Medication info

Demi Siljeong (Terbinafine Hydrochloride)

Prescription medicationTabletExpired
Ingredient · strength
Terbinafine Hydrochloride›140.625mg / 1 tablet
Manufacturer / importer
(주)시어스제약
Appearance
White to nearly colorless round tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Expired

MFDS item code 201902259 · Approved 2019.04.12

This product's status changed to Expired on 2024.04.12. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of dermatophyte infections (tinea pedis, tinea corporis, etc.) and onychomycosis
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 according to the condition is as follows. 1) Dermatophyte infections - Tinea pedis (interdigital type, plantar type/moccasin type): 2-6 weeks, Tinea corporis: 2-4 weeks, Tinea cruris (jock itch): 2-4 weeks. 2) Onychomycosis - Usually administered for 6 weeks to 3 months. If the infection is in the fingernail or a relatively small toenail, or in a younger patient, the treatment duration may be shortened to less than 3 months. The treatment duration for nail infections is usually sufficient at 3 months, but in some patients, it may take 6 months or longer. For patients with slow nail growth, the treatment duration may be extended.
Children's dosage
Administered to children 2 years and older. 1) For children under 20 kg (under 5 years old): 62.5 mg once daily. 2) For children weighing 20-40 kg (5-12 years old): 125 mg once daily.

Ingredients

Manufacturer
(주)시어스제약

Efficacy & effects

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

  • Dermatophyte infections such as tinea pedis
  • tinea corporis
  • tinea cruris
  • onychomycosis
  • and tinea capitis
View approved original text

This medication is used to treat tinea pedis, tinea corporis, and tinea cruris caused by fungal infections of the skin in adults, and it is also used for onychomycosis. In children, it helps improve tinea capitis. Therefore, this medication is used for the treatment of fungal infections affecting the skin, nails, and scalp.

Dosage and Administration

Adult dosage

As terbinafine, administer 125 mg once or twice daily, or 250 mg once daily. The duration of administration according to the condition is as follows. 1) Dermatophyte infections - Tinea pedis (interdigital type, plantar type/moccasin type): 2-6 weeks, Tinea corporis: 2-4 weeks, Tinea cruris (jock itch): 2-4 weeks. 2) Onychomycosis - Usually administered for 6 weeks to 3 months. If the infection is in the fingernail or a relatively small toenail, or in a younger patient, the treatment duration may be shortened to less than 3 months. The treatment duration for nail infections is usually sufficient at 3 months, but in some patients, it may take 6 months or longer. For patients with slow nail growth, the treatment duration may be extended.

Children's dosage

Administered to children 2 years and older. 1) For children under 20 kg (under 5 years old): 62.5 mg once daily. 2) For children weighing 20-40 kg (5-12 years old): 125 mg once daily.

Precautions

This medication is not recommended for patients with chronic liver disease or active liver disease. Prior to administration, liver function tests and a history of liver disease must be confirmed. If any symptoms of liver dysfunction occur, use should be discontinued immediately and medical attention sought. Liver function tests should be conducted regularly during the treatment for the first 4-6 weeks, and if abnormalities are detected, medication should be stopped immediately. Since this medication can cause liver damage, caution is required for patients with impaired liver function. Not to be administered to patients with blood disorders, severe renal failure, children under 2 years of age, nursing mothers, and certain hereditary lactose intolerance patients. Patients with reduced kidney function, elderly individuals, and children with low body weight should use this medication cautiously, and it should be discontinued immediately if severe rash or allergic reactions occur. During the use of this medication, careful observation for symptoms such as skin rashes, nausea, fatigue, and jaundice is essential. Caution is needed if symptoms like dizziness occur while driving or operating machinery. This medication may interact with other drugs, so if there are any concomitant medications, notify your doctor or pharmacist. Especially when taken with drugs affecting liver metabolism, dosage adjustments may be necessary. Women who are pregnant or may become pregnant should consult their physician if this medication is necessary, and nursing mothers are advised to discontinue breastfeeding. In case of overdose, symptoms such as headaches, nausea, and dizziness may occur, and immediate medical attention should be sought. This medication should be kept out of the reach of children and stored in a tightly sealed container away from direct sunlight at room temperature.

Side effects and when to seek care immediately

Serious side effects

Hepatobiliary failure, hepatitis, cholestasis, jaundice, neutropenia, pancytopenia, agranulocytosis, thrombocytopenia, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, erythema multiforme, toxic skin eruptions, exfoliative dermatitis, bullous dermatitis, rhabdomyolysis, respiratory distress, chest tightness, urticaria, anaphylactic reactions (angioedema), liver failure, neurological symptoms (paralysis), severe skin abnormalities

Mild side effects

Rash, skin itching, fever, nausea, vomiting, loss of appetite, lethargy, musculoskeletal reactions (arthralgia, myalgia), weakness, rhabdomyolysis accompanied by sudden deterioration of kidney function, hypotension, erythema, facial swelling, lymphangitis, gastrointestinal symptoms (abdominal distension, decreased appetite, dyspepsia, diarrhea), gastrointestinal discomfort, thirst, glossitis, depression, anxiety, headache, taste disturbances, dizziness, drowsiness, sensory disturbances and loss of sensation, attention issues

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

Storage

This medication should be stored in a tightly sealed container to prevent air from entering. It should also be kept away from extremely hot or cold environments, and it is best stored at a normal room temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

White to nearly colorless 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.