TERBINAFINE HYDROCHLORIDE tablet

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

Terbinafine Hydrochloride (UNII: 012C11ZU6G) (Terbinafine - UNII:G7RIW8S0XP)

Verfügbar ab:

Wockhardt USA, LLC

INN (Internationale Bezeichnung):

Terbinafine Hydrochloride

Zusammensetzung:

Terbinafine Hydrochloride 250 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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.

Produktbesonderheiten:

Terbinafine Hydrochloride Tablets Supplied as white, round, flat faced beveled edge tablets debossed with IG on one side and 209 on the other. Store between 20°–25°C (68°–77°F) (See USP Controlled Room Temperature); in a tight container. Protect from light.

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

TERBINAFINE HYDROCHLORIDE- TERBINAFINE HYDROCHLORIDE TABLET
WOCKHARDT USA, LLC
----------
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 fine 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:_ colloidal silicon dioxide, NF; hypromellose,
USP; magnesium stearate, NF;
microcrystalline cellulose, NF; sodium starch glycolate, 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 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 proteins and there are no specific binding sites. At
steady-state, in comparison to a single dose,
21
26
the peak concentration of terbinafine is 25% h