Medication info

Uninapin Tablets (Terbinafine Hydrochloride)

Prescription medicationExpired
Ingredient · strength
Terbinafine Hydrochloride›Strength being verified
Manufacturer / importer
구주제약(주)
Appearance
White to whitish round tablets
Packaging
In-house packaging unit
Approval status
Expired

MFDS item code 200403039 · Notified 2004.08.09

This product's status changed to Expired on 2023.04.01. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of skin mycosis (tinea pedis, tinea corporis, etc.) and onychomycosis caused by dermatophytes
Who uses it
Adults · Children
Adult dosage
For Terbinafine: 125 mg twice daily or 250 mg once daily. The duration of treatment depending on the disease is as follows: 1) Dermatophyte infections Tinea Pedis (interdigital type, plantar type/moccasin type): 2–6 weeks Tinea Corporis: 2–4 weeks Tinea Cruris: 2–4 weeks 2) Onychomycosis Typically administered for 6 weeks to 3 months. If the infection is in the fingernails or relatively small toes, or for younger patients, the treatment duration may be shortened to less than 3 months. The treatment duration for toenail infections is usually sufficient at 3 months, but some patients may take 6 months or longer. In cases where the nail growth rate is slow, the treatment period may be extended.
Children's dosage
Administered to children over 2 years of age. Tinea Capitis: 4 weeks 1) In children weighing less than 20 kg (under 5 years old): 62.5 mg once daily. Due to the lack of treatment experience, the benefits and risks of treatment should be considered.

Ingredients

Manufacturer
구주제약(주)

Efficacy & effects

Treatment of skin mycosis (tinea pedis, tinea corporis, etc.) and onychomycosis caused by dermatophytes

  • Skin mycosis
  • tinea pedis
  • tinea corporis
  • tinea cruris
  • onychomycosis
  • tinea capitis
View approved original text

This medication is used to treat skin mycosis such as tinea pedis, tinea corporis, and tinea cruris in adults. It is also used to treat tinea capitis in children.

Dosage and Administration

Adult dosage

For Terbinafine: 125 mg twice daily or 250 mg once daily. The duration of treatment depending on the disease is as follows: 1) Dermatophyte infections Tinea Pedis (interdigital type, plantar type/moccasin type): 2–6 weeks Tinea Corporis: 2–4 weeks Tinea Cruris: 2–4 weeks 2) Onychomycosis Typically administered for 6 weeks to 3 months. If the infection is in the fingernails or relatively small toes, or for younger patients, the treatment duration may be shortened to less than 3 months. The treatment duration for toenail infections is usually sufficient at 3 months, but some patients may take 6 months or longer. In cases where the nail growth rate is slow, the treatment period may be extended.

Children's dosage

Administered to children over 2 years of age. Tinea Capitis: 4 weeks 1) In children weighing less than 20 kg (under 5 years old): 62.5 mg once daily. Due to the lack of treatment experience, the benefits and risks of treatment should be considered.

Precautions

This medication is not recommended for patients with liver problems or a history of liver disease. Liver function tests should be performed before use, and liver function should be monitored regularly during treatment. If symptoms of liver dysfunction occur, discontinue use immediately and consult a doctor. This medication should not be used in patients with severe blood disorders or significantly impaired kidney function, children under 2 years of age, or nursing mothers. Additionally, individuals with allergies to this medication should not take it. Special caution is required for elderly patients or children with low body weight when using this medication. If severe skin rash or allergic reactions occur, discontinue use immediately. This medication is primarily metabolized in the liver, so individuals with weak liver or kidney function should use it after consulting a doctor. Dizziness or drowsiness may occur while taking this medication, so it is advisable to avoid driving or operating machinery. There may be interactions with other medications, so if you are taking other medications, be sure to inform your doctor or pharmacist. Women who are pregnant or may become pregnant should thoroughly consult with their doctor regarding the use of this medication, and nursing mothers should avoid taking it. Overdose may result in headaches, nausea, abdominal pain, and dizziness, and if these symptoms occur, seek medical attention immediately. This medication should be stored out of the reach of children, protected from direct sunlight, and kept at room temperature.

Side effects and when to seek care immediately

Serious side effects

Cholestatic hepatitis, hepatitis, cholestasis, jaundice, neutropenia, pancytopenia, agranulocytosis, thrombocytopenia, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute kidney injury accompanied by rhabdomyolysis, respiratory distress, chest tightness, urticaria, anaphylactic reactions (including angioedema, superficial and systemic lupus erythematosus), paralysis, severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis)

Mild side effects

Rash, skin itching, fever, nausea, vomiting, loss of appetite, malaise, leukopenia, anemia, photosensitivity reactions, acute generalized exanthematous pustulosis, erythema multiforme, toxic skin reactions, exfoliative dermatitis, vesicular dermatitis, psoriasiform rash or worsening of psoriasis, hair loss, musculoskeletal reactions (arthralgia, myalgia), muscle pain, weakness, elevated CPK, increased myoglobin in blood and urine, hypotension, erythema, facial edema, lymphangiectasia, abdominal discomfort

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

Storage

This medication should be stored in a sealed container to prevent air or moisture from entering, and it is recommended to keep it at room temperature between 1 and 30 degrees Celsius. Proper storage will help maintain its effectiveness for a longer period.

Appearance and packaging

Appearance

White to whitish round tablets

Package unit

In-house packaging unit

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.