Medication info
Terbinafine Hydrochloride Tablets 125 mg

Terbinafine Hydrochloride Tablets 125 mg

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

MFDS item code 201401304 · Approved 2014.03.21 · Insurance code 643506870

Summary

Main use
Treatment of dermatophyte infections (tinea pedis, tinea corporis, etc.) and onychomycosis
Who takes it
Adults · Children
Adult dose
As terbinafine, administer 125 mg once or twice a day or 250 mg once a day. For dermatophyte infections (tinea pedis, tinea corporis, tinea cruris): administer for 2-6 weeks. For onychomycosis: typically administer for 6 weeks to 3 months, although treatment duration may exceed 6 months for some patients.
Child dose
Administer to children over 2 years of age. Tinea Capitis: Administer for 4 weeks. If weight is less than 20 kg (under 5 years): administer 62.5 mg once daily. If weight is 20-40 kg (5-12 years)

Ingredients

Manufacturer
한미약품(주)

Efficacy & effects

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

  • 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, tinea cruris, and onychomycosis caused by dermatophytes in adults, and is also used for tinea capitis in children.

How to take

Adult dose

As terbinafine, administer 125 mg once or twice a day or 250 mg once a day. For dermatophyte infections (tinea pedis, tinea corporis, tinea cruris): administer for 2-6 weeks. For onychomycosis: typically administer for 6 weeks to 3 months, although treatment duration may exceed 6 months for some patients.

Child dose

Administer to children over 2 years of age. Tinea Capitis: Administer for 4 weeks. If weight is less than 20 kg (under 5 years): administer 62.5 mg once daily. If weight is 20-40 kg (5-12 years)

Precautions

This medication is not recommended for patients with chronic liver disease or active liver disease. It is essential to check liver health status prior to taking this drug, and regular liver function tests are important. If symptoms such as nausea, loss of appetite, fatigue, vomiting, right upper abdominal pain, jaundice, dark urine, or diarrhea occur while taking this medication, you must inform your doctor immediately. If liver dysfunction is suspected, discontinue this medication and seek medical attention. Additionally, this medication should not be taken by those with blood disorders or severe renal impairment, infants under 2 years old, or nursing mothers. Those who have had allergic reactions should also avoid this medicine. Caution is required when taken by elderly patients, underweight children, or patients with impaired renal function, and if a rash or severe allergic reaction occurs, discontinue use immediately. As this medication is metabolized in the liver, particular caution is needed for patients with impaired liver function, and regular liver function tests are necessary. Furthermore, this medication may interact with other drugs, so it is essential to consult your physician or pharmacist if you are taking other medications. Caution is advised when driving or operating machinery as dizziness may occur. Women who are pregnant or may become pregnant should consult a doctor before taking this medication, and nursing mothers are advised to discontinue breastfeeding while taking it. In case of overdose, symptoms such as headache, nausea, abdominal pain, and dizziness may appear, and you should seek medical attention immediately. Store this medication out of reach of children and protect it from direct sunlight at room temperature.

Side effects and when to seek care immediately

Serious side effects

Liver failure, jaundice, hepatitis, cholestasis, symptoms of liver function impairment (nausea, loss of appetite, fatigue, vomiting, right upper abdominal pain, jaundice, dark urine, loose stools), anaphylactic reaction (hives, severe swelling, angioedema), Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, erythema multiforme, toxic skin rash, exfoliative dermatitis, blistering dermatosis, severe allergic reactions, severe skin adverse reactions, respiratory distress,

Mild side effects

Fatigue, nausea, loss of appetite, vomiting, dark urine, loose stools, rash, itching, fever, musculoskeletal reactions (joint pain, muscle pain), myalgia, weakness, gastrointestinal symptoms (abdominal bloating, indigestion, mild abdominal pain, diarrhea), upper abdominal discomfort, thirst, glossitis, depression, anxiety, headache, taste disturbances, dizziness, drowsiness, sensory disturbances, decreased sensation, decreased attention, insomnia, elevated BUN, frequent urination, visual disturbances, tinnitus,

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is recommended to maintain a storage temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

White round tablets

Package unit

1 bottle/box [30 tablets/bottle], 1 bottle/box [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.