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What is terbinafine for. Terbinafine: Understanding Its Uses, Effects, and Important Considerations

How does terbinafine work. When will you feel better after using terbinafine. Are there any long-term side effects of terbinafine. What if terbinafine does not work. Are there other medicines for fungal infections. Do you need to have blood tests if you’re taking terbinafine tablets. Will terbinafine affect your contraception.

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The Mechanism of Action: How Terbinafine Combats Fungal Infections

Terbinafine is a powerful antifungal medication that operates through a specific mechanism to eradicate fungal infections. Its primary mode of action involves targeting the cell membrane of fungi. By creating holes in this protective barrier, terbinafine causes the internal contents of the fungal cells to leak out, ultimately leading to their demise. This process effectively treats the infection by eliminating the underlying cause.

The efficacy of terbinafine lies in its ability to disrupt the fungal cell structure without significantly affecting human cells. This selectivity is crucial in ensuring that the medication targets the pathogen while minimizing potential harm to the patient’s healthy tissues.

The Science Behind Terbinafine’s Fungicidal Action

At a molecular level, terbinafine interferes with the fungal cell’s ability to produce ergosterol, a vital component of fungal cell membranes. By inhibiting the enzyme squalene epoxidase, terbinafine disrupts the ergosterol biosynthesis pathway, leading to the accumulation of squalene within the fungal cell. This accumulation, combined with the lack of ergosterol, compromises the integrity of the cell membrane, ultimately causing cell death.

Timeline for Terbinafine Effectiveness: When to Expect Results

The duration required for terbinafine to produce noticeable improvements varies depending on the type and severity of the fungal infection. Generally, patients can expect to see some progress within a few days to several weeks after beginning treatment.

  • Terbinafine solution: Usually begins to work within a few days. If symptoms persist after one week, consult your doctor.
  • Cream, gel, or spray formulations: Typically start showing effects within a few days. Seek medical advice if symptoms don’t improve after two weeks.
  • Terbinafine tablets: May take several weeks to demonstrate significant improvement. For fungal nail infections, complete resolution can take 6 months or longer.

Factors influencing the speed of recovery include the patient’s age, with younger individuals often experiencing faster improvement, and the location of the infection. For instance, infections on the big toe tend to require more time to clear up compared to those on other toes.

Long-Term Use and Potential Side Effects of Terbinafine

While terbinafine is generally prescribed for short-term use to address specific fungal infections, certain conditions may necessitate prolonged treatment. Is extended use of terbinafine safe? When used as directed by a healthcare professional, long-term terbinafine treatment can be safe and effective, particularly for persistent infections like those affecting the nails.

However, it’s crucial to adhere to the recommended duration of use. Overuse or extended use beyond the prescribed period can lead to potential issues:

  1. Decreased efficacy: Fungal infections may develop resistance to terbinafine if used too frequently or for too long.
  2. Liver function concerns: In rare cases (less than 1 in 1,000), terbinafine can affect liver function. For this reason, doctors may request blood tests to monitor liver health during long-term use.

Always follow your healthcare provider’s instructions regarding the duration of treatment to maximize benefits while minimizing potential risks.

Alternative Treatment Options: Exploring Other Antifungal Medicines

While terbinafine is a highly effective antifungal medication, it’s not the only option available for treating fungal infections. Healthcare providers may recommend alternative treatments based on the specific type of infection, its location, and individual patient factors.

Common Antifungal Alternatives

  • Clotrimazole
  • Fluconazole
  • Econazole
  • Itraconazole
  • Ketoconazole
  • Miconazole
  • Griseofulvin

These medications come in various forms, including creams, gels, sprays, pessaries, tablets, capsules, liquids, and injections. The choice of formulation often depends on the infection site and severity.

Selecting the Right Antifungal Treatment

Choosing the most appropriate antifungal medication involves considering several factors:

  1. Type of fungal infection
  2. Location of the infection
  3. Severity of symptoms
  4. Patient’s medical history and potential drug interactions
  5. Treatment duration and convenience

Consulting with a healthcare professional or pharmacist is crucial in determining the best antifungal treatment for your specific condition.

Terbinafine and Contraception: Understanding Potential Interactions

For individuals using hormonal contraceptives, it’s natural to have concerns about potential interactions with terbinafine. Can terbinafine affect the efficacy of birth control methods? Generally, terbinafine is not known to significantly impact contraception, including the combined pill or emergency contraception.

However, there are some considerations to keep in mind:

  • Vomiting or severe diarrhea: If terbinafine causes these side effects for more than 24 hours, it may reduce the effectiveness of contraceptive pills. In such cases, refer to the pill packet instructions for guidance on maintaining protection.
  • Breakthrough bleeding: Some reports suggest a potential link between terbinafine tablets and spotting in individuals using the combined pill. While the exact relationship is unclear, it’s advisable to consult a healthcare provider if experiencing unexpected bleeding.

To ensure optimal contraceptive protection while using terbinafine, maintain open communication with your healthcare provider and report any unusual symptoms or concerns promptly.

Blood Donation Considerations for Terbinafine Users

Individuals using terbinafine may wonder about the implications for blood donation. Can you donate blood while using terbinafine? The answer depends on the form of terbinafine you’re using:

  • Topical formulations (cream, gel, spray, or solution): Generally safe for blood donation without restrictions.
  • Terbinafine tablets: A waiting period of at least 7 days after completing the course is necessary before donating blood.

This precautionary measure ensures that the medication has been sufficiently cleared from your system before donation. Always check with the blood donation center or consult the NHS Give Blood website for the most up-to-date guidelines on eligibility.

Terbinafine and Daily Activities: Driving, Alcohol Consumption, and Dietary Considerations

Understanding how terbinafine may affect your daily life is crucial for safe and effective treatment. Let’s explore some common concerns:

Driving and Operating Machinery

Can you drive or ride a bike while taking terbinafine? In most cases, terbinafine doesn’t impair your ability to drive or operate machinery. However, if you experience side effects such as dizziness, fatigue, or general malaise, it’s advisable to avoid these activities until you feel better. Always prioritize safety and use your judgment when deciding whether it’s appropriate to drive or operate machinery while using terbinafine.

Alcohol Consumption

Is it safe to drink alcohol while using terbinafine? Unlike some medications, terbinafine doesn’t have known interactions with alcohol. Therefore, moderate alcohol consumption is generally considered safe while using this antifungal medication. However, it’s always wise to consult with your healthcare provider for personalized advice, especially if you have underlying health conditions or are taking other medications.

Dietary Considerations

Are there any food or drink restrictions while taking terbinafine? While there are no strict dietary restrictions associated with terbinafine use, it’s worth noting that terbinafine tablets may enhance the effects of caffeine. Excessive caffeine intake can lead to various side effects, including:

  • Headaches
  • Insomnia
  • Agitation
  • Increased urination

To mitigate these potential effects, consider moderating your caffeine consumption while taking terbinafine tablets. This precaution can help ensure a more comfortable treatment experience.

Navigating Terbinafine Treatment: What to Do If It Doesn’t Work

Despite its efficacy, there may be instances where terbinafine doesn’t produce the desired results. What should you do if terbinafine isn’t clearing your fungal infection? First and foremost, it’s crucial to complete the prescribed course of treatment before concluding that it’s ineffective. If symptoms persist or worsen after completing the treatment, several steps can be taken:

  1. Consult your healthcare provider: They may recommend extending the treatment duration or adjusting the dosage.
  2. Consider alternative antifungal medications: Your doctor might prescribe a different antifungal agent that may be more effective for your specific infection.
  3. Investigate underlying factors: In some cases, persistent infections may be indicative of other health issues or environmental factors that need addressing.

Remember, fungal infections can be stubborn, and successful treatment often requires patience and sometimes a multifaceted approach. Open communication with your healthcare provider is key to finding the most effective solution for your condition.

Factors Influencing Treatment Success

Several factors can impact the effectiveness of terbinafine treatment:

  • Infection severity and duration
  • Patient’s immune system status
  • Adherence to treatment regimen
  • Presence of drug-resistant fungal strains
  • Concurrent medical conditions

Understanding these factors can help set realistic expectations for treatment outcomes and guide discussions with your healthcare provider about the best course of action.

Monitoring Liver Function During Long-Term Terbinafine Use

For individuals prescribed long-term terbinafine treatment, particularly in tablet form, healthcare providers may recommend periodic liver function tests. Why are these tests necessary? While rare, there is a small risk (less than 1 in 1,000) that terbinafine can affect liver function. These tests serve as a precautionary measure to ensure the medication isn’t causing any adverse effects on liver health.

Understanding Liver Function Tests

Liver function tests typically involve blood samples that measure various enzymes and proteins indicative of liver health. These may include:

  • Alanine transaminase (ALT)
  • Aspartate transaminase (AST)
  • Alkaline phosphatase (ALP)
  • Bilirubin

Elevated levels of these markers can signal potential liver stress or damage, prompting further evaluation or adjustment of treatment.

Frequency of Monitoring

The frequency of liver function tests may vary depending on individual risk factors and treatment duration. Your healthcare provider will determine the appropriate schedule for monitoring based on your specific situation. Typically, these tests are performed before initiating treatment and at regular intervals throughout the course of long-term terbinafine use.

By maintaining vigilant monitoring, healthcare providers can ensure the safe and effective use of terbinafine, particularly for those requiring extended treatment periods.

Common questions about terbinafine – NHS

How does terbinafine work?

Terbinafine is an antifungal medicine. It works by killing the fungus that is causing the infection.

It makes holes in the cell membrane of the fungus and the contents leak out. This kills the fungus and treats the infection.

When will I feel better?

It depends on the type of infection you have. Some will take longer to get better.

Terbinafine solution usually starts to work within a few days. Talk to your doctor if your symptoms do not get better within 1 week.

The cream, gel or spray usually starts to work within a few days. Talk to your doctor if your symptoms do not get better within 2 weeks.

Terbinafine tablets can take several weeks to work. If you have completed the course of tablets and still have symptoms, talk to your doctor.

Some fungal nail infections take 6 months or longer to get better. Nail infections often get better more quickly in younger people. Infections on the big toe often take longer to clear up than on other toes.

Are there any long-term side effects?

Terbinafine is usually used for a short time to clear an infection. Do not use it for longer than your pharmacist or doctor has recommended.

If you use it too often or for too long, the medicine may not work so well. This is because fungal infections can become resistant to terbinafine.

For some infections, such as fungal nail infections, you may need to take terbinafine tablets for up to 3 months (sometimes longer). It’s safe to take long term if your doctor tells you to.

What if it does not work?

If taking terbinafine is not working to clear an infection, your doctor may ask you to take it for longer or they may prescribe a different antifungal medicine.

If your symptoms get worse at any time, speak to your doctor.

Are there other medicines for fungal infections?

There are many different antifungal medicines. Some are available to buy from a pharmacy, and others are available on prescription.

They can come as creams, gels and sprays, pessaries (soft tablets you put into your vagina), tablets, capsules and liquid, or injections.

Your doctor or a pharmacist will be able to recommend the best treatment for you, based on your condition.

Other antifungal medicines include:

  • clotrimazole
  • fluconazole
  • econazole
  • itraconazole
  • ketoconazole
  • miconazole
  • griseofulvin

Do I need to have blood tests if I’m taking terbinafine tablets?

If you take terbinafine tablets for a long time, your doctor may ask you to come back for a blood test. This is to check that your liver is working properly.

There is a small chance (less than 1 in 1,000) that terbinafine can affect your liver.

Will it affect my contraception?

Terbinafine is not likely to affect your contraception, including the combined pill or emergency contraception.

If taking terbinafine makes you sick (vomit) or have severe diarrhoea for more than 24 hours, your contraceptive pills may not protect you from pregnancy. Look on the pill packet to find out what to do.

Find out what to do if you’re taking the pill and you’re being sick or have diarrhoea

There have been some reports of breakthrough bleeding, known as spotting, when people take terbinafine tablets and the combined pill together. It’s not known whether this is to do with the terbinafine. If you get any breakthrough bleeding while using oral contraception, speak to your doctor.

Can I donate blood if I’m using or taking terbinafine?

If you’re using terbinafine cream, gel, spray or solution, then it’s OK to donate blood.

But if you’re taking terbinafine tablets, it’s important to wait at least 7 days after completing the course of tablets before giving blood.

You can check if you’re able to give blood on the NHS Give Blood website.

Can I drive or ride a bike?

You can drive or cycle while taking terbinafine if you feel OK.

But if taking terbinafine makes you feel dizzy, tired or very unwell, do not drive or ride a bike until you feel OK again.

It’s an offence to drive a car if your ability to drive safely is affected. It’s your responsibility to decide if it’s safe to drive. If you’re in any doubt, do not drive.

Talk to your doctor or pharmacist if you’re unsure whether it’s safe for you to drive while taking or using terbinafine. GOV.UK has more information on the law on drugs and driving.

Can I drink alcohol while using or taking terbinafine?

Yes, you can drink alcohol while using or taking terbinafine.

Is there any food or drink I need to avoid?

Terbinafine tablets may increase the effects of caffeine. Having too much caffeine can give you headaches, stop you sleeping, make you feel agitated and it can make you pee more.

It’s a good idea to avoid having too much caffeine while taking the tablets. Caffeine is found in coffee, tea, colas, energy drinks and chocolate.

Other than this, you can eat and drink normally while using or taking terbinafine.

Can lifestyle changes help with fungal skin infections?

If you have a fungal skin infection, these tips may help:

  • always wash your hands after treating the infection to stop it from spreading
  • do not scratch the area with the infection, as this can make the infection worse
  • keep the affected areas of your skin clean and dry
  • do not share towels, bedsheets or combs with other people as you could spread the infection to them
  • wash towels and bedding regularly

Read more about what you can do if you have:

  • ringworm
  • athlete’s foot
  • a fungal nail infection

Page last reviewed: 24 March 2023

Next review due: 24 March 2026

Terbinafine – StatPearls – NCBI Bookshelf

Luke Maxfield; Charles V. Preuss; Rene Bermudez.

Author Information and Affiliations

Last Update: May 29, 2023.

Continuing Education Activity

Terbinafine is an antifungal medication that works through the inhibition of squalene epoxidase. It has activity against most dermatophytes, and it has approval for use as an oral therapy for the treatment of onychomycosis. Although most side effects are mild and self-limited, such as headache and gastrointestinal symptoms, taste disturbances (dysgeusia) can range from mild to severe, resulting in weight loss, and have rarely been reported permanent. This activity describes the indications, mode of action, and side effects of terbinafine and highlights the role of the interprofessional team in ensuring proper usage.

Objectives:

  • Identify the mechanism of action of terbinafine.

  • Describe the adverse effects of terbinafine.

  • Explain the appropriate monitoring for patients receiving antifungal therapy with terbinafine.

  • Review interprofessional team strategies for improving care coordination and communication to advance terbinafine and improve outcomes.

Access free multiple choice questions on this topic.

Indications

Terbinafine has FDA approval to treat onychomycosis that is suspected or proven to be caused by dermatophyte organisms. Indications for oral therapy include the following[1]:

  • Proximal subungual onychomycosis

  • Distal lateral subungual onychomycosis affecting over 50% of the nail plate with nail matrix involvement and plate thickness greater than two millimeters

  • Greater than or equal to three nails involved

Oral terbinafine has been demonstrated to be the most effective treatment for the mycological cure of toenail dermatophyte infections.[2]

Treatment of onychomycosis in the pediatric population with systemic medications is off-label, and it is not U.S. Food and Drug Administration (FDA) approved. Although there are no proposed USA guidelines, terbinafine has been recommended by the British Association of Dermatologists as a first-line treatment.[1]

The treatment of tinea capitis is an additional non-FDA use of terbinafine. Notably, although both griseofulvin and terbinafine are effective treatment options for pediatric tinea capitis, terbinafine has demonstrated superiority in the treatment of infections caused by Trichophyton spp., while griseofulvin was more effective at treating hair shaft infections caused by Microsporum spp. As Trichophyton spp. are the most common cause of tinea capitis in North America, terbinafine is often the treatment for this condition.[3]

Mechanism of Action

Most antifungal medications work through the inhibition of fungal membrane production and ergosterol synthesis. Terbinafine is an allylamine that works early in the pathway as a non-competitive inhibitor of the enzyme squalene epoxidase and subsequent conversion of squalene to squalene epoxide. [1]

Although not directly fungicidal, the intracellular accumulation of squalene results in fungal cell death.[4]

Administration

Terbinafine is formulated as a 250 mg tablet to be taken by mouth. The routine dosing for dermatophyte infections is one tablet, by mouth, daily. The duration of therapy varies, with treatment lasting for six weeks for fingernail onychomycosis and up to 12 weeks for toenail onychomycosis. Absorption and bioavailability are similar, regardless of food intake. The clearance of terbinafine occurs through both the liver and kidneys. Terbinafine has an inhibitory effect on the hepatic CYP450 2D6 (CYP2D6) enzyme, and monitoring for drug interactions is necessary.

Other dosing schedules that have not received approval from the FDA include pulse-dose treatment with terbinafine. This treatment schedule can be performed in multiple ways but can consist of one 250 mg tablet per day for four weeks, with four weeks of no therapy, and the resumption of one 250 mg tablet per day for another four weeks. The efficacy of this treatment schedule has been demonstrated to be similar to continuous dosing.[1]

Adverse Effects

The most common adverse events associated with terbinafine tend to be mild and self-limited. These include headaches, gastrointestinal symptoms, and rash. Additional uncommon but mild adverse events include visual disturbances, dysgeusia, and mild transaminitis. In rare instances, dysgeusia can be severe or permanent.[2] However, there are reports of fulminant liver failure.[1] Although cutaneous findings are usually non-specific, rarely Stevens-Johnson syndrome, toxic epidermal necrolysis, and cutaneous or systemic lupus erythematosus may develop.[1][5]

Contraindications

Contraindications to the use of terbinafine include:

  • Chronic or active liver disease

  • History of an allergic reaction to oral terbinafine

As terbinafine inhibits the hepatic CYP2D6 enzyme, drug interactions can occur.[1][6] The list of potentially interacting drugs includes, but is not limited to, cimetidine, fluconazole, cyclosporine, rifampin, caffeine, paroxetine, codeine, metoprolol, simvastatin, nifedipine, digoxin, phenytoin, and many others. [2][6]

Terbinafine, although a pregnancy safety category B medication, is not recommended for use during pregnancy. Similarly, as terbinafine is known to be excreted in breast milk, its use should be limited to after breastfeeding; this is due to the usually indolent nature of nail dermatophyte infections, lack of embryotoxicity data with terbinafine, and the litigious culture of the United States.[1] Although not FDA-approved, topical terbinafine has been recommended for the treatment of dermatophyte infections during pregnancy, and it is available over the counter in the United States of America.[7]

Monitoring

There is no standardized laboratory monitoring established for terbinafine. In light of reports of both mild and severe liver injuries, clinicians often perform liver enzyme testing. The FDA recommends measuring serum transaminases before drug initiation. Although no established monitoring guidelines exist, the average time to drug-induced liver injury is nearly 30 days and usually within three months. Therefore, monitoring for idiosyncratic liver injury during this period may be reasonable.[1] Blood dyscrasias may also rarely occur, and complete blood counts serve to monitor for this adverse drug effect.[1]

Toxicity

Taste disturbances, nausea, vomiting, abdominal cramping, and headache may occur in patients taking terbinafine. Despite these untoward effects, the continuation of the medication is often dependent on the severity of symptoms and the patient’s discomfort threshold. Discontinuation may be appropriate to resolve most symptoms. Although multiple symptoms may present in patients taking therapeutic or supratherapeutic doses of terbinafine, the most concerning and consistent severe adverse effects occur in the liver.

Hepatotoxicity may be asymptomatic and only detectable by lab evaluation and evidence of transaminitis. Liver enzymes over two times the normal value requires immediate discontinuation. Supportive care, including liver transplantation (in severe cases), may be necessary. [1][8]

Enhancing Healthcare Team Outcomes

In addition to the physician’s identification, diagnosis, and treatment of onychomycosis, as well as monitoring for adverse drug effects, the interprofessional team should be involved in multiple ways. As terbinafine undergoes hepatic metabolism, conversations with the pharmacist about concomitant alcohol consumption would be prudent, although the relationship between alcohol and other hepatotoxic substances and the idiosyncratic nature of terbinafine-induced liver disease is not entirely clear. The pharmacist should also verify dosing and perform therapeutic medication management, especially in light of terbinafine’s interaction profile, and report any concerns to the prescribing physician.[9] The nurse will usually encounter the patient first and can note the success or failure of therapy and report any adverse drug reactions that may present. Interprofessional care coordination and open communication between providers are crucial to successful treatment with terbinafine. [Level 5]

More importantly, the patient should be worked up to ensure that the diagnosis is correct when the patient presents with refractory symptoms. Both the nurse practitioner, primary care provider, and pharmacist should refrain from extending the duration of treatment until there is diagnostic confirmation. Finally, these clinicians should assess the liver function if the patient is on prolonged therapy, and the results require communication with the entire team. Both the pharmacist and nurse should regularly question the patient about the development of drug side effects and report back to the clinical team leader if untoward problems develop. Only with this type of interprofessional collaboration will terbinafine therapy be optimal, with minimal adverse drug reactions and drug interactions. [Level 5]

The level of evidence demonstrating terbinafine efficacy compared to placebo and alternative systemic anti-fungal agents is Level-I with confirmation from multiple randomized controlled trials. [10]

Level of evidence for terbinafine and liver injury: Likelihood score: B (highly likely cause of clinically apparent liver injury). 

Review Questions

  • Access free multiple choice questions on this topic.

  • Comment on this article.

References

1.

Lipner SR, Scher RK. Onychomycosis: Treatment and prevention of recurrence. J Am Acad Dermatol. 2019 Apr;80(4):853-867. [PubMed: 29959962]

2.

Zane LT, Chanda S, Coronado D, Del Rosso J. Antifungal agents for onychomycosis: new treatment strategies to improve safety. Dermatol Online J. 2016 Mar 16;22(3) [PubMed: 27136621]

3.

Gupta AK, Mays RR, Versteeg SG, Piraccini BM, Shear NH, Piguet V, Tosti A, Friedlander SF. Tinea capitis in children: a systematic review of management. J Eur Acad Dermatol Venereol. 2018 Dec;32(12):2264-2274. [PubMed: 29797669]

4.

Ryder NS. Terbinafine: mode of action and properties of the squalene epoxidase inhibition. Br J Dermatol. 1992 Feb;126 Suppl 39:2-7. [PubMed: 1543672]

5.

Kalińska-Bienias A, Kowalewski C, Woźniak K. Terbinafine-induced subacute cutaneous lupus erythematosus in two patients with systemic lupus erythematosus successfully treated with topical corticosteroids. Postepy Dermatol Alergol. 2013 Aug;30(4):261-4. [PMC free article: PMC3834709] [PubMed: 24278085]

6.

Gupta AK, Versteeg SG, Shear NH. Common drug-drug interactions in antifungal treatments for superficial fungal infections. Expert Opin Drug Metab Toxicol. 2018 Apr;14(4):387-398. [PubMed: 29633864]

7.

Patel VM, Schwartz RA, Lambert WC. Topical antiviral and antifungal medications in pregnancy: a review of safety profiles. J Eur Acad Dermatol Venereol. 2017 Sep;31(9):1440-1446. [PubMed: 28449377]

8.

Perveze Z, Johnson MW, Rubin RA, Sellers M, Zayas C, Jones JL, Cross R, Thomas K, Butler B, Shrestha R. Terbinafine-induced hepatic failure requiring liver transplantation. Liver Transpl. 2007 Jan;13(1):162-4. [PubMed: 17192859]

9.

Mikami A, Hori S, Ohtani H, Sawada Y. Analysis of the Mechanism of Prolonged Persistence of Drug Interaction between Terbinafine and Amitriptyline or Nortriptyline. Biol Pharm Bull. 2017;40(7):1010-1020. [PubMed: 28674244]

10.

Gupta AK, Daigle D, Foley KA. Network Meta-Analysis of Onychomycosis Treatments. Skin Appendage Disord. 2015 Sep;1(2):74-81. [PMC free article: PMC4857825] [PubMed: 27170937]

Disclosure: Luke Maxfield declares no relevant financial relationships with ineligible companies.

Disclosure: Charles Preuss declares no relevant financial relationships with ineligible companies.

Disclosure: Rene Bermudez declares no relevant financial relationships with ineligible companies.

Terbinafine cream

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Terbinafine cream

Antifungal drug for external use. It is used for the treatment and prevention of fungal diseases of the skin – mycosis of the feet, multi-colored lichen, skin candidiasis and other dermatomycosis.

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Terbinafine instructions for use: indications, contraindications, side effects – description of Terbinafine cream for external use.

approx. 1%: tubes 15 g or 30 g (16430)

💊 Composition of Terbinafine

✅ Use of Terbinafine

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Description of the active ingredients of the preparation

Terbinafine
(Terbinafine)

The scientific information provided is general and cannot be used to make decisions.
decisions about the use of a particular drug.

Update date: 2021.03.31

Marketing authorization holder:

VERTEKS, JSC
(Russia)

Manufactured:

VERTEKS, JSC

(Russia)

ATX code:

D01AE15

(Terbinafine)

Active substance:
terbinafine
(terbinafine)

Rec. INN

WHO registered

Dosage form

Terbinafine

Cream for external use approx. 1%: tubes 15 g or 30 g

reg. No.: LSR-003723/07
from 09.11.07
– Indefinitely

Release form, packaging and composition
drug Terbinafine

Cream for external use 1% white, homogeneous, with a slight characteristic odor.

Excipients : benzyl alcohol, polysorbate 60 (tween 60), sorbitan monostearate, cetyl alcohol, isopropyl myristate, cetyl palmitate, sodium hydroxide, purified water.

15 g – aluminum tubes (1) – packs of cardboard.
30 g – aluminum tubes (1) – packs of cardboard.

Clinical and pharmacological group:

Antifungal drug for external use

Pharmacotherapeutic group:

Antifungal agent

Pharmacological action

Topical antifungal agent with a broad spectrum of antifungal activity. Even at low concentrations, terbinafine has a fungicidal effect against dermatophytes (Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton verrucosum, Trichophyton violaceum, Trichophyton tonsurans, Microsporum canis, Epidermophyton floccosum), molds (mainly Candida albicans) and certain dimorphic fungi (Pityrosporum orbiculare). Activity against yeast fungi, depending on their type, can be fungicidal or fungistatic.

Terbinafine specifically alters the early stage of sterol biosynthesis in fungi. This leads to a deficiency of ergosterol and intracellular accumulation of squalene, which causes the death of the fungal cell. The action of terbinafine is carried out by inhibiting the enzyme squalene epoxidase, located on the cell membrane of the fungus.

Terbinafine has no effect on the cytochrome P450 system in humans and, accordingly, on the metabolism of hormones or other drugs.

Pharmacokinetics

When applied topically, absorption is 5%, has a slight systemic effect.

Indications of the active substances of the drug

Terbinafine

  • prevention and treatment of fungal infections of the skin, incl. athlete’s foot, athlete’s groin (tinea cruris), fungal infections of the smooth skin of the body (tinea corporis) caused by dermatophytes such as Trichophyton (including Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton verrucosum, Trichophyton violaceum), Microsporum canis and Epidermophyton floccosum ;
  • yeast infections of the skin, mainly those caused by the genus Candida (eg Candida albicans), in particular diaper rash;
  • Pityriasis versicolor caused by Pityrosporum orbiculare (also known as Malassezia furfur).

Open list of ICD-10 codes

B35.2 Mycosis of the hands
B35.3 Mycosis stop
B35.4 Trunk mycosis
B35.6 Athlete’s groin
B36.0 versicolor
B37.2 Skin and nail candidiasis

Dosing regimen

The route of administration and dosing regimen of a particular drug depends on its form of release and other factors. The optimal dosage regimen is determined by the doctor. Compliance of the dosage form of a particular drug with indications for use and dosing regimen should be strictly observed.

For external use.

Adults and children over 12 years old

Clean and dry the affected areas before applying the cream. The cream is applied 1 or 2 times / day with a thin layer on the affected skin and adjacent areas and lightly rubbed. For infections accompanied by diaper rash (under the mammary glands, in the interdigital spaces, between the buttocks, in the inguinal region), the places where the cream is applied can be covered with gauze, especially at night.

Average duration of treatment: ringworm of the trunk, legs – 1 week 1 time / day; ringworm of the feet – 1 week 1 time / day; skin candidiasis – 1-2 weeks 1 or 2 times / day; versicolor versicolor – 2 weeks 1 or 2 times / day.

If after 1-2 weeks of treatment there are no signs of improvement, the diagnosis should be verified.

The dosing regimen of the drug in elderly people does not differ from that described above.

This drug is not recommended for children under the age of 12 .

Side effects

Redness, itching or burning may occur at the site of application.

Possible: allergic reactions.

Contraindications for use

  • hypersensitivity to terbinafine or any of the inactive ingredients that make up the drug.

Precautions: liver and / or kidney failure, alcoholism, depression of bone marrow hematopoiesis, tumors, metabolic diseases, occlusive diseases of the vessels of the extremities, children under 12 years of age (lack of sufficient clinical experience).

Use in pregnancy and lactation

In experimental studies no teratogenic properties of terbinafine were identified. To date, no malformations have been reported with terbinafine. However, since clinical experience with terbinafine in pregnant women is very limited, it should only be used under strict indications.

Terbinafine is excreted in breast milk. However, when terbinafine cream is used by a nursing mother, a small amount of the active substance is absorbed through the skin, so an adverse effect on the infant is unlikely.

Use in hepatic impairment

Use with caution in hepatic impairment.

Use in impaired renal function

Use with caution in renal insufficiency.

Use in children

Not recommended for use in children under 12 years of age.

Use in the elderly

The dosing regimen for the elderly is the same.

Special instructions

A decrease in the severity of clinical manifestations is usually noted in the first days of treatment. In case of irregular treatment or its premature termination, there is a risk of recurrence of the infection.

Terbinafine cream is for external use only. Avoid contact with eyes, because. it can cause irritation. In case of accidental contact of the drug with the eyes, they should be immediately rinsed with running water, and in case of persistent irritation, it is necessary to consult a doctor.

With the development of allergic reactions, it is necessary to stop the drug.

Drug interactions

No drug interactions are known for terbinafine cream.

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