Lamisil (Oral)

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Lamisil (Oral)

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Method of action: Antifungal Broad Spectrum

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Overview of Lamisil (Oral)

Property Description
Active ingredient Terbinafine Hydrochloride
Form Oral Tablet
Pharmacological class Allylamine Antifungal Agent
Origin Synthetic Compound
General Purpose Eliminate systemic fungal infections

What Type of Medicine is Terbinafine (Oral)?

Terbinafine Hydrochloride is the active substance in this preparation, classified as an allylamine antifungal agent. This synthetic compound is generally designated as a prescription medicine intended for internal application against persistent fungal infections. The identification of Terbinafine as an allylamine compound places it in a distinct pharmacological group, differentiated by its chemical structure and specific method of disrupting fungal cellular metabolism, which contrasts with other antifungal classes such as the azoles. The allylamine structure is recognized for its efficacy against common fungal pathogens known as dermatophytes.

Composition and Delivery Form: The Oral Tablet

The medicine is formulated as an oral tablet, which is the required dosage form for systemic delivery of the active ingredient into the body. This solid preparation contains the Terbinafine Hydrochloride compound alongside solid pharmaceutical excipients that facilitate its ingestion and absorption. The choice of the oral route is fundamental to the drug's purpose, enabling the active substance to be distributed via the bloodstream to reach deep-seated fungal reservoirs, particularly in keratinized tissues like the fingernails and toenails. Pharmacological data indicates Terbinafine's chemical structure allows for high accumulation in these target tissues when administered orally.

General Function: Fungicidal Action for Systemic Purpose

The overarching function of this medicine is to exert a powerful fungicidal agent effect, meaning it is designed to actively destroy the fungal organism rather than simply stopping its growth. This is accomplished by the drug inhibiting the fungal enzyme squalene epoxidase, a key step in the synthesis of ergosterol, an essential component of the fungal cell membrane. The resultant fungal membrane disruption actively eliminates the causative pathogens, addressing the general therapeutic need for clearing extensive infections that necessitate a sustained, internal action for complete resolution.

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What side effects are possible with Lamisil (Oral)?

The official safety profile for Terbinafine (Oral) is structured according to standardized regulatory categories, outlining possible adverse reactions by frequency and the body systems they affect.

Adverse Reaction Scope

Key adverse reaction categories: Documented reactions primarily involve the gastrointestinal system (e.g., nausea, diarrhea, dyspepsia), the skin and subcutaneous tissues (e.g., rash, urticaria), and the nervous system (e.g., headache, taste disturbance).

Frequency classification: The safety data is divided into standard frequency tiers:

  • Very Common (ge 1/10): Headache, Gastrointestinal symptoms, Rash, Urticaria, Musculoskeletal reactions (Arthralgia, Myalgia).
  • Common (ge 1/100 to < 1/10): Vomiting, Decreased appetite, Dizziness, Visual disturbance, Depression.
  • Rare (ge 1/10,000 to < 1/1,000): Serious hepatobiliary dysfunction.

Serious adverse reactions (as documented in regulatory sources): Regulatory labels explicitly call out the rare but critical risk of Hepatic failure (some cases leading to liver transplant or death) and severe Dermatological Reactions (such as Stevens-Johnson Syndrome). Additionally, rare Blood Dyscrasias (e.g., severe neutropenia) have been reported.

Population-Specific Safety Considerations and Restrictions

Population-specific safety considerations: The medicine is contraindicated in patients with pre-existing chronic or active liver disease due to the risk of hepatotoxicity. Use is not recommended in patients with significant renal impairment (creatinine clearance <50 mL/min).

Dose- or exposure-related patterns: Taste disturbance (dysgeusia/ageusia) is a documented reaction that may be prolonged or, in rare cases, permanent following discontinuation.

Safety-related restrictions or limitations: Official regulatory guidance advises that assessment of liver function tests should be considered before initiating treatment. Treatment cessation is advised if clinical or biochemical evidence of liver injury is observed.

Connection to the Overall Safety Profile

This regulatory framework establishes the most frequently expected effects alongside the rare, serious events that affect major organ systems like the liver and blood. The profile includes explicit safety restrictions, such as the contraindication in chronic liver disease, which defines a fundamental boundary for the medicine's use and risk communication.

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Overdose and Emergency Response

A few cases of overdose with oral Lamisil (terbinafine) have been reported, with exposures documented up to 5 grams. The reported clinical manifestations primarily involve the central nervous and gastrointestinal systems.

Documented Overdose Symptoms

Symptoms that have been reported following an overdose event include:

  • Headache
  • Dizziness
  • Nausea
  • Epigastric pain (stomach pain)

Emergency Action Required

Immediate medical attention is required in the event of a suspected overdose. If an overdose occurs, contact a Poison Control Center or emergency services right away for advice. Even if symptoms are not severe or immediately present, urgent consultation is necessary.

Overdose Management

Official recommendations for the management of a terbinafine overdose focus on eliminating the medication from the body and providing symptomatic support. This typically includes the administration of activated charcoal and providing supportive care to manage any resulting symptoms. Monitoring of the individual's condition is a key component of the management process.

Important Consideration

Due to the way the medication is processed by the body, caution is generally advised for individuals with pre-existing liver disease or kidney impairment. This is a common factor influencing drug safety but is not explicitly a reported cause of overdose symptoms in the reviewed cases.

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Therapeutic Uses of Lamisil (Oral)

The primary therapeutic domain for this oral medicine is systemic support for fungal infection, which is generally applied across domains where additional symptomatic support is needed for infections that may be difficult for topical treatments to reach. The medicine is commonly used to treat fungal nail infections (onychomycosis), scalp ringworm (Tinea capitis), and widespread or persistent fungal skin infections.

Systemic Management of Fungal Dystrophy

This medication is relevant for managing symptoms that interfere with daily comfort, such as the severe nail thickening, discoloration, and crumbling associated with onychomycosis. Due to its systemic action, it supports the patient during difficult episodes by easing the distress and overall symptom burden. Oral therapy is considered appropriate when the infection has resisted localized management or when clinical necessity dictates systemic action.

“The systemic use is relevant in clinical settings that involve acute or unstable symptom patterns where internal symptomatic assistance is needed.”

Treatment for Extensive Dermatophytosis

Oral terbinafine is considered relevant in conditions characterized by periods of heightened symptoms, including Tinea capitis or extensive skin infections. It is applied in clinical settings where short-term symptom stabilization is important. This therapy assists with maintaining functional stability and can help ease the impact of symptoms on routine activities caused by persistent, extensive lesions.


Quick Fact: Relevant for Symptoms of Persistent Dermatophytosis

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Eligibility and Restrictions for Use

Lamisil (Oral) is contraindicated in certain patient populations based on official regulatory documentation. These constraints are primarily related to pre-existing medical conditions and physiological state.

Contraindicated Use

  • Chronic or Active Liver Disease: The medication is absolutely contraindicated in patients with active or chronic liver disease.
  • Hypersensitivity: Individuals with a documented history of allergic reaction to oral terbinafine or any of its excipients must not use this medicine.

Restricted or Not Recommended Use

  • Renal Impairment: Use is generally not recommended for patients with significant renal impairment, defined as creatinine clearance less than 50 mL/min.
  • Pregnancy: The medicine should not be used during pregnancy unless the potential benefits are determined to outweigh the potential risks, as clinical experience in pregnant women is limited.
  • Breastfeeding: Mothers who are nursing should not receive this medicine, as the active substance is known to be excreted into breast milk.
  • Age-Related Eligibility: The tablet formulation is generally not established for use in pediatric patients. The oral granules formulation is indicated for children 4 years of age and older.
  • Pre-existing Conditions: Caution and monitoring are advised for patients with pre-existing conditions such as lupus erythematosus or psoriasis, as cases of precipitation or exacerbation have been reported.
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What should I know about interactions with other medicines?

Interactions with other medicines and products

The primary interaction mechanism documented for oral terbinafine is the inhibition of the CYP450 2D6 isozyme. This effect decreases the clearance of medicinal products predominantly metabolized by this enzyme, including certain tricyclic antidepressants, beta-blockers, selective serotonin reuptake inhibitors, and Class 1C antiarrhythmics.

Exposure Modification

Co-administration with enzyme inhibitors alters terbinafine’s own systemic exposure. The CYP inhibitor Cimetidine is documented to decrease terbinafine clearance by 33%. Similarly, co-administration with Fluconazole (an inhibitor of both CYP2C9 and CYP3A4) increases terbinafine plasma C max by 52% and AUC by 69%. Conversely, the CYP inducer Rifampin is documented to accelerate terbinafine plasma clearance by 100%, significantly decreasing exposure.

Specific pharmacokinetic effects are also noted for other compounds. Oral terbinafine decreases the clearance of Caffeine by 19% and increases the clearance of Cyclosporine by 15%. No mandatory food interactions or timing separation rules are explicitly stated in regulatory labeling.

Population-Specific Restrictions

The medicine is formally contraindicated for use in patients with chronic or active hepatic disease. Furthermore, its use is not recommended in patients with renal impairment where creatinine clearance is less than 50 mL/ min. Terbinafine may functionally convert individuals known as extensive CYP2D6 metabolizers to a poor metabolizer phenotype, potentially increasing the interaction severity with co-administered CYP2D6 substrates.

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Mechanism of Action

Targeted Inhibition of Fungal Squalene Epoxidase

The drug's mechanism of action is a fungicidal process achieved through the blockade of an essential fungal metabolic pathway. Terbinafine (Oral) selectively binds to and inhibits squalene epoxidase, an enzyme essential to the ergosterol biosynthesis pathway of the fungal cell membrane. This enzyme inhibition begins a cascade that is selective for the fungal pathogen, affecting systems involved in fungal membrane stability. This mechanism initiates a chain of events that compromises the pathogen's ability to maintain its structure.

Dual Action: Structural Failure and Intracellular Toxicity

The enzyme blockade results in a dual-action mechanistic cascade: it causes a severe deficiency of ergosterol (the structural component of the membrane) while simultaneously allowing the precursor substance, squalene, to accumulate to toxic levels inside the fungal cell. This combination of structural weakening and chemical poisoning leads directly to the destruction and lysis of the fungal cell. This resulting physiological effect leads to the targeted destruction of the fungal pathogen.

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Dosage and Administration Information

How to Use Lamisil (Oral)

The administration of Lamisil (Terbinafine) oral tablets follows standardized instructions defining the route, dosage, and duration of use. This medicine is administered via the oral route for systemic delivery of the active compound against fungal infections.


Official Dosing and Frequency

The standard adult dosing regimen is fixed at one 250 mg tablet taken once daily (q.d.) for all approved indications. This once-daily frequency is maintained throughout the defined treatment course. The 250 mg tablets may be taken with or without food, providing flexibility for patient adherence.


Duration and Special Populations

Treatment duration is determined procedurally by the site of the infection, reflecting a fixed, short-term course that is not adjusted based on early clinical response. The typical duration of use is:

  • Fingernail Onychomycosis: 6 weeks
  • Toenail Onychomycosis: 12 weeks

For pediatric use, dosing is determined based on the child's body weight, utilizing specific weight thresholds. Regarding special populations, use is generally not recommended in patients with pre-existing chronic or active liver disease, and a dose adjustment or alternative therapy may be necessary for patients with significant renal impairment (creatinine clearance leq 50 mL/minute).

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Recent Clinical Evidence

Research Evidence / Overview of Studies for Lamisil (Oral)

Evidence for Use in Fungal Nail Infections (Onychomycosis)

The evidence for oral Lamisil in Fungal Nail Infections (Onychomycosis) was evaluated in numerous large-scale clinical research studies, including Randomized Controlled Trials (RCTs). These trials generally compared the medicine against a placebo or trials that included other antifungal agents. Researchers explored two main types of outcomes: Mycological Cure (laboratory testing to assess the fungal status of the nail) and Clinical Cure (visual assessment of how the nail's appearance evolved).

Studies reported measured frequencies related to both outcomes, primarily in adults with confirmed infections. The research base for this indication is based on a high volume of evidence. However, reviews noted that the reported outcomes and measured frequencies varied across the numerous individual trials. Furthermore, the methodology for assessing Clinical Cure can be subjective, and its definition was not fully standardized in all research.


Evidence for Use in Extensive Dermatophytosis and Scalp Ringworm (Tinea Capitis)

Research has also studied oral Lamisil in conditions presenting with cycles of stability and flare-ups of widespread fungal skin infections (dermatophytosis) and Tinea Capitis (scalp ringworm). This evidence often comes from Randomized Controlled Trials designed to observe outcomes when the medicine was studied alongside alternative systemic options.

Studies examined outcomes related to Mycological Assessment (assessing whether the organism was eradicated) and Symptom Assessment, which involved observations of changes on the scalp or skin. Specifically for Tinea Capitis, research was conducted in children/pediatric groups, tracking patterns of how symptoms evolved over time.


Key Research Gaps and Uncertainties

Scientific reviews point to several areas where the research landscape remains uncertain. The duration of randomized data that strictly follows patients to assess the Relapse Rate remains limited beyond the typical 18-month monitoring period required for toenails. Therefore, long-term effects are not fully established.

Additionally, data for certain groups remain insufficient. For many special populations, sample sizes were modest in the research conducted, and results apply only to the populations studied and do not offer broad conclusions. The evidence highlights what is known—and what is still uncertain.

Key Studies & References

  1. Terbinafine in fungal infections of the nails: a meta-analysis of randomized clinical trials (Cochrane Review)
  2. Use of Oral Terbinafine in Children (Addressing Tinea Capitis and Off-Label Use)
  3. Systemic antifungal therapy for tinea capitis in children (Meta-analysis)
  4. Which oral antifungal works best for toenail onychomycosis? (Addressing special populations and long-term recurrence)
  5. Terbinafine - StatPearls - NCBI Bookshelf (General overview and indications)
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Frequently Asked Questions (FAQ)

Common questions about Lamisil (Oral) (FAQ)

Q: What is the active ingredient in Lamisil oral tablets?

The active ingredient in Lamisil Oral tablets is terbinafine, which is chemically known as terbinafine hydrochloride.

Q: Is Lamisil Oral an antibiotic?

No, Lamisil Oral, which contains terbinafine, is classified as an antifungal medication. It works by stopping the growth of fungi, unlike antibiotics, which primarily target bacteria.

Q: Does Lamisil Oral treat all types of fungal infections?

Official documentation specifies that Lamisil Oral is indicated for infections caused by certain fungi, such as onychomycosis of the fingernail and toenail. It is also sometimes used for other specific fungal infections of the skin or scalp. It is not listed as treating all possible types of fungal infections.

Q: What is the main difference between Lamisil oral tablets and the cream for ringworm or athlete's foot?

The main difference is the method of delivery. Lamisil Oral tablets are designed for systemic delivery, meaning the medicine travels through the bloodstream to reach the infection site from within the body. In contrast, the cream is a topical treatment applied only to the surface of the skin.

Q: Is there a maximum time length for taking Lamisil Oral that is generally discussed in regulatory documents?

The duration of Lamisil Oral treatment is fixed according to the approved use. For approved nail infections, treatment is typically fixed at 6 weeks for fingernail infections and 12 weeks for toenail infections. These fixed durations represent the typical length of the prescribed course.

Q: What is the difference in how Lamisil Oral is used for fungal skin infections versus nail infections?

Official labeling approves Lamisil Oral for nail infections (onychomycosis) with courses of 6 or 12 weeks. The medicine is also sometimes used to treat certain fungal skin infections, such as ringworm or jock itch, which typically require a shorter duration of treatment.

Q: What are the general expectations about how long it takes to see results with Lamisil Oral?

According to official patient information, the full clearance of the infection may not be evident until several months after the treatment course is completed. This is related to the time needed for the healthy nail to grow out.

Q: What happens if I miss a dose of Lamisil Oral?

Regulatory guidance suggests taking the missed dose as soon as it is remembered. However, if the time until the next scheduled dose is less than four hours, the missed dose is generally skipped, and the regular schedule is resumed.

Q: Are there specific age restrictions for who can use Lamisil Oral?

Lamisil Oral tablets are primarily used in adults, but official labeling describes a weight-based dosing method for use in children. Regulatory labeling indicates that the safety and effectiveness of the tablets for treating nail infections in children has not been established.

Q: Is there any official information on Lamisil Oral use in children?

Official documents confirm that the medicine is sometimes used for certain fungal infections in children. When used, dosing is determined by the child’s body weight using specific thresholds listed in the regulatory guidance.

Q: Why do official documents state that Lamisil Oral is not for pregnant women?

Official documents state that the medicine should generally not be started during pregnancy because the treatment for fungal nail infections can usually be delayed until after the pregnancy. Current data on the use of oral terbinafine during human pregnancy is limited.

Q: Are there any specific liver risks associated with taking Lamisil Oral that I should know about?

Official regulatory documents describe a risk of liver injury, known as hepatotoxicity, associated with oral terbinafine. In rare cases, this has progressed to serious outcomes such as liver failure. Due to this potential risk, monitoring of liver function tests is described in official guidance as being performed before starting and periodically throughout the treatment.

Q: What are the signs of liver issues mentioned in the safety information for Lamisil Oral?

Official safety information lists signs of potential liver issues that have been reported. These signs include persistent nausea, fatigue, loss of appetite, vomiting, pain in the upper right abdomen, dark urine, or jaundice (yellowing of the skin/eyes).

Q: Do you have to avoid alcohol completely while taking Lamisil Oral, according to official warnings?

Official guidance discourages the use of Lamisil Oral in patients with pre-existing chronic or active liver disease. Consuming alcohol while taking the medicine is often noted as a factor that may increase the potential risk of liver problems.

Q: Can I take Lamisil Oral if I have a history of lupus?

Regulatory documents indicate that the onset or worsening (exacerbation) of cutaneous and systemic lupus erythematosus has been reported with the use of this medicine. Due to this potential effect, official documents state that the use of this medicine requires careful consideration in patients with pre-existing lupus.

Q: What are the rare but serious side effects of Lamisil Oral described in official prescribing information?

Rare but serious effects described in official prescribing information include liver failure, severe skin reactions (like Stevens-Johnson syndrome), severe neutropenia (low white blood cell count), and the onset or worsening of lupus erythematosus.

Q: Does official information suggest Lamisil Oral should be stopped immediately if I feel sick?

Yes, official guidance states that the medicine is typically discontinued immediately if symptoms suggesting a severe side effect, such as clinical signs of liver injury, are experienced.

Q: What kind of monitoring is typically mentioned in official sources for patients taking Lamisil Oral?

Official documentation indicates that liver function tests are typically performed before starting and periodically during the treatment course. Monitoring of complete blood counts is also sometimes considered, especially if the treatment continues for more than six weeks in certain patient groups.

Q: Why does Lamisil Oral sometimes need blood tests during the course of treatment?

Blood tests are used for monitoring potential adverse effects, specifically to check liver function before and periodically during treatment. They are also sometimes used to monitor neutrophil counts (a type of white blood cell) in patients receiving prolonged treatment.

Q: Can Lamisil Oral be taken if someone is also taking antidepressants or anxiety medications?

Official information indicates that oral terbinafine may affect how the body processes certain medications, specifically those broken down by the CYP2D6 enzyme. This group includes certain tricyclic antidepressants, SSRIs, and some beta-blockers. Official documents describe that other medicines may require dose adjustments when taken with Lamisil Oral.

Q: Does taking Lamisil Oral affect blood thinners like warfarin?

Yes, taking oral terbinafine with the blood thinner warfarin may increase the risk of bleeding. Regulatory guidance states that close monitoring of blood clotting levels is typically performed when these two medicines are used together.

Q: Is it described in official sources that Lamisil Oral interacts with birth control pills?

Official sources indicate that oral terbinafine is generally not expected to reduce the effectiveness of oral contraceptives (birth control pills). However, reports of breakthrough bleeding have been noted in some cases.

Q: Is it common for Lamisil Oral to cause stomach upset or nausea?

Yes, official documents list gastrointestinal symptoms among the common adverse events reported in clinical trials. These commonly reported symptoms include nausea, abdominal pain, diarrhea, and indigestion (dyspepsia).

Q: Can Lamisil Oral cause changes in my sense of taste or smell?

Yes, official sources describe reports of taste disturbance, including loss of taste, and smell disturbance, including loss of smell, as potential side effects. These sensory changes may be severe, and in some instances, have been reported as prolonged or permanent.

Q: Are there any long-term effects described in official documents after stopping Lamisil Oral?

Regulatory documents report that disturbances in the sense of taste or smell may occasionally be prolonged, lasting for more than one year, or potentially permanent, even after the medication has been discontinued.

Q: Can Lamisil Oral cause temporary vision changes?

Yes, official sources report that visual disturbances, including blurred vision and reduced visual acuity (sharpness), have been reported as potential side effects.

Q: Does Lamisil Oral make you more sensitive to the sun?

Photosensitivity reactions, meaning increased sensitivity to sunlight, have been reported as a side effect. Official documentation advises that patients typically avoid sunlamps and tanning beds, and use sunscreen and protective clothing when outdoors.

Q: Is it true that Lamisil Oral can sometimes cause a rash or hives?

Yes, official information confirms that rash and urticaria (hives) are among the dermatological symptoms reported by patients. Rash is listed as a common adverse event.

Q: What should I watch out for if I think Lamisil Oral is causing a skin reaction?

Serious skin and hypersensitivity reactions have been reported, including rash and hives. If a progressive skin rash or any signs suggestive of a severe skin reaction occur, regulatory information states that the medicine is typically discontinued.

Q: Can Lamisil Oral affect hair loss or hair growth?

Alopecia, which is hair loss or thinning, is listed in regulatory documents as a very rare side effect reported in the post-marketing surveillance setting.

Q: Are changes in blood count something mentioned as a possible side effect of Lamisil Oral?

Yes, regulatory documents describe hematologic effects, including reported cases of severe neutropenia, which is a significant decrease in a type of white blood cell count. Transient decreases in absolute lymphocyte counts have also been noted.

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How should Lamisil (Oral) be stored and disposed of?

Lamisil (terbinafine hydrochloride) tablets must be stored at Controlled Room Temperature, defined as 20 C to 25 C (68 F to 77 F). The medication must be kept in a tightly closed container and requires protection from light to maintain stability.

Storage and Protection

  • Temperature: Store at Controlled Room Temperature.
  • Container: Keep in a tightly closed container and protect from light.
  • Child Safety: The product must be stored out of the sight and reach of children.

Disposal Requirements

Expired or unused Lamisil must be disposed of in accordance with local requirements and must not be thrown away via wastewater or household waste. This environmental restriction ensures proper handling of the unused pharmaceutical product.

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

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