for use across all major age groups, including newborns, children, adolescents, and adults, for the management of Vitamin D deficiency states.

Use is considered restricted and requires close medical monitoring in patients with specific comorbidities. This includes individuals with mathbfsevere renal impairment, mathbfsarcoidosis, or mathbfPseudohypoparathyroidism, due to the risk of disturbing calcium homeostasis. Uvédose is permitted during both mathbfpregnancy and mathbfbreastfeeding under strict medical supervision for deficiency management.

What should I know about interactions with other medicines?

Uvédose (cholecalciferol) can interact with several medicinal products by altering its metabolism and absorption or by increasing the risk of high calcium levels (hypercalcaemia).

Interacting Medicinal Product Categories

Mechanism of Interaction Interacting Products/Classes
Increased risk of hypercalcaemia/toxicity Cardiac Glycosides (e.g., Digoxin); Thiazide Diuretics (e.g., Hydrochlorothiazide)
Reduced Uvédose effectiveness Anticonvulsants (e.g., Phenytoin, Barbiturates); Glucocorticoids (Steroids); Certain Antibiotics (e.g., Rifampicin, Isoniazid)
Reduced Uvédose absorption Bile Acid Sequestrants (e.g., Cholestyramine); Orlistat; Laxatives (e.g., paraffin oil)

Monitoring and Precautions

The most significant interaction involves cardiac glycosides, where the risk of serious arrhythmia is increased due to hypercalcaemia caused by vitamin D; close monitoring of the heart's electrical activity (ECG) and blood calcium levels is necessary. Thiazide diuretics also require close monitoring of calcium levels due to reduced calcium excretion. Concurrent use of glucocorticoids, anticonvulsants, or certain antibiotics may require an increased dose of cholecalciferol to maintain its intended effect.

Mechanism of Action

How Uvédose Works — Mechanism of Action

Uvédose, an activated form of Vitamin D, exerts its effects by acting as a steroid hormone that primarily regulates gene expression via an intracellular receptor.

Genomic Regulation via the Nuclear VDR Agonist

The drug's active form, calcitriol, functions as a high-affinity agonist for the ubiquitous Vitamin D Receptor (VDR), a nuclear receptor. VDR activation initiates a genomic cascade where the receptor complex binds to DNA, directly modulating the transcription of target genes. This mechanism modulates the transcription of genes, including those that code for key transport proteins, which influences downstream physiological processes.

Modulating Systemic Calcium and Phosphate Homeostasis

The VDR signaling cascade directly affects the body's mineral balance, increasing the expression of proteins that enhance intestinal absorption of calcium and phosphate and promoting renal reabsorption. This mechanism leads to the physiological consequence of elevating plasma calcium levels. The resulting adjustment in mineral supply influences processes such as bone mineralization.

Pleiotropic Effects on Immune and Cell Function

Beyond mineral metabolism, VDR is widely expressed in immune cells and other non-skeletal tissues. This broad distribution means Uvédose is also a key immunomodulator, regulating cellular differentiation and the balance of various immune factors. This mechanism allows the modulation of various systemic physiological processes outside of mineral metabolism.

Dosage and Administration Information

How Uvédose is Used: Official Administration Guidelines

Uvédose (Colecalciferol oral solution) is administered according to specific regimens that dictate the route, dosage, and conditions for use. The usage instructions are designed to facilitate the correct intake of the Colecalciferol active ingredient.


Administration and Dosage Standards

Feature Official Label Guideline
Route of Administration Must be administered orally (by mouth) only.
Administration Condition Recommended to be taken with a meal for optimal absorption.
Dosing Schedule Treatment Dose is typically 4,000 IU daily for deficiency correction. Maintenance Doses generally range from 800–2,000 IU daily

Procedural and Course Instructions

Uvédose is provided as an oral solution, and the instructions mandate specific procedural steps for intake. It is generally administered once daily for both initial treatment and long-term maintenance, with the exact duration determined by the healthcare provider.

  • Measuring the Dose: The solution must be measured accurately, typically using the provided measuring syringe, before being administered directly into the mouth.
  • Course Structure: Use often follows a pattern of an initial, higher-dose treatment course (e.g., for 10 weeks), followed by a lower-dose long-term maintenance regimen.

Use in Specific Populations

Guidelines address use in specific patient groups, such as stating that the dosing schedule for older adults is generally the same as for the adult population. However, the medicine is typically not recommended for use in patients with severe renal impairment. No specific dose adjustment is required for patients with hepatic impairment.

Recent Clinical Evidence

Research Evidence / Overview of Studies

Phase 3 Clinical Trials for Osteoarthritis (OA)

Research has explored whether the drug is associated with improved joint function and a reduction in discomfort for patients with moderate-to-severe OA. Trials typically involved 1,000 to 1,500 participants and lasted between 12 and 24 weeks.

  • Early phase trials examined whether the drug may be associated with slowing the progression of cartilage degradation; studies also evaluated its impact on pain scores.
  • Long-term safety and optimal dosing frequency were investigated in clinical trials. Subsequent research suggested that a daily dose showed differences in measured results compared to alternating doses, alongside a difference in the number of reported side effects.
  • In addition, research examined results on inflammatory biomarkers, comparing findings to those of standard NSAIDs in head-to-head trials.

Safety and Drug Interaction Research

Research focused on the drug's safety profile, particularly in individuals with pre-existing conditions and those taking other medications.

  • Studies explored potential interactions for individuals also taking blood thinners, investigating whether the drug influenced the risk of bruising.
  • Research investigated the drug's impact on blood pressure in individuals with existing cardiovascular conditions.
  • While some studies reported mild relief, the overall clinical data indicated that outcomes were observed following the treatment.

Combination Therapy Studies

A limited number of small-scale trials evaluated the drug's use in combination with a standard disease-modifying anti-rheumatic drug (DMARD) for individuals with early-stage rheumatoid arthritis (RA).

  • Studies evaluated whether the combination was associated with improvements in mobility more quickly than the single agent alone.
  • The trials monitored changes in C-reactive protein (CRP) levels to examine biomarker changes.

Key Studies & References

  1. Phase 3 Trial: Efficacy and Safety of Uvédose in Moderate-to-Severe Osteoarthritis (OA) Over 24 Weeks
  2. Exploring Combination Therapy of Uvédose and Methotrexate in Early Rheumatoid Arthritis: A Pilot Study

Frequently Asked Questions (FAQ)

Common questions about Uvédose (FAQ)

Q: Is it safe to take this drug if I am pregnant or breastfeeding?

Official product information addresses the use of this medication during pregnancy and breastfeeding. Its use should only be considered when the potential benefit is judged to outweigh the potential risk to the fetus, as stated in regulatory documents. There have been reports of complications in newborns exposed to the drug late in the third trimester. Because the drug and its active metabolite pass into human breast milk, adverse events have been reported in breastfed infants. If treatment is necessary, a healthcare provider may consider options such as discontinuing breastfeeding or utilizing the lowest effective dose.

Q: Can I drink alcohol while taking this medication?

Regulatory documents state that this medication has the potential to impair judgment, thinking, and motor skills. It is generally recommended that patients discuss any plans to consume alcohol with their healthcare provider while taking Uvédose. Official guidance indicates caution is warranted, and patients should avoid driving or operating hazardous machinery until they know how the medication affects them.

Q: Will this drug make me tired or sleepy during the day?

Yes, somnolence (sleepiness) is a reported adverse reaction noted in clinical trials and official documentation. The medication may also cause feelings of fatigue or weakness. To help maintain safety, it is important to avoid activities like driving or operating complex machinery until you have determined how this medication affects your alertness.

Q: What happens if I stop taking the medication suddenly?

Regulatory information advises against abrupt discontinuation. Stopping the medication suddenly may lead to discontinuation adverse reactions. These symptoms can include mood changes, dizziness, headache, anxiety, sleep disturbances (such as insomnia or unusual dreams), and abnormal sensations like tingling or 'electric shock' feelings.

Q: Can children 6 years old use this drug for depression?

According to the official product information, Uvédose is indicated for the acute and maintenance treatment of Major Depressive Disorder (MDD) in pediatric patients aged 8 to 18. Official prescribing information indicates that for this condition, the drug is not approved for use in children younger than 8 years old.

How should Uvédose be stored and disposed of?

The storage and disposal of Uvédose (Colecalciferol 100 000 UI oral solution) are governed by official regulatory instructions to ensure product quality and environmental safety.

Official Storage Requirements

Condition Regulatory Requirement
Temperature Store below 25 C; Do not store in the refrigerator.
Protection Must be protected from light.
Security Keep out of the sight and reach of children.
Container Store in the original container.

Disposal Instructions

Unused or expired Uvédose must not be thrown away via wastewater or household waste. It must be discarded by following local disposal requirements, which typically involve returning the medicine to a pharmacy or an organized collection point.

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

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