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:

Bryant Ranch Prepack

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 INDICATION AND USAGE section of the labeling.) Ciclopirox topical solution, USP 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. - 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% and systemic antifungal agents for onychomycosis, is not recommended. - Ciclopirox topical solution, 8% should be used only under medical supervision as described above. - The effectiveness and safety of ciclopirox topical solution, 8% in the following populations has not been studied. The clinical trials with use of ciclopirox topical solution, 8% excluded patients who: were pregnant or nursing, planned to become pregnant, had a history of immunosuppression (e.g., extensive, persistent, or unusual distribution of dermatomycoses, extensive seborrheic dermatitis, recent or recurring herpes zoster, or persistent herpes simplex), were HIV seropositive, received organ transplant, required medication to control epilepsy, were insulin dependent diabetics or had diabetic neuropathy. Patients with severe plantar (moccasin) tinea pedis were also excluded. - The safety and efficacy of using ciclopirox topical solution, 8% daily for greater than 48 weeks have not been established. Clinical Trials Data The results of use of 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 ciclopirox topical solution, 8%, in conjunction with monthly removal of the unattached, infected toenail by the investigator. Ciclopirox topical solution, 8% was applied for 48 weeks. At baseline, patients had 20-65% involvement of the target great toenail plate. Statistical significance was demonstrated in one of two studies for the endpoint “complete cure” (clear nail and negative mycology) and in two studies for the endpoint “almost clear” ≤10% nail involvement and negative mycology) at the end of study. These results are presented below. *Clear nail and negative mycology ** ≤10% nail involvement and negative mycology *** Negative KOH and negative culture The summary of reported patient outcomes for the ITT population at 12 weeks following the end of treatment are presented below. Note that post-treatment efficacy assessments were scheduled only for patients who achieved a complete cure. * Four patients (from studies 312 and 313) who were completely cured did not have post-treatment Week 12 planimetry data. Ciclopirox topical solution, 8% is contraindicated in individuals who have shown hypersensitivity to any of its components.

Tóm tắt sản phẩm:

Ciclopirox Topical Solution, USP 8% (Nail Lacquer) NDC: 72162-1321-2:  6.6 mL in a glass bottle with screw caps which are fitted with brushes.  Ciclopirox Topical Solution, USP 8% (Nail Lacquer) should be stored at 20° to 25°C (68° to 77°F), excursions permitted between 15° and 30°C (between 59° and 86°F). [See USP, “Controlled Room Temperature.”] Protect from light (e.g., store the bottle in the carton after every use). CAUTION: Flammable. Keep away from heat and flame. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

CICLOPIROX- CICLOPIROX SOLUTION
BRYANT RANCH PREPACK
----------
PRESCRIBING INFORMATION
RX ONLY
CICLOPIROX TOPICAL SOLUTION, USP 8% (NAIL LACQUER)
FOR USE ON FINGERNAILS AND TOENAILS AND IMMEDIATELY ADJACENT SKIN
ONLY
NOT FOR USE IN EYES
DESCRIPTION
Ciclopirox Topical Solution, USP 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, USP 8% (Nail Lacquer)
contains 80 mg
ciclopirox in a solution base consisting of ethyl acetate, isopropyl
alcohol and
monobutylester of poly[methyl vinyl ether/maleic acid] in isopropyl
alcohol. Ethyl acetate
and isopropyl alcohol are solvents that vaporize after application.
Ciclopirox Topical Solution, USP 8% (Nail Lacquer) 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 molecular 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
12
17
2
+3
+3
(1-2)
Trichophyton mentagrophytes species. Correlation between in vitro MIC
results and
clinical outcome has yet to be est