TERBINA (cream)
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Chemical Name:
Terbinafine (HCl) -
Therapeutic Category:
Antifungal drugs & Antiviral drugs -
Pharmacologic Category:
Antifungal Agent -
Pharmaceutical Form:
Cream -
Composition:
Terbinafine (HCl) 1 g/100 g
TERBINA
Tablets, Cream
Terbinafine (HCl)
Antifungal
1. PROPERTIES:
Terbinafine is an allylamine derivative which has broad spectrum of antifungal activity.
Terbinafine is fungicidal against dermatophytes and some yeasts but only fungistatic against candida albicans.
Terbinafine inhibits ergosterol synthesis in the fungal cell, this leads to accumulation of squalene within the cell resulting in cell death.
2. INDICATIONS:
TERBINA is used in the treatment of fungal infections of the skin caused by Trichophyton, Microsporumcanis or Epidermophyton fluccosum.
TERBINA is used in the treatment of tinea corporis, tinea cruris, onychomycosis, tineapedis and candida albicans.
3. CONTRA-INDICATIONS:
- Hypersensitivity to Terbinafine.
- Pregnancy.
4. SIDE EFFECTS:
TERBINA may cause nausea, diarrhoea, abdominal pain, skin rashes or urticaria.
5. PRECAUTIONS:
- Doses should be reduced to half of normal dose in patients with severe liver dysfunction or a creatinine clearance of less than 50 ml per minute.
- Mothers receiving oral TERBINA should not breast-feed.
6. DRUG INTERACTIONS:
The plasma clearance of TERBINA may be accelerated by drugs which induce metabolism such as rifampicin and may be inhibited by drugs which inhibit cytochrome P450 such as cimetidine.
7. DOSAGE & ADMINISTRATION:
The duration of treatment varies according to the indication and the severity of the infection.
Tablets:
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Adults:
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250 mg once daily
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< 20 kg
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62.5 mg (½ Terbina 125 tablet) once daily
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Children aged over 2 years:
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20 – 40 kg
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125 mg once daily
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> 40 kg
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250 mg once daily
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Skin infections:
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Tinea pedis
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2-6 weeks
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Tinea corporis, tinea cruris
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2-4 weeks
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Cutaneous candidiasis
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2-4 weeks
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Infections of the hair and scalp: Tinea capitis
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4 weeks
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Dermatophyte infection of the finger and/or toe nails
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6-12 weeks
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- Tinea capitis occurs primarily in children. Patients should be made aware that, if recurrence of infection is to be avoided, the treatment must be used regularly and for and adequate length of time.
- In some cases, such as big-toe involvement or reduced nail growth, treatment for up to six months may be necessary.
- Oral TERBINA should only be used to treat fungal infection of the nails for as long as mycological culture is positive. It should be borne in mind that mycological culture is often negative for several months before clinical cure becomes apparent. This is because it takes time for healthy nail tissue to grow.
Cream:
Cover the infected area and the area around in the morning and in the evening.
The duration of treatment is related to the severity of the infection and the indication.
8. PACKAGING & COMPOSITION:
- TERBINA 125 – Tablets: A pack of 14 tablets. Each tablet contains Terbinafine (HCl) 125 mg.
- TERBINA 250 – Tablets: A pack of 14 tablets. Each tablet contains Terbinafine (HCl) 250 mg.
- TERBINA – Cream: A pack of aluminum tube of 15 gr. Each tube contains Terbinafine (HCl) 1 %.
9. STORAGE:
- TERBINA – Tablets: Store below 25°C, in a tight container. Protect from light.
- TERBINA – Cream: Store at temperature between (5-30)°C.
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