Medication info
Terbinafine Tablets (Terbinafine Hydrochloride)

Terbinafine Tablets (Terbinafine Hydrochloride)

Prescription medicationTablet
Ingredient · strength
Terbinafine Hydrochloride›140.625mg / 1 tablet
Manufacturer / importer
한올바이오파마(주)
Appearance
White to off-white round tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 200308832 · Notified 2003.07.14

Summary

Main use
Treatment of skin and nail fungal infections
Who uses it
Adults · Children
Adult dosage
As terbinafine: administer 125 mg once or twice daily, or 250 mg once daily. The duration of administration varies according to the condition: 1) Dermatophyte infections Athlete's foot (interdigital, plantar/moccasin type): 2-6 weeks Tinea corporis: 2-4 weeks Tinea cruris (groin): 2-4 weeks 2) Nail fungus Typically administered for 6 weeks to 3 months. In cases of infection in fingernails or relatively smaller toes, or in younger patients, the treatment duration may be shortened to less than 3 months. The treatment duration for toenail infections is generally sufficient at 3 months, although some patients may require 6 months or longer. In patients with slow nail growth, the treatment duration may be extended. Children: Administered to children over 2 years old. For those under 2 years, due to lack of experience, administration is not recommended. Tinea capitis: 4 weeks Tinea capitis primarily occurs in children. To prevent recurrence of infection, regular treatment for a suitably defined duration is necessary. 1) Weight under 20 kg (under 5 years): administer 62.5 mg once daily. Due to a lack of experience, the benefits and risks of treatment should be assessed before administration. 2) Weight 20-40 kg (5-12 years): administer 125 mg once daily. 3) Weight over 40 kg (over 12 years): administer 250 mg once daily. Patients with renal impairment For patients with a creatinine clearance of less than 50 mL per minute, reduce the daily dose by half.
Children's dosage
Administer to children over 2 years old. For children under 2 years, due to the lack of experience, administration is not recommended. Tinea capitis: 4 weeks To prevent recurrence of infection, treatment must be conducted regularly for a suitably defined duration.

Ingredients

Manufacturer
한올바이오파마(주)

Efficacy & effects

Treatment of skin and nail fungal infections

  • Dermatophyte infections
  • athlete's foot
  • tinea corporis
  • tinea cruris
  • nail fungus
  • toenail fungus
  • tinea capitis
View approved original text

This medication is used to treat fungal infections of the skin and nails in both adults and children. In adults, it is effective against dermatophyte infections like athlete's foot, tinea corporis, tinea cruris, and nail fungus. In children, it is used to treat tinea capitis. This medication improves fungal infections of the skin and nails.

Dosage and Administration

Adult dosage

As terbinafine: administer 125 mg once or twice daily, or 250 mg once daily. The duration of administration varies according to the condition: 1) Dermatophyte infections Athlete's foot (interdigital, plantar/moccasin type): 2-6 weeks Tinea corporis: 2-4 weeks Tinea cruris (groin): 2-4 weeks 2) Nail fungus Typically administered for 6 weeks to 3 months. In cases of infection in fingernails or relatively smaller toes, or in younger patients, the treatment duration may be shortened to less than 3 months. The treatment duration for toenail infections is generally sufficient at 3 months, although some patients may require 6 months or longer. In patients with slow nail growth, the treatment duration may be extended. Children: Administered to children over 2 years old. For those under 2 years, due to lack of experience, administration is not recommended. Tinea capitis: 4 weeks Tinea capitis primarily occurs in children. To prevent recurrence of infection, regular treatment for a suitably defined duration is necessary. 1) Weight under 20 kg (under 5 years): administer 62.5 mg once daily. Due to a lack of experience, the benefits and risks of treatment should be assessed before administration. 2) Weight 20-40 kg (5-12 years): administer 125 mg once daily. 3) Weight over 40 kg (over 12 years): administer 250 mg once daily. Patients with renal impairment For patients with a creatinine clearance of less than 50 mL per minute, reduce the daily dose by half.

Children's dosage

Administer to children over 2 years old. For children under 2 years, due to the lack of experience, administration is not recommended. Tinea capitis: 4 weeks To prevent recurrence of infection, treatment must be conducted regularly for a suitably defined duration.

Precautions

This medication is not recommended for patients with chronic or active liver disease. Before taking this medication, it is essential to check for the presence of liver disease, and all patients should undergo regular liver function tests before and during treatment. Symptoms of liver dysfunction, such as persistent nausea, loss of appetite, fatigue, vomiting, pain in the upper right abdomen, jaundice, dark urine, and pale stools, must be reported to a doctor immediately. This medication can cause liver failure, so it should be discontinued promptly if liver damage is suspected. This medication should not be administered to patients with certain blood disorders, severe renal failure, breastfeeding mothers, and infants under 2 years of age. Patients with a history of hypersensitivity to this medication or lactose intolerance should also avoid its use. Patients with impaired kidney function, the elderly, children weighing less than 20 kg, and those with psoriasis or systemic lupus erythematosus should use this medication cautiously. Severe skin reactions may rarely occur, so if any skin rash or abnormal symptoms develop, medication should be stopped immediately. This medication may cause various side effects affecting the liver, blood, skin, musculoskeletal system, gastrointestinal tract, and nervous system; therefore, regular testing is necessary, and healthcare providers should be consulted immediately for any abnormal symptoms. This medication can impair the ability to drive or operate machinery, so caution should be exercised in case of dizziness or drowsiness. This medication may interact with other drugs; therefore, if you are taking other medications, you must inform your doctor or pharmacist, and dose adjustments may be necessary. Women who are pregnant or may become pregnant should use this medication cautiously, and breastfeeding mothers should discontinue nursing. In cases of overdose, symptoms such as headache, nausea, abdominal pain, and dizziness may occur, requiring immediate medical attention. This medication should be kept out of reach of children and stored in a cool, dry place, away from direct sunlight.

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, skin peeling, mucosal pain in the mouth/eyes, Stevens-Johnson syndrome, toxic epidermal necrolysis, rash accompanied by eosinophilia and systemic symptoms, jaundice, biliary tract failure, hepatitis, cholestasis, sudden and severe headaches, thunderclap headaches, seizures, confusion, vision abnormalities, paralysis, significantly reduced urine output.

Mild side effects

Fatigue, rash, skin itching, nausea, vomiting, decreased appetite, malaise, diarrhea, headache, taste disturbance, dizziness, drowsiness, sensory abnormalities, insomnia, increased BUN, frequent urination, visual disturbances, tinnitus, increased total cholesterol in the blood, increased triglycerides, glossitis, tongue discoloration, palpitations, menstrual irregularities, hair loss, musculoskeletal reactions (joint pain, muscle pain), muscle pain, weakness, fatigue, elevated blood creatine phosphokinase, influenza-like illnesses.

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

Storage

This medication should be stored in an airtight container that allows for good ventilation, maintaining a storage temperature between 1 to 30 degrees Celsius. Proper storage preserves the efficacy of the medication and prevents degradation.

Appearance and packaging

Appearance

White to off-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.