Medication info

Terbinafine Tablets (Terbinafine Hydrochloride)

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

MFDS item code 201903419 · 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 dermatophyte infections (athlete's foot, ringworm, etc.) and onychomycosis
Who uses it
Adults · Children
Adult dosage
As terbinafine, 125 mg once or 250 mg once daily. The treatment duration depends on the disease condition as follows: 1) Dermatophyte infections Athlete's foot (interdigital type, plantar type/moccasin 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. If the infection occurs on the finger or a relatively small toe, or in a younger patient, the treatment duration may be shortened to less than 3 months. The treatment duration for nail infections is generally sufficient at 3 months; however, in some cases, it may take 6 months or more. In patients with slow nail growth, the treatment duration may be prolonged. 2. Pediatrics: To be administered to children over 2 years of age. There is insufficient experience for those under 2, so administration should be considered with evaluation of benefit and risk. Tinea capitis: 4 weeks Tinea capitis primarily occurs in children. To prevent recurrence of infection, treatment should be carried out regularly for the appropriate designated duration. 1) For children under 20 kg (under 5 years): 62.5 mg once daily. Due to the lack of experience, the benefit-risk ratio must be carefully evaluated before deciding whether to administer. 2) For children weighing 20 to 40 kg (5 to 12 years): 125 mg once daily. 3) For children over 40 kg (over 12 years): 250 mg once daily. 3. Patients with renal impairment For patients with a creatinine clearance of less than 50 mL/min, reduce the daily dose by half.
Children's dosage
Administered to children over 2 years of age. There is insufficient experience for those under 2 years, therefore administration is not recommended. Tinea capitis: 4 weeks 1) For children under 20 kg (under 5 years): 62.5 mg once per dose.

Ingredients

Manufacturer
안국약품(주)

Efficacy & effects

Treatment of dermatophyte infections (athlete's foot, ringworm, etc.) and onychomycosis

  • Dermatophyte infections
  • athlete's foot
  • tinea corporis
  • tinea cruris
  • onychomycosis
  • tinea capitis
View approved original text

This medication is used to treat dermatophyte infections such as athlete's foot, tinea corporis, and tinea cruris caused by dermatophytes in adults. It is also effective against fungal infections affecting the nails. Additionally, it is used in children for the treatment of tinea capitis. Therefore, it is primarily used to improve fungal infections of the skin and nails.

Dosage and Administration

Adult dosage

As terbinafine, 125 mg once or 250 mg once daily. The treatment duration depends on the disease condition as follows: 1) Dermatophyte infections Athlete's foot (interdigital type, plantar type/moccasin 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. If the infection occurs on the finger or a relatively small toe, or in a younger patient, the treatment duration may be shortened to less than 3 months. The treatment duration for nail infections is generally sufficient at 3 months; however, in some cases, it may take 6 months or more. In patients with slow nail growth, the treatment duration may be prolonged. 2. Pediatrics: To be administered to children over 2 years of age. There is insufficient experience for those under 2, so administration should be considered with evaluation of benefit and risk. Tinea capitis: 4 weeks Tinea capitis primarily occurs in children. To prevent recurrence of infection, treatment should be carried out regularly for the appropriate designated duration. 1) For children under 20 kg (under 5 years): 62.5 mg once daily. Due to the lack of experience, the benefit-risk ratio must be carefully evaluated before deciding whether to administer. 2) For children weighing 20 to 40 kg (5 to 12 years): 125 mg once daily. 3) For children over 40 kg (over 12 years): 250 mg once daily. 3. Patients with renal impairment For patients with a creatinine clearance of less than 50 mL/min, reduce the daily dose by half.

Children's dosage

Administered to children over 2 years of age. There is insufficient experience for those under 2 years, therefore administration is not recommended. Tinea capitis: 4 weeks 1) For children under 20 kg (under 5 years): 62.5 mg once per dose.

Precautions

This medication is not recommended for patients with chronic liver disease or active liver disease. Before administration, liver disease status must be confirmed, and liver function tests should be carried out regularly. If symptoms of liver dysfunction are suspected, such as persistent nausea, loss of appetite, fatigue, vomiting, right upper abdominal pain, or jaundice, consult a physician immediately. This medication can cause severe liver damage leading to hepatic failure; therefore, administration should be discontinued if liver dysfunction is confirmed. This medication should not be administered to those with allergies to this drug or its components, patients with blood disorders, severe renal failure, infants under 2 years of age, nursing mothers, or patients with specific genetic digestive disorders. Caution is required when administering this medication to patients with decreased renal function, the elderly, children under 20 kg, or patients with psoriasis or systemic lupus erythematosus. Additionally, close observation of skin conditions is essential due to the potential for serious skin reactions. Adverse reactions may occur in various systems including the liver, blood, skin, musculoskeletal system, gastrointestinal, and nervous systems, so symptoms should be reported to healthcare professionals promptly. Common symptoms include myalgia, fatigue, rash, headache, taste disturbances, depression, etc. This medication should only be used for the treatment of fungal infections, and caution is advised when driving or operating machinery if dizziness occurs. Interactions may occur when used in conjunction with other medications; therefore, healthcare professionals should be informed of any ongoing medications as dosage adjustments may be necessary. Women who are pregnant or may become pregnant should carefully consider the benefits and risks when using this medication, and nursing mothers should discontinue breastfeeding if using this drug. Overdose may result in headache, nausea, upper abdominal pain, and dizziness, requiring immediate medical attention. This medication should be kept out of reach of children, protected from direct sunlight, and stored at room temperature.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, peeling skin, pain of mucous membranes in the mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities with cough + fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion of consciousness, vision disturbances, paralysis, urine

Mild side effects

Rash, itching, fever, nausea, vomiting, loss of appetite, malaise, musculoskeletal reactions (joint pain, muscle pain), weakness, gastrointestinal symptoms (abdominal bloating, dyspepsia, diarrhea), depression, anxiety, headache, taste disorders, dizziness, drowsiness, sensory disturbances, insomnia, increased BUN, frequent urination, vision disturbances, tinnitus, facial swelling, lymphadenopathy, erythema, increased cholesterol and triglycerides, tongue discoloration, palpitations, edema, menstrual irregularities,

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

Storage

This medication may be sensitive to air or humidity; therefore, it must be stored in a tightly closed container. The recommended storage temperature is room temperature between 1 to 30 degrees Celsius.

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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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.