Medication info
Terbinafine M Tablet (Terbinafine Hydrochloride)

Terbinafine M Tablet (Terbinafine Hydrochloride)

Prescription medicationTablet경구
Ingredient · strength
Terbinafine Hydrochloride›140.625mg / 1 tablet
Manufacturer / importer
(주)마더스제약
Appearance
White to almost off-white round tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201308717 · Approved 2013.08.08 · Insurance code 622801550

Summary

Main use
Treatment of skin fungal infections (athlete's foot, tinea corporis, etc.) and onychomycosis
Who takes it
Adults · Children
Adult dose
As terbinafine: 125 mg per dose, twice daily, or 250 mg per dose, once daily. The duration of treatment varies by condition: 1) Dermatophyte infections Athlete's foot (interdigital type, plantar type/moon type): 2 to 6 weeks Tinea corporis: 2 to 4 weeks Tinea cruris: 2 to 4 weeks 2) Onychomycosis Usually administered for 6 weeks to 3 months. In case of infection in a fingernail or relatively small toe, or in younger patients, the duration of treatment may be shortened to less than 3 months. Normally, a treatment duration of about 3 months is sufficient for toenail infections, but in some patients, it may take 6 months or longer. In cases of patients with slow nail growth, the treatment period may be prolonged.
Child dose
Administered to children over 2 years of age. There is no experience administering to those under 2 years; thus, administration is not recommended. Tinea capitis: 4 weeks Tinea capitis mainly occurs in children. To prevent recurrence of infection, treatment must be conducted consistently during a properly determined period.

Ingredients

Manufacturer
(주)마더스제약

Efficacy & effects

Treatment of skin fungal infections (athlete's foot, tinea corporis, etc.) and onychomycosis

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

This medication is used in adults for various skin fungal infections caused by dermatophytes such as athlete's foot, tinea corporis, and tinea cruris, as well as for onychomycosis. In children, it is used for the treatment of tinea capitis.

How to take

Adult dose

As terbinafine: 125 mg per dose, twice daily, or 250 mg per dose, once daily. The duration of treatment varies by condition: 1) Dermatophyte infections Athlete's foot (interdigital type, plantar type/moon type): 2 to 6 weeks Tinea corporis: 2 to 4 weeks Tinea cruris: 2 to 4 weeks 2) Onychomycosis Usually administered for 6 weeks to 3 months. In case of infection in a fingernail or relatively small toe, or in younger patients, the duration of treatment may be shortened to less than 3 months. Normally, a treatment duration of about 3 months is sufficient for toenail infections, but in some patients, it may take 6 months or longer. In cases of patients with slow nail growth, the treatment period may be prolonged.

Child dose

Administered to children over 2 years of age. There is no experience administering to those under 2 years; thus, administration is not recommended. Tinea capitis: 4 weeks Tinea capitis mainly occurs in children. To prevent recurrence of infection, treatment must be conducted consistently during a properly determined period.

Precautions

This medication is not recommended for patients with chronic or active liver disease. It is important to check for a history of liver disease and to perform regular liver function tests before and during treatment. If symptoms suggesting liver dysfunction or elevated test results are suspected, use of this medication should be discontinued immediately. This medication can cause serious liver damage, such as liver failure; hence, if signs of liver damage occur, treatment should be stopped immediately and professional examinations should be pursued. Patients with hypersensitivity to this medication, chronic liver disease, blood disorders, severe renal failure, lactating mothers, infants under 2 years of age, or specific hereditary metabolic disorders should not use this medication. Patients with impaired renal function, the elderly, underweight children, and those with skin conditions should use this medication with caution, and should discontinue immediately if serious skin reactions occur. This medication can cause various adverse reactions, particularly abnormal liver function, blood disorders, skin rashes, myalgia, gastrointestinal symptoms, and neurological symptoms, thus symptoms should be monitored closely. This medication should only be used for fungal infections that cannot be treated topically, and if dizziness or similar symptoms occur, it is advisable to avoid driving or operating machinery. This medication may interact with other drugs, thus if there are concomitant medications, it is essential to consult a doctor or pharmacist, as dose adjustments may be necessary. Women who are pregnant or are likely to become pregnant should weigh the risks and benefits carefully when administering this medication, and breastfeeding mothers should discontinue breastfeeding while on this medication. There is no experience administering this medication to children under 2 years of age, thus it is advisable not to administer it. Close observation of the physical condition is required when administering to children or the elderly. Overdose may lead to symptoms such as headache, nausea, abdominal pain, and dizziness, thus it is important to consult medical staff and receive appropriate treatment immediately. This medication should be kept out of reach of children, should not be transferred to other containers, and should be stored at room temperature away from sunlight.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions, severe rash with high fever, blisters, skin peeling, pain of oral/ocular mucosa, severe skin reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, liver abnormalities (jaundice), sudden and severe headaches,

Mild side effects

  • Abdominal distension
  • decreased appetite
  • dyspepsia
  • nausea
  • mild abdominal pain
  • diarrhea
  • stomach discomfort
  • thirst
  • vomiting
  • glossitis
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  • depression
  • anxiety
  • headache
  • taste disturbance
  • dizziness
  • drowsiness
  • sensory disturbances
  • sensory loss
  • decreased attention
  • insomnia
  • elevated BUN
  • frequent urination
  • visual disturbances
  • tinnitus
  • increased total cholesterol levels
  • increased triglyceride levels
  • malaise
  • discoloration of the tongue
  • palpitations
  • edema
  • menstrual irregularities
  • paralysis
  • systemic disorders
  • fever
  • fatigue

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 and moisture ingress. Additionally, it should be kept at a suitable room temperature between 1 degree and 30 degrees Celsius, avoiding extremes of heat and cold.

Appearance and packaging

Appearance

White to almost off-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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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.