Nicene

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Nicene

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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 Nicene

What is Nicene? Defining its Identity and Class

Property Description
Active Ingredients Nitroxoline, Pyridoxine HCl, Sulfamethizole
Form Tablet (Oral preparation)
Pharmacological Class Urological Anti-infective
Common Use Treating urinary system infections
Origin Synthetic

Nicene is defined as a synthetic Fixed-Dose Combination (FDC) oral preparation classified as a Urological Anti-infective, a type of medicine specifically formulated to address microbial issues in the urinary system. This specific three-component FDC formulation, which combines two antimicrobial agents with a supportive vitamin, is clinically recognized for its targeted application in managing infections within the urogenital tract. The preparation is delivered as a standardized tablet for oral administration, meaning the active ingredients are absorbed systematically to reach the site of action, distinguishing it from local or topical preparations.


What is Nicene Made Of? Composition and Action Concept

The preparation is composed of three active ingredients: Nitroxoline, Sulfamethizole, and Pyridoxine Hydrochloride (Vitamin B6). The antimicrobial action relies on the synergy between Nitroxoline (a quinolone derivative) and Sulfamethizole (a sulfonamide), both of which are synthetic compounds. Nitroxoline belongs to the class of antimicrobials that effectively inhibit the synthesis of bacterial DNA and RNA. This dual-antimicrobial system is characterized by the activity of Sulfamethizole against bacteria found in the urinary tract, affirming its role in targeted anti-infective therapy. The final component, Vitamin B6, is included in a supportive coenzyme role, a characteristic differentiating Nicene from purely antimicrobial regimens.


What is the General Purpose of Nicene? Therapeutic Area

The overall purpose of Nicene is to provide a comprehensive, multi-agent approach to combating microbial infections that develop within the urinary system. The combination is typically employed to manage acute bacterial issues, such as cystitis or urethritis, where a broad anti-infective spectrum is beneficial. By combining two distinct classes of antimicrobial agents, the medicine aims to maximize its inhibitory effect against a broad spectrum of pathogens often responsible for urinary tract issues.

Regulatory References

  1. Pyridoxine NIH/NCBI Bookshelf
  2. DNA Definition (NIH/NCI)

What side effects are possible with Nicene?

Officially Documented Adverse Reactions and Frequencies

Adverse drug reactions (ADRs) are categorized by frequency based on official regulatory data. Reactions classified as common (may affect more than 1 in 100 people) primarily involve Gastrointestinal Disorders such as nausea, vomiting, diarrhea, and anorexia. Dermatological manifestations, including rash and fever, are also typically categorized within this frequency tier.

Reactions categorized as uncommon (may affect up to 1 in 100 people) or rare include effects spanning the Hepatobiliary Disorders and Nervous System Disorders, presenting as jaundice, elevated liver enzymes, and peripheral neuritis. These classifications strictly reflect how government regulatory documents organize and communicate the medicine’s safety profile.

Serious Adverse Reactions and Safety Constraints

The official safety profile outlines serious adverse reactions due to their potential severity. These include rare but critical effects on the Blood and Lymphatic System, such as agranulocytosis and aplastic anaemia. Severe cutaneous reactions, notably Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), are also documented. Regulatory documentation specifies that the highest risk for these severe cutaneous reactions is typically observed within the first weeks of treatment.

Population-Specific Safety Considerations

Regulatory documents specify safety constraints for certain patient groups. The medicine is contraindicated in infants under two months old due to the risk of hyperbilirubinemia. It is also not to be used in individuals with pre-existing marked hepatic damage or severe renal insufficiency when monitoring is unavailable. Older adults are documented as being more susceptible to severe adverse reactions, and patients with G6PD deficiency have an increased risk of hemolytic anaemia.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory profile for Nicene overdose is based on the documented toxicological risks of its active components, focusing on specific organ toxicity and immediate response. In the event of suspected overdose, seeking immediate medical attention is a mandatory regulatory requirement.

Documented Manifestations and Severe Outcomes

Overdose may present with serious manifestations involving multiple physiological systems. Documented signs include crystalluria, leading to oliguria or anuria (indicating acute renal involvement), jaundice (hepatic involvement), and gastrointestinal symptoms such as nausea and vomiting. Severe, potentially life-threatening outcomes listed in official regulatory labeling include acute renal failure, hepatic necrosis, and severe blood dyscrasias (e.g., agranulocytosis) related to the sulfonamide component.

Emergency Response and Supportive Care

Regulators mandate that emergency services must be contacted immediately if severe symptoms are observed. Management is limited to symptomatic and supportive treatment, as the prescribing information states that no specific antidote is known. Procedural steps documented for elimination include gastric emptying and the use of forced diuresis. Hospital monitoring is required, specifically focusing on assessing renal function and hematological parameters due to the identified risks. Overdose severity is noted to potentially increase in patients with pre-existing renal impairment.

Therapeutic Uses of Nicene

What Nicene Treats: Main Uses and Benefits

The primary therapeutic role of Nicene is focused on symptomatic relief and providing support during episodes of heightened patient distress. The therapeutic role of Nicene aligns with domains where short-term symptom management is appropriate.

Nicene is commonly used to help with conditions characterized by periods of heightened symptoms, specifically managing manifestations such as pronounced physical discomfort, temporary functional strain, and distressing systemic manifestations. It is generally applied in clinical settings that involve acute or unstable symptom patterns and during phases when symptoms become temporarily overwhelming.

“The supportive benefit aims to help ease the overall symptom load and contributes to improved comfort during symptomatic periods.”

Quick Fact: Relief for Acute Symptom Clusters

The medication helps address symptom clusters that may become intense or disruptive, offering short-term symptomatic assistance. This support assists with maintaining functional stability and may help patients cope more steadily with symptom fluctuations. Nicene is relevant in contexts marked by increased discomfort or tension.

Regulatory References

  1. Wording of therapeutic indication - A guide for assessors of centralised applications

Eligibility and Restrictions for Use

Nicene, a Fixed-Dose Combination containing a sulfonamide (Sulfamethizole), has eligibility rules based on regulatory mandates for this drug class. These rules define who may use the medicine and who is strictly prohibited.

Populations for whom use is Contraindicated

Use is prohibited for patients with a known hypersensitivity to any component or to the sulfonamide class of medicines. Regulatory documents also state that Nicene must not be used in infants less than two months of age, patients with documented marked hepatic damage, or those with severe renal insufficiency when the patient's renal function cannot be monitored. Use is also contraindicated in patients with megaloblastic anemia due to folate deficiency.

Age and Physiological Restrictions

The medicine is contraindicated in women who are pregnant (especially near term) and in nursing mothers because the sulfonamide component is known to cross the placenta and be excreted in milk. Older adults may use Nicene, but are more susceptible to adverse effects and require special caution, often necessitating a dosage adjustment due to the likelihood of impaired kidney or liver function.

Condition-Based Restrictions

Patients with non-severe impaired renal function require a formal reduction in dosage to prevent drug accumulation. Individuals with specific metabolic conditions, such as G6PD deficiency, are in a restricted-use category due to increased risk of hemolytic reactions.

What should I know about interactions with other medicines?

Nicene Interactions with Other Medicines and Products

This section outlines interactions officially documented in government regulatory sources for Nicene's active components (Nitroxoline, Sulfamethizole, and Pyridoxine HCl).

Combination Type Examples of Interacting Medicines or Products
Formally Contraindicated Dofetilide, Methenamine
Metabolic/Transporter Effects Drugs metabolized by CYP2C8/ CYP2C9; OCT2 Substrates (e.g., Metformin, Memantine)
Pharmacodynamic Potentiation Oral Hypoglycemics, Warfarin and other Anticoagulants, Pyrimethamine
Reduced Absorption Products containing Multivalent Cations (e.g., Iron, Magnesium, Antacids)

Official Interaction Statements

  • Contraindicated Use: Regulatory labels prohibit the co-administration of Sulfamethizole-containing products with Dofetilide and Methenamine.
  • Exposure Modification: Co-administration of Sulfamethizole may increase the plasma concentration of certain drugs, including Digoxin and Indomethacin, as noted in official prescribing information.
  • Timing Restriction: Because Nitroxoline chelates multivalent cations, a mandatory time separation (e.g., three to four hours) is required when co-administering with preparations containing Iron, Magnesium, or other metal ions to avoid impaired absorption.
  • Pharmacodynamic Risk: Sulfamethizole is documented to potentiate the effect of Warfarin and oral hypoglycemic agents, and co-use with Pyrimethamine increases the risk of bone marrow suppression.
  • Population Note: Increased Digoxin blood levels due to interaction with Sulfamethizole are specifically noted as a concern in elderly patients.

This interaction structure is defined by formal prohibitions, interference with drug-metabolizing enzymes and transporters, and the physical chelation property of one component, all as described in official regulatory documentation.

Mechanism of Action

Dual Blockade of Essential Microbial Life Pathways

Sulfamethizole acts as a competitive inhibitor of the bacterial folate synthesis pathway, targeting dihydropteroate synthase (DHPS), which is critical for making DNA precursors. Concurrently, Nitroxoline functions as a chelating agent, binding to and sequestering essential divalent metal ions ( Fe^2+, Zn^2+) that are required as cofactors for key bacterial DNA/RNA synthetic enzymes. This dual, coordinated disruption prevents microbial replication and viability, resulting in the functional inhibition of microbial proliferation within the urogenital tract.

Interference with Microbial Colonization and Virulence

Nitroxoline's mechanism extends to modulating bacterial collective behavior. The compound interferes with bacterial quorum sensing and the ability of uropathogens to form protective biofilm matrices on urothelial surfaces. This molecular interference inhibits the molecular processes necessary for the establishment of persistent bacterial colonies and alters adherence mechanisms.

Coenzyme Precursor for Host Metabolic Pathways

The final component, Pyridoxine ( Vitamin B6), provides a necessary precursor for host coenzyme function by acting as a precursor to the essential coenzyme, Pyridoxal 5-phosphate ( PLP). This mechanism acts as a precursor supply, ensuring the required availability of PLP coenzyme for host-dependent metabolic reactions.

Dosage and Administration Information

The administration of Nicene is defined by its classification as a Fixed-Dose Combination (FDC) oral preparation intended for short-term use in the urinary system. The instructions below reflect the standardized principles of use for this formulation.


Established Administration Guidelines

Feature Standardized Instruction / Principle
Route of administration Oral administration only. The medicine is not available for alternative routes.
Dosing schedule (Adults) Typically involves divided daily doses to maintain consistent drug levels. For the Nitroxoline component, common schedules involve administration three times per day (e.g., 250 mg three times daily).
Timing in relation to meals The tablet may be administered with food or milk to aid tolerance, or taken with water generally, and requires concurrent adequate fluid intake.
Preparation requirements The FDC tablet must be swallowed whole and should not be crushed or chewed, as this ensures the combined delivery of the active ingredients.
Age-group administration rules Use is determined by the specific guidelines for each active ingredient.
Special procedural conditions Continued adequate hydration is a procedural requirement, often advised for sulfonamide-containing drugs like Sulfamethizole to support proper renal excretion.

Resulting Procedural Structure

The protocol for Nicene use is structured to maximize the consistent systemic delivery of the anti-infective agents over time. The Standardized step sequence is:

  • Administer the full dose via the oral route.
  • Swallow the Fixed-Dose Combination (FDC) tablet whole without altering its form.
  • Take the tablet on a timed daily schedule for the full finite course of treatment.
  • Ensure adequate fluid intake is maintained throughout the entire period of use.

This procedural structure standardizes the method and frequency of intake, defining the precise manner in which the medicine is used.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Nicene

Evidence for Use in Uncomplicated Urinary Tract Infections (uUTI)

The use of the medicine was studied for populations presenting with conditions characterized by fluctuating or episodic manifestations, such as uncomplicated urinary tract infections ( uUTI) in adult women. The research base largely relies on Individual Patient Data ( IPD) Meta-Analyses, which combined data from previously conducted Randomized Controlled Trials ( RCTs). These studies were evaluated in research contexts involving acute episodes and often included comparisons with control treatments. The aggregated findings describe patterns observed in the studies regarding the medicine's role as a urological anti-infective, and research provides insight into short-term changes in treatment settings.


Outcomes Measured in Regulatory Studies

Studies explored endpoints that help contextualize how patients reported their experience during episodes where symptoms become more noticeable. The primary focus of the research examined the Assessment of Bacteriuria Endpoints. This outcome is a technical measurement used to monitor bacterial counts to a very low, defined level after a course of treatment. The research examined this alongside the assessment of patient-reported outcomes. Findings describe patterns observed in the studies but reflect the specific conditions under which they were conducted.


Duration of Evidence and Follow-up

The research was observed in studies exploring short-term symptom changes. Most critical outcome assessments, often referred to as a Test of Cure, occurred on a short-term basis, typically within a window of about 7 to 13 days after the treatment course was completed. Follow-up durations were limited, and it is not yet clear whether observed patterns may be maintained over many months or years.


Understanding Research Gaps and Limitations

A notable limitation is that the research base relies on previously conducted trials, and modern, dedicated, high-quality RCTs that meet current regulatory standards are scarce. Furthermore, a significant gap exists because the trials often examined the individual antimicrobial component rather than the specific three-component Fixed-Dose Combination ( FDC) present in Nicene. Therefore, research provides context but not individual predictions about the specific triple-component formulation. The research contributes to understanding what has been studied — and what is still uncertain — about the medicine.

Frequently Asked Questions (FAQ)

Common questions about Nicene (FAQ)


Q: Can Nicene make you feel tired or drowsy?

The official safety profile for Nicene lists effects on the Nervous System as uncommon or rare adverse reactions. In studies involving medicines with similar components, reports of tiredness or drowsiness have occasionally occurred. Official information notes that patients should be mindful of how the medicine affects them, as these effects can potentially impact mental alertness.


Q: Why do some people experience mild stomach upset when taking Nicene?

According to official administration guidelines, gastrointestinal symptoms like nausea or stomach upset are commonly reported with Nicene. Official administration guidelines state that the medicine may be taken with food or milk to help aid tolerance. This instruction is defined by regulatory authorities as part of the standard use conditions.


Q: Is it normal to have a slight headache after starting Nicene?

The official product information on Nicene lists effects on the Nervous System as uncommon or rare. While a slight headache is a symptom reported across the use of various medications, the official safety profile reports Nervous System effects as uncommon or rare events.


Q: Are there any foods or drinks to avoid while taking Nicene?

Official product information specifies that a time separation is required when administering Nicene with products that contain multivalent cations, such as iron and magnesium. These ingredients are found in many supplements and fortified foods. This time separation is specified because one of the medicine’s components may bind to these metal ions, potentially impairing its absorption.


Q: Is it necessary to avoid alcohol completely while using Nicene?

Official information related to the sulfonamide component in Nicene notes a potential interaction with alcohol. This combination may lead to unpleasant effects like flushing, fast heartbeats, nausea, or vomiting. This is a common warning for this specific class of antimicrobial agents.


Q: Can Nicene affect the results of lab tests?

Studies involving related medicines that also contain Pyridoxine ( Vitamin B6) have indicated a potential for interference with certain laboratory tests. This may result in false positive findings in some urine screening tests, such as those for methadone or opiates.


Q: Can children or teenagers use Nicene?

Regulatory documents explicitly prohibit the use of Nicene in infants who are less than two months old. For children and teenagers above this age, the appropriate use and any specific restrictions are determined by the individual guidelines established for each of the active ingredients in the combination medicine.


Q: Do you need a prescription for Nicene?

Nicene contains two active antimicrobial agents, Nitroxoline and Sulfamethizole. In most regulatory jurisdictions, medicines belonging to this anti-infective class are classified as prescription-only and are typically distributed by prescription only.


Q: What happens if I miss a use of Nicene?

According to general patient information guidelines for this type of medicine, a forgotten use should be taken as soon as it is remembered. However, if it is almost time for the next scheduled use, the guidelines suggest skipping the missed use and resuming the regular schedule. A double use should never be taken to compensate for a missed one.


Q: Is Nicene addictive or habit-forming?

Nicene is an anti-infective medicine designed to treat infections. The active ingredients—Nitroxoline, Sulfamethizole, and Pyridoxine—are not classified as controlled substances by regulatory authorities. There is no official documentation indicating a potential for abuse or habit formation associated with its use.


Q: Are there different forms or strengths of Nicene available?

Official product documents define Nicene as a Fixed-Dose Combination ( FDC) oral tablet. This means that it is a standardized medicine containing specific amounts of all three active ingredients in a single form. It is generally available only in this specific tablet formulation.


Q: Does Nicene come with a Patient Information Leaflet (PIL)?

Yes, as a prescription medicine, Nicene is required by regulatory authorities to be supplied with detailed patient information materials. These materials, often called a Patient Information Leaflet ( PIL) or Medication Guide, provide comprehensive factual details about the medicine's use, warnings, and storage.


Q: What if I'm already taking multiple supplements—can I still use Nicene?

One of the active components in Nicene can bind to (chelate) multivalent cations, such as iron, magnesium, or calcium, which are common in many mineral supplements. To avoid impaired absorption of Nicene, official regulatory documents state that a time separation of several hours between the medicine and supplements containing these ingredients may be necessary.


Q: Is it true that Nicene is classified as a Schedule X drug?

Nicene is classified as an anti-infective medicine, not as a controlled substance like Schedule I through V drugs, which are classified based on their potential for abuse. Regulatory classification defines Nicene based on its therapeutic use and does not relate to drug scheduling for narcotics or controlled prescription items.


Q: What does the research say about stopping Nicene use suddenly?

Official instructions emphasize the importance of completing the full course of treatment as prescribed. Completing the full course of treatment is emphasized to help maximize the medicine's anti-infective effect and reduce the risk of incomplete treatment.


Q: Is Nicene a brand name, and what is its generic name?

Nicene is the trade name given to this medicine. The generic names of the three active ingredients in the Fixed-Dose Combination are Nitroxoline, Sulfamethizole (a sulfonamide), and Pyridoxine Hydrochloride ( Vitamin B6).


Q: Is Nicene known to cause problems with sleeping?

The official safety profile indicates that effects on the Nervous System are listed as rare adverse reactions. While specific problems with sleeping, such as insomnia, are not explicitly listed in the common reactions, they can be related to general Nervous System disturbances.


Q: What should be done if an interaction with Nicene is suspected?

In the event that a severe interaction or adverse reaction is suspected, the regulatory guidance provided in patient information materials suggests seeking immediate medical attention. Official safety instructions advise consulting with a health professional for assessment and direction.


Q: Are there special considerations for people with heart conditions using Nicene?

Official safety information specifically notes a potential interaction where one component may increase the blood levels of the drug Digoxin. This is noted as a particular concern for older patients who may be using Digoxin for heart conditions, reflecting the general susceptibility of the elderly population to adverse reactions.


Q: What does 'contraindication' mean in relation to Nicene?

In regulatory terms, a contraindication is a clear statement that use of the medicine is strictly prohibited under certain circumstances. This is based on official assessment that the potential risks of using Nicene outweigh the benefits due to a specific pre-existing medical condition, known allergy, or patient characteristic like age.


Q: How often do people generally need check-ups while using Nicene?

Official eligibility criteria state that Nicene must not be used in patients with severe kidney problems if monitoring is unavailable. This indicates that monitoring may be required for patients with pre-existing conditions or those taking specific interacting medicines to safely manage the medicine's use.


Q: Does Nicene need to be adjusted for changes in body weight?

Standardized dosing schedules are generally set for adults. However, based on official information, dose adjustment may be necessary for those with impaired kidney function. Furthermore, the administration guidelines for the individual components of Nicene, particularly in pediatric use, often rely on calculations based on body weight.


Q: What happens if Nicene is used for longer than the prescribed period?

Nicene is officially designated for a short and finite course of treatment. Regulatory safety data indicates that the risk of certain severe skin reactions is highest during the first weeks of use. As Nicene is intended for short-term use, exceeding the prescribed duration may potentially increase the risk of long-term or rare adverse effects.


Q: Does taking Nicene impact the ability to drive or operate machinery?

Because the medicine has the potential to cause rare effects on the nervous system, official regulatory labels state that caution should be exercised when engaging in activities that require complete mental alertness. This includes driving or the operation of heavy machinery.

How should Nicene be stored and disposed of?

The official regulatory requirements for Nicene (an oral tablet) define strict conditions for storage, handling, and disposal to maintain product integrity.

Storage and Environmental Conditions

Requirement Classification
Temperature Store at room temperature (typically 15 C to 25 C)
Protection Protect from light and moisture
Handling Do not refrigerate; Do not freeze

The product must remain in its original container, which must be kept tightly closed. This ensures the tablet form is protected from environmental factors that could impact its stability until the expiry date. All medicine must be kept out of the sight and reach of children.

Disposal Instructions

Disposal must be completed in accordance with local regulations for pharmaceutical waste. Nicene tablets must not be thrown into household garbage or disposed of via wastewater or sewage systems to prevent environmental contamination. Unused or expired medication should be returned to a pharmacy or designated drug take-back point.

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

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