Medication info
Terbinafine Tablets (Terbinafine Hydrochloride)

Terbinafine Tablets (Terbinafine Hydrochloride)

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

MFDS item code 201500625 · Approved 2015.02.05 · Insurance code 658202710

Summary

Main use
Treatment of dermatophytes (athlete's foot, tinea corporis, etc.) and onychomycosis.
Who takes it
Adults · Children
Adult dose
In adults, terbinafine is administered as 125 mg once or twice daily or 250 mg once daily. The administration period depends on the condition: 1) Dermatophyte infections Tinea pedis (interdigital, plantar/moccasin type): 2 to 6 weeks. Tinea corporis: 2 to 4 weeks. Tinea cruris: 2 to 4 weeks. 2) Onychomycosis Typically administered for 6 weeks to 3 months. If the infection is in the fingernail or in relatively small toes, or if the patient is younger, the treatment duration may be reduced to less than 3 months. The duration of treatment for toenail infections is usually sufficient at 3 months, but in some patients, it may take 6 months or more. In patients with slow nail growth, the duration of treatment may be prolonged.
Child dose
Administer to children over 2 years of age. Tinea capitis should be administered for 4 weeks. 1) For children under 20 kg (under 5 years), administer 62.5 mg once daily. Due to limited experience in this age group, the benefits and risks of treatment should be carefully considered.

Ingredients

Manufacturer
(주)비보존제약

Efficacy & effects

Treatment of dermatophytes (athlete's foot, tinea corporis, etc.) and onychomycosis.

  • Dermatophyte infections of the skin
  • tinea pedis
  • tinea corporis
  • tinea cruris
  • onychomycosis
  • tinea capitis.
View approved original text

In adults, it is used for tinea pedis, tinea corporis, tinea cruris, and onychomycosis due to dermatophytes. In children, it is used for the treatment of tinea capitis.

How to take

Adult dose

In adults, terbinafine is administered as 125 mg once or twice daily or 250 mg once daily. The administration period depends on the condition: 1) Dermatophyte infections Tinea pedis (interdigital, plantar/moccasin type): 2 to 6 weeks. Tinea corporis: 2 to 4 weeks. Tinea cruris: 2 to 4 weeks. 2) Onychomycosis Typically administered for 6 weeks to 3 months. If the infection is in the fingernail or in relatively small toes, or if the patient is younger, the treatment duration may be reduced to less than 3 months. The duration of treatment for toenail infections is usually sufficient at 3 months, but in some patients, it may take 6 months or more. In patients with slow nail growth, the duration of treatment may be prolonged.

Child dose

Administer to children over 2 years of age. Tinea capitis should be administered for 4 weeks. 1) For children under 20 kg (under 5 years), administer 62.5 mg once daily. Due to limited experience in this age group, 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 administration, it is essential to check for a history of liver disease and to conduct liver function tests, which should be repeated regularly during treatment. If symptoms of liver dysfunction occur, discontinue the medication immediately and consult a physician. It should not be administered to patients with blood disorders, severe renal impairment, infants under 2 years of age, or nursing mothers. Patients with hypersensitivity to this drug should also avoid taking it. Use with caution in patients with impaired renal function or elderly patients, and those under 20 kg; consult a physician immediately if any adverse reactions occur. If severe rashes or allergic reactions develop on the skin, administration should be stopped immediately. This drug may cause various side effects, including hepatotoxicity, hematological abnormalities, skin reactions, myalgia, and gastrointestinal symptoms, so report any unusual symptoms to a healthcare professional. This drug may interact with specific medications; therefore, inform your doctor or pharmacist if you are taking other medications. Pregnant women or those who may become pregnant should carefully consider the risks and benefits before taking this medication. If nursing, breastfeeding should be discontinued during the use of this drug. Store this medication out of reach of children, avoiding direct sunlight, and at room temperature. In case of overdose, symptoms such as headache, nausea, and dizziness may occur, and appropriate medical treatment should be sought immediately.

Side effects and when to seek care immediately

Serious side effects

Liver failure, biliary tract failure, hepatitis, cholestasis, jaundice, severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis), rhabdomyolysis, angioedema, anaphylactic reactions, thrombocytopenia, agranulocytosis, pancytopenia, severe blood disorders, respiratory distress, feelings of chest tightness.

Mild side effects

  • Nausea
  • decreased appetite
  • fatigue
  • vomiting
  • upper abdominal pain
  • rash
  • skin itching
  • fever
  • malaise
  • abdominal bloating
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  • dyspepsia
  • mild abdominal pain
  • diarrhea
  • discomfort in the stomach
  • thirst
  • glossitis
  • urticaria
  • erythema
  • pharyngitis
  • leukopenia
  • anemia
  • depression
  • anxiety
  • drowsiness
  • sensory disturbances and sensory loss
  • decreased attention
  • insomnia
  • elevated BUN
  • frequent urination
  • visual impairment
  • tinnitus
  • increased total cholesterol in the blood
  • increased triglycerides.

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 and moisture. It should be kept at room temperature between 1°C and 30°C, away from extreme heat or cold.

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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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.