CICLOPIROX solution

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

CICLOPIROX (UNII: 19W019ZDRJ) (CICLOPIROX - UNII:19W019ZDRJ)

Sẵn có từ:

Encube Ethicals Private Limited

Tuyến hành chính:

TOPICAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

(To understand fully the indication for this product, please read the entire INDICATIONS AND USAGE section of the labeling.) Ciclopirox topical solution, 8% (nail lacquer), 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. - No studies have been conducted to determine whether ciclopirox might reduce the effectiveness of systemic antifungal agents for onychomycosis. Therefore, the concomitant use of ciclopirox topical solution, 8% (nail lacquer) and systemic antifungal agents for onychomycosis, is not recommended. - Ciclopirox topical solution, 8% (nail lacquer), should be used

Tóm tắt sản phẩm:

Ciclopirox topical solution, 8% (nail lacquer), is supplied in 6.6 mL (NDC 21922-053-51) glass bottles with screw caps which are fitted with brushes. Protect from light (e.g., store the bottle in the carton after every use). Ciclopirox topical solution, 8% (nail lacquer), should be stored at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature.] CAUTION: Flammable. Keep away from heat and flame.   Rx ONLY   Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.   Manufactured by: Encube Ethicals Pvt. Ltd. Plot No. C-1, Madkaim Industrial Estate, Madkaim, Post: Mardol, Panda, Goa-403404, India. References: 1. Dittmar W., Lohaus G. 1973. HOE296, A new antimycotic compound with a broad antimicrobial spectrum. Arzneim-Forsch./ Drug Res. 23:670-674. 2. Niewerth et. al., 1998. Antimicrobial susceptibility testing of dermatophytes: Comparison of the agar macrodilution and broth micro dilution tests. Chemotherapy. 44:31-35. 3. Yang et. al. 1997. A new simulation model for studying in vitro topical penetration of antifungal drugs into hard keratin. J. Mycol. Med. 7:195-98. Gantrez is a registered trademark of GAF Corporation Rev. 01/23

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

CICLOPIROX - CICLOPIROX SOLUTION
ENCUBE ETHICALS PRIVATE LIMITED
----------
CICLOPIROX TOPICAL SOLUTION, 8% (NAIL LACQUER)
RX ONLY
FOR USE ON FINGERNAILS AND TOENAILS AND IMMEDIATELY ADJACENT SKIN ONLY
NOT FOR USE IN EYES
DESCRIPTION
Ciclopirox topical solution, 8% (nail lacquer) contains a synthetic
antifungal agent,
ciclopirox. It is intended for topical use on fingernails and toenails
and immediately
adjacent skin.
Each gram of ciclopirox topical solution, 8% (nail lacquer) 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.
Ciclopirox topical solution, 8% (nail lacquer) is a clear, colorless
to slightly yellowish
solution.
The chemical name for ciclopirox is 6-cyclohexyl-1-hydroxy-4-
methyl-2(1 H)-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
12
17
2
+3
+3
(1-2)
concentration (MIC) values for the dermatophytic molds.
As a consequence, a broad
range of MIC values, 1-20 μg/mL, were obtained for _Trichophyton
rubrum _and
_Trichophyton mentagrophytes_ species. Correlation bet