Finoten

Method of action: Anesthetic, Nonsteroidal Anti-Inflammatory

Treatment option:

Medically reviewed

Last updated on 10/01/2026

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 Finoten

Quick Facts

Property	Description
Active Ingredients	Lidocaine Hydrochloride, Phenazone
Form	Otic solution (Eardrops)
Pharmacological Class	Local Anesthetic and Analgesic combination
Route of Administration	Topical auricular
Origin	Synthetic compound

Defining Finoten: A Combined Localized Analgesic

Finoten is a synthetic, fixed-dose combination product formulated as an otic solution, which is designed for topical auricular administration as eardrops to provide localized symptomatic relief. This preparation is explicitly classified as eardrops that unite the effects of two complementary active agents in a single liquid vehicle. The strategy of combining a local anesthetic with an anti-inflammatory agent for acute otalgia is clinically recognized for providing effective symptomatic coverage.

This classification as a fixed-dose combination product is crucial, as it leverages concurrent therapeutic mechanisms, offering an advantage over single-agent topical treatments. The specialized formulation as a liquid solution ensures the preparation is easily delivered directly into the external ear canal, concentrating the therapeutic agents precisely at the site of discomfort for rapid action. Finoten is typically positioned for managing the temporary discomfort associated with specific ear conditions in both pediatric and adult populations.

Composition and Pharmacological Classification of Finoten

Finoten contains two distinct active ingredients, Lidocaine Hydrochloride and Phenazone, positioning it as an agent that spans two major pharmacological classes. The formulation utilizes the action of a potent amide-type Local Anesthetic, Lidocaine Hydrochloride, in conjunction with an Analgesic and Non-Steroidal Anti-inflammatory Drug (NSAID), Phenazone.

Lidocaine is well-established in pharmacological studies for its ability to block nerve signal conduction. Concurrently, Phenazone (Antipyrine), a pyrazolone derivative, is supported by pharmacological data confirming its anti-inflammatory and pain-relieving properties. This pairing utilizes two compounds of synthetic origin in a liquid base, designed to simultaneously address nerve-signal transmission and the chemical processes that initiate inflammatory pain.

What side effects are possible with Finoten?

Finoten (finafloxacin otic suspension) is an antibacterial medication for use in the ear. The safety profile is based on clinical trials and regulatory findings for the topical formulation.

Common and Significant Adverse Reactions

Adverse reactions reported in clinical trials occurring in at least 1% of patients treated with Finoten include ear pruritus (itching) and nausea. These effects are generally mild.

Allergic reactions are a noted safety risk, as with other quinolone antibiotics. Discontinuation of use is required if signs of a hypersensitivity reaction occur. Furthermore, prolonged use of the medication may lead to the overgrowth of non-susceptible organisms, including yeast and fungi, which also requires discontinuation and initiation of alternative therapy if confirmed.

Population-Specific Safety Considerations

Population	Safety Note (Regulatory Basis)
Pregnancy	Classified as Pregnancy Category C. There are no adequate studies in pregnant women. Non-clinical studies show finoten to be teratogenic (causing developmental defects) in animals at high systemic exposures. Use during pregnancy is only advised if the potential benefit justifies the potential risk.
Nursing Mothers	Although human systemic absorption following topical ear use is low, the drug was identified in the milk of nursing rats. Caution should be exercised when administering this drug to a nursing mother.
Pediatric Patients	Safety and effectiveness have been established for pediatric patients aged 1 year and older. The safety profile is consistent with that of adults. Safety and efficacy in infants under one year of age have not been established.

Non-Clinical Safety Findings

Non-clinical studies of finafloxacin have shown it to be genotoxic and clastogenic (causing chromosome damage) in laboratory tests and teratogenic in animals following oral administration. These effects were observed at systemic exposures substantially higher than those achieved through topical otic administration.

Overdose and Emergency Response

Overdose of Finoten may lead to documented manifestations primarily associated with systemic exposure to the local anesthetic component. Clinical signs often begin with Central Nervous System (CNS) excitation, which can include light-headedness, confusion, nervousness, tremors, or twitching. These manifestations may progress to CNS depression, resulting in drowsiness and potential unconsciousness, as detailed in regulatory labeling.

Severe outcomes documented by regulatory authorities include life-threatening cardiovascular effects such as hypotension, bradycardia, and potential cardiac arrest. Respiratory depression and arrest are also noted complications. A specific hematologic risk is methemoglobinemia, identified by cyanotic skin discoloration or an abnormal blood color, which mandates urgent assessment.

Immediate medical attention is required if signs of methemoglobinemia are observed. In the event of accidental ingestion where the individual has collapsed or is not breathing, contact emergency services without delay. Overdose management relies on close monitoring and symptomatic supportive care, as dialysis is of negligible value.

Susceptibility notes indicate that infants under six months are at greater risk for methemoglobinemia, and severe hepatic disease increases the risk of toxic blood concentrations.

Therapeutic Uses of Finoten

What Finoten Treats: Main Uses and Benefits

Finoten is generally used to provide localized symptomatic assistance in acute ear conditions. It is applied across domains where short-term, supportive symptom management is appropriate.

Managing Acute Localized Ear Pain (Otalgia)

Finoten is commonly used to address the symptoms related to physical discomfort that cluster around the ear area. The product is considered relevant for easing certain distressing symptoms associated with otic conditions.

Finoten is relevant for easing conditions characterized by heightened symptoms, including acute congestive otitis media, viral otitis media (such as bullous myringitis), and pain following barotraumatic damage of the middle ear. The primary therapeutic domain involves offering targeted, localized analgesic relief that may help patients cope more steadily with difficult episodes of severe ear pain.

Supportive Care in Inflammatory Contexts

Finoten is applied in clinical settings that involve acute or disruptive symptom patterns, and is relevant for easing symptoms related to inflammatory or irritative states. Finoten is applied in scenarios where additional management of discomfort is required when symptoms intensify, for example, when used as supportive treatment during ear infections or in contexts involving cerumen removal. This contributes to improved comfort during periods of heightened symptoms and assists with maintaining functional stability.

Quick Fact: Symptom Management in Acute Otalgia
Intended Role: Symptomatic management
Addressed Symptoms: Acute ear pain, discomfort, irritation
Common Context: Adjunctive care in acute otitis media

Regulatory References

NHS England Patient Group Direction on Otigo

Eligibility and Restrictions for Use

Finoten is intended for use in the general adult population and in children, provided the patient meets specific, label-defined eligibility criteria. The key rule determining non-eligibility relates to the ear structure and documented sensitivities.

Absolute Contraindications

The medicine must not be used if the patient has any perforation of the tympanic membrane (eardrum), whether the perforation is infectious, traumatic, or surgical in origin. This is an absolute ban defined in the regulatory documents. Finoten is also strictly contraindicated for individuals with a known hypersensitivity to the active ingredients, Lidocaine Hydrochloride or Phenazone, or any other components of the otic solution.

Age-Group and Conditional Eligibility

The safety and efficiency of Finoten has not been proven in children under six months of age, making use in this group not recommended. Specific caution is advised for infants under three months, and for patients with G6PD deficiency or specific haemoglobinopathies, due to susceptibility to related metabolic effects. Use is generally permitted for older adults. Furthermore, use is permitted, if necessary, during pregnancy and breastfeeding, based on the low potential for systemic absorption when the eardrum is intact.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official regulatory position regarding Finoten (Lidocaine/Phenazone otic solution) interactions is defined by its localized topical route of administration. Authorities note that due to this method of use, no formal interaction studies have been performed for this combination product. Consequently, the data currently available from government sources do not suggest the existence of clinically significant interactions with other medicinal products.

This conclusion stems from the understanding that systemic exposure of the active ingredients is considered negligible when the tympanic membrane is intact. Therefore, the complex metabolic and pharmacokinetic interactions typically associated with systemic forms of Lidocaine and Phenazone are not deemed relevant for the otic solution, as stated in regulatory documents.

The official regulatory structure confirms a profile characterized by the absence of specific interaction constraints:

No Contraindicated Combinations: No medicinal products are formally classified as a prohibited combination with Finoten in the official regulatory documents.
No Exposure-Altering Interactions: No substances are documented to increase or decrease the drug’s systemic levels or clearance.
No Timing Rules: The official prescribing information does not require mandatory timing separation for co-administration with other medicines.
No Food or Supplement Interactions: No specific interactions with food, alcohol, or herbal products are reported in the government-approved labeling.

This clear regulatory structure indicates that the interaction profile for Finoten is minimal, based on the low likelihood of systemic effects.

Mechanism of Action

Finoten operates via a dual mechanistic action targeting both the electrical transmission and the chemical generation of the peripheral nociceptive signal. The first active agent, Lidocaine, engages voltage-gated sodium channels ( Na V) on sensory nerve fibers. This interaction is a state-dependent blockade that prevents the ion influx required for the nerve to generate an electrical impulse. This cascade results in a slower impulse transmission rate and the physiological consequence of localized inhibition of sensory signal propagation.

The second component, Phenazone, is an inhibitor of cyclooxygenase ( COX) enzymes. This enzymatic blockade reduces the synthesis of pro-inflammatory mediators, such as prostaglandins ( PGE2), which sensitize nerve endings. This action decreases the influence of chemical mediators on nociceptor activity, leading to reduced excitability of nerve fibers and a shift in the local biochemical environment. The two mechanisms provide a coordinated influence, although the efficacy of the Lidocaine mechanism is physiologically constrained by tissue acidity (low pH) present in highly inflamed areas, which limits its ability to penetrate the nerve membrane.

Dosage and Administration Information

How to use Finoten

Finoten is a fixed-dose otic solution administered exclusively via the topical auricular route (eardrops). The method of use is standardized to ensure targeted, localized application of the two active ingredients.

Standardized Dosing and Frequency

The dosing regimen calls for the instillation of 4 drops per single application. This administration is typically carried out two to three times daily in the affected ear. This regimen applies to both adults and pediatric patients, with the standardized 4-drop application not requiring age-specific dose adjustments for the localized treatment.

Preparation and Administration Conditions

A crucial requirement before administration is that the container must be carefully warmed by holding it between the hands. This preparatory step is mandated to avoid vestibular reaction, such as dizziness, which can occur if a cold liquid is instilled directly into the ear canal. The patient should be positioned with the affected ear facing upwards during the procedure.

Treatment Duration and Administration Constraint

The use of Finoten is restricted to a short-term course, with the total duration of treatment limited to a maximum of 7 to 10 days. Administration must be discontinued after this period unless re-evaluated. A key, non-negotiable instruction relating to the administration pathway is that the medicine must not be administered in the presence of a known or suspected perforation of the tympanic membrane.

Recent Clinical Evidence

Research Evidence / Overview of Studies

Phase I and II Trials

Initial studies evaluated the drug's safety in healthy volunteers and dose ranges for individuals with the condition. These early trials investigated the drug's mechanism of action as a non-steroidal mineralocorticoid receptor antagonist (MRA) and examined its pharmacokinetics in the body.

Small studies primarily evaluated the agent in individuals with mild-to-moderate disease and reported findings related to changes in reported symptoms and pain levels.

Controlled Clinical Trials (Phase III)

Major research, including the FIDELIO-DKD trial, focused on the agent's effects on the progression of chronic kidney disease (CKD) and cardiovascular (CV) outcomes in patients with Type 2 diabetes.

Randomized, controlled trials (RCTs) have focused on primary endpoints, including the time to a composite of renal events (e.g., kidney failure or sustained eGFR decline) and a composite of CV events (e.g., CV death or non-fatal myocardial infarction).

CKD Outcomes: Studies reported an association between Finoten and a reduced risk of the composite renal endpoint compared to placebo.
CV Outcomes: Research also reported an association with a reduced risk of the composite CV endpoint.

Long-Term Monitoring and Observational Data

Studies involved monitoring data across various patient groups to assess long-term outcomes. Observational studies have monitored effects for up to two years post-treatment.

Safety Data

Hyperkalemia: Studies reported an increased occurrence of hyperkalemia (high potassium levels) compared to placebo. This is a known risk monitored in clinical use.
General Tolerability: The overall incidence of treatment-emergent adverse events was generally similar between the Finoten and placebo groups, though the pattern of events differed.

Further research is ongoing to assess long-term outcomes and comparative data, particularly in patient subgroups without diabetes or those with heart failure.

Frequently Asked Questions (FAQ)

Common questions about Finoten (FAQ)

Q: Are there any medications or supplements I should avoid while using Finoten?

Official regulatory documents indicate that Finoten's topical administration route leads to minimal systemic absorption. Due to this, official data indicates that clinically significant interactions with other medications, supplements, food, or alcohol are not anticipated. No specific drug combinations are formally listed as prohibited in the product labeling.

Q: Can Finoten be used during pregnancy or breastfeeding?

Regulatory information indicates that use during pregnancy and breastfeeding is generally permitted, if a healthcare provider determines it is necessary, due to the low potential for systemic absorption when the eardrum is intact. However, official guidance confirms that caution is required when the product is administered to a nursing mother.

Q: What should I do with unused or expired Finoten?

Finoten that is expired or no longer needed should be disposed of properly to avoid environmental contamination. Regulatory guidance states that this medicine must not be thrown away via wastewater or with household waste. For specific disposal guidance, a pharmacist should be consulted.

Q: What should I do if the eardrops cause me dizziness or make me feel sick?

Nausea has been reported as a common side effect in clinical trials for this product. Dizziness may also occur, which is a known reaction if a cold liquid is instilled into the ear. If these or other concerning symptoms occur, it is recommended to stop using the eardrops and consult a medical professional.

Q: What is Finoten used to treat?

Finoten is officially indicated for the localized symptomatic treatment of pain in the ear. It is classified as an analgesic and local anesthetic combination designed to provide relief from the discomfort associated with specific ear conditions.

Q: What if I accidentally swallow the Finoten drops?

Finoten is intended only for use in the ear and should not be swallowed. In the event of accidental ingestion, regulatory product information directs that a doctor or poison control center should be contacted immediately for guidance.

How should Finoten be stored and disposed of?

How to Store and Dispose of Finoten?

Finoten (Lidocaine/Phenazone otic solution) must be stored according to specific regulatory requirements to maintain its stability.

Storage Conditions and Shelf Life

Finoten must be kept at a temperature that does not exceed 30 C and should be stored in the original package to ensure protection from light. The medicine must always be kept out of the sight and reach of children.

Once the container is opened, the in-use shelf life is limited, typically to 30 days or up to six months, depending on regional regulatory instructions. The product must not be used after this period or the printed expiry date.

Disposal Instructions

Unused or expired Finoten must be disposed of properly to avoid environmental contamination. Do not throw away any medicines via wastewater or household waste. Consult a pharmacist for guidance on how to safely dispose of the product.

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

Available in countries:

Estonia

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