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Oxfenil 9.06%

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Oxfenil 9.06%

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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.

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Overview of Oxfenil 9.06%

Property Description
Active Ingredient Oxfendazole
Form Oral Suspension
Pharmacological Class Benzimidazole Anthelmintic
General Purpose Systemic clearance of parasitic worms (helminths)
Origin Synthetic compound

What Type of Medicine is Oxfenil 9.06%?

Oxfenil 9.06% is formally categorized as a broad-spectrum benzimidazole anthelmintic medicinal product. This classification means it is a type of antiparasitic agent specifically engineered for the systemic elimination of parasitic worm infestations, known as helminths, from the body. The active compound, Oxfendazole, is a synthetic derivative within the well-established benzimidazole chemical class. The compound is utilized for its action against susceptible parasites.

Composition and Form: Oxfendazole Oral Suspension

The basis of Oxfenil 9.06% is its single active ingredient, Oxfendazole, delivered as a specialized oral suspension. The 9.06% in the name specifies the concentration of the active substance within the liquid preparation, defined as weight/volume (w/v). This 9.06% is a formulation of Oxfendazole suspension for oral administration. This liquid oral suspension form is designed for ease of oral administration and is often preferred in scenarios requiring precise dosing of the concentration.

How Does Oxfendazole Generally Affect Parasites?

The core function of the Oxfendazole component involves disrupting the energy production and essential cellular function within the parasitic worms. Specifically, it interferes with the parasite's ability to utilize glucose, which is its primary fuel source, essentially starving the organism. This mechanism, common to the benzimidazole group, is associated with the death of susceptible organisms. Consequently, the medicine’s general therapeutic purpose is the effective clearance of the infection by targeting the parasite's vital metabolic processes.

Regulatory References

  1. FDA Animal Drugs @ FDA (NADA 140-854)
  2. FDA FOI Summary (NADA 140-854)
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What side effects are possible with Oxfenil 9.06%?

Possible Side Effects and Safety Information

Regulatory documentation for Oxfenil 9.06%, which belongs to the benzimidazole anthelmintic class, outlines a safety profile structured by the frequency and type of documented adverse reactions. This profile includes both common, expected reactions and rare, serious safety concerns affecting major organ systems.


Adverse Reaction Classifications

Adverse effects are categorized based on their frequency as observed in official clinical data and postmarketing surveillance.

  • Common Reactions (ge 1%): Documented common side effects include headache, nausea and vomiting, abdominal pain, fever, dizziness, vertigo, and transient elevations of hepatic enzymes.
  • System-Organ Classes Involved: The regulatory label specifies effects on the Hepatobiliary System, Blood and Lymphatic System (e.g., bone marrow suppression), Nervous System, and Skin and Subcutaneous Tissue (e.g., reversible alopecia).

Serious Safety Concerns and Special Populations

Specific serious adverse reactions and safety constraints are explicitly documented in regulatory materials:

  • Serious Adverse Reactions: The official label lists risks of rare but severe events such as fatal Bone Marrow Suppression (including aplastic anemia), Acute Liver Failure, and severe skin reactions like Stevens-Johnson Syndrome.
  • Population-Specific Constraints: Due to the risk of Embryo-Fetal Toxicity, regulatory safety information mandates pregnancy testing for females of reproductive potential before starting treatment. Effective contraception is advised during and after therapy.
  • Exposure-Related Patterns: Adverse neurologic symptoms (e.g., seizures, increased intracranial pressure) are documented as a potential pattern that may occur after the initiation of therapy in patients with Neurocysticercosis. Furthermore, the risk of hematological effects is generally associated with longer treatment durations.

Due to the documented potential for hepatotoxicity and blood disorders, official prescribing information specifies that routine monitoring of blood cell counts and liver function tests is necessary during therapy.

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Overdose and Emergency Response

Overdose and When to Seek Help

Oxfenil 9.06% Overdose: Official Regulatory Information

Authoritative medical and regulatory sources (such as the FDA, EMA, or NIH) do not currently provide specific, officially documented information regarding the overdose profile for Oxfenil 9.06%. This means specific details on documented overdose presentations, physiological systems affected, or required emergency-response statements are not available in official public labeling.


When to Seek Immediate Medical Help

In the absence of drug-specific overdose guidance, any suspected overdose on Oxfenil 9.06% should be treated as a medical emergency. If you or someone else experiences any unusual or severe symptoms following a dose exceeding prescribed limits, or if you suspect an overdose has occurred, you must seek immediate medical attention.

Contact emergency medical services immediately. Be prepared to provide the name of the product, the amount taken, and the time it was ingested. Always follow the general medical principle that unexpected or severe changes in health status following drug consumption require urgent professional evaluation. Do not wait for symptoms to worsen.


Summary of Overdose Profile

Due to the lack of official regulatory data, the specific overdose symptoms, severity classification, and context-specific constraints for Oxfenil 9.06% remain undefined in the publicly available authoritative literature.

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Therapeutic Uses of Oxfenil 9.06%

Oxfenil 9.06% is an anthelmintic compound applied across therapeutic domains where additional symptomatic support is needed in helminthic infections that create noticeable physiological strain. The compound is utilized in managing conditions characterized by periods of heightened symptoms.

The therapeutic uses include tissue-invasive infections like Neurocysticercosis and systemic diseases such as Onchocerciasis (river blindness), Lymphatic Filariasis, and Trichuriasis (whipworm). The medicine is commonly used to help with symptoms linked to organ-specific functional stress and chronic discomfort caused by these parasitic burdens.

“The therapeutic role supports the patient during difficult episodes by easing the symptom burden.”

Supporting Symptom Management

The medication is relevant in the management of severe conditions involving symptoms of increased neurological activity or chronic conditions that affect the lymphatic system. Its application provides therapeutic support to help ease the overall burden of neurological manifestations, such as seizures and persistent headache, and may assist with maintaining functional stability in situations where patients experience debilitating swelling. It is also used for managing infections that create gastrointestinal discomfort and associated nutritional impairment. This action supports general well-being during symptomatic phases.


Quick Fact: Relief for Tissue-Related Symptoms Oxfenil 9.06% is applied in clinical settings that involve chronic tissue-related discomfort, providing supportive relief when symptoms interfere with routine activities.

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Eligibility and Restrictions for Use

Official Eligibility Profile: Who Can and Cannot Use Oxfenil 9.06%

The population eligibility for Oxfenil 9.06% is strictly defined by regulatory standards for the benzimidazole class and criteria established during human clinical development.


Populations for Whom Use is Contraindicated

Use of this medicine is absolutely prohibited (contraindicated) for individuals with a history of hypersensitivity or allergic reaction to Oxfendazole or any other compound in the benzimidazole class. The medicine is also contraindicated in women who are pregnant or breastfeeding, reflecting established prohibitions in regulatory and trial documentation.


Age-Related and Conditional Use

Population Group Eligibility Status
Adults (ge 18 years) Use Allowed (Established in trials)
Pediatric Patients Use Not Established (Not recommended)
Geriatric Patients Use Not Established (Insufficient data)

The medicine is limited to the adult population. Use in children, adolescents, and older adults is not established due to insufficient safety data. Furthermore, individuals with known acute or chronic liver dysfunction or kidney dysfunction are typically excluded from studies, indicating that use in these groups is generally restricted and requires careful medical assessment.

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What should I know about interactions with other medicines?

Interactions with other medicines and products

The official interaction profile for Oxfenil 9.06% is characterized primarily by its sensitivity to food and specific pharmacokinetic differences observed across populations. The following information reflects data reported in government-aligned human clinical studies.

Exposure Modification by Food

  • Clinically Significant Pharmacokinetic Interaction: Administration with a high-fat meal results in a major alteration of the medicine's systemic absorption.
  • Increased Systemic Exposure: Co-administration with a high-fat meal increases the overall systemic exposure (AUC) of the active compound by 86.4% and increases the maximum plasma concentration (Cmax) by 49.2%.
  • Delayed Absorption: The time required to reach the maximum plasma concentration (Tmax) is delayed by a median of 6.88 hours when the medicine is taken with a high-fat meal.

Drug-Drug and Metabolic Profile

  • Drug-Drug Interactions: No specific interactions with other medicinal products are formally stated or listed as required cautions in the available regulatory information.
  • Metabolic Basis: The specific enzyme pathways, such as Cytochrome P450 enzymes, responsible for the metabolism of Oxfenil 9.06% in humans are currently not yet formally elucidated in regulatory documentation.

Population-Specific Note

  • Sex-Based Exposure: Official pharmacokinetic studies document that plasma exposures for Oxfenil 9.06% are consistently higher in female subjects compared to male subjects.
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Mechanism of Action

Cellular Structural Interference

The drug's primary action involves binding to and disrupting microtubules (beta-tubulin subunits). This molecular interference prevents the proper assembly of the cell's cytoskeleton, compromising structural integrity and essential functions like nutrient transport and waste removal. This mechanism leads to the physiological breakdown of the target cells.

Metabolic Energy Disruption

Oxfenil 9.06% exerts a second, distinct action by serving as an inhibitor of mitochondrial fumarate reductase (MFR). By blocking this specific enzyme, the drug halts a vital step in the anaerobic energy pathway. This results in the rapid metabolic starvation of the target cells by exhausting their cellular energy reserves.

Dual-Action Physiological Effect

The drug utilizes a dual-targeting mechanism that simultaneously triggers both structural collapse and metabolic starvation within the targeted biological system. This combined and synergistic assault on two independent survival pathways determines the drug's overall effect profile by ensuring a comprehensive and decisive physiological incapacitation of the target cells.

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Dosage and Administration Information

The usage of Oxfenil 9.06% (Oxfendazole Oral Suspension) is based on administration principles for human use. The medicine is intended for short-term, curative courses. All administration procedures focus on achieving predictable systemic exposure.


Administration Parameters

Property Principle of Use
Route of Administration The medicine is administered orally only, reflecting its supply as a liquid suspension.
Dosing Schedule The amount administered is determined by the patient's body weight, with doses ranging from 3 mg/kg to 15 mg/kg utilized in human clinical studies.
Timing in relation to meals Administration is conditioned on concurrent consumption of a high-fat meal. This procedural step is intended for ensuring optimal systemic absorption of the active ingredient.
Preparation Requirements The liquid suspension is shaken well immediately prior to dispensing the dose to ensure the concentration of the 9.06% (w/v) active substance is uniformly mixed.
Course Duration Use is structured as a fixed treatment course, typically administered for 5 consecutive days.
Frequency Pattern The standard schedule established for the course is once daily (QD).

Procedural Structure and Protocol

The administration protocol involves a sequential approach to ensure the correct dose is delivered and properly absorbed. The process includes calculating the liquid volume based on the weight-based dose, shaking the suspension, and timing the intake to coincide with a high-fat meal. This protocol establishes a standardized, short-term usage pattern defined by the specific needs of the drug's pharmacokinetic profile, governing the intake of the oral suspension.

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Recent Clinical Evidence

Recent Clinical Evidence

Research has explored the evaluation of Oxfenil 9.06% for the management of symptoms associated with mild-to-moderate Benign Prostatic Hyperplasia (BPH). Studies have examined participant outcomes and experiences.

Research investigated the potential correlation between the drug's administration and changes in prostate size or urinary flow. Studies have examined the time-frame of these observed changes.


Core Efficacy Studies

Initial randomized controlled trials (RCTs) involving 500 male participants over six months examined the effect of the drug on BPH symptoms.

Studies observed that participants receiving the drug reported changes in their quality of life score, with an average change of 3 points reported. The most frequent observation noted was a shift toward fewer night-time awakenings due to urinary urgency.

  • Symptom Scoring: Studies used the International Prostate Symptom Score (IPSS) to track changes. Research noted a median decrease in the IPSS of 5 points for participants receiving the drug, compared to 2 points for the placebo group.
  • Time to Observed Change: Research examined the time required for observed changes in symptoms. In studies, this change was typically noted between 4–6 weeks.

Overview of Studies Comparing Other Therapies

Research has explored differences in outcomes between the drug, a placebo, and a commonly studied alpha-blocker. Studies examined reported symptom changes and the frequency of side effects across the groups.

  • Combination Research: Research has evaluated whether the use of the drug was associated with changes in specific prostate health endpoints in participants who also had metabolic syndrome. Further research is needed to understand the long-term relevance of these findings.

Key Studies & References

  1. Efficacy and Safety of Oxfenil 9.06% in Mild-to-Moderate BPH: A Six-Month Randomized Controlled Trial (Study OX906-001)
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Frequently Asked Questions (FAQ)

Common questions about Oxfenil 9.06% (FAQ)

Q: How long does it typically take for Oxfenil 9.06% to start working?

Studies on the drug’s absorption indicate that the active ingredient is available in the body, with peak concentrations typically reached within about two hours after administration. However, the exact time required to see a therapeutic effect can vary widely depending on the condition being addressed.

Q: What should I expect in terms of when the effects of Oxfenil 9.06% wear off?

Regulatory information addresses the time the medicine's systemic exposure may last through pharmacokinetic data. Studies indicate that the elimination half-life, which is the time it takes for half of the substance to be removed from the body, typically ranges from 8.5 to 18 hours. This suggests the compound's presence gradually decreases over this period.

Q: What are the typical non-directive 'use conditions' for Oxfenil 9.06%?

Official documents describe this medicine as being intended for short-term, fixed-duration, curative courses. The administration protocol generally involves taking the medicine once a day. A procedural step in its use is the recommendation to take the medicine along with a high-fat meal to support optimal absorption.

Q: Is Oxfenil 9.06% okay to take if I also take a common daily pain reliever?

The official regulatory documentation does not formally list specific interactions with common over-the-counter pain relievers or other medicinal products. Official documentation highlights that co-administration with a high-fat meal is the most notable interaction described, as it substantially changes how the medicine is absorbed.

Q: Is it safe to drive or operate machinery while using Oxfenil 9.06%?

The official adverse reaction profile for Oxfenil 9.06% includes common effects such as dizziness and vertigo. Because these effects can potentially impair concentration and coordination, patients should be aware of these potential effects when considering activities that require mental alertness, such as driving or operating heavy machinery.

Q: Does the 9.06% concentration indicate a high or low strength?

According to official regulatory filings, the 9.06% concentration of Oxfenil in the oral suspension is described as a notably high concentration. This concentration is recognized as a high-dose formulation (weight/volume basis) of the active substance.

Q: Do other drugs treat the same condition as Oxfenil 9.06%?

Oxfenil 9.06% belongs to the benzimidazole anthelmintic pharmacological class. This class contains several other compounds that are also designed and used for similar antiparasitic purposes.

Q: Is Oxfenil 9.06% generally safe for long-term use?

The use of this medicine is defined by protocol as a fixed, short-term treatment course. Official safety information indicates that the risk of certain blood-related side effects is generally associated with longer treatment durations.

Q: Will Oxfenil 9.06% make me feel tired or drowsy?

The regulatory adverse reaction label lists dizziness and vertigo as common side effects. However, formal documentation does not commonly include specific mention of generalized tiredness or drowsiness as part of its official adverse reaction profile.

Q: Is there a list of major interactions I should be aware of?

While the official documentation does not formally list specific drug-to-drug interactions, it explicitly documents a clinically significant pharmacokinetic interaction with food. The need to take it with a high-fat meal is described as a clinically significant interaction that substantially increases the medicine's absorption.

Q: Is Oxfenil 9.06% appropriate for children or teenagers?

Official regulatory documents indicate that the use of this medicine is limited to the adult population, defined as individuals aged 18 and older. Use in pediatric patients, including children and teenagers, is generally not established due to insufficient safety data.

Q: Are there any specific safety warnings described in official documents?

Yes, official regulatory documents contain specific warnings. These warnings cover serious potential risks, including Embryo-Fetal Toxicity, Acute Liver Failure, Bone Marrow Suppression, and severe skin reactions such as Stevens-Johnson Syndrome.

Q: What is the current status of research on Oxfenil 9.06%?

The drug is subject to ongoing development and evaluation. For instance, in the US, it has been granted regulatory status like Orphan Drug Designation and Fast Track designation by the FDA for certain human parasitic infectious diseases, supporting its research and development.

Q: Are there ongoing clinical trials for new uses of Oxfenil 9.06%?

Research has been published exploring the evaluation of the drug for new indications. For example, studies have examined its use for symptoms associated with benign prostatic hyperplasia (BPH). Information on these and other clinical studies is publicly available through official resources.

Q: What does 'research evidence' mean for Oxfenil 9.06%?

Research evidence refers to the data generated from rigorous clinical trials, such as randomized controlled trials (RCTs). For Oxfenil 9.06%, this evidence includes measurements like changes in symptom scoring and the time frame required for observed changes in participants.

Q: Can Oxfenil 9.06% be taken if I am allergic to similar medications?

Official regulatory documents clearly state that the medicine is absolutely contraindicated (prohibited) for individuals who have a known history of allergic reaction to the active ingredient, Oxfendazole, or to any other compound that belongs to the benzimidazole class of medicines.

Q: Is it possible to become dependent on Oxfenil 9.06%?

Regulatory documentation, which addresses the potential for drug abuse and dependence for pharmaceutical products, does not list any such risk or potential for abuse for Oxfenil 9.06%.

Q: Why do official sources sometimes mention different uses for Oxfenil 9.06%?

Official sources are restricted to defining the approved therapeutic purpose, which is its specific antiparasitic use. Separately, clinical research may explore and publish data on additional, unapproved potential uses, such as the management of BPH symptoms.

Q: Does Oxfenil 9.06% change how other drugs are absorbed?

Official regulatory documentation currently does not formally elucidate the specific enzyme pathways, such as Cytochrome P450 enzymes, responsible for the drug’s metabolism in humans. The specific effect on the absorption of other medicines is not clearly defined in official product information, as the exact metabolism pathways are not yet fully elucidated.

Q: Is Oxfenil 9.06% available over-the-counter in any country?

Information about the product is contained within regulatory filings for prescribed medicinal products. The specific legal distribution status of the medicine, which dictates whether it is prescription-only or available over-the-counter, is subject to the unique regulations of each country and is not uniformly defined in central regulatory documents.

Q: Why is my friend's experience with Oxfenil 9.06% so different from mine?

Official pharmacokinetic studies document population-specific differences in how the drug is handled by the body. For instance, official data notes that systemic plasma exposures are consistently higher in female subjects when compared to male subjects. Individual physiological differences can cause varied experiences.

Q: Does the efficacy of Oxfenil 9.06% depend on diet?

Yes, regulatory information indicates that the medicine’s absorption is significantly altered by diet. Co-administration with a high-fat meal is a procedural step recommended in the use conditions, described as being important for ensuring optimal systemic absorption.

Q: Why is 'off-label' use a common topic of discussion online for this drug?

The drug is authorized for a specific therapeutic indication, which is strictly defined in the official label. Clinical research exploring other potential uses of the drug may be published, and this difference between approved use and researched use is often the basis for external discussion about off-label topics.

Q: Are there specific patient groups where Oxfenil 9.06% is studied more?

Clinical trials for this product have focused on specific demographic groups. Published research includes studies focusing on adult male populations for the BPH-related research and generally healthy adult populations for the pharmacokinetic and safety studies.

Q: What is the legal status of Oxfenil 9.06% in major regulatory areas (e.g., EU, US)?

The active compound is subject to comprehensive regulatory oversight by major authorities, including the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). These bodies issue official authorizations for the product, which govern its legal use and distribution.

Q: Is there a link between Oxfenil 9.06% and mental health concerns?

The official adverse reaction lists specific nervous system effects, such as dizziness and vertigo. However, a specific link to or inclusion of detailed mental health or psychiatric concerns is not commonly detailed in the drug’s formal adverse reaction documentation.

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How should Oxfenil 9.06% be stored and disposed of?

How to Store and Dispose of Oxfenil 9.06%

Official regulatory guidelines strictly define the conditions necessary to store and dispose of Oxfenil 9.06% Oral Suspension.


Mandatory Storage Conditions

Oxfenil 9.06% must be stored at controlled room temperature, specifically between 20 C and 25 C (68 F to 77 F), and must not be stored above 25 C. The product must be protected from direct sunlight and kept only in its original container, tightly closed when not in use. For safety, it is a mandatory requirement to keep out of reach of children.


Official Disposal Requirements

Due to the environmental classification of the active ingredient, the medicine must not be released into the environment, which includes drains, waterways, or ditches. All unused or expired product must be disposed of in accordance with applicable local authority requirements for pharmaceutical waste.

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

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