| TERBIFIN
Terbinafine Hydrochloride
Description:
Terbinafine hydrochloride is a synthetic allylamine
antifungal, which is fungicidal against dermatophytes, mold
fungi and some yeasts.
Terbinafine interferes with fungal ergosterol
biosynthesis by inhibiting squalene epoxidase in the cell membrane.
This leads to a deficiency of ergosterol and an intracellular
accumulation of squalene, thus disrupting fungal membrane function
and cell wall synthesis resulting in fungal cell death.
Terbinafine does not inhibit cytochrome P450
activity and is weakly bound to hepatic cytochrome P450 enzymes.
Terbinafine is distributed into the stratum corneum of the skin,
the nail plate and hair in higher concentration than found in
plasma.
Composition:
Terbifin Tablet: Each tablet contains
Terbinafine Hydrochloride INN equivalent to Terbinafine 250
mg.
Terbifin Cream: Each gram contains Terbinafine
Hydrochloride INN 10 mg.
Indications:
Terbifin Tablet: Dermatophyte infections
of the nails, ringworm infections (including tinea pedis, crusis
and corporis) where oral therapy is appropriate (due to site,
severity and extent).
Terbifin Cream: Dermatophyte infections
of the skin and hair, pityriasis (tinea) versicolor and yeast
infections of the skin.
Other uses:
Dosage:
Terbifin Tablet:
| Indications |
Daily Dosage |
Duration |
| Fingernail onychomycosis |
250
mg daily |
6
weeks |
| Toenail onychomycosis |
250
mg daily |
12
weeks |
| Tinea pedis |
250
mg daily |
2-6
weeks |
| Tinea cruris |
250
mg daily |
2-4
weeks |
| Tinea corporis |
250
mg daily |
4
weeks |
Child: Usually for 2 weeks, tinea capitis, over
1 year, body-weight 10-20kg, 62.5 mg once daily; body-weight
20-40kg, 125 mg once daily; body-weight over 40 kg, 250 mg once
daily.
Terbifin Cream:
Applied once or twice daily in
| Indications |
Duration |
| Tinea corporis, cruris |
1-2
weeks |
| Tinea pedis |
1
week |
| Cutaneous candidiasis |
2
weeks |
| Pityriasis (Tinea) versicolor |
2
weeks |
Application of Terbifin Cream:
Clean and dry the affected areas thoroughly before
application of Terbifin. Apply the cream to the affected
skin and surrounding area in a thin layer and rub it lightly.
In case of intertriginous infections (submammary, interdizital,
intergluteal, inguinal) the application may be covered with
a gauze strip, especially at night. Wash the hands thoroughly
after application.
Contraindication:
Hypersensitivity to terbinafine or any of the
excipients contained in the tablet or cream.
Use in elderly:
Terbinafine appears to be safe in the elderly.
The dose should be reduced by half if significant hepatic or
renal impairment is present.
Use in children:
Terbifin cream appears to be an effective and
well-tolerated treatment ofr tinea corporis and tinea cruris
in children.
Use in pregnancy and lactation:
Pregnancy category B. Treatment with Terbinafine
is not recommended in nursing mothers.
Warnings:
Good general hygiene is necessary in conjunction
with the use of Terbinafine in order to prevent reinfection
(e. g. from underwear, socks, shoes etc.).
Precautions:
Terbifine cream is for external use only. Contact
with eyes should be avoided.
Drug Interactions:
Terbifin Tablet: Plasma concentration
of terbinafine is increased by Rifampicin. Plasma concentration
of terbinafine is decreased by Cimetidine.
Side Effects:
Terbifin Tablet: Abdominal discomfort,
anorexia, nausea, diarrhoea, headache, rash and urticaria occasionally
with arthralgia or myalgia. Less frequently taste disturbance.
Rarely liver toxicity, photosensitivity, serious skin reactions
etc.
Terbifin Cream: Redness, itching, or stinging;
rarely allergic reactions.
Storage:
Store in a cool & dry place, protected from
light. Keep out of the reach of children.
Packing:
Terbifin Tablet: Each box containing 1x6’s
tablets in alu-alu blister pack.
Terbifin Cream: Tube containing 5g cream. |
