Ciclopirox Solution

Ciclopirox Solution

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Questions & Answers

Side Effects & Adverse Reactions

Ciclopirox Topical Solution, 8%, (Nail Lacquer), is not for ophthalmic, oral, or intravaginal use. For use on nails and immediately adjacent skin only.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

(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 8% ciclopirox topical solution and systemic antifungal agents for onychomycosis, is not recommended.

  • Ciclopirox Topical Solution, 8%, (Nail Lacquer), should be used only under medical supervision as described above.

  • The effectiveness and safety of Ciclopirox Topical Solution, 8%, (Nail Lacquer), in the following populations has not been studied.  The clinical trials with use of Ciclopirox Topical Solution, 8%, (Nail Lacquer), 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 recurringherpes 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%, (Nail Lacquer), daily for greater than 48 weeks have not been established.

Clinical Trials Data:

The results of use of Ciclopirox Topical Solution, 8%, (Nail Lacquer), 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%, (Nail Lacquer), 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.

At Week 48 (plus Last Observation Carried Forward) for the Intern-to-Treat (ITT) Population
*
Clear nail and negative mycology
≤10% nail involvement and negative mycology
Negative KOH and negative culture
Study 312 Study 313
Active Vehicle Active Vehicle
Complete Cure* 6/110
(5.5%)
1/109
(0.9%)
10/118
(8.5%)
0/117
(0%)
Almost Clear 7/107
(6.5%)
1/108
(0.9%)
14/116
(12%)
1/115
(0.9%)
Negative Mycology Alone 30/105
(29%)
12/106
(11%)
41/115
(36%)
10/114
(9%)

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.

Post-Treatment Week 12 Data for Patients Who Acheived Complete Cure at Week 48
*
Four patients (from studies 312 and 313) who were completely cured did not have post-treatment Week 12 planimetry data.
Study 312 Study 313
Active Vehicle Active Vehicle
Number of Treated Patients 112 111 119 118
Complete Cure at Week 48 6 1 10 0
Post Treatment Week
12 Outcomes:
Patients Missing All
Week 12 Assessments
Patients with Week 12
Assessments
  Complete Cure
  Almost Clear
  Negative Mycology



2

4
3
 2 *
3



0

1
1
1
1



2

8
4
1*
5



0

0
0
0
0

History

There is currently no drug history available for this drug.

Other Information

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(1H)-pyridone, with the molecular formula C12H17NO2 and a molecular weight of 207.27. The CAS Registry Number is [29342-05-0]. The chemical structure is:

Ciclopirox Chemical Structure

Ciclopirox Solution Manufacturers


  • Harris Pharmaceutical, Inc.
    Ciclopirox Solution [Harris Pharmaceutical, Inc.]
  • Rebel Distributors Corp.
    Ciclopirox Solution [Rebel Distributors Corp.]
  • Physicians Total Care, Inc.
    Ciclopirox Solution [Physicians Total Care, Inc.]
  • Sandoz
    Ciclopirox Solution [Sandoz]
  • Versapharm Incorporated
    Ciclopirox Solution [Versapharm Incorporated]
  • Perrigo New York Inc
    Ciclopirox Solution [Perrigo New York Inc]
  • Hi-tech Pharmacal Co., Inc.
    Ciclopirox Solution [Hi-tech Pharmacal Co., Inc.]

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