Medication info

Terbinafine Tablets (Terbinafine Hydrochloride)

Prescription medicationTabletApproval withdrawn
Ingredient · strength
Terbinafine Hydrochloride›140.625mg / 1 tablet
Manufacturer / importer
에이치엘비제약(주)
Appearance
White to almost beige round tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 200101878 · Notified 2001.12.01

This product's status changed to Approval withdrawn on 2024.04.18. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of skin fungal infections (tinea pedis, tinea corporis, etc.) and onychomycosis
Who uses it
Adults · Children
Adult dosage
As terbinafine, administer 125 mg once or twice daily, or 250 mg once daily. The duration of treatment depends on the disease as follows: 1) Dermatophytosis - Tinea pedis (interdigital type, plantar type/moccasin type): 2-6 weeks - Tinea corporis: 2-4 weeks - Tinea cruris: 2-4 weeks 2) Onychomycosis - Typically administered for 6 weeks to 3 months. - In cases of infection in the toenails or relatively small toes, or in younger patients, treatment duration may be reduced to less than 3 months. Typically, a treatment period of around 3 months is sufficient for toenail infections, but treatment may take 6 months or longer for some patients. Treatment duration may be prolonged in patients with slow nail growth.
Children's dosage
Administer to children aged 2 years and older. Tinea capitis: 4 weeks 1) Weight under 20 kg (under 5 years): 62.5 mg once daily. - Due to insufficient dosing experience, the benefits and risks of treatment should be carefully considered.

Ingredients

Manufacturer
에이치엘비제약(주)

Efficacy & effects

Treatment of skin fungal infections (tinea pedis, tinea corporis, etc.) and onychomycosis

  • Skin fungal infections
  • tinea pedis
  • tinea corporis
  • tinea cruris
  • onychomycosis
  • tinea capitis
View approved original text

This medication is used in adults for tinea pedis, tinea corporis, tinea cruris, and onychomycosis caused by dermatophytes, and in children for tinea capitis.

Dosage and Administration

Adult dosage

As terbinafine, administer 125 mg once or twice daily, or 250 mg once daily. The duration of treatment depends on the disease as follows: 1) Dermatophytosis - Tinea pedis (interdigital type, plantar type/moccasin type): 2-6 weeks - Tinea corporis: 2-4 weeks - Tinea cruris: 2-4 weeks 2) Onychomycosis - Typically administered for 6 weeks to 3 months. - In cases of infection in the toenails or relatively small toes, or in younger patients, treatment duration may be reduced to less than 3 months. Typically, a treatment period of around 3 months is sufficient for toenail infections, but treatment may take 6 months or longer for some patients. Treatment duration may be prolonged in patients with slow nail growth.

Children's dosage

Administer to children aged 2 years and older. Tinea capitis: 4 weeks 1) Weight under 20 kg (under 5 years): 62.5 mg once daily. - Due to insufficient dosing experience, the benefits and risks of treatment should be carefully considered.

Precautions

This medication is not recommended for patients with chronic liver disease or active liver disease. Before taking this medication, liver disease must be confirmed, and regular liver function tests should be performed. Symptoms of liver dysfunction include nausea, loss of appetite, fatigue, vomiting, upper right abdominal pain, jaundice, dark urine, and loose stools, and if any of these symptoms occur, the doctor must be notified immediately. If liver dysfunction is suspected while taking this medication, usage should be discontinued immediately and tests should be conducted. Patients with blood disorders, severely impaired kidney function, children under 2 years of age, and nursing women should avoid this medication. Additionally, if there is an allergy to this medication or its components, use should be avoided. Elderly patients, underweight children, and patients with impaired kidney function should use this medication with extra caution, and if severe rashes or allergic reactions occur, usage should be discontinued immediately. This medication can affect liver function, so it is important to receive monthly liver function tests during the first two months of treatment. Symptoms such as muscle pain, joint pain, headache, taste disturbances, indigestion, and dizziness may occur, and if symptoms worsen, consulting a doctor is advised. This medication can interact with other medications, so it is essential to inform the doctor or pharmacist of any medications being taken. Particularly, dosage adjustments may be needed when taken with medications metabolized in the liver. Women who are pregnant or could become pregnant should carefully consider the benefits and risks of using this medication, and nursing mothers should ideally discontinue breastfeeding while using it. This medication should be stored out of reach of children, away from direct sunlight, and at room temperature. In cases of overdose, symptoms such as headache, nausea, abdominal pain, and dizziness may appear, and immediate medical attention is required.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, liver dysfunction (jaundice), jaundice, dark urine, biliary tract dysfunction, liver failure, serious skin adverse reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis), severe allergic reactions, anaphylactic reaction, angioedema, mucocutaneous syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, erythema multiforme, toxic skin rash, exfoliative dermatitis

Mild side effects

Rash, skin itching, fever, nausea, vomiting, loss of appetite, fatigue, musculoskeletal reactions (joint pain, muscle pain), myalgia, weakness, increased CPK, elevated myoglobin in blood and urine, hypotension, difficulty breathing, chest tightness, urticaria, erythema, facial swelling, lymphangiectasia, abdominal distension, decreased appetite, indigestion, mild abdominal pain, diarrhea, vomiting, glossitis, depression, anxiety, headache, taste disorders, dizziness, drowsiness, chills

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly sealed container to prevent air or moisture from entering, and it is safe to store at room temperature between 1 degree and 30 degrees Celsius. Storing it this way can help maintain the medication’s effectiveness.

Appearance and packaging

Appearance

White to almost beige round tablets

Package unit

30 tablets/bottle, 100 tablets/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.