Medication info

Terbinafine Tablets (Terbinafine Hydrochloride)

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

MFDS item code 201903418 · Approved 2019.05.27

This product's status changed to Expired on 2024.05.27. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of dermatophytosis (tinea pedis, tinea corporis, etc.) and onychomycosis (fungal infection of nails)
Who uses it
Adults · Children
Adult dosage
As terbinafine, administer 125 mg twice daily or 250 mg once daily. The duration of treatment varies with the disease: 1) Dermatophyte infections Tinea pedis (interdigital, plantar/mocha-type): 2 to 6 weeks Tinea corporis: 2 to 4 weeks Tinea cruris (jock itch): 2 to 4 weeks 2) Onychomycosis Typically treated for 6 weeks to 3 months. Infections of the fingernails or relatively smaller toes, or in younger patients, the duration may be shortened to less than 3 months.
Children's dosage
Administer to children over 2 years of age. 1) For children weighing less than 20 kg (under 5 years): administer 62.5 mg once daily. 2) For children weighing 20 to 40 kg (5 to 12 years): administer 125 mg once daily.

Ingredients

Manufacturer
안국뉴팜(주)

Efficacy & effects

Treatment of dermatophytosis (tinea pedis, tinea corporis, etc.) and onychomycosis (fungal infection of nails)

  • Dermatophytosis
  • 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, as well as tinea capitis in children.

Dosage and Administration

Adult dosage

As terbinafine, administer 125 mg twice daily or 250 mg once daily. The duration of treatment varies with the disease: 1) Dermatophyte infections Tinea pedis (interdigital, plantar/mocha-type): 2 to 6 weeks Tinea corporis: 2 to 4 weeks Tinea cruris (jock itch): 2 to 4 weeks 2) Onychomycosis Typically treated for 6 weeks to 3 months. Infections of the fingernails or relatively smaller toes, or in younger patients, the duration may be shortened to less than 3 months.

Children's dosage

Administer to children over 2 years of age. 1) For children weighing less than 20 kg (under 5 years): administer 62.5 mg once daily. 2) For children weighing 20 to 40 kg (5 to 12 years): administer 125 mg once daily.

Precautions

This drug is not recommended for patients with liver health issues or a history of liver disease. Liver function tests must be performed before administration, and regular liver function tests should be conducted during treatment. If symptoms of liver dysfunction appear, discontinue use of this medication immediately and consult a doctor. This drug should not be used in patients with blood disorders or severe renal impairment, children under 2 years of age, or breastfeeding women. Also, patients who have had allergic reactions to this drug should avoid its use. Caution should be exercised when administering to elderly patients, those with renal insufficiency, or young children with low body weight. Immediate discontinuation of use is necessary if serious skin reactions occur. This medication can cause various adverse reactions, so if symptoms such as rash, itching, nausea, fatigue, myalgia, headache, visual disturbances occur, notify a healthcare professional immediately. Be cautious while driving or operating machinery, as symptoms such as dizziness may occur. Interactions may occur when taken with other medications, so if you are taking other drugs, it is essential to inform your doctor or pharmacist, and dosage adjustments may be necessary. Women who are pregnant or may become pregnant should carefully consider the risks and benefits before taking this medication. Breastfeeding women should discontinue breastfeeding while taking this drug. Overdose may cause headaches, nausea, abdominal pain, and dizziness, requiring immediate medical treatment. This medication should be stored out of the reach of children and kept away from direct sunlight at room temperature.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, hepatic failure, hepatitis, cholestasis, jaundice, Stevens-Johnson syndrome, toxic epidermal necrolysis, mucocutaneous syndrome, acute generalized exanthematous pustulosis, erythema multiforme, toxic skin rash, exfoliative dermatitis, vesiculobullous dermatitis, rhabdomyolysis, anaphylactic reactions, angioedema, systemic lupus erythematosus, severe skin reactions, blood disorders (neutropenia, pancytopenia)

Mild side effects

Fatigue, nausea, decreased appetite, vomiting, malaise, itching, rash, headache, dizziness, drowsiness, altered sensation, insomnia, diarrhea, abdominal bloating, indigestion, myalgia, arthralgia, visual disturbances, tinnitus, anxiety, depression, elevation of serum cholesterol and triglycerides, glossitis, paralysis, menstrual irregularities, fatigue, weight loss, hypotension, chest tightness, thrombocytopenia, anemia, leukopenia, elevated BUN, tongue discoloration

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 exposure to air or moisture, ideally in a temperature range of 1 to 30 degrees Celsius. Storing this way ensures the medication's efficacy is maintained and prevents degradation.

Appearance and packaging

Appearance

White 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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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.