Medication info
Laniten Tablet 125mg (Terbinafine Hydrochloride)

Laniten Tablet 125mg (Terbinafine Hydrochloride)

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

MFDS item code 201901480 · Approved 2019.03.11 · Insurance code 649104300

Summary

Main use
Treatment of dermatomycosis (tinea pedis, tinea corporis, etc.) and onychomycosis
Who uses it
Adults · Children
Adult dosage
As terbinafine: 125 mg once, twice a day, or 250 mg once a day. The treatment duration varies by condition: - Dermatophytosis - Tinea pedis (interdigital type, plantar type/moctail type): 2-6 weeks - Tinea corporis: 2-4 weeks - Tinea cruris (jock itch): 2-4 weeks - Onychomycosis - Typically treated for 6 weeks to 3 months. - If infected nails or relatively smaller toenails are involved, or if the patient is younger, the treatment duration may be shortened to less than 3 months. Treatment duration for toenail infections is usually sufficient at 3 months, but some patients may require longer, such as 6 months or more, depending on the rate of nail growth. 2. Pediatrics: Administered to children over 2 years old. There is no experience with administration in children under 2 years old, so administration is not recommended. Tinea capitis: 4 weeks. Tinea capitis primarily occurs in children. To prevent recurrence of infection, treatment should be done regularly for the appropriate specified duration. 1) Weight under 20 kg (under 5 years): 62.5 mg once daily. Due to insufficient experience with administration, the benefits and risks of treatment should be considered before deciding whether to administer. 2) Weight 20-40 kg (5-12 years): 125 mg once daily. 3) Weight 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 per minute, the daily dose should be reduced by half.
Children's dosage
Administered to children over 2 years old. There is no experience with administration in children under 2 years old, so administration is not recommended. Tinea capitis: 4 weeks. 1) Weight under 20 kg (under 5 years): 62.5 mg once, 1

Ingredients

Manufacturer
한국휴텍스제약(주)

Efficacy & effects

Treatment of dermatomycosis (tinea pedis, tinea corporis, etc.) and onychomycosis

  • Tinea pedis
  • tinea corporis
  • tinea cruris
  • onychomycosis
  • tinea capitis
View approved original text

This medication is used to treat tinea pedis, tinea corporis, tinea cruris, onychomycosis in adults, and tinea capitis in children, caused by dermatophytes.

Dosage and Administration

Adult dosage

As terbinafine: 125 mg once, twice a day, or 250 mg once a day. The treatment duration varies by condition: - Dermatophytosis - Tinea pedis (interdigital type, plantar type/moctail type): 2-6 weeks - Tinea corporis: 2-4 weeks - Tinea cruris (jock itch): 2-4 weeks - Onychomycosis - Typically treated for 6 weeks to 3 months. - If infected nails or relatively smaller toenails are involved, or if the patient is younger, the treatment duration may be shortened to less than 3 months. Treatment duration for toenail infections is usually sufficient at 3 months, but some patients may require longer, such as 6 months or more, depending on the rate of nail growth. 2. Pediatrics: Administered to children over 2 years old. There is no experience with administration in children under 2 years old, so administration is not recommended. Tinea capitis: 4 weeks. Tinea capitis primarily occurs in children. To prevent recurrence of infection, treatment should be done regularly for the appropriate specified duration. 1) Weight under 20 kg (under 5 years): 62.5 mg once daily. Due to insufficient experience with administration, the benefits and risks of treatment should be considered before deciding whether to administer. 2) Weight 20-40 kg (5-12 years): 125 mg once daily. 3) Weight 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 per minute, the daily dose should be reduced by half.

Children's dosage

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

Precautions

This medication is not recommended for patients with chronic liver disease or active liver disease. Liver function status must be checked prior to administration, and regular liver function tests should be performed during treatment. If liver function deteriorates, discontinue medication immediately, and inform a doctor if symptoms such as nausea, loss of appetite, fatigue, vomiting, abdominal pain, or jaundice occur. This medication should not be administered to individuals with blood disorders, severe renal failure, children under 2 years old, nursing mothers, and patients with certain genetic disorders. Use with caution in the elderly, patients with impaired renal function, and underweight children; if severe skin rash or allergic reactions occur, discontinue immediately. This medication can cause side effects affecting the liver, blood, skin, musculoskeletal system, gastrointestinal tract, and nervous system; consult a physician if any unusual symptoms arise. Symptoms such as dizziness may occur when driving or operating machinery, so caution is necessary. Potential interactions with other medications may occur, so inform your doctor or pharmacist of any other medications being taken, as dosage adjustments may be necessary. Women who are pregnant or may become pregnant should use this medication cautiously, and nursing mothers should discontinue breastfeeding. Overdosage may result in symptoms such as headache, nausea, abdominal pain, dizziness, and appropriate medical attention should be sought immediately. This medication should be stored out of reach of children, protected from direct sunlight, and kept at room temperature.

Side effects and when to seek care immediately

Serious side effects

Hepatobiliary failure, hepatitis, cholestasis, jaundice, neutropenia, pancytopenia, agranulocytosis, thrombocytopenia, mucocutaneous syndrome (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), acute generalized exanthematous pustulosis, anaphylactic reaction (including angioedema, systemic lupus erythematosus), severe skin reactions, severe hepatic failure, severe edema accompanied by hypertension, rhabdomyolysis, dyspnea, chest tightness, hypotension,

Mild side effects

Rash, skin itching, fever, nausea, vomiting, loss of appetite, malaise, photosensitivity reactions, acute generalized exanthematous pustulosis, erythema multiforme, toxic epidermal necrolysis (Lyell's syndrome), alopecia, arthralgia, myalgia, weakness, elevated CPK, increased myoglobin in blood and urine, hypotension, erythema, facial edema, lymphangiectasia, abdominal distension, decreased appetite, dyspepsia, mild abdominal pain, diarrhea,

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

Storage

This medication must be stored in a tightly sealed container to avoid exposure to air or moisture. Additionally, it is recommended to store the medication at a cool room temperature, specifically 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.