TERBINAFINE HYDROCHLORIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TERBINAFINE HYDROCHLORIDE (UNII: 012C11ZU6G) (TERBINAFINE - UNII:G7RIW8S0XP)

Available from:

Wockhardt Limited

INN (International Name):

TERBINAFINE HYDROCHLORIDE

Composition:

TERBINAFINE 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Terbinafine hydrochloride 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. Terbinafine hydrochloride tablets are contraindicated in individuals with hypersensitivity to terbinafine or to any other ingredients of the formulation.

Product summary:

Terbinafine hydrochloride tablets 250 mg, supplied as white circular, bi-convex, bevelled tablets embossed with ‘W’ on one side and ‘743’ on other side. Bottles of 30 tablets................................NDC 64679-743-01 Bottles of 1000 tablets............................NDC 64679-743-02 Bottles of 100 tablets..............................NDC 64679-743-03 Cartons of 1 blister card (30 tablets) ......NDC 64679-743-05 Store at 20° - 25 °C (68° - 77 ° F); in a tight container. Protect from light.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TERBINAFINE HYDROCHLORIDE- TERBINAFINE HYDROCHLORIDE TABLET
WOCKHARDT LIMITED
----------
TERBINAFINE HYDROCHLORIDE TABLETS
RX ONLY
PRESCRIBING INFORMATION
DESCRIPTION
Terbinafine hydrochloride tablets contain the synthetic allylamine
antifungal compound terbinafine
hydrochloride.
Chemically, terbinafine hydrochloride is
(E)-_N_-(6,6-dimethyl-2-hepten-4-ynyl)-N-methyl-1-
naphthalenemethanamine hydrochloride. The empirical formula C
H ClN with a molecular weight of
327.90, and the following structural formula:
Terbinafine hydrochloride is a white to off-white crystalline powder.
It is freely soluble in methanol
and methylene chloride, soluble in ethanol, and slightly soluble in
water.
_EACH TABLET CONTAINS:_
_Active Ingredients: _terbinafine hydrochloride (equivalent to 250 mg
base)
_Inactive Ingredients: _microcrystalline cellulose, NF; hypromellose 6
cps, USP; sodium starch glycolate,
NF; colloidal silicon dioxide, NF; magnesium stearate, NF
CLINICAL PHARMACOLOGY
PHARMACOKINETICS
Following oral administration, terbinafine is well absorbed (>70%) and
the bioavailability of terbinafine
hydrochloride tablets as a result of first-pass metabolism is
approximately 40%. Peak plasma
concentrations of 1 µg/mL appear within 2 h after a single 250 mg
dose; the AUC (area under the curve)
is approximately 4.56 µg·h/mL. An increase in the AUC of terbinafine
of less than 20% is observed
when terbinafine hydrochloride tablets is administered with food. No
clinically relevant age-dependent
changes in steady-state plasma concentrations of terbinafine have been
reported. In patients with renal
impairment (creatinine clearance ≤50mL/min) or hepatic cirrhosis,
the clearance of terbinafine is
decreased by approximately 50% compared to normal volunteers. No
effect of gender on the blood
levels of terbinafine was detected in clinical trials. In plasma,
terbinafine is >99% bound to plasma
21
26
proteins and there are no specific binding sites. At steady-state, in
comparison to a single dose, the peak
concentration of terbinafine is