PENLAC- ciclopirox solution

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

ciclopirox (UNII: 19W019ZDRJ) (ciclopirox - UNII:19W019ZDRJ)

Fáanlegur frá:

Bausch Health US LLC

INN (Alþjóðlegt nafn):

ciclopirox

Samsetning:

ciclopirox 80 mg in 1 mL

Stjórnsýsluleið:

TOPICAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

(To understand fully the indication for this product, please read the entire INDICATIONS AND USAGE section of the labeling.) PENLAC® Nail Lacquer (ciclopirox) Topical Solution, 8%, as a component of a comprehensive management program, is indicated as topical treatment in immunocompetent patients with mild to moderate onychomycosis of fingernails and toenails without lunula involvement, due to Trichophyton rubrum . The comprehensive management program includes removal of the unattached, infected nails as frequently as monthly, by a health care professional who has special competence in the diagnosis and treatment of nail disorders, including minor nail procedures. The results of use of PENLAC® Nail Lacquer (ciclopirox) Topical Solution, 8%, in treatment of onychomycosis of the toenail without lunula involvement were obtained from two double-blind, placebo-controlled studies conducted in the US. In these studies, patients with onychomycosis of the great toenails without lunula involvement were treated with c

Vörulýsing:

PENLAC® Nail Lacquer (ciclopirox) Topical Solution, 8%, is supplied in 6.6 mL (NDC 0187-5180-06) glass bottles with screw caps which are fitted with brushes. Protect from light (e.g., store the bottle in the carton after every use). PENLAC® Nail Lacquer (ciclopirox) Topical Solution, 8%, should be stored at room temperature between 59° and 86° F (15° and 30° C). CAUTION: Flammable. Keep away from heat and flame. Rx only Manufactured for: Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA by: Sanofi-Aventis Deutschland GmbH 65926 Frankfurt am Main, Germany References: Penlac is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates. Any other product/brand names are trademarks of their respective owners. ©2016 Valeant Pharmaceuticals North America LLC Rev. 06/2016 9542701

Leyfisstaða:

New Drug Application

Vara einkenni

PENLAC- CICLOPIROX SOLUTION
BAUSCH HEALTH US LLC
----------
PENLAC NAIL LACQUER
(CICLOPIROX) TOPICAL SOLUTION, 8%
FOR USE ON FINGERNAILS AND TOENAILS AND IMMEDIATELY ADJACENT SKIN ONLY
NOT FOR USE IN EYES
DESCRIPTION
PENLAC Nail Lacquer (ciclopirox) Topical Solution, 8%, contains a
synthetic antifungal agent,
ciclopirox. It is intended for topical use on fingernails and toenails
and immediately adjacent skin.
Each gram of PENLAC Nail Lacquer (ciclopirox) Topical Solution, 8%,
contains 80 mg ciclopirox
in a solution base consisting of ethyl acetate, NF; isopropyl alcohol,
USP; and butyl monoester of
poly[methylvinyl ether/maleic acid] in isopropyl alcohol. Ethyl
acetate and isopropyl alcohol are
solvents that vaporize after application.
PENLAC Nail Lacquer (ciclopirox) Topical Solution, 8%, is a clear,
colorless to slightly yellowish
solution.
The chemical name for ciclopirox is
6-cyclohexyl-1-hydroxy-4-methyl-2(1H)-pyridone, with the
empirical formula C
H NO and a molecular weight of 207.27. The CAS Registry Number is
[29342-05-0]. The chemical structure is:
CLINICAL PHARMACOLOGY
MICROBIOLOGY
MECHANISM OF ACTION
The mechanism of action of ciclopirox has been investigated using
various _in vitro_ and _in vivo_ infection
models. One _in vitro_ study suggested that ciclopirox acts by
chelation of polyvalent cations (Fe
or
Al
) resulting in the inhibition of the metal-dependent enzymes that are
responsible for the degradation
of peroxides within the fungal cell. The clinical significance of this
observation is not known.
ACTIVITY IN VITRO AND EX VIVO
_In vitro_ methodologies employing various broth or solid media with
and without additional nutrients
have been utilized to determine ciclopirox minimum inhibitory
concentration (MIC) values for the
dermatophytic molds.
As a consequence, a broad range of MIC values, 1–20 mcg/mL, were
obtained for _Trichophyton rubrum_ and _Trichophyton mentagrophytes_
species. Correlation between _in vitro_
MIC results and clinical outcome has yet to be established for
ciclopirox.
One