Interbi

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Interbi

Medically reviewed

Marina Burgos

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 Interbi

Interbi is an antifungal medication based on Terbinafine Hydrochloride, classified as a synthetic allylamine. It is specifically designed to eliminate the fungal organisms responsible for common infections in the skin, hair, and nails.

Property Description
Active Ingredient Terbinafine Hydrochloride
Form Tablet, Oral Granules, Cream, Gel, Solution, Spray
Pharmacological Class Allylamine Antifungal
Route of Administration Oral and Topical
Origin Synthetic

What Type of Medicine is Interbi?

Interbi is an Antifungal medication defined by the potent Active Ingredient, Terbinafine Hydrochloride. This drug is formally classified as an Allylamine Antifungal. Its classification places the medicine among a specific group of laboratory-derived synthetic chemical agents. The specialized nature of the Allylamine class is clinically recognized for its high efficacy against dermatophytes. Terbinafine Hydrochloride is consistently utilized as a Single-component product, focused solely on its primary function.

Composition and Available Forms

The therapeutic effect of Interbi relies entirely on its active constituent, Terbinafine Hydrochloride. The medication is manufactured in multiple Dosage forms, spanning two primary Route of administration types. For infections requiring Systemic use, it is formulated as an Oral medication, such as the Tablet or Oral Granules. For more superficial, localized infections, it is prepared for Topical application as a Cream, Gel, Solution, or Spray. These different forms are designed to treat infections either at the surface or internally, providing versatility.

General Therapeutic Purpose

The general purpose of Interbi is to stop the spread of persistent Fungal infections by delivering a definitive Fungicidal action, particularly against the dermatophytes. This action is characterized by the elimination of the fungal cell, ensuring that the Allylamine Antifungal specializes in clearing pathogens from the skin and nails to allow the body's tissues to recover.

What side effects are possible with Interbi?

Possible side effects and safety information

The officially documented safety profile for Interbi, which contains Terbinafine Hydrochloride, is classified based on frequency categories and System Organ Classes (SOC) established in regulatory documents such as the FDA DailyMed and the European Summary of Product Characteristics (SmPC).

Very Common (ge 10% of patients) adverse reactions typically include headache, gastrointestinal symptoms (such as diarrhea, dyspepsia, and nausea), and musculoskeletal reactions (such as joint or muscle pain). Common effects (ge 1% to <10% of patients) include a rise in liver enzyme abnormalities and changes in taste, known as taste disturbance (dysgeusia).

Serious Safety Considerations

The oral formulation is associated with Rare but serious adverse reactions. These include severe hepatic dysfunction such as hepatic failure (some cases resulting in death or liver transplant), hepatitis, and cholestasis. The profile also documents Very Rare instances of severe skin reactions, including Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), as well as blood dyscrasias (e.g., severe neutropenia).

Restrictions and Time-Related Patterns

Official labeling mandates that oral Interbi is contraindicated in individuals with chronic or active liver disease and is not recommended in patients with severe renal impairment (creatinine clearance <30 ml/min). Liver function tests (LFTs) must be performed before starting treatment. The label also notes that taste disturbance, including taste loss, and smell disturbance may be prolonged (greater than one year) or potentially permanent despite discontinuation of therapy.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory documentation for Interbi (Terbinafine) addresses the acute ingestion of supratherapeutic doses. This information focuses strictly on the expected clinical presentation and the mandatory emergency response required. Overdose cases, including ingestion of up to 5 grams, have been reported and managed using supportive care.

Overdose Scope Details based on Regulatory Labels
Documented Presentations Overdosage may be associated with symptoms affecting the gastrointestinal system, such as nausea, vomiting, and abdominal pain. Central Nervous System (CNS) effects, including dizziness and headache, are also documented manifestations.
Physiological Systems Gastrointestinal system, Central Nervous System, and dermatologic system (e.g., rash) are the systems most frequently affected in acute overdose.
Emergency Response Seek immediate medical attention or contact a healthcare professional or Poison Information Centre immediately in the event of suspected or confirmed overdosage.

Official Overdose Management

  • No specific antidote is known for overdose with oral Terbinafine.
  • The recommended management consists of providing symptomatic and supportive treatment.
  • Procedures for elimination of the drug, such as the administration of activated charcoal or gastric lavage, may be undertaken under medical supervision based on clinical judgment.

Connection to the Overall Overdose Profile The regulatory profile establishes that acute overdose is primarily characterized by the transient symptoms of gastrointestinal and CNS distress. The presence of these documented manifestations is the key trigger for the mandated action to seek urgent medical help, as standard management relies entirely on supportive measures and drug elimination procedures.

Therapeutic Uses of Interbi

WHAT INTERBI TREATS: MAIN USES AND BENEFITS

Interbi (Terbinafine) is used for managing the symptoms related to inflammatory or irritative states affecting the skin, hair, and nails. Its primary use is in situations where systemic action is needed when additional management is required to address persistent symptoms.


Therapeutic Focus and Symptom Relief

This medication is commonly used across conditions presenting with chronic or recurrent manifestations, including deep-seated infections of the nails (onychomycosis), scalp (Tinea Capitis), and widespread skin mycoses like Tinea Corporis, Tinea Cruris, and Tinea Pedis. It is applied in addressing pronounced structural damage, such as nail thickening, discoloration, and brittleness, and may assist with the process of the nail or hair regaining its healthy appearance.

The medication is relevant for easing intense pruritus (itching), widespread scaling, and inflammatory redness that interfere with daily comfort. This provides support that helps ease the overall symptom burden.

“It is commonly used across conditions presenting with chronic or recurrent manifestations, providing support that helps ease the overall symptom burden.”

Quick Fact: Relief for Persistent Fungal Discomfort


Deep-Seated and Extensive Use

Interbi is applied in settings where short-term symptom management is appropriate for conditions presenting with deep-seated or chronic manifestations in tissues or those that are associated with acute or disruptive episodes due to their extent. This supportive treatment contributes to improved comfort during periods of heightened symptoms, and helps maintain a sense of stability when symptoms are more noticeable.

Regulatory References

  1. NIH DailyMed Prescribing Information

Eligibility and Restrictions for Use

Who Can and Cannot Use Interbi?

This section describes the officially documented population eligibility and non-eligibility for systemic Interbi (Terbinafine Hydrochloride), as defined by government regulatory authorities.


Contraindications and Restrictions

Category Population Status
Absolute Contraindication Individuals with a history of allergic reaction to oral terbinafine or patients with chronic or active hepatic disease.
Use Not Recommended Patients with renal impairment where creatinine clearance is less than 50 mL/min. Pregnant and breastfeeding women.
Use with Caution Patients with pre-existing psoriasis or lupus erythematosus.

Age-Specific Eligibility

Systemic use of Interbi is approved for adults for onychomycosis and for children 4 years of age and older (oral granules) for tinea capitis. Safety and efficacy have not been established in children younger than 4 years of age. For older adults, the possibility of pre-existing impairment of liver or kidney function should be considered by the regulator.


Regulatory Summary

Regulatory documents use classifications such as Contraindicated, Not Recommended, and Use Not Established to define the boundaries of permitted use based on hepatic and renal function status, hypersensitivity history, and age.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile of systemic Interbi (Terbinafine) is primarily defined by pharmacokinetic interactions, specifically through the cytochrome P450 (CYP) enzyme system.

Interbi is officially classified as a potent inhibitor of the CYP450 2D6 enzyme. This metabolic effect decreases the clearance of co-administered medicines that are predominantly cleared by this pathway, potentially increasing their plasma concentrations.

Documented Exposure-Altering Interactions

Interaction Type Interacting Substance / Category Official Outcome Description
Increased Exposure of Co-administered Drugs CYP2D6 Substrates (e.g., Desipramine, certain Beta-Blockers) Significant increase in Cmax and AUC of the co-administered drug
Increased Exposure of Interbi CYP Inhibitors (e.g., Cimetidine, Fluconazole) Decrease in Terbinafine clearance, leading to higher plasma levels
Decreased Exposure of Interbi CYP Inducers (e.g., Rifampicin) Significant increase in Terbinafine clearance, leading to lower plasma levels

Co-administration with warfarin requires monitoring of prothrombin time due to documented spontaneous reports of changes in the International Normalized Ratio (INR).

Separately, Interbi has been observed to decrease the clearance of Caffeine and increase the clearance of Cyclosporine. No clinically significant interactions with food are documented; the medicine’s absorption is similar whether taken with or without food. Topical forms of Interbi have negligible systemic absorption and no documented interaction risk.

Mechanism of Action

Mechanism of Action: Terbinafine Hydrochloride

Interbi's action is fungicidal, produced by a dual mechanism that results in the destruction of the fungal cell. The mechanism exhibits selectivity, focusing on metabolic machinery crucial for fungal existence.

Targeted Inhibition of Fungal Enzyme Systems

Interbi acts as a non-competitive inhibitor of the enzyme Squalene Epoxidase, a molecular target found only in fungal cells. This enzyme is crucial for the early stages of the fungal Ergosterol Biosynthesis Pathway. By blocking this step, the drug prevents the necessary conversion of squalene, thereby initiating a cascade of destructive consequences unique to the pathogen. This enzymatic interference is the basis for the mechanism's specificity.

Fungal Cell Destruction via Dual Toxicity

The inhibition of Squalene Epoxidase creates two simultaneous physiological failures that lead to cell death. First, it causes a critical deficiency of Ergosterol in the fungal cell membrane, which leads to membrane destabilization. Second, it causes the buildup of the intermediate metabolite Squalene to toxic, damaging concentrations within the fungal cell cytoplasm. This combination of structural failure and intracellular poisoning culminates in Fungal Cell Lysis (rupture), producing a fungicidal effect.

Mechanistic Selectivity and Constraints

The mechanism is selective because the fungal Squalene Epoxidase is far more susceptible to inhibition than its human equivalent, confining the destructive effect to the pathogen. This mechanism, however, is constrained by the pathogen's biology: the drug exhibits fungicidal action against dermatophytes but is functionally irrelevant against organisms that do not utilize the ergosterol pathway, and may only be fungistatic against certain yeast species.

Dosage and Administration Information

How to Use Interbi: Administration Overview

Interbi (Terbinafine) is used according to distinct protocols depending on the route of administration, which is either oral for systemic treatment or topical for localized use. These protocols specify the correct form, dose, and duration for treatment.


Standardized Oral Dosing

The standard oral dosage for adults, such as for the management of onychomycosis, is a fixed 250 mg once daily regimen. The duration of this continuous daily treatment is determined by the infection site: 6 weeks for fingernail onychomycosis and 12 weeks for toenail onychomycosis. Oral tablets may be taken with or without food.

For pediatric patients receiving the oral granule form for Tinea Capitis, administration is based on body weight, and the medicine must be taken with food. The granules are to be sprinkled onto a spoonful of soft, non-acidic food, such as mashed potatoes, and the mixture must be swallowed whole without chewing.


Usage Constraints and Duration

Topical formulations, such as the 1% cream, are typically applied once or twice daily over a shorter, fixed course. The oral formulation is subject to specific constraints: use is not recommended in patients with severe renal impairment (creatinine clearance ≤ 50 mL/min) and is contraindicated in patients with chronic or active liver disease. If an oral dose is missed, it should be taken as soon as possible, unless the next scheduled dose is due, in which case the missed dose is skipped.

Recent Clinical Evidence

Research evidence / Overview of studies for Interbi

Evidence for Use in Fungal Nail Infection (Onychomycosis)

Research on Interbi (Terbinafine) for fungal nail infection, known as onychomycosis, primarily involves large Randomized Controlled Trials (RCTs). These studies were conducted to compare oral Interbi against a placebo (an inactive substance) or other active comparator medicines. Research examined key outcomes related to the physical status of the nail, focusing on mycological endpoints—lab tests to confirm the clearance of the fungus—and clinical endpoints—observing the appearance and thickness of the nail.

Studies explored the impact of short-term treatment, typically lasting 6 to 12 weeks, and then monitored patients for extended periods, sometimes up to a year. Findings describe patterns observed in these studies related to measurements of a negative fungal test status following short-term treatment. The evidence contributes to understanding measurements of mycological status in the observed populations. What remains uncertain is the long-term durability of clearance beyond the standard one-year follow-up, and data for certain groups, such as older adults with multiple chronic health issues, remain insufficient.

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

Research has explored Interbi's role in athlete's foot (Tinea Pedis), covering both the topical formulations and the oral tablet for more chronic cases. The evidence base comes from short-term RCTs that evaluated the topical product against a vehicle, and from trials of the oral tablet. Research examined the time needed for measurements of symptom changes linked to inflammatory or irritative states. Studies reported measurements of mycological status after only one to two weeks of topical application.

Evidence for Use in Scalp Ringworm (Tinea Capitis)

Interbi was evaluated in research exploring the systemic treatment of Tinea Capitis, an infection primarily affecting children. Research monitored measurements of both mycological status and the status of overall clinical metrics in children, typically aged 4 to 12 years. Findings describe group patterns related to measurements of mycological and clinical status within the observed pediatric populations. Data for adults with Tinea Capitis and some subgroups of children remain insufficient.

Frequently Asked Questions (FAQ)

Common questions about Interbi (FAQ)


Q: How quickly does Interbi usually start working?

Clinical studies have indicated that the average time observed to achieve overall success (healthy nail growth) was approximately 4 months for fingernails and 10 months for toenails in the study populations. While the medicine begins to work internally soon after starting treatment, visible signs of improvement take time due to the nature of fungal infections in the nails.


Q: Why do doctors prescribe Interbi instead of other options?

Official information describes Interbi as a powerful fungicidal agent, meaning it actively destroys fungal cells. The drug's profile makes it a highly effective option against dermatophytes, which is why it is commonly cited in clinical literature as an important oral treatment choice.


Q: Does Interbi cause drowsiness or tiredness?

Drowsiness is not listed as a common effect. However, unusual tiredness or weakness has been reported in official documents. This symptom may also be associated with rare, serious liver problems detailed in the official warnings.


Q: How long do the effects of Interbi last?

Official product information suggests that the medicine remains in tissues, such as the skin and fat, for an extended duration after the final dose. Despite this long presence in the body, long-term follow-up studies indicate that clinical relapse (the infection returning) is possible after treatment is completed.


Q: Has Interbi been approved in major countries like the US or Europe?

Yes, regulatory records show that the oral formulation of Interbi was approved for use in the United States by the FDA in 1996. The medicine also became available in Europe in 1991. Its approval is based on research evidence reviewed by these and other major regulatory bodies.


Q: What does 'contraindication' mean for Interbi?

A contraindication is a specific situation or pre-existing medical condition that would make the use of a medicine potentially unsafe. Official documents list absolute contraindications for Interbi, such as having chronic or active liver disease or a known allergy, which defines conditions where use of the medication is generally considered unsafe or inappropriate.


Q: What are the long-term data trends for Interbi?

Studies included long-term follow-up to check for durability after the initial treatment course. Data for toenail infection showed a clinical relapse rate of approximately 15% in patients evaluated one year or more after they stopped taking the medication.


Q: What are the main research findings that led to Interbi's approval?

The key research findings that supported approval demonstrated high rates of mycological cure, meaning the fungus was officially cleared based on lab tests. Results showed clearance rates of 70% for toenails and 79% for fingernails in the observed study populations.


Q: Does Interbi affect birth control pills?

Official patient information suggests the medicine is not likely to affect hormonal birth control pills. However, gastrointestinal distress, such as vomiting or severe diarrhea, can potentially reduce the absorption of certain oral contraceptives.


Q: Do you need a prescription to get Interbi?

This depends on the form of the medicine. The oral forms of Interbi (tablets and granules) require a prescription (Rx) from a healthcare provider. Many topical forms (creams, solutions, sprays) that are used for skin infections are typically available over-the-counter (OTC).


Q: Does Interbi interact with common pain relievers like ibuprofen?

According to patient information, the medicine is generally considered safe to take with non-opioid pain relievers such as ibuprofen, paracetamol, diclofenac, or naproxen. The interaction profile primarily concerns other categories of drugs.


Q: Can Interbi be taken with vitamins or herbal products?

Regulatory guidance notes that the safety of combining the medicine with most herbal remedies, supplements, or vitamins is not fully established. These products are not typically tested for interactions in the same way as prescription medicines, so official information on these combinations may be limited.


Q: Is Interbi habit-forming or addictive?

No, official records confirm that the medicine is not classified as a controlled substance by the Drug Enforcement Administration (DEA). Therefore, Interbi is not considered habit-forming or addictive.


Q: Is there a generic version of Interbi available?

Yes, Interbi is widely available in its generic form, which is known by the active ingredient name, terbinafine hydrochloride tablets. The FDA approved the generic version in 2007.


Q: Does Interbi affect blood pressure?

There is no official evidence that the medicine causes a direct change in blood pressure. However, it can interact with certain beta-blocker heart medications that regulate blood pressure, which may necessitate monitoring by a physician.


Q: Are there any known interactions between Interbi and alcohol?

Although there is no direct chemical interaction, both the medicine and alcohol can potentially affect the liver. Due to the rare, serious risk of liver injury associated with the medicine, healthcare providers commonly advise limiting or avoiding alcohol during the treatment period.


Q: Does Interbi have a 'Black Box Warning' from the FDA?

The medicine carries serious warnings regarding rare cases of severe liver failure, some of which have resulted in transplant or death. These warnings are prominently featured in the official prescribing information's Warnings section to emphasize the importance of monitoring liver function.


Q: Does Interbi cause weight changes?

Weight loss has been reported indirectly in the official safety profile. This may occur secondary to a loss of appetite caused by the reported changes in or permanent loss of taste or smell, which are known side effects.


Q: What if I take Interbi at a different time of day than usual?

The oral tablets can be taken with or without food and are prescribed as a single daily dose. Official labeling addresses missed doses but does not provide specific guidance on variable timing for daily administration.


Q: Can I drive while taking Interbi?

Official patient information advises that individuals experiencing side effects such as dizziness or unusual tiredness should consider avoiding driving or operating machinery. Discussing any potential impact with a healthcare professional is recommended.


Q: Are there any specific lifestyle changes recommended when starting Interbi?

The official safety leaflets note that the medicine can make your skin more sensitive to sunlight (photosensitivity). If sun exposure is unavoidable, individuals may consider measures such as using sunscreen and protective clothing.


Q: Where can I find the official regulatory information for Interbi?

Official prescribing information, known as the Full Prescribing Information or Summary of Product Characteristics (SmPC), is available online. You can typically find this authoritative information on regulatory websites such as DailyMed (NIH) or the FDA Drug Approval Package website.


How should Interbi be stored and disposed of?

The official labeling for Interbi (Terbinafine) dictates specific rules for storage and disposal to ensure stability and safety.

Official Storage Requirements

Condition Requirement
Temperature Store at controlled room temperature (20 C to 25 C) and avoid excessive heat and freezing [
Protection Keep in the original container, tightly closed, and protected from light and moisture [
Child Safety Must be stored out of the reach and sight of children [
Topical Stability Topical cream must be discarded after 28 days of first opening [

Disposal Instructions

Unused or expired medication must be disposed of according to local requirements. The product should not be flushed down the toilet or placed in household waste, but instead should be taken to a medicine take-back program or disposed of following government-approved household guidelines for non-flushable medications.

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

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