Medication info

Samsung Terbinafine Tablet (Terbinafine Hydrochloride)

Prescription medicationExpired
Ingredient · strength
Terbinafine Hydrochloride›Strength being verified
Manufacturer / importer
삼성제약(주)
Appearance
White round tablet
Packaging
Bottle - 30 tablets/bottle, Bottle - 100 tablets/bottle
Approval status
Expired

MFDS item code 200400228 · Notified 2004.10.08

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 and nail fungal infections
Who uses it
Adults · Children
Adult dosage
As terbinafine, administer 125 mg twice a day or 250 mg once a day. The duration of treatment depends on the condition: 1) Dermatophytosis Athlete's foot (interdigital type, plantar type/moccasin type): 2 to 6 weeks Body ringworm: 2 to 4 weeks Jock itch: 2 to 4 weeks 2) Nail fungal infections Typically treated for 6 weeks to 3 months. If the infection is on a nail or a relatively small toe, or if the patient is young, the treatment period can be shortened to less than 3 months. Generally, 3 months is sufficient for treating nail infections, though in some cases, it may take 6 months or longer. In patients with slow nail growth, the treatment duration may be extended.
Children's dosage
Administer to children over 2 years of age. Tinea capitis: 4 weeks 1) For children weighing less than 20 kg (under 5 years): administer 62.5 mg once a day. 2) For children weighing 20 to 40 kg (ages 5 to 12):

Ingredients

Manufacturer
삼성제약(주)

Efficacy & effects

Treatment of skin and nail fungal infections

  • Skin fungal infections
  • athlete's foot
  • body ringworm
  • jock itch
  • nail fungal infections
  • tinea capitis
View approved original text

This medication is used for the treatment of skin fungal infections caused by dermatophytes, such as athlete's foot, body ringworm, and jock itch, as well as for nail fungal infections in adults. It is effective for treating tinea capitis in children. In summary, it helps improve various fungal infections occurring on the skin and nails.

Dosage and Administration

Adult dosage

As terbinafine, administer 125 mg twice a day or 250 mg once a day. The duration of treatment depends on the condition: 1) Dermatophytosis Athlete's foot (interdigital type, plantar type/moccasin type): 2 to 6 weeks Body ringworm: 2 to 4 weeks Jock itch: 2 to 4 weeks 2) Nail fungal infections Typically treated for 6 weeks to 3 months. If the infection is on a nail or a relatively small toe, or if the patient is young, the treatment period can be shortened to less than 3 months. Generally, 3 months is sufficient for treating nail infections, though in some cases, it may take 6 months or longer. In patients with slow nail growth, the treatment duration may be extended.

Children's dosage

Administer to children over 2 years of age. Tinea capitis: 4 weeks 1) For children weighing less than 20 kg (under 5 years): administer 62.5 mg once a day. 2) For children weighing 20 to 40 kg (ages 5 to 12):

Precautions

This drug is not recommended for patients with liver dysfunction or a history of liver disease. Liver function tests must be performed before administration, and liver function should be regularly monitored during treatment. If symptoms of liver dysfunction (e.g., nausea, vomiting, fatigue, jaundice) occur, you should immediately notify your physician and discontinue the medication. This drug should not be used in patients with blood disorders, severe renal failure, nursing women, children under 2 years of age, or certain genetically predisposed lactose intolerant patients. In patients with reduced kidney function, the elderly, and smaller children, careful administration is required, and if skin rashes or serious skin reactions occur, treatment should be discontinued immediately. This medication can cause adverse reactions in various areas, including the liver, blood, skin, and muscles, so if symptoms appear, you should consult medical staff immediately. Caution is advisable when driving or operating machinery as dizziness may occur as a side effect. There may be interactions with other medications when taken together, so it is essential to inform your healthcare provider of any medications currently being taken, and dose adjustments may be necessary. Women who are pregnant or may become pregnant should use this drug cautiously after consulting a physician, and nursing mothers are advised to discontinue breastfeeding. Particular caution is needed for children and the elderly, and patients' conditions should be closely monitored before and after administration. In cases of overdose, symptoms such as headache, nausea, abdominal pain, and dizziness may occur; you should immediately inform medical staff and seek appropriate treatment. This medication should be kept out of children's reach and stored 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, paleness, severe rash with high fever, blisters, skin peeling, pain in oral/eye mucous membranes, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination problems

Mild side effects

Rash, itching, fever, nausea, vomiting, loss of appetite, fatigue, gastrointestinal symptoms (abdominal bloating, dyspepsia, mild abdominal pain, diarrhea), upper abdominal discomfort, dry mouth, glossitis, depression, anxiety, headache, taste disturbances, dizziness, drowsiness, sensory abnormalities, decreased sensation, decreased attention, insomnia, elevated BUN, frequent urination, visual disturbances, tinnitus, increased total cholesterol and triglycerides in the blood, discoloration of the tongue, palpitations, edema, menstrual irregularities

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

Storage

This medication should be stored in a well-closed container that is air-tight, ideally at temperatures between 1 to 30 degrees Celsius. Proper storage will help maintain the medication's efficacy and prevent degradation.

Appearance and packaging

Appearance

White round tablet

Package unit

Bottle - 30 tablets/bottle, 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.

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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.