Medication info
Seoul Terbinafine Hydrochloride Tablets

Seoul Terbinafine Hydrochloride Tablets

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

MFDS item code 201903042 · Approved 2019.05.10 · Insurance code 652904390

Summary

Main use
Treatment of dermatophyte infections (such as athlete's foot and tinea corporis) and onychomycosis
Who uses it
Adults · Children
Adult dosage
As terbinafine, administer 125 mg twice daily, or 250 mg once daily. The duration of treatment varies according to the condition: 1) Dermatophyte infections - Athlete's foot (interdigital type, plantar type/moccasin-type): 2-6 weeks - Tinea corporis: 2-4 weeks - Tinea cruris: 2-4 weeks 2) Onychomycosis - Generally treated for 6 weeks to 3 months. - Treatment duration may shorten to under 3 months for fingernails or relatively small toenails, or for younger patients. The treatment duration for nail infections is generally sufficient at 3 months, but in some patients may take 6 months or longer. Treatment duration may be extended for patients with slow nail growth.
Children's dosage
Administer to children aged 2 years and older. 1) Weight under 20 kg (under 5 years): Administer 62.5 mg once daily. 2) Weight 20-40 kg (5-12 years): Administer 125 mg once.

Ingredients

Manufacturer
(주)서울제약

Efficacy & effects

Treatment of dermatophyte infections (such as athlete's foot and tinea corporis) and onychomycosis

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

This medication is used for the treatment of dermatophyte infections caused by dermatophytes such as athlete's foot, tinea corporis, and tinea cruris in adults, as well as for the treatment of 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 according to the condition: 1) Dermatophyte infections - Athlete's foot (interdigital type, plantar type/moccasin-type): 2-6 weeks - Tinea corporis: 2-4 weeks - Tinea cruris: 2-4 weeks 2) Onychomycosis - Generally treated for 6 weeks to 3 months. - Treatment duration may shorten to under 3 months for fingernails or relatively small toenails, or for younger patients. The treatment duration for nail infections is generally sufficient at 3 months, but in some patients may take 6 months or longer. Treatment duration may be extended for patients with slow nail growth.

Children's dosage

Administer to children aged 2 years and older. 1) Weight under 20 kg (under 5 years): Administer 62.5 mg once daily. 2) Weight 20-40 kg (5-12 years): Administer 125 mg once.

Precautions

This medication is not recommended for patients with chronic or active liver disease. It is essential to confirm any liver disease before taking this medication, and regular liver function tests should be conducted. If symptoms of liver dysfunction appear, discontinue the medication immediately and consult a physician. Since this medication may affect liver function, it should be stopped if liver function test results worsen. Additionally, this medication should not be given to patients with hematological disorders, severe renal impairment, children under 2 years old, or breastfeeding women. Patients with lactose intolerance should also avoid this medication. Caution is advised when administering to the elderly, those with reduced kidney function, or underweight children, as severe skin reactions may occur; careful observation is necessary. Discontinue the medication immediately if skin rashes or allergic reactions develop. This medication may cause adverse reactions in various organs including the liver, blood, skin, and muscles; consult a doctor immediately if symptoms arise. Pay particular attention to symptoms such as liver dysfunction, skin rashes, muscle pain, and dizziness. Dizziness and other side effects may occur while driving or operating machinery, so caution is advised. This medication may interact with other drugs, so inform your doctor or pharmacist about any drugs you are currently taking, as dosage adjustments may be necessary when used in combination with some medications. Women who are pregnant or may become pregnant should use this medication with caution, and breastfeeding should be discontinued while using this medication. An overdose may lead to symptoms such as headache, nausea, abdominal pain, and dizziness, so be careful not to exceed the recommended dose. This medication should be kept out of the reach of children and stored at room temperature, away from direct sunlight and moisture.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pale skin, severe rash with fever, blisters, skin peeling, pain in oral or ocular mucosa, shortness of breath or difficulty breathing, asthma attack, cough with fever accompanied by respiratory abnormalities, yellowing of skin or eyes (jaundice), profound lethargy, sudden and severe headache, lightning headache, seizures, confusion, visual disturbances, paralysis, urination

Mild side effects

Rash, skin itching, fever, nausea, vomiting, loss of appetite, fatigue, leukopenia, anemia, photosensitivity reactions, acute generalized exanthematous pustulosis, erythema multiforme, toxic skin rashes, exfoliative dermatitis, vesicular dermatitis, psoriasis-like rash, psoriasis exacerbation, hair loss, joint pain, muscle pain, weakness, hypotension, dyspnea, chest tightness, urticaria, erythema, facial swelling, lymphadenopathy, abdominal distention, dyspepsia, diarrhea, stomach discomfort, throat

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. It is advisable to maintain a storage temperature between 1°C and 30°C to ensure the medication's efficacy is preserved safely over time.

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.