Medication info
Tebafine Tablet (Terbinafine Hydrochloride)

Tebafine Tablet (Terbinafine Hydrochloride)

Prescription medicationTablet경구
Ingredient · strength
Terbinafine Hydrochloride›140.625mg / 1 tablet
Manufacturer / importer
(주)일화
Appearance
White round tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 200400802 · Notified 2004.09.14 · Insurance code 640901180

Summary

Main use
Treatment of dermatophyte infections (tinea pedis, tinea corporis, etc.) and onychomycosis caused by skin fungi
Who takes it
Adults · Children
Adult dose
As terbinafine, 125 mg once or twice daily or 250 mg once daily. The duration of treatment depends on the disease. 1) Dermatophyte infections - Tinea pedis (interdigital type, plantar/moccasin type): 2-6 weeks - Tinea corporis: 2-4 weeks - Tinea cruris: 2-4 weeks 2) Onychomycosis - Usually administered for 6 weeks to 3 months; shorter treatment may be needed for infections of the fingernails or small toe or in younger patients.
Child dose
For children over 2 years of age. Tinea capitis: 4 weeks of treatment. 1) For weight under 20 kg (under 5 years old): 62.5 mg once daily. - Due to insufficient experience in administration, treatment benefits...

Ingredients

Manufacturer
(주)일화

Efficacy & effects

Treatment of dermatophyte infections (tinea pedis, tinea corporis, etc.) and onychomycosis caused by skin fungi

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

This medication is used to treat tinea pedis, tinea corporis, and tinea cruris caused by dermatophytes in adults. It is also effective for fungal infections affecting the nails. In children, it can help treat tinea capitis. In conclusion, this drug is used to treat various skin and nail fungal infections.

How to take

Adult dose

As terbinafine, 125 mg once or twice daily or 250 mg once daily. The duration of treatment depends on the disease. 1) Dermatophyte infections - Tinea pedis (interdigital type, plantar/moccasin type): 2-6 weeks - Tinea corporis: 2-4 weeks - Tinea cruris: 2-4 weeks 2) Onychomycosis - Usually administered for 6 weeks to 3 months; shorter treatment may be needed for infections of the fingernails or small toe or in younger patients.

Child dose

For children over 2 years of age. Tinea capitis: 4 weeks of treatment. 1) For weight under 20 kg (under 5 years old): 62.5 mg once daily. - Due to insufficient experience in administration, treatment benefits...

Precautions

This medication is not recommended for patients with chronic liver disease or active liver disease. Regular liver function tests should be conducted before and during treatment to check for liver function issues. If liver function deteriorates or symptoms of liver dysfunction (persistent nausea, loss of appetite, fatigue, vomiting, upper right abdominal pain, jaundice, etc.) appear, it is crucial to inform a doctor immediately and discontinue use. Although this medication is used to treat onychomycosis, serious liver failure can occur rarely, so liver health should be monitored carefully. Those allergic to this medication, individuals with chronic liver disease, blood disorders, severe renal failure, infants under 2 years of age, nursing mothers, and those with hereditary lactose intolerance should not take it. Patients with impaired kidney function, elderly patients, and children weighing less than 20 kg should use this medication with caution, and if severe skin reactions occur, they should stop taking it immediately. Common side effects may include skin rash or itching, joint pain, muscle aches, dyspepsia, headaches, taste disorders, and depression, and if symptoms are severe, consultation with a doctor is advisable. This medication may cause dizziness when driving or operating machinery, so caution is required. There may also be interactions with other medications, so it is essential to inform a doctor or pharmacist about any other medications being taken, especially when used with drugs metabolized by the liver. Pregnant women or women who may become pregnant should consult with a doctor and carefully decide on the use of this drug, and breastfeeding should be discontinued if applying this medication. In cases of overdose, symptoms such as headaches, nausea, abdominal pain, and dizziness may occur, and immediate medical treatment should be sought. This medication should be kept out of reach of children and stored at room temperature away from direct sunlight.

Side effects and when to seek care immediately

Serious side effects

Hepatobiliary failure, hepatitis, cholestasis, jaundice, neutropenia, pancytopenia, agranulocytosis, thrombocytopenia, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), acute generalized exanthematous pustulosis, anaphylactic reactions (angioedema, superficial and generalized lupus erythematosus), severe allergic reactions, severe skin adverse reactions, respiratory distress, rhabdomyolysis, seizures, altered consciousness, paralysis, neurological effects

Mild side effects

Rash, itching, photosensitivity reactions, acute generalized exanthematous pustulosis, erythema multiforme, toxic skin eruptions, exfoliative dermatitis, blistering dermatitis, psoriatic rash, worsening of psoriasis, hair loss, musculoskeletal reactions (joint pain, muscle pain), muscle pain, weakness, hypotension, erythema, facial edema, lymphadenopathy, gastrointestinal symptoms (abdominal bloating, loss of appetite, dyspepsia, nausea, mild abdominal pain, diarrhea), discomfort in the upper abdomen, thirst, vomiting, glossitis, depression,

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 from entering, and it is recommended to keep it at a temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the medication's effectiveness for a longer period.

Appearance and packaging

Appearance

White round tablet

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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For anything that needs medical judgment, consult a doctor or pharmacist.

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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.