Terbinafin AL

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Terbinafin AL

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Method of action: Antifungal Broad Spectrum

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Overview of Terbinafin AL

Property Description
Active ingredient Terbinafine Hydrochloride
Primary Form Tablet (Oral)
Pharmacological class Allylamine Antifungal Agent
General Purpose To eliminate fungal pathogens
Origin Synthetic compound

Defining Terbinafin AL and its Antifungal Classification

Terbinafin AL is a specific synthetic pharmaceutical preparation that contains the active ingredient Terbinafine Hydrochloride. This medicine is broadly classified as an Antifungal Agent, specifically a synthetic allylamine. Terbinafin AL is often recognized as a generic version of the formulation, positioning it as an accessible alternative with the same core composition.

The identity of Terbinafin AL is rooted in its highly targeted approach to managing fungal pathogens. Terbinafine is a unique allylamine antifungal compound, clinically recognized for its potent activity against dermatophytes, which cause many common skin and nail infections. The medicine is designated as a systemic treatment option, meaning it is absorbed into the bloodstream to reach internal or deep-seated infection sites effectively, often when topical applications are insufficient.

Composition and Primary Systemic Form

The therapeutic action of the drug is entirely dependent on its sole component, Terbinafine Hydrochloride, making it a single-active-ingredient product. Terbinafin AL is most commonly provided as a tablet for oral use, which sets it apart from surface-level topical preparations.

The oral route is strategically chosen when treating infections, such as those embedded within the nail plate, because pharmacological studies have confirmed its high lipophilicity allows it to concentrate effectively in the skin and nails. The composition consists of the Terbinafine active substance along with a standard solid excipient base, ensuring reliable systemic delivery of the antifungal agent.

The General Purpose of Terbinafine Hydrochloride

The general therapeutic purpose of Terbinafin AL is to clear fungal infections by actively eliminating the causative organism, a function primarily achieved through its fungicidal action. The medicine accomplishes this by acting as a potent inhibitor of the fungal enzyme squalene epoxidase. This unique, well-researched mechanism disrupts the fundamental life cycle of the pathogen by preventing it from manufacturing the essential sterol needed for its cell membrane.

Regulatory References

  1. Terbinafine MEB Public Assessment Report
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What side effects are possible with Terbinafin AL?

Possible Side Effects and Safety Information

The official safety profile of Terbinafin AL (terbinafine) details adverse reactions across several physiological systems, classified by frequency as documented in regulatory sources such as the EMA and FDA. This information is intended to communicate the medicine's documented safety characteristics in a non-advisory manner.

Documented Adverse Reaction Classification

Adverse effects are formally categorized based on their rate of occurrence:

  • Very Common (may affect more than 1 in 10 people): Reactions include headache and gastrointestinal disturbances such as diarrhea, dyspepsia, and abdominal pain. Musculoskeletal symptoms like arthralgia (joint pain) and myalgia (muscle pain) are also classified as very common.
  • Common (may affect up to 1 in 10 people): Frequently documented effects include taste disturbance (dysgeusia), sometimes involving complete taste loss (ageusia), dizziness, and elevated liver enzyme values.

Serious and Systemic Safety Considerations

Regulatory documentation outlines infrequent but clinically significant safety events, typically classified as Rare or Very Rare.

Hepatobiliary Effects: Serious hepatobiliary reactions, including hepatitis, cholestasis, jaundice, and rare cases of liver failure (some resulting in transplant or death), are documented. Due to this risk, the medicine is contraindicated in patients with chronic or active liver disease.

Dermatologic and Hematologic Reactions: Very rare serious skin events include Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), and DRESS syndrome. Rare reports of blood dyscrasias, such as severe neutropenia and agranulocytosis, are also listed.

Time-Related and Population-Specific Safety Notes

Official safety notes detail that taste disturbance may be prolonged (lasting over one year) or, in some cases, permanent. The use of oral terbinafine is not recommended in individuals with severely impaired renal function. The label also documents the potential for precipitation or exacerbation of systemic and cutaneous lupus erythematosus.

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Overdose and Emergency Response

Overdose and when to seek help

The following information details the officially documented signs and required emergency actions in the event of an overdose with oral Terbinafin AL (terbinafine hydrochloride), strictly as described in government regulatory labeling.


Documented Overdose Manifestations

Acute overdose with terbinafine is associated with a cluster of symptoms primarily affecting the gastrointestinal and central nervous systems. Officially documented presentations include nausea, vomiting, and abdominal pain. Central effects reported are headache and dizziness. Other documented signs may include rash and frequent urination.

Official Emergency Actions and Management

In the event of a suspected or known overdose, official regulatory guidance mandates specific emergency actions:

  • Seek medical help immediately or contact a Poison Control Center right away.
  • Call emergency services (e.g., 911) if the person has collapsed, had a seizure, has trouble breathing, or cannot be easily awakened.

Treatment for overdose is symptomatic and supportive. Regulatory documents confirm that no specific antidote is known for acute terbinafine overdose. Management often includes considering the administration of activated charcoal to limit the systemic absorption of the active substance, as described in authorized prescribing information.

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Therapeutic Uses of Terbinafin AL

What Terbinafin AL Treats: Main Uses and Benefits

Terbinafin AL is an oral antifungal medication that is commonly used to help manage fungal infections, particularly those that are extensive or embedded in deep tissues. This systemic approach is relevant for conditions presenting with systemic or localized discomfort. The core therapeutic purpose is to address the underlying infection, which is relevant for managing chronic symptoms and supports the desired therapeutic goal.

The medicine helps address conditions such as onychomycosis (fungal infection of the nails) and various Tinea infections, including Tinea capitis (scalp ringworm), Tinea corporis (body ringworm), Tinea cruris (jock itch), and Tinea pedis (Athlete's foot). This treatment is often applied when appropriate for deep-seated infections that require therapeutic concentrations to reach the fungal organisms embedded in the nail or tissue structures, a common scenario is its use in infections where localized treatments have proven insufficient.

By applying the medication in areas of fungal growth, it is used to manage the infection, which supports the patient during symptomatic periods and helps with maintaining tissue integrity. This action helps address symptom clusters like intense itching, scaling, and skin fissuring, contributing to easing the overall symptom load.

“This systemic approach supports the patient during difficult episodes and assists with maintaining functional stability.”


Quick Fact: Relief for Deep-Seated Fungal Symptoms Terbinafin AL is commonly used to help manage symptoms related to physical discomfort and structural damage caused by fungi embedded in tissues like the nail plate or hair shaft, which is generally relevant when systemic medication is appropriate.

Regulatory References

  1. US National Library of Medicine’s DailyMed entry
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Eligibility and Restrictions for Use

Who can and cannot use Terbinafin AL?

The eligibility for Terbinafin AL (oral tablet) is strictly defined by regulatory documents, classifying patients into groups that are approved, restricted, or contraindicated.

Absolute Contraindications

The medicine must not be used in patients with a history of hypersensitivity to terbinafine or in those with chronic or active hepatic disease (liver disease). Use is also contraindicated for mothers who are breastfeeding, as the active substance is known to be excreted into breast milk.

Restricted and Not Recommended Use

Use is officially not recommended for the pediatric population (children and adolescents under 18) due to limited clinical data; specifically, safety and efficacy have not been established for treating onychomycosis in children. Treatment is also not recommended for pregnant women or for patients with renal impairment (impaired kidney function), including those with severe renal impairment. Regulators advise caution when prescribing to patients with pre-existing psoriasis or lupus erythematosus.

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What should I know about interactions with other medicines?

Interactions with other medicines and products

The regulatory interaction profile of Terbinafin AL is defined by its effects on metabolic enzymes and the resulting significant modifications to the plasma concentrations of co-administered medicines.

Metabolic-Based Exposure Alterations

Terbinafin AL is an officially documented potent inhibitor of the CYP450 2D6 isozyme. This inhibition significantly increases the systemic exposure of many drugs that are CYP2D6 substrates.

Interacting Drug or Class Official Outcome
CYP2D6 Substrates (e.g., Desipramine) Clearance decreased (e.g., Desipramine AUC increased 5-fold).
CYP Inhibitors (e.g., Fluconazole, Cimetidine) Terbinafine exposure significantly increased (e.g., AUC increased up to 69%).
CYP Inducers (e.g., Rifampicin) Terbinafine clearance significantly increased ( 100% increase).

Other Documented Interactions

Official documents also detail effects not tied to CYP2D6 inhibition, including interactions that alter clearance or cause specific non-metabolic effects:

  • Ciclosporin/Cyclosporine: Terbinafine increases the clearance of this medicine by 15%, leading to reduced exposure.
  • Caffeine: Terbinafine decreases the clearance of Caffeine by 19%.
  • Warfarin: Rare postmarketing cases of changes in INR and/or prothrombin time have been reported.
  • Oral Contraceptives: Reports of menstrual disturbance (e.g., breakthrough bleeding, irregular cycle) have been noted when the medicines are co-administered.
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Mechanism of Action

Targeting Fungal Cell Membrane Synthesis

This mechanism involves the precise inhibition of the fungal enzyme Squalene Epoxidase, which is essential for manufacturing ergosterol, the key structural component of the fungal cell membrane. The resulting deficiency in ergosterol leads to the structural breakdown and functional failure of the fungal cell barrier.


Dual Effect: Toxic Accumulation and Cell Death

By blocking the pathway, the drug simultaneously causes a toxic buildup of the precursor substance, squalene, inside the fungal cell, leading to the formation of internal lipid droplets. This dual mechanistic action (membrane depletion plus internal toxicity) produces a fungicidal physiological effect, resulting in the lysis and death of the fungal cell.


Sustained Localized Activity

Terbinafine's high lipophilicity (fat-solubility) allows it to rapidly distribute into and persist within keratin-rich tissues such as the skin, nails, and hair shafts. This tissue partitioning creates a sustained drug reservoir that provides a sustained presence with fungicidal activity directly at the site of colonization, which contributes to the sustained physiological effect on the target organism.

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Dosage and Administration Information

How to Use Terbinafin AL

Terbinafin AL is intended for systemic administration and is typically used in its 250 mg oral tablet form. The correct use of this medicine is defined by a consistent daily intake and a strict treatment duration determined by the infection's location.

Standard Administration and Dosing

The standard regimen for adults is 250 mg taken once daily. This frequency is maintained throughout the entire prescribed course. The tablets are swallowed whole, preferably at the same time each day for maximum consistency, and may be taken with or without food.

Infection Site Standard Adult Duration
Fingernail Onychomycosis 6 weeks
Toenail Onychomycosis 12 weeks
Tinea (Skin) Infections 2 to 6 weeks

Procedural and Population Guidance

If a daily dose is missed, it should be taken as soon as it is remembered. However, if the time until the next scheduled dose is less than four hours, the missed dose is skipped to resume the normal schedule; double doses are not used to compensate.

For pediatric patients, the daily dose is calculated based on body weight for specific indications. Use is generally not recommended for patients with pre-existing chronic or active liver disease or in those with significant renal impairment, defined as creatinine clearance ≤ 50 mL/min.

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Recent Clinical Evidence

Research Evidence / Overview of studies for Terbinafin AL


Evidence for use in Onychomycosis (Fungal Nail Infection)

This section will summarize the structure of major research, including Randomized Controlled Trials and systematic reviews, focusing on the specific mycological and clinical endpoints measured for nail infections.

The research landscape for oral Terbinafin AL includes controlled trials where patients with confirmed nail fungus (onychomycosis) were evaluated in controlled study designs. These studies monitored two main types of outcomes: Mycological endpoints, which involved laboratory tests to monitor for fungal presence or clearance, and Clinical endpoints, which involved visual assessment of the affected nail area to measure changes in physical appearance, such as clearing of visible symptoms.

Findings describe patterns observed in these study populations, where outcomes related to physical discomfort were observed over long study intervals. However, data derived from short-term study intervals are limited in characterizing long-term outcomes, as comprehensive assessment often requires observation extending up to a year or more.


Evidence for use in Dermatophyte Skin Infections (Ringworm)

This section will describe the clinical trial landscape for skin conditions like Tinea corporis, Tinea cruris, and Tinea pedis, detailing the study designs and the primary outcomes researchers used to assess clearance and symptom resolution.

For conditions characterized by inflammatory or irritative states of the skin, research has explored short-term symptom changes. Studies focusing on episodes where symptoms become more noticeable were typically evaluated in short-term Randomized Controlled Trials. Research examined adults with widespread skin infections, and studies in children monitored outcomes related to scalp ringworm (Tinea capitis).

These studies used Clinical assessment scores to monitor outcomes related to physical discomfort, such as scaling and itching. Comparative evidence explored outcomes when Terbinafin AL was studied against other tested comparators or inactive substances.


Long-term Studies and Follow-up Duration

Because nail fungus takes a long time to clear, research related to oral Terbinafin AL was evaluated in trials that required intermediate to long-term observation. These extended follow-up durations were necessary because the assessment of resolution is dependent on the slow growth of the nail plate. These long-term studies monitored relapse rates, which is the frequency with which the fungal infection reappeared after the treatment phase ended.

Long-term effects are not fully established for all patient subgroups, and the duration needed to assess sustained lack of fungal presence contributes to uncertainty. Findings describe group patterns, not personal outcomes regarding the stability of the long-term measured outcomes.

Key Studies & References

  1. DailyMed - Terbinafine hydrochloride tablet (US National Library of Medicine)
  2. Terbinafine (Oral) - MedlinePlus Drug Information
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Frequently Asked Questions (FAQ)

Common questions about Terbinafin AL (FAQ)

Q: Can I take my regular over-the-counter vitamins and supplements with the tablets?

A: Official product information emphasizes the importance of informing your doctor or pharmacist about all medicines, vitamins, nutritional supplements, and herbal products currently being taken. This is because certain non-prescription products may affect the way the medication works or may require monitoring.

Q: How does the medication work to kill the fungus?

A: The mechanism of action involves the medication stopping the growth of fungi through a process called fungicidal action. This is achieved by inhibiting a specific fungal enzyme, squalene epoxidase, which the fungus needs to build its cell wall.

Q: Will this medicine affect my ability to drive or operate machinery?

A: Regulatory documents indicate that common side effects can include dizziness or vertigo. If these or other effects that affect concentration occur, regulatory information indicates that caution is generally advised in such circumstances.

Q: Is there specific information on use in older adults?

A: Official product information does not indicate a need for a specific dosage adjustment in the elderly population (over 65 years old). However, pre-existing impairment of kidney or liver function—which may be more common in older adults—is a factor regulatory information indicates should be considered.

Q: Are there any lifestyle factors I should consider, like sun exposure?

A: Official product information includes a warning about potential photosensitivity. This means the tablets may make the skin sensitive to sunlight. Avoidance of unnecessary or prolonged exposure to natural and artificial sunlight (such as tanning beds) and the use of protective measures like clothing and sunscreen are noted as relevant precautions.

Q: What are the reasons discontinuation of the medication may be warranted?

A: Regulatory documents state that discontinuation of the medication is warranted if signs or symptoms suggestive of severe adverse reactions occur. These reactions include indicators of liver dysfunction (like persistent nausea or dark urine), a progressive skin rash (like Stevens-Johnson Syndrome), or evidence of blood disorders (like severe neutropenia).

Q: What is the official information regarding terbinafine and alcohol consumption?

A: Although alcohol is not listed as an absolute contraindication, official warnings describe a rare but serious risk of liver problems (hepatotoxicity) associated with terbinafine. Because alcohol use can also affect liver health, it may increase this underlying risk.

Q: Does the medication commonly cause tiredness or fatigue?

A: According to the official list of adverse reactions, fatigue is documented as a common undesirable effect of the medication. This means it may affect up to 1 in 10 people.

Q: What is the official information regarding pre-existing stomach or digestive issues?

A: Regulatory documents classify gastrointestinal symptoms, such as diarrhea, indigestion, and mild abdominal pain, as very common side effects. While the drug is not contraindicated for simple digestive issues, it is strictly prohibited for people with chronic or active liver disease, which can sometimes present as stomach issues.

Q: What are the official contraindications (reasons not to take it)?

A: Regulatory documents list two main contraindications, meaning that use is strictly prohibited by regulatory authorities. These are a history of allergic reaction (hypersensitivity) to terbinafine itself, and a diagnosis of chronic or active hepatic (liver) disease.

Q: How long until improvement in symptoms is typically seen?

A: Official product information and studies indicate that relief of clinical symptoms for skin infections usually occurs within a few days. However, the physical signs of a complete cure for nail infections are only visible after several months, as they rely on the slow growth of the new, healthy nail.

Q: Does it need to be taken with food?

A: According to the official product information, the tablets can be taken with or without food. Taking the medication at approximately the same time each day is generally advised to maintain consistency.

Q: Will I need to have blood tests while taking this medication?

A: Due to the documented risk of liver injury, regulatory documents indicate that periodic monitoring of liver function tests (blood tests) is necessary for certain patients. This monitoring is typically advised around the 4-to-6-week mark of treatment.

Q: Are there different strengths or forms available?

A: The medication is most commonly available as tablets for oral use, which is the systemic treatment route. Official information also mentions the availability of topical forms (such as creams, gels, or sprays), which are typically intended for surface infections.

Q: Does it interact with common cold or flu medications?

A: Official interaction data shows that terbinafine inhibits a metabolic enzyme called CYP2D6. Therefore, it has the potential to interact with other medicines that are processed by this enzyme, including certain antihistamines or cough suppressants found in cold and flu remedies.

Q: Does it interact with common pain relievers?

A: Terbinafine's effect on the CYP2D6 enzyme may affect the concentration of certain pain relievers, particularly opioid analgesics like codeine and tramadol, which are processed by this pathway. However, common non-opioid pain relievers such as paracetamol or ibuprofen are not listed as having interactions based on the documented CYP2D6 pathway.

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How should Terbinafin AL be stored and disposed of?

How to Store and Dispose of Terbinafin AL

The following are the official storage and disposal requirements for Terbinafin AL (terbinafine) tablets, as specified in regulatory documentation.


Storage Requirements

Condition Requirement
Temperature Store at ambient room temperature, typically not above 30 C (86 F); the product must be kept from freezing.
Protection Keep the tablets in the original, tightly closed container to protect the medicine from light and moisture.
Child Safety The medicine must be stored out of the sight and reach of children.

Disposal Instructions

Any unused or expired Terbinafin AL must be disposed of in accordance with local regulations and requirements. The medicine should generally not be discarded in household waste or flushed down wastewater, as advised in official pharmaceutical waste guidance.

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

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