A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Lamisil Indications, Dosage, Storage, Stability - Terbinafine Hcl
Lamisil Indications, Dosage, Storage, Stability - Terbinafine Hcl
INDICATIONS AND USAGE
LAMISIL® (terbinafine hydrochloride tablets)
Tablets are indicated for the treatment of onychomycosis of the toenail or fingernail
due to dermatophytes (tinea unguium) (see DOSAGE
AND ADMINISTRATION and CLINICAL STUDIES).
Prior to initiating treatment, appropriate nail specimens for
laboratory testing (KOH preparation, fungal culture, or nail biopsy) should
be obtained to confirm the diagnosis of onychomycosis.
DOSAGE AND ADMINISTRATION
LAMISIL® (terbinafine hydrochloride tablets)
Tablets, one 250 mg tablet, should be taken once daily for 6 weeks by patients
with fingernail onychomycosis. LAMISIL®, one 250 mg tablet, should
be taken once daily for 12 weeks by patients with toenail onychomycosis. The
optimal clinical effect is seen some months after mycological cure and cessation
of treatment. This is related to the period required for outgrowth of healthy
nail.
HOW SUPPLIED
LAMISIL®
(terbinafine hydrochloride tablets)
Tablets
Supplied as white to yellow-tinged white circular, bi-convex,
bevelled tablets containing 250 mg of terbinafine imprinted with "LAMISIL"
in circular form on one side and code "250" on the other.
Bottles of 100 tablets
NDC 0078-0179-05
Bottles of 30 tablets
NDC 0078-0179-15
Store tablets below 25°C (77°F); in a tight container. Protect
from light.
Manufactured by: Novartis Pharmaceuticals Canada
Inc. Dorval (Québec), Canada H9S 1A9 Distributed by: Novartis Pharmaceuticals
Corporation East Hanover, New Jersey 07936 REV: APRIL 2001, T2001-29 89006802
2295-25-01A © 2001 Novartis
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