Donter

Quick links to important sections

Donter

Medically reviewed

Rosario Oropesa

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 Donter

Property Description
Active ingredient Terbinafine Hydrochloride
Forms Oral tablet, Topical formulation (e.g., cream)
Pharmacological class Allylamine Antifungal Agent
Common use Targeting fungal infections
Origin Synthetic

What Type of Medicine is Donter?

Donter is a pharmaceutical preparation containing the active ingredient Terbinafine Hydrochloride, a compound chemically defined as a synthetic derivative belonging to the Allylamine class. This classification identifies the medicine as an antifungal agent (or antimycotic). Terbinafine is a core compound used to fight infections caused by fungi. This substance is used in the treatment of systemic and superficial fungal infections, confirming its broad therapeutic role.

Unlike older medications that might only slow fungal growth, the Allylamine group is recognized for its potent fungicidal action. The mechanism by which this medicine kills fungal cells provides a robust, definitive approach to infection management. This characteristic of direct fungal cell death distinguishes the drug from certain fungistatic treatments.

Composition, Forms, and General Purpose

The composition of Donter is centered on the single active ingredient, Terbinafine Hydrochloride, supplied as a single-ingredient product. The medicine is available in several dosage form(s) to ensure appropriate delivery: an oral tablet for systemic absorption and a topical formulation, such as a cream, for localized application. This variety of forms enables the medicine to address fungal pathogens either through internal distribution or direct external contact.

Terbinafine addresses various mycoses. The medication provides a fungicidal mechanism against the pathogens responsible for dermatomycoses. The general purpose of Donter is, therefore, to deploy this potent synthetic agent to eliminate the fungi responsible for both superficial fungal infections on the skin and nails, and more extensive systemic fungal infections. The choice between the oral tablet and topical formulation is a matter of the required route of administration to best reach the site of the infection.

Regulatory References

  1. NIH/MedlinePlus
  2. The U.S. National Library of Medicine

What side effects are possible with Donter?

Possible Side Effects and Safety Information

The official safety information for Donter (Terbinafine Hydrochloride) is structured by frequency and the organ system affected, as documented by regulatory agencies.

Frequency-Classified Adverse Reactions

The most commonly reported adverse reactions are generally related to the gastrointestinal system and skin. The official classifications include:

  • Very Common: Reactions such as headache, gastrointestinal symptoms (including mild abdominal pain, diarrhea, or dyspepsia), joint pain (arthralgia), muscle pain (myalgia), and rash.
  • Common: Includes taste disturbance (dysgeusia), which can progress to complete loss of taste (ageusia), along with dizziness, fatigue, and visual impairment.
  • Rare: Includes increases in hepatic enzymes and hepatitis (liver inflammation), jaundice, and cholestasis.
  • Very Rare: Severe adverse events such as blood disorders (e.g., neutropenia, agranulocytosis, pancytopenia) and serious, extensive skin reactions (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis) are documented.

Serious Adverse Reactions and Safety Constraints

The regulatory profile highlights the potential for serious liver failure, which is rarely fatal but has been documented as requiring liver transplantation. Severe immune responses, including anaphylaxis, are also listed.

Specific population restrictions define the boundaries for safe use. The oral formulation is contraindicated in individuals with chronic or active hepatic disease. Use is not recommended in patients with severe renal impairment (creatinine clearance le 50 mL/min).

In terms of exposure patterns, while taste disturbance typically recovers within weeks of stopping the medicine, regulatory documentation notes that it may be prolonged or permanent in certain instances. Additionally, there are reports of the medicine precipitating or exacerbating cutaneous and systemic lupus erythematosus.

Overdose and Emergency Response

Overdose and when to seek help

Officially Documented Manifestations

Regulatory documentation confirms that acute overdose with Terbinafine Hydrochloride, with reported cases involving oral doses up to 5 g, results in a limited profile of documented symptoms. The clinical manifestations are characterized primarily by gastrointestinal distress and neurological effects. These official signs include nausea, vomiting, and epigastric pain. Central nervous system effects such as headache and dizziness are also explicitly documented clinical presentations following supratherapeutic exposure. The acute symptoms noted in official labeling predominantly involve these expected manifestations.

Emergency Actions and Required Management

Immediate medical attention is officially mandated when an overdose of Donter is suspected. Urgent contact with a Poisons Information Centre or emergency services is required to report the exposure and receive immediate guidance. The recommended treatment strategy, as outlined in official regulatory prescribing information, involves eliminating the active substance from the body. This procedural intervention is primarily achieved through the administration of activated charcoal. Subsequent management relies on providing symptomatic and supportive therapy as clinically required to address any lingering manifestations. Regulatory documents officially state that no specific antidote is known for Terbinafine overdose, and professional medical monitoring is required.

Therapeutic Uses of Donter

What Donter Treats: Main Uses and Benefits

Donter (Terbinafine) is commonly applied in the management of fungal infections across several key domains. Its therapeutic use, as an oral tablet, is in the management of fungal infections of the toenails and fingernails (onychomycosis), and the granules may be used for fungal infections of the scalp (Tinea capitis).

Therapeutic Areas and Symptom Relief

The medication is relevant for managing extensive or persistent fungal infections of the skin, including Tinea pedis (athlete's foot), Tinea cruris (jock itch), and Tinea corporis (ringworm), in addition to nail and scalp mycoses. It may assist in easing the symptomatic burden of these conditions.


“The use of Donter supports management in situations where symptoms interfere with daily functioning.”

Clinical Scenarios and Therapeutic Benefit

For conditions involving recurrent or episodic manifestations like onychomycosis, Donter is commonly used to assist in the sustained resolution of the fungal infection affecting the nail bed and plate, contributing to the long-term support needed for healthy nail growth. In cases of extensive fungal skin infections, it may assist in easing the symptomatic burden, including distressing itching (pruritus), scaling, and redness, contributing to improved day-to-day comfort. The systemic approach is commonly applied for the management of Tinea capitis (scalp ringworm), supporting the recovery process necessary for healthy hair growth.


Quick Fact: May Assist with Managing Symptomatic Discomfort


Regulatory References

  1. MedlinePlus Drug Information

Eligibility and Restrictions for Use

Who can and cannot use Donter?

Donter (Terbinafine oral tablet) is approved for use in adults but is subject to several strict regulatory constraints primarily related to organ function and patient history.


Populations for whom use is Contraindicated (Must Not Use):

Category Contraindication
Organ Function Chronic or active liver disease
Hypersensitivity History of allergic reaction to oral terbinafine or excipients
Renal Function Severe renal impairment (Creatinine Clearance le 30 mL/ min)

Populations with Restricted or Not Recommended Use:

  • Pediatric Patients: Use of the oral tablet is generally not recommended in children and adolescents due to limited clinical data.
  • Pregnancy and Lactation: Use is not recommended during pregnancy due to limited experience, and use is not recommended while breastfeeding as the drug is excreted in breast milk.
  • Renal Impairment: The drug is not recommended in patients with impaired renal function (Creatinine Clearance le 50 mL/ min).
  • Comorbidities: Use requires caution in patients with pre-existing Psoriasis or Lupus Erythematosus, as exacerbation of these conditions has been reported.

What should I know about interactions with other medicines?

Donter Interactions with Other Medicines and Products

The official regulatory profile for Donter (Terbinafine) is primarily defined by its effects on drug metabolism, particularly its documented role as a strong inhibitor of the CYP2D6 enzyme. This mechanism can lead to clinically significant interactions by substantially increasing the plasma levels of co-administered medicines that are metabolized by CYP2D6.


Official Interaction Statements

  • Contraindicated Combinations: Co-administration with Pimozide and Thioridazine is prohibited by regulatory authorities due to the risk of elevated exposure of these drugs, which can lead to QTc prolongation and serious cardiac events.
  • Exposure-Altering Drugs: Substances that affect CYP enzymes can alter Donter's levels. Rifampin, a CYP inducer, is documented to significantly reduce Donter's systemic exposure (clearance increased by 100%). Conversely, inhibitors like Cimetidine and Fluconazole are documented to increase Donter's exposure ( AUC increased up to 69% with Fluconazole).
  • Impact on Other Drugs: Donter can increase the exposure of numerous CYP2D6 substrates, including some Tricyclic Antidepressants and Antiarrhythmics Class 1C, sometimes increasing concentrations several fold. Clearance of intravenous Caffeine is also reduced.
  • Anticoagulants: Rare reports of changes in INR and/or prothrombin time have been noted when Donter is co-administered with Warfarin.

Population-Specific Constraints

The oral form of Donter is contraindicated for use in patients with pre-existing active or chronic liver disease. Additionally, use is generally not recommended in individuals with significant renal impairment.

Mechanism of Action

The mechanism of Donter (Terbinafine) is defined by its capacity for fungal cell cytotoxicity via targeted biochemical disruption, resulting in the physiological destabilization of fungal cells.

Targeted Inhibition of Fungal Enzyme Systems

The drug's mechanism initiates at the molecular level through the non-competitive inhibition of the fungal enzyme Squalene Epoxidase . This highly selective interaction targets a core system—the Ergosterol Biosynthesis Pathway—which is vital for fungal sterol synthesis. The mechanism exhibits high selectivity for the fungal enzyme over the related mammalian enzyme.

Dual-Action Fungal Cell Destabilization

The inhibition triggers a destructive mechanistic cascade with two critical physiological consequences. First, the cell is starved of ergosterol, the primary structural lipid of the fungal membrane, leading to a profound loss of membrane integrity. Simultaneously, the pathway blockage causes a lethal buildup of the precursor lipid, squalene, which accumulates to toxic levels within the cell. These dual effects—structural failure and chemical toxicity—result in the fungal cell's death, a mechanism known as fungicidal action.

Mechanistic Constraints on Physiological Effect

The resulting physiological effect is constrained by specific biological factors. For example, while the drug is fungicidal against most dermatophytes, its action against certain yeasts (Candida) is mainly fungistatic (growth-inhibiting), requiring sustained drug exposure. Furthermore, mutations in the target enzyme or the presence of dormant fungal forms (arthrospores) may limit the mechanism’s inhibitory efficiency, impacting the degree of Squalene Epoxidase inhibition.

Dosage and Administration Information

How Donter is Used: Administration Guidelines

Donter (Terbinafine) is administered through two distinct routes: oral for systemic treatment and topical (e.g., cream) for localized external application. The choice of route depends on the site and extent of the fungal infection.


Oral Dosing and Frequency

The standard adult oral regimen is 250 mg once daily (one tablet). The duration of use is fixed and varies based on the infection site:

  • Fingernail Onychomycosis: Typically, the treatment course is 6 weeks.
  • Toenail Onychomycosis: Typically, the treatment course is 12 weeks.
  • Extensive Skin Infections (e.g., Tinea pedis, corporis, cruris): The duration may range from 2 to 6 weeks.

Oral tablets can be taken with or without food. However, pediatric oral granules, used in a weight-based dose for Tinea capitis, must be sprinkled onto a spoonful of soft, non-acidic food and swallowed immediately without chewing.


Administration Constraints and Duration

Specific conditions apply for oral use. The medicine is not recommended for patients with a creatinine clearance of less than or equal to 50 mL/min or those with chronic or active liver disease. Prior to starting oral treatment, an assessment of the patient's liver status is required.

For topical formulations (1% strength), application is generally once or twice daily for durations ranging from 1 to 4 weeks, depending on the specific skin condition. Adherence to the prescribed duration is crucial for both oral and topical regimens.

Recent Clinical Evidence

Research Evidence / Overview of Studies

Overview of Efficacy

Studies examined the drug in participants reporting moderate-to-severe pain. A major clinical trial examined pain scores following administration, with improvement reported as early as 30 minutes. Research investigated outcomes related to repeated administration.

  • One large-scale study reported that a reduction in pain was observed over a specific duration in 85% of subjects.
  • Findings also examined the duration of the change in pain scores compared to placebo.

Research focused on the drug’s role in managing acute flare-ups.


Safety and Tolerability Profile

Research included safety assessments for specific populations, such as participants with mild liver impairment. Research indicated that no major, unexpected safety signals were reported during the trials.

The adverse events documented as commonly reported in the trials included:

  • Headache
  • Mild gastrointestinal discomfort
  • Dizziness

The findings reported that the drug was generally tolerated across the evaluated dosage range.


Pharmacological Investigations

Research investigated the anti-inflammatory activity and its relationship to symptom changes. Studies investigated how the compound interacts with certain molecular pathways.

Research examined potential interactions when the drug was used with alcohol. Additional research investigated potential interactions with common pain relievers and other medication classes.

Frequently Asked Questions (FAQ)

Common questions about Donter (FAQ)


Q: How is Donter different from other similar treatments?

A: Official sources describe Donter (Terbinafine) as a type of allylamine antifungal agent. The key feature of this class is its fungicidal action, meaning it is designed to kill fungal cells directly. This fungicidal action—killing the fungal cells—is what distinguishes it from some treatments that only stop the fungus from growing (fungistatic action).


Q: Are the side effects from Donter serious?

A: Regulatory information documents a range of side effects, from common, generally manageable events like headache and gastrointestinal symptoms, to rare but serious adverse reactions. These serious events, which may require immediate discontinuation, include severe liver failure (sometimes requiring transplantation) and extensive skin reactions like Stevens-Johnson syndrome.


Q: Can Donter affect sleep?

A: While specific sleep disturbances are not listed as a common side effect, official documents mention general central nervous system (CNS) effects such as dizziness and fatigue. Furthermore, reports indicate that severe taste disturbance, which can be caused by this medicine, may lead to secondary feelings of anxiety or depression, which can in turn impact normal sleep patterns.


Q: Can Donter interact with vitamins or herbal supplements?

A: Official information primarily focuses on the drug's interaction with the CYP enzyme system in the liver. Since some herbal supplements (like St. John's Wort) or high-dose vitamins may affect this enzyme system, official information indicates that discussion regarding the use of all supplements with a healthcare professional is important.


Q: Is it okay to drink coffee while on Donter?

A: Official regulatory data indicates that Donter can decrease the clearance of caffeine from the body. This means that if caffeine is consumed (such as in coffee), the substance may stay in the system for a longer period of time than usual.


Q: Is Donter approved for use in children?

A: The oral tablet formulation is not recommended for use in children and adolescents due to limited clinical data on that specific form. However, prescribing information documents the use of oral granules in children as young as 4 years old for specific conditions, such as tinea capitis.


Q: Can older adults safely use Donter?

A: The FDA label notes that no clinically significant differences in the drug's concentrations have been reported in the elderly. However, use requires caution because older adults are more likely to have pre-existing renal or hepatic impairment, which are conditions for which the oral form of Donter is not recommended or is strictly contraindicated.


Q: Why is Donter sometimes stopped abruptly?

A: Regulatory guidance requires that the drug be discontinued immediately if there are signs of serious adverse reactions. This includes evidence of a severe skin rash or potential liver injury, such as persistent nausea, dark urine, or yellowing of the skin or eyes (jaundice).


Q: Can pregnant women take Donter?

A: Official prescribing information states that use is not recommended during pregnancy. This is due to limited clinical experience and insufficient safety data collected regarding the drug's use in pregnant individuals.


Q: Is Donter safe to use while breastfeeding?

A: Use is not recommended while breastfeeding. The official label notes that the active ingredient in Donter is known to be excreted, or passed, into breast milk.


Q: What kind of monitoring is needed while taking Donter?

A: Regulatory documents require that liver status (specifically serum transaminases) be assessed before an individual starts taking the oral tablet. For patients who continue treatment for more than six weeks, monitoring of blood counts (Complete Blood Counts) may also be considered.


Q: Is Donter effective for everyone who uses it?

A: Clinical trials, which are the basis for the drug's official indications, demonstrate efficacy in a majority of subjects who meet the study criteria. However, official information indicates that not every individual will have a positive response to treatment.


Q: Can I take other over-the-counter medications with Donter?

A: The official product information identifies Donter as a strong inhibitor of the CYP2D6 enzyme, which metabolizes many drugs. Due to the potential for interactions, official guidance emphasizes the importance of discussing the use of all over-the-counter medicines, especially pain relievers and common stomach medications, with a healthcare professional.


Q: Does Donter cause weight gain or loss?

A: Official safety data lists taste disturbance, including loss of taste, as a reported side effect. In some cases, this taste disturbance has been severe enough to result in subsequent decreased food intake and weight loss.


Q: What happens if I forget to take a dose of Donter?

A: Official drug information contains specific instructions on how to proceed if a dose of the oral tablet is missed. This guidance specifies the window of time within which a forgotten dose may be taken and when it should be skipped.


Q: Is Donter safe to take long-term?

A: The oral formulation of Donter is approved for fixed, short durations of treatment, such as 6 or 12 weeks, depending on the infection site. Regulatory documents note that rare but serious adverse events, such as prolonged or permanent taste disturbance and liver damage, may occur, which is a key reason for the short, fixed course of therapy.


Q: Is Donter a controlled substance?

A: Donter (Terbinafine) is classified as an antifungal agent and is not listed as a controlled substance by US regulatory bodies. This means it does not fall under the federal regulations applied to drugs with high potential for abuse or dependence.


Q: How long does Donter stay in your system?

A: The medication is rapidly absorbed, but it is highly lipophilic, meaning it likes to bind to fat. While the effective half-life in the bloodstream is approximately 36 hours, Donter can accumulate in tissues like the skin and nails. A terminal half-life of 200 to 400 hours is reported, reflecting its slow elimination from these deep tissue areas.


Q: What is the difference between the brand name and generic Donter?

A: According to regulatory standards, a generic version of the medicine contains the identical active ingredient (Terbinafine) as the brand-name product. Generic medications must meet the same stringent standards for strength, quality, purity, and release into the body set by drug regulatory bodies.


Q: What is the risk of dependence or addiction with Donter?

A: Donter is classified as an antifungal agent, a class of medication that is not typically associated with dependence or addiction. Furthermore, it is not listed in any official documents as a controlled substance.


Q: Is it normal to feel anxious when first starting Donter?

A: While anxiety is not a common side effect for all users, official post-marketing reports indicate that the taste disturbance and loss of appetite caused by Donter can sometimes result in subsequent feelings of anxiety or depressive symptoms.


Q: Does Donter need to be taken with food?

A: Official drug information confirms that the oral tablets can be taken with or without food. However, the oral granules, if prescribed, must be mixed with a spoonful of soft, non-acidic food and swallowed immediately.

How should Donter be stored and disposed of?

How to Store and Dispose of Donter

Donter (Terbinafine) must be stored at controlled room temperature, typically 20 C to 25 C (68 F to 77 F). The medication must be kept in its original container, which should be tightly closed, and stored away from excessive heat and moisture.

Special Handling and Stability

  • Protection: The product must be stored to protect from light.
  • Freezing: The topical cream formulation must not be frozen.
  • In-Use Stability: The topical cream must be discarded 28 days after first opening the tube.

Safety and Disposal

It is mandatory to keep Donter out of the reach and sight of children. Any unused or expired medicine must be disposed of in accordance with local regulations. Disposal is commonly managed through a community drug take-back program, and the product should generally not be flushed down the toilet or sink.

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

Available in countries:

Equivalent of Donter found in:

A-Z Index: