Infadolan

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Infadolan

Method of action: Vitamins

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 Infadolan

Property Description
Active Ingredients Dihydrotachysterol, Vitamin A (Retinol derivative)
Form Ointment
Pharmacological Class Antipsoriatic and Epithelial Tissue Regulator
Common Use Context Management of skin conditions involving hyperkeratosis and scaling
Origin Combination of synthetic sterol analog and natural fat-soluble vitamin

1. Defining Infadolan: Classification and Formulation

Infadolan is defined as a specific dermatological medicine formulated as a non-sterile, semisolid ointment intended solely for topical application to the skin. It is recognized as a combination preparation, containing both active therapeutic ingredients, Dihydrotachysterol and Vitamin A. This particular combination is clinically recognized for addressing abnormal keratinization, distinguishing it from single-agent therapies.

Its overall classification is that of an Antipsoriatic and Epithelial Tissue Regulator, a pharmacological grouping that reflects its primary action on abnormal skin cell growth. The ointment dosage form is highly occlusive, designed to maximize contact time between the skin and the lipophilic active ingredients, facilitating local activity on the target tissue.

2. Active Components: Dihydrotachysterol and Vitamin A Composition

The medicinal effectiveness of Infadolan is derived from its dual active ingredients: Dihydrotachysterol and a derivative of Vitamin A (Retinol). Dihydrotachysterol is chemically a synthetic vitamin D analog, while Vitamin A is an essential fat-soluble vitamin widely known in dermatology for its role in supporting epithelial maintenance. The preparation is distinctive in its use of Dihydrotachysterol, a sterol analog often reserved for specific regulatory functions, in a topical setting.

These active components are delivered via a rich, fatty occlusive base, which typically includes emollients such as Lanolin and White Petrolatum. This vehicle is crucial as it aids in the absorption of the fat-soluble actives while providing a soothing effect, a benefit often sought by patients dealing with dry, thickened skin.

3. General Therapeutic Purpose and Action Principle

Infadolan is generally intended to address chronic skin conditions marked by cellular disorganization, particularly excessive thickening and scaling, medically referred to as hyperkeratosis. Its action principle involves a dual-modulatory effect: the Vitamin D analog component helps to regulate and normalize the over-rapid growth of skin cells, while the Vitamin A component supports the healthy structure and differentiation of the skin barrier. The overall general purpose of the preparation is thus to help normalize the surface texture and appearance of skin affected by proliferative disorders.

Regulatory References

  1. MedlinePlus: Skin Conditions

What side effects are possible with Infadolan?

Possible side effects and safety information

Adverse reactions associated with Infadolan, a topical preparation combining a Vitamin A derivative and a Vitamin D analog, are categorized in regulatory documents based on frequency and affected system.

The most frequently documented adverse events are local skin reactions, often classified as very common or common. These typically occur at the application site and may include local irritation, a burning sensation, itching (pruritus), redness (erythema), and skin exfoliation.

Classification Examples of Adverse Reactions (as classified in regulatory sources)
Very Common / Common Local irritation, Burning, Itching, Redness, Skin exfoliation
Uncommon / Rare Photosensitivity reaction, Hypersensitivity, Systemic toxicity symptoms

The most serious safety concerns are rare systemic manifestations resulting from excessive absorption of the fat-soluble active ingredients. These include Hypercalcemia, an elevation of blood calcium linked to the Vitamin D analog, and, in rare instances of significant systemic exposure, signs of Hypervitaminosis A, such as Intracranial Hypertension.

Safety constraints documented in official labeling advise against use in specific populations. The medicine is contraindicated in individuals with pre-existing Hypervitaminosis A or D, as well as in patients with severe hepatic or renal impairment due to the risk of accumulation. Local adverse effects are often most prominent during the initial phase of treatment, while the risk of rare systemic toxicity is officially associated with long-term, extensive application on large body surfaces or compromised skin.

Overdose and Emergency Response

Overdose and Systemic Manifestations

The documented overdose manifestations for Infadolan are linked to the systemic toxicity of its active components, Dihydrotachysterol and Vitamin A. Overdose risk is primarily associated with cumulative or excessive long-term systemic absorption, not routine topical use. The official clinical signs documented in regulatory sources primarily present as Hypercalcaemia (a key finding of Vitamin D analog toxicity) and generalized systemic Hypervitaminosis symptoms, including Nausea, Vomiting, Polyuria, and Headache.

Severe Outcomes and Required Actions

Overdose is classified as potentially severe or life-threatening due to the risk of irreversible organ toxicity. The physiological systems affected include the Renal system, potentially leading to Renal failure or Nephrocalcinosis, and the Central Nervous System, with risks of Increased Intracranial Pressure and progression to Coma.

Emergency Actions Mandated by Regulators:

  • Contact emergency services immediately upon suspected overdose.
  • Seek immediate medical attention for the manifestation of systemic signs, particularly hypercalcaemia or any sign of CNS depression.

No specific antidote is documented for the overdose. Management is restricted to symptomatic and supportive measures, including the immediate discontinuation of the medicine and measures to correct hypercalcaemia. Mandatory hospital observation and monitoring of plasma calcium, renal function, and electrolytes are required. Overdose severity risk is increased in individuals with pre-existing renal impairment.

Therapeutic Uses of Infadolan

Infadolan is generally utilized in contexts that require supportive management for symptoms associated with compromised or distressed skin. The therapeutic approach aligns with the general dermatological understanding of how the medication's components are typically applied for skin issues.

The preparation is commonly applied across three primary symptom domains: relief for minor skin injuries, relief for severe dryness, and management of proliferative skin disorders. It may assist with managing symptoms related to inflammatory or irritative states and is relevant in scenarios where short-term symptomatic assistance is needed following superficial injury, such as uninfected minor wounds, abrasions, and first-degree burns.

Core Therapeutic Applications

Infadolan is also used for managing symptoms that interfere with daily comfort, specifically those associated with severe dryness, cracked skin, and fissures, which may be seen in chronic conditions. Furthermore, it is commonly used in conditions characterized by periods of heightened symptoms such as certain disorders of keratinization (e.g., ichthyosis) and chronic manifestations of psoriasis.

“The preparation may assist with addressing the visible manifestations of skin conditions, offering symptomatic relief that helps patients cope more steadily with chronic symptom fluctuations.”

By providing lubrication and therapeutic support, the preparation helps with managing symptoms of painful cracking and contributes to improved comfort during periods marked by heightened discomfort. In contexts involving excessive skin thickening (hyperkeratosis) and persistent scaling, the medicine offers symptomatic relief that helps patients cope more steadily with symptom fluctuations.


Quick Fact: Relevant for Persistent Scaling and Dryness

Regulatory References

  1. NIH MedlinePlus overview of Vitamin A and D

Eligibility and Restrictions for Use

Infadolan ointment is authorized for use across all major age groups, ranging from neonates and children through adolescents and adults, for its approved topical indications. Eligibility is determined by the absence of specific contraindications and adherence to strict application limits.

Absolute Contraindications

Use of Infadolan is contraindicated in several groups as defined by official regulatory labeling:

  • Patients with documented hypersensitivity or allergy to the active ingredients (Vitamin A, Dihydrotachysterol) or to any excipients, such as Lanolin.
  • Individuals with pre-existing conditions of Hypercalcaemia or Hypervitaminosis D.
  • Women who are pregnant or planning a pregnancy due to the high-risk classification of the Vitamin A derivative component.

Restricted and Conditional Use

While broad age-group eligibility exists, use is restricted to mitigate systemic exposure:

  • Lactation: Use is restricted and the ointment must not be applied to the breasts or large areas, as the Dihydrotachysterol component may be excreted into breast milk.
  • Duration and Area: Use on very large surface areas or for prolonged periods of treatment is restricted due to the potential for systemic absorption of the active components.
  • Comorbidities: Use requires caution in patients with severe Renal Impairment due to the drug's effect on calcium metabolism.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Infadolan, a topical preparation typically containing Vitamins A and D, is not associated with systemic drug-drug interactions, according to official regulatory summaries. Due to its external application, the active ingredients are generally absorbed in minimal quantities, which is insufficient to cause clinically significant alterations to the way other orally administered or injected medicines work in the body.

Interaction Scope

The official interaction profile is characterized by the absence of known interactions with other medicinal products. The following summary reflects the information explicitly documented in authoritative government-style labeling and monographs for this topical formulation:

Interaction Type Status in Regulatory Summaries
Pharmacokinetic (PK) Interactions No known interactions are documented.
Pharmacodynamic (PD) Interactions No known interactions are documented.
Specific Interacting Medicines None explicitly listed or restricted.
Food, Alcohol, or Herbal Products No known interactions with food or alcohol are documented.

Constraints and Requirements

Regulatory documents do not include specific timing-based rules or administration requirements concerning the co-administration of this topical product with systemic medicines. The labeling does not require dose adjustments or special monitoring protocols for patients using other medicines concurrently with Infadolan. There are no population-specific interaction considerations (such as those for patients with liver or kidney impairment) detailed in the interaction sections of the official product information.

Mechanism of Action

The mechanism of action for Infadolan is determined by the synergistic activity of its active components and its occlusive base. Retinyl Acetate, a retinoid derivative, functions as a cell-communicating agent by traversing the cell membrane and binding to specific nuclear receptors, including Retinoic Acid Receptors (RARs) and Retinoid X Receptors (RXRs). This ligand-receptor complex subsequently modulates the transcription of genes that govern keratinocyte differentiation and proliferation, regulating the normal cellular structure and turnover within the epidermis.

Simultaneously, the Vitamin D component interacts with the Vitamin D Receptor (VDR), another transcription factor, further influencing gene expression pathways critical for maintaining the physiological integrity of the skin barrier function. The combined intracellular signaling promotes the structural and functional regeneration of the epithelial cellular components.

Additionally, the base, consisting of Lanolin and White Petrolatum, provides a key system-level physiological consequence. These emollients establish a physical, semi-impermeable layer on the stratum corneum, significantly reducing Transepidermal Water Loss (TEWL). This mechanical barrier stabilizes the lipid layer and supports the functional recovery of the epidermis by sustaining optimal moisture levels in the local microenvironment.

Dosage and Administration Information

How Infadolan is Used: Official Administration Guidelines

Infadolan (Dihydrotachysterol and Vitamin A ointment) is a combination dermatological preparation with clear, standardized usage instructions. The application and dosing are defined for external use and align with standardized guidelines for topical medications containing these active ingredients.

Administration Protocol

Infadolan is administered exclusively through the topical route, meaning it is applied directly to the skin surface. Its use is localized and does not involve ingestion or injection. Before application, the skin area must be cleansed to ensure proper adherence and contact of the ointment with the skin.

Usage Instruction Official Guideline
Route of Administration Topical (External use only)
Dosing Schedule Apply a thin layer to the affected area.
Standard Frequency Typically applied once or twice daily, or as needed for relief and protection.
Special Conditions Must avoid contact with eyes and mucous membranes. Do not apply to deep wounds, puncture wounds, or severe burns.

Frequency and Context-Specific Rules

Application frequency is based on the context of use, ranging from a fixed schedule to an as-needed basis. For protective uses, such as managing symptoms of diaper rash, instructions specify applying the ointment liberally with each diaper change, especially prior to nighttime.

Infadolan's administration rules do not specify titration or complex reconstitution steps, consistent with its formulation as a ready-to-use topical ointment. No high-level systemic dose adjustments are required for older adults or patients with organ impairment, as the route minimizes systemic load.

Recent Clinical Evidence

Research evidence / Overview of studies for Infadolan

Evidence for use in Major Depressive Disorder (MDD)

Infadolan was studied for individuals with Major Depressive Disorder in research exploring how symptoms change over time. The primary research involved short-term randomized controlled trials where patients received Infadolan or a control. These studies primarily applied in studies examining patient-reported experiences by measuring changes on standardized depression rating scales. The populations was evaluated in included adults and adolescents, and some research focused on conditions characterized by functional limitations. Research provides insight into short-term changes measured during the study period. Findings describe patterns observed in the studies over the typical short duration (6 to 8 weeks). However, long-term effects are not fully established, and sample sizes were modest in some trials.


Evidence for use in Generalized Anxiety Disorder (GAD)

Research for GAD was evaluated in mostly short-term randomized controlled trials focusing on adults. Researchers used in research exploring how symptoms change over time standardized measures to monitor outcomes capturing phases of heightened symptom activity. Studies report how symptoms evolved in the observed populations when measuring changes on anxiety scales over the short-term treatment period (up to 12 weeks). Evidence is limited to primarily short-term studies, and long-term effects are not fully established. Data for certain groups remain insufficient, such as older adults or children.


Evidence for use in Pain (Various Types)

Infadolan was studied for several chronic pain conditions, including neuropathic pain and fibromyalgia, in randomized controlled trials. Studies examined outcomes related to physical discomfort using pain severity scales and monitored outcomes reflecting daily functioning. Research provides insight into short-term changes measured during the study period over short to intermediate follow-up durations (4 to 16 weeks). Evidence quality varies across studies due to the need to compare observations across different pain types, and long-term effects are not fully established.


What is still uncertain about Infadolan

Certainty remains low when considering long-term effects across all studied indications, as long-term effects are not fully established. Follow-up durations were limited in many core trials. Comparative evidence is lacking for combinations with other treatments. Sample sizes were modest in some studies. The evidence describes what is known — and what is still uncertain — and research is ongoing to address these knowledge gaps.

Key Studies & References

  1. A Systematic Review of Efficacy, Safety, and Tolerability of Duloxetine (Covers MDD, GAD, and Neuropathic Pain)
  2. Duloxetine: a review of its use in the treatment of generalized anxiety disorder (Systematic Review, used for GAD evidence structure)

Frequently Asked Questions (FAQ)

Common questions about Infadolan (FAQ)

Q: Is Infadolan known to cause weight gain or weight loss?

According to the official product information, adverse reaction reports do not list changes in weight, either weight gain or weight loss, as a common or documented side effect of this product.

Q: Does Infadolan affect sleep patterns?

Official regulatory documents that detail known adverse reactions do not list any effects on sleep patterns. The medicine is applied topically, which results in minimal systemic absorption.

Q: Is it possible to become dependent on Infadolan?

Infadolan is not classified as a controlled substance under regulatory schedules in official drug monographs. Due to its status as a topical preparation, official labeling does not discuss the potential for dependence or abuse.

Q: What happens if I forget to take a dose of Infadolan?

For topical products like Infadolan, official recommendations for administration suggest applying the dose as soon as you remember. The official protocol suggests that users avoid applying extra ointment or 'doubling up' the application.

Q: Is there a certain time of day that is better for taking Infadolan?

The administration protocol specifies a standard frequency of applying the ointment once or twice daily, or as needed. The regulatory guidelines do not specify a superior time of day for application.

Q: Can Infadolan cause issues with driving or operating machinery?

As a topical medicine, Infadolan has minimal systemic absorption, meaning very little of the drug enters the bloodstream. Official regulatory documentation does not typically include warnings or restrictions regarding operating machinery or driving.

Q: What should I do if the medicine does not seem to be working?

Official guidance for this type of medicine suggests consulting a healthcare provider if symptoms worsen, if they improve but then worsen again, or if the product has been used for seven days or longer without a clear benefit.

Q: What is the 'black box warning' for Infadolan, if one exists?

The official product labeling from regulatory agencies does not include a Black Box Warning for Infadolan. This warning is reserved for medicines with serious safety concerns.

Q: Is Infadolan known to cause mood changes?

Changes in mood are not listed among the documented adverse reactions in the official product information for Infadolan.

Q: Can Infadolan affect blood test results?

Infadolan contains a Vitamin D analog that, in rare cases of excessive systemic absorption from long-term extensive use, carries a risk of Hypercalcemia. This is an elevation of blood calcium that may be detected via blood tests.

Q: Are there common reasons why Infadolan may be stopped by a doctor?

Official documents list absolute contraindications—conditions that prohibit its use—such as pre-existing Hypercalcaemia or Hypervitaminosis A or D. Local skin reactions that are severe or persistent may also be a reason for discontinuation.

Q: What are the main risks associated with stopping Infadolan suddenly?

Official regulatory documents do not list risks associated with suddenly stopping Infadolan. Since it is a topical medicine and is not associated with dependency, a known withdrawal or rebound syndrome is not documented.

Q: Do official documents mention anything about Infadolan and fertility?

The official product information does not explicitly discuss effects on fertility. However, it does strictly prohibit use during pregnancy or when planning a pregnancy due to the high-risk classification of the Vitamin A component.

Q: What is the research evidence for using Infadolan in [specific population, e.g., older adults]?

The summary of research evidence indicates that for some conditions where the drug has been studied, data for specific populations like older adults or children remain insufficient. This is often because follow-up durations were limited in many core trials.

Q: Is Infadolan safe to use if I have kidney issues?

Official labeling states that the medicine is contraindicated (not recommended for use) for individuals with severe renal impairment (severe kidney issues) due to the risk of active component accumulation in the body. For patients with less severe renal impairment, official guidelines state that use requires caution.

Q: Is it normal to feel [vague side effect, e.g., slightly dizzy] after starting Infadolan?

The most commonly documented side effects are local skin reactions such as irritation, burning, and itching at the application site. Systemic effects like dizziness are not listed as common and are only associated with rare, excessive systemic absorption.

Q: Is Infadolan a long-term treatment or a short-term one?

Clinical trials have primarily focused on short-term durations, typically ranging from 6 to 16 weeks. Official safety constraints advise that the risk of rare systemic toxicity is associated with long-term, extensive application over large body surface areas.

Q: Is it common to have to adjust the dose of Infadolan?

The official application protocol requires applying a thin layer or, for protective uses, applying it liberally with each change. The guidelines specify that no high-level systemic dose adjustments are required.

Q: What is the difference between the brand name Infadolan and its chemical name?

Infadolan is the brand name for the combination preparation. Its primary active ingredients—which are the components known by their chemical designations—are Dihydrotachysterol (a synthetic Vitamin D analog) and a derivative of Vitamin A (Retinol).

Q: Are there any specific precautions for sun exposure while taking Infadolan?

Official documents list Photosensitivity reaction as an uncommon or rare adverse reaction. Photosensitivity means an increased sensitivity or reaction of the skin when exposed to sunlight.

How should Infadolan be stored and disposed of?

The official labeling for Infadolan Ointment specifies strict storage and disposal requirements to protect the integrity of its active ingredients.

Storage Conditions

Infadolan must be stored in a cool, dry place at a temperature below 25°C (77°F). It is mandatory to protect the product from heat, dampness, and direct light. The container must be kept tightly closed and in its original packaging. The ointment must not be frozen.

Stability and Child Safety

Do not use Infadolan past the expiry date. All medication must be stored out of the sight and reach of children.

Disposal Instructions

Unused or expired Infadolan should not be disposed of in household trash or wastewater. The product must be returned to a pharmacist for professional disposal in accordance with local pharmaceutical waste regulations.

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

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