Elater

Quick links to important sections

Elater

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 Elater

Property Description
Active ingredient Terbinafine Hydrochloride
Form Tablet (Oral), Cream/Solution (Topical)
Pharmacological class Antifungal Agent (Allylamine)
Common use Eliminating fungal infections
Origin Synthetic (Naphthalene Derivative)

What is Elater and Its Classification?

Elater is a specific pharmaceutical preparation containing the active ingredient Terbinafine Hydrochloride, a compound primarily employed to address fungal infections. This medicine is formally classified as an antifungal agent, specifically belonging to the allylamine chemical class. This substance is synthetic, a chemically synthesized derivative of the naphthalene structure, and is used as a single-ingredient product. Terbinafine is utilized for its recognized efficacy in combating dermal and nail fungal infections, a critical role it plays in dermatological care. The fundamental purpose of the allylamine class is the robust elimination of fungal organisms, particularly the dermatophytes responsible for the majority of skin and nail mycoses.


Elater's Forms and General Purpose

Elater is produced in diverse dosage form(s), allowing for both localized and internal use. It is available as topical preparations (cream, gel, or solution) and for systemic internal treatment, generally as an oral tablet. This range of forms dictates the route of administration. The oral tablet is used to achieve systemic circulation, ensuring the drug reaches deep-seated infections that topical applications cannot fully penetrate. Terbinafine is distinctive among antifungals because its mechanism is fungicidal against key pathogens like dermatophytes, meaning it directly kills the fungal cells, rather than merely inhibiting their growth. The direct fungicidal action means the medicine is designed to definitively clear the infection by destroying the fungal organism itself.

What side effects are possible with Elater?

Possible Side Effects and Safety Information

The safety profile of Elater (Terbinafine Hydrochloride) is documented by regulatory authorities, classifying possible reactions according to their frequency and the body system affected. The medicine is associated with a range of effects, spanning from frequently reported, less severe symptoms to rare but serious systemic reactions.

Adverse Reactions by Frequency

Adverse reactions are formally categorized based on the likelihood of occurrence:

  • Very Common: These include nervous system effects such as headache, gastrointestinal disturbances like nausea, diarrhea, dyspepsia, and abdominal pain, and musculoskeletal symptoms like arthralgia and myalgia.
  • Uncommon: This category includes sensory changes, specifically taste disturbance (dysgeusia) or loss of taste (ageusia).
  • Rare: Documented rare effects involve the liver, including cases of hepatic failure, hepatitis, cholestasis, and jaundice, as well as general symptoms like malaise and fever.

Systemic Safety Considerations

The safety profile includes rare, serious adverse reactions documented in regulatory labeling across multiple organ systems:

  • Hepatobiliary Disorders: Serious hepatic failure has been reported, sometimes requiring liver transplant or leading to fatal outcomes, and can occur in individuals with or without pre-existing liver conditions.
  • Dermatological Reactions: Rare but severe skin disorders, such as Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been documented.
  • Hematological Effects: Rare reports include blood dyscrasias like neutropenia and agranulocytosis.

Safety Restrictions and Patterns

The official labeling defines specific constraints and duration-related patterns:

  • Contraindication: Use of oral Elater is restricted and is contraindicated in patients with chronic or active liver disease.
  • Time-Related Pattern: Taste disturbance, while uncommon, may be prolonged, potentially persisting or recovering slowly after treatment discontinuation.

Overdose and Emergency Response

The official regulatory documents define the overdose profile of Elater by detailing specific clinical manifestations and mandating immediate actions based on symptom severity. Documented overdose presentations may include gastrointestinal distress, such as nausea, vomiting, and epigastric pain, as well as systemic effects like dizziness, headache, and a rash. Overdose may also affect the urinary system, presenting as frequent urination.

In the event of an accidental ingestion of a large amount, individuals are required to seek immediate medical attention. Urgent contact with emergency services is specifically mandated if severe, life-threatening outcomes occur, including collapse, seizure, trouble breathing, or a state of being unable to be awakened.

Regulatory management confirms that no specific antidote is known for the drug. Procedural steps focus on supportive and symptomatic measures, alongside efforts to eliminate the drug from the body, such as the administration of activated charcoal. This approach reflects the required protocol for managing the effects of systemic exposure, with hospital monitoring and observation potentially required following severe events. The official overdose information does not document specific additional risks for pediatric, geriatric, or renally impaired populations.

Therapeutic Uses of Elater

Elater is commonly used to help with a variety of conditions presenting with systemic or localized discomfort. The core domain is applied across areas where additional symptomatic support is needed, particularly in conditions characterized by periods of heightened symptoms that may escalate temporarily. This class of agents is relevant for easing symptoms related to inflammatory or irritative states, such as those linked to joint swelling and stiffness, which may interfere with daily functioning.

Quick Fact: Support for Physical Discomfort

Elater helps manage symptom clusters that can become intense or disruptive, including symptoms related to physical discomfort like headaches, muscular aches, and menstrual pain. The use is applied in clinical settings where short-term symptomatic assistance is appropriate. The therapy supports patients during difficult episodes by easing distress and assists with maintaining functional stability when symptoms become more noticeable.

The medicine is commonly used to help with acute or episodic manifestations such as minor aches, stiffness associated with inflammatory states, and pain that creates noticeable functional strain.

“The therapy contributes to easing the overall symptom load during periods of heightened symptoms, which supports general well-being during symptomatic phases.”

Regulatory References

  1. NIH MedlinePlus Drug Information overview

Eligibility and Restrictions for Use

The official regulatory eligibility profile for Elater defines specific groups who must not use the medicine and others for whom use is restricted or not established, based on authoritative government documentation.

Contraindicated Populations

Elater is contraindicated and must not be used by patients with a known hypersensitivity to the active substance or any non-active ingredient in the formulation. Use is also contraindicated in patients with a specific, severe, and uncontrolled pre-existing cardiac or hepatic condition as explicitly listed in the regulatory label.

Age and Physiological Restrictions

Population Group Eligibility Status (Regulatory)
Pediatric Patients (e.g., < 18 years) Safety and efficacy are not established.
Geriatric Patients Use may require heightened monitoring due to age-related organ function.
Pregnancy Not recommended; use requires effective contraception during therapy.
Lactation Not recommended due to potential risk to the breastfed infant.

Organ Function Limitations

Patients with moderate or severe renal impairment or hepatic impairment are subject to restricted or conditional use, as the drug's clearance may be affected. Use in certain severe stages of organ impairment is classified as not recommended or, in some cases, contraindicated.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official regulatory profile for Elater (Terbinafine) is defined by its pharmacokinetic interactions, primarily its status as a potent inhibitor of the CYP450 2D6 enzyme. This metabolic inhibition increases the plasma exposure of co-administered medicines that are metabolized by this enzyme, such as certain antidepressants (desipramine) and beta-blockers. For example, co-administration with Terbinafine is formally documented to cause a significant increase (up to 5-fold in AUC) of desipramine exposure.

Interaction severity is also influenced by other metabolic agents. Cimetidine, an inhibitor, is documented to reduce Terbinafine clearance by 33%, increasing its exposure. Conversely, Rifampin, an inducer, is documented to increase Terbinafine clearance by 100%, leading to reduced exposure of the medicine. Co-administration of Fluconazole also results in documented increases in Terbinafine’s plasma concentrations.

Specific administration constraints exist for the oral granule formulation, which must be taken with a soft, non-acidic food, and must not be co-administered with applesauce or fruit-based foods. While Terbinafine tablets may be taken without regard to food, co-administration of oral Terbinafine with alcohol is generally not recommended due to increased liver risk. Furthermore, the use of oral Terbinafine is formally contraindicated in patients with chronic or active liver disease due to the heightened severity and risk of drug clearance issues.

Mechanism of Action

Targeted Molecular Inhibition: Blocking Fungal Ergosterol Production

Elater's mechanism begins with the highly specific, non-competitive inhibition of the fungal enzyme Squalene Epoxidase (SQLE) . This action immediately halts the conversion of squalene into the necessary precursor for ergosterol, the primary structural lipid of the fungal cell membrane.


Causal Cascade: Dual Toxicity and Fungicidal Action

The inhibition triggers a dual-action mechanism: first, the fungal cell becomes severely deficient in ergosterol, compromising its structural integrity; second, toxic concentrations of un-metabolized squalene rapidly accumulate, causing physical disruption of internal organelles. This combined failure of membrane structure and internal intoxication results in the direct and lethal breakdown (lysis) of the fungal cell, a fungicidal action where the mechanism results in cell death rather than solely inhibiting growth.


Mechanistic Selectivity and Constraints

The mechanism exhibits marked selective toxicity due to the drug's significantly greater affinity for fungal SQLE compared to the analogous human enzyme. However, the fungicidal action can be inherently constrained against certain yeasts (e.g., Candida species) where the effect is primarily growth-inhibiting (fungistatic), and against resistant strains bearing mutations in the SQLE gene which reduce the drug’s binding capacity. This susceptibility variation defines the boundaries where the mechanism must be sufficiently engaged to achieve fungal cell death.

Dosage and Administration Information

How to Use Elater: Administration Guidelines

The usage of Elater (Terbinafine Hydrochloride) is determined by its pharmaceutical form, with administration being either oral for systemic infections or topical for localized skin infections. The choice of route is determined by the site and extent of the condition. The oral form is available as tablets (typically 250 mg strength) and granules, while topical forms include creams and solutions (typically 1% strength).

Dosing and Frequency

For systemic treatment in adults, the standard regimen is one 250 mg tablet taken once daily. The duration of this continuous therapy is based on the affected area: typically 6 weeks for fingernail infections and 12 weeks for toenail infections. Topical products are applied once or twice daily, generally for a shorter course of 1 to 2 weeks for common cutaneous fungal infections.

Administration Conditions and Adjustments

Oral tablets may be taken with or without food. However, the oral granules, primarily used for weight-based pediatric dosing, must be mixed with a small amount of soft, non-acidic food and swallowed immediately. Before starting oral treatment for onychomycosis, laboratory confirmation of the fungal diagnosis is utilized.

Dosage adjustments apply in certain populations; for instance, the systemic use of Elater is not recommended in patients with pre-existing chronic or active liver disease, or with severely impaired renal function. If a daily dose is missed, it should be taken as soon as remembered unless the next dose is near, in which case the missed dose is skipped; a double dose must not be taken.

Recent Clinical Evidence

Research evidence / Overview of Studies for Elater (Terbinafine)

This section summarizes the research used to evaluate Elater, detailing the types of trials conducted, the outcomes measured, and noted limitations. This is a descriptive overview of the research landscape and not clinical advice.


Evidence for Use in Fungal Infections of the Nails (Onychomycosis)

Research exploring the use of oral Elater relies on numerous high-level Randomized Controlled Trials (RCTs) and Meta-Analyses. Studies examine two key outcomes: Mycological Cure (fungal absence confirmed by lab test) and Clinical Cure (measurements of change in nail appearance). Due to slow nail regrowth, trials were designed to observe measurements of Complete Cure over extended follow-up time, sometimes up to a year or more after treatment. The use of different definitions for "clinical cure" across various global trials means that a direct comparison of success rates between trials is difficult to establish.

Evidence for Use in Fungal Infections of the Skin (Tinea Pedis, Tinea Corporis, Tinea Cruris)

The evidence base for Elater in patients with common skin infections includes short-term RCTs for both oral and topical preparations. These studies focused on measuring the speed and extent of Mycological Cure and tracking changes in Clinical Signs and Symptoms Scores. While findings describe short-term patterns, comparative evidence against all other topical and oral antifungal agents using identical protocols is often lacking.

Evidence for Use in Tinea Capitis (Scalp Fungal Infection)

Research involved RCTs conducted primarily in children. Studies examined outcomes by the specific fungal species, observing that findings may vary depending on whether the infection was caused by Trichophyton or Microsporum species. Evidence quality varies, indicating a need for further research to provide clearer context for all specific infectious organisms.

Research Gaps and Uncertainty

While substantial research exists, there is limited information for long-term outcomes, especially regarding the recurrence rate in certain special populations. The results apply only to the specific groups studied, and comparative evidence against all alternative treatments is not fully available across all indications.

Frequently Asked Questions (FAQ)

Common questions about Elater (FAQ)


Q: Are the side effects of Elater permanent?

Most side effects typically resolve once the medicine is stopped. However, official post-marketing reports indicate that taste and smell disturbances have sometimes been reported as prolonged or even permanent. Other rare effects, such as blood disorders like neutropenia, are typically noted as reversible upon treatment discontinuation.


Q: How is Elater eliminated from the body?

According to official product information, Elater is broken down primarily by the liver and eliminated from the body through the kidneys. Because these organs are key to clearance, patients with severe liver or kidney problems have specific use restrictions documented in the regulatory label.


Q: Are there any long-term effects of taking Elater?

Serious adverse reactions, including rare cases of liver failure and blood disorders, are documented in official safety information. Separately, studies and official information indicate that while rare, sensory changes like loss of taste or smell have been documented as prolonged or permanent in some post-marketing reports.


Q: What is the risk of having a serious allergic reaction to Elater?

Serious skin and hypersensitivity reactions, such as Stevens-Johnson syndrome, have been reported rarely in post-marketing experience. Official warnings indicate that symptoms such as a spreading rash, blistering, fever, or swelling of the face or throat should be immediately discussed with a healthcare provider.


Q: Are children allowed to use Elater?

Regulatory documents state that the safety and effectiveness of the oral form of Elater are not established for most conditions in pediatric patients. Therefore, the use of the medicine in children and adolescents is generally not recommended due to limited clinical data in this age group.


Q: How does a doctor decide if Elater is the right medicine?

The decision to prescribe is guided by multiple factors, including the required confirmation of a fungal diagnosis using laboratory tests. Additionally, the prescriber must review a patient’s medical history for contraindications, which are conditions like active liver disease or severe renal impairment where the medicine must not be used.


Q: How quickly should someone start feeling something after taking Elater?

While the medicine begins to act quickly in the body, visible results for infections like fungal nails take time because they depend on new, uninfected nail growth. The active substance stays accumulated in the nail bed for weeks to months, meaning visible improvement may only become apparent several months after the full course of treatment is finished.


Q: Does Elater affect sleep or cause drowsiness?

Official documents list changes in sleep pattern or trouble with sleeping as possible adverse reactions reported in post-marketing experience. These sleep disturbances are sometimes noted in reports also describing depressive symptoms.


Q: Is Elater addictive or habit-forming?

Official drug facts confirm that Elater is not classified as a controlled substance by regulatory agencies. This classification means the drug has no regulatory designation related to abuse potential.


Q: Does Elater cause weight gain or loss?

According to official reports, weight loss has been documented in some patients using the medicine. This is often associated with the reported side effect of taste or smell disturbance, which may lead to a decrease in food intake.


Q: Can Elater be crushed or split in half?

European regulatory documents state that the oral tablet can be divided into equal halves as it is scored. However, instructions are different for the granule formulation, which must be mixed whole with a small amount of food.


Q: Is it normal to feel a little dizzy when starting Elater?

Dizziness has been reported in post-marketing experience, although the frequency of this occurrence is not clearly established in clinical trials. Official information also notes that dizziness is a symptom associated with drug overdose.


Q: Does taking Elater affect driving or operating machinery?

Official documents contain warnings regarding caution when driving or operating machinery while using Elater. This guidance is due to reports of side effects such as dizziness, visual disturbances, and fatigue, which could impact coordination and reaction time.


Q: Does Elater interact with herbal supplements?

Regulatory guidance from official health bodies states that there is limited information to confirm the safety of taking the medicine alongside herbal supplements. This is because these products are generally not systematically tested for potential interactions with Elater.


Q: Is there a generic version of Elater available?

Yes, the medicine is available in a generic version. This generic version is sold under the name of the active ingredient, Terbinafine, and is considered therapeutically equivalent by regulatory authorities.


Q: How long does Elater stay in your system after stopping it?

The active substance is mostly cleared from the bloodstream within about seven to eight days after the final dose. However, Elater accumulates in the skin and nails, meaning traces of the medicine can remain present in those tissues for weeks to months after stopping treatment.


Q: Can Elater cause changes in mood or personality?

Official reports include the occurrence of depressive symptoms and other mood changes in some patients using the medicine. Official warnings emphasize that any changes in mood or personality should be promptly discussed with a healthcare provider.


Q: Can Elater be taken with coffee or tea?

Regulatory documents show that Elater can interfere with the way the body breaks down and clears caffeine. This means that taking the medicine may increase the effects of caffeinated drinks like coffee or tea.


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

According to UK government health guidance, it is generally considered safe to use the medicine alongside common over-the-counter pain relievers such as ibuprofen. Official guidance stresses the importance of always informing a healthcare provider of all medicines being taken.


Q: Is Elater considered a controlled substance?

The medicine is not classified as a controlled substance by regulatory agencies. This means the drug is not subject to the same strict controls regarding its prescribing, dispensing, or record-keeping as drugs with potential for abuse.


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

A contraindication is an official regulatory term that describes a situation or condition where the medicine must not be used. For Elater, having active liver disease is a contraindication because the potential harm to the patient outweighs any possible therapeutic benefit.


Q: Does Elater affect fertility?

Regulatory reviews of the medicine's safety profile indicate that there is no evidence that Elater reduces fertility in either men or women. However, due to limited data, use during pregnancy and lactation is typically not recommended.


Q: Can I stop taking Elater suddenly?

The course of treatment is fixed for a specific duration. Stopping the medicine early is not recommended by regulatory guidance, as this action can reduce the treatment's effectiveness. Premature discontinuation may lead to the fungal infection returning or becoming resistant to the medicine.


Q: Is Elater available over the counter?

The oral tablet form of the medicine is available by prescription only. Some topical formulations containing the active ingredient, Terbinafine, may be available over the counter, but the oral form is regulated and requires a prescription.


Q: What is the difference between brand-name Elater and its generic component?

The brand-name product is the original formulation, while the generic component contains the same active ingredient, Terbinafine. Regulatory bodies confirm that the generic version is therapeutically equivalent to the brand-name product.


Q: Are there specific symptoms that signal a serious side effect from Elater?

Yes, official labels list specific symptoms that signal the potential onset of a serious side effect. For example, signs of potential liver problems include yellowing of the skin or eyes (jaundice) or dark urine. Signs of severe skin reactions include a spreading rash or blistering.


Q: Can Elater be taken with vitamins?

Regulatory guidance states that there is limited information available to confirm the safety of using the medicine with general supplements, including vitamins. These products are not systematically tested alongside the drug for potential interactions.


Q: Does Elater need to be taken at the exact same time every day?

European regulatory documents state that the tablets should preferably be taken at the same time each day to maintain a consistent level of medicine in the body. The tablets may be taken with or without food.

How should Elater be stored and disposed of?

How to Store and Dispose of Elater?

Official regulatory guidelines dictate specific requirements for storing and discarding Elater (Terbinafine Hydrochloride) to ensure product integrity and safety.

Storage and Handling

Detail Requirement Statement
Temperature Oral tablets require storage at Controlled Room Temperature (20 to 25 C). Topical cream must not exceed 25 C.
Protection The product must be protected from direct light, heat, and moisture. The topical cream must not be frozen.
Container Keep the medicine in its original container and ensure the container is closed tightly.
Safety Elater must be stored out of the sight and reach of children.

Disposal

Any unused or expired product must be discarded in accordance with local regulations. It is officially required to avoid release to the environment, meaning the product must not be disposed of in wastewater or down the drain.

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

Available in countries:

Equivalent of Elater found in:

A-Z Index: