Oxicone

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Oxicone

Medically reviewed

Laura Arias

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 Oxicone

Quick Facts

Property Description
Active Ingredient Oxiconazole nitrate
Form Topical Cream, Topical Lotion
Pharmacological Class Azole Antifungal / Imidazole Derivative
General Purpose To eliminate or reduce superficial fungal infections
Origin Synthetic Compound

What Type of Medicine is Oxicone?

Oxicone, a preparation containing the active substance Oxiconazole nitrate, is classified as a synthetic azole antifungal agent. This compound is chemically defined as an imidazole derivative, placing it within a well-established family of drugs specifically designed to target fungal organisms. It is manufactured exclusively as a topical dermatologic preparation, which means the medicine is applied directly to the skin's surface. Unlike systemic medications that travel through the bloodstream, Oxicone is a single-ingredient product focusing its activity solely on the area of application. This formulation is recognized in clinical practice for its high substantivity within the stratum corneum, ensuring the active ingredient remains localized where needed. Azole antifungals are consistently effective against a wide range of dermatophytes and yeasts. This indicates that the preparation provides a robust mechanism for controlling common skin fungi.


Composition and General Use

The core active ingredient in Oxicone is Oxiconazole nitrate, which provides the preparation's therapeutic functionality. This ingredient is suspended in an emulsified dermatologic vehicle, creating either a cream or a lotion, which represents the available dosage forms. The choice between the cream and lotion forms allows for flexibility based on the site of infection; for instance, the lotion may be preferred for larger, hair-covered, or weeping skin areas due to its lower viscosity. The preparation is intended for topical route of administration only. By delivering the Oxiconazole nitrate directly to the affected skin, the drug's general purpose is to eliminate or significantly reduce the presence of susceptible fungal microorganisms, thereby resolving the infection and providing relief from associated skin discomfort. Oxiconazole's chemical structure allows it to interfere with the fungal cell membrane's structure through its effect on fungal sterols.

Regulatory References

  1. azole antifungal
  2. dermatophytes and yeasts

What side effects are possible with Oxicone?

Possible Side Effects and Safety Information

The safety profile of Oxicone is established by its risk of opioid-related adverse events, which range from very common, expected reactions to severe, life-threatening events highlighted by regulatory agencies.

Documented Adverse Reactions

Side effects are categorized by the body system affected and their reported frequency in clinical studies:

Frequency System-Organ Class Involved Examples of Adverse Reactions
Very Common (ge 1/10) Gastrointestinal, Nervous System Constipation, Nausea, Somnolence (Drowsiness), Dizziness
Common (ge 1/100 to < 1/10) Skin, Gastrointestinal Vomiting, Pruritus (Itching), Headache, Dry Mouth, Sweating
Not Known Psychiatric, Systemic Opioid Withdrawal Syndrome, Neonatal Opioid Withdrawal Syndrome (NOWS)

Serious Safety Risks

The most serious documented adverse reactions include life-threatening respiratory depression, which poses the highest risk upon initiation or dose increase. The potential for Addiction, Abuse, and Misuse leading to overdose is also a major risk factor highlighted in official warnings. Other serious effects include severe hypotension and adrenal insufficiency.

Safety Considerations for Specific Populations

Regulatory documents emphasize specific cautions for certain patient groups:

  • Pregnancy: Use during pregnancy may result in fetal harm and NOWS in the newborn.
  • Elderly and Impaired Function: Patients with hepatic or renal impairment or elderly patients may experience higher plasma concentrations, necessitating conservative initiation.

Regulatory Restrictions

Oxicone is contraindicated in patients with significant respiratory depression, acute or severe bronchial asthma, or known or suspected gastrointestinal obstruction. Concomitant use with CNS depressants (e.g., benzodiazepines) increases the risk of profound sedation and death, as noted in official drug safety warnings.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory documents for Oxicone (oxiconazole nitrate) define the product's overdose profile based on its use as a topical medicine with low systemic absorption. This information is derived from official governmental prescribing standards, such as those published by the FDA.

Element Official Regulatory Statement
Documented Manifestations No specific clinical signs or symptoms of overdose have been formally reported in humans using the topical cream or lotion formulation, according to official regulatory data.
Exposure-Related Factors The primary overdose risk is associated with inappropriate administration. The product is strictly indicated for topical use only and is explicitly not for oral or other non-dermal administration.
Treatment & Antidote Treatment for an overdose is generally described as symptomatic and supportive, as no specific antidote is known or specified in the official labeling.

Emergency Action Mandates

The primary regulatory mandate concerning overdose relates to the requirement to seek professional medical attention for any use that deviates from the approved route of administration.

  • Urgent Medical Help: Immediate medical attention is required for assessment following any non-approved use, such as accidental ingestion, due to the product being strictly labeled as not for oral use.
  • Regulatory Basis: The official overdose profile is defined by the absence of documented human clinical data, which mandates a focus on supportive measures and seeking help if the product is administered via a non-approved route.

This structure maintains strict alignment with the official regulatory framework, providing only the facts explicitly stated in governmental labeling regarding overdose.

Therapeutic Uses of Oxicone

Oxicone is an imidazole antifungal used in situations involving certain distressing symptoms associated with superficial fungal infections of the skin. It is primarily indicated for addressing dermatomycoses caused by dermatophytes and yeasts. It is considered relevant in managing the fungal pathogen for general adult and pediatric groups, when appropriate.


Treating Common Superficial Fungal Conditions

The treatment is commonly used across conditions presenting with systemic or localized discomfort, specifically Tinea infections, including athlete's foot (Tinea pedis), jock itch (Tinea cruris), ringworm of the body (Tinea corporis), and the skin discoloration known as Pityriasis Versicolor. Applied in clinical settings that involve acute or unstable symptom patterns, it is relevant for easing the overall symptom burden.

Relief from Fungal Infection Symptoms

The medication is applied in addressing symptoms related to inflammatory or irritative states associated with fungal activity. It helps address symptom clusters that may become intense or disruptive, such as persistent itching (pruritus), may assist with easing visible signs of inflammation like redness (erythema), and is commonly used for managing symptoms that interfere with daily comfort, such as scaling or flaking of the skin. This contributes to easing the overall symptom load and helps improve day-to-day comfort during symptomatic periods.


Quick Fact: Symptom Management
Symptom Cluster Itching, redness, scaling, burning
Use Context Conditions involving inflammatory or irritative processes in moisture-prone regions (feet, groin)
Primary Benefit Contributes to improved comfort during symptomatic periods

Regulatory References

  1. DailyMed Label for Oxiconazole

Eligibility and Restrictions for Use

Who Can and Cannot Use Oxicone?

Eligibility for Oxicone (Oxiconazole nitrate) is strictly defined by regulatory authorities based on age, allergies, and physiological status. This medication is a topical antifungal, limiting its systemic effects and organ-related restrictions, but eligibility constraints still apply.


Official Eligibility Constraints

Category Regulatory Status
Populations Allowed Adults and adolescents 12 years of age and older.
Contraindication Individuals with a known hypersensitivity to oxiconazole nitrate or any component of the cream or lotion formulation.
Pediatric Use Limitation Safety and effectiveness are not established for children below the age of 12 years.
Pregnant Individuals Use is conditional (Pregnancy Category B); should be administered only if clearly needed after a risk-benefit assessment.
Lactating Individuals Caution should be exercised, as the drug is known to be excreted in human milk.

Older adults are generally permitted to use this medicine without special dose adjustments, as clinical data show comparable safety and effectiveness to younger adults. No specific eligibility restrictions are imposed for conditions such as severe hepatic or renal impairment.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official regulatory profile for Oxicone (oxiconazole nitrate topical) is characterized by the absence of formally documented interactions with other medicinal products, food, or supplements.

This absence is attributed to the medicine's route of administration. Oxicone is a topical dermatologic preparation with minimal systemic absorption; less than 0.3% of the applied dose is typically recovered in the urine, limiting the active ingredient's presence in the bloodstream to cause systemic interactions.

Official Interaction Status

Property Official Regulatory Status (Based on Labeling)
Documented Drug-Drug Interactions None documented.
Interactions with Food, Alcohol, or Supplements None documented.
Systematic Evaluation Status Potential drug interactions have not been systematically evaluated, according to the U.S. FDA prescribing information.
Contraindicated Combinations No combinations are listed as contraindicated due to interaction risk.
Timing Separation Rules No mandatory separation rules for co-administered products are listed in official documents.

European regulatory documents confirm this structure, stating that there are no known interactions with other medicinal products. Consequently, official labeling does not include specific warnings, mandatory timing requirements, or prohibited co-administrations related to pharmacokinetic or pharmacodynamic interactions.

Mechanism of Action

How Oxicone Works

The action of Oxiconazole nitrate is based on targeted interference with the fundamental biological machinery of susceptible fungal organisms. Its mechanism is strictly localized to the fungal organism, causing functional and structural disruption through two primary, cascading mechanistic domains.


Interference with Fungal Sterol Biosynthesis

Oxiconazole nitrate acts as a non-competitive inhibitor of lanosterol 14-alpha demethylase (L D M 1 4 A), a cytochrome P450 enzyme essential to the fungal organism. By binding to and blocking this enzyme, the drug prevents the conversion of lanosterol into ergosterol, the primary sterol necessary for building the fungal cell membrane.


Disruption of Cell Membrane Integrity and Viability

The subsequent severe ergosterol depletion, combined with the toxic buildup of the un-processed intermediate lanosterol, leads to the fungal cell membrane becoming leaky, structurally unsound, and abnormally permeable. This loss of integrity destroys the cell's ability to maintain its internal environment, resulting in uncontrolled leakage of vital contents and, ultimately, the fungal cell lysis (breakdown) or the cessation of cellular proliferation.

Dosage and Administration Information

Administration Guidelines: Oxicone (Oxycodone)

The proper administration of Oxicone, an oral opioid analgesic, is governed by clinical standards to ensure use as intended. Dosing is individualized based on the patient's condition, prior analgesic experience, and risk factors for addiction.

Formulation Route & Frequency Special Instructions
Extended-Release Tablets Oral, every 12 hours Swallow tablets intact with enough water to ensure complete swallowing. Do not cut, break, chew, crush, or dissolve to avoid rapid release of the medication.
Immediate-Release Forms Oral, every 4 to 6 hours as needed For solutions/liquids, accurately measure the dose using a provided calibrated device; household spoons must not be used.

Official Procedural Rules

  1. Initiation: For opioid-non-tolerant adults, the initial dose is typically 10 mg orally every 12 hours for extended-release tablets, or 5 to 15 mg every 4 to 6 hours as needed for immediate-release forms.
  2. Dose Limits: Doses of 60 mg and 80 mg extended-release tablets, a single dose greater than 40 mg, or a total daily dose greater than 80 mg are only for patients in whom opioid tolerance has been established.
  3. Specific Populations: In debilitated geriatric patients or patients with hepatic impairment, initiate dosing at one third to one half the recommended starting dosage and titrate carefully. Pediatric use (age 11+) is limited to those already tolerating specific minimum daily opioid doses for at least five consecutive days.
  4. Discontinuation: This medication is not abruptly discontinued in a physically dependent patient due to the risk of withdrawal symptoms. The dose is titrated down over time.

Recent Clinical Evidence

Research Evidence: Overview of Studies for Oxicone

Evidence for Use in Tinea Pedis (Athlete's Foot)

Research for Tinea pedis, commonly known as athlete's foot, primarily involves Randomized, Double-Blind, Vehicle-Controlled Clinical Trials. These are controlled study designs where patients are randomly assigned to receive either the active preparation or an inactive cream or lotion base. These studies were used in research exploring how symptoms change over time.

Studies monitored two main outcomes, classified as Mycological Outcome and Clinical Outcome. Mycological Outcome was measured by tracking whether the fungus was detectable through laboratory tests. Clinical Outcome involved the investigator assessing the measured change in physical signs like scaling, redness, itching, and cracking over a defined time interval. Findings describe patterns observed in the studies related to measured outcomes defined as Mycological Outcome and the assessed evolution of visible signs. However, research for this indication has primarily focused on the interdigital subtype of Tinea pedis.


Evidence for Use in Tinea Cruris (Jock Itch) and Tinea Corporis (Ringworm)

The evidence base for Tinea cruris (jock itch) and Tinea corporis (ringworm of the body) includes both Controlled Clinical Trials and Non-Comparative Multicenter Studies. Research has explored the relationship to the fungal organisms responsible for these common superficial infections.

Studies monitored outcomes related to Microbiologic Outcome and Clinical Outcome. Findings describe patterns observed in the studies related to measured outcomes defined as Microbiologic Outcome after the typical two-week treatment course. Comparative evidence is lacking, as some older evidence includes non-comparative studies, which limits the ability to draw conclusions relative to other treatments.


What is Still Uncertain About Oxicone

Several areas of research remain uncertain. For all indications, long-term effects are not well characterized. The existing studies provide limited insight into extended observation periods to track the return of the infection (recurrence) after the study periods were over. Furthermore, the available data are mainly derived from adults and adolescents, and evidence for use in older adults or in patients with complex co-existing health conditions remains insufficient. While findings describe group patterns, they do not provide personal outcomes or predictions.

Key Studies & References

  1. Oxiconazole nitrate: pharmacology, efficacy, and safety of a new imidazole antifungal agent (Review of Clinical Trials)
  2. Label: OXICONAZOLE NITRATE cream (FDA/DailyMed)

Frequently Asked Questions (FAQ)

Common questions about Oxicone (FAQ)

Q: What is Oxicone and how does it work?

Oxicone is an opioid pain medication used to manage moderate to severe pain. It belongs to a class of drugs known as opioid agonists. It works by binding to opioid receptors in the central nervous system (brain and spinal cord). This action blocks pain signals from reaching the brain, changing how the body feels and responds to pain.

Q: How should I take Oxicone?

Always take Oxicone exactly as your doctor prescribes. The dose and schedule will depend on your pain level and medical condition. Oxicone is usually taken by mouth as a tablet or capsule. Do not crush, chew, or break extended-release tablets, as this can lead to a rapid release of the medication and a potentially dangerous dose. If you are taking the liquid form, measure the dose carefully using the provided measuring device. Never stop taking this medicine abruptly without consulting your healthcare provider, as this can cause withdrawal symptoms.

Q: What are the common side effects of Oxicone?

Common side effects of Oxicone may include:

  • Constipation (often the most frequent)
  • Nausea and vomiting
  • Drowsiness or sedation
  • Dizziness
  • Headache

Contact your doctor if these side effects are persistent or severe. If you experience severe difficulty breathing or extreme drowsiness, seek emergency medical attention immediately.

Q: Can Oxicone be taken with other medications?

Oxicone can interact with many other medications. It is crucial to tell your doctor about all other prescription and non-prescription drugs, herbal supplements, and vitamins you are currently taking.

Specific types of drugs that can have serious interactions include:

  • Benzodiazepines or other central nervous system depressants (e.g., sedatives, tranquilizers)
  • MAO inhibitors (used to treat depression)
  • Other opioid pain medications
  • Medications that affect serotonin levels (risk of serotonin syndrome)

Combining Oxicone with alcohol or other depressants can dangerously increase the risk of severe respiratory depression and profound sedation.

Q: Is Oxicone addictive?

Yes, Oxicone is an opioid and carries a significant risk of physical dependence and addiction, even when used as prescribed. Physical dependence means your body adapts to the drug and you may experience withdrawal symptoms if you stop taking it suddenly. Addiction is a chronic disease characterized by compulsive drug seeking and use despite harmful consequences. Your doctor will monitor you closely to manage pain effectively while minimizing these risks.

Q: What should I do if I miss a dose of Oxicone?

If you are taking the immediate-release form and miss a dose, take it as soon as you remember unless it is almost time for your next scheduled dose. In that case, skip the missed dose and take the next dose at the regular time. Do not take two doses at once to make up for a missed dose. If you are taking the extended-release form, follow the specific instructions provided by your doctor or pharmacist, as the timing of these medications is very important for maintaining pain control and avoiding serious side effects.

How should Oxicone be stored and disposed of?

Storage and Disposal of Oxicone

The topical formulations of Oxicone (Oxiconazole nitrate) must be stored at Controlled Room Temperature, which is officially defined as between 15 C and 30 C (59 F and 86 F). It is essential to keep the medicine from freezing and to store the container tightly closed and away from excess moisture.

Protection and Handling

All Oxicone products must be kept out of the sight and reach of children and pets to prevent accidental exposure. For disposal, unused or expired medication should be discarded immediately. The official preferred method is through a drug take-back program. If a program is unavailable, the product should be mixed with an undesirable substance, placed in a sealed bag, and discarded in the household trash.

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

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