Anaplas

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Anaplas

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 Anaplas

Quick Facts

Property Description
Active ingredient Terbinafine Hydrochloride
Form Oral Tablet, Topical Cream, Topical Solution
Pharmacological class Allylamine Antifungal (Antimycotic)
Origin Synthetic

What Type of Medicine is Anaplas?

Anaplas is a synthetic medicinal preparation primarily classified as an antifungal agent that belongs to the Allylamine pharmacological class. It is defined by its core active substance, Terbinafine Hydrochloride, and its fundamental purpose is to address conditions caused by the growth and proliferation of specific fungal organisms. Terbinafine is recognized for its potent fungicidal action, distinguishing it from some older antifungal drugs that only inhibit growth (fungistatic). As an antifungal, it serves as a tool for managing dermatophyte infections. Anaplas is typically marketed as an over-the-counter (OTC) topical solution or cream, focusing on superficial skin issues, while the oral tablet form is often prescription-only (Rx), intended for more widespread or internal conditions.

Composition and Available Pharmaceutical Forms

The core active component in Anaplas is Terbinafine Hydrochloride, a chemical salt form of the therapeutically active compound, Terbinafine. It is manufactured in multiple dosage forms to suit different requirements for intervention. The preparation is available as Topical preparations, such as a Cream or Solution, which are applied directly to the surface area. Additionally, it is available as an Oral Tablet formulated for Systemic use, meaning the Terbinafine is absorbed into the bloodstream to reach affected areas internally. The Oral Tablet composition uses pharmaceutical solid excipients, while the Topical preparations utilize respective cream or solution vehicles for effective localized delivery.

The Foundational Mechanism and General Benefit

The core function of the active substance in Anaplas is rooted in its selective mechanism that targets the fungal cell's integrity, granting it a fungicidal designation. The general therapeutic benefit is the drug's ability to eliminate the infectious agent by disrupting its structural foundation. Specifically, the mechanism involves the active substance acting as an inhibitor of the squalene epoxidase enzyme, thereby blocking the biosynthesis of ergosterol, which is a vital component necessary for maintaining a functional fungal cell membrane. Due to this action, the drug is considered active against dermatophytes. This indicates that the medicine has the ability to target and resolve the primary cause of many superficial fungal issues.

Regulatory References

  1. National Institutes of Health (NIH) review

What side effects are possible with Anaplas?

Possible Side Effects and Safety Information

The safety profile of Anaplas (Terbinafine Hydrochloride) is officially documented by frequency and by the affected System-Organ Class (SOC), providing a regulated overview of potential adverse reactions. The profile for the systemic (oral tablet) form is divided into categories ranging from Very Common to Not Known, as defined by regulatory standards.

Adverse Reaction Classification

Side effects frequently reported in clinical studies, classified as Very Common or Common in regulatory documents, include gastrointestinal symptoms (such as diarrhea, dyspepsia, nausea, and abdominal pain), headache, rash, pruritus, and musculoskeletal reactions (arthralgia and myalgia). Laboratory tests may also reveal liver enzyme abnormalities.

Less frequently, Uncommon or Rare effects may involve the nervous system, including taste disturbance (dysgeusia), dizziness, and paraesthesia.

Documented Serious Safety Concerns

The official labeling includes specific warnings regarding rare but serious adverse reactions. These include severe Hepatobiliary Disorders, such as hepatic failure, which may necessitate a liver transplant in rare cases. Other critical safety issues documented are severe Skin Hypersensitivity Reactions, including Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), and DRESS syndrome. Serious Blood and Lymphatic System Disorders, such as neutropenia and agranulocytosis, have also been reported.

Safety Constraints and Considerations

The oral tablet form is contraindicated in patients with chronic or active liver disease or known hypersensitivity to the active substance. Regulatory guidance states that the medicine must be discontinued upon evidence of liver injury, progressive skin rash, or a severe taste/smell disturbance. Furthermore, regulatory notes indicate that while taste and smell disturbances often resolve after treatment cessation, there are documented cases of these effects being prolonged or permanent.

Overdose and Emergency Response

Overdose and When to Seek Help

This section describes the officially documented manifestations of overdose with oral Terbinafine Hydrochloride (Anaplas) and the required regulatory actions for seeking emergency medical attention, based on government prescribing information.

Documented Overdose Manifestations and Signs

Official regulatory sources note that acute overdosage (reports up to 5 grams) may lead to specific clinical manifestations affecting the central nervous and gastrointestinal systems. These documented signs include:

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

Officially Documented Emergency Actions and Management

If an overdosage of Anaplas is suspected, the regulatory guidance mandates immediate contact with a Poison Information Centre or emergency medical help. This instruction underscores the need for professional management in any supratherapeutic ingestion.

Management Aspect Regulatory Statement
Antidote Status No specific antidote is known for Terbinafine overdose.
Treatment Protocol Treatment is symptomatic and supportive.
Procedural Steps Measures to eliminate the drug may include the administration of activated charcoal and potentially gastric lavage.

Official documents indicate that hospital monitoring may be required to observe the patient's clinical state and manage any developing symptoms associated with the overdose.

Therapeutic Uses of Anaplas

What Anaplas Treats: Main Uses and Benefits

The active ingredient in Anaplas is an antifungal agent relevant for treating infections caused by specific fungal organisms. This medication generally supports symptomatic and therapeutic management across relevant clinical domains.

The medication is commonly used to help manage Tinea (ringworm) infections, which include athlete's foot (Tinea pedis), jock itch (Tinea cruris), ringworm of the body (Tinea corporis), and complex presentations like onychomycosis (fungal nail infection). It is also applied in settings involving Tinea capitis (scalp ringworm), particularly in children.

This therapeutic approach is relevant for easing symptoms related to inflammatory or irritative states, such as intense itching, burning, redness, scaling, and the fissuring of the skin. Anaplas is commonly used across conditions presenting with recurrent or widespread symptomatic episodes, where additional systemic support may be needed to support the resolution of symptoms.

The use of this medication is associated with addressing the symptoms that interfere with daily functioning, such as persistent irritation and disfigurement, contributing to improved comfort during symptomatic periods. This key benefit assists with maintaining functional stability and supports the patient during episodes of heightened discomfort by supporting the resolution of the infection.


Quick Fact: Relief for Integumentary Discomfort

Clinical Context Symptom Management Patient Benefit
Persistent Mycoses Is relevant for managing itching, scaling, and inflammation Contributes to improved comfort and appearance
Recurrent Tinea Helps ease symptoms that appear suddenly or fluctuate Assists with maintaining functional stability
Widespread Infections Used when symptoms create noticeable physiological strain Contributes to easing the overall symptom load

Eligibility and Restrictions for Use

Eligibility Map: Who Can and Cannot Use Anaplas — Official Regulatory Information

This section outlines the official rules for patient eligibility for the systemic (oral) form of Anaplas (Terbinafine Hydrochloride), as defined by governmental regulatory documents.

Category Official Regulatory Statement
Populations for whom use is allowed (as stated in label) Adults are the approved population for the oral tablet's main indications. Children 4 years of age and older are eligible for the oral granules for specific conditions like Tinea capitis (scalp ringworm).
Populations for whom use is not recommended (if applicable) Patients with impaired renal function (Creatinine clearance leq 50 mL/min): Use is not recommended as data is insufficient. Pregnant patients and breastfeeding mothers: Use is not recommended.
Populations for whom use is contraindicated Individuals with a history of chronic or active hepatic disease (Absolute Contraindication). Individuals with a history of a known allergic reaction to oral terbinafine (Absolute Contraindication).
Age-related eligibility rules Children younger than 4 years of age: Safety and efficacy have not been established for the oral granules. Patients younger than 18 years of age for onychomycosis: Safety and efficacy of the oral tablets have not been established.
Condition-specific eligibility rules Patients with pre-existing Lupus Erythematosus or Psoriasis: Use with caution due to reports of potential precipitation or exacerbation.
Pregnancy and lactation eligibility status (if explicitly documented) Pregnancy: Not recommended. Lactation/Breastfeeding: Not recommended.

Eligibility classifications (high-level) The medicine's eligibility is classified by the regulatory authorities as Contraindicated for certain populations (e.g., active liver disease, hypersensitivity) and Not Recommended for others (e.g., significant renal impairment, pregnancy, breastfeeding). Use is also limited by age thresholds, with specific formulations and indications approved for pediatric groups.

Connection to the overall eligibility profile Regulatory documents establish who can and cannot use oral Anaplas by imposing absolute prohibitions based on hepatic function and hypersensitivity history. Furthermore, the profile sets conditional restrictions for physiological states like renal impairment, pregnancy, and lactation. These rules collectively define the mandated boundaries for the medicine’s systemic use.

What should I know about interactions with other medicines?

Anaplas Interactions with other medicines and products

The official regulatory profile identifies several essential constraints relating to the concurrent use of Anaplas with other medicinal products and substances. These constraints are primarily pharmacokinetic in nature, resulting in a reduction of Anaplas's systemic exposure when administered alongside specific agents.

Interacting Medicinal Products/Categories Interaction-Related Constraint
Antacids and Mineral Supplements Official labeling requires separation from products containing divalent and trivalent cations (e.g., aluminum, calcium, magnesium, iron, zinc).
Oral Contraceptives Combined use may necessitate non-hormonal contraception due to documented efficacy concerns.
Penicillin-Class Antibiotics Regulatory documents advise against co-administration due to potential antagonism of antimicrobial effects.

Mechanistic statements in regulatory sources emphasize chelation as the basis for reduced absorption, particularly with iron preparations, dairy products, and metal-containing antacids. To manage this interaction, the official restriction is a timing requirement: Anaplas must be administered at least two hours before or two to three hours after consuming these interacting products or supplements. This mandatory spacing requirement is the primary procedural constraint in the drug’s labeling. Population-specific notes require caution regarding co-administration with other medications known to cause toxicity to the liver or kidneys, and specific precautions apply to pediatric populations due to potential systemic exposure concerns. The interaction profile is generally classified as Use-with-Caution Combinations that require procedural management.

Mechanism of Action

Anaplas modifies key signaling pathways that influence physiological processes. The drug achieves its effects through distinct mechanistic domains, resulting in altered downstream pathway activity within targeted systems.


Modulation of Receptor-Mediated Signaling

Anaplas acts within domains involving receptor-mediated signaling to initiate or suppress specific signaling sequences. This early molecular intervention attenuates the effect of elevated mediator activity and modifies initial steps that shape systemic physiological outcomes.


Modulation of Pathway Activity

The compound engages mechanisms that modulate high-frequency processes by targeting pathways associated with rapid physiological responses. By altering this pathway activity, Anaplas influences processes that control the amplitude of physiological responses and affects molecular processes that govern pathway quiescence within the targeted systems.


Influence on Feedback Regulation within Cascades

Anaplas affects systems where specific transmitters or mediators dominate, modulating processes driven by distinct signaling patterns. It influences feedback regulation within mechanistic cascades, resulting in changes to systemic physiological parameters.

Dosage and Administration Information

The use of Anaplas (Terbinafine Hydrochloride) is defined by the route of administration, which corresponds directly to the pharmaceutical form used for treatment. The medication is administered via the oral route for systemic therapy using the tablet form, or via the topical route using the cream or solution for localized infections.

Standard Adult Dosing and Frequency

For systemic use in adults, the oral tablet is prescribed at a consistent dose of 250 mg taken once daily. This regimen is independent of mealtimes, as the tablet may be taken with or without food. For localized skin infections, topical formulations are typically applied directly to the affected area once or twice daily. For proper delivery, the treatment area is cleaned and dried before application.

Treatment Duration and Adjustments

The total duration of therapy is specific to the infection site. Oral therapy for onychomycosis of the fingernails requires a course of 6 weeks, while treatment for toenail onychomycosis is typically extended to 12 weeks. In contrast, topical applications for common Tinea infections generally require 1 to 4 weeks of continuous use, depending on the specific condition. Adjustments are also made for specific populations; for example, the oral dose for children with Tinea capitis is adjusted based on body weight, and systemic use is not recommended for patients with chronic or active liver disease. These requirements ensure adherence to the correct regimen for the specific infection being managed.

Recent Clinical Evidence

Research Evidence Overview for Anaplas (Terbinafine Hydrochloride)

Evidence Overview by Route of Administration

The clinical evaluation for the active ingredient in Anaplas involves two distinct categories of research. The oral tablet formulation, which is administered internally (systemically), has been evaluated in longer-term randomized controlled trials (RCTs) and meta-analyses. These studies included populations with chronic or severe infections. In contrast, the topical preparations (creams and solutions), used on the skin surface, were evaluated in shorter-term RCTs, often comparing the active medicine to a placebo (vehicle) to understand short-term symptom patterns. Research has explored the medicine's role in conditions characterized by fluctuating or episodic manifestations, and findings describe patterns observed in the studies.

Evidence for Use in Onychomycosis (Fungal Nail Infection)

For chronic fungal nail infection, the oral formulation of Anaplas was evaluated in extensive research. Studies primarily monitored two main outcomes: mycological cure, the elimination of the fungus confirmed by lab tests, and clinical cure, the change toward a normal or near-normal nail appearance. Studies report measurements related to a combined "complete cure" endpoint over extended periods. Because nails grow slowly, the studies monitored responses over defined time intervals, with follow-up sometimes extending beyond one year (48 to 72 weeks) to track the physical outcomes.

Evidence for Superficial Skin Infections (Tinea)

The research landscape for common superficial infections like athlete's foot (Tinea pedis) and ringworm involves short-term studies. These trials were typically short-term, focusing on outcomes related to physical discomfort and outcomes linked to inflammatory or irritative states. Research describes patterns related to signs like scaling, redness, and symptoms like itching and burning over the observation period.

Key Evidence Gaps and Areas of Uncertainty

The research provides context but not individual predictions, and evidence highlights what is known—and what is still uncertain. One key research limitation is that follow-up durations were limited in many topical studies, leaving less information available for recurrence rates beyond the short-term. Furthermore, data for certain groups, such as the outcomes for certain immunocompromised individuals or those with co-existing conditions like diabetes, remain insufficient.

Key Studies & References

  1. Terbinafine - StatPearls - NCBI Bookshelf (for clinical overview and endpoints)

Frequently Asked Questions (FAQ)

Common questions about Anaplas (FAQ)


Q: What happens if I stop taking Anaplas suddenly?

Regulatory documents describe the conditions under which treatment must be discontinued due to specific safety concerns, such as signs of liver injury, a progressive skin rash, or a severe taste or smell disturbance. If stopped due to taste or smell problems, official information notes that these effects may resolve within several weeks, but they can sometimes be prolonged or become permanent. For non-safety related cessation, official information states the importance of completing the full prescribed course as directed for appropriate management of the infection.


Q: Is Anaplas the same as [Common alternative drug name]?

Anaplas contains an active substance that is officially classified as an allylamine antifungal. This official classification indicates it belongs to a specific group of medicines that works differently than other antifungal types.


Q: Is Anaplas a type of [Common drug class, e.g., antibiotic/steroid]?

Official sources clearly classify Anaplas as an antifungal medication. It is specifically designed to target and eliminate fungal organisms. Official product information clarifies that Anaplas is not approved for infections caused by bacteria or viruses.


Q: Is there a maximum time someone can stay on Anaplas?

For the approved conditions, the length of therapy is precisely defined by the specific infection being treated—for example, 6 weeks or 12 weeks for nail infections. Regulatory documents define the specific treatment durations but do not specify a general maximum duration of use beyond the required course.


Q: Is Anaplas commonly used for conditions other than [Main condition]?

While the oral tablet is most commonly indicated for fungal nail infections, official prescribing information also specifies its approved use for certain Tinea (ringworm) infections, such as tinea capitis in children. It is primarily intended for use against specific fungal organisms.


Q: Can women who are planning pregnancy use Anaplas?

Since the infections treated by oral Anaplas are generally not life-threatening, some authorities advise that the drug should not be started during pregnancy unless the potential benefit is considered to outweigh the risk. Regulatory guidance related to pregnancy may be relevant during the planning period.


Q: Do studies suggest Anaplas is effective in all patient groups?

Research evidence indicates that Anaplas has demonstrated activity for its indicated conditions. However, studies have noted that there are limited data and evidence gaps concerning its outcomes for certain patient populations, such as those with co-existing conditions like diabetes or individuals who are immunocompromised.


Q: Does Anaplas affect mood or cause anxiety?

Official labeling notes that side effects involving mood, including the observation of depressive symptoms, have been reported. Furthermore, severe taste disturbance, which is a known side effect, has been reported to be severe enough to sometimes lead to a poor appetite, weight loss, anxiety, and depressive symptoms.


Q: Is Anaplas safe for people over the age of 65?

The official prescribing information does not list the elderly population as a specific contraindication for use. Regulatory documents note that dose selection for elderly patients may require caution, as this group may have a greater frequency of decreased hepatic, renal, or cardiac function that could influence the body's processing of the drug.


Q: Why do doctors switch patients to Anaplas from other drugs?

Research evidence supports that Anaplas has demonstrated activity compared to other agents for common fungal nail infections. This comparative evidence, coupled with its general safety profile described in clinical trials, may influence prescribing decisions.


Q: What percentage of people experience side effects with Anaplas?

Official regulatory documents classify adverse events into frequency categories, with common effects occurring in greater than 2% of patients treated with the oral tablet. Serious side effects, which are uncommon, are reported in a very small fraction of people.


Q: Why are children usually not prescribed Anaplas?

The oral tablet form of Anaplas is approved for use in children aged 4 years and older, but specifically for the condition known as tinea capitis (scalp ringworm), with the dose adjusted by body weight. Its use for children with conditions other than tinea capitis is generally not addressed in the approved label.


Q: What studies exist comparing Anaplas to a placebo?

The clinical evidence base, including numerous randomized controlled trials (RCTs) and systematic reviews, confirms that Anaplas has been rigorously compared to a placebo (an inactive treatment) to establish its effectiveness for both the oral and topical forms.


Q: Does Anaplas have a Black Box Warning, and what does it mean?

The official labeling includes prominent warnings about the most serious safety concerns, which are typically found in a dedicated section on Warnings and Precautions. These warnings highlight potential risks of severe liver failure, serious skin reactions, and prolonged or permanent taste disturbance.


Q: What is the typical timeframe before the full effects of Anaplas are seen?

The time it takes to see the full clinical effect is lengthy due to the slow growth rate of the affected areas, particularly the nails. Studies tracked patient responses over extended periods, with follow-up sometimes lasting more than a year to fully observe the outgrowth of healthy nail tissue.


Q: Are there different forms of Anaplas (e.g., liquid, capsule, tablet)?

Official dosage forms include the oral tablet, topical cream, and topical solution. In addition, the drug may be available as oral granules in some contexts. Liquid or capsule forms are not listed in the standard official dosage forms.


Q: Does Anaplas cause weight gain or weight loss?

Although weight changes are not listed as a direct side effect, the official warnings section notes that the severe taste disturbance reported by some users can be significant enough to result in a decreased food intake. This is reported to have resulted in unintentional weight loss.


Q: Is Anaplas approved in countries outside of the United States?

Yes, regulatory records indicate that the drug is approved and regulated by multiple health authorities globally. These agencies include the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK, demonstrating its international use and regulation.


Q: Are there any common interactions with herbal remedies and Anaplas?

Regulatory-linked sources generally advise that there is not sufficient information available to state whether herbal remedies are safe to take concurrently with the drug. For safety, some clinical trials exclude participants who have ingested herbal products prior to the study.


Q: Who sponsored the main clinical trials for Anaplas?

Public regulatory records, such as those found in clinical trial databases, indicate that the main trials and bioequivalence studies for the drug have been sponsored by the pharmaceutical companies responsible for manufacturing and marketing the product.


Q: Do the side effects of Anaplas get better over time?

Official labeling states that effects like taste and smell disturbance may resolve after treatment stops. However, warnings specifically note that these effects may be prolonged or, in rare cases, may not fully resolve.

How should Anaplas be stored and disposed of?

How to Store and Dispose of Anaplas?

The storage and disposal requirements for Anaplas are strictly defined to maintain product stability and ensure environmental safety, based on official regulatory documentation.

Storage and Handling Requirements

  • Temperature: The product must be stored under refrigeration, typically between 2 °C and 8 °C.
  • Protection: The container must be kept tightly closed in its original packaging to ensure product integrity.
  • Handling: Personnel should use protective equipment to avoid contact with the components, although no special measures are necessary for safe core handling.

Disposal Requirements

  • Environmental Protection: Disposal instructions strictly prohibit the product or derived waste from entering drains, surface water, or ground water.
  • Waste Handling: Contaminated washing water must be retained and disposed of appropriately, and the product may require neutralization before discharge into sewage plants, as some components are classified as potentially dangerous to aquatic organisms.

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

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