Rofluzol

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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 Rofluzol

Quick Facts

Property Description
Active ingredient Fluconazole
Form Tablets, capsules, suspension, solution for infusion
Pharmacological class Antifungal drug (Triazole derivative)
Common use Systemic and mucosal fungal infections
Origin Synthetic

What Type of Medicine is Rofluzol (Fluconazole)?

Rofluzol is a synthetic single-ingredient medication containing the active substance Fluconazole, which is its International Nonproprietary Name (INN). It is classified as an antifungal drug, specifically belonging to the triazole derivative subclass. This classification defines its role in combating infections caused by fungi. Fluconazole's high bioavailability and established efficacy have made it a standard treatment for mucosal candidiasis and systemic mycoses. This medicine is used for managing various fungal infections affecting different body systems and is clinically recognized for its efficacy against infections originating in the mouth, esophagus, and vaginal areas.

Composition, Origin, and Available Forms

The composition of Rofluzol centers entirely on Fluconazole, formulated as a single-ingredient product. This medication is of synthetic origin, meaning it is manufactured through controlled chemical processes rather than being isolated from natural sources. Rofluzol is available in various pharmaceutical preparations to ensure flexibility in delivery, specifically including solid forms such as tablets and capsules for oral intake, an oral suspension for liquid administration, and a sterile solution for infusion designed for intravenous use. The foundational ingredients of these forms consist of the active Fluconazole combined with necessary solid excipients or an aqueous vehicle, dependent on the preparation, confirming its nature as a versatile systemic treatment option, unlike many antifungals restricted to topical application.

The General Purpose of this Azole Antifungal Agent

The general therapeutic purpose of Rofluzol is to achieve systemic control over the expansion of fungal pathogens throughout the body. As an azole antifungal agent, its general function is to exert a fungistatic effect, which means it limits the fungi's ability to grow and multiply by disrupting key cellular processes. By impeding the structural integrity of the fungal organism, this medication provides the necessary internal intervention to manage fungal infections and control their progression within the host system. This indicates the drug is a recognized option for managing widespread fungal growth, particularly when a fungal pathogen has entered the bloodstream, a typical neutral use scenario requiring systemic coverage.

Regulatory References

  1. National Institutes of Health (NIH) Review

What side effects are possible with Rofluzol?

Possible Side Effects and Safety Information

Rofluzol may cause a range of adverse effects affecting various body systems. Understanding the reported side effects and safety precautions is essential for its use, as documented in authoritative regulatory sources.

Classification Common Adverse Reactions (Affecting 1 in 10 or more)
Systemic Asthenia (lack of strength), Fatigue
Gastrointestinal Nausea, Abdominal pain
Nervous System Headache
Hepatic Elevated Liver Enzymes (ALT/AST)

Common reactions (affecting between 1 in 10 and 1 in 100 people) include dizziness, diarrhea, vomiting, somnolence (drowsiness), and rash. Changes in the way food tastes have also been noted.

Serious and Clinically Significant Adverse Reactions

The most serious safety concerns identified in official documentation primarily relate to Liver Toxicity and Hypersensitivity Reactions.

  • Liver Function Abnormalities: Significant elevations of liver enzymes, clinical hepatitis, and, rarely, severe hepatic injury (including fatalities) have been reported. Liver function tests must be monitored regularly before and during treatment.
  • Serious Skin Reactions: Severe cutaneous adverse reactions, including exfoliative dermatitis, Stevens-Johnson syndrome, and Toxic Epidermal Necrolysis (TEN), have occurred, requiring immediate discontinuation of the medication.
  • Cardiovascular Effects: In rare cases, changes in the heart's electrical activity, specifically QT prolongation and Torsade de Pointes, have been reported, which may lead to an irregular heart rhythm. Caution is advised for individuals with pre-existing heart conditions or those taking other medications that affect heart rhythm.

Population and Safety Notes

Safety is often a dose-related concern, and lower initial dosing is typically recommended for individuals with existing liver impairment. Pregnancy safety is a consideration, as use during pregnancy may carry a risk of fetal harm. Due to the potential for dizziness and somnolence, patients are advised to exercise caution when driving or operating machinery. Hypersensitivity to the drug is a formal contraindication.

Overdose and Emergency Response

The official regulatory documentation for Rofluzol (Fluconazole) provides specific clinical manifestations associated with overdose, which necessitate immediate medical intervention. Documented overdose presentations primarily involve the central nervous system (CNS). Case reports describe severe mental disturbances, specifically hallucinations and pronounced paranoid behavior. These neuropsychiatric effects are classified as severe and signal the requirement for urgent attention.

In any known or suspected overdose scenario, regulatory guidance explicitly mandates that individuals seek immediate medical attention. If a severe physiological outcome occurs, such as collapse, seizure, trouble breathing, or the patient cannot be awakened, official protocols advise contacting emergency services immediately.

The management approach is strictly symptomatic and supportive, as regulatory labeling confirms that no specific antidote is known. The procedural measures recognized for use in the management of overdose include gastric lavage if clinically indicated to remove unabsorbed material. Furthermore, hemodialysis is noted in the regulatory documents as a highly effective method for accelerated elimination; the procedure is capable of reducing the plasma concentration of Fluconazole by approximately 50% over a standard three-hour session. This intervention may be utilized in cases of severe exposure to aid in the clearance of the substance from the plasma.

Therapeutic Uses of Rofluzol

Quick Facts: Rofluzol Therapeutic Uses

  • Chronic Obstructive Pulmonary Disease (COPD): Used in the therapeutic approach to reduce the risk of disease exacerbations in individuals with severe COPD associated with chronic bronchitis.
  • Plaque Psoriasis: A treatment option for the management of plaque psoriasis.
  • Seborrheic Dermatitis: May be used for the management of seborrheic dermatitis.

What Rofluzol Treats: Main Uses and Benefits

Rofluzol (Roflumilast) is a medication available for the management of specific conditions in adults. The oral form is an option available to reduce the risk of exacerbations associated with severe Chronic Obstructive Pulmonary Disease (COPD), specifically when linked to chronic bronchitis and a history of previous events. This therapeutic application is part of a maintenance approach and is not for the immediate relief of acute symptoms.

In topical formulations, Rofluzol is an approved treatment option for the management of two common inflammatory skin conditions. It may be used to address the symptoms of plaque psoriasis and is also indicated in the therapeutic approach for seborrheic dermatitis.

Eligibility and Restrictions for Use

Rofluzol (fluconazole) is an antifungal medication primarily used to treat and prevent various fungal and yeast infections, including systemic candidiasis, cryptococcal meningitis, and vaginal candidiasis. Its use is determined by the specific infection, the patient's immune status, and age.

Most adults and children are candidates for Rofluzol, with dosages adjusted based on weight for pediatric patients and often on renal function for others. Certain underlying conditions and concomitant medications, however, can make Rofluzol unsafe or require careful monitoring.

Contraindications (Should not use) Precautions (Use with caution)
Known hypersensitivity or allergy to Rofluzol or other azole antifungals. Liver disease or pre-existing liver problems.
Taking certain medications that prolong the QT interval (risk of serious irregular heartbeat). Kidney disease, which may require a dose adjustment.
Use of high, chronic doses during the first trimester of pregnancy (due to risk of birth defects). Electrolyte abnormalities, such as low potassium or magnesium levels.

It is essential for patients to discuss their full medical history and all current medications with a healthcare provider before starting Rofluzol to ensure appropriate and safe use.

What should I know about interactions with other medicines?

Rofluzol is known to interact with a wide variety of medicines primarily through its action as a potent inhibitor of certain cytochrome P450 (CYP) enzymes, specifically CYP2C9, CYP2C19, and CYP3A4. This enzyme inhibition can reduce the rate at which other medications are broken down by the body, leading to increased plasma concentrations and a higher risk of adverse effects from the co-administered drug.

Major Contraindicated Combinations

Specific medicines are strictly contraindicated due to the high risk of serious or life-threatening reactions. These include: Astemizole, Cisapride, Erythromycin, Pimozide, and Terfenadine. Co-administration with these drugs is prohibited due to the potential for QT prolongation and the subsequent risk of severe cardiac arrhythmias like Torsades de Pointes.

Clinically Significant Interactions

Close monitoring and potential dosage adjustment are required when Rofluzol is used with other substance categories:

  • Anticoagulants (e.g., Warfarin): Increased risk of bleeding due to elevated anticoagulant levels. Prothrombin time (INR) must be strictly monitored.
  • Statins (e.g., Atorvastatin, Simvastatin): Inhibition of their metabolism can significantly raise the risk of myopathy and rhabdomyolysis.
  • Antiepileptic Drugs (e.g., Phenytoin, Carbamazepine): Rofluzol can increase the concentrations of these narrow therapeutic index drugs, necessitating therapeutic drug monitoring.
  • Immunosuppressants (e.g., Cyclosporine, Tacrolimus): Increased blood levels can lead to nephrotoxicity and other serious adverse events.

Patients should inform their healthcare provider of all prescription and non-prescription products, including herbal and dietary supplements, prior to starting Rofluzol therapy.

Mechanism of Action

How Rofluzol Works

Targeting Essential Fungal Enzymes

Rofluzol acts through a high-affinity non-competitive inhibition of the fungal enzyme Lanosterol 14-alpha-demethylase (CYP51). This enzyme is a cytochrome P450 protein essential for sterol biosynthesis. The drug's molecule binds to the heme iron of the enzyme, forming a stable blockade that precisely halts a key molecular step: the demethylation of lanosterol.

Compromising Fungal Cell Integrity

The resulting molecular cascade leads to the accumulation of toxic, methylated sterol precursors and the significant depletion of essential ergosterol in the cell membrane. This deficiency fundamentally compromises the structural and functional integrity of the fungal cell barrier, resulting in increased permeability.

Suppressing Growth and Replication

The structural damage and instability prevent the foreign organism from multiplying or maintaining cellular functions necessary for proliferation. The loss of cellular integrity impairs the organism's ability to multiply, resulting in the arrested growth of the organism, which renders it vulnerable to the body's natural defense mechanisms.

Dosage and Administration Information

Official Administration Guidelines

Administration of the oral forms of Riluzole is governed by a fixed schedule and specific procedural steps to ensure proper delivery of the medication. The recommended dosage is 50 mg twice daily, with doses scheduled every 12 hours.

Administration Scope Detail
Route of Administration Oral
Dosing Schedule 50 mg twice daily, every 12 hours
Timing in Relation to Meals Must be taken at least 1 hour before or 2 hours after a meal

Procedural Requirements

For Oral Suspension (e.g., Tiglutik):

  1. Before use, gently shake the bottle for at least 30 seconds until the suspension is thoroughly mixed.
  2. The measured dose (10 mL) must be administered by mouth or via percutaneous endoscopic gastrostomy (PEG) tubes.

For Oral Film (e.g., Exservan):

  1. The oral film is applied directly on top of the tongue where it adheres and dissolves.
  2. The film must not be cut or split.
  3. The patient should refrain from chewing, spitting, or talking while the film dissolves; saliva should be swallowed normally. Do not take with liquids.

Missed Dose and Other Conditions

If a dose is missed, the next scheduled dose is taken at the usual time; a double dose is not taken to make up for the missed one. Patients are subject to specific safety monitoring requirements, including measuring serum aminotransferases before and periodically during treatment.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Rofluzol


Evidence for use in Chronic Obstructive Pulmonary Disease (COPD)

Research examining the use of oral Rofluzol was studied in individuals who have been diagnosed with a specific type of COPD known as chronic bronchitis and who have a history of frequent symptom flare-ups or acute disruptive episodes. The primary evidence for this research area was developed through several large-scale studies called Randomized, Double-blind, Placebo-Controlled Trials (RCTs). Research explored whether Rofluzol administration was related to the rate of reported episodes of heightened symptom activity, with findings indicating patterns in the active group. Studies monitored FEV1 measurements, with data showing patterns related to this physiological strain or stress between the groups. Research is limited regarding the episodes where symptoms become more noticeable (acute exacerbations).


Evidence for use in Plaque Psoriasis

The evidence for the topical formulation of Rofluzol was evaluated through dedicated, short-term (8-week) Phase 3 Randomized, Vehicle-Controlled Trials. Researchers measured outcomes such as plaque clearance using scales like the Investigator Global Assessment (IGA) and monitored symptom intensity. Studies reported that the Rofluzol group was associated with a higher measured frequency of participants achieving the predefined endpoint for skin clearance. The primary endpoint measurements from these studies are based on follow-up durations that were limited to just eight weeks. There is limited information for long-term outcomes, and comparative evidence is lacking.


Evidence for use in Seborrheic Dermatitis

The topical formulation of Rofluzol was evaluated in research for seborrheic dermatitis. The trials monitored outcomes related to disease severity using the IGA score and focused on erythema and scaling. Studies reported that a higher percentage of participants in the Rofluzol group met the specified clearance targets compared to the vehicle group. Data show patterns related to the intensity of erythema and scaling monitored. Follow-up durations were limited in the primary data.


What is Still Uncertain About the Research

While Rofluzol was observed in studies for its approved conditions, several areas remain where certainty remains low. Comparative evidence is lacking from the core research for all studied indications. The follow-up durations were limited in the RCTs, and the applicability of the findings to less severe COPD or individuals without the chronic bronchitis phenotype is less certain.

Key Studies & References

  1. Roflumilast and the Risk of Exacerbations in Patients with Severe COPD and Chronic Bronchitis (REACT Trial)
  2. Roflumilast Cream for Plaque Psoriasis: An Integrated Analysis of Two Phase 3 Trials (DERMIS-1 and DERMIS-2)

Frequently Asked Questions (FAQ)

Common questions about Rofluzol (FAQ)


Q: How quickly does Rofluzol start working?

Official product information, based on pharmacokinetic data, describes how Rofluzol is absorbed into the bloodstream. Peak concentrations in the body are generally observed within one to two hours following administration. Because the medicine works by disrupting the internal structure of fungal cells, the time it takes to see the full clinical effect varies and is generally achieved over the course of the treatment period.


Q: Are there any common interactions with over-the-counter pain relievers and Rofluzol?

Rofluzol is classified as an inhibitor of certain liver enzymes, meaning it can slow down the body's process for breaking down many other drugs. This enzyme-blocking action means that some co-administered medications could have increased levels in the body, which might necessitate monitoring. Official materials describe that patients should inform their healthcare provider of all prescription and non-prescription products, including common pain relievers.


Q: How long does Rofluzol stay in my system after I stop taking it?

Regulatory documents describe Rofluzol's elimination characteristics, stating that the time it takes for the concentration of the medicine in the body to be cut in half (the half-life) is approximately 30 hours. Based on this measurement, the medicine is described as remaining detectable in the body's system for several days after administration has stopped.


Q: Can people with kidney problems take Rofluzol?

Yes, official administration guidelines specify that Rofluzol can be used by individuals with kidney impairment. However, regulatory information describes that a dose adjustment is typically required for these patients. This helps manage the concentration of the medication in the body, and the required adjustment is determined by the patient's level of kidney function.


Q: Does Rofluzol affect blood pressure?

Changes in blood pressure are not commonly listed as an expected side effect of Rofluzol in clinical reports. Regulatory safety information does mention that the medicine is associated with rare cardiovascular effects related to the heart's electrical activity (specifically QT prolongation), but direct effects on blood pressure are not commonly listed in the safety information.


Q: What is the typical duration of treatment with Rofluzol?

The typical duration of Rofluzol treatment is not fixed and varies widely. According to official administration guidelines, the length of therapy depends entirely on the specific type of fungal infection being treated, the site of the infection, and how the patient responds to the medication. Treatment can range from a single dose for certain conditions to several months for more persistent or deep-seated fungal issues.


Q: Is Rofluzol the same kind of drug as [Similar Drug Name]?

Rofluzol is categorized by major health organizations as an azole antifungal drug, specifically belonging to the triazole derivative subclass. Regulatory and authoritative sources classify it based on its active ingredient, Fluconazole, which determines its chemical structure and its defined mechanism of action against fungal cells.


Q: Does Rofluzol interact with caffeine?

Caffeine is not explicitly listed as a contraindicated product in the official drug-interaction documents. However, Rofluzol's known ability to affect the breakdown of many substances in the body means that high consumption of products like caffeine may be related to slower metabolism. Patients are described as being advised to discuss all products they use with their healthcare provider.


Q: Is Rofluzol safe for older adults (seniors)?

Official administration guidelines state that Rofluzol can be used in older adults. The standard adult dose is typically described for use in this population if there is no evidence of kidney impairment. Any dose adjustment for older adults is typically related to their kidney function, rather than age alone.


Q: Are there different strengths or formulations of Rofluzol?

Yes, regulatory documentation confirms that Rofluzol is available in multiple forms to allow flexible administration. These include solid forms like capsules and tablets, an oral suspension (liquid), and a sterile solution for intravenous infusion. It is manufactured in various strengths depending on the formulation.


Q: Are there any specific foods to avoid when taking Rofluzol?

According to official product information, Rofluzol's absorption is generally not significantly affected by whether it is taken with food or without. Regulatory documents do not specifically advise avoiding any particular foods. However, one specific formulation—the oral film—has explicit instructions stating it should not be taken with liquids.


Q: Does Rofluzol affect my ability to drive?

The official safety documentation advises caution regarding driving or operating machinery. This is because some individuals may experience side effects such as dizziness or, rarely, seizures. Patients are cautioned to avoid operating machinery or driving until they are certain the medication does not affect their ability to perform such tasks.


Q: Can Rofluzol be crushed or cut?

Regulatory instructions for the oral film formulation explicitly state that the film must not be cut or split before it is administered. The official product information typically advises swallowing the capsule and tablet forms whole, unless an oral suspension (liquid formulation) is prescribed.


Q: Is Rofluzol a habit-forming medicine?

Rofluzol is not classified as a controlled or habit-forming substance in regulatory documents. Official labeling provides no information or evidence to suggest that its use carries a risk of dependence or addiction.


Q: Can I take Rofluzol if I have diabetes?

Diabetes is not listed as a formal contraindication for the use of Rofluzol. However, official warnings mention that Rofluzol can influence the metabolism of some medications used to treat diabetes (specifically sulfonylureas). This indicates that co-administration may necessitate monitoring and potential adjustment of the diabetic medication's dosage, as described in regulatory guidance.


Q: Is there a generic version of Rofluzol available?

Rofluzol is a brand name for the active substance Fluconazole. Since Fluconazole is no longer under patent protection, generic versions containing the same active ingredient are widely available internationally.


Q: Does taking Rofluzol affect laboratory test results?

Yes, regulatory documents indicate that Rofluzol can affect certain laboratory values. It is a requirement that serum aminotransferases (liver enzymes, ALT and AST) be measured and monitored periodically during treatment. Additionally, patients taking blood thinners may need strict monitoring of their INR results, as Rofluzol can affect those levels.


Q: What is the evidence regarding Rofluzol's use in children?

Official documents contain detailed dosage and administration information specifically for pediatric patients, with dosages adjusted based on weight. The safety and effectiveness of Rofluzol have been established in children for certain approved fungal infections, and the regulatory data is supported by clinical trials conducted in this population.


Q: Is Rofluzol safe for teenagers (adolescents)?

According to official administration guidelines, teenagers (adolescents, typically 12 to 17 years old) are included within the pediatric population for Rofluzol use. The medication is permitted for approved conditions, and the dose is calculated based on the treatment needs and the patient's weight.


Q: Can Rofluzol be taken with antacids?

Antacids are not listed as a major or clinically significant interaction in regulatory materials. The text notes that Rofluzol’s absorption is not significantly affected by food, suggesting that minor interactions with common antacids are not expected to cause a major issue.


Q: Is Rofluzol associated with any mood changes or mental health side effects?

The official safety documentation lists common side effects that are generally physical, such as gastrointestinal upset and liver enzyme elevations. While reported adverse reactions can include central nervous system (CNS) effects like headache and dizziness, serious mental health side effects or mood changes are not listed among the common or clinically significant warnings.


Q: Is it normal to not notice any effects from Rofluzol right away?

Yes, it is expected that the effects are not immediate. Rofluzol is designed to work by arresting the growth and replication of fungal organisms, a process that takes time. Full clinical benefit and management of the infection are typically achieved gradually over the entire prescribed course of treatment.


Q: How often do people experience the rare side effects of Rofluzol?

Regulatory documents define the frequency of reported adverse events using standard clinical terms. The classification 'Rare' means that the event is reported in approximately 1 in 1,000 to 1 in 10,000 people. This includes the most serious safety concerns, such as severe hepatic injury.


Q: Has Rofluzol received approval from international health agencies like the EMA?

Yes, Rofluzol (Fluconazole) is an established medication whose safety and efficacy have been recognized and approved by major international regulatory bodies. This includes the European Medicines Agency (EMA), as well as authorities in other regions like Health Canada.

How should Rofluzol be stored and disposed of?

How to Store and Dispose of Rofluzol (Fluconazole)

Official regulatory documents define specific storage and disposal requirements for Rofluzol (Fluconazole) to maintain product stability.


Storage Conditions

Capsules and tablets must be stored at controlled room temperature, specifically 20 C to 25 C (68 F to 77 F), and protected from moisture. All dosage forms must be kept in their original, tightly closed container and out of the reach of children. The intravenous solution must not be frozen, and the reconstituted oral suspension must not be refrigerated.


Stability and Disposal

The reconstituted oral suspension is stable for 14 days when stored at 30 C or below, and must be discarded thereafter. Unused or expired Rofluzol must be disposed of according to local requirements. The medication must not be discarded via wastewater or household waste.

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

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