Medication info

Terbinafine Tablets (Terbinafine Hydrochloride)

Prescription medicationTabletExpired
Ingredient · strength
Terbinafine Hydrochloride›140.625mg / 1 tablet
Manufacturer / importer
독립바이오제약(주)
Appearance
Round tablets, white to off-white in color
Packaging
For oral use - 30 tablets/bottle, For oral use - 100 tablets/bottle
Approval status
Expired

MFDS item code 201903598 · Approved 2019.05.31

This product's status changed to Expired on 2024.05.31. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of dermatophytosis (athlete's foot, tinea corporis, etc.) and onychomycosis
Who uses it
Adults · Children
Adult dosage
Administer 125 mg of terbinafine per dose, twice a day, or 250 mg per dose, once a day. The duration of treatment varies with the disease as follows: 1) Dermatophytosis Athlete's foot (interdigital type, plantar type/moccasin type): 2 to 6 weeks Tinea corporis: 2 to 4 weeks Tinea cruris: 2 to 4 weeks 2) Onychomycosis Typically treated for 6 weeks to 3 months. If the infection is in the fingernails or smaller toes, or if the patient is a younger child, the treatment period may be shortened to less than 3 months. The treatment period for toenail infections is usually sufficient at 3 months, but in some patients, it may take 6 months or longer. In patients with slow nail growth, the treatment period may be extended.
Children's dosage
Administer to children over 2 years old. There is no experience with administration in children under 2 years old, so it is not recommended. Tinea capitis: 4 weeks 1) Weight under 20 kg (under 5 years old): 1 dose of 62.5 mg, 1

Ingredients

Manufacturer
독립바이오제약(주)

Efficacy & effects

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

  • Athlete's foot
  • tinea corporis
  • tinea cruris
  • onychomycosis
  • tinea capitis
View approved original text

This medicine is used in adults for the treatment of dermatophytosis caused by dermatophytes, such as athlete's foot, tinea corporis, and tinea cruris, as well as onychomycosis. It is also effective for treating tinea capitis in children. In other words, it helps improve fungal infections present in the skin and nails.

Dosage and Administration

Adult dosage

Administer 125 mg of terbinafine per dose, twice a day, or 250 mg per dose, once a day. The duration of treatment varies with the disease as follows: 1) Dermatophytosis Athlete's foot (interdigital type, plantar type/moccasin type): 2 to 6 weeks Tinea corporis: 2 to 4 weeks Tinea cruris: 2 to 4 weeks 2) Onychomycosis Typically treated for 6 weeks to 3 months. If the infection is in the fingernails or smaller toes, or if the patient is a younger child, the treatment period may be shortened to less than 3 months. The treatment period for toenail infections is usually sufficient at 3 months, but in some patients, it may take 6 months or longer. In patients with slow nail growth, the treatment period may be extended.

Children's dosage

Administer to children over 2 years old. There is no experience with administration in children under 2 years old, so it is not recommended. Tinea capitis: 4 weeks 1) Weight under 20 kg (under 5 years old): 1 dose of 62.5 mg, 1

Precautions

This medication is not recommended for patients with chronic liver disease or active liver disease. Liver function tests must be conducted before administration and periodically during treatment. If symptoms of liver dysfunction appear, discontinue the medication immediately and consult a physician. This medicine should not be administered to patients with blood disorders, severe renal failure, infants under 2 years old, or nursing mothers. Patients with certain genetic disorders should also avoid this medication. Exercise caution when using in patients with decreased kidney function, elderly individuals, or underweight children. If a severe rash or allergic reaction occurs, discontinue the medication immediately. This medicine can cause adverse reactions in various regions, including the liver, blood, skin, muscles, gastrointestinal tract, mental, and nervous systems, so consult medical personnel immediately if any unusual symptoms appear. Caution should be exercised while driving or operating machinery if dizziness occurs. There may be interactions with other medications, so be sure to inform your doctor or pharmacist of any other medications being taken. Women who are pregnant or may become pregnant should carefully consider the risks and benefits of taking this medication, and nursing mothers should cease breastfeeding while taking it. Special care should be taken when administering to children and the elderly, and in cases of overdose, immediate medical attention should be sought. Store this medication out of reach of children and keep it at room temperature, avoiding direct sunlight.

Side effects and when to seek care immediately

Serious side effects

  • Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor
  • Hepatobiliary failure, hepatitis, cholestasis, jaundice
  • Stevens-Johnson syndrome, toxic epidermal necrolysis
  • Rhabdomyolysis with rapid decline of kidney function
  • Hypotension, respiratory distress, chest tightness (shock symptoms)
  • Anaphylactic reactions (including angioedema and diffuse erythema)
  • Paresis
  • Severe skin adverse reactions (severe rash, blisters, skin peeling with high fever)

Mild side effects

  • Rash, itching, photosensitivity reactions, acute generalized exanthematous pustulosis, erythema multiforme, toxic skin rash, exfoliative dermatitis, vesicular dermatitis, psoriasiform rash, worsening of psoriasis, hair loss
  • Musculoskeletal reactions (arthralgia, myalgia), myalgia, weakness, increased CPK, elevated myoglobin in blood and urine
  • Hypotension, respiratory distress, chest tightness
  • Hives, erythema, facial swelling, lymphangiectasia
  • Gastrointestinal symptoms (abdominal distension, decreased appetite, dyspepsia, nausea)

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

Storage

This medicine should be stored in a tightly sealed container to prevent air or moisture from entering. It is best stored at room temperature between 1°C and 30°C.

Appearance and packaging

Appearance

Round tablets, white to off-white in color

Package unit

For oral use - 30 tablets/bottle, For oral use - 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.